Daiichi Sankyo-Merck Ifinatamab Deruxtecan Granted FDA Priority Review for Extensive-Stage SCLC
Daiichi Sankyo (TYO: 4568) and Merck & Co., Inc. (MSD; NYSE: MRK) announced that the...
Drug
CureGene’s CG-0255 Receives NMPA Approval for Ischemic Stroke Trial – First Thiol-Based P2Y12 Inhibitor
Shanghai CureGene Pharmaceutical Co., Ltd announced it has received clinical trial approval from China’s National...
Grand Pharmaceutical’s SIR-Spheres Achieves Phase III Success in Unresectable HCC, Supporting China Expansion
Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) announced that the Phase III clinical trial for...
Zelgen’s Jaktinib Hits Primary Endpoint in Phase III Atopic Dermatitis Trial – Dual JAK/ACVR1 Inhibitor Expands Beyond Myelofusion
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that its Phase III clinical trial evaluating...
Youcare Pharmaceutical Advances Dual mRNA Vaccine Pipeline with NMPA Approvals for RSV and Herpes Zoster Candidates
Youcare Pharmaceutical Group (SHA: 688658) announced separate clinical trial approvals from China’s National Medical Products...
Eli Lilly’s Jaypirca Combination Therapy Demonstrates Significant PFS Benefit in Phase III CLL/SLL Trial – Non-Covalent BTK Inhibitor Shows Promise Regardless of Prior Treatment History
Eli Lilly and Company (NYSE: LLY) announced positive topline results from the Phase III BRUIN...
Sanofi Secures EC Approval for Dupixent in Pediatric Chronic Spontaneous Urticaria – First Biologic Therapy for Children 2–11 Years
Sanofi SA (NASDAQ: SNY) announced that the European Commission (EC) has granted marketing authorization for...
AstraZeneca’s Imjudo Gains NMPA Approval for First-Line NSCLC in China, Backed by POSEIDON Data
AstraZeneca plc (NYSE: AZN) has secured marketing approval from China’s National Medical Products Administration (NMPA)...
RemeGen’s Disitamab Vedotin Wins World’s First HER2-ADC Approval for First-Line Advanced Urothelial Carcinoma
RemeGen Ltd. (HKG: 9995) has announced that China’s National Medical Products Administration (NMPA) has approved...
Henlius Biotech Doses First Patient in Phase I Trial for HLX319, a Biosimilar to Roche’s Phesgo
Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the dosing of the first subject in...
AbbVie Secures NMPA Label Expansion for Rinvoq in China, Clarifying Use in UC and Crohn’s Disease
AbbVie Inc. (NYSE: ABBV) has announced that China’s National Medical Products Administration (NMPA) has approved...
CanSino Biologics Secures NMPA Approval for Pankangxin, China’s First Three-Component Acellular DTaP Vaccine
CanSino Biologics Inc. (HKG: 6185) has announced that China’s National Medical Products Administration (NMPA) has...
Cutia Therapeutics’ CU-20101 Meets Phase III Endpoints, Demonstrating Non-Inferiority to BOTOX for Glabellar Lines
Cutia Therapeutics (HKG: 2487) has announced the successful completion of its pivotal Phase III clinical...
Hotgen Biotech’s Novel Treg-Targeting Bispecific Antibody SGT003 Clears NMPA Filing Hurdle
Hotgen Biotech Co., Ltd. (SHA: 688068) has announced that the National Medical Products Administration (NMPA)...
FDA Accepts NDA for Telix’s Pixclara (TLX101-Px) Glioma Imaging Agent, Decision Expected September 2026
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX), the Australian partner of Grand Pharmaceutical Group Co.,...
GSK’s B7-H4 ADC Mocertatug Rezetecan Shows 62-67% Response Rates in Phase I Ovarian and Endometrial Cancer Trials
GlaxoSmithKline plc (GSK, NYSE: GSK) has reported highly promising data from the global Phase I...
Boehringer Ingelheim and BioNTech Launch Phase Ib/II Trial of Novel T-Cell Engager and Bispecific Antibody Combo for ES-SCLC
Boehringer Ingelheim and BioNTech SE (NASDAQ: BNTX) have announced a clinical collaboration to evaluate a...
Duality Biologics Files NMPA Market Approval for DB-1303 HER2 ADC – Phase III Study Beats T-DM1 in Metastatic Breast Cancer
Duality Biologics (HKG: 9606), a US‑China dual‑headquartered antibody‑drug conjugate (ADC) developer, announced that the National Medical...
Sino Biopharm Doses First Patient in Phase II Study of Kylo-11 – First-in-Class siRNA Targeting LPA for Cardiovascular Disease
Sino Biopharmaceutical Ltd (HKG: 1177) announced first patient enrollment in the Phase II Kylo-11-II-C01 study evaluating...
Henlius Biotech Secures Two New NMPA Approvals for Hanlikang – Expands Rituximab Biosimilar into DLBCL Combination Therapies
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has granted...