CDE Drafts Proposal on Generic Drug Studies for Varieties without Reference Preparations
The Center for Drug Evaluation (CDE) has released a Notice on the “Generic Study for...
Mural Health Partners with Clinflash to Enhance Patient Payments in Clinical Trials
US-based Mural Health has announced a strategic partnership with China-based Clinflash, both companies specializing in...
Hanx Biopharmaceuticals’ HX009 Receives US IND Approval for Lymphoma Treatment
Wuhan-based firm Hanx Biopharmaceuticals Inc. has announced the receipt of an Investigational New Drug (IND)...
Clover Biopharmaceuticals Partners with Kyuan Trade for Commercial Launch of AdimFlu-S (QIS) in China
China-based Clover Biopharmaceuticals Ltd (Clover; HKG: 2197) has announced the establishment of a commercial partnership...
Minghui Pharmaceutical Initiates First-in-Human Trial for IGF-1R Antibody Fusion Protein MHB018A
China-based Minghui Pharmaceutical Inc. has announced the commencement of a first-in-human Phase Ia trial for...
Shanghai Ark Biopharmaceutical Partners with WuXi STA for Commercial Supply of Ziresovir
China’s Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) has entered into a partnership with WuXi STA,...
China’s NMPA and NHC Tighten Regulations on Tramadol Compound Preparations
The National Medical Products Administration (NMPA) and National Health Commission (NHC) have released a notification...
Sino Biopharmaceutical’s TQ-B3525 Files for Market Approval with CDE
Sino Biopharmaceutical Ltd (HKG: 1177) has announced a market approval filing for its Category 1...
MabPharm’s CMAB007 Receives NMPA Approval for IgE-Mediated Asthma Treatment
Taizhou-based monoclonal antibody (mAb) biosimliars specialist MabPharm Ltd (HKG: 2181) has announced that it has...
Alibaba Health Reports 30.1% Revenue Growth in 2022 Financial Report
China-based Alibaba Health Information Technology Ltd (HKG: 0241) has released its financial report for the...
Enhertu, HER2-Targeted ADC, Officially Launched in China for Breast Cancer Treatment
Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and...
BeiGene’s Tislelizumab Approved in China for First-Line Esophageal Squamous Cell Carcinoma
BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved...
Bayer’s Copanlisib (Aliqopa) Approved by NMPA for Recurrent Follicular Lymphoma
The National Medical Products Administration (NMPA) has indicated on its website that Bayer’s (ETR: BAYN)...
Azenta Life Sciences and Vazyme Biotech Form Global Partnership for Comprehensive Services
Azenta Life Sciences (NASDAQ: AZTA) has entered into a global partnership with China-based Vazyme Biotech...
3SBio Inc. Initiates Phase III Clinical Study for Thrombopoietin in Chronic Liver Disease Patients
China-based 3SBio Inc. (HKG: 1530) has announced the enrollment of the first patient in a...
Shanghai Junshi Biosciences’ Tuoyi Combo for Triple Negative Breast Cancer Accepted for Review
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the regulatory authorities...
Oculis’ OCS-01 Achieves Primary Efficacy Endpoint in Phase III DIAMOND Trial for DME
US-based Oculis Holding AG (NASDAQ: OCS) has announced positive top-line results from Stage 1 of...
Nona Biosciences and ModeX Therapeutics Partner to Develop Polyspecific Antibodies
Nona Biosciences, a wholly owned subsidiary of Harbour BioMed (HKG: 2142), which operates across the...
NHSA Proposes Draft to Enhance Basic Medical Insurance Payment Management for Consumables
The National Healthcare Security Administration (NHSA) has issued a Notice seeking public feedback on draft...
SinoMab BioScience’s SM17 IND Accepted by NMPA for Potential Global First-in-Class Monoclonal Antibody
Hong Kong-based biotech SinoMab BioScience Ltd (HKG: 3681) has announced that the National Medical Products...