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.,...
Drug
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...
Konruns Pharma Wins NMPA Approval for KC1036 Phase III in Esophageal Cancer – Multi‑Target TKI Advances in 2L+ ESCC
Konruns Pharmaceutical Co., Ltd (SHA: 603590) announced that China’s National Medical Products Administration (NMPA) has approved...
Lynk Pharmaceuticals’ JAK1 Inhibitor Zemprocitinib Enters NMPA Review for Atopic Dermatitis
Lynk Pharmaceuticals Co., Ltd., a clinical-stage Chinese biopharmaceutical company, announced that the National Medical Products...
Shanghai Ark Bio Advances AK0406, a Next-Gen Long-Acting Influenza ADFC, into Phase I Trial in Australia
Shanghai Ark Biopharmaceutical Co., Ltd., a China-based clinical-stage biotech, announced that its investigational long-acting antiviral...
BeOne Medicines Secures NMPA Conditional Approval for Imdelltra (Tarlatamab) in Heavily Pretreated Small Cell Lung Cancer
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), formerly BeiGene, announced that China’s National...
Duality Biologics’ HER2-Targeted ADC DB-1303 (BNT323) Enters NMPA Review for Metastatic Breast Cancer
Duality Biologics Co., Ltd. (HKG: 9606), a U.S.-China biotech specializing in antibody-drug conjugates (ADCs), announced...
Haisco Pharma’s HSK42360 Selected for NMPA SPARK Program – First BRAF V600 Inhibitor for Pediatric Glioma in China
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that its novel drug candidate HSK42360 has been...
Luye Pharma Doses First Patient in Phase II Study of LY03020 – World’s First Dual‑Target TAAR1/5‑HT2CR Agonist for Schizophrenia
Luye Pharma Group (HKG: 2186) announced first patient enrollment in a Phase II clinical study evaluating...
Sino Biopharm Wins FDA Approval for Pan‑KRAS Inhibitor TQB3205 – First‑in‑Human Trial in Advanced Malignancies
Sino Biopharmaceutical Ltd (HKG: 1177) announced that the US Food and Drug Administration (FDA) has granted...
GenFleet Therapeutics Secures First‑Ever NMPA Breakthrough Designation for KRAS G12D Inhibitor in Pancreatic Cancer
GenFleet Therapeutics (Shanghai) Inc. (HKG: 2595) announced that China’s National Medical Products Administration (NMPA) has granted...
Sino Biopharm’s Chia Tai Tianqing Secures GDMPA Approval for Naldemedine in Greater Bay Area – World’s First Oral OIC Therapy Enters China
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), a wholly‑owned subsidiary of Sino Biopharmaceutical Limited...
UniXell Biotechnology Secures NMPA IND Approval for UX-GIP001, World’s First iPSC-Derived Cell Therapy for Drug-Resistant Epilepsy
UniXell Biotechnology, a clinical-stage cell therapy innovator, announced that China’s National Medical Products Administration (NMPA)...
Shionogi Secures $119M BARDA Contract for Fetroja Antibiotic as Biothreat Countermeasure
Shionogi Co., Ltd. (TYO: 4507) announced that its U.S. subsidiary, Shionogi Inc., has been awarded...
Joincare Pharmaceutical Receives NMPA Approval to Initiate JKN2401 Clinical Study in CRSwNP, Expanding TSLP-Targeting Biologic Development Across Respiratory Indications
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) announced that China’s National Medical Products Administration...
Haisco Pharmaceutical Secures NMPA Breakthrough Therapy Designation for HSK39004 Inhalation Powder in COPD, Following Successful Phase II Lung Function Data
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...