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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…
