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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…
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MicroPort Endovascular’s Vewatch Filter Gets NMPA Green Light for Pulmonary Embolism Prevention
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical device company, has announced that its Vewatch vena cava filter has received approval from the National Medical Products Administration (NMPA) for the prevention of pulmonary embolism caused by thrombus detachment in the inferior vena cava system. This product marks…
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Kintor Pharmaceutical Initiates Phase II Clinical Trial for Acne Treatment GT20029 in China
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Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its drug candidate GT20029, which is being investigated for the treatment of acne in China. The Phase II study is a multi-center, randomized, double-blinded,…
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RemeGen’s Telitacicept Receives NMPA Approval for Clinical Trial in IgG4 Related Diseases
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RemeGen (HKG: 9995), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate telitacicept in IgG4 related diseases (IgG4 RD), which are at risk of recurrence. Telitacicept is a novel recombinant fusion protein that targets both…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Green Light for Breast Cancer Drug Combo
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HRS7415 in combination with HRS-8080 for the treatment of breast cancer. HRS7415 is an anti-tumor agent that works by…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Phase II Trial in Pancreatic Cancer
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 innovative drug, chiauranib. The drug will be evaluated in combination with chemotherapy…
