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Sinocelltech’s Finotonlimab Gets NMPA Approval for Liver Cancer Treatment
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China-based Sinocelltech Group Ltd (SHA: 688520) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its finotonlimab. The approval allows the use of the programmed-death 1 (PD-1) monoclonal antibody (mAb) in combination with Anbeizhu, Sinocelltech’s biosimilar version of Roche’s Avastin (bevacizumab), for the…
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Shanghai Moyang Biotech’s Aphranel CC Needle Wins NMPA Approval
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China-based Shanghai Moyang Biotechnology Co., Ltd, an innovation-focused company in nanomedical biomaterials and Class III absorbable implants, announced it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its Aphranel CC needle. The high-end medical aesthetics product is used for subcutaneous injection of…
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Hepalink Pharmaceutical’s Enoparin Receives Argentina Approval for Thromboembolic Diseases
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China-based Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) announced that its subsidiary, Shenzhen Techdow Pharmaceutical Co., Ltd, has received marketing approval from Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) for its Enoparin (enoxaparin) product. The approved specifications include 0.2ml: 20mg, 0.4ml: 40mg, 0.6ml: 60mg, and 0.8ml:…
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Bio-heart’s Iberis System Approved by NMPA for Hypertension Treatment
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China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced that its subsidiary, Shanghai Angiocare Medical Technology Co., Ltd, has received market approval from the National Medical Products Administration (NMPA) for its multipole renal arterial radiofrequency ablation system, Iberis. The device is approved as an adjuvant therapy for refractory hypertension…
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Fosun Pharma’s Tenapanor Approved in China for CKD Dialysis Patients
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tenapanor, an innovative phosphate absorption inhibitor, in China. The drug, commercially known as Wan Ti Le, is now available for controlling serum phosphorus levels…
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J&J’s Tremfya Wins NMPA Approval for Crohn’s Disease Treatment
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Johnson & Johnson (J&J, NYSE: JNJ) announced that its Tremfya (guselkumab) has received marketing approval from China’s National Medical Products Administration (NMPA) for treating moderate to severe active Crohn’s disease (CD) in adults who have not responded adequately to traditional therapies or biologics. Drug ProfileTremfya, an interleukin-23 monoclonal antibody, was…
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Sanofi’s Sarclisa Wins New Japan Approval for Multiple Myeloma Combination Therapy
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a new indication for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed multiple myeloma (NDMM). This marks the fourth treatment regimen approved for Sarclisa in…
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Sandoz Launches Pyzchiva Biosimilar of J&J’s Stelara in US
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Switzerland-based Sandoz (SWX: SDZ) announced the launch of Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) autoimmune drug Stelara (ustekinumab), in the US. The drug, developed by South Korea’s Samsung Bioepis Co., Ltd., is approved for the same chronic inflammatory disease indications as the originator. Licensing DealSandoz…
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Medtronic’s BrainSense Adaptive DBS Wins FDA Approval for Parkinson’s Treatment
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US-Irish medical device giant Medtronic (NYSE: MDT) announced that the US Food and Drug Administration (FDA) has approved its BrainSense Adaptive deep brain stimulation (aDBS) system and BrainSense Electrode Identifier (EI) for treating Parkinson’s disease (PD). The approval marks a milestone in personalized neurological therapies. Technology HighlightsThe BrainSense system uses…
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Takeda’s Takhzyro Receives EMA Approval for New Administration Form in HAE Patients
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Japan-headquartered Takeda (NYSE: TAK, TYO: 4502) announced that the European Medicines Agency (EMA) has approved a label extension for Takhzyro (lanadelumab) for subcutaneous administration in adolescents aged 12 and above and adult patients with Hereditary Angioedema (HAE) using a 2 mL pre-filled pen. Drug ProfileTakhzyro is now approved in the…
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Meyer FSMP Hong Kong Secures NMPA Approval for First FSMP in Greater China
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Hong Kong-based Meyer FSMP Hong Kong Limited, an oncology-focused foods for special medical purpose (FSMP) company, announced it has received marketing approval from China’s National Medical Products Administration (NMPA) for its carbohydrate component formula. The product is the first FSMP approved in the Hong Kong, Macao, and Taiwan regions. Product…
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Subtle Medical Integrates DeepSeek with FDA-Approved SupMR AI Platform
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Shanghai-based Subtle Medical Inc., an AI-powered medical imaging firm operating in the U.S. and China, announced FDA approval for the updated version of its SupMR generative AI image enhancement technology. The upgraded platform delivers significant improvements in MRI image quality, speed, and efficiency. Technology HighlightsThe new SupMR AI leverages the…
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MicroPort CardioFlow’s AnchorMan LAA Occluder System Earns CE Mark Approval
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Hong Kong-listed MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) has received the CE mark for its AnchorMan left atrial appendage (LAA) occluder system and its guidance system, marking a significant milestone for the China-based medical device company. The approval paves the way for the commercialization of the device in Europe.…
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Roche’s Tecentriq Wins Japan Approval for Alveolar Soft Part Sarcoma
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) and its Japanese partner Chugai Pharmaceutical Co., Ltd. (TYO: 4519) announced that the Ministry of Health, Labour and Welfare of Japan has approved Tecentriq (atezolizumab) for the treatment of unresectable alveolar soft part sarcoma. This marks the first approval of an immune…
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Gilead’s Livdelzi Receives Conditional EC Approval for Primary Biliary Cholangitis
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US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that it has received conditional approval from the European Commission (EC) for its liver disease drug Livdelzi (seladelpar). The drug is approved for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary cholangitis (PBC) in adults who have an inadequate response…
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Henlius Biotech’s Avastin Biosimilar Hanbeitai Approved in Bolivia
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that its biosimilar of Roche’s Avastin (bevacizumab), Hanbeitai, has received marketing approval in Bolivia. This marks the first approval for the drug outside of China. The product will be marketed under the trade name Longiva in the Latin American country. Licensing DealHenlius entered…
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Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
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Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products Administration (NMPA) has converted the conditional approval for its Xospata (gilteritinib) into regular approval. The decision is based on data from the COMMODORE study, a Phase III trial comparing gilteritinib to salvage chemotherapy in patients…
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Huadong Medicine’s MediBeacon TGFR System Approved by NMPA for GFR Measurement
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for the MediBeacon Transdermal GFR System (TGFR), a Category III medical device licensed from US firm MediBeacon Inc. The device is designed to assess the glomerular filtration rate (GFR)…
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Merck’s Welireg Wins Conditional EU Approval for VHL Disease and Advanced RCC
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US pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that it has received conditional approval from the European Commission (EC) for its oral drug Welireg (belzutifan) for the treatment of von Hippel-Lindau (VHL) disease and advanced clear cell renal cell carcinoma (RCC). Drug ProfileWelireg is a hypoxia-inducible factor-2…
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Samsung Bioepis’ Ospomyv and Xbryk Gain FDA Approval for RANKL Inhibitor Biosimilars
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South Korea-based Samsung Bioepis Co., Ltd. announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Ospomyv (denosumab-dssb; SB16; 60 mg pre-filled syringe) and Xbryk (denosumab-dssb; SB16; 120 mg vial), biosimilars of US major Amgen’s RANKL inhibitors Prolia and Xgeva, respectively. Additionally, the…
