Fineline Cube

AstraZeneca Initiates CLARITY-Gastric 02 Phase III – Sonesitatug Vedotin Combo Triggers $45 Million Milestone from KYM Biosciences

Fineline Cube Mar 11, 2026

AstraZeneca (AZ, NASDAQ: AZN) announced the initiation of CLARITY-Gastric 02, a multi-center, randomized, controlled Phase...

Company

Bayer Co.Lab Adds Arbele and Alphelix – China Innovation Cluster Reaches 12 Resident Biotech Startups

Fineline Cube Mar 11, 2026

Bayer Co.Lab announced that Arbele Limited and Alphelix Bioscience have joined its co-creation platform, bringing...

Company Drug

FDA Approves GSK’s Wellcovorin for Cerebral Folate Deficiency – First Treatment for Rare FOLR1 Genetic Disorder

Fineline Cube Mar 11, 2026

The U.S. Food and Drug Administration (FDA) approved expanded use of GlaxoSmithKline’s (GSK, NYSE: GSK)...

Company Drug

Astellas’ XOSPATA Fails Phase III Primary Endpoint in Frontline AML – FLT3 Inhibitor Misses OS Benefit vs. Midostaurin

Fineline Cube Mar 11, 2026

Astellas Pharma Inc. (TYO: 4503) and the HOVON Foundation announced that the Phase III HOVON...

Company Drug

Keymed Biosciences Initiates CMG901 Phase III – AstraZeneca Triggers $45 Million Milestone for Claudin 18.2 ADC

Fineline Cube Mar 11, 2026

Keymed Biosciences Inc. (HKG: 2162) announced the initiation of Phase III clinical trials for CMG901,...

Company Drug

SicaGene’s SG12 ASO Wins NMPA Approval – Antisense Oligonucleotide Targets Hepatitis B Functional Cure

Fineline Cube Mar 10, 2026

SicaGene (Beijing) Biotechnology Co., LTD announced that SG12 injection, a self-developed antisense oligonucleotide (ASO), has...

Company Drug

Kelun-Biotech’s SKB575/HBM7575 Wins NMPA Approval – Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential

Fineline Cube Mar 10, 2026

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that SKB575/HBM7575, a long-acting bispecific antibody (bsAb)...

Company Drug

Henlius Biotech’s HLX3901 Wins NMPA Approval – First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors

Fineline Cube Mar 10, 2026

Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX3901, a first-in-class tetra-specific antibody targeting DLL3...

Company Drug

Qyuns Therapeutics’ QX002N NDA Accepted by NMPA – IL-17A Antibody Targets Ankylosing Spondylitis Market

Fineline Cube Mar 10, 2026

Qyuns Therapeutics (HKG: 2509) announced that the New Drug Application (NDA) for QX002N, its first...

Company Deals

GSK Licenses Linerixibat to Alfasigma for $300 Million Upfront – IBAT Inhibitor Targets PBC Pruritus with $690 Million Total Deal Value

Fineline Cube Mar 10, 2026

GlaxoSmithKline (GSK, NYSE: GSK) and Alfasigma S.p.A. announced a licensing agreement granting Alfasigma exclusive global rights...

Policy / Regulatory

FDA Streamlines Biosimilar Development – New Guidance Cuts PK Study Costs by 50%, Accelerates Path to Market

Fineline Cube Mar 10, 2026

The U.S. Food and Drug Administration (FDA) announced a major policy shift to accelerate biosimilar...

Company Drug

Everest Medicines Launches Etrasimod in China – Next-Gen S1P Modulator Hits Market for Ulcerative Colitis

Fineline Cube Mar 10, 2026

Everest Medicines (HKG: 1952) announced the formal commercial launch of Etrasimod, with the first prescription...

Policy / Regulatory

FDA Advances Section 804 Drug Importation Program – States Meet Agency on Canadian Prescription Import Pathway

Fineline Cube Mar 10, 2026

The U.S. Food and Drug Administration (FDA) convened meetings with multiple states this week to...

Company Deals Drug

Novo Nordisk Settles with Hims & Hers – Ozempic Wegovy Distribution Deal Ends Patent Litigation, Eliminates Compounded GLP-1 Advertising

Fineline Cube Mar 10, 2026

Novo Nordisk A/S (NYSE: NVO) announced a settlement agreement with telehealth company Hims & Hers...

Policy / Regulatory

NMPA Removes OCALIVA from GQCE Reference List – Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile

Fineline Cube Mar 10, 2026

China’s National Medical Products Administration (NMPA) released the 102nd batch of reference drugs for generic...

Company Drug

HutchMed Withdraws TAZVERIK from China – Safety Concerns Drive Global Recall of Epizyme/Ipsen EZH2 Inhibitor

Fineline Cube Mar 10, 2026

HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced immediate withdrawal and product recall of TAZVERIK...

Company Drug

Fosun Pharma’s HLX316 Wins NMPA Approval – First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors

Fineline Cube Mar 10, 2026

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that HLX316, a novel...

Company Drug

Hengrui’s HRS9531 Wins NMPA Approval for CKD Trial – Dual GIPR/GLP-1R Agonist Expands Beyond Diabetes and Obesity

Fineline Cube Mar 10, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS9531, a novel dual...

Company

Merck KGaA Cuts SpringWorks Hippo Inhibitor and Hengrui PARP1 Program – R&D Pipeline Optimization Ditches €3.7 Billion in Acquired Assets

Fineline Cube Mar 10, 2026

Merck KGaA (ETR: MRK) announced completion of a new R&D pipeline optimization, terminating development of...

Company Drug

Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis

Fineline Cube Mar 9, 2026

Bristol-Myers Squibb (BMS, NYSE: BMY) announced FDA approval for a label extension of Sotyktu (deucravacitinib),...

Fineline Cube

AstraZeneca Initiates CLARITY-Gastric 02 Phase III – Sonesitatug Vedotin Combo Triggers $45 Million Milestone from KYM Biosciences

Bayer Co.Lab Adds Arbele and Alphelix – China Innovation Cluster Reaches 12 Resident Biotech Startups

FDA Approves GSK’s Wellcovorin for Cerebral Folate Deficiency – First Treatment for Rare FOLR1 Genetic Disorder

Astellas’ XOSPATA Fails Phase III Primary Endpoint in Frontline AML – FLT3 Inhibitor Misses OS Benefit vs. Midostaurin

Keymed Biosciences Initiates CMG901 Phase III – AstraZeneca Triggers $45 Million Milestone for Claudin 18.2 ADC

SicaGene’s SG12 ASO Wins NMPA Approval – Antisense Oligonucleotide Targets Hepatitis B Functional Cure

Kelun-Biotech’s SKB575/HBM7575 Wins NMPA Approval – Long-Acting TSLP Bispecific Targets Atopic Dermatitis with Q3+ Dosing Potential

Henlius Biotech’s HLX3901 Wins NMPA Approval – First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors

Qyuns Therapeutics’ QX002N NDA Accepted by NMPA – IL-17A Antibody Targets Ankylosing Spondylitis Market

GSK Licenses Linerixibat to Alfasigma for $300 Million Upfront – IBAT Inhibitor Targets PBC Pruritus with $690 Million Total Deal Value

FDA Streamlines Biosimilar Development – New Guidance Cuts PK Study Costs by 50%, Accelerates Path to Market

Everest Medicines Launches Etrasimod in China – Next-Gen S1P Modulator Hits Market for Ulcerative Colitis

FDA Advances Section 804 Drug Importation Program – States Meet Agency on Canadian Prescription Import Pathway

Novo Nordisk Settles with Hims & Hers – Ozempic Wegovy Distribution Deal Ends Patent Litigation, Eliminates Compounded GLP-1 Advertising

NMPA Removes OCALIVA from GQCE Reference List – Obeticholic Acid Stripped Over Safety Concerns, Benefit-Risk Profile

HutchMed Withdraws TAZVERIK from China – Safety Concerns Drive Global Recall of Epizyme/Ipsen EZH2 Inhibitor

Fosun Pharma’s HLX316 Wins NMPA Approval – First-in-Class B7-H3 Sialidase Heterodimer Targets Advanced Solid Tumors

Hengrui’s HRS9531 Wins NMPA Approval for CKD Trial – Dual GIPR/GLP-1R Agonist Expands Beyond Diabetes and Obesity

Merck KGaA Cuts SpringWorks Hippo Inhibitor and Hengrui PARP1 Program – R&D Pipeline Optimization Ditches €3.7 Billion in Acquired Assets

Bristol-Myers Squibb’s Sotyktu Wins FDA Label Extension – TYK2 Inhibitor Expands to Psoriatic Arthritis

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Abbisko Therapeutics Wins FDA Orphan Drug Designation for ABSK061 – Oral FGFR2/3 Inhibitor Targets Achondroplasia in Pediatric Patients

Huahai Pharmaceutical Initiates Phase III Trial for HB0025 – PD-L1/VEGF Bispecific Targets First-Line Endometrial Cancer

Konruns Pharma Wins NMPA Phase III Approval for KC1036 – Multi-Target VEGFR2/AXL Inhibitor Targets Thymic Carcinoma

InventisBio’s D-2570 Wins FDA Phase II Clearance – Oral TYK2 Inhibitor Targets Moderate-to-Severe Plaque Psoriasis