Gilead’s Kite Pharma Secures FDA Label Expansion for Yescarta in Primary CNS Lymphoma
Kite Pharma, a Gilead Sciences (NASDAQ: GILD) subsidiary, announced that the U.S. Food and Drug...
Drug
Hengrui Pharma’s HRS-4642 Wins Breakthrough Therapy Designation for KRAS G12D Pancreatic Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS-4642, its KRAS G12D-targeting...
Pfizer’s Hympavzi Wins FDA Priority Review for Pediatric Hemophilia Expansion
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted...
Zhongsheng Pharma Reports Positive Phase III Data for Onradivir Pediatric and Adolescent Influenza Trials
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced positive top-line results from two Phase III...
InnoCare Pharma’s ICP-538 Becomes First VAV1 Molecular Glue Degrader to Enter China Clinical Trials
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that its self-developed VAV1-targeting molecular glue degrader,...
Betta Pharma Secures NMPA Approval for Beizeting, First Domestic Pertuzumab Biosimilar in China
Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced that the National Medical Products Administration (NMPA) has...
Kelun-Biotech’s Jiatailai Secures Fourth NMPA Approval for HR+/HER2- Breast Cancer Indication
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that the National Medical Products Administration (NMPA)...
Fosun Pharma’s Fumaining Wins Priority Review for NF1 Adult Indication in China
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that the National Medical Products...
Hengrui Pharma Secures NMPA Nod for SHR-1894 Atopic Dermatitis Trial
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276), one of China’s largest pharmaceutical companies,...
Akeso’s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China
Akeso, Inc. (HKG: 9926) announced that Yidafang (ivonescimab) has been awarded Breakthrough Therapy Designation (BTD)...
Ascentage Pharma Secures NMPA Approval for APG‑3288 BTK Degrader Trial in Hematologic Malignancies
Ascentage Pharma Group International (NASDAQ: AAPG, HKG: 6855) announced that China’s National Medical Products Administration...
HighTide Therapeutics Reports Positive Phase IIb CENTRICITY Data for HTD1801 in MASH Patients
HighTide Therapeutics Inc. (HKG: 2511), the China‑based biopharmaceutical company, announced completion of the Phase IIb...
J&J Darzalex Faspro Gets NMPA Approval for Transplant-Eligible Myeloma Patients
Johnson & Johnson (J&J, NYSE: JNJ) announced that Darzalex Faspro (daratumumab and hyaluronidase-fihj) has received National...
Everest Medicines Files Velsipity for Ulcerative Colitis in China
Everest Medicines (HKG: 1952) announced it has submitted a marketing filing in China for Velsipity...
Keytruda Wins 20th China Approval for Endometrial Cancer in First-Line Setting
Merck & Co. (MSD, NYSE: MRK) announced that Keytruda (pembrolizumab) has received its 20th indication approval...
Hanx Biopharma HX111 ADC Begins Phase I Trial for Lymphoma and Solid Tumors
Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (HKG: 3378) announced the initiation of a Phase I clinical...
Shouyao’s SY-9453 MAT2A Inhibitor Gets NMPA Nod for MTAP-Deleted Tumors
Shouyao Holdings (Beijing) Co., Ltd. (SHA: 688197) announced that the National Medical Products Administration (NMPA)...
Huadong Medicine DR10624 Gets NMPA Nod for Hypertriglyceridemia Study
Huadong Medicine Co., Ltd (SHE: 000963) announced that its subsidiary Doer Biologics has received National...
AstraZeneca Saphnelo Faces FDA Setback with Complete Response Letter
AstraZeneca (AZ, NASDAQ: AZN) announced it has received a Complete Response Letter (CRL) from the U.S....
Hualan Biological’s HL08 GLP-1 Drug Gets NMPA Nod for Obesity Trial
Hualan Biological Engineering Inc. (SHE: 002007) announced that the National Medical Products Administration (NMPA) has...