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Gilead’s Lenacapavir Shows 100% Efficacy in Phase III HIV PrEP Study
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Gilead Sciences Inc. (NASDAQ: GILD), a U.S. biopharmaceutical company, has announced topline results from the Phase III PURPOSE 1 study. The study indicates that lenacapvir has successfully demonstrated its potential as a twice-yearly pre-exposure prophylaxis (PrEP) drug to prevent HIV infection. The trial involved 5,300 cisgender women and adolescent girls…
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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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Zhangzhou Pien Tze Huang’s PZH2113 Receives NMPA Clinical Trial Approval for Lymphoma Treatment
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Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436), a renowned traditional Chinese medicine (TCM) company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its PZH2113. This is an in-house developed Category 1 chemical drug intended for the treatment…
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Tonghua Dongbao Pharmaceuticals’ THDBH120 Receives NMPA Approval for Phase II Clinical Trial
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), based in China, has announced that the National Medical Products Administration (NMPA) has approved the Phase Ib clinical study for its drug candidate THDBH120, a glucagon-like peptide-1/gastrin inhibitor (GLP-1/GIP) dual-targeted receptor agonist. The drug is intended for the treatment of overweight or obese adults. THDBH120…
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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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Fudan-Zhangjiang Bio-Pharmaceutical Advances Aminolevulinic Acid Study for Glioma Visualization
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505) has announced that the first subject has been enrolled in a confirmatory clinical study for its aminolevulinic acid used in the intraoperative visualization of advanced gliomas. This development comes as the company seeks to enhance surgical outcomes for patients with this…
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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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Keymed Biosciences’ CM313 Shows Promise in Treating Immune Thrombocytopenia, NEJM Study Says
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Keymed Biosciences Inc. (HKG: 2162), a biopharmaceutical company based in China, has published results from an exploratory clinical study on its Category 1 drug CM313 in the New England Journal of Medicine. CM313 is a CD38-targeted monoclonal antibody (mAb) being investigated for the treatment of primary immune thrombocytopenia (ITP). The…
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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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NMPA Releases 81st Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 81st batch of reference drugs for generic quality consistency evaluation (GQCE) work, comprising a total of 84 specifications. This batch includes 44 new specifications and 40 specifications that have undergone modifications.- Flcube.com
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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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Suzhou Zelgen’s Recombinant Human Thyroid Stimulating Hormone Accepted for NMPA Review
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review its market approval filing for recombinant human thyroid stimulating hormone (rhTSH). The biomacromolecular drug is intended for use in radioactive iodine (131I) whole body…
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Clover Biopharmaceuticals’ RSV Vaccine Candidate Shows Promising Results in Elderly
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Clover Biopharmaceuticals Ltd. (HKG: 2197), a biopharmaceutical company based in China, has announced positive preliminary results from the Phase I clinical study of its pipeline candidate SCB-1019 in the elderly population. The molecule is a respiratory syncytial virus (RSV) PreF trimeric subunit candidate vaccine. A total of 48 subjects were…
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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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AstraZeneca’s AKT Inhibitor Truqap Misses Primary Endpoints in Phase III TNBC Trial
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AstraZeneca (NASDAQ: AZN), a leading UK-based pharmaceutical company, has encountered a setback in the Phase III clinical trial for its first-in-class adenosine triphosphate (ATP)-competitive AKT inhibitor, Truqap (capivasertib). The trial, known as CAPItelo-290, failed to meet its dual primary endpoints of improved overall survival (OS) in both the overall trial…
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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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Ascentage Pharma Presents Positive Clinical Results for Olverembatinib and Lisaftoclax at EHA Meeting
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has presented the results of multiple clinical trials for two of its pipeline candidates at the 29th European Hematology Association (EHA) Annual Meeting. The candidates are olverembatinib, a Category 1 drug and approved BCR-ABL inhibitor, and the investigational BCL-2 inhibitor…
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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…
