Drug

Company Drug

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

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

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,...

Company Drug

Hybio Files First tirzepatide Generic ANDA in China, Challenging Eli Lilly’s GLP-1 Dominance

Fineline Cube Aug 10, 2026

Shenzhen Hybio Pharmaceutical Co., Ltd. (SHE: 300199) announced it has submitted a Class 4 Chemical Abbreviated New...

Company Deals Drug

Daiichi Sankyo Enlists Innovent Biologics as Exclusive China Partner for Vanflyta FLT3 Inhibitor in AML

Fineline Cube Aug 10, 2026

Daiichi Sankyo Co., Ltd. (TYO: 4568) and Innovent Biologics, Inc. (HKG: 1801) announced an exclusive entrusted promotion...

Company Drug

CARsgen Therapeutics Secures NMPA Clinical Trial Approval for Allogeneic CAR-T Therapy CT1190B in Relapsed/Refractory Large B-Cell Lymphoma

Fineline Cube Aug 7, 2026

CARsgen Therapeutics (HKG: 2171) announced that its allogeneic CAR-T cell therapy CT1190B has received clinical...

Company Drug

Takeda Expands Revestive Approval in China with New 1.25 mg Specification for Pediatric Short Bowel Syndrome Patients as Young as 4 Months

Fineline Cube Aug 7, 2026

Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that China’s National Medical Products Administration...

Company Drug

Hengrui Pharmaceuticals Secures Fifth NMPA Approval for Ivarmacitinib in Non-Radiographic Axial Spondyloarthritis

Fineline Cube Aug 7, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its self-developed Class 1...

Company Drug

Westlake Consortium Secures NMPA Approval for Iscartrelvir, Novel Oral 3CLpro Inhibitor for Mild-to-Moderate COVID-19

Fineline Cube Aug 7, 2026

The Category 1 innovative drug Iscartrelvir, jointly developed by Westlake University, Westlake Laboratory, and Westlake...

Company Drug

Hengrui Pharmaceuticals Secures Third NMPA Approval for Trastuzumab Rezetecan in HER2-Positive Colorectal Cancer

Fineline Cube Aug 7, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its HER2-targeting antibody-drug conjugate...

Company Drug

TransThera Sciences Secures NMPA Conditional Approval for Tinengotinib in Advanced Cholangiocarcinoma with FGFR2 Alterations

Fineline Cube Aug 7, 2026

TransThera Sciences (HKG: 2617) announced that China’s National Medical Products Administration (NMPA) has granted conditional...

Company Drug

Takeda Receives FDA Approval for ORZEYFUL (oveporexton), First Oral OX2R Agonist for Narcolepsy Type 1 in Adults

Fineline Cube Aug 6, 2026

Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug...

Company Drug

Shandong Boan Biotech Submits BLA to Brazil’s ANVISA for Aflibercept Biosimilar BA9101, Expanding Global Ophthalmic Footprint

Fineline Cube Aug 6, 2026

Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of a Biologics License Application...

Company Drug

Eli Lilly’s KRAS G12C Inhibitor Olomorasib Receives Second FDA Breakthrough Therapy Designation for Advanced Pancreatic Cancer

Fineline Cube Aug 6, 2026

Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA)...

Company Drug

CSPC Pharmaceutical’s NDA for Anbenitamab-HB1801 Combination Accepted by China NMPA as Neoadjuvant Therapy for HER2+ Breast Cancer

Fineline Cube Aug 6, 2026

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

Drug

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

Hybio Files First tirzepatide Generic ANDA in China, Challenging Eli Lilly’s GLP-1 Dominance

Daiichi Sankyo Enlists Innovent Biologics as Exclusive China Partner for Vanflyta FLT3 Inhibitor in AML

CARsgen Therapeutics Secures NMPA Clinical Trial Approval for Allogeneic CAR-T Therapy CT1190B in Relapsed/Refractory Large B-Cell Lymphoma

Takeda Expands Revestive Approval in China with New 1.25 mg Specification for Pediatric Short Bowel Syndrome Patients as Young as 4 Months

Hengrui Pharmaceuticals Secures Fifth NMPA Approval for Ivarmacitinib in Non-Radiographic Axial Spondyloarthritis

Westlake Consortium Secures NMPA Approval for Iscartrelvir, Novel Oral 3CLpro Inhibitor for Mild-to-Moderate COVID-19

Hengrui Pharmaceuticals Secures Third NMPA Approval for Trastuzumab Rezetecan in HER2-Positive Colorectal Cancer

TransThera Sciences Secures NMPA Conditional Approval for Tinengotinib in Advanced Cholangiocarcinoma with FGFR2 Alterations

Takeda Receives FDA Approval for ORZEYFUL (oveporexton), First Oral OX2R Agonist for Narcolepsy Type 1 in Adults

Shandong Boan Biotech Submits BLA to Brazil’s ANVISA for Aflibercept Biosimilar BA9101, Expanding Global Ophthalmic Footprint

Eli Lilly’s KRAS G12C Inhibitor Olomorasib Receives Second FDA Breakthrough Therapy Designation for Advanced Pancreatic Cancer

CSPC Pharmaceutical’s NDA for Anbenitamab-HB1801 Combination Accepted by China NMPA as Neoadjuvant Therapy for HER2+ Breast Cancer

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BeOne Medicines and Revolution Medicines Announce Clinical Collaboration and Regional Licensing Deal on RAS(ON) Inhibitors Across Select Asian Markets

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

Hanx Biopharmaceuticals Partners With Swiss AI Biotech TwinEdge Bioscience to Advance Bispecific Antibody Candidate HX009 for DLBCL