AccurEdit Therapeutics’ Gene-Editing Drug ART001 Clears FDA Hurdle for US Clinical Trials
SUZHOU—AccurEdit Therapeutics (Suzhou) Co., Ltd, a leading Chinese specialist in gene editing therapies, has announced...
Drug
Bio-Thera Solutions’ BAT2406 Biosimilar Gets Green Light for Clinical Trials in China
GUANGZHOU—Bio-Thera Solutions (SHA: 688177), a leading biopharmaceutical company based in Guangzhou, has received approval from...
Hutchmed Withdraws Fruquintinib’s New Indication Application in China, Seeks Alternative Regulatory Path
HONG KONG—Hutchmed (HKG: 0013) has announced its decision to proactively withdraw the new indication application...
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)...
Merck Ends Phase III Keytruda Studies in NSCLC and cSCC Due to Insufficient Results
US-based Merck, Sharp & Dohme Inc. (NYSE: MRK) announced the discontinuation of two Phase III...
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...
Doma Biopharmaceutical Receives FDA Clearance for Phase I Trial of EGFR-MET Targeting ADC, DM005
Doma Biopharmaceutical (Suzhou) Co., Ltd, a Chinese pharmaceutical firm, has received approval from the U.S....
Jiyuan Biotechnology’s Stem Cell Therapy for Type 2 Diabetes Gains NMPA Tacit Approval for Clinical Trials
BEIJING—Jiyuan Biotechnology, a leading Chinese biopharmaceutical company, has secured tacit clinical trial approval from the...
CNGB Virogin’s VG161 On Track for Breakthrough Designation in China for Advanced Liver Cancer
BEIJING—CNGB Virogin, a joint venture between Virogin Biotech and China National Biotec Group, is poised...
Sinopharm and Ruidio Pharmaceutical Advance in Priority Review for Innovative Drugs and Vaccines
BEIJING—The Center for Drug Evaluation (CDE) has indicated that two Chinese companies, Foshan Ruidio Pharmaceutical...
Jiangsu Simcere and AnDiConBio’s Anti-Influenza Drug ADC189 Doses First Patient in Phase III Study
JIANGSU—In a significant development for the pharmaceutical industry, Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096),...
Sino Biopharmaceutical’s Anlotinib-Penpulimab Combo Meets Milestone in Phase III HCC Study
HONG KONG—Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced...
Jiangxi Jemincare Secures First Generic Approval for GSK’s Requip in China
Jiangxi Jemincare Group, based in China, has received marketing approval from the National Medical Products...
Sanofi Halts Flu Vaccine Distribution in China Amid Potency Concerns
Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has reportedly suspended the distribution and sale of...
JW Therapeutics’ CAR-T Therapy Carteyva Secures NMPA Approval for Mantle Cell Lymphoma Indication
JW Therapeutics, a biopharmaceutical company based in China and listed on the Hong Kong Stock...
Shanghai-Based ANEXT Commences Clinical Trials for Exosome Product ANEXT FIT CELL in Respiratory Conditions
ANEXT, a Shanghai-based exosome specialist, has launched two clinical studies for their product ANEXT FIT...
Legend Biotech’s Carvykti Receives NMPA Approval for Relapsed/Refractory Multiple Myeloma After Multi-Center Phase II Study
Legend Biotech Corporation (NASDAQ: LEGN) has secured a significant milestone with the announcement of marketing...
Jiangsu Hengrui’s Vunakizumab Receives NMPA Approval as First Homegrown Autoimmune IL-17A Drug
Jiangsu Hengrui Pharmaceuticals Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange...
Hinova Pharmaceuticals’ HP515 Receives NMPA Approval for NASH Clinical Study
Hinova Pharmaceuticals Inc., a biotech firm headquartered in Chengdu and listed on the Shanghai Stock...
Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange...