Duality DB-1324 ADC FDA IND Approval Advances GSK Partnership
Duality Biotherapeutics, Inc. (HKG: 9606) announced that its Investigational New Drug (IND) application for DB-1324,...
Clinical trial approval / initiation
Antengene ATG-022 CLDN18.2 ADC Gets China Nod for Keytruda Combo in Gastric Cancer
Antengene Corporation Limited (HKG: 6996) announced that China’s National Medical Products Administration (NMPA) has approved...
Generate GB-0895 Asthma Phase III Trials to Enroll 1,600 Patients
Generate: Biomedicines today announced plans to initiate two global Phase III clinical trials (SOLAIRIA-1 and...
Henlius HLX37 Bispecific NMPA Approval Targets Advanced Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its self-developed investigational new drug, HLX37 (Recombinant...
Leads-Biolabs LBL047 Bispecific Secures China IND Approval for SLE
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that the National Medical Products Administration (NMPA)...
Abbisko ABSK141 KRAS-G12D Inhibitor Secures FDA IND Approval
Abbisko Cayman Limited (HKG: 2256) announced that its Investigational New Drug (IND) application for ABSK141,...
Lynk Pharma LNK01006 FDA Approval Targets TYK2 for CNS Diseases
Lynk Pharmaceuticals Co., Ltd. announced that its self‑developed TYK2 allosteric inhibitor LNK01006 has received FDA...
Humanwell’s HWS117 Long-Acting FSH Secures NMPA Clinical Trial Approval for Assisted Reproduction
Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced that its Class 1 biological product HWS117 injection...
GenSci’s GenSci142 Wins NMPA Nod for Bacterial Vaginosis Clinical Trials
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary GenSci...
Hengrui’s Ivarmacitinib Wins NMPA Nod for Vitiligo Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that Ivarmacitinib Tablets and SHR0302...
Gene Key’s iNKT Cell Therapy Wins NMPA Nod for ARDS, First Allogeneic Ready-to-Use
Beijing Gene Key Life Technology Co., Ltd. announced that its GKL‑006RTU Injection, China’s first novel...
Hengrui’s Three Oncology Assets Win NMPA Clinical Trial Approval
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that three of its investigational...
Qihan-Biotech’s QT-019B Universal CAR-T Wins Implied NMPA Approval
Hangzhou Qihan Biotech Co., Ltd. announced that its New Drug Clinical Trial (IND) application for...
Salubris’ SAL0139 Wins NMPA Nod for Hyperlipidemia Clinical Trial
Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced that its independently developed innovative small molecule...
Zhongsheng’s Onradivir Granules Enroll First Phase 3 Pediatric Influenza Patient
Guangdong Zhongsheng Pharmaceutical Co., Ltd. (SHE: 002317) announced the enrollment and dosing of the first...
Luye’s LY03017 Wins FDA Nod for Psychosis Trials in Alzheimer’s and Parkinson’s
Luye Pharma Group Limited (HKG: 2186) announced that its independently developed LY03017 received U.S. FDA...
Pien Tze Huang’s PZH2108 Cancer Pain Drug Enrolls First Phase IIa Patient
Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436) announced the enrollment of the first...
Sino Biopharm’s LM-350 CDH17-ADC Wins NMPA Nod for Clinical Trials
Sino Biopharmaceutical Limited (HKG: 1177) announced that its self‑developed LM‑350, a CDH17‑targeting Antibody‑Drug Conjugate (ADC),...
Hengrui’s HRS-6209 CDK4 Inhibitor Wins NMPA Nod for Breast Cancer Combo Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS‑6209 capsules, a novel...