Insight, China's Pharmaceutical Industry

Policy / Regulatory

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

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)...

Company Drug

CF PharmTech Wins NMPA Approval for Olopatadine Mometasone Combo Trial – Fixed-Dose Nasal Spray Targets Moderate-to-Severe Allergic Rhinitis

Fineline Cube Mar 9, 2026

CF PharmTech Inc. (HKG: 2652) announced NMPA clearance to initiate a clinical study for its...

Company Drug

Dongcheng Pharma Doses First Patient in 225Ac-LNC1011 Phase I/II Trial – PSMA-Targeted Alpha Radiotherapy for Metastatic Prostate Cancer

Fineline Cube Mar 9, 2026

Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced first subject enrollment in a Phase...

Company Drug

Bio-Thera Wins NMPA Approval for BAT8008 BAT1006 Trastuzumab Combo Trial – Dual HER2 Trop2 Targeting in Advanced Solid Tumors

Fineline Cube Mar 9, 2026

Bio-Thera Solutions Ltd (SHA: 688177) announced NMPA clearance to initiate a clinical study evaluating BAT8008...

Company Drug

Novo Nordisk’s IcoSema Wins NMPA Approval – Once-Weekly Insulin-Semaglutide Combo Targets China Type 2 Diabetes Market

Fineline Cube Mar 9, 2026

Novo Nordisk A/S (NYSE: NVO) secured NMPA approval for IcoSema, a once-weekly fixed-dose combination of...

Company Drug

Roche’s Petrelintide Hits 10.7% Weight Loss in Phase II ZUPREME-1 Trial – Amylin Analog Shows Sustained Efficacy Through Week 42

Fineline Cube Mar 6, 2026

Roche (SWX: ROG, OTCMKTS: RHHBY) announced positive topline results from the Phase II ZUPREME-1 trial...

Company Drug

Sciwind’s Ecnoglutide Wins NMPA Approval for Weight Loss – World’s First cAMP-Biased GLP-1 Agonist Targets China Obesity Market

Fineline Cube Mar 6, 2026

Sciwind Biosciences announced that Ecnoglutide injection (Xianweiying), the world’s first cAMP-biased GLP-1 receptor agonist, has...

Company Drug

Roche’s Xofluza Wins NMPA Approval for Pediatric Expansion – Oral Suspension Cleared for Children Under 5 Years

Fineline Cube Mar 6, 2026

Roche (SWX: ROG, OTCMKTS: RHHBY) announced that Xofluza (baloxavir marboxil) has received expanded NMPA approval...

Company

Merck KGaA Reports €21.1 Billion 2025 Sales – Healthcare Drives 3.7% Organic Growth Amid Currency Headwinds

Fineline Cube Mar 6, 2026

Merck KGaA (ETR: MRK) announced fiscal year 2025 results, recording €21.102 billion (~$24.5 billion) in net sales...

Insight, China's Pharmaceutical Industry

Allogene Therapeutics Terminates Asian CAR-T Joint Venture with Overland Pharmaceuticals – Strategic Retreat from Allogeneic Cell Therapy Market in Asia

Eli Lilly Commits $50M to UNICEF USA Alliance Targeting Non-Communicable Disease Prevention in Children Across 21 LMICs

TenNor Therapeutics Raises $71M in Hong Kong IPO – Antimicrobial Pipeline Targets H. pylori and Implant-Associated Infections

Fosun Pharma Secures Global Rights to AriBio’s Alzheimer’s Drug AR1001 in $240M Deal – PDE-5 Inhibitor Shows Promise in Phase III

Merck & Co. Forges Four Strategic Partnerships with Chinese Biotechs to Advance Autoimmune and Oncology Pipeline Through MCICC Platform

AstraZeneca’s Baxfendy Secures FDA Approval for Uncontrolled Hypertension – First-in-Class Aldosterone Synthase Inhibitor with Selective CYP11B2 Targeting

Harbour BioMed Unveils Preclinical Data for LET003 – AI-Discovered ACVR2A/2B Antibody Shows Best-in-Class Potential in Obesity Combination Therapy with GLP-1 Drugs

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

CF PharmTech Wins NMPA Approval for Olopatadine Mometasone Combo Trial – Fixed-Dose Nasal Spray Targets Moderate-to-Severe Allergic Rhinitis

Dongcheng Pharma Doses First Patient in 225Ac-LNC1011 Phase I/II Trial – PSMA-Targeted Alpha Radiotherapy for Metastatic Prostate Cancer

Bio-Thera Wins NMPA Approval for BAT8008 BAT1006 Trastuzumab Combo Trial – Dual HER2 Trop2 Targeting in Advanced Solid Tumors

Novo Nordisk’s IcoSema Wins NMPA Approval – Once-Weekly Insulin-Semaglutide Combo Targets China Type 2 Diabetes Market

Roche’s Petrelintide Hits 10.7% Weight Loss in Phase II ZUPREME-1 Trial – Amylin Analog Shows Sustained Efficacy Through Week 42

Sciwind’s Ecnoglutide Wins NMPA Approval for Weight Loss – World’s First cAMP-Biased GLP-1 Agonist Targets China Obesity Market

Roche’s Xofluza Wins NMPA Approval for Pediatric Expansion – Oral Suspension Cleared for Children Under 5 Years

Merck KGaA Reports €21.1 Billion 2025 Sales – Healthcare Drives 3.7% Organic Growth Amid Currency Headwinds

You Missed

AstraZeneca’s Baxfendy Secures FDA Approval for Uncontrolled Hypertension – First-in-Class Aldosterone Synthase Inhibitor with Selective CYP11B2 Targeting

Harbour BioMed Unveils Preclinical Data for LET003 – AI-Discovered ACVR2A/2B Antibody Shows Best-in-Class Potential in Obesity Combination Therapy with GLP-1 Drugs

Allogene Therapeutics Terminates Asian CAR-T Joint Venture with Overland Pharmaceuticals – Strategic Retreat from Allogeneic Cell Therapy Market in Asia

AstraZeneca and Daiichi Sankyo’s ENHERTU Secures Dual FDA Approval for HER2-Positive Early Breast Cancer – Neoadjuvant and Adjuvant Indications Supported by Landmark Phase 3 Data