Insight, China's Pharmaceutical Industry

Ledeinno Medical Valley Closes Over 200 Million RMB in Series B+ and B++ Rounds – Shining Capital Leads Backing for Wireless SCS Neuromodulation Platform

Fineline Cube Aug 18, 2026

Ledeinno Medical Valley announced the completion of its Series B+ and Series B++ funding rounds...

Company Deals

Enginprime Medical Closes Nearly 100 Million RMB Series A Round with Qiming Venture Partners as Sole Investor – Capital Earmarked for OpusOne pVAD Clinical Trials

Fineline Cube Aug 18, 2026

Enginprime Medical announced the completion of its Series A funding round of nearly 100 million...

Company Drug PIC

AstraZeneca Launches Tezspire in China, Bringing First‑In‑Class TSLP Inhibitor Tezepelumab to Severe Asthma and CRSwNP Patients

Fineline Cube Aug 17, 2026

AstraZeneca plc (NYSE: AZN) announced the official market launch in China of Tezspire (generic name:...

Drug Medical Device Policy / Regulatory

Guangdong Regulator Issues Recall, Traceability and Emergency Response Rules for Imported Hong Kong–Macao Pharmaceuticals and Medical Devices in GBA

Fineline Cube Aug 17, 2026

The Guangdong Medical Products Administration issued three landmark policy documents governing imported Hong Kong and...

Company Drug

Fosun Pharma Launches Phase 2 Trial of FXS7553 DPP‑1 Inhibitor for COPD in China

Fineline Cube Aug 17, 2026

Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that FXS7553 has initiated a...

Company Drug

Asieris Pharmaceuticals Wins FDA Clearance for APL‑2501, an Anti‑CLDN6/9 ADC in Advanced Solid Tumors

Fineline Cube Aug 17, 2026

Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that its independently developed APL‑2501 has received...

Company Drug

Hengrui Pharmaceuticals Wins NMPA Clearance for Phase II Trial of HRS‑4729, a Triple‑Agonist Peptide Drug for Type 2 Diabetes

Fineline Cube Aug 17, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its drug HRS‑4729 has...

Company Drug

CanSino Biologics Files NDA in China for Td5cp, a First-In-Nation Adolescent and Adult DTaP Booster Vaccine

Fineline Cube Aug 17, 2026

CanSino Biologics (HKG: 6185) announced that it has submitted a New Drug Application (NDA) in...

Company Drug

Easton Pharmaceutical Doses First Patient in Phase I/II Trial of HP‑002, a Brain‑Penetrant BTK PROTAC for B‑Cell Non‑Hodgkin Lymphoma

Fineline Cube Aug 17, 2026

Easton Pharmaceutical Co., Ltd. (SHA: 688513) announced that Phase I/II clinical trials are underway for...

Company Deals

Henlius and Sandoz Strike Strategic Biosimilars Deal Covering Up to 10 mAb and ADC Products Worth USD 314 Million for Initial Assets

Fineline Cube Aug 17, 2026

Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that it has entered into a strategic collaboration...

Company Drug

Shanghai Ark Biopharmaceutical Wins FDA Clearance for Ziresovir Phase II Trials in Severe Pediatric RSV

Fineline Cube Aug 17, 2026

Shanghai Ark Biopharmaceutical Co., Ltd. announced that the US Food and Drug Administration (FDA) has...

Company Drug

Chongqing Pharscin Wins China Clinical Trial Approval for ORIC‑1327 in Glaucoma and Ocular Hypertension

Fineline Cube Aug 17, 2026

Chongqing Pharscin Pharmaceutical Co., Ltd. (SHE: 002907) announced that its drug candidate ORIC‑1327 has received...

Company Drug

Yiling Pharmaceutical Files IND in China for LB220-D08, a First-In-Class Factor B Inhibitor for aHUS

Fineline Cube Aug 17, 2026

Yiling Pharmaceutical (SHE: 002603) announced that it has submitted an Investigational New Drug (IND) application...

Company Drug

Pfizer and Valneva See EMA Validate MAA for PF‑07307405, the First‑Potential Blockbuster Lyme Disease Vaccine

Fineline Cube Aug 17, 2026

Pfizer Inc. (NYSE: PFE) and Valneva SE (NASDAQ: VALN) announced that the European Medicines Agency...

Company Medical Device

Sino Medical Sciences Wins Turkish Approval for Ghunter Intracranial Thrombectomy Stent – Broadening Global Footprint in Ischemic Stroke Care

Fineline Cube Aug 17, 2026

Sino Medical Sciences Technology Inc. (SHA: 688108) announced that its independently developed Ghunter Revascularization Device,...

Company Drug

Bristol-Myers Squibb Secures FDA Approval for Iberdomide Combination in Multiple Myeloma – First‑Ever Nod Based on MRD‑Negative Response Data

Fineline Cube Aug 17, 2026

Bristol-Myers Squibb (BMS) (NYSE: BMY) announced that the US Food and Drug Administration (FDA) has...

Company Deals

Xbiome Strikes NewCo‑Style Technology Collaboration with Biogent Therapeutics for AI‑Driven Bispecific Antibody Development

Fineline Cube Aug 14, 2026

Xbiome, a China‑based AI‑driven microbiome drug development company, announced a technology collaboration deal with Biogent...

Company Drug

CDE Adds Two New Drugs to Rare Disease “Caring Program – Extension” Pilot – SZJ0107 and JAB-8263 Included

Fineline Cube Aug 14, 2026

According to the latest announcement from the Center for Drug Evaluation (CDE) of the National...

Company Deals PIC

ACROBiosystems and Bailinke Pharmaceutical Form Strategic Partnership to Build AI‑Empowered Affinity Purification Solutions

Fineline Cube Aug 14, 2026

ACROBiosystems Co., Ltd. (SHE: 301080) and Bailinke Pharmaceutical Technology (Shanghai) Co., Ltd. have entered into...

Company Drug

Celgenyx Secures FDA IND Clearance for CG101 Off‑the‑Shelf iPSC‑Derived Cell Therapy in Acute Myeloid Leukemia – Multicenter Phase I Study to Begin

Fineline Cube Aug 14, 2026

Celgenyx, Inc. announced today that CG101, its self‑developed off‑the‑shelf immune cell therapy product for the...

Insight, China's Pharmaceutical Industry

NMPA Approves Novartis’ Pluvicto Plus ARPI for PSMA‑Positive mHSPC in China, Advancing Radioligand Therapy to Earlier Prostate Cancer

FDA Approves J&J’s IMAAVY for Warm Autoimmune Hemolytic Anemia, Marking Second Indication for Nipocalimab

FDA Approves BeOne’s Tevimbra Plus Zanidatamab and Chemotherapy for First‑Line HER2‑Positive Gastroesophageal Adenocarcinoma

MHLW Approves Takeda’s First‑in‑Class ORZEYFUL (Oveporexton) for Narcolepsy Type 1 in Japan

WuXi Biologics 2026H1 Revenue Climbs 18.4% to RMB 11.8 Billion as Project Pipeline Hits 1,064 Integrated Programs

NMPA Approves Novartis’ Pluvicto Plus ARPI for PSMA‑Positive mHSPC in China, Advancing Radioligand Therapy to Earlier Prostate Cancer

FDA Approves J&J’s IMAAVY for Warm Autoimmune Hemolytic Anemia, Marking Second Indication for Nipocalimab

Ledeinno Medical Valley Closes Over 200 Million RMB in Series B+ and B++ Rounds – Shining Capital Leads Backing for Wireless SCS Neuromodulation Platform

Enginprime Medical Closes Nearly 100 Million RMB Series A Round with Qiming Venture Partners as Sole Investor – Capital Earmarked for OpusOne pVAD Clinical Trials

AstraZeneca Launches Tezspire in China, Bringing First‑In‑Class TSLP Inhibitor Tezepelumab to Severe Asthma and CRSwNP Patients

Guangdong Regulator Issues Recall, Traceability and Emergency Response Rules for Imported Hong Kong–Macao Pharmaceuticals and Medical Devices in GBA

Fosun Pharma Launches Phase 2 Trial of FXS7553 DPP‑1 Inhibitor for COPD in China

Asieris Pharmaceuticals Wins FDA Clearance for APL‑2501, an Anti‑CLDN6/9 ADC in Advanced Solid Tumors

Hengrui Pharmaceuticals Wins NMPA Clearance for Phase II Trial of HRS‑4729, a Triple‑Agonist Peptide Drug for Type 2 Diabetes

CanSino Biologics Files NDA in China for Td5cp, a First-In-Nation Adolescent and Adult DTaP Booster Vaccine

Easton Pharmaceutical Doses First Patient in Phase I/II Trial of HP‑002, a Brain‑Penetrant BTK PROTAC for B‑Cell Non‑Hodgkin Lymphoma

Henlius and Sandoz Strike Strategic Biosimilars Deal Covering Up to 10 mAb and ADC Products Worth USD 314 Million for Initial Assets

Shanghai Ark Biopharmaceutical Wins FDA Clearance for Ziresovir Phase II Trials in Severe Pediatric RSV

Chongqing Pharscin Wins China Clinical Trial Approval for ORIC‑1327 in Glaucoma and Ocular Hypertension

Yiling Pharmaceutical Files IND in China for LB220-D08, a First-In-Class Factor B Inhibitor for aHUS

Pfizer and Valneva See EMA Validate MAA for PF‑07307405, the First‑Potential Blockbuster Lyme Disease Vaccine

Sino Medical Sciences Wins Turkish Approval for Ghunter Intracranial Thrombectomy Stent – Broadening Global Footprint in Ischemic Stroke Care

Bristol-Myers Squibb Secures FDA Approval for Iberdomide Combination in Multiple Myeloma – First‑Ever Nod Based on MRD‑Negative Response Data

Xbiome Strikes NewCo‑Style Technology Collaboration with Biogent Therapeutics for AI‑Driven Bispecific Antibody Development

CDE Adds Two New Drugs to Rare Disease “Caring Program – Extension” Pilot – SZJ0107 and JAB-8263 Included

ACROBiosystems and Bailinke Pharmaceutical Form Strategic Partnership to Build AI‑Empowered Affinity Purification Solutions

Celgenyx Secures FDA IND Clearance for CG101 Off‑the‑Shelf iPSC‑Derived Cell Therapy in Acute Myeloid Leukemia – Multicenter Phase I Study to Begin

You Missed

NMPA Approves Novartis’ Pluvicto Plus ARPI for PSMA‑Positive mHSPC in China, Advancing Radioligand Therapy to Earlier Prostate Cancer

FDA Approves J&J’s IMAAVY for Warm Autoimmune Hemolytic Anemia, Marking Second Indication for Nipocalimab

FDA Approves BeOne’s Tevimbra Plus Zanidatamab and Chemotherapy for First‑Line HER2‑Positive Gastroesophageal Adenocarcinoma

MHLW Approves Takeda’s First‑in‑Class ORZEYFUL (Oveporexton) for Narcolepsy Type 1 in Japan