Fineline Cube

Company Drug

Lepu Medical’s siRNA Drug MWN117 Wins NMPA Clinical Trial Approval for Overweight and Obesity – INHBE‑Targeting Therapy Shows Synergy Potential with GLP‑1 Agonists

Fineline Cube Aug 19, 2026

Lepu Medical (SHE: 300003) announced that MWN117 injection has received approval from China’s National Medical...

Policy / Regulatory

FDA Issues Discussion Paper on GenAI‑Enabled Medical Devices – Seeks Feedback on Risk Framework, Premarket Evaluation and Postmarket Monitoring by October 19

Fineline Cube Aug 19, 2026

The U.S. Food and Drug Administration (FDA) issued a discussion paper on considerations for the...

Company Medical Device

Johnson & Johnson Wins U.S. 510(k) Clearance for MONARCH QUEST 3 Software Update – Advancing Robotic Bronchoscopy Navigation and Targeting

Fineline Cube Aug 19, 2026

Johnson & Johnson (J&J, NYSE: JNJ) announced U.S. 510(k) regulatory clearance for MONARCH QUEST 3,...

PIC Policy / Regulatory

Trump Picks White House Policy Advisor Heidi Overton to Lead FDA – Replacing Acting Commissioner Kyle Diamantas After Makary’s Resignation

Fineline Cube Aug 19, 2026

U.S. President Donald Trump has chosen White House policy advisor Heidi Overton to lead the...

Company Drug

Shanghai Yizhong Pharmaceutical’s YXC‑002 Wins IND Approval – Fourth‑Generation Brain‑Penetrant EGFR‑TKI for Non‑Small Cell Lung Cancer Overcomes C797S Resistance

Fineline Cube Aug 19, 2026

Shanghai Yizhong Pharmaceutical Co., Ltd (SHA: 688091) announced that the Investigational New Drug (IND) application...

Company Drug

Genrix Bio’s GR2302 Bispecific Antibody Receives NMPA IND Approval for Chronic Hepatitis B – TCR‑Mimic T‑Cell Engager Targets HBV‑Infected Hepatocytes

Fineline Cube Aug 19, 2026

Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) announced that its investigational product GR2302 (subcutaneous...

Company

Novo Nordisk China Launches Organizational Restructuring – Merges Diabetes and Insulin Divisions into Hospital Business Division, Creates New Emerging Channels Division

Fineline Cube Aug 19, 2026

Novo Nordisk A/S China (NYSE: NVO) announced the initiation of an organizational restructuring of its...

Company Drug

Nhwa Pharmaceutical Wins NMPA IND Approval for Two Category 1 Chemical Drugs – NH130 for Schizophrenia & Alzheimer’s Psychosis, NH302 for Acute Pain

Fineline Cube Aug 19, 2026

Nhwa Pharmaceutical Co., Ltd. (SHE: 002262) announced that its two Category 1 chemical drugs, NH130...

Company Drug

CSPC Pharmaceutical’s Anbenitamab (KN026) Plus HB1801 NDA Accepted by NMPA for First‑Line Advanced Breast Cancer – HER2 Bispecific Combo Advances in China

Fineline Cube Aug 19, 2026

CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the New Drug Application (NDA) for its...

Company Deals

Bio-Thera Solutions Expands Partnership with Avalon Pharma: Exclusive MENA Licensing Deal for Dupixent Biosimilar BAT2406 – Second Collaboration After BAT3306

Fineline Cube Aug 19, 2026

Bio-Thera Solutions, Ltd. (SHA: 688177) and Saudi Arabia‑headquartered Avalon Pharma announced the expansion of their...

Company Drug

Betta Pharmaceuticals Partner EyePoint Reports EYP‑1901 Misses Primary Endpoint in First Pivotal Phase III LUGANO Trial for Wet AMD – DURAVYU Fails Non‑Inferiority vs. Aflibercept

Fineline Cube Aug 19, 2026

Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced that its partner EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT)...

Company Deals

OmniAb Signs Global Collaboration and License Agreement with Eli Lilly for Ion Channel Program – Up to $370 Million in Milestones Plus Royalties

Fineline Cube Aug 18, 2026

OmniAb, Inc. (NASDAQ: OABI) announced a global collaboration and license agreement with Eli Lilly (NYSE:...

Company Drug PIC

European Commission Revokes EU Marketing Authorisation for CSL and VFMCRP’s TAVNEOS – Avacopan Withdrawn Across EU and EEA Markets

Fineline Cube Aug 18, 2026

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced that the European Commission (EC)...

Company Deals PIC

Navi Therapeutics Completes Angel and Series A Rounds Totaling Several Hundred Million RMB – Legend Capital Co‑Leads Backing for Next‑Generation ADC Platform

Fineline Cube Aug 18, 2026

Navi Therapeutics (Shanghai) Co., Ltd. announced the successful completion of two financing rounds — Angel...

Company Drug

Shanghai Yizhong’s First‑in‑Class Tri‑Specific Biologic YXC‑001 Wins NMPA Clinical Trial Approval for Advanced Solid Tumors

Fineline Cube Aug 18, 2026

Shanghai Yizhong Pharmaceutical Co., Ltd (SHA: 688091) announced that its Category 1 therapeutic biologic YXC‑001,...

Company Drug

CANbridge Pharmaceuticals’ Livmarli Granted NHIA Reimbursement Approval in Taiwan – IBAT Inhibitor Coverage for ALGS and PFIC Takes Effect September 1

Fineline Cube Aug 18, 2026

CANbridge Pharmaceuticals Inc. (HKG: 1228) announced that its rare disease drug Livmarli (Maralixibat Chloride Oral...

Company Deals PIC

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 Deals PIC

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

Company Drug

NMPA Accepts MediLink Therapeutics’ NDA for Tam‑Peli, Self‑Developed B7‑H3‑Targeting ADC for Relapsed Small Cell Lung Cancer

Company Deals Digital PIC

Insilico Medicine and MobiDrop Sign Strategic Partnership to Advance AI‑Ready Single‑Cell Data for Drug Discovery

Company PIC

Innovent Biologics’ Suzhou Base Passes EMA On‑Site Inspection, Securing EU GMP Certification on First Attempt