Sino Biopharmaceutical’s Rovadicitinib Granted Breakthrough Therapy Designation for Chronic Graft-versus-Host Disease
China-based Sino Biopharmaceutical Limited (HKG: 1177) announced that its self-developed JAK/ROCK dual small molecule inhibitor,...
Product approvals
Everest Medicines’ Nefecon Granted Full Approval by Taiwan’s TFDA for IgA Nephropathy
China-based Everest Medicines (HKG: 1952) announced today that the Taiwan Food and Drug Administration (TFDA)...
CSPC Pharmaceutical’s Semaglutide Injection NMPA Marketing Application Accepted
China-based CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the marketing application for its semaglutide...
Gaush Meditech’s Frequency-Domain Biometer Gains Medical Device Registration in Jiangsu
Suzhou-based Gaush Meditech Ltd (HKG: 2407) has recently obtained the medical device registration certificate for...
Zhaoke Ophthalmology’s TONO-i Gains NMPA Approval for Glaucoma Management in China
China-based Zhaoke Ophthalmology Limited (HKG: 6622) announced that its innovative product, TONO-i, has received a...
Cutia Therapeutics’ CU-40102 Approved in Hong Kong for Androgenetic Alopecia Treatment
China-based dermatology specialist Cutia Therapeutics (HKG: 2487) announced today that its CU-40102 (finasteride topical spray)...
Lee’s Pharma’s Socazolimab Approved by NMPA for ES-SCLC First-Line Treatment
Lee’s Pharmaceutical Holdings Ltd. (HKG: 0950) announced that its in-licensed programmed-death ligand 1 (PD-L1) monoclonal...
BeOne Medicines’ BGB-16673 Granted PRIME Designation by EMA for Waldenström’s Macroglobulinemia
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced on July 31, 2025,...
AstraZeneca’s Ultomiris Gains NMPA Approval for Neuromyelitis Optica Spectrum Disorder
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced that China’s National Medical Products Administration (NMPA)...
Sanofi’s SAR446523 Gains FDA Orphan Drug Status for Relapsed or Refractory Multiple Myeloma
French pharmaceutical major Sanofi (NASDAQ: SNY) reported that the U.S. Food and Drug Administration (FDA)...
HRAIN Biotech’s HICARA Approved by NMPA for Relapsed/Refractory LBCL
The National Medical Products Administration (NMPA) officially approved the New Drug Application (NDA) for lenecabtagene...
Bayer’s Sevabertinib Granted Priority Review by China’s NMPA for NSCLC Treatment
German pharmaceutical giant Bayer AG (ETR: BAYN) announced on July 28, 2025, that the marketing...
Pierre Fabre’s Braftovi Approved in China for BRAF V600E-mutant Metastatic Colorectal Cancer
France-based Pierre Fabre Laboratories announced that Braftovi (encorafenib) in combination with cetuximab has been approved...
Henlius Biotech’s HLX14 Recommended for EU Approval by EMA’s CHMP
China-based Shanghai Henlius Biotech, Inc. (HKG: 2696) announced on July 28, 2025, that the European...
Eli Lilly’s Mounjaro Approved by China’s NMPA for Type 2 Diabetes Treatment with Insulin
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) announced that the National Medical Products Administration...
Antengene’s XPOVIO Approved for New Multiple Myeloma Indication by China’s NMPA
China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced that the China National Medical Products Administration...
BeOne Medicines’ Tislelizumab Receives Positive CHMP Opinion for NSCLC Treatment
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that its PD-1 antibody...
Bristol-Myers Squibb Gains NMPA Approval for Opdivo-Yervoy Combo in NSCLC
US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that it has received another indication approval...
Aidea Pharma’s Aitribond Approved by Zanzibar Food and Drug Agency
China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced that its anti-HIV-1 drug Aitribond has...
Sobi North America’s Doptelet Approved by FDA for Pediatric ITP Treatment
Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi), announced today...