Insight, China's Pharmaceutical Industry

Company Drug

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

AstraZeneca (NYSE: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. Food and Drug...

Company Drug

Roche’s Tecentriq Secures FDA Approval for ctDNA-Guided Adjuvant Treatment in Muscle-Invasive Bladder Cancer – First MRD-Directed Immunotherapy with 41% Mortality Reduction

Fineline Cube May 18, 2026

Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration (FDA)...

Company Drug

Biogen’s Zorevunersen Receives China Breakthrough Therapy Designation for Dravet Syndrome – First ASO Targeting SCN1A Gene in Rare Epileptic Encephalopathy

Fineline Cube May 18, 2026

Biogen Inc. (NASDAQ: BIIB) announced that zorevunersen, an investigational antisense oligonucleotide (ASO) for Dravet syndrome,...

Company Drug

Shanghai CureGene’s CG-0255 Receives NMPA Clearance for Ischemic Stroke Clinical Trial – First Thiol-Based P2Y12 Inhibitor Overcoming Clopidogrel Resistance

Fineline Cube May 18, 2026

Shanghai CureGene Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...

Company Drug

Shenzhen Salubris Secures Chinese Approval for Xinfutai Plus – First Once-Weekly Teriparatide for High-Risk Postmenopausal Osteoporosis

Fineline Cube May 18, 2026

Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced market approval from China’s National Medical Products...

Company Drug

Changchun GeneScience’s GenSci161 Receives FDA Clearance for Hidradenitis Suppurativa Clinical Trial – Novel Bispecific Antibody Targeting IL-1α/IL-1β

Fineline Cube May 18, 2026

Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun...

Company Digital

Alibaba Health Reports Strong FY2026 Results with 35.2% Profit Growth and Launches Medical LLM “H+”

Fineline Cube May 15, 2026

Alibaba Health Information Technology Ltd. (HKG: 0241) released its fiscal year 2026 financial results for...

Company Drug

Amgen’s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration

Fineline Cube May 15, 2026

Amgen Inc. (NASDAQ: AMGN) announced that China’s National Medical Products Administration (NMPA) has accepted for...

Policy / Regulatory

China Issues National Guidelines for Home Hospital Bed Services to Address Healthcare Access for Vulnerable Populations

Fineline Cube May 15, 2026

China’s National Health Commission (NHC) and the National Administration of Traditional Chinese Medicine (NATCM) issued...

Company Drug

Chongqing Genrix Bio Receives NMPA Clinical Approval for GR1803 Bispecific Antibody in Relapsed/Refractory Multiple Myeloma

Fineline Cube May 15, 2026

Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) announced it has received clinical trial approval...

Company Drug

AstraZeneca Reports Positive Phase III VOLGA Interim Results for Imfinzi-Based Combinations in Muscle-Invasive Bladder Cancer

Fineline Cube May 15, 2026

AstraZeneca plc (NYSE: AZN) released high-level results from a prespecified interim analysis of the Phase...

Company Drug

Chipscreen Biosciences Secures Macao Market Approval for Bilessglu (Chiglitazar), Novel PPAR Pan-Agonist for Type 2 Diabetes

Fineline Cube May 15, 2026

Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced it has received marketing clearance from the Pharmaceutical...

Company Drug

Biogen Reports Positive Phase II CELIA Results for Diranersen, First-in-Class Tau-Targeting ASO Therapy in Early Alzheimer’s Disease

Fineline Cube May 15, 2026

Biogen Inc. (NASDAQ: BIIB) announced positive top-line results from the Phase II CELIA study, evaluating...

Company Drug

Hengrui Pharmaceuticals Secures NMPA Clinical Approval for RSS0393 Latex in Atopic Dermatitis Treatment

Fineline Cube May 15, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received clinical approval...

Company Deals

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

Fineline Cube May 15, 2026

Eli Lilly and Company (NYSE: LLY) announced a strategic alliance with UNICEF USA this week,...

Company Drug

Sichuan Biokin Receives NMPA Go-Ahead for SI-B036 Bispecific Antibody Clinical Study in Advanced Solid Tumors

Fineline Cube May 15, 2026

Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that China’s National Medical Products Administration (NMPA)...

Company Drug

Hansoh Pharma Receives NMPA Approval for HS-10541 Phase I Trial – Category 1 KRAS G12C Inhibitor Targets Advanced Solid Tumors

Fineline Cube May 14, 2026

Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced it has received regulatory approval from China’s...

Company Medical Device

Basecare Medical Device Secures NMPA Approval for Gems Embryo Culture Medium – Chinese IVF Specialist Completes Global Regulatory Triad

Fineline Cube May 14, 2026

Basecare Medical Device Co., Ltd. (HKG: 2170), a high-throughput sequencing-based assisted reproduction specialist, announced it...

Company Drug

Pfizer’s Hympavzi Gains European Approval for Hemophilia with Inhibitors – Novel TFPI-Targeting Therapy Offers Weekly Subcutaneous Alternative to Factor Replacement

Fineline Cube May 14, 2026

Pfizer Inc. (NYSE: PFE) announced it has received European Commission (EC) approval for an indication...

Company Drug

Henlius Biotech Secures Australian TGA Approval for HLX48 Phase I Trial – Novel EGFR/c-Met Bispecific ADC Targets Advanced Solid Tumors

Fineline Cube May 14, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received regulatory approval from Australia’s Therapeutic...

Insight, China's Pharmaceutical Industry

Suzhou AsiFlyer Biotechnology Secures Exclusive Worldwide License from ShanghaiTech University for AI‑Designed Recombinant Botulinum Toxin Patent

Liaocheng University and Shanghai Maiboxing Biotechnology Sign RMB 19 Million Pact to Co‑Develop LCUGZ1007 – Next‑Generation E‑PDC Probody Drug Conjugate

China Biotech’s Panboron BNCT Hospital Signs Strategic Pact with OncoCare Cancer Centre HK – Launching Cross‑Border BNCT Oncology Cooperation

Guangdong Taienkang Completes Capital Increase in Procapzoom – Secures Exclusive China Rights to World‑First Ocular Surface Cell Therapy SZ018

HepaBio Therapeutics Raises Series A Strategic Funding From TriApex to Advance Organoid Technology and Next‑Generation Drug R&D Systems

Shionogi Wins TGA Marketing Authorization in Australia for Cefiderocol – Siderophore Cephalosporin Targeting Carbapenem‑Resistant Gram‑Negative Infections

China’s CDE Releases 110th Batch of Reference Preparations for Generic Quality and Consistency Evaluation – 27 New Drugs Added in Draft Open for Public Feedback

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

Roche’s Tecentriq Secures FDA Approval for ctDNA-Guided Adjuvant Treatment in Muscle-Invasive Bladder Cancer – First MRD-Directed Immunotherapy with 41% Mortality Reduction

Biogen’s Zorevunersen Receives China Breakthrough Therapy Designation for Dravet Syndrome – First ASO Targeting SCN1A Gene in Rare Epileptic Encephalopathy

Shanghai CureGene’s CG-0255 Receives NMPA Clearance for Ischemic Stroke Clinical Trial – First Thiol-Based P2Y12 Inhibitor Overcoming Clopidogrel Resistance

Shenzhen Salubris Secures Chinese Approval for Xinfutai Plus – First Once-Weekly Teriparatide for High-Risk Postmenopausal Osteoporosis

Changchun GeneScience’s GenSci161 Receives FDA Clearance for Hidradenitis Suppurativa Clinical Trial – Novel Bispecific Antibody Targeting IL-1α/IL-1β

Alibaba Health Reports Strong FY2026 Results with 35.2% Profit Growth and Launches Medical LLM “H+”

Amgen’s Izervay NDA Accepted by NMPA for Geographic Atrophy Secondary to Age-Related Macular Degeneration

China Issues National Guidelines for Home Hospital Bed Services to Address Healthcare Access for Vulnerable Populations

Chongqing Genrix Bio Receives NMPA Clinical Approval for GR1803 Bispecific Antibody in Relapsed/Refractory Multiple Myeloma

AstraZeneca Reports Positive Phase III VOLGA Interim Results for Imfinzi-Based Combinations in Muscle-Invasive Bladder Cancer

Chipscreen Biosciences Secures Macao Market Approval for Bilessglu (Chiglitazar), Novel PPAR Pan-Agonist for Type 2 Diabetes

Biogen Reports Positive Phase II CELIA Results for Diranersen, First-in-Class Tau-Targeting ASO Therapy in Early Alzheimer’s Disease

Hengrui Pharmaceuticals Secures NMPA Clinical Approval for RSS0393 Latex in Atopic Dermatitis Treatment

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

Sichuan Biokin Receives NMPA Go-Ahead for SI-B036 Bispecific Antibody Clinical Study in Advanced Solid Tumors

Hansoh Pharma Receives NMPA Approval for HS-10541 Phase I Trial – Category 1 KRAS G12C Inhibitor Targets Advanced Solid Tumors

Basecare Medical Device Secures NMPA Approval for Gems Embryo Culture Medium – Chinese IVF Specialist Completes Global Regulatory Triad

Pfizer’s Hympavzi Gains European Approval for Hemophilia with Inhibitors – Novel TFPI-Targeting Therapy Offers Weekly Subcutaneous Alternative to Factor Replacement

Henlius Biotech Secures Australian TGA Approval for HLX48 Phase I Trial – Novel EGFR/c-Met Bispecific ADC Targets Advanced Solid Tumors

You Missed

Shionogi Wins TGA Marketing Authorization in Australia for Cefiderocol – Siderophore Cephalosporin Targeting Carbapenem‑Resistant Gram‑Negative Infections

China’s CDE Releases 110th Batch of Reference Preparations for Generic Quality and Consistency Evaluation – 27 New Drugs Added in Draft Open for Public Feedback

Shanghai Pharmaceuticals Signs Strategic Framework Pact with CAS Institute of Materia Medica to Bridge Drug Discovery and Industrial Translation

CanSino Biologics Signs Strategic Pact with DeepGeneAI to Co‑Develop mRNA Personalized Therapeutic Cancer Vaccines – Targeting GI and Rare Tumors Globally