MicuRx MRX-5 Gets FDA Nod for Phase II NTM Lung Disease Study
MicuRx Pharmaceuticals Inc., (SHA: 688373) a Sino‑US biopharmaceutical company, announced it has received approval from...
Clinical trial approval / initiation
Huiyu Pharma HYP-6589 Gets NMPA Nod for NSCLC Osimertinib Combo
Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) announced that the National Medical Products Administration (NMPA)...
Henlius Triple Combo Gets NMPA Nod for Advanced Solid Tumor Trials
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received National Medical Products Administration (NMPA)...
Betta Pharmaceuticals’ BPI-572270 RAS Inhibitor Gets NMPA Nod for Solid Tumor Trials
Betta Pharmaceuticals (SHE: 300558) announced that the National Medical Products Administration (NMPA) has approved the...
Ascletis Doses First Patient in US Phase II Diabetes Study for Oral GLP‑1 ASC30
Ascletis Pharma Inc. (HKG: 1672) announced that the first patient has been dosed in a 13‑week...
Zhongsheng’s RAY1225 Wins NMPA Approval for Obesity‑Sleep Apnea Study as Phase III Wraps Up
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced that China’s National Medical Products Administration (NMPA)...
Changchun High‑Tech’s GenSci145 PI3Kα Inhibitor Cleared by NMPA for Solid Tumor Study
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that China’s National Medical Products...
Hengrui Pharma’s SHR‑7877 Gets NMPA Nod for Small Cell Lung Cancer Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that SHR‑7877 has received National Medical Products...
Henlius’s HLX701 Gets NMPA Nod for Phase Ib/II Advanced CRC Combination Study
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Shanghai Pharma’s iNKT Cell Therapy B023 Gets NMPA Nod for Advanced Solid Tumors
Shanghai Pharmaceuticals Holding Co., Ltd (SPH, HKG: 2607, SHA: 601607) announced that its B023 cell...
AIM Vaccine’s PCV20 Gets NMPA Clinical Approval, Challenging Pfizer’s Monopoly
AIM Vaccine Co., Ltd (HKG: 6660) announced that China’s National Medical Products Administration (NMPA) has...
D3 Bio’s KRAS Programs Advance: FDA Clears Phase I G12D Inhibitor D3S‑003 and Phase II G12C‑ERK Combo
D3 Bio announced FDA clearance for two clinical programs: a Phase I first‑in‑human study for D3S‑003,...
Aidea’s ADC205 HIV Combo Gets NMPA Nod for Clinical Trials, Targeting $2.8B Market
Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced that China’s National Medical Products Administration (NMPA)...
Duality’s DB‑1317 ADC Receives IND Approval for ADAM9‑Targeted Solid Tumor Therapy
Duality Biologics (HKG: 9606) announced that its ADAM9‑targeting ADC candidate DB‑1317 has received Investigational New...
Zelgen’s ZGGS18 & ZG005 Cleared by NMPA for Advanced Solid Tumor Studies
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that China’s National Medical Products Administration (NMPA)...
Huadong Medicine’s DR10624 Wins FDA Nod for MASLD Study, First Triple Agonist to Enter Clinic
Huadong Medicine Co., Ltd (SHE: 000963) announced that the U.S. Food and Drug Administration (FDA) has...
ImmuneOnco’s IMM2510 Advances to Phase II/III in Endometrial Cancer After Axion Bio Deal Termination
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced that China’s National Medical Products Administration (NMPA) has...
ImmuneOnco’s Timdarpacept Receives NMPA Nod for Atherosclerosis Study, Expanding CD47 Platform
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced that China’s National Medical Products Administration (NMPA) has...
Hengrui’s HRS-7535 GLP-1R Agonist Cleared for Hypertension with Obesity Study in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s National Medical Products Administration (NMPA)...