Hong Kong Aims for “First-Level Approvals” with New Drug Regulatory Institution
Hong Kong is taking steps to establish a drug regulatory institution that will permit “first-level...
Sino Medical Sciences Secures Market Approvals in Hong Kong, China, and Malaysia for Medical Devices
China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approvals for two...
J&J’s Carvykti Demonstrates Extended Time to Symptom Worsening in Multiple Myeloma Patients
Johnson & Johnson (J&J; NYSE: JNJ) has released data from a Phase III study showing...
Dizal Pharmaceutical Presents Positive Trial Data for Golidocitinib at ASH Annual Meeting
China-based Dizal Pharmaceutical Co., Ltd, (SHA: 688192), a spin-off from AstraZeneca (AZ, NASDAQ: AZN) China...
China Medical System Gets NMPA Green Light for Phase III Vitiligo Study with Ruxolitinib Cream
China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from...
CARsgen Therapeutics Halts Clinical Studies for Three CAR-T Therapies in the US Following FDA Request
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the US Food and Drug...
Shanghai Henlius Biotech Submits Another Application for Serplulimab in China
Shanghai Henlius Biotech Inc., (HKG: 2696) has announced a new market filing for its anti-programmed...
Clover Biopharmaceuticals Commences Phase I Trial for RSV Vaccine in Australia
China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the successful enrollment of the first batch...
HutchMed’s Elunate-Tyvyt Combination Study for Renal Cell Carcinoma Completes Enrollment
China-based HutchMed (NASDAQ: HCM) has announced the completion of patient enrollment in its Phase II/III...
Luye Pharma’s Lurbinectedin Receives Market Approval in Hong Kong for SCLC Treatment
China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board...
Suzhou OSAI Biopharma’s L. crispatus Capsule Meets Phase III Endpoints in Bacterial Vaginosis Study
China-based Suzhou OSAI Biopharma Inc., a specialist in live biotherapeutic products (LBPs), has announced that...
Sanofi Abandons MZE001 Licensing Deal Following FTC Intervention Over Pompe Disease Monopoly Concerns
Sanofi (NASDAQ: SNY) has withdrawn from an agreement announced earlier this year to in-license the...
BMS Advances TIGITxCD96 Bispecific Antibody into Phase II Dose Expansion
Bristol Myers Squibb (BMS; NYSE: BMY) has advanced its development program for the TIGITxCD96 bispecific...
Sanofi Partners with Minapharm for Local Production of Anticoagulant Clexane in Egypt
Sanofi (NASDAQ: SNY) has entered into a partnership with Egyptian biotechnology company Minapharm to locally...
Sisram Medical’s Profhilo Accepted for Review by China’s NMPA
Sisram Medical Ltd (HKG: 1696), an Israel-based company within the Fosun Pharmaceutical Group (SHA: 600196),...
Staidson Pharmaceutical Initiates Clinical Study for ARDS Treatment STSA-1002
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a Chinese pharmaceutical company, has announced the dosing...
Cryofocus Medtech Receives NMPA Approval for Complete Cardiac Cryoablation System
Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922), a Shanghai-based specialist in cryoablation treatment, has announced...
Staidson Pharmaceutical Halts Clinical Trial for Hepatitis B Drug Due to Efficacy Concerns
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a Chinese pharmaceutical company, has announced the cancellation...
Zylox-Tonbridge Medical Technology’s ZENFLOW T18 Receives NMPA Marketing Approval
Zylox-Tonbridge Medical Technology (HKG: 2190), a developer of nerve and peripheral vascular interventional devices based...
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...