Drug

TJ Biopharma and Biogen Win NMPA Approval for Felzartamab (JINGFEI) in Multiple Myeloma – First Commercial Milestone Under Greater China Licensing Deal

TJ Biopharma and Biogen Inc. (NASDAQ: BIIB) announced today that felzartamab for injection (brand name:...

Ark Biopharmaceutical’s First-in-Class AFC AK0406 Wins NMPA Approval for Influenza Prevention Clinical Trials

Fineline Cube Aug 13, 2026

Shanghai Ark Biopharmaceutical Co., Ltd. announced that its independently developed first-in-class long-acting antiviral drug-Fc conjugate...

Company Drug

Youcare Pharmaceutical’s YKYY033 siRNA Injection Wins US FDA Approval to Conduct Clinical Trials for Arterial and Venous Thrombosis

Fineline Cube Aug 13, 2026

Youcare Pharmaceutical (SHA: 688658) announced that YKYY033 injection has received approval from the US Food...

Company Drug PIC

AstraZeneca and Daiichi Sankyo’s Enhertu Wins China Approval for First-Line HER2-Positive Metastatic Breast Cancer in Combination With Pertuzumab

Fineline Cube Aug 13, 2026

AstraZeneca plc (NYSE: AZN) and Daiichi Sankyo (TYO: 4568) announced that a new indication for...

Company Drug

Hengrui Pharma’s SHR-7590 Injection Wins NMPA Clinical Trial Approval for Ulcerative Colitis and Crohn’s Disease

Fineline Cube Aug 13, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its SHR-7590 injection has...

Company Drug

IMPACT Therapeutics Nominates KAT6A-Specific PROTAC IMP2794 as Preclinical Candidate From Proprietary TPD Platform

Fineline Cube Aug 13, 2026

IMPACT Therapeutics, Inc. (HKG: 7630) announced the nomination of IMP2794 as a preclinical candidate (PCC)...

Company Drug

Akeso’s Ivonescimab Wins NMPA Approval for First-Line Advanced Squamous Non-Small Cell Lung Cancer in Combination With Chemotherapy

Fineline Cube Aug 13, 2026

Akeso Biopharma (HKG: 9926) announced that the National Medical Products Administration (NMPA) of China has...

Company Drug R&D

Insilico Medicine Nominates ISM0900, AI‑Designed Oral Lp(a) Inhibitor, as 9th Preclinical Candidate of 2026

Fineline Cube Aug 12, 2026

Insilico Medicine (HKG: 3696) announced the nomination of ISM0900 — a potent, highly selective, oral...

Company Drug

Wantai’s 9‑Valent HPV Vaccine Wins Thailand Approval – China’s First and World’s Second 9vHPV Vaccine Expands Into Southeast Asia

Fineline Cube Aug 12, 2026

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. (SHA: 603392) announced that its self‑developed 9‑valent human...

Company Drug

Zhifei Biological Submits Clinical Trial Application in China for Nasal Spray Recombinant RSV Vaccine Based on Chimpanzee Adenovirus Vector

Fineline Cube Aug 11, 2026

Zhifei Biological (SHE: 300122) announced that it has submitted a clinical trial application in China...

Company Drug

Keymed Biosciences’ Bispecific Antibody CM512 Achieves All Endpoints in Phase 2 Trial for Chronic Rhinosinusitis With Nasal Polyps

Fineline Cube Aug 11, 2026

Keymed Biosciences Inc. (HKG: 2162) announced that the Phase 2 trial of CM512 injection, a...

Company Drug

CSPC Pharmaceutical Group’s Monkeypox mRNA Vaccine SYS6037 Receives FDA Approval to Conduct Clinical Trials in the US

Fineline Cube Aug 11, 2026

CSPC Pharmaceutical Group Limited (HKG: 1093) announced that its Category 1 preventive biologic product SYS6037...

Company Drug PIC

BeOne Medicines Announces Imdelltra (Tarlatamab), First-in-Class DLL3/CD3 T-Cell Engager Co-Developed With Amgen, Enters Clinical Use Across 17 Chinese Cities

Fineline Cube Aug 11, 2026

BeOne Medicines Ltd. (NASDAQ: ONC; HKG: 6160; SHA: 688235) announced that Imdelltra (tarlatamab for injection)...

Company Drug

Astellas Submits NDA in Japan for Fezolinetant, a First-in-Class Nonhormonal NK3 Receptor Antagonist for Menopausal Vasomotor Symptoms

Fineline Cube Aug 11, 2026

Astellas Pharma Inc. (TYO: 4503) announced that it has submitted a New Drug Application (NDA)...

Company Drug

Huadong Medicine’s Sinclair Secures EU MDR CE Certification for KIO015 Chitosan Skin Booster Kytogen Defend

Fineline Cube Aug 10, 2026

Huadong Medicine (SHE: 000963) announced that KIO015 — a novel, patented carboxymethyl chitosan solution for...

Company Drug

GenFleet Therapeutics Initiates Phase 3 Trial of GFH375 for KRAS G12D‑Mutant NSCLC in China, First Patient Enrolled

Fineline Cube Aug 10, 2026

GenFleet Therapeutics (HKG: 2595) announced that “Kylin‑Flight 01,” the registrational Phase 3 clinical trial of...

Company Drug

Salubris’s SAL0195 siRNA Drug Wins NMPA Nod for Lp(a) Clinical Trials

Fineline Cube Aug 10, 2026

Salubris Pharmaceuticals (SHE: 002294) announced that its self‑developed innovative siRNA drug SAL0195 has been approved by...

Company Drug PIC

Grand Pharma’s GPN01530-2 RDC Drug Snags FDA Fast Track for Solid Tumor Diagnosis

Fineline Cube Aug 10, 2026

Grand Pharmaceutical Group Limited (HKG: 0512) announced that GPN01530-2, a global innovative radionuclide drug conjugate (RDC)...

Company Drug

Alebund’s AP301 NDA Accepted by NMPA for Hyperphosphatemia in CKD Dialysis Patients

Fineline Cube Aug 10, 2026

Alebund Pharmaceuticals (Jiangsu) Limited (HKG: 9637) announced that the New Drug Application (NDA) for its core...

Company Drug

Sino Biopharma’s benmelstobart-anlotinib Combo Wins NMPA Nod for First-Line sq-NSCLC

Fineline Cube Aug 10, 2026

Sino Biopharmaceutical Limited (HKG: 1177) announced that benmelstobart in combination with chemotherapy, sequentially followed by anlotinib,...

Drug

TJ Biopharma and Biogen Win NMPA Approval for Felzartamab (JINGFEI) in Multiple Myeloma – First Commercial Milestone Under Greater China Licensing Deal

Ark Biopharmaceutical’s First-in-Class AFC AK0406 Wins NMPA Approval for Influenza Prevention Clinical Trials

Youcare Pharmaceutical’s YKYY033 siRNA Injection Wins US FDA Approval to Conduct Clinical Trials for Arterial and Venous Thrombosis

AstraZeneca and Daiichi Sankyo’s Enhertu Wins China Approval for First-Line HER2-Positive Metastatic Breast Cancer in Combination With Pertuzumab

Hengrui Pharma’s SHR-7590 Injection Wins NMPA Clinical Trial Approval for Ulcerative Colitis and Crohn’s Disease

IMPACT Therapeutics Nominates KAT6A-Specific PROTAC IMP2794 as Preclinical Candidate From Proprietary TPD Platform

Akeso’s Ivonescimab Wins NMPA Approval for First-Line Advanced Squamous Non-Small Cell Lung Cancer in Combination With Chemotherapy

Insilico Medicine Nominates ISM0900, AI‑Designed Oral Lp(a) Inhibitor, as 9th Preclinical Candidate of 2026

Wantai’s 9‑Valent HPV Vaccine Wins Thailand Approval – China’s First and World’s Second 9vHPV Vaccine Expands Into Southeast Asia

Zhifei Biological Submits Clinical Trial Application in China for Nasal Spray Recombinant RSV Vaccine Based on Chimpanzee Adenovirus Vector

Keymed Biosciences’ Bispecific Antibody CM512 Achieves All Endpoints in Phase 2 Trial for Chronic Rhinosinusitis With Nasal Polyps

CSPC Pharmaceutical Group’s Monkeypox mRNA Vaccine SYS6037 Receives FDA Approval to Conduct Clinical Trials in the US

BeOne Medicines Announces Imdelltra (Tarlatamab), First-in-Class DLL3/CD3 T-Cell Engager Co-Developed With Amgen, Enters Clinical Use Across 17 Chinese Cities

Astellas Submits NDA in Japan for Fezolinetant, a First-in-Class Nonhormonal NK3 Receptor Antagonist for Menopausal Vasomotor Symptoms

Huadong Medicine’s Sinclair Secures EU MDR CE Certification for KIO015 Chitosan Skin Booster Kytogen Defend

GenFleet Therapeutics Initiates Phase 3 Trial of GFH375 for KRAS G12D‑Mutant NSCLC in China, First Patient Enrolled

Salubris’s SAL0195 siRNA Drug Wins NMPA Nod for Lp(a) Clinical Trials

Grand Pharma’s GPN01530-2 RDC Drug Snags FDA Fast Track for Solid Tumor Diagnosis

Alebund’s AP301 NDA Accepted by NMPA for Hyperphosphatemia in CKD Dialysis Patients

Sino Biopharma’s benmelstobart-anlotinib Combo Wins NMPA Nod for First-Line sq-NSCLC

You Missed

NMPA CDE Issues Draft Guideline to Reduce or Replace Animal Testing for Monoclonal Antibodies, Opening Public Comment

Shanghai RAAS’s SR604 Enters NMPA CDE Rare Disease Encouragement Program for Hemophilia and Factor VII Deficiency Treatment

Eisai Launches LEQEMBI IQLIK Subcutaneous Auto-Injector for Early Alzheimer’s Disease in the United States

Trump Signs Nine New MFN Drug Pricing Agreements, Expanding Pharma Deals to 26 Companies Covering 89% of Branded Market