Innovent Biologics Secures Macau Approval for Dual-Immunotherapy Neoadjuvant Regimen in MSI-H/dMMR Colon Cancer
Innovent Biologics (HKG: 1801) announced that its independently developed Daboxin (ipilimumab N01) has received marketing...
Drug
Kelun-Biotech’s Sacituzumab Tirumotecan Achieves World’s First ADC-Immunotherapy Phase III Success in PD-L1-Negative NSCLC
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that its Phase III clinical study evaluating sacituzumab...
CSPC Pharmaceutical Secures Dual NMPA Breakthrough Therapy Designations for HER2-Positive Breast Cancer Combination
CSPC Pharmaceutical Group (HKG: 1093) announced that its self-developed docetaxel (albumin-bound) (HB1801) and Anbenitamab (KN026)—developed...
Biogen Advances Diranersen into Phase 3 Development Following Positive Alzheimer’s Phase 2 Data
Biogen Inc. (NASDAQ: BIIB) presented positive Phase 2 CELIA study data for diranersen (BIIB080), an...
Sino Biopharmaceutical’s TRD205 Secures NMPA Breakthrough Therapy Designation for Chronic Post-Surgical Neuropathic Pain
Sino Biopharmaceutical (HKG: 1177) announced that TRD205, a Category 1 innovative drug self-developed by its...
Lynk Pharmaceuticals Completes Phase 3 Enrollment for Zemprocitinib in Ankylosing Spondylitis Trial
Lynk Pharmaceuticals Co., Ltd. announced that enrollment has been completed for zemprocitinib capsules, a second-generation...
Haisco Pharmaceutical Secures NMPA IND Acceptance for HSK60002 Tablets in Inflammatory Diseases
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that the Investigational New Drug (IND) application...
B&K Corporation Completes Patient Enrollment in Phase II Diabetic Foot Ulcer Trial for Pro-101-2 rhPDGF-BB Therapy
B&K Corporation Limited (HKG: 2396) announced the completion of patient enrollment in its Phase II...
Huadong Medicine’s Subsidiary Secures NMPA Approval for First-in-Class Trispecific Agonist DR10624 in Heart Failure Treatment
Huadong Medicine Co., Ltd. (SHE: 000963) announced that the clinical trial application for DR10624 injection,...
Hengrui Pharmaceuticals Secures NMPA Clinical Trial Approval for SHR-3079 in Systemic Lupus Erythematosus and Rheumatoid Arthritis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that SHR-3079 injection has received...
Hengrui Pharmaceuticals Secures NMPA Breakthrough Therapy Designation for HRS-7058 in KRAS G12C-Mutant Pancreatic Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its Category 1 chemical...
Fosun Pharma Secures NMPA Approval for Phase 1 Trial of HLX37 Bispecific Antibody in Combination Therapies for Advanced Solid Tumors
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196; HKG: 2196) announced that China’s National Medical...
Haisco Submits NMPA Marketing Application for Crisugabalin’s New Indication in Neuropathic Pain Treatment
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that it has submitted a marketing application...
Shenyang Xingqi Pharmaceutical Secures NMPA Approval for SQ-23101 Injection – Novel Bispecific Antibody Therapy for Thyroid Eye Disease
Shenyang Xingqi Pharmaceutical Co., Ltd. (SHE: 300573) announced that China’s National Medical Products Administration (NMPA)...
EMA CHMP Recommends Revocation of TAVNEOS Marketing Authorization Following Data Integrity Concerns in ADVOCATE Trial
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL Limited announced that the European Medicines...
Abbisko Therapeutics Secures FDA IND Clearance for Pan-KRAS Inhibitor ABSK211, Targeting Broad Spectrum of KRAS Alterations in Solid Tumors
Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that the U.S. Food and Drug Administration (FDA)...
LongBio Pharma Secures FDA IND Approval for Novel Anti-IgE Antibody LP-003 in Peanut Allergy, Expanding Global Allergic Disease Pipeline
LongBio Pharma (Suzhou) Co., Ltd. (HKG: 1779) announced that the clinical trial application for LP-003...
Pfizer and Astellas Secure FDA Approval for PADCEV-KEYTRUDA Combination as First Platinum-Free Neoadjuvant/Adjuvant Therapy for Muscle-Invasive Bladder Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TYO: 4503) announced that the U.S. Food...
Sanofi Secures FDA Approval for Sarclisa Escena Subcutaneous Formulation, First Dual-Administration Anti-Cancer Therapy for Multiple Myeloma
Sanofi S.A. (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has approved...
Hansoh Pharma’s B7-H3 ADC Risvutatug Rezetecan Meets Primary Endpoint in Phase III SCLC Trial, Showing Significant Survival Benefit Over Topotecan
Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that Risvutatug Rezetecan (HS-20093), its proprietary B7-H3-targeted...