Fineline Cube

Company Drug

Novartis Secures Fourth China Approval for Tafinlar-Mekinist Combo in BRAF V600E-Mutated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

Novartis AG (NYSE: NVS) announced that China’s National Medical Products Administration (NMPA) has granted approval...

Company Drug

Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed/Refractory AML

Fineline Cube Jun 11, 2026

Yipinhong Pharmacy Co., Ltd. (SHE: 300723) announced it has received Investigational New Drug (IND) clearance...

Company Drug

CSPC Pharmaceutical’s Phase III Trial of Anbenitamab-Docetaxel Combination Meets Primary Endpoint in First-Line HER2-Positive Advanced Breast Cancer

Fineline Cube Jun 11, 2026

CSPC Pharmaceutical Group (HKG: 1093) announced that its Phase III clinical trial evaluating Ennituo (anbenitamab)...

Others

Harbour BioMed’s IND for HBM7004 Bispecific Antibody Accepted by NMPA for Advanced Solid Tumors Following U.S. Clearance

Fineline Cube Jun 11, 2026

Harbour BioMed (HKG: 2142) announced that China’s National Medical Products Administration (NMPA) has accepted its...

Company Deals

QingSong Health and Basel Medical Forge Three-Year Strategic Alliance to Deploy AI-Driven Healthcare Solutions Across Southeast Asia

Fineline Cube Jun 11, 2026

QingSong Health (HKG: 2661) announced a three-year strategic cooperation memorandum of understanding (MoU) with Singapore-headquartered...

Company Drug

Imviva Biotech Receives FDA Clearance for Phase 1b Basket Trial of CTA313 Allogeneic CAR-T Therapy in B Cell-Mediated Autoimmune Diseases

Fineline Cube Jun 11, 2026

Imviva Biotech announced it has received Investigational New Drug (IND) clearance from the U.S. Food...

Company Drug

Akeso Biopharma Secures NMPA Approval for Gumokimab, IL-17A Monoclonal Antibody for Moderate-to-Severe Plaque Psoriasis

Fineline Cube Jun 11, 2026

Akeso Biopharma (HKG: 9926) announced it has received marketing approval from China’s National Medical Products...

Company Drug

Hansoh Pharmaceutical’s NDA for HS-10568 Calcium-Sensing Receptor Modulator Accepted by China’s NMPA for Secondary Hyperparathyroidism in Dialysis Patients

Fineline Cube Jun 11, 2026

Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s National Medical Products Administration (NMPA)...

Others

Orionis Biosciences Secures $1.44 Billion Novartis Partnership for Molecular Glue Drug Discovery Using AI-Powered Allo-Glue Platform

Fineline Cube Jun 11, 2026

Orionis Biosciences announced a multi-year strategic collaboration with global pharmaceutical leader Novartis AG (NYSE: NVS)...

Company Drug

Bio-Thera Solutions Secures Singapore Approval for BAT2206, Biosimilar to J&J’s Stelara, Expanding Access Across Multiple Autoimmune Indications

Fineline Cube Jun 11, 2026

Bio-Thera Solutions Ltd. (SHA: 688177) announced it has received marketing approval from Singapore’s Health Sciences...

Company Drug Policy / Regulatory

PKU Hi-Tech Huatai Pharmaceuticals Blacklisted from China’s Volume-Based Procurement Following Quality Compliance Failures

Fineline Cube Jun 11, 2026

PKU Hi-Tech Huatai Pharmaceuticals Co., Ltd. has been blacklisted from China’s national volume-based procurement (VBP)...

Company Drug

Sanofi Halts Phase 3 MOBILIZE Trial for Riliprubart in Refractory CIDP Patients Following Interim Analysis

Fineline Cube Jun 11, 2026

Sanofi (NASDAQ: SNY) announced the discontinuation of its MOBILIZE phase 3 clinical trial evaluating riliprubart...

Company Drug

NeuroGen Pharma Secures NMPA Approval for Ajovy (Fremanezumab) in China, Launching First Quarterly CGRP Migraine Prevention Therapy

Fineline Cube Jun 10, 2026

NeuroGen Pharma announced it has received marketing approval from China’s National Medical Products Administration (NMPA)...

Company Drug

Harbour BioMed’s TSLP Inhibitor HBM9378/WIN378 Doses First Patient in Phase II COPD Study with Windward Bio, Supporting Twice-Yearly Dosing Regimen

Fineline Cube Jun 10, 2026

Harbour BioMed (HKG: 2142) announced that the first patient has been dosed in the Phase...

Company Drug

Haisco Pharmaceutical Files Nav1.8 Inhibitor HSK51155 with NMPA Following $700M+ AbbVie Licensing Deal for Novel Pain Therapeutic

Fineline Cube Jun 10, 2026

Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced it has submitted a clinical filing for...

Company Medical Device

Huadong Medicine’s Ellansé S Dermal Filler Receives NMPA Acceptance for Forehead Contouring Indication, Expanding China’s Premium Aesthetic Portfolio

Fineline Cube Jun 10, 2026

Huadong Medicine Co., Ltd. (SHE: 000963) announced that the National Medical Products Administration (NMPA) has...

Company Drug

Henlius Biotech’s Serplulimab Becomes World’s First PD-1 Inhibitor Approved for Perioperative Gastric Cancer Treatment Following Landmark Phase III Results

Fineline Cube Jun 10, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...

Company Drug

Hengrui Pharmaceuticals Advances Triple-Asset Breast Cancer Strategy with NMPA Approval for HRS-6209 Combination Study, Leveraging Selective CDK4 Inhibitor and Novel SERD

Fineline Cube Jun 10, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received regulatory clearance...

Company Deals

WestGene Biopharma and Cartesian Therapeutics Forge $500M+ mRNA Partnership for In Vivo CAR-T and T Cell Engager Autoimmune Therapies

Fineline Cube Jun 10, 2026

WestGene Biopharma Co., Ltd. announced a strategic licensing agreement with Cartesian Therapeutics, Inc. (NASDAQ: RNAC)...

Company Drug

Takeda’s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn’s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+

Fineline Cube Jun 10, 2026

Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug...

Fineline Cube

Novartis Secures Fourth China Approval for Tafinlar-Mekinist Combo in BRAF V600E-Mutated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed/Refractory AML

CSPC Pharmaceutical’s Phase III Trial of Anbenitamab-Docetaxel Combination Meets Primary Endpoint in First-Line HER2-Positive Advanced Breast Cancer

Harbour BioMed’s IND for HBM7004 Bispecific Antibody Accepted by NMPA for Advanced Solid Tumors Following U.S. Clearance

QingSong Health and Basel Medical Forge Three-Year Strategic Alliance to Deploy AI-Driven Healthcare Solutions Across Southeast Asia

Imviva Biotech Receives FDA Clearance for Phase 1b Basket Trial of CTA313 Allogeneic CAR-T Therapy in B Cell-Mediated Autoimmune Diseases

Akeso Biopharma Secures NMPA Approval for Gumokimab, IL-17A Monoclonal Antibody for Moderate-to-Severe Plaque Psoriasis

Hansoh Pharmaceutical’s NDA for HS-10568 Calcium-Sensing Receptor Modulator Accepted by China’s NMPA for Secondary Hyperparathyroidism in Dialysis Patients

Orionis Biosciences Secures $1.44 Billion Novartis Partnership for Molecular Glue Drug Discovery Using AI-Powered Allo-Glue Platform

Bio-Thera Solutions Secures Singapore Approval for BAT2206, Biosimilar to J&J’s Stelara, Expanding Access Across Multiple Autoimmune Indications

PKU Hi-Tech Huatai Pharmaceuticals Blacklisted from China’s Volume-Based Procurement Following Quality Compliance Failures

Sanofi Halts Phase 3 MOBILIZE Trial for Riliprubart in Refractory CIDP Patients Following Interim Analysis

NeuroGen Pharma Secures NMPA Approval for Ajovy (Fremanezumab) in China, Launching First Quarterly CGRP Migraine Prevention Therapy

Harbour BioMed’s TSLP Inhibitor HBM9378/WIN378 Doses First Patient in Phase II COPD Study with Windward Bio, Supporting Twice-Yearly Dosing Regimen

Haisco Pharmaceutical Files Nav1.8 Inhibitor HSK51155 with NMPA Following $700M+ AbbVie Licensing Deal for Novel Pain Therapeutic

Huadong Medicine’s Ellansé S Dermal Filler Receives NMPA Acceptance for Forehead Contouring Indication, Expanding China’s Premium Aesthetic Portfolio

Henlius Biotech’s Serplulimab Becomes World’s First PD-1 Inhibitor Approved for Perioperative Gastric Cancer Treatment Following Landmark Phase III Results

Hengrui Pharmaceuticals Advances Triple-Asset Breast Cancer Strategy with NMPA Approval for HRS-6209 Combination Study, Leveraging Selective CDK4 Inhibitor and Novel SERD

WestGene Biopharma and Cartesian Therapeutics Forge $500M+ mRNA Partnership for In Vivo CAR-T and T Cell Engager Autoimmune Therapies

Takeda’s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn’s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+

You Missed

CSPC Pharmaceutical’s Cosentyx Biosimilar Accepted for NMPA Review in China’s Competitive IL-17A Market

CSPC Pharmaceutical Secures FDA Clearance for SYHX2008 Octreotide Biosimilar Clinical Trials in US Market

Samsung Biologics and Organon Expand Biosimilars Partnership with Canadian Rights for Pyzchiva (Ustekinumab)

Johnson & Johnson Secures Second NMPA Approval for Akeega in BRCA2-Mutated Metastatic Prostate Cancer Following AMPLITUDE Trial Success