Skyline Therapeutics’ Gene Therapy SKG0201 for SMA Gets Green Light from China’s NMPA
Skyline Therapeutics has received clinical trial approval from China’s National Medical Products Administration (NMPA) for...
Drug
Kelun-Biotech’s SKB264 NDA Accepted by NMPA for mTNBC, Poised to Be China’s First TROP2-targeted ADC
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan...
Chinese Biotech Precision Biotechnology Gets NMPA Green Light for Advanced Cancer Therapies
Chongqing Precision Biotechnology Co., Ltd, a Chinese biopharmaceutical company, has received approval from the National...
MSD Halts Phase III Trial of Keytruda Combo in NSCLC After Missing Primary Endpoints
Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced the discontinuation of a Phase III...
Novartis Reports Kisqali Success in Reducing Recurrence Risk in Early Breast Cancer
Novartis (NYSE: NVS) has announced an update on the late-stage trial for its CDK4/6 inhibitor...
Keymed Biosciences’ Stapokibart Filing Accepted for Priority Review in China for Atopic Dermatitis
Keymed Biosciences Inc. (HKG: 2162) has announced that its market filing for stapokibart (CM310), a...
Pfizer and CStone Secure NMPA Approval for Sugemalimab, First PD-L1 Inhibitor for ESCC
Pfizer (NYSE: PFE) and CStone Pharmaceuticals (HKG: 2616) have secured market approval from the National...
Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the...
Mabwell Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it has received approval from...
HutchMed’s Sovleplenib Set for Priority Review in China for Chronic Immune Thrombocytopenia
China’s Center for Drug Evaluation (CDE) has indicated that HutchMed (China) Ltd (NASDAQ: HCM; HKG:...
Trinomab’s TNM002 Antitetanus Monoclonal Antibody Filing Accepted for Review in China
China’s Center for Drug Evaluation (CDE) has accepted Trinomab Biotech Co., Ltd.’s market approval filing...
Eli Lilly Seeks Approval for Pirtobrutinib in China for Relapsed Mantle Cell Lymphoma
Eli Lilly (NYSE: LLY) has submitted a marketing approval application for pirtobrutinib, an oral, non-covalent...
Shenzhen TargetRx’s TGRX-678 Set to Receive Breakthrough Therapy Designation for CML-AP
Shenzhen TargetRx, Inc., a China-based developer of small-molecule kinase inhibitors, is poised to receive breakthrough...
Changchun BCHT Secures NMPA Approval for Freeze-Dried Human Rabies Vaccine Trials
Changchun BCHT Biotechnology Co., Ltd. (SHA: 688276), based in China, has announced that it has...
Shanghai Pharmaceuticals Gains NMPA Approval for WST04 Clinical Trials in Oncology
Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading pharmaceutical distribution company in China, has...
Jiangsu Hengrui Seeks NMPA Approval for Camrelizumab-Famitinib Combo in Cervical Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), based in China, has announced that its market...
Antengene Secures NDA Approval for Xpovio in Macau for Advanced Multiple Myeloma
Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it...
Novartis’ Fabhalta Wins FDA Nod as First-in-Class Treatment for Paroxysmal Nocturnal Hemoglobinuria
Swiss pharmaceutical giant Novartis (NYSE: NVS) has secured regulatory approval from the US Food and...
China Medical System’s Methotrexate Injection Receives NMPA Review for Rheumatoid Arthritis Indication
China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration...
Huadong Medicine Gets NMPA Green Light for Sirolimus Real-World Study in Pediatric Epilepsy
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has received approval from the...