Jiangsu Hengrui Pharmaceuticals’ SHR-1701 Combo Therapy for Gastric Cancer Accepted for Review by China’s NMPA
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...
Market approval filings
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Receives Priority Review from China’s NMPA
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...
Novo Nordisk Advances in China with Submission of Sogroya for Adult Growth Hormone Deficiency
Denmark’s pharmaceutical heavyweight, Novo Nordisk (NYSE: NVO), has reached a significant milestone with the National...
Roche’s Columvi for Relapsed DLBCL Gets Review Nod from China’s CDE for New Indication
The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication...
Jiangsu Hengrui’s Ivarmacitinib for Adult Alopecia Areata Accepted for Review by China’s CDE
The Center for Drug Evaluation (CDE) has given the green light for the review of...
Shandong Buchang Pharmaceuticals’ rhEPO-Fc for CKD Anemia Accepted for Review by China’s CDE
BEIJING—The Center for Drug Evaluation (CDE) in China has accepted the market filing for a...
HutchMed Halts China Filing for Gastric Cancer Drug Fruquintinib Following Regulatory Feedback
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013), a China-based biopharmaceutical company, has announced the withdrawal...
J&J Files NDA for FcRn Blocker Nipocalimab, Targets Myasthenia Gravis Market
US-based Johnson & Johnson (NYSE: JNJ) has made a global first New Drug Application (NDA)...
Tonghua Golden-Horse, UCB Seek China Approvals for Alzheimer’s, Myasthenia Gravis Drugs
China’s Tonghua Golden-Horse Pharmaceutical Industry Co. Ltd. and Belgium-based UCB (FRA: UNC) are seeking marketing...
Diversifying HPV Protection: Beijing Wantai’s Vaccine Filing Competes with Gardasil 9 in China
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai...
CK Life Sciences’ Halneuron Receives FDA Fast-Track Designation for Chemotherapy-Induced Neuropathic Pain
CK Life Sciences (HKG: 0775), a biopharmaceutical company headquartered in China, has received fast-track designation...
Hangzhou Biosunpharma’s OB756 New Drug Application Accepted for Myelofibrosis Treatment by China’s NMPA
Hangzhou Biosunpharma Co., Ltd. has announced that the National Medical Products Administration (NMPA) has accepted...
Pfizer’s Hemophilia Treatment Marstacimab Accepted for Review in China
The China Center for Drug Evaluation (CDE) has accepted for review a market approval filing...
Junshi Biosciences Submits Twelfth Indication for PD-1 Inhibitor Loqtorzi in China
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced a new indication filing...
Ascendis Pharma’s Hypoparathyroidism Therapy Yorvipath Wins FDA Nod, Fills Market Gap
This week, the U.S. Food and Drug Administration (FDA) granted market approval to Ascendis Pharma...
Sino Biopharmaceutical’s Benmelstobart Files for New Indication in China for Advanced RCC Treatment
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that...
Innovent Biologics’ Mazdutide NDA for Type 2 Diabetes Accepted for Review in China
Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has announced that the...
Cutia Therapeutics’ CU-30101 NDA Accepted for Review by China’s NMPA
Cutia Therapeutics (HKG: 2487), a company specializing in dermatological treatments, has announced that the National...
Junshi Biosciences’ Toripalimab Recommended for EU Approval for Two Indications
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has been recommended for approval by...
Akeso Biopharma’s Ivonescimab NDA Accepted by NMPA, Strengthening NSCLC Treatment Options
Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has received a significant boost...