GeneQuantum Healthcare’s GQ1005 ADC Receives CDE Clearance for Phase III Breast Cancer Trial
SUZHOU—GeneQuantum Healthcare (Suzhou) Co., Ltd has received clearance from the Center for Drug Evaluation (CDE)...
Drug
Sinocelltech’s Anti-Angiogenic Biologic SCT520FF Gets NMPA Green Light for Neovascular AMD Clinical Study
SHANGHAI—Sinocelltech Group Ltd (SHA: 688520), a Chinese biopharmaceutical company, has announced that it has received...
China’s Evopoint Biosciences and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Evopoint Biosciences’ EZH2 inhibitor...
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...
Biocon Biologics Resolves Patent Dispute with J&J, Secures Market Entry for Biosimilar Stelara
Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE:...
Zuellig Pharma Partners with Regeneron for Libtayo Launch in South Korea and Taiwan
Singapore-headquartered Zuellig Pharma, a leading healthcare solutions provider, has entered into an agreement with US...
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...
Novo Nordisk to Resubmit Wegovy Heart Failure Application with Updated Clinical Data
Denmark’s pharmaceutical giant, Novo Nordisk (NYSE: NVO), has reported significant findings on the efficacy of...
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...
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...