Betta Pharmaceuticals’ BPI-D0316 Accepted for Review by CDE for First-Line NSCLC
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for...
Jiangsu Alpha Biopharma’s Zorifertinib NDA Accepted for Review by CDE
China-based Jiangsu Alpha Biopharma Ltd has announced that the New Drug Application (NDA) for its...
Grand Pharma’s Jext Auto-Injector Approved for Import into Greater Bay Area
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced receiving official approval from the Guangdong...
Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD)...
CDE Grants Priority Review Status to Kechow’s HL-085 for Melanoma Treatment
The Center for Drug Evaluation (CDE) website indicates that Kechow Pharma’s HL-085 is set to...
NMPA Approves Two China-Developed COVID-19 Small-Molecule Therapies
The National Medical Products Administration (NMPA) has issued conditional marketing approvals to two novel, China-discovered...
China’s NHC Issues Guidelines to Improve Pediatric Medication Management
The National Health Commission (NHC) has released a notification aimed at refining management measures for...
China’s Multi-Bureau Plan Aims to Eradicate Cervical Cancer by 2030
The National Health Commission (NHC), Ministry of Education, Ministry of Civil Affairs, and six other...
JS InnoPharm’s US Subsidiary Initiates Phase I Trial for AURKA Inhibitor VIC-1911
Shanghai-based JS InnoPharm Ltd has announced the initiation of a Phase I clinical study by...
Akeso Receives First $300M Installment from Summit for Bispecific Antibody Ivonescimab
Akeso Inc. (HKG: 9926) has announced receiving the first installment of USD 300 million as...
NMPA Proposes Emergency Use Management Measures for Medical Devices
The National Medical Products Administration (NMPA) has released the “Medical Device Emergency Use Management Measures”...
InnoCare’s Gunagratinib Shows Promising Data in Cholangiocarcinoma at ASCO-GI 2023
Beijing InnoCare Pharma Tech Co. (HKG: 9969), a China-based biotech specializing in cancer and autoimmune...
Exegenesis Bio Gains FDA Approval for Gene Therapy EXG102-031 in Wet AMD
Hangzhou-based clinical stage gene therapy firm Exegenesis Bio has announced receiving approval from the US...
Simcere’s Cosela Receives First Prescription in China for CDK4/6 Inhibition
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the issuance of the first prescription for...
China Updates Export Controls on Technologies, Adds Gene Editing to List
The Ministry of Finance (MOF) has released an updated notification regarding technologies banned and restricted...
Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical...
Fosun Pharma’s Comirnaty Bivalent Vaccine Approved in Macau for Booster Shots
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its Comirnaty...
HuidaGene Receives FDA IND Approval for Ophthalmology Gene Therapy HG004
China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from...
HutchMed Signs Licensing Deal with Takeda for Global Fruquintinib Development
Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced a licensing deal with Japanese...