Drug

Changchun GeneScience Receives NMPA Approval for Firsekibart Phase III Trial in Gout Flare Prevention During Urate-Lowering Therapy

Changchun GeneScience Pharmaceutical Co., Ltd. (SHE: 000661) announced it has received approval from China’s National...

Company Drug

Merus’ Bizengri Becomes First FDA-Approved Therapy for NRG1 Fusion-Positive Cholangiocarcinoma

Fineline Cube May 12, 2026

The U.S. Food and Drug Administration (FDA) granted approval to Merus N.V.’s Bizengri (zenocutuzumab-zbco) for...

Company Drug

Zai Lab Secures FDA Fast Track Designation for DLL3-Targeting ADC Zocilurtatug Pelitecan in Extrapulmonary NEC

Fineline Cube May 12, 2026

Zai Lab (NASDAQ: ZLAB, HKG: 9688) announced that the U.S. Food and Drug Administration (FDA)...

Company Drug

Ribo Life Science Files EMA Application for Vortosiran Phase IIb Study in Venous Thromboembolism Prevention

Fineline Cube May 12, 2026

Suzhou Ribo Life Science Co., Ltd. (HKG: 6938) announced it has submitted a clinical trial...

Company Drug

Haisco Pharmaceutical’s Sishujing Seeks Postoperative Pain Indication, Expanding Peripheral Kappa Agonist Franchise

Fineline Cube May 12, 2026

Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...

Company Drug

Juventas Cell Therapy’s CAR-T Yuanruida Seeks Pediatric ALL Indication, Expanding China’s Only Dual-Malignancy CAR-T Franchise

Fineline Cube May 12, 2026

Juventas Cell Therapy Ltd., the Chinese cell therapy innovator, announced that China’s National Medical Products...

Company Drug

Hengrui and Braveheart Bio Report Positive Phase 2 Results for Next-Gen Cardiac Myosin Inhibitor HRS-1893 in Non-Obstructive HCM

Fineline Cube May 12, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) and Braveheart Bio announced positive results...

Company Drug

CSPC Pharmaceutical Secures Second Breakthrough Therapy Designation for EGFR-Targeting ADC SYS 6010 in Esophageal Cancer

Fineline Cube May 12, 2026

CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced it has received a second Breakthrough Therapy Designation...

Company Drug

AmoyDx PCR11 Companion Diagnostic Approved in Japan for Johnson & Johnson’s Rybrevant in NSCLC with EGFR Exon 20 Insertions

Fineline Cube May 12, 2026

Amoy Diagnostics Co., Ltd. (SHE: 300685) announced in collaboration with Japanese partners Riken Genesis Co.,...

Company Drug

CanSino Biologics’ Five-Component Pertussis Vaccine Enters NMPA Priority Review for Ages 6+

Fineline Cube May 12, 2026

CanSino Biologics Inc. (HKG: 6185) announced that China’s National Medical Products Administration (NMPA) has included...

Company Drug

Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor

Fineline Cube May 11, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has secured two additional indication approvals from...

Company Drug

Henlius Biotech Receives FDA Clearance for Phase I Trial of HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer

Fineline Cube May 11, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received Investigational New Drug (IND) clearance...

Company Drug

Hansoh Pharmaceutical’s B7-H3 ADC HS-20093 Receives Fifth NMPA Breakthrough Therapy Designation for Esophageal Cancer

Fineline Cube May 11, 2026

Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its B7-H3-targeted antibody-drug conjugate (ADC) HS-20093...

Company Drug

CStone Pharmaceuticals Launches First Commercial Batch of Gavreto in China Following NRDL Inclusion

Fineline Cube May 11, 2026

CStone Pharmaceuticals (HKG: 2616) announced the first batch manufacturing and release of its Gavreto (pralsetinib...

Company Drug

Wenda Pharmaceutical Secures NMPA Breakthrough Therapy Designation for NHWD-870 in Rare NUT Carcinoma

Fineline Cube May 9, 2026

Zhejiang Wenda Pharmaceutical Technology Co., Ltd. announced it has received Breakthrough Therapy Designation (BTD) from...

Company Drug

European Commission Approves Bristol Myers Squibb’s Sotyktu for Psoriatic Arthritis Following FDA Clearance

Fineline Cube May 9, 2026

The European Commission (EC) granted marketing authorization this week for Bristol-Myers Squibb‘s (BMS, NYSE: BMY)...

Company Drug

Keymed Biosciences Secures NMPA Breakthrough Therapy Designation for CM336 in AL Amyloidosis

Fineline Cube May 9, 2026

Keymed Biosciences Inc. (HKG: 2162) announced that its BCMA×CD3 T cell engager (TCE), CM336 (OM336),...

Company Drug

Innovent Biologics Secures Third Breakthrough Therapy Designation for IBI363 in MSS/pMMR Colorectal Cancer

Fineline Cube May 9, 2026

Innovent Biologics, Inc. (HKG: 1801) announced that its first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein,...

Company Drug

Hengrui Pharmaceuticals Secures NMPA Clinical Approval for KRAS G12D Inhibitor HRS-6093 and Multiple Combination Regimens in Advanced Solid Tumors

Fineline Cube May 9, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received clinical trial...

Company Drug

Kelun-Biotech Submits New NMPA Filing for Jaitailai in First-Line NSCLC Combination Therapy with Keytruda

Fineline Cube May 9, 2026

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced it has submitted a new indication approval...

Drug

Changchun GeneScience Receives NMPA Approval for Firsekibart Phase III Trial in Gout Flare Prevention During Urate-Lowering Therapy

Merus’ Bizengri Becomes First FDA-Approved Therapy for NRG1 Fusion-Positive Cholangiocarcinoma

Zai Lab Secures FDA Fast Track Designation for DLL3-Targeting ADC Zocilurtatug Pelitecan in Extrapulmonary NEC

Ribo Life Science Files EMA Application for Vortosiran Phase IIb Study in Venous Thromboembolism Prevention

Haisco Pharmaceutical’s Sishujing Seeks Postoperative Pain Indication, Expanding Peripheral Kappa Agonist Franchise

Juventas Cell Therapy’s CAR-T Yuanruida Seeks Pediatric ALL Indication, Expanding China’s Only Dual-Malignancy CAR-T Franchise

Hengrui and Braveheart Bio Report Positive Phase 2 Results for Next-Gen Cardiac Myosin Inhibitor HRS-1893 in Non-Obstructive HCM

CSPC Pharmaceutical Secures Second Breakthrough Therapy Designation for EGFR-Targeting ADC SYS 6010 in Esophageal Cancer

AmoyDx PCR11 Companion Diagnostic Approved in Japan for Johnson & Johnson’s Rybrevant in NSCLC with EGFR Exon 20 Insertions

CanSino Biologics’ Five-Component Pertussis Vaccine Enters NMPA Priority Review for Ages 6+

Henlius Biotech Expands European Footprint with Two Additional EC Approvals for HanSiZhuang PD-1 Inhibitor

Henlius Biotech Receives FDA Clearance for Phase I Trial of HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer

Hansoh Pharmaceutical’s B7-H3 ADC HS-20093 Receives Fifth NMPA Breakthrough Therapy Designation for Esophageal Cancer

CStone Pharmaceuticals Launches First Commercial Batch of Gavreto in China Following NRDL Inclusion

Wenda Pharmaceutical Secures NMPA Breakthrough Therapy Designation for NHWD-870 in Rare NUT Carcinoma

European Commission Approves Bristol Myers Squibb’s Sotyktu for Psoriatic Arthritis Following FDA Clearance

Keymed Biosciences Secures NMPA Breakthrough Therapy Designation for CM336 in AL Amyloidosis

Innovent Biologics Secures Third Breakthrough Therapy Designation for IBI363 in MSS/pMMR Colorectal Cancer

Hengrui Pharmaceuticals Secures NMPA Clinical Approval for KRAS G12D Inhibitor HRS-6093 and Multiple Combination Regimens in Advanced Solid Tumors

Kelun-Biotech Submits New NMPA Filing for Jaitailai in First-Line NSCLC Combination Therapy with Keytruda

You Missed

Changchun GeneScience Receives NMPA Approval for Firsekibart Phase III Trial in Gout Flare Prevention During Urate-Lowering Therapy

MacroGenics Sells GMP-Compliant API Manufacturing Business to Bora Pharmaceuticals for $122.5 Million

Merus’ Bizengri Becomes First FDA-Approved Therapy for NRG1 Fusion-Positive Cholangiocarcinoma

Zai Lab Secures FDA Fast Track Designation for DLL3-Targeting ADC Zocilurtatug Pelitecan in Extrapulmonary NEC