Tarlatamab Enters China via Hainan Pilot Zone as First SCLC Immunotherapy
Ruijin Hospital Hainan Boao Research Hospital (Ruijin Hainan Hospital) successfully introduced Tarlatamab for Injection, making...
Cancer
HutchMed’s Savolitinib NDA Accepted by NMPA for MET-Amplified Gastric Cancer with Priority Review
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
Zelgen Licenses ZG006 to AbbVie for $1.2 Billion in Milestones Ex-China
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced a strategic collaboration and licensing option agreement...
HutchMed’s Fanregratinib Wins NMPA Priority Review for FGFR2+ Cholangiocarcinoma
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
Easton Pharmaceutical Doses First Patient in Phase I/II Trial of HP‑001 for Relapsed Multiple Myeloma
Easton Pharmaceutical Co., Ltd. (SHA: 688513) announced that the first subject has been dosed in...
Haihe Biopharma’s Risovalisib Enters China SPARK Project for Pediatric PIK3CA Disorders
Haihe Biopharma Co., Ltd. announced that risovalisib mesylate (CYH33), a highly potent and selective PI3Kα...
Innovent Biologics Secures NMPA Approval for TABOSUN as First Neoadjuvant Dual‑IO Therapy for MSI‑H/dMMR Colon Cancer
Innovent Biologics, Inc. (HKG: 1801) announced that China’s National Medical Products Administration (NMPA) has approved...
Allist Pharmaceuticals Secures Breakthrough Therapy Designation for Furmonertinib in EGFR PACC‑Mutated NSCLC
Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that furmonertinib has been added to the Breakthrough...
J&J’s Amivantamab Subcutaneous Wins China Approval for NSCLC
Johnson & Johnson (J&J, NYSE: JNJ) announced that its Amivantamab Injection (Subcutaneous), marketed as RYBREVANT, received...
Alphamab JSKN003 ADC FDA Breakthrough Therapy Targets Ovarian Cancer
Alphamab Oncology (HKG: 9966) announced that its independently developed HER2‑targeting biparatopic antibody‑drug conjugate (ADC), JSKN003,...
Lilly Imlunestrant Breast-Cancer EMBER-3 Shows 38% Risk Reduction
Eli Lilly (NYSE: LLY) announced updated results from the Phase III EMBER‑3 clinical trial evaluating its...
Grand Pharmaceutical’s TLX591‑CDx RDC Wins China Phase III for Prostate Cancer Diagnosis
Grand Pharmaceutical Group Limited (HKG: 0512) announced that its China‑based Phase III clinical trial for TLX591‑CDx...
Simcere Zaiming Licenses ADC SIM0613 to Ipsen in $1.06 Billion Deal
Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary Simcere Zaiming entered into an exclusive global licensing...
Merck’s Pimicotinib Wins China Approval as First Class 1 Therapy for TGCT
Merck KGaA (ETR: MRK) announced that China’s National Medical Products Administration (NMPA) granted priority review approval...
Asieris’ APL-2401 FGFR2/3 Inhibitor Wins NMPA Nod for Phase 1 Solid Tumor Trial
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that China’s National Medical Products Administration (NMPA)...
Hansoh Licenses EGFR Drug Aumolertinib to Glenmark for $1B+ in Milestones
Jiangsu Hansoh Pharmaceutical Co. Ltd. (HKG: 3692) entered into an exclusive license, collaboration, and distribution...
ENHERTU Wins FDA Approval as First-Line HER2 Breast Cancer Therapy
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) announced that ENHERTU (fam-trastuzumab deruxtecan-nxki) in...
Konruns Doses First Patient in Phase 2 Esophageal Cancer Trial for KC1036
Konruns Pharmaceutical Co., Ltd. (SHA: 603590) announced first patient dosing in the Phase 2 KC1036‑COM‑01...
Johnson & Johnson’s TECVAYLI Gets FDA Priority Review for Myeloma Combo
Johnson & Johnson (NYSE: JNJ) announced that the U.S. FDA selected the teclistamab MajesTEC‑3 supplemental...
Hengrui NMPA Approves Four Clinical Trials Advancing Oncology and Metabolic Pipeline
Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276, HKG: 1276) announced that China’s National Medical Products...