3SBio Wins NMPA Approval for Eltrombopag Generic – TPO-RA Copycat Targets Novartis’ Revolade in China ITP/SAA Market
3SBio Inc. (HKG: 1530) announced NMPA marketing approval for its generic version of Novartis’ Revolade...
Drug
Chipscreen Biosciences’ CS08399 Wins NMPA Approval – PRMT5-MTA Inhibitor Targets MTAP-Deficient Solid Tumors and Lymphomas
Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced NMPA clearance to initiate a clinical study...
Novartis’ Cosentyx Wins FDA Pediatric Approval – Only IL-17A Inhibitor for Hidradenitis Suppurativa in Adolescents 12+
Novartis (NYSE: NVS) announced that Cosentyx (secukinumab) received U.S. FDA approval for treating pediatric patients aged...
Cutia Therapeutics’ CU-40105 Wins NMPA Approval – Topical Dutasteride Targets Androgenetic Alopecia with Reduced Systemic Exposure
Cutia Therapeutics announced NMPA clearance to initiate a clinical study for CU-40105, a topical dutasteride...
J&J’s Erda-iDRS Shows 89% Complete Response in NMIBC – Intravesical Erdafitinib System Advances to Phase II/III
Johnson & Johnson (J&J, NYSE: JNJ) announced positive Phase I results for Erda-iDRS, an investigational...
BeBetter Medicine’s Ifupinostat Wins NMPA Approval for PTCL Trial – First HDAC/PI3Kα Dual Inhibitor Enters First-Line Lymphoma Study
Guangzhou BeBetter Medicine Technology Co., Ltd (SHA: 688759) announced NMPA clearance to initiate a clinical...
Abbisko’s Irpagratinib Doses First Patient in Phase II HCC Trial – FGFR4 Inhibitor Plus Toripalimab/Bevacizumab Targets First-Line Liver Cancer
Abbisko Therapeutics Co., Ltd (HKG: 2256) announced first patient dosing in a Phase II clinical...
YolTech’s YOLT-202 Wins FDA Phase II/III Approval – In Vivo Base Editing Gene Therapy Targets Alpha-1 Antitrypsin Deficiency
YolTech Therapeutics announced FDA clearance to initiate an open-label, single-dose expansion Phase II/III clinical study...
GSK’s Arexvy Wins FDA Label Expansion – RSV Vaccine Now Covers High-Risk Adults Aged 18-49
GlaxoSmithKline (GSK, NYSE: GSK) announced FDA approval for a label expansion of its adjuvanted respiratory...
Biogen’s Salanersen Shows 75% NfL Reduction in SMA Phase Ib – Once-Yearly ASO Advances to Phase III
Biogen Inc. (NASDAQ: BIIB) presented supplemental Phase Ib data for salanersen, its investigational antisense oligonucleotide...
Sino Biopharm’s TQB3454 Hits Phase III Endpoints in IDH1+ Biliary Tract Cancer – China’s First IDH1 Inhibitor Poised for NDA Filing
Sino Biopharmaceutical (HKG: 1177) announced that TQB3454 Tablets, a Category 1 innovative drug developed by...
CMS Launches Opzelura Nationwide – First Topical JAK Inhibitor for Vitiligo Reaches 1,300+ Pharmacies Across 30 Chinese Provinces
China Medical System Holdings (CMS; HKG: 0867) announced that first prescriptions of Ruxolitinib Phosphate Cream...
Essight Bio’s ES502 Wins FDA Phase I Approval – First TCR×CD3 Bispecific Targeting RAS G12V Mutations Enters Clinic
Shanghai Essight Biotechnology Co., Ltd. announced that ES502 Injection has received FDA approval to proceed...
Changchun GeneScience’s GenSci128 Wins FDA Orphan Drug Designation – TP53 Y220C Reactivator Targets Pancreatic Cancer
Changchun GeneScience Pharmaceutical Inc. announced that GenSci128 tablets, its independently developed selective TP53 Y220C mutation...
Sino Biopharm’s TQB3205 Wins NMPA Approval – First China-Developed Pan-KRAS Inhibitor Enters Clinic for Advanced Cancers
Sino Biopharmaceutical Limited (HKG: 1177) announced that TQB3205, an orally administered Pan-KRAS inhibitor independently developed...
Huadong Medicine’s HDM2017 Wins FDA Orphan Drug Designation – CDH17 ADC Targets Three Gastrointestinal Cancers
Huadong Medicine Co., Ltd (SHE: 000963) announced that HDM2017, its independently developed CDH17-targeting antibody-drug conjugate...
Hengrui’s SHR-2524 Wins NMPA Phase I Approval – Novel Subcutaneous Formulation Plus Bevacizumab Targets First-Line Liver Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance to initiate a...
Boehringer Ingelheim’s Jascayd (Nerandomilast) Launches in Shanghai – First PDE4B Inhibitor for Idiopathic Pulmonary Fibrosis
Boehringer Ingelheim announced the first prescription issuance for Jascayd (nerandomilast tablets) in Shanghai, marking the...
Huadong Medicine’s HDM2024 Wins FDA Phase I Approval – First-in-Class EGFR/HER3 Bispecific ADC Targets Advanced Solid Tumors
Huadong Medicine Co., Ltd (SHE: 000963) announced that HDM2024, a Category 1 innovative bispecific antibody-drug...
J&J’s AKEEGA Wins EU Approval for mHSPC – PARP/Abiraterone Combo Expands to Earlier-Line Prostate Cancer
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved a...