FDA Issues Second CRL to Hengrui’s Camrelizumab Combo Due to Manufacturing Issues
The US Food and Drug Administration (FDA) last week issued another complete response letter (CRL)...
Drug
Shanghai Junshi Biosciences’ Loqtorzi Approved for Hepatocellular Carcinoma Treatment
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving approval from the...
HutchMed’s Tazverik Receives Conditional Approval from China’s NMPA for Lymphoma Treatment
China-based HutchMed (NASDAQ: HCM, HKG: 0013) has announced receiving conditional marketing approval from the National...
Innovent Biologics Doses First Patient with IBI354 in HeriCare-Ovarian01 Study
China-based Innovent Biologics, Inc. (HKG: 1801) has administered the first dose of its antibody-drug conjugate...
Everest Medicines’ EVM14 mRNA Cancer Vaccine Clears US FDA IND Application
China-based Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for...
CSPC Pharmaceutical Group Gains NMPA Approval for SYS6040 Clinical Trial
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical...
Daiichi Sankyo Launches Datroway in Japan for HR Positive, HER2 Negative Breast Cancer
Japan-based Daiichi Sankyo (TYO: 4568) has announced the launch of Datroway (datopotamab deruxtecan) in Japan....
Triastek’s 3D-Printed T20G Receives US Clinical Approval for NOAC Treatment
China-based Triastek Inc., a pharmaceutical-focused 3D printing company, has announced receiving clinical approval in the...
Johnson & Johnson’s Tremfya Gains FDA Approval for Crohn’s Disease Treatment
US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced receiving clearance from the...
Elevation Oncology Halts EO-3021 Development After Poor Phase 1 Data
US-based Elevation Oncology, Inc. (NASDAQ: ELEV) has announced the decision to terminate development of EO-3021...
Changchun High & New Technology Industries Receives US Trial Approval for GenSci120 in Rheumatoid Arthritis
China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced its subsidiary GenScipt...
Novartis’ Fabhalta Approved by FDA for C3 Glomerulopathy Treatment
Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan, marketed as Fabhalta, has received approval from the...
Arcutis Biotherapeutics’ Zoryve Cream Nears FDA Approval for Pediatric Atopic Dermatitis
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its US partner Arcutis Biotherapeutics, Inc....
Kintor Pharmaceutical’s KX-826 Shows Promising Results in Alopecia Phase III Trial
China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced positive topline results from the long-term safety Phase...
Junshi Biosciences Receives NMPA Approval for JS212 in Advanced Solid Tumors
China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced receiving clearance from the...
Hengrui’s Trastuzumab Rezetecan Nears 8th Breakthrough Therapy Designation
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an...
Fosun’s Henlius Receives FDA Orphan Drug Designation for HER2-Targeting HLX22
On March 19, 2025, Fosun Pharmaceutical (SHA: 600196) announced that its subsidiary, Henlius, has received...
Joyo Pharma’s JYP0035 Receives Clinical Trial Approval for Breast Cancer Treatment
On March 14, 2025, Joyo Pharma announced that its independently developed next-generation, highly selective Class...
Tonghua Dongbao Initiates Phase III Trial for Insulin Degludec, Liraglutide Combo in Type 2 Diabetes
China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has initiated a Phase III clinical study for its...
AccurEdit Therapeutics Receives FDA Orphan Drug Designation for ATTR Treatment
China-based AccurEdit Therapeutics (Suzhou) Co., Ltd announced receiving Orphan Drug Designation (ODD) from the US...