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Medtronic Receives US Approval for InPen App with Missed Meal Dose Detection
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US-Irish firm Medtronic (NYSE: MDT) has announced US market approval for its new InPen app, which features missed meal dose detection. This innovation marks a significant step in the launch of Medtronic’s Smart MDI system, integrated with the Simplera continuous glucose monitor (CGM). InPen App: A Pioneer in Real-Time Insulin…
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NMPA Approves Alpha Biopharma’s Zorifertinib for First-Line NSCLC Treatment with CNS Metastases
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The National Medical Products Administration (NMPA) has granted approval to China-based Alpha Biopharma’s zorifertinib, commercially known as Zorifer, for the treatment of first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation and central nervous…
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Pfizer’s Hympavzi Receives European Commission Approval for Hemophilia A and B
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US pharmaceutical major Pfizer Inc. (NYSE: PFE) has announced that the European Commission (EC) has granted approval for its drug Hympavzi (marstacimab-hncq) for the routine prophylaxis of bleeding episodes in patients aged 12 years and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency,…
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UCB’s Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa
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Belgium-based biopharmaceutical company UCB (FRA: UNC) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody. The FDA has approved Bimzelx for the treatment of adults with moderate to severe hidradenitis suppurativa…
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New Horizon Health Registers Three Medical Devices in Hong Kong’s Department of Health
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Hangzhou-based New Horizon Health Ltd (HKG: 6606) has announced the successful registration of three of its medical products with the Department of Health in the Hong Kong Special Administrative Region, facilitated through the Medical Device Administrative Control System (MDACS). This development marks a significant expansion of the company’s reach and…
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Biogen and Samsung Bioepis Win EC Approval for Opuviz Biosimilar in Europe
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US-based Biogen Inc. (NASDAQ: BIIB) and South Korea’s Samsung Bioepis Co., Ltd. have jointly announced that they have received marketing approval from the European Commission (EC) for their Opuviz 40 mg/mL solution for injection in a vial. This biosimilar product, a version of Bayer/Regeneron’s Eylea (aflibercept), is now approved for…
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AbbVie’s Elahere Receives EC Approval for FRα-Positive Ovarian Cancer Treatment
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US-based AbbVie (NYSE: ABBV) has announced the European Commission (EC) approval for its antibody drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. This approval marks Elahere as the first and…
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Everest Medicines’ Nefecon Receives Full Approval from South Korea’s MFDS for IgAN Treatment
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China-based Everest Medicines (HKG: 1952) has announced that it has received full approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for its Nefecon (targeted-release budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who have a urine protein excretion of ≥1.0 g/day…
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Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
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Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from the European Commission (EC) for its biosimilar of Bayer/Regeneron’s (ETR: BAYN / NASDAQ: REGN) Eylea (aflibercept). The product is now available in the form of a 2 mg vial kit and pre-filled syringe for intravitreal…
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Shanghai Junshi Biosciences’ Toripalimab Wins UK Approval for Nasopharyngeal and Oesophageal Cancers
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its PD-1 inhibitor, toripalimab, marketed as Loqtorzi. This approval allows the use of toripalimab in…
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GE Healthcare’s SIGNA MAGNUS MRI Scanner Receives FDA 510(k) Clearance
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US medical device and life sciences leader GE Healthcare Technologies Inc. (NASDAQ: GEHC) has announced the receipt of FDA 510(k) clearance for its innovative SIGNA MAGNUS, a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner. This clearance marks a significant advancement in medical imaging technology, offering new capabilities for the…
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Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced the receipt of supplementary Biologic License Application (sBLA) approval from the National Medical Products Administration (NMPA) for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows Vygart Hytrulo to be…
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Cutia Therapeutics’ CU-10201 Receives NMPA Approval for Acne Vulgaris Treatment
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Cutia Therapeutics (HKG: 2487), a developer of dermatology therapies, has announced that its CU-10201, a 4% minocycline foam agent for external use, has received market approval from the National Medical Products Administration (NMPA) in China. The approval is for the treatment of non-nodular moderate to severe acne vulgaris in individuals…
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Sino Medical Sciences Technology Secures Marketing Approval in Peru for HT Supreme Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical technology company, has announced that it has received marketing approval in Peru for its HT Supreme drug-eluting stent system. This approval allows the use of the system to improve the diameter of the coronary artery lumen in symptomatic heart…
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Sino Biopharmaceutical Ltd Receives NMPA Approval for KRAS G12C Inhibitor Garsorasib
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company in China, has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for garsorasib (D-1553), a KRAS G12C inhibitor co-developed with InventisBio (Shanghai) Co., Ltd. The drug is indicated for the treatment of patients with…
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Johnson & Johnson MedTech’s Varipulse Platform Receives FDA Approval for Atrial Fibrillation Treatment
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Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Varipulse platform, marking a significant advancement in the treatment of drug refractory paroxysmal atrial fibrillation (AFib). The Varipulse platform is the company’s first pulsed field…
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Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System
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Germany-based Bayer AG (ETR: BAYN) has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MEDRAD Centargo CT Injection System. This innovative multi-patient injector is designed to enhance workflow efficiency and integrates seamlessly with Bayer’s existing portfolio of products, particularly in high-volume…
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Pfizer’s Talzenna (talazoparib) Approved by China’s NMPA for mCRPC Treatment
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The National Medical Products Administration (NMPA) website has indicated that Pfizer’s (NYSE: PFE) marketing filing for Talzenna (talazoparib) has been approved, clearing the way for the poly ADP-ribose polymerase (PARP) inhibitor to treat metastatic castration-resistant prostate cancer (mCRPC) in China. Talazoparib’s Global Approvals and IndicationsTalazoparib received approval in the US…
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Sanofi’s Dupixent Gains EMA Approval for Eosinophilic Esophagitis in Children
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from the European Medicines Agency (EMA) for its drug Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged one to 11 years who weigh at least 15 kg. The approval covers patients who are inadequately…
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Amgen’s Tavneos Receives NMPA Approval for ANCA-Associated Vasculitis Treatment in China
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US biotechnology company Amgen (NASDAQ: AMGN) has announced that it has received market approval in China for its drug Tavneos (avacopan). The National Medical Products Administration (NMPA) has approved Tavneos for use as adjuvant therapy in adults with severe and active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, specifically granulomatous polyangitis…
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Changchun High & New Technology Industries Receives NMPA Approval for Long-Acting Somatropin
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Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading China-based company, has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its polyethylene glycol recombinant human somatropin, a long-acting somatropin, for the treatment of idiopathic short stature (ISS). Understanding Idiopathic…
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Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab), named SaiLeXin. This development marks a significant step forward…
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China Medical System’s Opzelura Approved in Hong Kong for Non-segmental Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that the market filing for its Opzelura (ruxolitinib) cream has been approved in Hong Kong. This topical Janus kinase (JAK) inhibitor is now approved for use as a local treatment for non-segmental vitiligo in patients aged 12 years and above, expanding…
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Asieris Pharmaceuticals Receives NMPA Approval for Hexvix (APL-1706) in Bladder Cancer Diagnosis
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced that the National Medical Products Administration (NMPA) has approved a marketing filing for its product Hexvix (APL-1706), which is used in the diagnosis and management of bladder cancer. Product Approval and ImpactThe approval of Hexvix by the NMPA marks a…
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BMS’s Opdivo Secures NMPA Approval for Urothelial Carcinoma Treatment
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with cisplatin and gemcitabine. This approval is for a first-line treatment of unresectable or metastatic urothelial carcinoma (UC). The Opdivo/chemo…
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Shanghai HeartCare Medical Technology Receives NMPA Approval for Embolization Stent
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China’s National Medical Products Administration (NMPA) has granted marketing approval to Shanghai HeartCare Medical Technology Co., Ltd (HKG: 6609) for its innovative intracranial aneurysm embolization assisted stent. This product is now cleared for use in clinical standard interventional surgical settings for intravascular embolization and blood flow reconstruction in patients diagnosed…
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NMPA Grants Marketing License to Abonisi Medical Technology’s Knee Joint Prosthesis System
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China’s National Medical Products Administration (NMPA) has issued a marketing license to Abonisi Medical Technology (Suzhou) Co., Ltd. for its knee joint prosthesis system, a significant advancement for domestic medical device innovation. Innovative Design of the Knee Joint Prosthesis SystemThe knee joint prosthesis system, designed for first-time knee replacement surgery…
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Suzhou Basecare Medical’s BKA210 Receives Marketing Approval in Jiangsu Province
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China-based in vitro fertilization (IVF) specialist Suzhou Basecare Medical Co., Ltd (HKG: 2170) has announced that it has received marketing approval for its intelligent sperm quality analyzer, BKA210, in Jiangsu province. This marks the world’s first device capable of detecting unstained live sperm, offering a significant advancement in the field…
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Humanwell Healthcare Receives NMPA Approval for Compound Sodium Lactate Ringer’s Injection
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has received approval from the National Medical Products Administration (NMPA) for the registration of its compound sodium lactate Ringer’s injection. The product, classified as a Class 3 chemical drug, has been granted marketing approval and is considered to have passed consistency evaluation. The…
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CStone Pharmaceuticals’ Sugemalimab Wins UK Approval for NSCLC Treatment
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China-based CStone Pharmaceuticals (HKG: 2616) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for sugemalimab, in combination with platinum-based chemotherapy, as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This…
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AbbVie’s Allergan Aesthetics Launches Juvéderm VOLUX in China
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced the official market launch of its Juvéderm VOLUX dermal filler product in China. Juvéderm VOLUX is a hyaluronic acid-based product specifically designed for contouring the lower jaw area. It is used for injection onto the facial periosteum to enhance the…
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Acotec Secures NMPA Approval for Acotrace Disposable Catheter Sheath
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Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received marketing approval from the National Medical Products Administration (NMPA) for its Acotrace, a disposable catheter sheath group. The Acotrace is designed for the insertion of medical devices, including guide wires and catheters, into blood vessels, facilitating percutaneous puncture access…
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Novartis Secures FDA Accelerated Approval for Scemblix in Newly Diagnosed CML Patients
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Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its drug Scemblix (asciminib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). This accelerated approval is supported by the…
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Xi’an Xintong Pharma’s Pradefavir Wins NMPA Nod for Chronic Hepatitis B Treatment
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The National Medical Products Administration (NMPA) has granted market approval for pradefavir, a Category 1 drug developed by Xi’an Xintong Pharmaceutical Research Co., Ltd., for the treatment of adult chronic hepatitis B virus (HBV) infection under the trade name XinShuMu. Pradefavir, a nucleoside liver-targeting drug, functions by inhibiting HBV DNA…
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Eli Lilly’s Mounjaro Approved in Hong Kong for Obesity and Type 2 Diabetes Treatment
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Eli Lilly & Co. (NYSE: LLY) has received market approval from Hong Kong’s Department of Health for its Mounjaro (tirzepatide) in KwikPen presentation, marking a significant step in the treatment of weight management and type 2 diabetes. Mounjaro is indicated for adults with obesity (BMI of 30 kg/m^2 or greater)…
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Merck’s Keytruda Gains Two Additional EU Indications for Gynecologic Cancer Treatment
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Merck, Sharp & Dohme Inc., known as MSD (NYSE: MRK), has received two additional indication approvals from the European Union for its immunotherapy drug Keytruda (pembrolizumab), increasing the total number of approved uses in the region to 30. The PD-1 inhibitor is now approved for use in combination with carboplatin…
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AstraZeneca’s Fasenra Approved by EU for Eosinophilic Granulomatosis Treatment
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UK pharmaceutical giant AstraZeneca Inc. (NASDAQ: AZN) has received marketing approval from the European Commission for its drug Fasenra (benralizumab) as an additional treatment for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The approval follows the successful outcomes of the MANDARA Phase III trial, marking…
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AstraZeneca’s Zoladex Receives NMPA Approval for Higher Dosage Form in Breast Cancer Treatment
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AstraZeneca Inc., (AZ, NASDAQ: AZN), a UK-based pharmaceutical giant, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Zoladex (goserelin sustain-released implant) 10.8mg. This new dosage form is intended for use in premenopausal and perimenopausal women with breast cancer who can be…
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Wantai Biological’s P85 Ab Detection Kit Receives NMPA Approval for Nasopharyngeal Carcinoma Screening
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a Chinese pharmaceutical company, announced last week that it has received marketing approval from the National Medical Products Administration for its EB virus BNLF2b antibody (P85 Ab) detection kit, which utilizes the magnetic particle chemiluminescence method. This product is a collaborative…
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Zhuhai Beihai Biotech’s Beizary Receives FDA Clearance for Multiple Cancer Indications
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Zhuhai Beihai Biotech Co., Ltd has announced that it has received marketing clearance from the US Food and Drug Administration (FDA) for its in-house developed drug, Beizary, a modified version of docetaxel, which is indicated for the treatment of various cancers including breast cancer, non-small cell lung cancer, head and…
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Chongqing Zhifei Biological’s Influenza Vaccine Application Accepted by China’s Drug Evaluation Center
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On October 24, 2024, the Center for Drug Evaluation of the National Medical Products Administration indicated that the influenza virus split vaccine marketing application from Chongqing Zhifei Biological Products Co., Ltd. (SHE: 300122)’s wholly-owned subsidiary, Zhifei Longkoma, has been accepted, with the acceptance number CXSS2400114. Currently, Chongqing Zhifei Biological has…
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Eli Lilly’s Alzheimer’s Drug Kisunla Secures Marketing Approval in Great Britain
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Eli Lilly & Co. (NYSE: LLY) has announced that it has received marketing approval in Great Britain for Kisunla (donanemab), an Alzheimer’s disease (AD) treatment. Kisunla is an intravenous infusion administered every four weeks to eligible adults with mild cognitive impairment and mild dementia due to AD. Eligibility is restricted…
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Sino Medical Sciences Technology Secures Marketing Approval for Coronary Balloon Dilation Catheter in Morocco
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Sino Medical Sciences Technology Inc., (SHA: 688108) a China-based medical device company, has announced that it has received marketing approval in Morocco for its SC HONKYTONK coronary balloon dilation catheter. This product, designed for balloon catheter dilation of narrowed segments or bridging sites in coronary arteries to enhance myocardial perfusion,…
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China Grand Pharmaceutical Receives NMPA Approval for Innovative Adjustable Thrombectomy Stent
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China Grand Pharmaceutical and Healthcare Holdings Ltd (CGP; HKG: 0512) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its adjustable intracranial thrombectomy stent, marking a significant milestone as the first domestically produced device of its kind in China for the treatment of…
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Walvax Biotechnology’s Weuphoria Vaccine Approved in Oman for Pediatric Pneumococcal Infections
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Walvax Biotechnology Co., Ltd (SHE: 300142), a Chinese biopharmaceutical company, has announced that it has received market approval in the Sultanate of Oman for its vaccine Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine (PCV-13). This approval marks a significant step for the company as it expands the reach of its…
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German Endoscope Maker KARL STORZ Secures Marketing Approval for Disposable Ureteroscope in China
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KARL STORZ SE & Co. KG, a leading German endoscope manufacturer, has announced that it has received marketing approval in China for its FLEX-XC1, a disposable electronic ureteroscope. This new product employs cutting-edge imaging technology to offer a broader field of view, ensuring ample brightness and detailed visibility of the…
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Thermo Fisher’s Oncomine Dx Target Test Gets FDA Green Light as Companion Diagnostic for Servier’s Voranigo
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US pharmaceutical and biotechnology company Thermo Fisher Scientific (NYSE: TMO) has received marketing approval from the US Food and Drug Administration (FDA) for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets. Voranigo, the first…
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Johnson & Johnson’s Akeega Approved in China as First Dual Action Tablet for mCRPC
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Johnson & Johnson (J&J, NYSE: JNJ), a leading US pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has granted indication approval for Akeega (niraparib and abiraterone acetate), to be taken with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2…
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Everest Medicines’ Nefecon Approved in Taiwan for Primary IgAN Treatment
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that it has received market approval from the Taiwan Food and Drug Administration for its targeted-release budesonide, Nefecon, for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. This approval allows for the use…
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BeiGene’s Tevimbra Approved in China for NSCLC Patients as Neoadjuvant and Adjuvant Therapy
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has announced that it has received market approval in China for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The National Medical Products Administration (NMPA) has granted approval for tislelizumab in combination with platinum-containing chemotherapy as both neoadjuvant…
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Novo Nordisk’s Alhemo Receives CHMP Recommendation for Haemophilia Prophylaxis in Europe
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Novo Nordisk (NYSE: NVO), a Danish pharmaceutical company, has been notified that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Alhemo (concizumab). This would make Alhemo the first once-daily subcutaneous prophylactic treatment for individuals aged 12 years or…
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Novartis’s Kisqali Receives Positive CHMP Opinion for Early Breast Cancer Treatment in the EU
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Kisqali (ribociclib), a CDK4/6 inhibitor, for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth…
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Astellas Pharma’s Vyloy Receives FDA Approval for Gastric Cancer Treatment in CLDN18.2 Positive Tumors
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Astellas Pharma Inc. (TYO: 4503), a Japanese pharmaceutical company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its drug Vyloy (zolbetuximab-clzb). The approval is for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally…
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MicroPort Sorim CRM’s PLATINIUM Series ICD Receives NMPA Approval, A First for China
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MicroPort Sorim CRM, a Chinese medical device company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its PLATINIUM series implantable cardioverter defibrillator (ICD). This marks a significant milestone as the PLATINIUM series becomes the first domestically developed ICD in China. The approved…
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MicroPort NeuroTech’s NUMEN Silk Receives FDA Approval for Embolization Treatment
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MicroPort NeuroTech Limited (HKG: 2172), a Chinese medical device company, has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its product NUMEN Silk, a spring coil embolization system that marks its first international approval. This milestone follows the initial approval of the…
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Astellas Pharma’s Vyloy Receives FDA Approval for CLDN18.2 Positive Gastric Cancer Treatment
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Astellas Pharma (TYO: 4503) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Claudin18.2 (CLDN18.2) targeting antibody Vyloy (zolbetuximab) in combination with a fluoropyrimidine- and platinum-based chemotherapy regimen for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative gastric or…
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MicroPort CardioFlow’s Heart Valve Balloon Dilatation Catheter Alwide Plus Gains Mexican Approval
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MicroPort Scientific Corp., a leading Chinese medical device company (HKG: 0853), through its spin-off MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has announced that it has received market approval for its heart valve balloon dilatation catheter, Alwide Plus, from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) in…
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Changshan Biochemical Pharmaceutical Wins Marketing Approval for Enoxaparin in Niger
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received marketing approval for its enoxaparin in Niger. This development marks an important step for Changshan Bio as it expands the international reach of its pharmaceutical products. Changshan Bio’s enoxaparin is a…
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Huahai Pharmaceutical Gets FDA Nod for Generic Empagliflozin and Metformin ANDA
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a prominent Chinese pharmaceutical company, has announced the receipt of Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim’s (BI) empagliflozin and metformin combination therapy. This therapy was originally approved in…
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Antengene’s Xpovio Secures Expanded Access in South Korea for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a China-based biopharmaceutical company, has announced that it has received an additional supplementary New Drug Application (sNDA) approval from the National Health Insurance Service (NHIS) of South Korea for its drug Xpovio (selinexor). This marks Xpovio as the world’s first and only FDA-approved oral XPO1…
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AbbVie’s Vyalev Wins FDA Approval as First Subcutaneous Levodopa Therapy for Advanced Parkinson’s
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AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the US, has received approval from the US Food and Drug Administration (FDA) for its drug Vyalev (ABBV-951, foscarbidopa and foslevodopa). Vyalev is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). This approval positions Vyalev…
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Chongqing Zhifei Biological’s EC Injection Receives Market Approval in Indonesia
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Chongqing Zhifei Biological Co., Ltd (SHE: 300122), a leading biopharmaceutical company based in China, has announced that it has received market approval in Indonesia for its in-house developed Category 1 drug, the recombinant Mycobacterium tuberculosis fusion protein (EC) injection. This development marks an important milestone for the company as it…
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Novocure’s Optune Lua Wins FDA Approval for mNSCLC Treatment in Combination with Immunotherapies
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Novocure (NASDAQ: NVCR), a Swiss firm renowned for its pioneering Tumor Treating Fields (TTFields) cancer therapy, has received marketing approval from the US Food and Drug Administration (FDA) for its Optune Lua device. This portable device is now cleared for use in combination with PD-1/PD-L1 inhibitors or docetaxel to treat…
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Shanghai Junshi Biosciences’ Toripalimab Wins Marketing Approvals in India and Hong Kong for Nasopharyngeal Carcinoma
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biotech company based in China, has announced that it has received marketing approvals in India and Hong Kong for its drug toripalimab, used for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The drug will be marketed under…
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Lepu Medical Receives Approval for Noninvasive Blood Glucose Meter NeoGlu 01 in China
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions in China, has announced that it has received marketing approval from the National Medical Products Administration for its innovative product, NeoGlu 01, a noninvasive blood glucose meter. This new device combines optical and thermal methods…
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Roche’s Vabysmo Receives NMPA Approval for Macular Edema Treatments in China
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval from the National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab). The new indication is for macular edema secondary to central retinal vein occlusion (CRVO) or hemi-retinal vein occlusion (HRVO). Vabysmo,…
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Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
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Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
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AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
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AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2)…
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BMS’s Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China
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On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products Administration (NMPA) of China has approved a new indication for its dual immune combination therapy, Opdivo (nivolumab) and Yervoy (ipilimumab), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or deficient…
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Junshi Biosciences’ Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment
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Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for…
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Pfizer’s Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B
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Pfizer Inc. (NYSE: PFE) has scored a significant win with the US Food and Drug Administration’s (FDA) approval of its drug Hympavzi (marstacimab-hncq) for routine prophylaxis in adults and pediatric patients aged 12 and older with hemophilia A, characterized by a congenital deficiency of factor VIII (FVIII), or hemophilia B,…
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Roche’s Genentech Scores FDA Approval for Itovebi in Advanced Breast Cancer Treatment, Advancing Personalized Oncology
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Roche (SWX: ROG)’s Genentech, a leader in pharmaceutical innovation, has received approval from the US Food and Drug Administration (FDA) for Itovebi (inavolisib), a potent PI3Kα inhibitor. This marks a significant advancement in the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
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Jiangsu Hengrui Secures FDA Nod for Generic Abraxane, Strengthening Oncology Portfolio
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has achieved a first in the US market with the FDA’s approval of its Abbreviated New Drug Application (ANDA) for a generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). This marks a significant milestone for the Chinese pharmaceutical firm, which now leads in…
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Roche’s VENTANA CLDN18 Assay Receives EU Approval, Enhances Targeted Therapy Options for Gastric Cancer
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Roche (SWX: ROG; OTCMKTS: RHHBY) has secured CE Mark approval in the European Union for its VENTANA CLDN18 (43-14A) RxDx Assay, marking a pivotal advancement in the treatment landscape for gastric cancer. This immunohistochemistry (IHC) companion diagnostic (CDx) test is the first to determine CLDN18 protein expression in tumors of…
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Sunvozertinib’s Companion Diagnostic Gets NMPA Nod, Fortifying Targeted Therapy Arsenal for NSCLC in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib,…
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Sino Medical Sciences Secures NMPA Nod for Balloon Guided Catheter to Aid Vascular Procedures
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its balloon guided catheter. The device is designed to assist in the insertion of intravascular catheters and guide them into the target vessel within the peripheral…
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Biogen’s China Unit Gets Conditional NMPA Nod for Qalsody (Tofersen) in ALS Treatment
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Biogen (NASDAQ: BIIB)’s Chinese subsidiary has announced that it has received conditional approval from the National Medical Products Administration (NMPA) for its drug Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) who have a superoxide dismutase 1 (SOD1) gene mutation. ALS is a rare disease,…
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Joincare Pharmaceutical Secures NMPA Approval for Triptorelin Microspheres to Treat Endometriosis
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received another market approval from the National Medical Products Administration (NMPA) for its triptorelin microspheres, now indicated for the treatment of endometriosis. Triptorelin microspheres are an in-house developed long-acting formulation administered via monthly intramuscular injection as…
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CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). CSPC Pharma’s biosimilar product is described as the first omalizumab biosimilar developed…
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Jiangsu Aidea Pharmaceutical Secures NMPA Approval for Expanded Indication of Fubangde in HIV Treatment
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has approved an additional indication filing for its HIV treatment Fubangde (ainuovirine, lamivudine, tenofovir disoproxil). The new indication targets two groups of adults infected with human immunodeficiency virus type 1 (HIV-1) weighing over…
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MicroPort Endovascular MedTech’s Fiber Wool Plug Spring Coil Gains NMPA Marketing Approval
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) has received marketing approval from the National Medical Products Administration (NMPA) for its fiber wool plug spring coil, a device used for the filling treatment of peripheral vascular aneurysms, arteriovenous malformations, and arteriovenous fistulas. The spring coil is constructed from a platinum…
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BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
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The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS, NYSE: BMY) Opdivo (nivolumab) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC), followed by Opdivo as an adjuvant treatment post-surgery. This decision…
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LenoMed Medical’s Touch-Insulin Pump Receives NMPA Approval, Aids China’s Diabetes Management
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Shanghai-based LenoMed Medical, a medical device platform company backed by Legend Capital and Legend Star, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed touch-insulin pump. This product, which boasts an infusion accuracy of 0.01U per hour, is lauded as…
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Qilu Pharmaceutical’s QL1706 Receives NMPA Conditional Approval for Cervical Cancer Treatment
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab and tuvonralimab, has received conditional marketing approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer. QL1706 (PSB205), originally developed by the U.S. biotech Qilu Puget Sound Biotherapeutic…
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AstraZeneca’s Tagrisso Secures FDA Approval for Unresectable Stage III EGFRm NSCLC
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AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received a new indication approval from the US Food and Drug Administration (FDA) for its non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The FDA has approved Tagrisso for the treatment of adult patients with unresectable,…
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Sansure Biotech’s HPV Detection Kit Receives NMPA Approval for Comprehensive Screening
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Sansure Biotech Inc., a molecular diagnostics specialist based in China and listed on the Shanghai Stock Exchange (SHA: 688289), has announced that it has received marketing approval from the National Medical Products Administration for its human papillomavirus (HPV) nucleic acid detection kit. This kit, which uses the PCR fluorescent probe…
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Sino Biopharmaceutical Receives NMPA Approval for Rivastigmine Patch for Mild-to-Moderate Alzheimer’s
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its rivastigmine transdermal patch. This new treatment is intended for the management of symptoms associated with mild-to-moderate Alzheimer’s disease (AD). Rivastigmine, classified…
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Shanghai Haihe Pharmaceutical’s Oral Paclitaxel RMX3001 Wins NMPA Nod for Advanced Gastric Cancer
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Shanghai Haihe Pharmaceutical Co., Ltd from China and its South Korean partner Daehwa Pharmaceutical have received approval from the National Medical Products Administration (NMPA) for their co-developed paclitaxel oral solution RMX3001. This new drug is intended for use in patients with advanced gastric cancer who have experienced disease progression during…
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Eli Lilly’s Kisunla Secures Market Approval in Japan for Early Symptomatic Alzheimer’s
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Eli Lilly & Co. (NYSE: LLY) has announced that its Alzheimer’s disease (AD) treatment, Kisunla (donanemab), has been granted market approval in Japan. The drug is indicated for adults with early symptomatic AD, including those with mild cognitive impairment (MCI) and/or mild dementia stage, who have confirmed amyloid pathology. Kisunla…
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Amgen’s Tepezza Receives Approval in Japan for Treating Thyroid Eye Disease
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Amgen (NASDAQ: AMGN), a prominent biotechnology company based in the U.S., has announced that its drug Tepezza (teprotumumab, genetical recombination) has received market approval in Japan. The country’s Ministry of Health, Labour, and Welfare (MHLW) has authorized the medication for treating active or high clinical activity score (CAS) thyroid eye…
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Junshi Biosciences’ Toripalimab Secures EC Nod for Two Cancer Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received two indication approvals from the European Commission (EC) for its PD-1 inhibitor, Loqtorzi (toripalimab). This marks a significant expansion of the drug’s utility in the European Union, where it can now be used in combination…
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Huadong Medicine’s V20 Device Receives NMPA Approval for Market Launch
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category III medical device, V20. The V20 is an intense pulsed light radiofrequency therapy device designed for various dermatological treatments. The V20 therapeutic…
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UCB’s Bimzelx Gains FDA Approval for Three Additional Autoimmune Indications
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Belgium-based biopharmaceutical company UCB has announced that the US Food and Drug Administration (FDA) has granted approval for Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody, in three new indications. The FDA’s approval expands the use of Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic…
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Antengene’s Xpovio Receives NDA Approval in Thailand for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory…
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Hainan Province Approves Heart-Lung Walking Test Analysis Software as Category II Device
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The Hainan Medical Products Administration has granted marketing approval to a heart-lung walking test data analysis software following a priority review process. This digital therapy product, classified as a Category II medical device, is designed to assist healthcare professionals in evaluating patients’ exercise cardiopulmonary function, excluding automatic diagnosis. The approval…
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Sanofi’s Sarclisa Secures FDA Approval for First-Line Multiple Myeloma Treatment
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Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
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Lee’s Pharmaceutical’s Zhaoke Ophthalmology Receives NMPA Approval for Generic Lumigan
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its generic version of Allergan’s (NYSE: AGN) Lumigan (bimatoprost), a treatment for glaucoma. The product, marketed under the Chinese trade…
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Ocumension Therapeutics’ Zerviate Receives Marketing Approval in China for Allergic Conjunctivitis Treatment
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Ocumension Therapeutics (HKG: 1477), a leading ophthalmology specialist in China, has announced that its histamine H1 receptor-targeted drug Zerviate (OT-1001) has been granted marketing approval in China with priority review status. The drug is indicated for the treatment of itching symptoms associated with allergic conjunctivitis. Zerviate, originally developed by the…
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MSD’s Keytruda Secures FDA Approval for First-Line Mesothelioma Treatment in Combination with Chemotherapy
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab). The approval allows for the use of Keytruda in combination with pemetrexed and platinum chemotherapy as a first-line treatment…
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AstraZeneca’s Fasenra Secures FDA Nod for EGPA Treatment, Strengthening Rare Disease Portfolio
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UK pharmaceutical giant AstraZeneca (NASDAQ: AZN, LON: AZN) has announced that the US Food and Drug Administration (FDA) has approved a new indication for its interleukin-5 (IL-5)-targeted antibody, Fasenra (benralizumab), for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and potentially fatal disease. The approval comes on the…
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BeiGene’s Tislelizumab Receives Israeli Nod for Oesophageal Cancer Treatment
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China-based biotech firm BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has been granted market approval in Israel for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The Israeli Ministry of Health has approved Tevimbra for use as a monotherapy second-line treatment for adult patients with unresectable or metastatic oesophageal squamous…
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MicroPort Scientific’s Firesorb Bioabsorbable Stent Begins Clinical Use in China
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MicroPort Scientific Corp., a leading medical device company based in Shanghai (HKG: 0853), has announced the initial clinical applications of its new-generation bioabsorbable stent, Firesorb, across seven clinical centers in five Chinese cities. The product received marketing approval in China in July this year. Firesorb is a bioabsorbable rapamycin targeted…
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Merck’s Keytruda Gains Expanded Approval for First-Line Melanoma Treatment in China
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Merck & Co., Inc. (NYSE: MRK), a leading US pharmaceutical company, has announced that its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab), has received expanded approval in China. The updated approval allows the drug’s package insert to be revised to include “pembrolizumab is suitable for the treatment of unresectable or metastatic…
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Novartis’ Cemiplimab Approved in China for Moderate-to-Severe Atopic Dermatitis
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Novartis (SWX: NOVN, NYSE: NVS)’s Chinese arm has announced that it has received approval from the National Medical Products Administration (NMPA) for its drug candidate, cemiplimab, to be used in the treatment of adults and children aged 12 and over with moderate-to-severe atopic dermatitis (AD). The drug, known as cemiplimab…
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Lilly’s Once-Monthly Atopic Dermatitis Treatment Ebglyss Gets Green Light from FDA
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Eli Lilly & Co. (NYSE: LLY) has announced that it has received market approval from the US Food and Drug Administration (FDA) for Ebglyss (lebrikizumab), a new treatment for adults and children aged 12 years and over suffering from moderate-to-severe atopic dermatitis (AD). Ebglyss is an interleukin-13 (IL-13) inhibitor that…
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Keymed Biosciences’ IL-4Rα mAb Stapokibart Receives NMPA Approval for Atopic Dermatitis Treatment
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Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a market filing for its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), for the treatment of moderate to severe atopic dermatitis (AD). This marks a significant milestone…
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Siemens Healthineers’ 7T MRI System Terra. X Receives NMPA Marketing Approval
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Siemens Healthineers AG has secured marketing approval from China’s National Medical Products Administration (NMPA) for its Magnetom Terra X, a localized next-generation 7T magnetic resonance imaging (MRI) system. This marks a significant advancement in medical imaging technology within the Chinese market. Terra. X, the first domestically produced 7T clinical MRI…
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Medtronic Secures China Market Approval for Pulsed Electric Field Atrial Fibrillation Treatment Devices
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Medtronic (NYSE: MDT), the US-Irish medical technology giant, has announced that it has received approvals from Chinese regulatory authorities for its innovative heart pulse electric field ablation device and disposable heart pulse electric field ablation catheter. These products, when used in tandem, employ the non-thermal effects of pulsed electric fields…
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CIRC’s Subsidiary HTA Co., Ltd. Secures NMPA Approval for Sodium Fluoride [18F] for Bone Imaging
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China Isotope & Radiation Corporation’s (CIRC) subsidiary, HTA Co., Ltd. (HKG: 1763), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its sodium fluoride [18F]. This product is primarily utilized in positron emission tomography (PET) to identify areas of altered osteogenic activity in…
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Fosun Pharmaceutical’s Daxxify Receives NMPA Approval for Aesthetic Use in China
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has granted market approval for its product Daxxify (daxibotulinumtoxin, RT002). This type A botulinum toxin is now approved for the temporary improvement of moderate to severe eyebrow wrinkles in adults in…
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Amoy Diagnostics’ AiHuiJie Lung Cancer Companion Diagnostic Receives NMPA Approval
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its AiHuiJie, a companion diagnostic (CDx) reagent designed for lung cancer. This PCR-based product is capable of detecting 11 key driver…
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Genesis MedTech Secures NMPA Approval for Innovative Surgical Energy Products
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Genesis MedTech, a leading medical device company headquartered in Singapore, has secured marketing approvals from China’s National Medical Products Administration (NMPA) for two of its high-frequency electrosurgical energy products: the “OP9 ultrasonic high frequency integrated surgical equipment” and the “disposable cutting and closing knife head.” The OP9 device is a…
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True Health’s Advanced Microwave Ablation System Gains NMPA Nod for Liver Tumor Treatment
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True Health (Guangdong Hengqin) Medical Technology Co., Ltd has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative navigation positioning microwave ablation system. This advanced medical device utilizes CT images to devise a precise needle insertion plan prior to surgery and provides real-time guidance for the…
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Sansure Biotech Wins NMPA Nod for ALDH2 Gene Polymorphism Detection Kit
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Sansure Biotech Inc., (SHA: 688289), a leading molecular diagnostics company based in China, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for its nucleic acid detection kit for the human ALDH2 gene polymorphism, utilizing the PCR fluorescent probe method. The kit is designed…
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Jafron Biomedical’s Blood Purification Devices Gain EU Market Approval Under MDR
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Jafron Biomedical Co., Ltd, a prominent player in the blood purification sector based in China, has announced that its Category III medical devices, the cytokine adsorption column and the disposable blood perfusion device, have secured market approvals within the European Union. This approval is in accordance with the stringent Medical…
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Beijing Balance Medical Secures NMPA Nod for Renatus Transcatheter Aortic Valve System
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BEIJING—Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has received market approval from the National Medical Products Administration (NMPA) for its Renatus transcatheter aortic valve system. This in-house developed product is now approved for use in patients aged 70 years or older who are diagnosed with symptomatic, calcified, and severe…
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Sino Medical Sciences Secures Hong Kong Approval for Coronary Balloon Dilation Catheter
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HONG KONG—Sino Medical Sciences Technology Inc., (SHA: 688108), a leading medical device company based in China, has announced that it has received marketing approval in Hong Kong for its SC HONKYTONK coronary balloon dilation catheter. This approval marks a significant expansion of the product’s reach, as it is already registered…
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Advancing Peripheral Artery Disease Care: Boston Scientific’s JETSTREAM Receives Marketing Nod in China
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NEW YORK—Boston Scientific Corporation (NYSE: BSX), a leading innovator in medical solutions, has secured a significant regulatory milestone with the National Medical Products Administration’s (NMPA) marketing approval for its JETSTREAM vascular plaque rotary cutting system. This development marks a significant step forward in the treatment of peripheral arterial disease (PAD)…
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Jiangxi Jemincare Secures First Generic Approval for GSK’s Requip in China
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Jiangxi Jemincare Group, based in China, has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of GSK’s Requip (ropinirole), marking the first generic approval for this medication in China. The drug is indicated for the treatment of Parkinson’s disease (PD) and PD with non-motor…
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JW Therapeutics’ CAR-T Therapy Carteyva Secures NMPA Approval for Mantle Cell Lymphoma Indication
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JW Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2126), has received additional indication approval from the National Medical Products Administration (NMPA) for its chimeric antigen receptor (CAR) T cell therapy, Carteyva (relmacabtagene autoleucel injection). This approval extends to adult patients with…
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Legend Biotech’s Carvykti Receives NMPA Approval for Relapsed/Refractory Multiple Myeloma After Multi-Center Phase II Study
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Legend Biotech Corporation (NASDAQ: LEGN) has secured a significant milestone with the announcement of marketing approval from China’s National Medical Products Administration (NMPA) for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). This therapy is intended for patients with relapsed/refractory multiple myeloma (MM) who have undergone…
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Jiangsu Hengrui’s Vunakizumab Receives NMPA Approval as First Homegrown Autoimmune IL-17A Drug
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Jiangsu Hengrui Medicine Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 600276), has announced that the National Medical Products Administration (NMPA) has approved its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic…
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Chongqing Genrix Bio Pharmaceutical Receives NMPA Approval for Xeligekimab, First Domestic Anti-IL-17 Antibody
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Chongqing Genrix Bio Pharmaceutical Co., Ltd, a Chinese biopharmaceutical company, has received marketing approval from China’s National Medical Products Administration (NMPA) for its self-developed Category 1 biologic product, xeligekimab. This marks the first domestically developed anti-IL-17 antibody in China approved for the treatment of moderate-to-severe plaque psoriasis. The introduction of…
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Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of adult patients with relapsed or refractory (R/R) follicular…
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Chinese NMPA Grants License to MicroPort Endovascular MedTech’s Venous Stent for Treating Vascular Conditions
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Shanghai MicroPort Endovascular MedTech Co., Ltd, a Chinese endovascular device manufacturer listed on the Shanghai Stock Exchange (SHA: 688016), has received a Category III medical device license from China’s National Medical Products Administration (NMPA) for its venous stent system. This product was granted special review status as an innovative medical…
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Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
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Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 2696), has announced that its UK partner, Accord Healthcare Inc., has received marketing approval from Health Canada. This approval permits the use of Hanquyou (trastuzumab; HLX02), a biosimilar to Roche’s…
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Allgens Medical Technology’s BonGold Receives Marketing Approval from Malaysia’s MDA
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Allgens Medical Technology Co., Ltd, a Beijing-based innovator in regenerative medicine materials and implantable devices listed on the Shanghai Stock Exchange (SHA: 688613), has secured marketing approval from the Medical Device Authority (MDA) of Malaysia for its flagship product, BonGold, an artificial bone repair material. BonGold is a biomimetic mineralized…
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Regeneron’s Linvoseltamab Faces FDA Complete Response Letter, Awaiting Reinspection of Manufacturer
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Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the Nasdaq (NASDAQ: REGN), has encountered a setback in its pursuit of market approval for the bispecific antibody (BsAb) linvoseltamab. The US FDA has issued a Complete Response Letter (CRL) regarding the company’s filing for this…
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Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
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Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1801), has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its drug fulzerasib. This approval grants the company the green light to market fulzerasib, under…
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Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster drug Lucentis (ranibizumab) has received market approval from the National Medical Products Administration (NMPA). This regulatory nod positions the product as the first biosimilar of its kind to be approved in China. Ranibizumab, a vascular…
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J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United States for the combined use of its bispecific antibody Rybrevant (amivantamab) and the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). Following a priority review, the US FDA approved this dual therapy for the first-line treatment of…
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Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
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NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone with the US FDA’s approval of its bispecific antibody Rybrevant (amivantamab) in combination with the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). The priority review has led to a green light for the combined use of…
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MicroPort MedTech’s ReeAmber Catheter Wins NMPA Nod for Peripheral Artery Treatments
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SHANGHAI—Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a leading player in the medical device industry, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its ReeAmber peripheral balloon dilation catheter. This next-generation device is designed to address a broad spectrum of vascular…
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Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
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TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
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China’s NMPA Grants Medical Device License to DaAn Gene’s Monkeypox Detection Kit
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GUANGZHOU—DaAn Gene Co., Ltd, a subsidiary of Sun Yat-sen University based in China (SHE: 002030), has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its Monkeypox virus nucleic acid detection kit, which utilizes the fluorescence PCR method. This development is significant…
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Changchun High & New Technology Secures NMPA Approval for Turner Syndrome Treatment
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CHANGCHUN—Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading biopharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its polyethylene glycol recombinant human somatropin. This long-acting somatropin is now approved for use in growth disorders…
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AstraZeneca’s Fasenra Secures NMPA Approval for Severe Eosinophilic Asthma Maintenance Therapy
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BEIJING—The National Medical Products Administration (NMPA) of China has granted market approval for AstraZeneca (NASDAQ: AZN, LON: AZN) ‘s Fasenra (benralizumab) as a maintenance therapy for severe eosinophilic asthma (SEA) in adults and adolescents aged 12 and above. This decision follows the positive outcomes of the MIRACLE Phase III clinical…
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Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
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COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large…
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Lepu Medical Secures Approval for RECATCHOR Catheter, Enhancing Cardiovascular Procedures
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions in China, has secured marketing approval from the National Medical Products Administration for its innovative RECATCHOR device. This anchored balloon dilation catheter is designed to facilitate the anchoring of guidewires and assist in the exchange…
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Robotrak Secures NMPA License for China’s First Smart Ophthalmic Navigation Laser
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Robotrak, a Nanjing-based ophthalmic innovation platform, has secured a Category III medical device license from the National Medical Products Administration (NMPA) for its cutting-edge smart ophthalmic navigation laser. This marks the first such device of its kind in China. The all-solid-state laser photocoagulation device offers a suite of advanced features,…
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Lepu Scientech Secures NMPA Approval for MemoSORB Biodegradable Atrial Septal Defect Occluder
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd. (HKG: 2291) has announced that it has received a medical device license from China’s National Medical Products Administration (NMPA) for its innovative MemoSORB biodegradable atrial septal defect occluder. This cutting-edge device offers significant advantages over traditional nitinol occluders by markedly reducing inflammatory responses,…
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Sino Medical Secures Moroccan Approvals for NC Rockstar Catheter and HT Supreme Stent System
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Sino Medical Sciences Technology Inc. (SHA: 688108), a prominent player in China’s medical device sector, has secured marketing approvals in Morocco for its NC Rockstar non-compliant coronary artery balloon dilation catheter and the HT Supreme drug-eluting stent system. The NC Rockstar catheter is designed for balloon dilation of autologous coronary…
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Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
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Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2). According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a…
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Biogen and Eisai Secure UAE Approval for Alzheimer’s Therapy Leqembi
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Biogen Inc. (NASDAQ: BIIB), based in the U.S., and Japan’s Eisai Co., Ltd. have announced that their Alzheimer’s disease therapy, Leqembi (lecanemab), has received approval in the United Arab Emirates (UAE) for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and/or mild AD dementia.…
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China’s Sansure Biotech Launches Approved Kit for Alzheimer’s and Cardiovascular Risk Assessment
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Sansure Biotech Inc. (SHA: 688289), a China-based leader in molecular diagnostics, has secured marketing approval from the National Medical Products Administration (NMPA) for its human ApoE gene polymorphism nucleic acid detection kit, utilizing the PCR fluorescent probe method. This kit is classified as a Category III medical device. The detection…
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Qilu Pharmaceutical Gains Approval for Generic Dasatinib, Expanding CML Treatment Options in China
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Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) in China. This second-generation BCR-ABL tyrosine kinase inhibitor (TKI) is now available for the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant to or intolerant…
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Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and Daiichi Sankyo (TYO: 4568), has received conditional approval in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have undergone two or more…
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Lepu Medical’s PeakHeat Vascular Sheath Gains Regulatory Green Light for Market Launch
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions in China, has secured marketing approval from the National Medical Products Administration for its PeakHeat disposable vascular sheath. This innovative product facilitates the percutaneous insertion of vascular systems, enabling the introduction of medical devices such…
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Sihuan Pharmaceutical Secures NMPA Approval for First Biosimilars of Novo Nordisk’s Diabetes Drugs
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Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has secured separate marketing approvals from China’s National Medical Products Administration (NMPA) for its biosimilars of Novo Nordisk (NYSE: NVO)’s Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart), both of which are indicated for the treatment of type 2 diabetes. These…
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Ascendis Pharma’s Hypoparathyroidism Therapy Yorvipath Wins FDA Nod, Fills Market Gap
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This week, the U.S. Food and Drug Administration (FDA) granted market approval to Ascendis Pharma A/S (NASDAQ: ASND), a Denmark-based pharmaceutical company specializing in rare diseases, for its hypoparathyroidism treatment, palopegteriparatide. The therapy, to be marketed as Yorvipath, is a once-daily prodrug of parathyroid hormone (PTH[1-34]) designed to address the…
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Artech Medical’s Balloon Cryoablation Catheter Wins NMPA Nod for Atrial Fibrillation Treatment
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Shanghai Artech Medical Technology Co., Ltd., a company known for its innovation in the medical device sector, has received marketing approval from China’s National Medical Products Administration (NMPA) for its balloon cryoablation catheter, a groundbreaking product designed for the treatment of paroxysmal atrial fibrillation. This novel device marks a significant…
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Chinese NMPA Approves Hengrui Med’s Generic Abraxane for Metastatic Pancreatic Cancer Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). The drug is now approved for use in combination with gemcitabine…
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Guangdong Zhongsheng Pharmaceutical’s COVID-19 Drug Leritrelvir Approved in Macau
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a pharmaceutical company based in China, has announced that it has obtained marketing approval for its drug Yueruiling (leritrelvir) in Macau. The drug, a 3CL protease (3CLpro) inhibitor, is now authorized for use in treating mild to moderate cases of COVID-19. Leritrelvir functions…
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Sansure Biotech’s MTHFR Gene Detection Kit Receives NMPA Approval, Aids in Pregnancy Health Management
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Sansure Biotech Inc. (SHA: 688289), a specialist in molecular diagnostics based in China, has achieved a regulatory milestone with the National Medical Products Administration (NMPA) granting marketing approval for its in-house developed human MTHFR gene polymorphism nucleic acid detection kit, which utilizes the PCR fluorescent probe method. This product is…
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Huadong Medicine Expands Global Footprint with Launch of Aesthetic Injection MaiLi in Singapore
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced the international expansion of its medical aesthetics portfolio with the launch of its high-end aesthetic injection product, MaiLi, in Singapore. This marks another milestone in the company’s global foray into the medical aesthetics sector. MaiLi is a premium…
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Changshan Biochemical Gets Marketing Nod for Enoxaparin in Kyrgyzstan for Venous Thromboembolic Diseases
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received marketing approval in Kyrgyzstan for its enoxaparin products, available in 0.4mL and 0.6mL dosages. Enoxaparin, originally developed by Sanofi, is recognized for its significant efficacy in preventing venous thromboembolic diseases following…
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Vazyme Biotech Secures NMPA Nod for Two RSV Antigen Detection Kits
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Vazyme Biotech Co., Ltd (SHA: 688105), a biotechnology company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for two of its respiratory syncytial virus (RSV) detection kits. The newly approved products include the RSV antigen detection kit utilizing the colloidal…
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Antengene’s Xpovio Receives NDA Approval in Malaysia for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced the approval of its New Drug Application (NDA) for Xpovio (selinexor) in Malaysia. The drug is now approved for use in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (r/r…
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CMS’s Methotrexate Injection Gains NMPA Approval for Active Rheumatoid Arthritis Treatment
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China Medical System Holdings (CMS; HKG: 0867) has received approval from the National Medical Products Administration (NMPA) for an additional indication for its methotrexate injection. The drug is now approved for the treatment of active rheumatoid arthritis (RA) in adults. Methotrexate is internationally recognized as a first-line treatment and cornerstone…
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Takeda’s Vonicog Alfa Receives NMPA Approval for Von Willebrand Disease Treatment in China
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Takeda Pharmaceutical Company Limited (TYO: 4502 / NYSE: TAK), a leading Japanese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for vonicog alfa, a recombinant von Willebrand factor (rVWF), for the on-demand treatment and control of bleeding events in adult patients…
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Sino Medical Sciences’ HT Supreme Drug-Eluting Stent System Gains Market Approval in Mexico
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Sino Medical Sciences Technology Inc. (SHA: 688108), a prominent player in the medical device industry in China, has announced that its HT Supreme drug-eluting stent system has received marketing approval in Mexico. This development marks a significant expansion of the company’s global footprint. The HT Supreme system is a state-of-the-art…
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Roche’s Alzheimer’s Disease Diagnostic Kits Gain Approval in Hainan, Set for Use in Shanghai Ruijin Hospital
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Swiss pharmaceutical and diagnostics giant Roche (SWX: ROG) has received approval from the Hainan Medical Products Administration for its suite of Alzheimer’s disease (AD) cerebrospinal fluid diagnostic kits. The approved products include Elecsys β-Amyloid (1-42) CSF II, Elecsys Phospho Tau (181P) CSF, Elecsys Total Tau CSF detection reagents, along with…
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AbbVie’s Allergan Aesthetics Wins NMPA Approval for Juvéderm Dermal Filler in China
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has secured marketing approval from China’s National Medical Products Administration (NMPA) for its Juvéderm product line, specifically the Juvéderm越致 dermal filler. This crosslinked sodium hyaluronate gel, which includes lidocaine for comfort during treatment, is designed for injection into the middle to deep…
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GSK’s Jemperli Receives EC Approval for Endometrial Cancer Treatment in Combination Therapy
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GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced that the European Commission (EC) has granted a new indication approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab). The approval allows for the use of Jemperli in combination with carboplatin-paclitaxel, a chemotherapy regimen, for the treatment of adult…
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MicroPort Scientific’s Bioabsorbable Stent System Gains NMPA Nod for Ischemic Heart Disease Treatment
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Shanghai-based medical device conglomerate MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its proprietary bioabsorbable rapamycin eluting coronary stent system. This innovative device is designed for the treatment of patients suffering from ischemic heart disease due to…
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Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Receives European Commission Approval
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi (bevacizumab), has received market approval from the European Commission (EC). The approval encompasses all existing indications for Avastin, which include the treatment of a range of cancers such as metastatic colorectal cancer, metastatic breast cancer,…
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Gan & Lee Pharmaceuticals Gains Market Foothold in Algeria with Insulin Product Approvals
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Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company, has announced that it has received registration approval from Algerian authorities for two of its insulin products: the insulin aspart injection pre-filled pen and the insulin aspart 30 injection pre-filled pen. These products are slated to be manufactured locally by…
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MicroPort Scientific’s Fully Biodegradable Cardiac Stent Earns NMPA Nod
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Shanghai-based medical device titan MicroPort Scientific Corp. (HKG: 0853) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its new generation fully biodegradable and absorbable cardiac stent. This innovation marks a significant advancement in the field of interventional cardiology. The stent is the…
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ShuWen Biotech’s Preeclampsia Self-Test Receives NMPA Approval, Marking a Global First
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Zhejiang-based ShuWen Biotech Co., Ltd has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative CercaTest Red, a patented self-test designed for household use by pregnant women to screen for preeclampsia. This marks the first time a self-test of this kind has…
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Shanghai Sanyou Medical Gains NMPA Approval for 3D Printed Cervical Fusion Device
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Shanghai Sanyou Medical Co., Ltd (SHA: 688085), a prominent player in the medical device industry in China, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its innovative 3D printing metal additive manufacturing cervical fusion device. This breakthrough product…
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Luye Pharma’s Antipsychotic Erzofri Gains FDA Nod for Schizophrenia Treatment
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has achieved a significant milestone with the US Food and Drug Administration’s (FDA) marketing approval of its in-house developed antipsychotic medication, Erzofri (paliperidone palmitate extended-release injectable suspension). The approval grants Erzofri the clearance for treatment of schizophrenia and…
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3SBio’s Thrombopoietin Meets Primary Endpoint in Phase III Trial for Chronic Liver Disease Patients
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3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced the successful conclusion of the Phase III TPO106 clinical trial for its thrombopoietin drug in patients with chronic liver disease associated thrombocytopenia who are scheduled for invasive surgery. The trial has met its pre-set primary endpoint, paving the…
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CStone Pharmaceuticals’ Sugemalimab Wins EU Nod as First-Line NSCLC Treatment
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has received marketing approval from the European Commission (EC) for its PD-L1 inhibitor, Cejemly (sugemalimab). The approval covers the drug’s use in combination with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small-cell lung cancer (NSCLC), excluding…
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Beijing Balance Medical Secures NMPA Nod for Pioneering Heart Valve Patch
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198), a leading medical technology firm based in China, has achieved a significant regulatory milestone with the National Medical Products Administration’s (NMPA) approval for its heart valve biological patch. This marks the first market approval for a product specifically designed for the repair…
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MicroPort MedTech’s Aortic Occlusion Catheter Gets Green Light from China’s NMPA
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a leading player in the medical technology sector, has secured a significant regulatory milestone with its aortic occlusion balloon catheter receiving marketing approval from China’s National Medical Products Administration (NMPA). This product, designed for temporary blood flow obstruction in the aorta, marks…
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Zhejiang Haichang Biotech Secures EU Approval for Apexelsin: A New Hope in Cancer Treatment
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Zhejiang Haichang Biotech Co., Ltd, a partner of China-based Kexing Pharmaceutical (SHA: 688136), has secured marketing approval from the European Commission for its biosimilar, Apexelsin. This groundbreaking treatment, which mirrors the quality of BMS/Celgene’s Abraxane (paclitaxel, albumin-bound), is indicated for metastatic breast cancer, metastatic pancreatic cancer, non-small cell lung cancer,…
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Lepu Scientech Secures NMPA Approval for RF Lance, Advancing Atrial Septal Puncture Technology
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Lepu Scientech Medical Technology (Shanghai) Co., Ltd (HKG: 2291), a leading medical technology company based in China, has announced that it has obtained a medical device license from the National Medical Products Administration (NMPA) for its RF Lance, a novel disposable radiofrequency atrial septal puncture needle. This product is designed…
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Amoy Diagnostics’ APACE Receives Japanese Approval as Companion Diagnostic for MET-Inhibiting Therapies
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a Chinese diagnostics company, has announced that it has received two new indication approvals in Japan for its APACE (also known as PCR-11 gene product), a multi-target rapid screening product designed for lung cancer detection. The product is now approved as a companion…
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Novo Nordisk’s Wegovy Approved in the UK to Reduce Cardiovascular Risks in Overweight Adults
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Novo Nordisk (NYSE: NVO)’s anti-obesity drug Wegovy (semaglutide) has received a new indication approval in the United Kingdom, with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granting approval for its use in reducing the risk of serious heart problems or strokes in overweight or obese adults. This marks…
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Hangzhou Jianjia Medical’s Arthbot Surgical Robot Receives NMPA Approval for Orthopedic Procedures
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Hangzhou Jianjia Medical Technology Co., Ltd has received marketing approval from China’s National Medical Products Administration (NMPA) for its Arthrobot surgical robot, a significant step for the company as it looks to enhance precision in orthopedic procedures. The Arthbot is a multifunctional device capable of performing joint replacement surgeries, including…
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RemeGen’s Telitacicept Earns Full NMPA Approval for RA Treatment and PMN Clinical Study Green Light
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RemeGen (HKG: 9995), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted full approval for its drug telitacicept, which is used in combination with methotrexate for the treatment of moderate to severe rheumatoid arthritis (RA) patients who have not responded well to…
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NMPA Approves Chengdu Chipscreen’s Bilessglu for Type 2 Diabetes in Combination with Metformin
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The National Medical Products Administration (NMPA) has granted approval for Chengdu Chipscreen Pharmaceutical Co., Ltd (SHA: 688321)’s Category 1 drug Bilessglu (chiglitazar sodium) for use in combination with metformin to treat type 2 diabetes. This decision marks another milestone for the Chinese pharmaceutical company, which has developed chiglitazar as a…
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Eli Lilly’s Mounjaro Approved by China’s NMPA for Long-Term Weight Management
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Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company in the US, has announced that it has received a new market approval from the National Medical Products Administration (NMPA) in China for its drug Mounjaro (tirzepatide) as a long-term weight management treatment. Administered as a once-weekly injection, Mounjaro is…
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Bain Capital-Backed Tenacia Wins NMPA Approval for Ganaxolone Oral Suspension for CDKL5 Deficiency
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Tenacia, a central nervous system (CNS) specialist company incubated by Bain Capital, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-licensed drug, ganaxolone oral suspension. This medication is indicated for the treatment of epileptic seizures in patients aged 2 years and…
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MicroPort MedTech’s Vepack Filter Retriever Earns NMPA Marketing Approval
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a prominent medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Vepack filter retriever. The Vepack system, comprising a catcher and a sheath/expander, is designed to percutaneously remove…
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Venus Medtech’s VenusP-Valve Receives Marketing Approval in Venezuela, Expanding Global Reach
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Venus Medtech (Hangzhou) Inc., (HKG: 2500), a leading medical device company, has announced that it has received marketing approval for its VenusP-Valve, a transcatheter pulmonary valve replacement (TPVR) system, in Venezuela. This marks another significant milestone for the company, as VenusP-Valve is the first self-expanding TPVR product to be approved…
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Zai Lab and argenx Receive NMPA Approval for Vygart Hytrulo (efgartigimod alfa SC) in gMG
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) and its US partner argenx SE (NASDAQ: ARGX) have announced that China’s National Medical Products Administration (NMPA) has granted Biologic License Application (BLA) approval for Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). Vygart Hytrulo is indicated for use in combination with conventional therapy…
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Shanghai Pharmaceuticals Secures NMPA Nod for Roche’s Valcyte Generic
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Roche’s Valcyte (valganciclovir). Valganciclovir is a crucial medication primarily used to treat cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS)…
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Ipsen S.A. Receives NMPA Green Light for Six-Month Diphereline Dosage in Central Precocious Puberty
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Ipsen S.A. (EPA: IPN; OTCMKTS: IPSEY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its six-month dosage form of Diphereline (triptorelin), a treatment for central precocious puberty (CPP), a condition that leads to early sexual development in children. This makes Diphereline the…
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Shanghai HeartCare Medical Secures Taiwan Approval for Homegrown Femoral Artery Occluder
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Shanghai HeartCare Medical Technology Co., Ltd (HKG: 6609), a leading player in the Chinese medical device industry, has announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its innovative vascular closure device, the first home-grown femoral artery occluder. The device, which was approved…
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Huadong Medicine’s Partner Arcutis Gets FDA Nod for Roflumilast Cream
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, announced that its co-development partner Arcutis Biotherapeutics Inc., (NASDAQ: ARQT), has received approval from the U.S. Food and Drug Administration (FDA) for a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast). This clearance is for treating mild to moderate…
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Eisai and Biogen’s Alzheimer’s Therapy Leqembi Receives Marketing Approval in Hong Kong
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Eisai Co., Ltd, a Japanese pharmaceutical company, along with its co-development partner Biogen Inc. (NASDAQ: BIIB), has announced that they have received marketing approval in Hong Kong for their Alzheimer’s disease (AD) therapy Leqembi (lecanemab). Known as 乐意保 in Chinese, the drug is administered intravenously every two weeks and is…
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Haohai Biotech’s Sodium Hyaluronate Gel Receives NMPA Approval for Aesthetic Treatments
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Shanghai Haohai Biology Science & Technology Co., Ltd (HKG: 6826, SHA: 688366) has announced that it has received Medical Device Registration Approval from the National Medical Products Administration for its innovative amino acid cross-linked sodium hyaluronate gel. The product is indicated for injection into the middle to deep layers of…
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Johnson & Johnson’s Opsumit Faces Generic Competition with Qilu Pharmaceutical’s Entry
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Johnson & Johnson (J&J, NYSE: JNJ)’s pulmonary hypertension treatment, Opsumit (macitentan), is set to encounter intensified competition in China following the approval of a generic version by local pharmaceutical company Qilu Pharmaceutical last month. Macitentan, classified as an endothelin receptor antagonist (ERA), initially received marketing approval in the US in…
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China Isotope & Radiation Corporation Secures NMPA License for Innovative Radiotherapy System
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China Isotope & Radiation Corporation (CIRC; HKG: 1763) has announced that it has received a medical device license from the National Medical Products Administration (NMPA) for its innovative gamma beam stereotactic radiotherapy system. This new system represents a significant advancement in the field of radiation therapy. The product streamlines the…
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Boston Scientific’s FARAPULSE Pulse Field Ablation System Earns NMPA Approval
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Boston Scientific Corporation (NYSE: BSX), a leading medical device company in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its FARAPULSE pulse field ablation system. This system includes the FARAWAVE disposable cardiac pulse field ablation catheter and the FARASTAR cardiac…
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Ascentage Pharma’s Olverembatinib Receives Marketing Approval from Macau SAR for CML Treatment
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Macau Special Administrative Region (SAR) of China for its drug olverembatinib. This novel BCR-ABL1 tyrosine kinase inhibitor (TKI) is indicated for the treatment of adult patients with chronic-phase chronic myeloid…
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Allist Pharmaceuticals Receives NMPA Approval for Phase III Trial of Furmonertinib in EGFR Mutated NSCLC
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Allist Pharmaceuticals Co., Ltd, a Shanghai-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study. The study will assess the efficacy and safety of Allist’s furmonertinib in combination with chemotherapy compared to osimertinib (Tagrisso) in…
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Yantai Dongcheng Pharmaceutical Gets NMPA Approval for ⁹⁹ᵐTc Tetrofosmin Imaging Agent
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its ⁹⁹ᵐTc tetrofosmin, a SPECT myocardial perfusion imaging agent. This radiopharmaceutical drug, which is utilized for myocardial perfusion imaging in…
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Shenzhen Salubris Pharmaceuticals’ Fotagliptin Receives NMPA Approval for Type 2 Diabetes Treatment
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Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug, fotagliptin. This drug is intended to improve blood sugar control in adult patients with type 2 diabetes,…
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Roche’s Alecensa Secures NMPA Approval as Adjuvant Therapy for Early-Stage NSCLC
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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its drug Alecensa (alectinib). This new indication is for use as a post-surgery adjuvant therapy in patients with stage 1B to stage IIIA non-small cell…
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Novo Nordisk’s Esperoct Receives NMPA Approval, First Long-Acting Factor VIII for Hemophilia A in China
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The National Medical Products Administration (NMPA) has granted approval to Novo Nordisk (NYSE: NVO), a Denmark-based pharmaceutical giant, for its drug Esperoct (turoctocog alfa pegol). This marks Esperoct as the first and only long-acting recombinant coagulation factor VIII approved in China for on-demand treatment and control of bleeding events, as…
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PharmaEssentia’s Besremi Receives Approval for Polycythemia Vera Treatment in China
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PharmaEssentia Corporation (TPE: 6446, FRA: 8Z1), a biopharmaceutical company based in Taiwan, has announced that its drug Besremi (ropeginterferon alfa-2b) has been approved by the National Medical Products Administration (NMPA) to treat adult polycythemia vera (PV) in China. This ultra-long-acting interferon, developed in-house, is already registered in the European Union,…
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Haisco Pharmaceutical’s Crisugabalin Gains NMPA Approval for Post-Herpes Neuralgia Treatment
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved an additional market approval filing for its drug candidate crisugabalin (HSK16149). This latest approval expands the drug’s indication to include the treatment of post-herpetic neuralgia…
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Easton Pharmaceutical Receives NMPA Approval for Generic Oxcarbazepine
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Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s oxcarbazepine. This neurogenic drug is now approved for the treatment of primary generalized tonic-clonic seizures and partial seizures, with or…
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Daiichi Sanky’s Mirogabalin Gets Green Light from China for Diabetic Neuropathic Pain
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Daiichi Sanky (TYO: 4568), a pharmaceutical company based in Japan, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Tarlige (mirogabalin) for the treatment of diabetes peripheral neuropathic pain (DPNP). Mirogabalin is a gabapentinoid drug, which belongs to the same class…
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Antengene’s Xpovio Secures NMPA Approval for R/R Diffuse Large B-Cell Lymphoma
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received new indication approval from the National Medical Products Administration (NMPA) for its drug Xpovio (selinexor). The drug is now approved for the treatment of adult patients with recurrent or refractory (R/R) diffuse large…
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Luye Pharma’s Oxycodone/Naloxone Product Receives NMPA Approval for Severe Pain Management
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Luye Pharma Group (HKG: 2186), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its oxycodone, naloxone product, LY 021702. The drug is indicated for use in adults requiring opioid analgesics to manage severe pain, including both…
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J&J’s Rybrevant Earns First-Line NSCLC Approval in Canada, a Milestone for EGFR Exon 20 Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that Rybrevant (amivantamab) has received its first market approval in Canada. The drug is approved as a first-line treatment in combination with chemotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating epidermal growth factor receptor (EGFR) Exon…
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Blue Sail Medical’s Fastroad Catheter Earns NMPA Marketing Approval
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Blue Sail Medical Co., Ltd (SHE: 002382), a medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category III medical device, Fastroad. Fastroad is a distal pathway catheter designed for radial artery neurovascular access and was…
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Astellas Pharma’s Xtandi Secures Third Market Approval in China for Prostate Cancer Treatment
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer…
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China’s Jiangsu Hengrui First to Market Generic Exparel in the US with FDA ANDA Approval
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pacira’s Exparel (bupivacaine liposome). This approval positions Hengrui as the first…
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MabPharm’s Biosimilar Infliximab CMAB807 Receives Market Approval in Peru
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MabPharm Ltd (HKG: 2181), a biosimilar specialist in monoclonal antibody (mAb) based in Taizhou, has announced that it has received market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J)’s Remicade (infliximab), in Peru. The approval encompasses all six indications, which include adult ulcerative colitis, ankylosing spondylitis, rheumatoid…
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Eisai and Biogen Launch Alzheimer’s Drug Leqembi in China Following Market Approval
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Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, in partnership with Biogen Inc. (NASDAQ: BIIB), has announced the official market launch of Leqembi (lecanemab), a therapy for Alzheimer’s disease (AD), in China. This follows the drug’s official market approval in China in January this year. Leqembi is a humanized…
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Jiangsu Hengrui’s Henagliflozin Gains Expanded Indication for Type 2 Diabetes Treatment in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its proline, henagliflozin. The Category 1 drug is now approved for use in combination with retagliptin and metformin to…
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BeiGene’s Tislelizumab Approved by China’s NMPA for First-Line Extensive Stage Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a biopharmaceutical company, has announced that its programmed-death (PD)-1 monoclonal antibody (mAb), tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China. The drug is now approved to be used in combination with chemotherapy for the treatment of patients with…
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CSPC Pharmaceutical’s Enronsubaimab Gets NMPA Nod for Recurrent Cervical Cancer
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) of China has approved its market approval filing for enronsubaimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb). The drug is indicated for the treatment of recurrent or metastatic…
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Bio-Thera Solutions’ BAT2094 Wins NMPA Nod for Acute Coronary Syndrome Treatment
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug BAT2094 (Betagrin). The drug is indicated for use in patients with acute coronary syndrome who are undergoing percutaneous…
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Genmab and AbbVie’s Epcoritamab Earns FDA Accelerated Approval for Follicular Lymphoma
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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment…
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Bio-Thera Solutions’ BAT1806 Biosimilar Receives European Commission Approval
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received market approval from the European Commission (EC) for BAT1806, a biosimilar version of Roche Holding AG’s (OTCM: RHHBY) Actemra/RoActemra (tocilizumab). BAT1806 is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,…
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AstraZeneca’s Tagrisso Wins NMPA Approval for First-Line EGFR-mutated NSCLC Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI). The drug is now approved for use in combination with chemotherapy as a first-line treatment for…
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Sino Biopharmaceutical Gains NMPA Approval for Liraglutide Biosimilar for Type 2 Diabetes
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Sino Biopharmaceutical Ltd (HKG: 1177), a major player in China’s pharmaceutical industry, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s Victoza (liraglutide), a treatment designed to control blood sugar levels in patients with type 2 diabetes…
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Novo Nordisk’s Semaglutide for Long-Term Weight Management Receives NMPA Approval
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Novo Nordisk (NYSE: NVO, CPH: NOVO-B), a leading healthcare company from Denmark, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for semaglutide, indicated for long-term weight management. Globally, Novo Nordisk markets semaglutide under the trade name Wegovy for weight loss. The STEP series…
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Jiangsu Simcere Pharmaceutical Wins NMPA Nod for Biosimilar Version of Erbitux
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for CMAB009, a biosimilar of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab, which is marketed under the trade name Erbitux. The EGFR-targeted monoclonal antibody (mAb) was…
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J&J’s Tecvayli Earns NMPA Approval for Relapsed or Refractory Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S. healthcare company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Tecvayli (teclistamab) for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have received three or…
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Hybio Pharmaceutical’s Biosimilar Liraglutide Gets Temporary FDA Nod Pending Patent Expiry
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received temporary approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide). This indicates that the drug has met…
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Shanghai Haihe Pharmaceutical’s Glumetinib Earns Marketing Approval in Japan for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd, a Chinese pharmaceutical company, has announced that it has received marketing approval in Japan for its MET targeted tyrosine kinase inhibitor (TKI), glumetinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET 14 exon mutation. The approval is…
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Haisco Pharmaceutical Gets NMPA Green Light for Cofrogliptin to Treat Type 2 Diabetes
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug cofrogliptin (HSK7653), a long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor. The drug is now approved for use in improving blood sugar control in patients with…
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Novo Nordisk’s Once-Weekly Insulin Awiqli Approved by China’s NMPA for Type 2 Diabetes
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The National Medical Products Administration (NMPA) has granted market approval for Awiqli (insulin icodec), a type 2 diabetes treatment developed by Denmark-based Novo Nordisk (NYSE: NVO). Awiqli, the first and only weekly insulin preparation globally, marks a significant milestone as it was developed concurrently in China, the European Union, and…
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Takeda’s Fruquintinib for Metastatic Colorectal Cancer Receives European Commission Marketing Approval
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its partner Takeda (TYO: 4502, NYSE: TAK) has received marketing approval from the European Commission for fruquintinib, a treatment for adult patients with metastatic colorectal cancer (CRC) who have previously been treated with chemotherapy regimens based on fluorouracil, oxaliplatin, and…
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Zai Lab’s Partner Argenx Receives FDA Approval for CIDP Treatment Vygart Hytrulo
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Argenx SE (NASDAQ: ARGX), the U.S. partner of China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), has announced that the U.S. Food and Drug Administration (FDA) has granted approval for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).…
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Qilu Pharmaceutical’s Generic Version of Vyndaqel Receives NMPA Marketing Approval
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The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic version of Pfizer’s Vyndaqel (tafamidis meglumine), marking it as the first generic to pass the generic quality consistency evaluation (GQCE) in China. This development is highlighted on the NMPA’s official website. Tafamidis meglumine is indicated for…
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Luye Pharma’s Once-Weekly Parkinson’s Disease Treatment Receives NMPA Approval
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Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration for its once-weekly rotigotine extended-release microspheres for injection (LY03003), indicated for the treatment of Parkinson’s disease (PD). Parkinson’s disease is a prevalent neurodegenerative condition among middle-aged and elderly individuals, characterized by…
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Dizal Pharmaceutical’s Golidocitinib Wins NMPA Approval for Relapsed/Refractory PTCL
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a spin-off from AstraZeneca China established in 2017, has announced that the National Medical Products Administration (NMPA) has granted approval for its drug golidocitinib. The drug is indicated for the treatment of adult patients with relapsed or refractory (r/r) peripheral T-Cell lymphoma (PTCL) who…
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AbbVie’s Skyrizi Secures FDA Approval for Ulcerative Colitis, Expands Treatment Portfolio
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AbbVie (NYSE: ABBV) has announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Skyrizi (risankizumab), marking it for use in treating adults with moderate to severely active ulcerative colitis (UC). This approval positions Skyrizi as the first IL-23 specific inhibitor to be approved for…
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Hybribio Ltd Secures NMPA Approval for α-Thalassemia Genotyping Detection Kit
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Hybribio Ltd (SHE: 300639), a Guangdong-based provider of nucleic acid molecular diagnostic products, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its α-thalassemia genotyping detection kit. The kit, which utilizes PCR and flow cytometry technology, is designed for qualitative detection of 10…
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Kanghong Pharmaceutical’s Lumitin Approved in Myanmar for Neovascular AMD Treatment
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a Chinese pharmaceutical company, has announced that it has received marketing approval in Myanmar for its product Lumitin (conbercept) for the treatment of neovascular age-related macular degeneration (nAMD). Lumitin, a fusion protein of VEGF receptor and human immunoglobulin Fc segment, is a…
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China Medical System’s Methylthioninium Tablets Get NMPA Green Light for Colonoscopy Use
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its methylthioninium enteric coated sustained-release tablets. This oral formulation is the first of its kind in China and is indicated for enhancing the visualization…
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MSD’s Capvaxive Vaccine Targets 21 Serotypes of Streptococcus Pneumoniae
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine). The vaccine is indicated to prevent invasive disease caused by a range of Streptococcus pneumoniae serotypes in adults,…
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Envonalkib, Chia Tai Tianqing’s Next-Gen ALK Inhibitor, Wins NMPA Approval for Untreated ALK+ NSCLC
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Chia Tai Tianqing’s next-generation ALK inhibitor, envonalkib, has received approval from the National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive for anaplastic lymphoma kinase (ALK) and have not been previously treated with ALK inhibitors. A…
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Nanjing Sanhome’s Oritinib Wins NMPA Approval for EGFR T790M Positive NSCLC
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Nanjing Sanhome Pharmaceutical Co., Ltd has received approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug oritinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for EGFR T790M mutation in patients who have confirmed disease progression during or…
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MicroPort Endovascular’s Vewatch Filter Gets NMPA Green Light for Pulmonary Embolism Prevention
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical device company, has announced that its Vewatch vena cava filter has received approval from the National Medical Products Administration (NMPA) for the prevention of pulmonary embolism caused by thrombus detachment in the inferior vena cava system. This product marks…
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Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
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Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received a new indication approval from the U.S. Food and Drug Administration (FDA) for the U.S. market. The drug is now approved for the treatment of adult and pediatric patients aged one month or older with…
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MSD’s Keytruda Secures FDA Approval for Advanced or Recurrent Endometrial Carcinoma
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has granted an additional indication for its programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab). The drug is now approved for use in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma,…
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FDA Approves Broadened Use of BMS’ Next-Gen TKI Augtyro for Advanced Solid Tumors
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an accelerated approval for its next-generation tyrosine kinase inhibitor (TKI), Augtyro (repotrectinib), for the treatment of locally advanced, metastatic, or unresectable NTRK fusion-positive solid tumors. This decision follows the drug’s progression after treatment or in…
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AstraZeneca’s Farxiga Receives FDA Approval for Pediatric Type-2 Diabetes Treatment
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The US Food and Drug Administration (FDA) has granted regulatory approval to AstraZeneca (AZ; NASDAQ: AZN) for its SGLT2 inhibitor, Farxiga (dapagliflozin), expanding its use to pediatric patients aged 10 and above with type-2 diabetes (T2D). This approval supplements the drug’s original indication for adult patients. The FDA’s decision was…
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Amgen’s Prolia Secures NMPA Approval for Treating Glucocorticoid-Induced Osteoporosis in High-Risk Patients
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Biopharmaceutical giant Amgen has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Prolia (denosumab) to treat glucocorticoid-induced osteoporosis (GIOP) in patients at high risk of fractures. This approval marks a significant expansion of Prolia’s indication in China, where it is already approved to treat osteoporosis…
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Eli Lilly’s Baqsimi Gains NMPA Approval for Diabetes Hypoglycemia Treatment
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The National Medical Products Administration (NMPA) in China has granted approval to Eli Lilly & Co. (NYSE: LLY) for its Baqsimi (glucagon nasal powder spray), marking a significant advancement in the treatment of severe hypoglycemia in diabetic patients aged four and above. Hypoglycemia, a common and potentially dangerous complication of…
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Joincare Pharmaceutical Receives NMPA Approval for Generic Seretide
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Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a leading pharmaceutical company based in China, has announced that it has obtained marketing approval from the National Medical Products Administration (NMPA) for its generic version of GlaxoSmithKline’s (GSK) Seretide (salmeterol, fluticasone). This compound inhalable preparation is now approved for use as…
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Accuray Wins Chinese Nod for Precision Treatment Planning System, Boosting Regional Expansion
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U.S. medical device company Accuray Inc. (NASDAQ: ARAY) has announced that it has received market approval from Chinese regulatory authorities for its Accuray Precision Treatment Planning System (TPS). This approval will enable the integration of the TPS with the Tomo C radiation therapy system, which is part of the CNNC-Array…
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Junshi Biosciences’ Toripalimab Scores New Indication for First-Line ES-SCLC Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced an expansion of indications for its immunotherapy drug Loqtorzi (toripalimab) following approval from China’s National Medical Products Administration (NMPA). The programmed death-1 (PD-1) inhibitor is now approved for use in combination with chemotherapy for the first-line treatment of patients…
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Kyowa Kirin’s Evocalcet Wins NMPA Nod for Chronic Kidney Disease Treatment
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Kyowa Kirin Co. (TYO: 4151), a Japanese pharmaceutical firm, has secured marketing approval from China’s National Medical Products Administration (NMPA) for its novel drug evocalcet. The drug is indicated for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing maintenance dialysis due to chronic kidney disease (CKD). Evocalcet, classified as…
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Luye Pharma’s Paliperidone Palmitate Injection Wins NMPA Nod for Schizophrenia Treatment
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its paliperidone palmitate injection. This second-generation antipsychotic long-acting injection is now approved for the treatment of schizophrenia during both the acute and…
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Sansure Biotech’s Tuberculosis Detection Kit Gains CE IVDR Certification for EU Market
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Sansure Biotech Inc. (SHA: 688289), a leading molecular diagnostics company based in China, has announced that it has received CE IVDR certification from the European Union for its mycobacterium tuberculosis nucleic acid detection kit, which utilizes the PCR fluorescence probe method. This certification marks a significant milestone, as it grants…
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Novartis’s Tabrecta Earns NMPA Nod for MET-Positive Advanced NSCLC in China
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Swiss pharmaceutical titan Novartis has secured marketing approval from China’s National Medical Products Administration (NMPA) for its drug Tabrecta (capmatinib), intended for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a mesenchymal–epithelial transition (MET) exon 14 skipping mutation, who have not received…
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MicroPort Endovascular MedTech Secures NMPA Approval for Vena Cava Filter
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a prominent medical device company based in China, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its newly developed vena cava filter. This device is designed to be percutaneously inserted…
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Qilu Pharmaceutical’s Generic Pomalidomide Wins NMPA Nod for Multiple Myeloma Treatment
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Qilu Pharmaceutical, a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its generic version of Celgene’s pomalidomide, expanding treatment options for multiple myeloma patients in China. This drug, a derivative of the immunomodulator thalidomide, is recognized for its anti-tumor efficacy. It…
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Rightongene Bio Receives NMPA Approval for BCR-ABL P210 Fusion Gene Detection Kit
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Shanghai Rightongene Biotechnology Co., Ltd (SHA: 688217), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its BCR-ABL P210 fusion gene detection kit, which uses the fluorescence reverse transcription polymerase chain reaction (RT-PCR) method. The kit is…
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Zylox-Tonbridge Medical Technology Earns NMPA Approval for First Vascular Stapler in China
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Zylox-Tonbridge Medical Technology (HKG: 2190), a leading developer of nerve and peripheral vascular interventional devices based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its proprietary ZYLOX Unicorn vascular stapler, marking the first approval of its kind in China. The…
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Allergan Aesthetics’ Botox Secures New Indication for Masseter Muscle Protrusion in China
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Allergan Aesthetics, a division of AbbVie (NYSE: ABBV), has announced that it has received approval for a new indication from the National Medical Products Administration (NMPA) for its Botox (botulinum toxin type A) product. The drug is now approved for the temporary improvement of significant or very significant masseter muscle…
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Varian Medical Gets China Approval for Fourth-Generation Halcyon Radiotherapy System
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Varian Medical Systems (NYSE: VAR), a US-based leader in cancer treatment technology, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its fourth-generation Halcyon radiotherapy platform. The Halcyon system is a circular rack radiotherapy platform designed to deliver efficient image-guided automated radiation therapy.-…
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CSPC Pharmaceutical Secures NMPA Nod for Generic Version of AstraZeneca’s Lynparza
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of AstraZeneca’s PARP inhibitor Lynparza (olaparib). This marks CSPC Pharmaceutical’s entry into the segment with the third generic…
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Hygea Medical’s Subsidiary Gets Green Light for Innovative Intrahepatic Puncture Instrument in China
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Hygea Medical Technology Co., Ltd, a China-based medical device company, has announced that its subsidiary, Beijing Ailin Medical Technology Co., Ltd, has received marketing approval in China for an innovative intrahepatic puncture instrument designed for use via the jugular vein. The instrument is intended for intrahepatic portal vein puncture to…
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FDA Extends Indication for BMS’ CAR-T Therapy Breyanzi to Include Relapsed MCL in Adults
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two…
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Eli Lilly Launches New Formula of Taltz in China with Reduced Injection Site Pain
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Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical company in the U.S., has announced the launch of a new formula for Taltz (ixekizumab) in China, following its approval in the country in November of the previous year. The new formula of the IL-17A monoclonal antibody (mAb) is free from…
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Amgen’s Bkemv Becomes First Biosimilar to Challenge AstraZeneca’s Soliris with FDA Approval
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Amgen Inc. (NASDAQ: AMGN), a leading biopharmaceutical company, has been granted regulatory approval by the US Food and Drug Administration (FDA) for Bkemv, marking a significant milestone as the first biosimilar in the US to compete with AstraZeneca’s (AZ; NASDAQ: AZN) Soliris (eculizumab). Both the originator drug from AstraZeneca and…
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Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, its biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
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Henlius Biotech’s Biosimilar Rituximab Receives First Overseas Marketing Approval from Peru
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) of Peru for Hanlikang, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). This marks the first international marketing approval for…
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Luye Pharma’s Subsidiary Gets NMPA Green Light for Biosimilar Xgeva
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a controlling subsidiary of China-based Luye Pharma Group (HKG: 2186), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for BA1102, a biosimilar version of Amgen’s Xgeva (denosumab). BA1102 is now approved for use in treating giant…
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Blue Sail Medical Receives NMPA Approval for Disposable Coronary Intravascular Impact Waveguide
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China’s Blue Sail Medical Co., Ltd (SHE: 002382) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its disposable coronary intravascular impact waveguide, SoniCracker CL. This product is designed to be used in conjunction with the company’s proprietary coronary intravascular shock wave therapy…
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RareStone Group’s Pitolisant Secures NMPA Approval to Treat Narcolepsy in Children and Adolescents
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RareStone Group, a China-based company specializing in rare diseases (formerly known as Citrine Medicine), has secured marketing approval from the National Medical Products Administration (NMPA) for pitolisant, its in-licensed drug candidate. The histamine 3 (H3) receptor antagonist/inverse agonist is now approved for treating excessive daytime sleepiness (EDS) or cataplexy in…
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Boston Scientific Gets NMPA Approval for Agent DCB, First of Its Kind for Coronary ISR Treatment
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Boston Scientific Corporation (NYSE: BSX), a leading medical device manufacturer in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Agent paclitaxel coated PTCA balloon catheter (AGENT DCB). This product is designed for the treatment of coronary in-stent restenosis (ISR)…
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Akeso Biopharma’s Ivonescimab Approved for NSCLC Treatment in China
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced that its bispecific antibody (BsAb) ivonescimab (AK112), which targets programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), has been approved for use in combination with chemotherapy to treat locally advanced or metastatic non-squamous non-small cell lung cancer…
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Sandoz Receives European Commission Approval for Biosimilars Wyost and Jubbonti
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The European Commission (EC) has granted registration approval to Sandoz, a Switzerland-headquartered pharmaceutical company (SWX: SDZ), for its biosimilars Wyost and Jubbonti. These products are reference treatments for Amgen’s (NASDAQ: AMGN) bone treatments Xgeva (denosumab) and Prolia (denosumab), respectively. Sandoz anticipates launching the biosimilars in November 2025. Wyost is indicated…
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Gan & Lee Pharmaceuticals Gains Marketing Approval for Insulin Glargine in Mexico
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced that it has received marketing approval for its insulin glargine pre-filled pen in Mexico. This marks the company’s first marketing authorization as a holder (MAH) in the Mexican market. Insulin glargine, a long-acting insulin analogue that requires daily…
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Fosun Pharmaceutical’s Humira Biosimilar Gains New Indications with NMPA Approval
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
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Simcere Pharmaceutical’s Quviviq Secures Hong Kong Marketing Approval for Insomnia Treatment
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received marketing approval from the Hong Kong health authorities for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd. The dual orexin receptor antagonist (DORA) will now be available in 50mg and 20mg dosages in the region,…
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Jiangsu Hengrui’s Fluzoparib Gains NMPA Approval as Maintenance Therapy for Ovarian Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has approved a new indication for its PARP inhibitor, fluzoparib. The drug is now approved for use as a maintenance therapy in patients with advanced epithelial ovarian cancer,…
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Eli Lilly’s Tirzepatide Earns China Approval for Type 2 Diabetes Treatment
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Eli Lilly & Co. (NYSE: LLY), a leading US pharmaceutical company, has announced that it has received its first market approval from the National Medical Products Administration (NMPA) in China for Mounjaro (tirzepatide). The drug is indicated for the treatment of type 2 diabetes mellitus (T2DM) in patients who have…
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Zai Lab and Innoviva Win China Approval for SUL-DUR to Treat Hospital-Acquired Pneumonia
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a China-based biopharmaceutical company, in collaboration with US partner Innoviva Specialty Therapeutics, has announced the marketing approval of Sulbactam-Durlobactam (SUL-DUR) by China’s National Medical Products Administration (NMPA). The novel intravenous combination antibiotic is now approved for the treatment of hospital-acquired bacterial pneumonia (HABP)…
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FDA Gives Accelerated Nod to Amgen’s Imdelltra in Small Cell Lung Cancer
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The US Food and Drug Administration (FDA) has granted accelerated approval to Amgen (NASDAQ: AMGN) for its bispecific T-cell engager (BiTE), Imdelltra (tarlatamab), for the treatment of extensive-stage small cell lung cancer (ES-SCLC) that has proven unresponsive to chemotherapy. This accelerated approval is based on early Phase II data highlighting…
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North China Pharmaceutical’s Ormutivimab Approved for Pediatric Use in China
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North China Pharmaceutical Group Corporation (SHA: 600812) has announced that it has received approval from the National Medical Products Administration (NMPA) for a new indication for its Category 1 therapeutic biologic, ormutivimab. The drug, a recombinant humanized rabies virus monoclonal antibody (mAb), is now approved for use in children aged…
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Chunlizhengda’s Handheld Orthopedic Robot Approved by China’s NMPA
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Beijing Chunlizhengda Medical Instruments Co., Ltd (HKG: 1858, SHA: 688236) has received marketing approval from China’s National Medical Products Administration (NMPA) for its INS 1 handheld orthopedic robot. This development marks a significant step forward in the adoption of domestic medical robotics in China. To date, 17 domestically produced joint…
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ViiV Healthcare’s HIV-PreP Therapy Approved by China’s NMPA, Offers Alternative to Daily Medication
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GlaxoSmithKline’s (GSK; NYSE: GSK) subsidiary, ViiV Healthcare, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for both cabotegravir tablets and cabotegravir injection. These medications are intended for pre-exposure prophylaxis (PrEP) of HIV-1 in adults and adolescents weighing at least 35kg who are at…
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BeiGene’s Brukinsa Secures Conditional Approval in China for R/R Follicular Lymphoma
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading biopharmaceutical company based in China, has received conditional approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The approval is for the use of Brukinsa in combination with the CD20-targeted obinutuzumab for…
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Zai Lab’s ROS1 Inhibitor Augtyro Earns NMPA Nod for Advanced NSCLC Treatment
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Augtyro (repotrectinib). This treatment is intended for adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).…
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Shenzhen Hepalink’s Enoxaparin Sodium Gets Green Light in Singapore
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the Health Sciences Authority of Singapore for its enoxaparin sodium injection in four specifications: 0.2ml:20mg, 0.4ml:40mg, 0.6ml:60mg, and 0.8ml:80mg. The approval is valid for a period…
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Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China
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Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug (AED) Fycompa (perampanel) has received a new indication approval from China’s National Medical Products Administration (NMPA). The drug is now approved for use as an additional treatment for adults and children aged 12 and above…
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Qilu Pharmaceutical Achieves First Approval for Generic Bendamustine in China
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The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic bendamustine, marking it as the first of its kind in China for the treatment of malignant tumors. Bendamustine, a bifunctional nitrogen mustard derivative, is recognized for its ability to induce cell death through multiple mechanisms, thereby…
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Jiangsu BioPerfectus’ Dengue Detection Kit Gains NMPA Approval for Commercialization
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Jiangsu BioPerfectus Technologies Co., Ltd (SHA: 688399), a leading in vitro diagnostic (IVD) product manufacturer based in China, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its Dengue virus NS1 antigen detection kit, which employs the colloidal gold method. The product…
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China Grants Marketing Nod to Ferring Pharmaceuticals’ Rekovelle for Assisted Reproduction
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Switzerland-based Ferring Pharmaceuticals Ltd announced that its recombinant human follicle stimulating hormone δ injection, Rekovelle, has been granted marketing approval in China. This product, a recombinant follicle stimulating hormone (rFSH) known as follitropin delta derived from human cell lines, has already received approvals across numerous countries and regions. It is…
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MicroPort MedBot’s Toumai Robot Gets EU Green Light for Broad Surgical Applications
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that its Toumai endoscopic surgery robot has received CE qualification from the European Union, allowing the product to be marketed and used for urology, general surgery, thoracic surgery, and gynecological endoscopic surgeries within the EU. The Toumai robot is the…
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Blue Sail Medical’s New Catheter Receives NMPA Approval for Complex Coronary Lesion Treatment
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China’s Blue Sail Medical Co., Ltd (SHE: 002382) has received marketing approval from the National Medical Products Administration (NMPA) for its new coronary artery balloon dilation catheter, classified as a Category III medical device. This development marks a significant step forward in the treatment of complex coronary artery lesions, including…
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Everest Medicines’ Velsipity for UC Receives First Asian Approval in Macau
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that the regulatory authority in Macau has approved the New Drug Application (NDA) for Velsipity (etrasimod) for the treatment of moderate-to-severe active ulcerative colitis (UC). This makes Macau the first region in Everest’s licensed territory in Asia to grant approval…
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Andon Health’s Triplex Virus Test Kit Receives US FDA Emergency Use Authorization
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Andon Health Co., Ltd (SHE: 002432), a leading healthcare company based in China, has announced that it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its novel triplex test kit, capable of detecting COVID-19, influenza A virus, and influenza B virus. The product…
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Medtronic’s RDN System Symplicity Spyral Earns First-Ever NMPA Approval
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Medtronic (NYSE: MDT), the US-Irish medical device giant, has announced that its Symplicity Spyral renal denervation (RDN) system has become the first of its kind to receive market approval from China’s National Medical Products Administration (NMPA). The company celebrates this milestone, which positions it at the forefront of the RDN…
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Everest Medicines’ Nefecon Secures Market Approval for IgAN Treatment in Hong Kong
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, announced that it has received market approval from the Hong Kong Department of Health for its drug Nefecon (targeted-release budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. This approval marks the…
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Wondfo Biotech’s WELLlife Test Kit Receives FDA Nod for Home Use in the US
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Guangzhou Wondfo Biotech Co., Ltd (SHE: 300482), a leading biotechnology company based in China, has announced that it has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its WELLlife COVID-19/Influenza A&B Home Test. This triplex test kit, available in an over-the-counter (OTC) version, is…
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United Imaging’s uMR Jupiter 5T Becomes First Ultra-High Frequency MRI System to Gain FDA Approval
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Shanghai-based medical equipment manufacturer United Imaging Healthcare (UIH, SHA: 688271) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its uMR Jupiter 5T magnetic resonance imaging (MRI) system. This product is recognized as the world’s first ultra-high frequency (UHF) system approved for…
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BeiGene’s Anti-PD-1 Therapy Tislelizumab Expands Indication for Gastric Cancer in China
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that its anti-PD-1 therapy, tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China for the first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the stomach or gastroesophageal junction (G/GEJ) in combination with fluorouracil and platinum-based…
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China’s NMPA Approves Shenzhen Chipscreen’s Chidamide for DLBCL Indication
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Shenzhen Chipscreen Pharmaceutical Co., Ltd, a biopharmaceutical company based in China, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Epidaza (chidamide). The drug is indicated for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2…
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Bristol-Myers Squibb’s Camzyos Approved by China’s NMPA for Hypertrophic Cardiomyopathy Treatment
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Bristol-Myers Squibb (BMS; NYSE: BMY) has received marketing approval from China’s National Medical Products Administration (NMPA) for its innovative drug Camzyos (mavacamten) for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) graded as II to III under the New York Heart Association (NYHA) functional classification. The drug is indicated…
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EOC Pharma’s Entinostat Secures Chinese Approval for Breast Cancer Treatment
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US-China biotech firm EOC Pharma has received market approval from China’s National Medical Products Administration (NMPA) for its entinostat, an oral histone deacetylase (HDAC) inhibitor, for the treatment of locally advanced or metastatic breast cancer in patients with hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER2) negative…
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Pfizer’s Gene Therapy Beqvez Wins FDA Nod for Moderate-to-Severe Hemophilia B
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The US Food and Drug Administration (FDA) has granted marketing authorization to Pfizer (NYSE: PFE) for its gene therapy Beqvez (fidanacogene elaparvovec) for the treatment of adults with moderate-to-severe hemophilia B. The one-time treatment is indicated for patients using factor IX prophylaxis therapy, those experiencing life-threatening hemorrhages, or those with…
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Novartis’s Iptacopan (Fabhalta) Receives Marketing Approval in China for PNH Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received marketing approval from China for its iptacopan (trade name: Fabhalta) for the treatment of adult paroxysmal nocturnal hemoglobinuria (PNH) in patients previously untreated with complement inhibitor. PNH is a rare and life-threatening blood disorder characterized by anemia, hemoglobinuria, bone marrow failure, and…
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US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
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Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval for marketing Hanquyou (trastuzumab; HLX02), a biosimilar to Roche (SWX: ROG)’s cancer treatment Herceptin (trastuzumab). The biosimilar will be available in the US under the trade name Hercessi. Originally approved…
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Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
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The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS) for its radioligand therapy (RLT) Lutathera (lutetium Lu 177 dotatate) for the treatment of SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients aged 12 and older. This expansion of the drug’s original indication for adult patients…
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European Commission Approves Pfizer’s Antibiotic Emblaveo for Multiple Indications
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The European Commission (EC) has granted approval for Pfizer’s (NYSE: PFE) antibiotic Emblaveo (aztreonam + avibactam) for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), complicated urinary tract infections (cUTI), and infections caused by aerobic Gram-negative organisms in adults. The drug was reviewed under an accelerated assessment process…
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Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
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Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis,…
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GenScript’s Subsidiary Legend Biotech Expands EU Approval for CAR-T Therapy Carvykti
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has secured an expanded indication approval from the European Union for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy is now approved as a…
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Roche’s Alecensa approved by FDA as First ALK Inhibitor for Adjuvant Treatment of NSCLC
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Roche Holding AG (SWX: ROG; OTCMKTS: RHHBY), a Swiss multinational healthcare company, announced last week that the US Food and Drug Administration (FDA) has granted regulatory approval for Alecensa (alectinib) as an adjuvant treatment for patients with ALK-positive non-small cell lung cancer (NSCLC). This marks the first approval of an…
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Takeda Scores FDA Nod for Subcutaneous Vedolizumab to Treat Inflammatory Bowel Disease
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The US Food and Drug Administration (FDA) has granted Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese pharmaceutical company, registration authorization for a subcutaneous formulation of its alpha4beta7 integrin antagonist Entyvio (vedolizumab). This new formulation is intended for use as a maintenance therapy in patients with moderately to severely active…
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Guangzhou LBP Earns NMPA Nod for HER2 Detection Reagent to Guide Breast Cancer Treatment
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Guangzhou LBP Medicine Science & Technology Co., Ltd (SHA: 688393), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its HER2 antibody reagent, which is utilized for immunohistochemistry. This new product is designed for the in vitro…
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Innovent Biologics’ Pemazyre Wins Macau Approval for Cholangiocarcinoma Treatment
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has received marketing approval from Macau for its cancer therapy Pemazyre (pemigatinib). The drug is indicated for patients with advanced, metastatic, or unresectable cholangiocarcinoma, who have been previously treated with at least one systemic therapy and have confirmed FGFR2…
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China Medical System’s Opzelura Approved in Macau for Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received market approval in Macau for Opzelura (ruxolitinib) cream, a topical treatment indicated for patients aged 12 and above with non-segmental vitiligo involving the face. Opzelura, a topical Janus kinase (JAK) inhibitor, was initially approved in the U.S.…
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3SBio Secures NMPA Approval for Pediatric Thrombopoietin Treatment of ITP
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3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its thrombopoietin product, used in the treatment of persistent or chronic primary immune thrombocytopenia (ITP) in children or adolescents. This marks a significant…
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AstraZeneca’s Fasenra Gains FDA Approval for Pediatric Severe Asthma Treatment
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AstraZeneca (AZ; NASDAQ: AZN) has secured an indication extension from the U.S. Food and Drug Administration (FDA) for its anti-eosinophil biologic Fasenra (benralizumab). The drug is now approved as an add-on maintenance treatment for severe asthma in pediatric patients aged 6 to 11 years with an eosinophilic phenotype, expanding its…
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Qilu Pharmaceutical Gets NMPA Green Light for Generic Romiplostim for ITP Treatment
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The National Medical Products Administration (NMPA) in China has granted marketing approval to Qilu Pharmaceutical for its generic version of Amgen’s romiplostim, a treatment for chronic idiopathic thrombocytopenia (ITP) that has not responded well to other treatments such as corticosteroids and immunoglobulins. This marks the first approval of its kind…
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GSK’s ViiV Healthcare Expands Dovato Indication to Include Adolescents with HIV-1 Infection
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GlaxoSmithKline’s (GSK; NYSE: GSK) ViiV Healthcare has received an indication extension from the US Food and Drug Administration (FDA) for its antiretroviral treatment Dovato (dolutegravir + lamivudine). The drug is now approved for use in virologically suppressed or treatment-naive adolescents aged 12 years and older with HIV-1 infection, a demographic…
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AstraZeneca and Daiichi Sankyo’s Enhertu Secures FDA Approval for HER2-Positive Solid Tumors
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Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional indication by the US Food and Drug Administration (FDA) for their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). The new indication authorizes the use of Enhertu as a treatment for unresectable or metastatic HER2-positive solid…
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Bristol Myers Squibb’s Abecma Receives FDA Approval for Wider Use in Multiple Myeloma Treatment
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The US Food and Drug Administration (FDA) has granted an indication extension for Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T therapy Abecma (idecabtagene vicleucel), approving it for use in adult patients with triple-class exposed relapsed or refractory multiple myeloma (r/rMM) who have received two or more prior lines of therapy.…
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Junshi Biosciences’ Toripalimab Approved for First-Line RCC Treatment in China
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has received a new indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 therapy, Loqtorzi (toripalimab). The drug is now approved for use in combination with axitinib to treat first-line moderate- to high-risk unresectable or metastatic renal cell…
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Ipsen Secures NMPA Approval for Somatuline in Advanced Neuroendocrine Tumors
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Ipsen (EPA: IPN; OTCMKTS: IPSEY), a France-based biopharmaceutical company, has received new indication approval from the National Medical Products Administration (NMPA) for its Somatuline (lanreotide) sustained-release injection. This approval allows for the treatment of unresectable, highly differentiated or moderately differentiated, locally advanced, or metastatic gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs), aimed…
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Mabwell Bioscience Receives NMPA Approval for Biosimilar Version of Amgen’s Xgeva
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its biosimilar product 9MW0321, a version of Amgen’s Xgeva (denosumab). This makes Mabwell the first company to gain approval for a biosimilar version of the drug in…
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Legend Biotech’s Carvykti Secures FDA Approval for Expanded Use in Multiple Myeloma
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its BCMA-targeted chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel). The therapy has now received an expanded indication for the treatment of relapsed/refractory multiple myeloma (r/r…
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European Commission Approves Reblozyl for First-Line Treatment of MDS-Related Anemia
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The European Commission (EC) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension for its erythropoietic agent Reblozyl (luspatercept) as a first-line treatment for transfusion-dependent anemia associated with lower-risk myelodysplastic syndromes (MDS) in adult patients. Originally indicated for anemia related to beta-thalassemia, Reblozyl is now positioned to address…
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Hepalink Secures TFDA Approval for Enoxaparin Sodium Injection, Expanding Thrombosis Treatment Options in Thailand
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), based in China, has announced that it has received marketing approval from the Thailand Food and Drug Administration (TFDA) for its enoxaparin sodium for injection. The approved specifications include 0.2ml (20mg) and 0.4ml (40mg), indicated for the prevention of venous thromboembolic diseases,…
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Sino Medical Secures Approval for Innovative Drug-Coated Stent System Targeting Intracranial Stenosis
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Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced that it has received marketing approval from the Center for Medical Device Evaluation for its innovative self-expanding intracranial drug-coated stent system. This approval was granted through the special review channel, recognizing the device’s potential to treat intracranial atherosclerotic…
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Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
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Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has secured regulatory approval from the US Food and Drug Administration (FDA) for its Factor D inhibitor Voydeya (danicopan). The drug is approved as an add-on therapy to ravulizumab or eculizumab, which are marketed as Ultomiris…
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Huihe Healthcare’s Vispearl Microsphere Earns Marketing Approval in China for Innovative Cancer Treatment
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Shanghai-based Huihe Healthcare, a developer of interventional medical devices for structural heart diseases, has secured marketing approval in China for its innovative Vispearl drug-loaded microsphere product. This product is designed for use in the embolization treatment of malignant tumors within vascular-rich parenchymal organs and is recognized as the first of…
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AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative…
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Hepalink’s Enoxaparin Sodium Injection Receives Marketing Approval in New Zealand
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), a prominent pharmaceutical company based in China, has announced that it has received marketing approval from New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE) for its enoxaparin sodium injection, which will be marketed under the trade name Exarane. Enoxaparin sodium injection…
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Takeda Gains MHLW Approval for Adzynma, Targeting Rare Blood Disorder cTTP
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Takeda Pharmaceutical Company (TYO: 4502) has secured regulatory approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its enzyme replacement therapy, Adzynma (apadamtase alfa), to treat congenital thrombotic thrombocytopenic purpura (cTTP) in patients aged 12 and older. cTTP is a rare and potentially life-threatening blood clotting disorder resulting…
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Acotec Scientific Receives NMPA Approval for Innovative Cardiovascular Devices
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Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for two of its innovative products: the coronary hypertension balloon dilation catheter wing extension and the microcatheter Vericor-RS. The coronary…
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Alexion’s Ultomiris Secures FDA Approval for Anti-AQP4 Positive NMOSD Treatment
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AstraZeneca’s (AZ; NASDAQ: AZN) rare disease unit, Alexion, has registered its biologic Ultomiris (ravulizumab) with the US Food and Drug Administration (FDA) for the treatment of anti-AQP4 antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) in adults. This registration follows an initial rejection by the FDA last year and positions Ultomiris…
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MSD’s Winrevair Approved by FDA as First Activin Signaling Inhibitor for Pulmonary Arterial Hypertension
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The US Food and Drug Administration (FDA) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) regulatory approval for Winrevair (sotatercept), marking it as the first activin signaling inhibitor for the treatment of pulmonary arterial hypertension (PAH) in adults. This milestone concludes a review process under the breakthrough therapy designation…
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FDA Grants Full Approval to AbbVie’s Elahere for Advanced Ovarian Cancer Treatment
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This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE: ABBV) antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer following up to three prior therapies. This approval marks an upgrade from the 2022…
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Zylox-Tonbridge Secures NMPA Approval for Advanced Flow Diverter Targeting Intracranial Aneurysms
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Zylox-Tonbridge Medical Technology (HKG: 2190), a China-based developer of nerve and peripheral vascular interventional devices, has secured marketing approval from the National Medical Products Administration (NMPA) for its flow diverter (FD). This device represents a significant advancement in the treatment of intracranial aneurysms, particularly large and giant aneurysms. Notably, this…
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Jiangsu Hengrui’s Generic Version of Tepadina Approved for Transplantation Conditioning in China
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Tepadina (thiotepa), originally developed by Switzerland-based Adienne S.r.l. The infusion is indicated as a conditioning treatment…
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Shanghai Institute’s Biosimilar Rituximab Approved by NMPA for Lymphoma Treatments
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Shanghai Institute of Biological Products Co., Ltd has announced that its biosimilar version of Roche/Genentech’s Mabthera (rituximab) has received approval from the National Medical Products Administration (NMPA) for the treatment of Non-Hodgkin’s lymphoma, including follicular non-Hodgkin’s lymphoma and CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma, as well as chronic lymphoblastic…
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EMA Panel Backs Novartis’s Fabhalta for PNH Treatment, Awaits EC Decision
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Novartis’s (NYSE: NVS) Factor B inhibitor Fabhalta (iptacopan) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults with hemolytic anemia. The European Commission (EC) is anticipated to make a…
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FibroGen’s Roxadustat Approved in Macau for Chronic Kidney Disease-Related Anemia
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FibroGen Inc. (NASDAQ: FGEN), a biopharmaceutical company based in the US, has announced that it has received marketing approval in Macau for its drug roxadustat. The drug is indicated for the treatment of anemia caused by chronic kidney disease (CKD), encompassing both dialysis and non-dialysis patients. Roxadustat, an oral hypoxia-inducible…
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Yifan Pharmaceutical’s F-627 Approved by European Commission for Marketing in EU
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Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that its subsidiary Evive Biotech Ltd’s drug Ryzneuta (efbemalenograstim alfa, F-627) has received marketing approval from the European Commission (EC) in the European Union (EU), following a recommendation by the European Medicines Agency’s Committee for Medicinal Products for…
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FDA Grants Accelerated Approval for Takeda’s Iclusig in Newly Diagnosed Ph+ ALL
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The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s Takeda Pharmaceutical Company (TYO: 4502) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This follows the drug’s previous…
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Everest Medicines’ Nefegan Approved by Singapore HSA for Primary IgAN Treatment
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Everest Medicines (HKG: 1952), a China-based biotechnology company, has received marketing approval from the Singapore Health Sciences Authority (HSA) for its drug Nefegan, also known as Nefecon, which is indicated for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. Nefecon is…
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Sino Medical Sciences Secures South Korean Approvals for Three Cardiovascular Devices
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical device company, has announced that it has received marketing approvals from South Korean regulatory authorities for three of its cardiovascular products: the HT Supreme drug-eluting stent, the NC ROCKSTAR non-compliant balloon dilation catheter, and the SC HONKYTONK coronary balloon…
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BeiGene’s Tislelizumab Receives FDA Approval for Esophageal Squamous Cell Carcinoma
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BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). The approval is for patients who have been previously treated…
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Bristol Myers Squibb’s Breyanzi Receives FDA Accelerated Approval for CLL/SLL Treatment
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The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines…
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KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
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Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug HL-085, aimed at treating advanced melanoma with NRAS mutations in patients who have experienced failure with anti-PD-1/PD-L1 therapies. HL-085 is a groundbreaking ATP non-competitive MEK inhibitor that specifically targets NRAS…
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Pfizer’s Sugemalimab Secures NMPA Approval for Gastric and Gastroesophageal Junction Adenocarcinoma
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Pfizer (NYSE: PFE), a leading pharmaceutical company in the US, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor, for the first-line treatment of inoperable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (G/GEJ) expressing…
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Madrigal Pharmaceuticals’ Rezdiffra Earns FDA Accelerated Approval for NASH in Adults
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The US Food and Drug Administration (FDA) has granted an accelerated approval to Madrigal Pharmaceuticals’ (NASDAQ: MDGL) Rezdiffra (resmetirom) for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) in adults with moderate-to-advanced liver fibrosis. This marks the first approval in the US for a therapy indicated for liver scarring due to…
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European Commission Approves Pfizer’s Prevenar 20 for Pediatric Use
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its 20-valent pneumococcal vaccine, Prevenar 20, aimed at preventing invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in individuals aged 6 weeks to 18 years. This vaccine was previously approved for use in adults…
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ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
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Hangzhou Kang Ming Information Technology Co., Ltd. (HKG: 9955), known as “ClouDr,” has officially launched dapagliflozin, its self-operated product with marketing rights. This drug serves as a generic version of AstraZeneca (NASDAQ: AZN)’s Forxiga, a leading treatment for type 2 diabetes. The approval for dapagliflozin was secured through Nanjing F&S…
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FDA Approves Wegovy for Cardiovascular Risk Reduction in Obese Patients, First of Its Kind
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The U.S. Food and Drug Administration (FDA) granted an indication extension approval last week to Novo Nordisk (NYSE: NVO) for its GLP-1 receptor agonist Wegovy (semaglutide), allowing it to be used for the reduction of major adverse cardiovascular events (MACE) in overweight or obese adults with established cardiovascular disease (CVD).…
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BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its anti-PD-1 drug Opdivo (nivolumab). The drug is now approved in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma (UC) in adults. The…
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China Grand Pharmaceutical Receives FDA Approval for Post-Surgical Ophthalmic Drug GPN00833
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its hormone nanosuspension eye drops GPN00833 (APP13007), designed for anti-inflammatory and analgesic effects following ophthalmic surgery. Additionally, the company has gained clinical trial…
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Boehringer Ingelheim’s Spevigo Receives NMPA Approval for GPP Treatment in China
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German pharmaceutical giant Boehringer Ingelheim (BI) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its biologic drug Spevigo (spesolimab) subcutaneous injection. The drug is indicated for reducing the incidence of generalized pustular psoriasis (GPP) in adolescents aged 12 and above weighing at…
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Henlius Biotech’s HER2 Targeting Biosimilar Secures Thai and Philippine Approvals
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Shanghai Henlius Biotech Inc., (HKG: 2696) a leading China-based biotech firm, has announced that its biosimilar version of Roche’s Herceptin, known as Hanquyou (trastuzumab; HLX02), has been granted marketing authorization in both Thailand and the Philippines. The drug, which is marketed under the trade names TRAZHER and Hertumab in these…
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Sino Medical Sciences Gains Pakistani Nod for SC HONKYTONK and NC ROCKSTAR Catheters
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Sino Medical Sciences Technology Inc., (SHA: 688108) a Chinese medical device company, has announced that it has received marketing approvals in Pakistan for two of its cardiovascular products: the SC HONKYTONK coronary balloon dilation catheter and the NC ROCKSTAR non-compliant balloon dilation catheter. These approvals mark a further expansion into…
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Formosa Pharmaceuticals Secures FDA Nod for New Steroidal Eye Drug, Set to Launch via Eyenovia
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Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has received approval from the US Food and Drug Administration (FDA) for its new formulation of the steroidal eye drug clobetasol propionate (0.05%), designed to treat post-operative inflammation and pain following ocular surgery. The drug will be commercialized in the US by Eyenovia Inc., (Nasdaq:…
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Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
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The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become…
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Pfizer’s Cibinqo Secures NMPA Approval for Expanded Use in Atopic Dermatitis
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The National Medical Products Administration (NMPA) has released drug approval certificate delivery information that points to a new indication approval for Pfizer (NYSE: PFE)’s JAK1 inhibitor Cibinqo (abrocitinib), a small molecule targeted therapy. This approval expands the drug’s use to include the treatment of moderate to severe atopic dermatitis (AD)…
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Sino Medical Sciences Receives Hong Kong Approval for HT Supreme Drug-Eluting Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that it has received marketing approval in Hong Kong for its HT Supreme drug-eluting stent system. The system is now approved for use in symptomatic heart disease patients to improve the coronary artery lumen diameter caused…
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Hainan Poly Pharm Secures Tentative FDA Approval for Generic Version of UCB’s Briviact
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received tentative marketing approval from the US Food and Drug Administration (FDA) for its generic version of Belgium-based UCB’s Briviact (brivaracetam). Briviact is recognized as a selective high-affinity synaptic vesicle protein 2A (SV2A) ligand,…
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J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
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The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb)…
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CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now…
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Gilead’s Biktarvy Receives FDA Approval for Expanded HIV Treatment Indication
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Gilead (NASDAQ: GILD), a leading US pharmaceutical company, has been granted an indication extension approval for its antiretroviral combination Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide) by the Food and Drug Administration (FDA). The approval expands Biktarvy’s use as an HIV treatment for individuals who have suppressed viral loads and…
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Alvotech Scores FDA Nod for Interchangeable High-Concentration Biosimilar to Humira
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The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO) Simlandi, marking it as the first interchangeable high-concentration, citrate-free biosimilar to AbbVie’s (NYSE: ABBV) immunosuppressant Humira (adalimumab). Humira faced patent expiration in the US last year, leading to biosimilar competition. Simlandi is approved for various…
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Takeda’s Recombinant Pig FVIII Drug for Acquired Hemophilia A Approved in China
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The National Medical Products Administration (NMPA) website has indicated that Takeda (TYO: 4502)’s Obizur (susoctocog alfa), intended for on-demand treatment and control of bleeding events in adult patients with acquired hemophilia A, has received approval in China. This drug marks the first recombinant pig FVIII (rpFVIII) to be approved by…
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Rossum Robot’s Intelligent Surgical Robot for Trauma and Spinal Surgery Clears NMPA Approval
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Rossum Robot, a Beijing-based developer of orthopedic surgical robots specializing in pelvic fracture procedures, has received marketing approval from the National Medical Products Administration (NMPA) for its intelligent small surgical robot designed for trauma and spinal surgery applications. This regulatory clearance marks a significant advancement for Rossum Robot as it…
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AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily…
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Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P receptor modulator Velsipity (etrasimod) as a treatment for patients aged 16 and older with moderately to severely active ulcerative colitis (UC). The approval applies to patients who have had an inadequate response, lost response, or…
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FDA Authorizes Biweekly Dosing for J&J’s Tecvayli in Multiple Myeloma Treatment
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The US Food and Drug Administration (FDA) has granted authorization for a biweekly dosing regimen of Johnson & Johnson’s (J&J; NYSE: JNJ) bispecific T-cell engager (BiTE) Tecvayli (teclistamab). Tecvayli received accelerated approval in 2022 for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have undergone at…
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Innovent Biologics’ Tyvyt Receives Marketing Approval for Multiple Indications in Macau
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced that it has received marketing approval for Tyvyt (sintilimab injection), a PD-1 inhibitor co-developed with US pharmaceutical giant Eli Lilly, for multiple indications in Macau. The drug has been approved to treat classic Hodgkin’s lymphoma (cHL),…
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Zylox-Tonbridge Receives UAE Approval for Five Medical Devices, Expands Middle East Presence
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Zylox-Tonbridge (HKG: 2190), a Chinese specialist in medical devices, has announced a series of product marketing approvals from the United Arab Emirates (UAE) Ministry of Health and Prevention. The company received approval for a total of five products, including the ZENFluxion Drug-coated PTA Balloon Catheter, ZENFlow HP PTA Balloon Catheter,…
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WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
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WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG: 2359) based in China, has announced the U.S. FDA’s approval of its Philadelphia facility to commence analytical testing and manufacturing of Amtagvi (lifileucel) for Iovance. This novel therapy received accelerated approval for its Biologics License…
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Hainan Poly Pharm Wins FDA Nod for Generic Version of UCB’s Vimpat
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received marketing approval from the US Food and Drug Administration for its generic version of UCB’s Vimpat (lacosamide), originally developed by the Belgium-headquartered UCB. The approved generic will be used for the treatment of…
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FDA Approves Takeda’s Eohilia as First Oral Therapy for Eosinophilic Esophagitis in Patients Aged 11 and Up
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The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO: 4502)’s Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE). This marks Eohilia as the first and currently only oral therapy available for EoE patients aged 11 and older. Previously, Novartis (NYSE: NVS)’s…
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Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
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The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche (SWX: ROG) for Piasky (crovalimab) under priority review status. This approval is specifically for the treatment of adult and adolescent patients aged 12 and older with paroxysmal nocturnal hemoglobinuria who have not previously received treatment…
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MSD’s Keytruda Secures 13th Indication Approval in China for Biliary Carcinoma Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that its drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced or metastatic biliary…
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Peijia Medical’s Taurus Atlas Pro Balloon Dilation Catheter Approved by NMPA for Pulmonary Valve Procedures
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Peijia Medical Ltd (HKG: 9996) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its second-generation balloon dilation catheter, Taurus Atlas Pro. This non-compliant balloon is designed for percutaneous transluminal valvuloplasty of the pulmonary valve. The Taurus Atlas Pro balloon dilation catheter is…
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MicroPort CRM Receives NMPA Approval for Next-Generation MRI-Safe Implantable Cardiac Pacing System
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MicroPort Scientific Corp. (HKG: 0853), a leading Shanghai-based medical device company, has announced that its France-based subsidiary MicroPort Cardiac Rhythm Management Limited (MicroPort CRM) has received a market license from the National Medical Products Administration (NMPA) for its next-generation intravenous magnetic resonance conditionally safe implantable cardiac pacing system. The product…
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CSPC Pharmaceutical’s rhTNK-tPA Gets NMPA Approval for Acute Ischemic Stroke Treatment
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved a supplementary market approval filing for its recombinant human TNK tissue-type plasminogen activator for injection (rhTNK-tPA). The drug is now approved for use as a thrombolytic…
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Biotech Pharmaceutical Secures Approval for Nimotuzumab in Head and Neck Cancer Treatment
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Sino-Cuban joint venture Biotech Pharmaceutical Limited (BPL) has secured another indication approval in China for its biologic drug nimotuzumab, now authorized for the treatment of locally advanced head and neck squamous cell carcinoma (HNCC). Nimotuzumab, an EGFR monoclonal antibody (mAb), previously received marketing approvals in China for nasopharyngeal carcinoma (NPC)…
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Jiangsu Hengrui Receives Chinese Approval for First Domestic Category 1 Opioid Analgesic for Postoperative Pain
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has proclaimed the receipt of marketing approval in China for its proprietary drug, tegileridine, indicated for the management of moderate to severe pain following abdominal surgery. This milestone marks the drug as the nation’s inaugural Category 1 opioid analgesic developed indigenously, highlighting a…
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Acotec Scientific’s Peridge Catheter Receives NMPA Nod for Hemodialysis Lesion Treatment
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Acotec Scientific Holdings Ltd (HKG: 6669), a China-based medical device company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its innovative peripheral scoring balloon dilation catheter, Peridge. This device is designed for the treatment of occlusive lesions in autologous or synthetic arteriovenous…
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Gilead’s Kite Subsidiary Reduces CAR T-Cell Therapy Turnaround Time with FDA Approval
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Kite, a subsidiary of Gilead (NASDAQ: GILD), has announced a significant enhancement in the treatment process for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). The median turnaround time (TAT) for this life-saving therapy is set to decrease from 16 days to 14 within the United States, following an approval by…
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Sandoz Launches Biosimilar Natalizumab in Germany, Challenging Biogen’s Tysabri
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Sandoz, a division of Novartis and a leader in generic drugs and biosimilars headquartered in Switzerland (SWX: SDZ), has announced the launch of Tyruko (natalizumab), the first biosimilar version of Biogen’s (NASDAQ: BIIB) blockbuster Tysabri, in the German market. This move marks a significant advancement in the treatment options for…
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European Commission Approves Takeda’s Hyqvia for Chronic Inflammatory Demyelinating Polyneuropathy
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The European Commission (EC) has granted regulatory approval to Takeda Pharmaceutical Company Limited (TYO: 4502) for its plasma-derived therapy Hyqvia (human immune globulin infusion 10% with recombinant human hyaluronidase) as a maintenance treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). This follows a similar indication extension for the subcutaneous drug in…
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Hengrui Medicine Scores First-Mover Status with FDA Approval for Generic Astagraf XL
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its sustained-released generic version of Astagraf XL (tacrolimus), originally developed by Japan-based Astellas. With this…
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Takeda’s Gammagard Liquid Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
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The US Food and Drug Administration (FDA) has granted regulatory approval for Takeda’s (TYO: 4502) plasma-derived therapy Gammagard Liquid, a human immune globulin, for use as induction therapy and treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. This decision is supported by clinical data demonstrating that the intravenous immunoglobulin…
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EMA’s CHMP Endorses Bristol Myers Squibb’s CAR-T Therapy Abecma for Multiple Myeloma
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy, Abecma (idecabtagene vicleucel), for the treatment of relapsed and refractory multiple myeloma (r/r MM) in adults who have undergone at least two prior therapies.…
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Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
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The US Food and Drug Administration (FDA) has concluded a priority review and granted approval to Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) for their interleukin blocker Dupixent (dupilumab) as a treatment for eosinophilic esophagitis (EoE) in patients aged 1 to 11 years. This indication expansion makes Dupixent the sole…
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Eisai’s Alzheimer’s Drug Leqembi Earns Marketing Approval in China
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Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This…
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Gan & Lee Pharmaceuticals Receives Bolivian Approval for Insulin Aspart, Expanding Access to Rapid-Acting Insulin
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced that it has received marketing approval from Bolivia’s Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) for its Insulin Aspart (cartridge bottle). Insulin Aspart, a rapid-acting insulin analogue, begins to take effect within 10-20 minutes of subcutaneous…
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Pfizer’s Nurtec Approved by China’s NMPA for Acute Treatment of Migraines
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Pfizer Inc. (NYSE: PFE), a leading pharmaceutical company in the U.S., has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for Nurtec (rimegepant), indicated for the acute treatment of migraine with or without aura. Rimegepant, developed originally by Biohaven, is the first oral CGRP…
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Novo Nordisk’s Rybelsus Approved for Type 2 Diabetes in China, Setting New Oral Treatment Standard
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Novo Nordisk (NYSE: NVO), a major Danish pharmaceutical company, has received approval from China’s National Medical Products Administration (NMPA) for its drug Rybelsus (semaglutide) for the treatment of type 2 diabetes. The approval covers filing numbers JXSS2200016, JXSS2200017, and JXSS2200018. Rybelsus, recognized as the world’s first and currently only oral…
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Zylox-Tonbridge Medical Technology Secures NMPA Nod for Innovative Iliac Vein Stent System
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Zylox-Tonbridge Medical Technology (HKG: 2190), a leading developer of nerve and peripheral vascular interventional devices based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its ZYLOX Penguin iliac vein stent system. This innovative product is designed for the treatment of…
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Jiangsu Wuzhong Pharmaceutical’s Aesthetics Subsidiary Wins Approval for Facial Filler in China
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Jiangsu Wuzhong Pharmaceutical Group Corp., (SHA: 600200), a prominent player in the Chinese pharmaceutical industry, has announced that its medical aesthetics subsidiary’s polylactic acid facial filler, AestheFill, has received marketing approval in China. The product is slated to become available in mainland China in the first half of 2024. AestheFill,…
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Lepu Medical Technology Gains NMPA Approval for Innovative Coronary Device
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading Chinese provider of cardiovascular disease solutions, has received marketing approval from the National Medical Products Administration (NMPA) for its self-developed coronary mastoid balloon dilation catheter. The device, classified as a Category III medical device, is indicated for balloon dilation in…
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AstraZeneca Wins FDA Nod for Airsupra in Asthma Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK pharmaceutical company, announced this week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its respiratory drug Airsupra (albuterol + budesonide). The drug is now approved for the treatment or prevention of asthma symptoms and for the…
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NMPA Grants Marketing Approval for Hui Sheng Bio-pharmaceutical’s Janagliflozin
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The National Medical Products Administration (NMPA) has granted marketing approval for Hui Sheng Bio-pharmaceutical Co., Ltd’s Category 1 drug janagliflozin, which is indicated for the control of blood sugar levels in adults with type 2 diabetes. The drug can be used as a monotherapy or in combination with metformin. Janagliflozin,…
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J&J’s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. Balversa is indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 mutations in patients who…
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Uni-Bio Science Group Wins NMPA Nod for Generic Forteo Injection for Osteoporosis
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Hong Kong-listed biopharmaceutical company Uni-Bio Science Group Ltd (HKG: 0690) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Eli Lilly Inc (NYSE: LLY)’s Forteo (teriparatide) injection, indicated for the treatment of osteoporosis in postmenopausal women who are at…
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Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
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Sanofi’s Dupixent Receives FDA Label Update for Atopic Dermatitis Patients with Hand or Foot Involvement
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Sanofi (NASDAQ: SNY) has been granted authorization by the US Food and Drug Administration (FDA) to update the label of Dupixent (dupilumab) to include efficacy and safety data for patients aged 12 and older with atopic dermatitis that involves uncontrolled moderate-to-severe hand or foot symptoms. The data from a late-stage…
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Ultrasound Biotechnology Earns FDA Nod for Disposable Endoscopic Ultrasound Probes
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Ultrasound Biotechnology, the Shanghai-based wholly owned subsidiary of US firm Ultrasound Wondering, Inc., has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its “Endoscopic ultrasound diagnostic equipment and disposable sterile endoscopic ultrasound probes” product. This marks a significant milestone as the company…
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FDA Approves Casgevy, the First CRISPR-Based Gene Editing Therapy for β-Thalassemia
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Casgevy (exagamglogene autotemcel), the pioneering gene editing therapy based on CRISPR technology, has received approval from the US Food and Drug Administration (FDA) for the treatment of patients aged 12 and above with transfusion-dependent β-Thalassemia (TDT). This marks a significant milestone as Casgevy becomes the world’s first CRISPR-based gene editing…
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Sino Biopharmaceutical Receives NMPA Approval for Generic Revolade Equivalent
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Sino Biopharmaceutical Ltd (HKG: 1177), a major player in the Chinese pharmaceutical industry, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s Revolade (eltrombopag olamine). The drug is indicated for the treatment of adults and children aged six and…
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Takeda’s Hyqvia Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
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Japanese pharmaceutical company Takeda (TYO: 4502) has received an indication extension approval from the US Food and Drug Administration (FDA) for its plasma-derived therapy Hyqvia (human immunoglobulin 10%). The therapy is now approved for use as a maintenance treatment in chronic inflammatory demyelinating polyneuropathy (CIDP). Initially approved in the US…
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Qilu Pharmaceutical’s Iruplinalkib Gains Additional Indication Approval in China for ALK-Positive NSCLC
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The National Medical Products Administration (NMPA) website has indicated that Qilu Pharmaceutical’s Category 1 drug, Iruplinalkib, has received additional indication approval in China. The new indication is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Previously approved in China…
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Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
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Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s…
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Yifan Pharmaceutical Wins Nod for Generic Diazoxide Oral Suspension in China
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Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products for its generic version of German pharmaceutical giant Bayer’s diazoxide oral suspension. This signifies that the drug has successfully passed the generic quality consistency evaluation (GQCE) process…
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3D Medicines Secures Registration for Envafolimab in Macau for Advanced Solid Tumors
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3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the registration of its PD-L1 monoclonal antibody (mAb) envafolimab in Macau. The approval designates envafolimab for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. Envafolimab is notable for being the world’s first…
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MSD’s Keytruda Gains FDA Approval for Advanced Cervical Cancer Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has received regulatory approval from the US Food and Drug Administration (FDA) for the use of its anti-PD-1 drug Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 stage III-IVA cervical cancer. This marks…
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BMS’s Mavacamten Used to Treat First Patient with Hypertrophic Cardiomyopathy in Hainan
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that the first patient with obstructive hypertrophic cardiomyopathy (oHCM) has been treated using its drug mavacamten at Ruijin Hospital’s Hainan branch. Mavacamten, the world’s first cardiac myosin inhibitor, received approval from the Hainan Medical Products Administration for special entry into the Hainan Bo’ao…
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Lepu Medical Secures NMPA Approval for Innovative Coronary Intravascular Impact Waveguide Tube
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a China-based provider of cardiovascular disease solutions, has received marketing approval from the National Medical Products Administration (NMPA) for its proprietary disposable coronary intravascular impact waveguide tube. This Category III device is now authorized for use in the pre-treatment and balloon dilation…
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Eli Lilly Secures NMPA Approval for Emgality as Preventive Migraine Treatment in China
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Eli Lilly (NYSE: LLY) has received marketing approval from the National Medical Products Administration (NMPA) for Emgality (galcanezumab) as a preventive treatment for migraines in adults. Emgality, a monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP), was initially approved by the U.S. FDA in September 2018 for migraine prevention…
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Novartis’s Cosentyx Secures Additional Indication for Psoriatic Arthritis in China
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Swiss pharmaceutical giant Novartis (SWX: NOVN) has announced that its drug Cosentyx (secukinumab), which targets IL-17A, has received an additional indication approval from the National Medical Products Administration (NMPA) in China. The drug is now approved for the treatment of active psoriatic arthritis (PsA), adding to its existing indications in…
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MSD’s Gardasil 9 Receives NMPA Approval for Two-Dose Schedule in Younger Females
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a prominent pharmaceutical company in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) 9-valent vaccine, Gardasil 9. The vaccine is now approved for a two-dose vaccination schedule (0,…
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3SBio Inc. Receives NMPA Approval for OTC Minoxidil Foam for Male Hair Loss Treatment
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3SBio Inc., a leading biopharmaceutical company based in China (HKG: 1530), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its over-the-counter (OTC) drug, a 5% minoxidil foam agent, which is indicated for the treatment of male pattern hair loss and alopecia areata.…
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ShuWen Biotech’s MammaTyper Diagnostic Kit Receives NMPA Approval for Breast Cancer Molecular Classification
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ShuWen Biotech Co., Ltd, a biopharmaceutical company based in Zhejiang, has announced that its MammaTyper diagnostic kit has received market approval from the National Medical Products Administration (NMPA). The kit is intended for use in cases where immunohistochemistry (IHC) results are indeterminate or unsatisfactory, or when the IHC outcome significantly…
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Gilead’s Descovy Receives Additional Indication Approval from China’s NMPA for HIV-1 PrEP
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Gilead Sciences, Inc. (NASDAQ: GILD), a major player in the pharmaceutical industry in the U.S., has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its anti-viral drug Descovy (emtricitabine, tenofovir alafenamide fumarate). The NMPA has granted approval for the use of…
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BMS’s Abraxane Approved in China for First-Line Metastatic Pancreatic Cancer Treatment
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Bristol Myers Squibb (BMS, NYSE: BMY), a leading U.S. pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug Abraxane (paclitaxel, albumin). This approval is for the first-line treatment of metastatic pancreatic cancer in combination with gemcitabine. Since June 2008,…
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Jiangsu Hengrui Medicine Wins NMPA Nod for SGLT-2 Inhibitor and Metformin Combo for Type 2 Diabetes
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its fixed dose combination (FDC) drug, henagliflozin, metformin sustained-release tablets. This new formulation is designed to enhance blood glucose control in…
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MicroPort CardioFlow Medtech’s AnchorMan System Receives NMPA Approval as First Semi-Closed LAA Occluder in China
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MicroPort Scientific Corp (HKG: 0853), a leading medical device company based in China, has announced that its spin-off, MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160), has received marketing approval from the National Medical Products Administration (NMPA) for La Ronda’s AnchorMan left atrial appendage occluder system. This marks the first semi-closed…
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Jiangsu Hengrui Medicine Secures NMPA Approval for Abiraterone in Prostate Cancer Treatment
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug abiraterone, a modified androgen synthesis inhibitor. The drug is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and newly diagnosed high-risk…
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Sino Biopharmaceutical Ltd Secures Exclusive Rights for Generic Everolimus in China
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis AG’s Afinitor (everolimus). This achievement marks a significant milestone as the company’s product is set to enjoy…
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AstraZeneca and Sanofi’s RSV Prevention Drug Beyfortus Approved by China’s NMPA
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AstraZeneca (AZ, NASDAQ: AZN) and Sanofi (NASDAQ: SNY), co-development partners in the pharmaceutical industry, have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their drug Beyfortus (nirsevimab). The antibody is now approved for use in preventing lower respiratory tract infections caused by respiratory…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Approval for NSCLC Perioperative Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced an additional indication approval for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), from China’s National Medical Products Administration (NMPA). The drug is now approved for use as perioperative treatment in combination with…
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Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
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The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related…
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BeiGene’s Tislelizumab Secures 12th Indication Approval in China for HCC First-Line Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received approval in China for the first-line treatment of irresectable or metastatic hepatocellular carcinoma (HCC), marking the drug’s 12th indication approval in the country. The approval is supported by the RATIONALE 301 study, a randomized, open-label, global…
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Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
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Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and Drug Administration (FDA) to update the label of Yescarta (axicabtagene ciloleucel) to include overall survival (OS) data for its use as a second-line treatment for relapsed or refractory large B-cell lymphoma (r/r LBCL). This new…
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Sino Medical Secures Approvals for Key Coronary Devices in Taiwan, India, and Uzbekistan
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Sino Medical Sciences Technology Inc. (SHA: 688108), a China-based medical device company, has announced that it has received market approvals in Taiwan, India, and Uzbekistan for its SC HONKYTONK coronary artery balloon dilation catheter, NC Rockstar non-compliant coronary artery balloon dilation catheter, and HT Supreme drug-eluting stent system. The NC…
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Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) for its anti-PD-1 monoclonal antibody, HanSiZhuang (serplulimab). This approval allows the drug to be used in the treatment of extensive-stage small-cell lung cancer (ES-SCLC). Henlius is collaborating with…
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Cryofocus Biotechnology Secures NMPA Approval for Cryotherapy Equipmen
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Shanghai-based Cryofocus Biotechnology Co., Ltd. (HKG: 6922) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its cryotherapy equipment, which supports its innovative frozen adhesion treatment system. The cryotherapy equipment comprises a main unit, a foot switch, and an exhaust pipe, and is…
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NMPA Approves Pulnovo Medical’s Novel Catheter for Treating Pulmonary Arterial Hypertension
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The National Medical Products Administration (NMPA) has granted marketing approval for Pulnovo Medical’s disposable circular pulmonary artery radiofrequency ablation catheter, marking it as a novel product in the medical device landscape. This innovative catheter employs a puncture intervention technique to access the bloodstream, targeting pulmonary arterial hypertension by disrupting the…
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Sanofi Gains NMPA Approval for Innovative Rosuvastatin and Ezetimibe Combination Therapy
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its fixed-dose combination tablets of rosuvastatin and ezetimibe. This therapy is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). This product marks the first…
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AstraZeneca Secures FDA Approval for Self-Administered hATTR-PN Therapy Wainua
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AstraZeneca (AZ, NASDAQ: AZN), headquartered in the UK, announced last week that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for its ligand-conjugated antisense oligonucleotide (LICA) Wainua (eplontersen) as a treatment for hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR-PN/ATTRv-PN) in adults. Developed in collaboration with Ionis Pharmaceuticals (NASDAQ: IONS),…
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Takeda’s Livtencity Receives NMPA Approval, a First in China for CMV Infection Treatment
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Japanese pharmaceutical company Takeda (TYO: 4502) has received its first market approval from China’s National Medical Products Administration (NMPA) for Livtencity (maribavir), a significant milestone for the treatment of adult patients with cytomegalovirus (CMV) infection/disease following hematopoietic stem cell transplantation or solid organ transplantation. The drug is particularly indicated for…
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Beijing Balance Medical Secures NMPA Approval for Innovative Mitral Valve Annuloplasty Ring
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Beijing Balance Medical Technology Co., Ltd (SHA: 688198), a Chinese medical device company, has received market approval from the National Medical Products Administration (NMPA) for its proprietary mitral valve annuloplasty ring product. This development marks a significant milestone for the company, which aims to provide advanced cardiac solutions to patients.…
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Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for recurrent-metastatic cervical cancer, according to the National Medical Products Administration (NMPA) website. This drug marks the first programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb) for cervical cancer in China. Socazolimab, originally developed by US-based Sorrento…
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FDA Rejects MSD’s Gefapixant for Chronic Cough Treatment Over Efficacy Concerns
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The US Food and Drug Administration (FDA) has declined to approve a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) for its P2X3 receptor antagonist, gefapixant, which was being considered as a treatment for refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults. The rejection was due…
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European Commission Expands Keytruda Indications for Advanced Cancer Treatments
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The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications for its leading anti-PD-1 therapy, Keytruda (pembrolizumab), approving its use as a first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic biliary tract carcinoma (BTC) and HER2-negative gastric or gastroesophageal junction (GEJ)…
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EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment
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Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on Sanofi’s (NASDAQ: SNY) Fexinidazole Winthrop (fexinidazole) as a 10-day treatment for acute sleeping sickness caused by Trypanosoma brucei (T.b.) rhodesiense in both adults and children. The EMA is…
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BGI Genomics Receives NMPA Approval for Innovative Colorectal Cancer Detection Kit
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BGI Genomics Co., Ltd. (SHE: 300676), a leading genomics firm based in China, has announced the approval of its medical device license from the National Medical Products Administration (NMPA) for a novel gene methylation detection kit. The kit employs fluorescence PCR technology to assess the combined methylation status of the…
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Keytruda Gains 12th Indication Approval in China for HER2-Negative Gastric Cancer
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US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its immunotherapy drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced unresectable or metastatic HER2-negative…
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Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab), which is indicated for the treatment of diabetic macular edema (DME). Vabysmo targets both vascular endothelial growth factor A (VEGF-A) and…
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FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
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Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have secured U.S. Food and Drug Administration (FDA) approval for their combination therapy consisting of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) for the treatment of locally advanced or metastatic urothelial cancer (la/mUC). The FDA’s decision is…
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Sanofi’s Rezurock Secures Marketing Approval in China for Chronic Graft-vs-Host Disease
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that its drug Rezurock (belumosudil), the world’s first and only ROCK2 inhibitor for the treatment of chronic graft-versus-host disease (cGVHD), has received marketing approval in China. Clinical data indicates that Rezurock achieves a 75% overall response rate (ORR), a 75% 6-month failure-free…
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MSD’s Welireg Gains FDA Approval for Advanced Renal Cell Carcinoma
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The US Food and Drug Administration (FDA) has granted an indication extension approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan), expanding its use as a therapy for advanced renal cell carcinoma (RCC) in adults who have previously received a PD-1/L1 inhibitor and a VEGF tyrosine…
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MicroPort MedBot’s R-ONE Vascular Intervention Robot Approved by China’s NMPA
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its R-ONE vascular intervention surgical robot. The robot was introduced by Cathbot, a joint venture between MicroPort and French firm Robocath S.A.S in China. R-ONE, a…
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Sino Medical Sciences Secures Market Approvals in Hong Kong, China, and Malaysia for Medical Devices
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approvals for two of its medical devices in Hong Kong, China, and Malaysia. The NC Rockstar non compliant coronary artery balloon dilation catheter has been approved in Hong Kong and China, while the HT Supreme drug eluting stent…
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Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board has approved a market approval filing for the company’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients with tumor progression during or after platinum-based chemotherapy. The approval, facilitated by the…
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Cryofocus Biotechnology Receives NMPA Approval for Complete Cardiac Cryoablation System
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Cryofocus Biotechnology Co., Ltd (HKG: 6922), a Shanghai-based specialist in cryoablation treatment, has announced that it has received marketing approvals from China’s National Medical Products Administration (NMPA) for all components of its cardiac cryoablation system. The approvals include the cryoablation equipment, balloon type cryoablation catheter (previously known as the atrial…
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Zylox-Tonbridge Medical Technology’s ZENFLOW T18 Receives NMPA Marketing Approval
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Zylox-Tonbridge Medical Technology (HKG: 2190), a developer of nerve and peripheral vascular interventional devices based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed ZENFLOW T18 peripheral balloon dilation catheter. The ZENFLOW T18 is a conical balloon designed…
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Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
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Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National Medical Products Administration (NMPA) for sugemalimab, a treatment for first-line irresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) in combination with fluorouracil and platinum. This approval marks sugemalimab as the first programmed…
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AK Medical Secures NMPA Approval for Advanced 3D-Printed Hip Prosthesis Component
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China-based AK Medical Holdings Ltd (HKG: 1789) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Acetabular Component of Hip Prosthesis, classified as a Class III medical device. This innovative product is a 3D-printed titanium alloy orthopedic implant. AK Medical first gained…
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Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal…
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Antengene Secures NDA Approval for Xpovio in Macau for Advanced Multiple Myeloma
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Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval from the regulatory authority in Macau for its product Xpovio (selinexor). This approval is specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R…
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Novartis’ Fabhalta Wins FDA Nod as First-in-Class Treatment for Paroxysmal Nocturnal Hemoglobinuria
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has secured regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class orphan drug Fabhalta (iptacopan) as an oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH). The approval was granted based on Phase III clinical data that demonstrated a significant…
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Sinocare Inc’s Blood Glucose Monitoring System Earns US FDA Approval
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Sinocare Inc (SHE: 300298), a Chinese medical device company, has announced that it has received market approval from the US Food and Drug Administration (FDA) for its TRUNESS/ TRUNESS AIR blood glucose monitoring system product. The TRUNESS blood glucose monitoring system includes the TRUNESS blood glucose meter and corresponding test…
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Jingxin Pharmaceutical’s Didaxini Gains NMPA Approval as Category 1 Drug
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Jingxin Pharmaceutical Co., Ltd (SHE: 002020), a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Category 1 drug, Didaxini. This drug is a partial agonist of GABAA (γ-aminobutyric acid A) receptors and selectively targets the α1 subtype of…
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Sino Medical Secures Market Approval in Taiwan for NC Rockstar Coronary Catheter
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Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that its NC Rockstar non-compliant coronary artery balloon dilation catheter has received market approval in Taiwan, China. This innovative device, which includes a TIP head, balloon protective sheath, balloon, and inner tube, is designed for balloon catheter dilation of autologous coronary…
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Luye Pharma’s Lurbinectedin for Metastatic SCLC Wins Macau Regulatory Nod
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that Macau’s medical products administration bureau has approved a market approval filing for the firm’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients experiencing tumor progression during or after platinum-based chemotherapy. The approval is…
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Tonghua Dongbao Pharmaceuticals Secures NMPA Approval for Biosimilar Liraglutide
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) GLP-1 receptor agonist Victoza (liraglutide), which is indicated for blood sugar control in type 2 diabetes patients.…
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Nanchang Baiji Pharmaceutical’s Budesonide Nasal Spray Approved by China’s NMPA
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Nanchang Baiji Pharmaceutical Co. Ltd., a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) for its generic budesonide nasal spray. The product is indicated for the treatment of seasonal and perennial allergic rhinitis, as well as perennial non-allergic rhinitis, and for the prevention of nasal…
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Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
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The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory…
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Valgen Secures NMPA Approval for China’s First Transcatheter Mitral Valve Clamp System
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Hangzhou-based Valgen Holding Corporation has received market approval from the National Medical Products Administration (NMPA) for its innovative DragonFly transcatheter mitral valve clamp system, marking it as the first of its kind in China. The DragonFly system is designed for use in transcatheter mitral valve edge-to-edge repair (TEER) procedures and…
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Ambio Gains FDA Approval for Generic Forteo, Challenging Eli Lilly’s Osteoporosis Market
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Ambio has secured regulatory approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly’s (NYSE: LLY) recombinant peptide Forteo (teriparatide), both of which are indicated for the treatment of osteoporosis. The subcutaneous injection will be marketed in partnership with Apotex. According to the public…
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Chinese Firms Secure EUAs for Omicron XBB Vaccines Amid Dominant Variant Surge
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A wave of Chinese pharmaceutical companies has announced the receipt of Emergency Use Authorizations (EUAs) for their COVID-19 vaccines targeting the Omicron XBB variant. Among the notable developments are Lizhu Pharmaceutical’s (HKG: 1513) recombinant bivalent vaccine, which combines the prototype strain with the Omicron XBB variant, and CanSino Biologics’ (SHA:…
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NMPA Approves TINGSN Technology’s Disposable Intracardiac Ultrasound Diagnostic Catheter
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The National Medical Products Administration (NMPA) has granted market approval to TINGSN Technology, a China-based firm, for its disposable intracardiac ultrasound diagnostic catheter. This approval is the 239th for an official innovative medical device by the NMPA. The product comprises a catheter body, an operating handle, and a connector, and…
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Lee’s Pharmaceutical Secures NMPA Approval for Adasuve, Pioneering Loxapine Inhaler for Agitation
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured marketing approval from China’s National Medical Products Administration (NMPA) for Adasuve, a loxapine inhaler designed to treat acute agitation in adults with schizophrenia or bipolar I disorder. This approval is supported by a series of clinical studies conducted across the United States,…
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AK Medical Holdings Receives NMPA Approval for Hip Surgery Navigation System iBot
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AK Medical Holdings Ltd (HKG: 1789), a Chinese medical technology company, has announced that it has received Category III medical device approval from the National Medical Products Administration (NMPA) for its iBot, a navigation and positioning system designed for hip joint surgery. The iBot system, which includes a robotic arm,…
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Everest Medicines’ Nefecon for IgAN Receives NMPA Approval in China
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Everest Medicines (HKG: 1952), a China-based pharmaceutical company, has announced that its New Drug Application (NDA) for Nefecon (targeted-release formulation budesonide) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression has been approved by the National Medical Products Administration (NMPA). Nefecon is a…
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Takeda’s Takecab Receives NMPA Approval for Helicobacter pylori Eradication in China
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Takeda (TYO: 4502), a Japan-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Takecab (vonoprazan) to eradicate Helicobacter pylori (HP) when combined with appropriate antibiotics. The vonoprazan-based quadruple regimen, which includes bismuth, is the first of its…
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Fujian Cosunter’s Oral COVID-19 Therapy Receives Conditional Approval in China
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a Chinese pharmaceutical company, has announced that its Category 1 product, GST-HG171/ritonavir, an oral COVID-19 therapy, has received conditional marketing approval in China. GST-HG171 is a 3CL protease (3CLpro) inhibitor, characterized as having broad-spectrum anti-COVID-19 activity. 3CL protease is an essential protease for…
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Jiangxi Jemincare Group Secures NMPA Approval for Generic Ibrance Capsules
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Jiangxi Jemincare Group, a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Pfizer’s (NYSE: PFE) Ibrance (palbociclib). This follows the company’s earlier approval for its active pharmaceutical ingredients (APIs) of palbociclib in China. Palbociclib, initially…
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Boehringer Ingelheim and Eli Lilly’s Jardiance Receives NMPA Approval for CKD Treatment
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Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced that their SGLT2 inhibitor, Jardiance (empagliflozin), has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of adult chronic kidney disease (CKD). This development expands the drug’s therapeutic applications in China. EMPA-KIDNEY Study Outcomes The approval…
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Boehringer Ingelheim and Eli Lilly Secure NMPA Approval for Jardiance in Chronic Kidney Disease
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Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have announced the receipt of marketing approval from the National Medical Products Administration (NMPA) for their SGLT2 inhibitor Jardiance (empagliflozin) aimed at treating adult chronic kidney disease (CKD). This pivotal approval marks a significant advancement in the management of CKD, further establishing…
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RemeGen’s Telitacicept Receives Full Approval for Systemic Lupus Erythematosus in China
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced the conversion of conditional approval to complete approval from the National Medical Products Administration (NMPA) for its fusion protein drug telitacicept, used in the treatment of systemic lupus erythematosus (SLE). This approval follows a multi-center, randomized, double-blind, placebo-controlled Phase III study involving…
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Sumitomo Pharma Receives Chinese Approval for Xenleta to Treat Pneumonia
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Japan-based Sumitomo Pharma Co., Ltd (OTCMKTS: DNPUF) has secured market approval in China for Xenleta (lefamulin acetate), a drug indicated for the treatment of community-acquired pneumonia in adults. The approval was obtained through Sumitomo’s Suzhou-based subsidiary, which already has Mepem (meropenem), a carbapenem antibiotic, in its Chinese market portfolio, and…
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BMS and 2seventy Bio’s Abecma Faces FDA Review Extension
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The US Food and Drug Administration (FDA) has postponed the target action date for Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy Bio (NASDAQ: TSVT)’s CAR-T cell therapy Abecma (idecabtagene vicleucel) from December 16. The decision affects the therapy’s filing for earlier lines of triple-class exposed relapsed or refractory multiple…
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BeiGene’s Brukinsa Secures Additional EU Approval for Follicular Lymphoma Treatment
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for the Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The European Commission has approved Brukinsa in combination with obinutuzumab (Roche’s CD20-targeted Gazyva) as a third-line treatment for relapsed or refractory (R/R) follicular lymphoma (FL). This marks…
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Ascentage Pharma Secures Additional Indication Approval for Olverembatinib from NMPA
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China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Category 1 drug, olverembatinib. This second market-approved indication is for the treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) who are resistant and/or intolerant…
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Apollomics’ Partner Avistone Wins Conditional Approval for c-Met Inhibitor in China
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US-based biotech Apollomics Inc., (NASDAQ: APLM) has announced that its Chinese partner, Avistone Biotechnology Co., Ltd, has received conditional market approval for the c-Met inhibitor vebreltinib from the National Medical Products Administration (NMPA). The approval is for the treatment of patients with MET exon 14 skipping non-small cell lung cancer…
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Pfizer and Astellas Pharma Secure FDA Approval for Xtandi in High-Risk Non-Metastatic Prostate Cancer
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Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval from the US Food and Drug Administration (FDA) for their androgen receptor signaling inhibitor Xtandi (enzalutamide). The drug is now approved as a treatment for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high…
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Yifan Pharmaceutical’s Subsidiary Receives FDA Approval for Ryzneuta (F-627)
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary, Evive Biotech Ltd., has received Biologic License Application (BLA) approval from the US Food and Drug Administration (FDA) for Ryzneuta (efbemalenograstim alfa, F-627). The drug is indicated to reduce the incidence of infection manifested as febrile neutropenia in…
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AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with fulvestrant. This treatment is indicated for HR-positive, HER2-negative locally advanced or metastatic recurrent or refractory breast…
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BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase…
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Easton Pharmaceutical Receives FDA Approval for Generic Nalmefene
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Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced receiving Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Hikma Pharma’s (LON: HIK) Revex (nalmefene). Nalmefene is utilized to reverse the effects of opioid drugs, including respiratory suppression caused by…
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Vertex Pharmaceuticals and CRISPR Therapeutics Receive Conditional Approval for CRISPR Gene-Editing Therapy
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Vertex Pharmaceuticals (NASDAQ: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) have received conditional approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for their jointly developed therapy, Casgevy (exagamglogene autotemcel), a treatment for sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) and for transfusion-dependent beta thalassemia (TDT) in…
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Sino Medical Sciences Technology’s HT Supreme Stent Gains Brazilian Market Approval
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Sino Medical Sciences Technology Inc., (SHA: 688108) a leading China-based medical device company, has announced that its HT Supreme drug-eluting stent system has received market approval in Brazil. This system is designed to improve the diameter of the coronary artery lumen in patients suffering from symptomatic heart disease caused by…
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EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
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Sansure Biotech Secures CE IVDR Certifications for Chemiluminescence Analyzers in the EU
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China-based molecular diagnostics specialist, Sansure Biotech Inc., (SHA: 688289), has announced that it has received CE IVDR certifications in the European Union for two of its fully automatic chemiluminescence immunoassay analyzer products. This regulatory milestone marks a significant step forward for the company in expanding its presence in the EU…
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Servier’s Tibsovo Receives FDA Approval for IDH1-Mutated R/R MDS, Expanding Indications
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France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has granted market approval for its drug Tibsovo (ivosidenib) for the treatment of recurrent or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutation. This marks the fifth indication for the drug in the IDH1 mutant cancer…
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AstraZeneca’s Imfinzi Gains NMPA Approval for First-Line Cholangiocarcinoma Treatment
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The National Medical Products Administration (NMPA) of China has indicated on its website that it has approved AstraZeneca’s (AZ, NASDAQ: AZN) programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab), for use in combination with chemotherapy for the treatment of first-line locally advanced or metastatic cholangiocarcinoma (BTC). This marks a significant expansion…
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China’s NMPA Grants Conditional Approval for Juventas’ CAR-T Therapy Inaticabtagene Autoleucel
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The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Chinese firm Juventas Cell Therapy Ltd. The drug is indicated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel’s…
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Eli Lilly’s Zepbound Approved by FDA for Chronic Weight Management in Adults
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Eli Lilly (NYSE: LLY) has received registration approval from the US Food and Drug Administration (FDA) for its once-weekly injection Zepbound (tirzepatide). The drug is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity or overweight conditions, including those with at least one…
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Sino Medical Sciences Technology Secures EU MDR Approval for HT Supreme Drug-Eluting Stent System
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced that it has received Medical Device Regulation (MDR) approval in the European Union for its HT Supreme drug-eluting stent system. Features of the HT Supreme Drug-Coated Coronary Artery Stent SystemThe HT Supreme drug-coated coronary artery stent system is a combination…
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Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have…
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Lifetech Scientific Corporation Receives NMPA Approval for Peripheral Thrombus Suction Catheter
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Lifetech Scientific Corporation (HKG: 1302), a China-based medical device company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its innovative peripheral thrombus suction catheter. This device is designed for the removal of thrombi from the peripheral arterial and venous vascular systems, offering…
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US FDA Approves HutchMed and Takeda’s Fruzaqla for Metastatic Colorectal Cancer Treatment
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The US Food and Drug Administration (FDA) has granted approval to HutchMed (NASDAQ: HCM) and its partner Takeda (NYSE: TAK, TYO: 4502) for their oral tyrosine kinase inhibitor Fruzaqla (fruquintinib), marking the second approval this year for a China-developed innovative drug. The drug is indicated for adult patients with previously…
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Gaush Meditech Ltd Receives NMPA Approval for Rigid Corneal Contact Lens
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Gaush Meditech Ltd (HKG: 2407), a company based in Suzhou, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its rigid corneal contact lens. This development marks a significant step forward for the company, as it now offers a highly rigid gas permeable…
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Amoy Diagnostics Receives NMPA Approval for MSI Detection Kit as Companion Diagnostic for Immunotherapy
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Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in the Chinese diagnostics industry, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its human microsatellite instability (MSI) detection kit. This kit, which utilizes fluorescent PCR capillary electrophoresis,…
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Wuhan Hiteck Biological Pharma Receives NMPA Approval for Aponermin in Multiple Myeloma Treatment
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Wuhan Hiteck Biological Pharma Co., Ltd (SHE: 300683), a Chinese biopharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aponermin. This approval is for the treatment of adult patients with recurrent or refractory multiple myeloma who have previously undergone…
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Sino Medical Sciences Technology Secures TFDA Approval for HT Supreme Drug-Eluting Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for its HT Supreme drug-eluting stent system. This significant milestone marks the company’s expansion into the Taiwan market with a cutting-edge drug-device…
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Luye Pharma Group’s Rivastigmine Patch LY03013 Approved by China’s NMPA for Alzheimer’s Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its rivastigmine twice-weekly transdermal patch (LY03013), a treatment for symptoms of mild and moderate Alzheimer’s disease (AD). Product Development and AdvantagesLY03013, a modified version of rivastigmine, was developed…
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Novartis’ Cosentyx Gains FDA Approval for Hidradenitis Suppurativa Treatment
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The US Food and Drug Administration (FDA) has issued regulatory approval for Novartis’ (NYSE: NVS) IL-17A-targeting drug Cosentyx (secukinumab) for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa (HS). This approval positions Cosentyx as a new entrant in the HS biologic therapy market, potentially challenging AbbVie’s (NYSE: ABBV) Humira…
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Siyi Intelligence Secures Approval for Innovative Rehabilitation Robots in China
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Shanghai-based Siyi Intelligence, a developer of soft rehabilitation robots, has announced that it has received marketing approvals from the National Medical Products Administration (NMPA) for two of its groundbreaking rehabilitation robots: the “Yisheng Upper Limb Intelligent Rehabilitation Training and Evaluation System” and the “Yisheng Brain Computer Interface (BCI) Rehabilitation Training…
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CStone Pharmaceuticals Receives NMPA Approval for Sugemalimab in R/R ENKTL
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor. The drug is now approved for the treatment of recurrent or refractory extranodal NK/T cell lymphoma (R/R…
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Simcere Pharmaceutical Group Secures Full Approval for Cosela in China
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Simcere Pharmaceutical Group (HKG: 2096), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has converted the first conditional approval in China for Cosela (trilaciclib) to full approval. Originally discovered by US biotech G1 Therapeutics Inc, trilaciclib was in-licensed by Simcere in August…
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Roche’s Vabysmo Receives FDA Approval for Macular Edema Treatment Following RVO
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Swiss pharmaceutical giant Roche (SWX: ROG) announced last week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO). This approval broadens the therapeutic applications of Vabysmo, which…
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Dr. Reddy’s Laboratories Reports 9% YOY Revenue Growth in Q2 2024 Fiscal Year
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India-based generics giant Dr. Reddy’s Laboratories Ltd (NYSE: RDY) has released its financial report for the Q2 2024 fiscal year ended September 30, 2023. The company reported consolidated revenues of USD 828 million for the quarter, marking a 9% year-on-year (YOY) increase. This growth was primarily driven by robust generic…
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Junshi Biosciences’ PD-1 Inhibitor Loqtorzi Approved by FDA for Nasopharyngeal Carcinoma
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the US FDA has approved its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), for the treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). The approval marks a significant milestone as Loqtorzi becomes the first…
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Everest Medicines’ Nefecon Receives First Regional NDA Approval in Macau for IgAN Treatment
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China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon, a treatment for primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression, has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China. This marks the first regional…
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GSK’s ViiV Healthcare Secures NMPA Approval for Vocabria in HIV-1 Treatment
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UK pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that its HIV joint venture, ViiV Healthcare, has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir injection). The drug is approved for use in combination with Johnson & Johnson/Janssen Pharmaceutical’s (J&J, NYSE: JNJ) Rekambys (rilpivirine long-acting injection)…
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AbbVie’s Rinvoq Gains Two New Indications in China: AxSpA and Ankylosing Spondylitis
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US-based pharmaceutical company AbbVie (NYSE: ABBV) has announced the receipt of two additional indication approvals from China’s National Medical Products Administration (NMPA) for its drug Rinvoq (upadacitinib). The selective JAK inhibitor is now approved for treating adult patients with active radiologically negative axial spinal arthritis (axSpA) who show a poor…
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Eli Lilly’s Omvoh Receives FDA Approval for Ulcerative Colitis Treatment
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The US Food and Drug Administration (FDA) has granted regulatory approval to Eli Lilly (NYSE: LLY) for its interleukin-23p19 antagonist, Omvoh (mirikizumab), as a treatment for moderately to severely active ulcerative colitis (UC) in adults. This approval is a significant milestone for Eli Lilly, expanding its portfolio in the inflammatory…
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Life Molecular Imaging and Sinotau Pharmaceutical Secure NMPA Approval for Neuraceq in China
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Germany-headquartered Life Molecular Imaging (LMI) and China-based Sinotau Pharmaceutical Group have announced that Neuraceq (florbetaben F-18 injection) has received regulatory approval from the National Medical Products Administration (NMPA) in China. This marks a significant milestone as Neuraceq becomes the first radiopharmaceutical targeting β-amyloid approved in China to support the diagnosis…
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MicroPort MedBot’s Toumai Robot Gains NMPA Approval for Endoscopic Surgery
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252), a leading medical robotics company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Toumai endoscopic surgery robot. This approval allows the robot to be used across multiple departments for a variety of surgical…
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EC Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Advanced HER2+ NSCLC
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The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) to AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568). This approval is for the treatment of advanced HER2-positive non-small cell lung cancer (NSCLC) in adults who require systemic therapy following chemotherapy. The…
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Walvax Biotechnology Secures BPOM Approval for Weuphoria Pneumococcal Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received market approval from the Indonesian Food and Drug Control Agency (BPOM) for its Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine (PCV-13). This approval is a significant milestone for Walvax as it expands its reach into the Indonesian…
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Pfizer’s Penbraya Receives FDA Approval for Meningococcal Immunization
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Pfizer Inc. (NYSE: PFE) announced last week that it has successfully registered its pentavalent meningococcal vaccine, Penbraya, with the US Food and Drug Administration (FDA). The vaccine is designed for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged…
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Health Canada Approves Pfizer and Sumitomo Pharma’s Myfembree for Endometriosis Pain Management
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Health Canada has granted regulatory approval to Pfizer (NYSE: PFE) and Sumitomo Pharma (TYO: 4506) for their women’s health product Myfembree (relugolix + estradiol + norethindrone acetate). The approval is for the management of moderate-to-severe pain associated with endometriosis in pre-menopausal women, supported by late-stage data from multiple trials. Previous…
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BMS’s Sotyktu Receives NMPA Approval for Psoriasis Treatment
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The National Medical Products Administration (NMPA) has granted regulatory approval to US-based pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) for its first-in-class selective tyrosine kinase 2 (TYK2) inhibitor, Sotyktu (deucravacitinib). The drug is indicated for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Mechanism of…
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AstraZeneca’s Soliris Gains Approval in China for NMOSD Treatment
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) has announced that its rare disease drug Soliris (eculizumab) has received marketing approval in China for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in AQP4 antibody positive (Ab+) adults. This approval marks a significant expansion of Soliris’s application in the Chinese…
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Lepu Medical Gains NMPA Approval for Semi-Automatic External Defibrillator
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its in-house developed semi-automatic external defibrillator. This approval marks a significant milestone in expanding Lepu’s portfolio of life-saving medical devices. The…
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Pfizer’s Velsipity Approved by FDA for Ulcerative Colitis Treatment
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China-based pharmaceutical company Everest Medicines (HKG: 1952) announced that its licensing partner, Pfizer Inc. (NYSE: PFE), has secured market approval from the US FDA for Velsipity (etrasimod). This oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator is indicated for adults with moderately to severely active ulcerative colitis (UC), marking a significant…
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FDA Approves Pfizer’s Braftovi + Mektovi Combo for BRAF V600E Metastatic NSCLC
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) regulatory approval for the combination therapy of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation. This decision is supported by interim results from an ongoing Phase…
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Nanjing Geneseeq’s NSCLC TMB Detection Kit Approved by NMPA
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China-based Nanjing Geneseeq Medical Device and Diagnostic Inc. has announced that its tissue tumor mutation burden (TMB) detection kit, utilizing a reversible end termination sequencing method, has received marketing approval from the National Medical Products Administration (NMPA). This marks the kit as the 231st novel medical device approved in China.…
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Betta Pharmaceuticals Secures NMPA Approval for Befotertinib in NSCLC Treatment
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China-based Betta Pharmaceuticals Co., Ltd. (SHE: 300558) has officially announced its receipt of market approval from the National Medical Products Administration (NMPA) for befotertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This critical approval allows befotertinib to be used as a first-line treatment for locally advanced or…
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Jiangsu BioPerfectus Secures NMPA Approval for Norovirus Nucleic Acid Detection Kit
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China-based Jiangsu BioPerfectus Technologies Co., Ltd (SHA: 688399), a leading manufacturer of in vitro diagnostic (IVD) products, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its Norovirus nucleic acid detection kit, utilizing the fluorescence PCR method. Innovative Detection of Norovirus The…
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Cochlear’s Artificial Cochlear Sound Processor Gains NMPA Approval for Marketing in China
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Australia-based Cochlear has received marketing approval from the National Medical Products Administration (NMPA) for its artificial cochlear sound processor, as announced by the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration. This innovative product is designed to convert received sounds and transmit electrical stimulation to the auditory nerve through…
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Med Vision’s Sleep Disorder Software Receives Category II Approval in China
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Hangzhou-based Med Vision, a provider of virtual reality (VR)-enabled digital therapeutics (DTx) solutions, has reportedly received a Category II medical device approval in China for its sleep disorder assisted treatment software. This marks a significant milestone as it is the first VR-based sleep disorder device to be approved both in…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
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Sanofi’s Nexviazyme Approved in China as Enzyme Replacement Therapy for Pompe Disease
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Sanofi’s (NASDAQ: SNY) next-generation enzyme replacement therapy (ERT), Nexviazyme (avalglucosidase alfa), has received marketing approval from the National Medical Products Administration (NMPA) as a long-term treatment for Pompe disease. This marks Sanofi’s second drug approved for Pompe disease in China, following the approval of Myozyme (alglucosidase alfa) in October 2015.…
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Amicus Therapeutics Secures FDA Approval for Pombiliti and Opfolda Combination Therapy
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Amicus Therapeutics (NASDAQ: FOLD), headquartered in the United States, has announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for its combination therapy of Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) 65 mg capsules. This innovative two-component therapy is specifically indicated for adults diagnosed with…
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Takeda Receives FDA Approval for Subcutaneous Entyvio as UC Maintenance Therapy
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The US Food and Drug Administration (FDA) has granted Japan’s Takeda Pharmaceuticals (TYO: 4502) regulatory approval for the subcutaneous version of its alpha4beta7 integrin inhibitor, Entyvio (vedolizumab), as a maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) following induction therapy with intravenous Entyvio. This decision comes…
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Neusoft Medical’s NeuRT Aurora Receives NMPA Approval for Advanced Radiotherapy Platform
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Neusoft Medical Systems Co., Ltd, a leading player in the medical technology sector, has announced that its radiotherapy unit, Neusoft Ruizhi Radiotherapy Technology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for the high-end medical linear accelerator, NeuRT Aurora intelligent radiotherapy platform. This approval marks…
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CStone Pharmaceuticals’ PDGFRA Mutation Detection Kit Receives NMPA Approval
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its “Human PDGFRA Gene D842V Mutation Detection Kit”. This companion diagnostic (CDx) kit, co-developed with Beijing-based Genetron Holdings Ltd (Nasdaq: GTH), is used for the detection…
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Eli Lilly’s Insulin Biosimilar YouBiAn Approved for Diabetes Treatment in China
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US pharmaceutical major Eli Lilly (NYSE: LLY) has announced that it has received market approval from the National Medical Products Administration in China for its insulin glargine product, YouBiAn. This treatment is indicated for adults with type 1 or type 2 diabetes requiring insulin therapy, as well as for children…
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Everest Medicines’ Xerava Receives Marketing Approval from TFDA for cIAI Treatment
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Everest Medicines (HKG: 1952) has announced that it has received marketing approval for its antibiotic Xerava (eravacycline) from the Taiwan Food and Drug Administration (TFDA). This approval grants the drug permission to be used in the treatment of complicated intra-abdominal infections (cIAI) in Taiwan, expanding the drug’s reach in the…
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Sino Medical Sciences Receives Turkish Approval for HT Supreme Drug-Eluting Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical device company, has announced that it has received market approval for its HT Supreme drug-eluting stent system from the Ministry of Health in Turkey. This approval marks a significant expansion of the product’s reach and is set to benefit…
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EC Approves AbbVie’s Tepkinly for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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The European Commission (EC) has granted marketing approval to AbbVie (NYSE: ABBV) for its bispecific antibody (BsAb) Tepkinly (epcoritamab), a treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in adults who have undergone two or more lines of systemic therapy. This decision comes on the heels of…
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Sanofi’s Altuviiio Receives Marketing Approval from Japan’s MHLW for Hemophilia A Treatment
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its first-in-class drug Altuviiio (Fc-VWF-XTEN fusion protein). This new treatment is indicated for controlling the bleeding tendency in patients with hemophilia A, a genetic disorder that…
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Japan’s MHLW Approves Eisai and BioArctic’s Leqembi for Alzheimer’s Treatment
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted approval to Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) for their amyloid-beta (Aβ)-targeting drug, Leqembi (lecanemab), as a treatment for slowing the progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This marks…
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Fosun Pharma’s Serplulimab Approved for Esophageal Squamous Cell Carcinoma and Grafalon for GvHD Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has issued updates on the development statuses of two of its key products. The company’s Programmed-death 1 (PD-1) inhibitor, HaiSiZhuang (serplulimab), has been approved for a new indication in the treatment of first-line PD-L1 positive unresectable locally advanced/recurrent or metastatic esophageal squamous…
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Boehringer Ingelheim and Eli Lilly’s Jardiance Wins FDA Approval for CKD Prevention
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Boehringer Ingelheim (BI) and Eli Lilly (NYSE: LLY) have received regulatory approval from the US Food and Drug Administration (FDA) for their SGLT2 inhibitor, Jardiance (empagliflozin), marking a significant advancement in the treatment of chronic kidney disease (CKD). The drug is now approved for the prevention of kidney function decline,…
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Acotec Scientific Holdings Receives Japanese Marketing Approval for Peripheral Support Catheter Vericor
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Acotec Scientific Holdings Ltd (HKG: 6669), a China-based medical device company, has announced that it has received marketing approval from the Ministry of Health, Labour and Welfare of Japan for its peripheral support catheter, Vericor. This approval allows the product to be used in conjunction with a guide wire to…
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Sanofi’s Dupixent Secures NMPA Approval for Pruritigo Nodosa Treatment in China
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France-based pharmaceutical company Sanofi (NASDAQ: SNY) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) in China for its drug Dupixent (dupilumab), which is now approved to treat prurigo nodosa (PN) in adults. This makes Dupixent the first and only drug approved for…
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Sansure Biotech Secures CE Mark for 60 Molecular Diagnostic Products, Including Procalcitonin Assay Kit
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Sansure Biotech Inc., a leading molecular diagnostics specialist based in China (SHA: 688289), has announced that it has received CE marks for 60 of its products, including a procalcitonin assay kit that utilizes chemiluminescent immunoassay technology. This significant milestone underscores the company’s commitment to expanding its global footprint and enhancing…
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Novartis’s Aimovig Approved by China’s NMPA for Preventive Migraines Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aimovig (erenumab), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb), which can now be used as a preventive treatment for adult migraines in China. Phase III…
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Organon’s Liptruzet Approved in China for Hypercholesterolemia Treatment
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US-based Organon (NYSE: OGN) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Liptruzet (ezetimibe, atorvastatin), which is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH) in China. DYSIS China Study and Liptruzet’s ImpactThe DYSIS China study reveals…
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GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
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The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical company, for its JAK1/JAK2/ACVR1 inhibitor Ojjaara (momelotinib). The drug is indicated for anemic adults with intermediate or high-risk myelofibrosis, a blood cancer affecting approximately 25,000 people in the United States. This…
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EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment
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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead’s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized…
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FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
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The US Food and Drug Administration (FDA) has granted priority review status to an indication extension application filed by Merck, Sharp & Dohme (MSD; NYSE: MRK) for its oral HIF-2α inhibitor Welireg (belzutifan). The application seeks approval for the treatment of advanced renal cell carcinoma (RCC) in adults who have…
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Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens
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Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo (ritlecitinib), a JAK3/TEC inhibitor, for the treatment of severe alopecia areata in adults and adolescents. This once-daily drug is the first to be approved in the region for this autoimmune disease, including teenage patients. The…
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AbbVie’s Allergan Aesthetics Secures NMPA Approval for Juvéderm VOLUMA with Lidocaine
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Juvéderm VOLUMA with Lidocaine, expanding its indications to include nose augmentation procedures. Product Description and BenefitsJuvéderm VOLUMA with Lidocaine is a cross-linked sodium hyaluronate gel designed…
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MicroPort MedBot’s SkyWalker Robot Approved for Orthopedic Surgery by NMPA
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its innovative navigation and positioning system, the SkyWalker hip and knee joint replacement surgery robot. This marks the first approval of an in-house developed mechanical arm…
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Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
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Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE: NVS) next month, has received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar. The biosimilar is intended for use in treating HER2-positive…
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EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung…
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EMA’s CHMP Recommends Approval of Keytruda as Adjuvant NSCLC Treatment
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy, Keytruda (pembrolizumab), as an adjuvant treatment for non-small cell lung cancer (NSCLC) in adults who are at a high risk of…
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Tuodao Medical’s Percutaneous Puncture Surgery Robot NP100 Approved in China
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China-based surgical robot developer Tuodao Medical Technology Co., Ltd has received marketing approval for its percutaneous puncture surgery robot, known as the puncture surgery navigation and positioning system NP100. This approval marks a significant advancement in the field of surgical robotics within the country. Puncture Surgery and Its ChallengesPuncture surgery…
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CSPC Pharmaceutical Group Receives NMPA Approval for Irinotecan Liposome Injection
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its irinotecan liposome injection. The drug is indicated for the treatment of metastatic pancreatic cancer in patients after gemcitabine treatment and is also used in…
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Genesis MedTech Receives Chinese Market Approval for Antibacterial Absorbable Sutures
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Singapore-based medical device company Genesis MedTech has announced that it has received market approval in China for its absorbable sutures with antibacterial protection. This milestone marks the company as the first domestic brand to successfully develop such a product, enhancing its position in the medical device market. Innovation in Surgical…
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EMA Approves Astellas’ Xtandi for Non-Metastatic Hormone-Sensitive Prostate Cancer
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The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval for its androgen receptor inhibitor Xtandi (enzalutamide). This approval expands the use of Xtandi as a treatment for non-metastatic hormone-sensitive prostate cancer (nmHSPC) in patients with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.…
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Grand Pharmaceutical Receives NMPA Approval for Generic Carbaglu for Hyperammonemia Treatment
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Italy’s Recordati’s Carbaglu (carglumic acid). This marks the first approval of such a generic drug in China, offering a treatment for hyperammoniaemia caused…
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FDA Extends Pfizer’s Comirnaty Vaccine Indication for Omicron XBB.1.5 Variant
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension for its SARS-CoV-2 Omicron XBB.1.5 single-dose monovalent vaccine, Comirnaty. The vaccine is now approved for individuals aged 12 years and older, in addition to receiving an emergency use authorization (EUA) for children between 6 months…
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Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
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Zai Lab Ltd (Nasdaq: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy…
