Drug

ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sjögren’s Syndrome, Expanding Dual-Target Bispecific Platform

ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced it has received clinical approval from China’s...

Company Drug

Alphamab Oncology Initiates Phase II Trial of Subcutaneous Co-Formulation JSKN033 in First-Line Advanced Cervical Cancer

Fineline Cube May 13, 2026

Alphamab Oncology (HKG: 9966) announced the initiation of a Phase II clinical study for its...

Company Drug

Bio-Thera’s CD25-Targeted ADC BAT8013 Receives NMPA Approval for Advanced Solid Tumor Clinical Studies in China

Fineline Cube May 13, 2026

Bio-Thera Solutions Ltd. (SHA: 688177) announced that its CD25-targeted antibody drug conjugate (ADC) BAT8013 has...

Company Drug

Sichuan Biokin’s Bispecific ADC Iza-Bren Receives NMPA Approval for NSCLC Clinical Study in China

Fineline Cube May 13, 2026

Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its bispecific antibody-drug conjugate (ADC) izalontamab...

Company Drug

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

Fineline Cube May 13, 2026

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)...

Drug

ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sjögren’s Syndrome, Expanding Dual-Target Bispecific Platform

Alphamab Oncology Initiates Phase II Trial of Subcutaneous Co-Formulation JSKN033 in First-Line Advanced Cervical Cancer

Bio-Thera’s CD25-Targeted ADC BAT8013 Receives NMPA Approval for Advanced Solid Tumor Clinical Studies in China

Sichuan Biokin’s Bispecific ADC Iza-Bren Receives NMPA Approval for NSCLC Clinical Study in China

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

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ImmuneOnco Receives NMPA Approval for IMM0306 Clinical Study in Primary Sjögren’s Syndrome, Expanding Dual-Target Bispecific Platform

Bayer Reports 4.1% Q1 Sales Growth to €13.4B, with Mixed Pharmaceutical Performance Amid IRA Impact and Generic Competition

Boehringer Ingelheim Secures Global Rights to Immunitas’ First-in-Class Antibody Program for Chronic Inflammatory Diseases in €407.5M Deal

Roche Secures CE Mark for Elecsys pTau217 Blood Test, First Single-Assay Alzheimer’s Diagnostic with Amyloid Pathology Detection