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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 Pharmaceuticals’ Generic Abraxane for Metastatic Pancreatic Cancer Treatment
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Jiangsu Hengrui Pharmaceuticals 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…
