United Labs TUL108 Gets FDA Nod for Antibiotic Resistance Trial
United Laboratories International Holdings Ltd (HKG: 3933) announced that the U.S. Food and Drug Administration (FDA)...
Drug
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...
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)...
Changchun High‑Tech’s Firsekibart Filing Accepted for Non‑Infectious Uveitis
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that the National Medical Products...
Sino Biopharm’s TQA3605 Meets Endpoint in Hepatitis B Phase II Trial
Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Category 1 drug TQA3605 has met the primary...
J&J Darzalex Faspro Gets FDA Nod for NDMM D-VRd Regimen
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved...
Roche CT-388 Obesity Drug Shows 22.5% Weight Loss in Phase II Trial
Roche (SWX: ROG, OTCMKTS: RHHBY) announced positive topline results from its Phase II clinical trial (CT388‑103)...
Leqvio Gets NMPA Nod for Monotherapy in China Hypercholesterolemia
Novartis (NYSE: NVS) announced that Leqvio (inclisiran) has received an additional indication approval from the National...
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)...
Hengrui’s HRS-5346 Lp(a) Inhibitor Gets China Breakthrough Therapy Designation in $1.97B Merck Deal
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS-5346, the centerpiece of a USD 1.97 billion...
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...
Nanjing Leads Biolabs Secures FDA Fast Track for LBL-034 in Multiple Myeloma
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that LBL-034, a GPRC5D/CD3 bispecific antibody (BsAb) T‑cell...
Innovent Biologics Secures FDA Fast Track for IBI3003 Trispecific Antibody in Multiple Myeloma
Innovent Biologics, Inc. (HKG: 1801) announced that the U.S. Food and Drug Administration (FDA) has...
Aucta Pharma Files for Hong Kong IPO with CNS and Rare Disease Pipeline
Shanghai Aucta Pharmaceuticals Co., Ltd. made its initial public offering (IPO) filing to the Hong...
BioArctic Partner Eisai Submits EMA Application for Four-Week Lecanemab Dosing in Alzheimer’s
BioArctic AB (OTCMKTS: BRCTF) partner Eisai (TYO: 4523) announced submission of a proposed Marketing Authorisation Variation...
Nuance Pharma Secures NMPA Review for Ensifentrine COPD Maintenance Therapy
Nuance Pharma announced that its market filing for Ohtuvayre (ensifentrine) as maintenance treatment for patients...
Visen Pharma Secures NMPA Approval for Skytrofa in Pediatric Growth Hormone Deficiency
Visen Pharmaceuticals (HKG: 2561), a joint venture between Ascendis Pharma (Denmark) and Vivo Capital, announced...
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...
Sanofi’s Amlitelimab Hits Phase III Goals in Atopic Dermatitis, Targets Q4W/Q12W Dosing Edge
Sanofi (NASDAQ: SNY) announced positive results from two global Phase III studies (SHORE and COAST 2) for amlitelimab,...
Huahui Health’s Libevitug Wins NMPA Approval as World’s First HDV Antibody Therapy
Huahui Health announced that China’s National Medical Products Administration (NMPA) has granted conditional approval for...