BeOne Medicines Receives FDA Breakthrough Therapy Designation for Sonrotoclax in Relapsed Mantle Cell Lymphoma
BeOne Medicines Ltd. (NASDAQ: ONC; HKG: 6160; SHA: 688235) announced today that the U.S. Food...
Cancer
Everest Medicines Commences Global Phase I Trial of Universal mRNA Cancer Vaccine EVM14
Everest Medicines Limited (HKG: 1952) announced today that the first patient has been successfully dosed...
Sino Biopharma Subsidiary Secures Breakthrough Therapy Designation for TQB2102 ADC Targeting HER2‑Positive Colorectal Cancer
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a wholly‑owned subsidiary of China‑listed Sino Biopharmaceutical Ltd....
Beihai Biotech Secures FDA IND Approval for First‑In‑Class Peptide‑Drug Conjugate BH1621
China‑based Zhuhai Beihai Biotech Co., Ltd. announced today that its Category 1 innovative drug BH1621 has...
Mirxes Secures China’s First Blood‑Test Approval for Gastric‑Cancer Screening
Mirxes Holding Company Limited (HKG: 2629) announced that its flagship in‑vitro diagnostic (IVD) test, GASTROClear,...
Roche Secures FDA Approval for Tecentriq‑Lurbinectedin Combo in ES‑SCLC
Roche (SWX: ROG, OTCMKTS: RHHBY) announced today that the U.S. Food and Drug Administration (FDA)...
Hengrui, SHR‑4298, RAS: China Approves Two Novel Anti‑Tumor Drugs for Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration...
C‑MER Medical, Gilead, and Hanmi Sign Global Licensing Deal for First‑In‑Class P‑glycoprotein Inhibitor Encequidar
C‑MER Medical Holdings Limited (HKG: 3309) announced that its joint‑venture arm, Health Hope Pharma Limited...
Shanghai Junshi Biosciences Announces Nearly RMB 380 Million Capital Increase for Grit Biotechnology
Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877, SHA: 688180) disclosed that its subsidiary, Shanghai JunTop...
Simcere Secures FDA Approval for ADC SIM0609 in Advanced Solid Tumors
Simcere Pharmaceutical Group Limited (HKG: 2096) announced that the U.S. Food and Drug Administration (FDA)...
HanX Biopharmaceuticals Secures NMPA Approval for HX044‑HX008 PD‑1 Therapy Combination in Advanced Solid Tumors
HanX Biopharmaceuticals (Wuhan) Co., Ltd., a fast‑growing Chinese biotech, announced that the National Medical Products...
Beijing Unicet’s QH104A Receives Chinese NMPA Approval for CNS Solid‑Tumor Clinical Trials
Beijing Unicet Biotechnology Co., Ltd. announced that its pioneering QH104A—the world’s first B7H3‑targeted, off‑the‑shelf allogeneic...
Fosun Pharma’s Alovatinib Enters China’s Pediatric Anti‑Tumor SPARK Pilot
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that...
Illumina Partners with Pharma Giants on Pan‑Cancer Companion Diagnostics Using TruSight Oncology
Illumina Inc. (NASDAQ: ILMN) announced a new alliance with a group of global pharmaceutical companies...
AstraZeneca and Daiichi Sankyo Submit Priority‑Review sBLA for Enhertu as First‑Line Therapy for HER2‑Positive Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have filed a supplemental Biologics License...
DualityBio Initiates Global Phase Ia/Ib Study of ADAM9‑Targeting ADC DB‑1317
Hong Kong‑listed Duality Biologics (DoalityBio, HKG: 9606) announced that the first patient has been dosed...
Jiangsu Hengrui’s Adebrelimab New Indication Accepted by NMPA for Stage II‑IIIB NSCLC
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products...
Yantai Dongcheng Secures NMPA Approval for 225Ac‑LNC1011 Alpha‑Particle Radiopharmaceutical to Target Prostate Cancer
China‑based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that its investigational 225Ac‑LNC1011 injection...
Roche’s SC Lunsumio Gains CHMP Recommendation for Relapsed Follicular Lymphoma
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products...
Roche’s giredestrant Yields Positive PFS Results in evERA Phase III Study
Roche (SWX: ROG, OTCMKTS: RHHBY) announced that its Phase III evERA trial has met both co‑primary...