Insight, China's Pharmaceutical Industry

Mabwell Bioscience Hits Phase II Milestone with First‑Patient Dose of 9MW3011, the Only Anti‑TMPRSS6 Monoclonal Antibody for Polycythemia Vera

Shanghai‑listed Mabwell Bioscience (SHA: 688062) announced today that its anti‑TMPRSS6 monoclonal antibody 9MW3011 (R&D code 9MW3011/DISC‑3405)...

Medical Device

Burning Rock Secures Japanese Approval for OncoGuide OncoScreen Plus CDx, Enabling Capivasertib Therapy

Fineline Cube Sep 25, 2025

Burning Rock Ltd. (NASDAQ: BNR), a China‑based medical‑technology company, announced that its OncoGuide OncoScreen Plus CDx...

Company Drug

FibroGen Launches Phase 2 Dose‑Optimization Trial for CD46‑Targeted ADC FG‑3246 in Metastatic Castration‑Resistant Prostate Cancer

Fineline Cube Sep 25, 2025

FibroGen, Inc. (NASDAQ: FGEN) announced today the start of a randomized, open‑label Phase 2 monotherapy trial...

Drug

DualityBio Initiates Global Phase Ia/Ib Study of ADAM9‑Targeting ADC DB‑1317

Fineline Cube Sep 25, 2025

Hong Kong‑listed Duality Biologics (DoalityBio, HKG: 9606) announced that the first patient has been dosed...

Company Medical Device Policy / Regulatory

Trump Administration Expands Section 232 Tariffs on Robotics, Industrial Machinery and Medical Devices

Fineline Cube Sep 25, 2025

President Donald J. Trump’s administration has opened new investigations under Section 232 of the Trade Expansion Act, targeting...

Company Deals Drug

Hengrui Pharma & Glenmark Partner on Trastuzumab Rezecan ADC for HER2‑Positive Lung Cancer

Fineline Cube Sep 25, 2025

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced an exclusive licensing agreement with Glenmark...

Company Drug

Jiangsu Hengrui Receives NMPA Acceptance for SHR7280 Oral GnRH Antagonist

Fineline Cube Sep 24, 2025

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products...

Company Medical Device

Johnson & Johnson Announces International Withdrawal of Linx Reflux System

Fineline Cube Sep 24, 2025

US giant Johnson & Johnson (J&J, NYSE: JNJ) disclosed that it will cease sales of...

Company Drug

RM Bio‑Tech Secures CDE Approval for HF001 Stem‑Cell Therapy in Type 2 Diabetes

Fineline Cube Sep 24, 2025

Beijing RM Bio‑Tech Co., Ltd. announced that the Center for Drug Evaluation (CDE) under the...

Company Drug

Jiangsu Hengrui’s Adebrelimab New Indication Accepted by NMPA for Stage II‑IIIB NSCLC

Fineline Cube Sep 24, 2025

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products...

Company Drug

Yantai Dongcheng Secures NMPA Approval for 225Ac‑LNC1011 Alpha‑Particle Radiopharmaceutical to Target Prostate Cancer

Fineline Cube Sep 24, 2025

China‑based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that its investigational 225Ac‑LNC1011 injection...

Company

Eli Lilly Announces $6.5 B Houston Facility to Boost Synthetic‑Medicine API Production

Fineline Cube Sep 24, 2025

Eli Lilly (NYSE: LLY) announced today that it will construct a new $6.5 billion manufacturing complex...

Company Drug

Sino Biopharmaceutical Reports First‑Patient Enrollment for LM‑2417 Phase I Trial

Fineline Cube Sep 24, 2025

China‑based Sino Biopharmaceutical (HKG: 1177) announced today that its internally‑developed Class 1 innovative drug LM‑2417 has...

Company Deals

MSD Teams with Variational AI in $349 Million Generative‑AI Drug Discovery Deal

Fineline Cube Sep 24, 2025

Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has struck a $349 million partnership with Canada‑based...

Company Deals

ProBio and Immunofoco Forge Global CGT Manufacturing Alliance

Fineline Cube Sep 23, 2025

ProBio, a subsidiary of GenScript Biotech Corporation (HKG: 1548), and China‑based Immunofoco have inked a...

Company Drug

Stealth BioTherapeutics Receives FDA Accelerated Approval for Forzinity in Barth Syndrome

Fineline Cube Sep 23, 2025

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Stealth BioTherapeutics’ Forzinity (elamipretide)...

Policy / Regulatory

China Drug Procurement: Centralized Rules Shape 11th Round Of VBP

Fineline Cube Sep 23, 2025

The Joint Procurement Office of the National Healthcare Security Administration (NHSA) published the definitive rules...

Company Deals Drug

Genrix Bio Secures Exclusive Deal for Vecantoxatug and Silevimig with CMS

Fineline Cube Sep 23, 2025

China‑based Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) and China Medical System Holdings Ltd....

Company Drug

Roche’s SC Lunsumio Gains CHMP Recommendation for Relapsed Follicular Lymphoma

Fineline Cube Sep 23, 2025

Roche (SWX: ROG, OTCMKTS: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products...

Company Drug

Roche’s giredestrant Yields Positive PFS Results in evERA Phase III Study

Fineline Cube Sep 23, 2025

Roche (SWX: ROG, OTCMKTS: RHHBY) announced that its Phase III evERA trial has met both co‑primary...

Insight, China's Pharmaceutical Industry

Novo Nordisk’s Sogroya (Somapacitan) Wins NMPA Approval for Three New Pediatric Indications – Now China’s Broadest‑Label Long‑Acting Growth Hormone

Inno Medicine Completes Nearly RMB 800 Million Series D Led by YuanBio – Funds to Drive International Multi‑Center Trials of Nanomedicine Targeted‑Delivery Pipeline

Novo Nordisk’s Wegovy Wins NMPA Approval for MASH in China – First and Only GLP‑1 Receptor Agonist Indicated for Metabolic Dysfunction‑Associated Steatohepatitis with F2–F3 Fibrosis

METiS Life Sciences and JOINN Biologics Form JOINMETiS Biopharma Joint Venture – Integrated mRNA Therapeutics R&D and Manufacturing Platform

Merck Launches Clesrovimab in China – World’s First Single Fixed‑Dose, Long‑Acting RSV Monoclonal Antibody Now Commercially Available for Infant Protection

Novo Nordisk’s Sogroya (Somapacitan) Wins NMPA Approval for Three New Pediatric Indications – Now China’s Broadest‑Label Long‑Acting Growth Hormone

Inno Medicine Completes Nearly RMB 800 Million Series D Led by YuanBio – Funds to Drive International Multi‑Center Trials of Nanomedicine Targeted‑Delivery Pipeline

Mabwell Bioscience Hits Phase II Milestone with First‑Patient Dose of 9MW3011, the Only Anti‑TMPRSS6 Monoclonal Antibody for Polycythemia Vera

Burning Rock Secures Japanese Approval for OncoGuide OncoScreen Plus CDx, Enabling Capivasertib Therapy

FibroGen Launches Phase 2 Dose‑Optimization Trial for CD46‑Targeted ADC FG‑3246 in Metastatic Castration‑Resistant Prostate Cancer

DualityBio Initiates Global Phase Ia/Ib Study of ADAM9‑Targeting ADC DB‑1317

Trump Administration Expands Section 232 Tariffs on Robotics, Industrial Machinery and Medical Devices

Hengrui Pharma & Glenmark Partner on Trastuzumab Rezecan ADC for HER2‑Positive Lung Cancer

Jiangsu Hengrui Receives NMPA Acceptance for SHR7280 Oral GnRH Antagonist

Johnson & Johnson Announces International Withdrawal of Linx Reflux System

RM Bio‑Tech Secures CDE Approval for HF001 Stem‑Cell Therapy in Type 2 Diabetes

Jiangsu Hengrui’s Adebrelimab New Indication Accepted by NMPA for Stage II‑IIIB NSCLC

Yantai Dongcheng Secures NMPA Approval for 225Ac‑LNC1011 Alpha‑Particle Radiopharmaceutical to Target Prostate Cancer

Eli Lilly Announces $6.5 B Houston Facility to Boost Synthetic‑Medicine API Production

Sino Biopharmaceutical Reports First‑Patient Enrollment for LM‑2417 Phase I Trial

MSD Teams with Variational AI in $349 Million Generative‑AI Drug Discovery Deal

ProBio and Immunofoco Forge Global CGT Manufacturing Alliance

Stealth BioTherapeutics Receives FDA Accelerated Approval for Forzinity in Barth Syndrome

China Drug Procurement: Centralized Rules Shape 11th Round Of VBP

Genrix Bio Secures Exclusive Deal for Vecantoxatug and Silevimig with CMS

Roche’s SC Lunsumio Gains CHMP Recommendation for Relapsed Follicular Lymphoma

Roche’s giredestrant Yields Positive PFS Results in evERA Phase III Study

You Missed

Novo Nordisk’s Sogroya (Somapacitan) Wins NMPA Approval for Three New Pediatric Indications – Now China’s Broadest‑Label Long‑Acting Growth Hormone

Inno Medicine Completes Nearly RMB 800 Million Series D Led by YuanBio – Funds to Drive International Multi‑Center Trials of Nanomedicine Targeted‑Delivery Pipeline

Novo Nordisk’s Wegovy Wins NMPA Approval for MASH in China – First and Only GLP‑1 Receptor Agonist Indicated for Metabolic Dysfunction‑Associated Steatohepatitis with F2–F3 Fibrosis

Adagene Achieves New Milestone in SAFEbody ADC Collaboration with Exelixis – USD 2 Million Payment Triggered by Preclinical Progress of ROR1/2‑Targeted XB404