Insight, China's Pharmaceutical Industry

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

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),...

Company Deals

Servier to Acquire Day One Biopharmaceuticals for $2.5 Billion – French Pharma Expands U.S. Oncology Presence with ADC Assets

Fineline Cube Mar 9, 2026

Servier Group announced a definitive agreement to acquire Day One Biopharmaceuticals, Inc. (NASDAQ: DAWN) for...

Company Drug

Hengrui’s Adebrelimab Wins NMPA Approval for Two Perioperative Cancer Trials – PD-L1/CTLA-4 Combo Targets Rectal and Gastric/GEJ Cancers

Fineline Cube Mar 9, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced NMPA clearance for two pivotal...

Company Drug

Leads Biolabs’ Opamtistomig Enters Phase II in First-Line Esophageal Cancer – PD-L1/4-1BB Bispecific with BTD/ODD Designations

Fineline Cube Mar 9, 2026

Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced first patient enrollment in a Phase II...

Company Drug

CSPC’s SYH2059 Inhalation Powder Wins FDA IND Approval – PDE4B Inhibitor Targets Pulmonary Fibrosis with Enhanced Delivery

Fineline Cube Mar 9, 2026

CSPC Pharmaceutical Group Ltd (HKG: 1093) announced FDA clearance to initiate a clinical study for...

Company

AstraZeneca China Reorganizes Biopharma Operations – Omni-Channel Unit and Early Oncology Pipeline Restructuring

Fineline Cube Mar 9, 2026

AstraZeneca Plc’s (AZ, NASDAQ: AZN) China unit announced a strategic reorganization of its biopharmaceutical operations,...

Company Drug

Haisco’s HSK39297 NMPA Filing Accepted – Oral Factor B Inhibitor Targets Paroxysmal Nocturnal Hemoglobinuria Market

Fineline Cube Mar 9, 2026

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

Insight, China's Pharmaceutical Industry

GSK Partners with SPH Keyuan Trade to Relaunch Engerix B – Hepatitis B Vaccine Targets China’s Adult Self-Paid Market

MSD to Acquire Terns Pharmaceuticals for $6.7 Billion – TERN-701 BCR::ABL1 Inhibitor Targets Chronic Myeloid Leukemia

Daiichi Sankyo Partners with Tempus AI – Foundation Models Target ADC Biomarker Discovery and Patient Stratification

Thermo Fisher Partners with SHL Medical – Autoinjector Manufacturing Expansion Targets U.S. Drug-Device Combination Market

Insilico Medicine Expands AI Collaboration with Tenacia Bio – $94.75M Deal Targets CNS Drug Discovery with Blood-Brain Barrier Penetration

Lee’s Pharma Wins NMPA Approval for Intrarosa – Estrogen-Free DHEA Pessary Targets Postmenopausal Vulvovaginal Atrophy

United Laboratories Novo Nordisk Report Positive Phase II Data for UBT251 – Triple GLP-1/GIP/GCG Agonist Achieves 19.7% Weight Los

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

Servier to Acquire Day One Biopharmaceuticals for $2.5 Billion – French Pharma Expands U.S. Oncology Presence with ADC Assets

Hengrui’s Adebrelimab Wins NMPA Approval for Two Perioperative Cancer Trials – PD-L1/CTLA-4 Combo Targets Rectal and Gastric/GEJ Cancers

Leads Biolabs’ Opamtistomig Enters Phase II in First-Line Esophageal Cancer – PD-L1/4-1BB Bispecific with BTD/ODD Designations

CSPC’s SYH2059 Inhalation Powder Wins FDA IND Approval – PDE4B Inhibitor Targets Pulmonary Fibrosis with Enhanced Delivery

AstraZeneca China Reorganizes Biopharma Operations – Omni-Channel Unit and Early Oncology Pipeline Restructuring

Haisco’s HSK39297 NMPA Filing Accepted – Oral Factor B Inhibitor Targets Paroxysmal Nocturnal Hemoglobinuria Market

You Missed

China State Council Mandates Long-Term Care Insurance System – 0.3% Contribution Rate Targets Severe Disability Coverage Within Three Years

Simcere Pharma 2025 Revenue RMB 7.7B – Innovative Drugs Drive 28% Growth, Profit Surges 86%

GSK Partners with SPH Keyuan Trade to Relaunch Engerix B – Hepatitis B Vaccine Targets China’s Adult Self-Paid Market

Lee’s Pharma Wins NMPA Approval for Intrarosa – Estrogen-Free DHEA Pessary Targets Postmenopausal Vulvovaginal Atrophy