Merus’ Bizengri Becomes First FDA-Approved Therapy for NRG1 Fusion-Positive Cholangiocarcinoma
The U.S. Food and Drug Administration (FDA) granted approval to Merus N.V.’s Bizengri (zenocutuzumab-zbco) for...
Cancer
Zai Lab Secures FDA Fast Track Designation for DLL3-Targeting ADC Zocilurtatug Pelitecan in Extrapulmonary NEC
Zai Lab (NASDAQ: ZLAB, HKG: 9688) announced that the U.S. Food and Drug Administration (FDA)...
Juventas Cell Therapy’s CAR-T Yuanruida Seeks Pediatric ALL Indication, Expanding China’s Only Dual-Malignancy CAR-T Franchise
Juventas Cell Therapy Ltd., the Chinese cell therapy innovator, announced that China’s National Medical Products...
Akari Therapeutics Partners with WuXi XDC to Advance Novel PH1 Payload Platform for Urothelial Cancer
Akari Therapeutics (NASDAQ: AKTX), the US-UK dual-headquartered biotechnology company, announced a strategic development partnership with...
Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from...
Hansoh Pharmaceutical’s B7-H3 ADC HS-20093 Receives Fifth NMPA Breakthrough Therapy Designation for Esophageal Cancer
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its B7-H3-targeted antibody-drug conjugate (ADC) HS-20093...
CStone Pharmaceuticals Launches First Commercial Batch of Gavreto in China Following NRDL Inclusion
CStone Pharmaceuticals (HKG: 2616) announced the first batch manufacturing and release of its Gavreto (pralsetinib...
Wenda Pharmaceutical Secures NMPA Breakthrough Therapy Designation for NHWD-870 in Rare NUT Carcinoma
Zhejiang Wenda Pharmaceutical Technology Co., Ltd. announced it has received Breakthrough Therapy Designation (BTD) from...
Innovent Biologics Secures Third Breakthrough Therapy Designation for IBI363 in MSS/pMMR Colorectal Cancer
Innovent Biologics, Inc. (HKG: 1801) announced that its first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein,...
Hengrui Pharmaceuticals Secures NMPA Clinical Approval for KRAS G12D Inhibitor HRS-6093 and Multiple Combination Regimens in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received clinical trial...
Kelun-Biotech Submits New NMPA Filing for Jaitailai in First-Line NSCLC Combination Therapy with Keytruda
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced it has submitted a new indication approval...
Fosun Pharma Secures Exclusive China Rights to InxMed’s FAK Inhibitors for Solid Tumor Treatment
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced a strategic partnership with...
Avistone Biotechnology’s Andatinib Receives China Conditional Approval for EGFR Ex20ins NSCLC
Beijing Avistone Biotechnology Co., Ltd. announced that its self-developed EGFR exon 20 insertion (ex20ins) inhibitor,...
Allist Pharmaceuticals Secures China BTD for KRAS G12C NSCLC Combination Therapy with 71% Response Rate
Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that China’s regulatory authorities have granted Breakthrough Therapy...
Astellas Reports Strong FY2025 Results with 12% Revenue Growth Driven by Oncology Portfolio Expansion
Astellas Pharma Inc. (TYO: 4503) reported FY2025 financial results showing JPY 2,139.2 billion (USD 13.9...
Santo Therapeutics Secures Dual FDA Designations for ST002 Gene Therapy in NF2-Related Schwannomatosis – Advancing In Vivo Lentiviral Platform
Santo Therapeutics, a Hangzhou-based in vivo gene therapy developer, announced it has received both Orphan...
Hangzhou’s Adcoris Licenses First-in-Class 5T4-Targeting ADC ACR246 to U.S. Biotech K2 Therapeutics in Deal Worth Up to $730 Million
Adcoris, a Hangzhou-based bioconjugation specialist, announced a global licensing agreement with U.S.-headquartered K2 Therapeutics, Inc....
Sino Biopharmaceutical’s Chia Tai Tianqing and Shanghai Reunion Partner to Commercialize Respacio Hydrogel for Cervical Cancer Radiotherapy Protection in China
Chia Tai Tianqing Pharmaceutical Group, a wholly owned subsidiary of Sino Biopharmaceutical Ltd (HKG: 1177),...
Brii Biosciences Presents Promising HBsAg Rebound Data for Elebsiran-Based Regimens at APASL 2026, Highlighting Potential Functional Cure Profile in Chronic Hepatitis B
Brii Biosciences (HKG: 2137) unveiled a cross-study pooled analysis of hepatitis B surface antigen (HBsAg)...
CSPC Pharmaceutical Receives FDA Clearance to Launch First-in-Class KAT6 Inhibitor SYH2095 Clinical Trial for Advanced Cancers
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA)...