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)...
Cancer
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...
Eli Lilly’s Jaypirca Achieves Primary Endpoint in Phase III BRUIN CLL-314 Trial
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) announced on July 29, 2025, that...
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...
Alphamab Oncology’s JSKN003 Granted FDA Orphan Drug Designation for Gastric and Gastroesophageal Junction Cancer
China-based Alphamab Oncology (HKG: 9966) announced today that its drug candidate JSKN003 has received Orphan...
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...
Mirxes and NAGAWA Launch Free Gastric Cancer Screening Project in Japan
Singapore-based Mirxes Group (HKG: 2629) announced on July 23, 2025, that it has entered into...
Hengrui and GSK Enter Global Licensing Pact for PDE3/4 Inhibitor HRS-9821
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced on July 28, 2025, that it...
Sanofi’s Sarclisa Approved in EU for Newly Diagnosed Multiple Myeloma
France-based Sanofi (NASDAQ: SNY) announced that the European Commission has approved its anti-CD38 monoclonal antibody...
3Sbio and Pfizer Finalize Licensing Agreement for PD-1/VEGF Bispecific Antibody SSGJ-707
China-based 3Sbio Inc. (HKG: 1530) announced today that its global licensing agreement with Pfizer Inc.,...
GenFleet Therapeutics Announces Fast Track Designation for GFH375/VS-7375 in Pancreatic Cancer
China-based GenFleet Therapeutics announced on July 25, 2025, that its oral KRAS G12D inhibitor, GFH375/VS-7375,...
Leads Biolabs Lists on Hong Kong Stock Exchange in $189 Million IPO
China-based Leads Biolabs (HKG: 9887) officially listed on the Main Board of the Hong Kong...
Ipsen’s Cabometyx Approved by European Commission for Neuroendocrine Tumors
France-based pharmaceutical company Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced that its anticancer drug Cabometyx...
CTTQ Doses First Patient in China for TQB6411 Phase I Clinical Trial
Subsidiary of China based Sino Biopharmaceutical Ltd (HKG: 1177) Jiangsu Chia Tai Tianqing Pharmaceutical Co.,...
Grand Pharma’s TLX591 Granted NMPA Approval for Phase III Prostate Cancer Trial
China-based Grand Pharmaceutical Group Limited (HKG: 0512) announced that its innovative radiolabeled drug conjugate (RDC)...
Abbisko Therapeutics Completes First Patient Dosing for PRMT5×MTA Inhibitor ABSK131
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the completion of the first patient...
Novatim and ERIGEN Ink Licensing Pact for Dual-Target CAR-T Therapy KQ-2003
Novatim Immune Therapeutics (Zhejiang) Co., Ltd. announced a strategic cooperation with US-based biopharmaceutical company ERIGEN...
AstraZeneca’s FLAURA2 Study Confirms Osimertinib Combo’s Survival Benefit in NSCLC
UK-based AstraZeneca (AZ, NASDAQ: AZN) announced the final overall survival (OS) results from the Phase III...
Simcere Zaiming Receives FDA Clearance for Phase I Trial of FGFR2b-Targeting ADC SIM0686
China-based Simcere Pharma’s (HKG: 2096) oncology arm, Simcere Zaiming Pharmaceutical, has secured U.S. FDA clearance...
DualityBio’s Next-Generation HER3 ADC DB-1310 Granted FDA Fast Track Designation
Duality Biologics (HKG: 9606) announced that the US Food and Drug Administration (FDA) has granted...