Roche’s Rozlytrek on Track for Priority Review for Pediatric NTRK Fusion Tumor Treatment
The Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Rozlytrek (entrectinib)...
Drug
Asieris Pharmaceuticals to Present Phase I Results of APL-1202 Combo at ASCO
China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced that it will publish the...
Antengene’s ATG-022 Earns FDA Orphan Drug Designations for Gastric and Pancreatic Cancers
China-based Antengene Corporation Limited (HKG: 6996) has announced that its in-house discovered and developed antibody...
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...
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...
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)...
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...
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...
HighTide Therapeutics’ HTD1801 Meets Primary and Secondary Endpoints in Type 2 Diabetes Phase II Study
China-based HighTide Therapeutics Inc. (HKG: 2511) has announced that its Phase II study for the...
Zhejiang Conba Pharmaceutical’s Inhalable Pirfenidone for IPF Clears for Chinese Clinical Trials
Zhejiang Conba Pharmaceutical Co., Ltd (SHA: 600572) has announced that its modified version of US...
Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for Two Autoimmune Disease Drug Candidates
China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has separately announced clinical trial approvals from the National...
Sino-US Laekna Receives FDA Clearance for LAE102 Clinical Trial in NSCLC
Sino-US Laekna has announced that it has received clinical trial clearance from the US Food...
Cabaletta Bio’s CABA-201 Clears FDA for Phase I/II Study in Idiopathic Inflammatory Myopathy
US-based Cabaletta Bio, Inc. (NASDAQ: CABA) has announced that the US Food and Drug Administration...