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BrightGene Bio-Medical Technology Gains NMPA Approval for Oseltamivir Dry Suspension
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China-based BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166) has announced receiving market approval from the National Medical Products Administration (NMPA) for its oseltamivir dry suspension. The drug is approved for treating influenza A and B in patients aged two weeks and older, and for the prophylaxis of influenza A and…
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Lee’s Pharmaceutical Wins NMPA Approval for ALS Drug Teglutik
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has announced receiving market approval from the National Medical Products Administration (NMPA) for its drug Teglutik (riluzole), intended to prolong the life of patients with amyotrophic lateral sclerosis (ALS) or delay the need for mechanical ventilation. Drug Background and MechanismTeglutik, a neuroprotective agent…
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Merck KGaA’s Erbitux Approved in China for Head and Neck Cancer Treatment
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Germany-based pharmaceutical firm Merck KGaA announced that China’s National Medical Products Administration (NMPA) has issued market approval for a new indication for the epidermal growth factor receptor (EGFR) inhibitor Erbitux (cetuximab). The approval allows Erbitux to be used in combination with radiotherapy for treating locally advanced squamous cell carcinoma of…
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Ocumension Therapeutics’ OT-401 Approved for Chronic Non-Infectious Uveitis in China
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China-based Ocumension Therapeutics (HKG: 1477) has received approval from the National Medical Products Administration (NMPA) for its drug OT-401 (fluocinolone intravitreal implant) for treating chronic non-infectious uveitis. This marks a significant milestone as the first new drug approved in China based on real-world data (RWD), accelerating its commercialization by approximately…
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Qingdao HuaRen Pharmaceutical Gains CE Marks for Monkeypox and COVID-19 Detection Kits
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China-based Qingdao HuaRen Pharmaceutical Co., Ltd (SHE: 300110) has announced receiving CE marks in the European Union (EU) for its monkeypox virus nucleic acid detection kit (fluorescent PCR method) and novel coronavirus (SARS-CoV-2) antigen detection kit. Monkeypox Virus Detection KitThe monkeypox virus nucleic acid detection kit uses a real-time fluorescent…
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SSY Group’s Blonanserin and Paracetamol Approved by China’s NMPA
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China-based SSY Group Limited (HKG: 2005) has announced receiving market approvals from the National Medical Products Administration (NMPA) for its generic versions of blonanserin, paracetamol, mannitol, and levofloxacin. Notably, the generic versions of blonanserin and paracetamol are the first of their kind to be approved in China. Drug Details and…
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Innovent Biologics’ Tyvyt Approved for First-Line Esophageal Squamous Cell Carcinoma
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The National Medical Products Administration (NMPA) website indicates that China-based Innovent Biologics, Inc. (HKG: 1801) has received approval for a new indication of its PD-1 inhibitor Tyvyt (sintilimab) for the treatment of first-line esophageal squamous cell carcinoma (ESCC). This marks the fifth indication approval for the drug in China. Drug…
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Boston Scientific Launches Expect Airway Ultrasound Needle in China for Lung Cancer Diagnosis
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US-based Boston Scientific Corporation (NYSE: BSX) has announced the official market launch of its Expect airway ultrasound needle in mainland China. The product is designed for use in transbronchial needle aspiration biopsies guided by endoscopic ultrasonography, offering a significant advancement in lung cancer diagnosis. Product Innovation and AdvantagesThe Expect airway…
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BeiGene’s Brukinsa Faces Three-Month FDA Approval Delay for CLL/SLL Indication
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China-based biotech company BeiGene Inc. (Nasdaq: BGNE) will experience a three-month delay in its pursuit of US approval for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The US Food and Drug Administration (FDA) has pushed back the…
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Innovent Biologics Receives BPOM Approval for Bevagen in Indonesia
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China-based Innovent Biologics Inc. (HKG: 1801) has announced receiving indication approvals from Indonesia’s Badan Pengawas Obat dan Makanan (BPOM) for its Bevagen (bevacizumab), a biosimilar version of Avastin. This approval marks a significant milestone for Innovent as it expands its market presence in Southeast Asia. Approved IndicationsInnovent’s bevacizumab has been…
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Huadong Medicine’s SaiYueXin Receives NMPA Approval for Pediatric Psoriasis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA) has approved another indication for its SaiYueXin, a biosimilar version of Johnson & Johnson’s (J&J) autoimmune disease drug Stelara (ustekinumab). The drug is now approved for use in China to treat children and adolescents aged…
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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…
