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...
Drug
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...
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...
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...
Ascletis Receives IND Approval for ASC10 in Monkeypox Treatment
China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving Investigational New Drug (IND) approval from...
Legend Biotech’s Carvykti Meets Primary Endpoint in CARTITUDE-4 Phase III Study
Legend Biotech (NASDAQ: LEGN) has released positive data from the CARTITUDE-4 Phase III study, evaluating...
CSPC’s Octreotide Long-Acting Injection Approved for Acromegaly Clinical Study
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical...
BeiGene’s Brukinsa Approved by FDA for Chronic Lymphocytic Leukemia
China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the US FDA has...
CNBG-Virogin’s Omicron-Targeted mRNA Vaccine Approved for Clinical Trials
CNBG-Virogin Biotech (Shanghai) Co., Ltd has announced obtaining clinical trial approval from the National Medical...
Hepagene’s FXR Agonist HPG1860 Shows Positive Phase IIa Data in NASH Study
China-based liver disease specialist Hepagene Therapeutics (HK) Limited has revealed positive data from the Phase...
BMS’s Opdivo Approved in China for Neoadjuvant Therapy in Urothelial Carcinoma
US-based Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another new indication approval in China for...
Harbour BioMed Receives FDA Approval for HBM1007 Clinical Study
China-based Harbour BioMed (HKG: 2142) has announced receiving approval from the US FDA to initiate...
Joincare’s Biosimilar Tocilizumab Approved for Marketing in China
China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that its subsidiary Zhuhai...
CANbridge Pharmaceuticals Initiates Phase II Dosing for CAN103 in Gaucher Disease
China-based CANbridge Pharmaceuticals, Inc. (HKG: 1228) has announced the first patient dosing in the Phase...
CDE Grants Priority Review to Takeda’s Vonicog Alfa, Zhongmei’s Rilonacept, and Zai Lab’s SUL-DUR
The Center for Drug Evaluation (CDE) has indicated that Takeda’s Vonicog alfa, Zhongmei Huadong Pharma’s...
Immunofoco’s CLDN18.2-Targeted CAR-T Therapy IMC002 Accepted for CDE Review
China’s Center for Drug Evaluation (CDE) has accepted a clinical trial filing for IMC002, an...