Clinical trial approval / initiation

Hengrui Pharma’s HRS9531 Wins NMPA Approval for Cardiovascular Outcomes Trial – Dual GIPR/GLP-1R Agonist Targets MACE Reduction

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) received National Medical Products Administration (NMPA)...

Company Drug

Chengdu Kanghong’s KHN922 Wins NMPA Approval – Dual-Payload HER3 ADC Targets Advanced Solid Tumors with Anti-Resistance Mechanism

Fineline Cube Mar 27, 2026

Chengdu Kanghong Pharmaceutical Group Co., Ltd. (SHE: 002773) announced clinical trial approval from China’s National...

Company Drug

Huadong Medicine’s HDM2024 Wins NMPA Approval – EGFR/HER3 Bispecific ADC Targets Advanced Solid Tumors

Fineline Cube Mar 27, 2026

Huadong Medicine Co., Ltd. (SHE: 000963) announced clinical trial approval from China’s National Medical Products...

Company Drug

Biocytogen’s NEOK002 Wins FDA Approval for Phase I – EGFR/MUC1 Bispecific ADC Targets Solid Tumors

Fineline Cube Mar 27, 2026

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (SHA: 688796, HKG: 2315) announced that NEOK Bio, Inc., its...

Company Drug

Joincare Pharma’s JKN2404 Wins NMPA Approval for Asthma Trial – Next-Gen Inhaled Corticosteroid Targets Improved Safety Profile

Fineline Cube Mar 27, 2026

Joincare Pharmaceutical Group Industry Co., Ltd. (SHA: 600380) announced that JKN2404 inhalation suspension, a Category...

Company Drug

Zhifei Bio Initiates Phase I Study for DTaP-Hib Quadrivalent Vaccine – Component Combination Targets Pediatric Immunization Compliance

Fineline Cube Mar 25, 2026

Chongqing Zhifei Biological Co., Ltd. (SHE: 300122) announced the initiation of a Phase I clinical...

Company Drug

Gan & Lee’s Bonfaglutide Wins NMPA Approval for OSA Study – Biweekly GLP‑1 Expands to Sleep Apnea Indication

Fineline Cube Mar 25, 2026

Gan & Lee Pharmaceuticals (SHA: 603087) announced NMPA clinical trial approval to initiate a study...

Company Drug

Haixi Pharma Advances HXP056 to Phase II – Oral Multi‑Selective Therapy for Wet AMD and Hemorrhagic Retinal Diseases

Fineline Cube Mar 25, 2026

Fujian Haixi Pharmaceuticals Co., Ltd. (HKG: 2637) announced the initiation of a Phase II clinical...

Company Drug

IASO Bio Wins Japan PMDA Approval for Fucaso CAR‑T – BCMA Therapy Enters Phase III in Relapsed/Refractory Multiple Myeloma

Fineline Cube Mar 25, 2026

IASO Biotherapeutics announced receiving tacit clinical approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)...

Company Drug

Hope Medicine Doses First Patient in HMI-115 Phase III – First-in-Class Non-Hormonal Endometriosis Therapy Advances in China

Fineline Cube Mar 25, 2026

Hope Medicine Inc. announced first patient dosing in a Phase III clinical study evaluating HMI-115,...

Company Drug

Kelun‑Biotech’s SKB103 Wins NMPA Approval – Novel TAA‑PD‑L1 Bispecific ADC Enters Clinical Trials for Advanced Solid Tumors

Fineline Cube Mar 25, 2026

Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that its SKB103, a novel TAA‑PD‑L1 bispecific...

Company Drug

Alphamab Oncology Doses First Patient in Phase III KN026 Study – Bispecific HER2 Antibody Targets Adjuvant Breast Cancer

Fineline Cube Mar 24, 2026

Alphamab Oncology (HKG: 9966) announced first patient dosing in a Phase III clinical study of...

Company Drug

Shenzhen Salubris Wins NMPA Approval for SAL0150 – Oral Long-Acting Diabetes/Obesity Drug Targets Weekly Dosing Regimen

Fineline Cube Mar 24, 2026

Shenzhen Salubris Pharmaceuticals Co., Ltd. (SHE: 002294) announced clinical trial approval from China’s National Medical...

Company Drug

Qilu Pharma’s QLS1317 Wins NMPA Approval – First‑in‑Class MSI‑H Targeted Therapy Enters Solid Tumor Clinical Trials

Fineline Cube Mar 24, 2026

Qilu Pharmaceutical Co., Ltd. announced that its self‑developed Category 1 innovative drug, QLS1317 tablets, has...

Company Drug

Henlius Biotech’s HLX18 Wins NMPA Approval – Nivolumab Biosimilar Enters Phase I Solid Tumor Trials in China

Fineline Cube Mar 23, 2026

Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX18, a recombinant humanized anti‑PD‑1 monoclonal antibody...

Company Drug

Lepu Biopharma Wins NMPA Approval for Perioperative HNSCC Trial – First‑in‑World EGFR ADC + PD‑1 Combination Advances to Clinic

Fineline Cube Mar 23, 2026

Lepu Biopharma Co., Ltd. (HKG: 2157) announced NMPA IND approval for a groundbreaking Phase II/III...

Company Drug

Biokin Pharma’s BL‑ARC002 Wins NMPA Approval – First‑in‑Class Antibody‑Radionuclide Conjugate Enters Solid Tumor Trials

Fineline Cube Mar 23, 2026

Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that its BL‑ARC002 injection, a Category 1...

Company Drug

Hansoh Pharma Wins NMPA Approval for Two Category 1 Drugs – HS‑20152 and HS‑10587 Enter Clinical Trials in Rare Disease and Oncology

Fineline Cube Mar 23, 2026

Hansoh Pharmaceutical Group Company Limited (HKG: 3692) announced that two Category 1 innovative drugs have...

Company Drug

Hengrui Pharma’s SHR-3836 Wins NMPA Approval for Multiple Myeloma – First-in-Class Anti-Tumor Agent Enters Clinical Development

Fineline Cube Mar 23, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its independently developed drug...

Company Drug

Innovent Biologics Doses First Patient in Phase 3 Tigulixostat Study – Next‑Gen Xanthine Oxidase Inhibitor Targets Gout Market

Fineline Cube Mar 23, 2026

Innovent Biologics, Inc. (HKG: 1801) announced that the first subject has been dosed in the...

Clinical trial approval / initiation

Hengrui Pharma’s HRS9531 Wins NMPA Approval for Cardiovascular Outcomes Trial – Dual GIPR/GLP-1R Agonist Targets MACE Reduction

Chengdu Kanghong’s KHN922 Wins NMPA Approval – Dual-Payload HER3 ADC Targets Advanced Solid Tumors with Anti-Resistance Mechanism

Huadong Medicine’s HDM2024 Wins NMPA Approval – EGFR/HER3 Bispecific ADC Targets Advanced Solid Tumors

Biocytogen’s NEOK002 Wins FDA Approval for Phase I – EGFR/MUC1 Bispecific ADC Targets Solid Tumors

Joincare Pharma’s JKN2404 Wins NMPA Approval for Asthma Trial – Next-Gen Inhaled Corticosteroid Targets Improved Safety Profile

Zhifei Bio Initiates Phase I Study for DTaP-Hib Quadrivalent Vaccine – Component Combination Targets Pediatric Immunization Compliance

Gan & Lee’s Bonfaglutide Wins NMPA Approval for OSA Study – Biweekly GLP‑1 Expands to Sleep Apnea Indication

Haixi Pharma Advances HXP056 to Phase II – Oral Multi‑Selective Therapy for Wet AMD and Hemorrhagic Retinal Diseases

IASO Bio Wins Japan PMDA Approval for Fucaso CAR‑T – BCMA Therapy Enters Phase III in Relapsed/Refractory Multiple Myeloma

Hope Medicine Doses First Patient in HMI-115 Phase III – First-in-Class Non-Hormonal Endometriosis Therapy Advances in China

Kelun‑Biotech’s SKB103 Wins NMPA Approval – Novel TAA‑PD‑L1 Bispecific ADC Enters Clinical Trials for Advanced Solid Tumors

Alphamab Oncology Doses First Patient in Phase III KN026 Study – Bispecific HER2 Antibody Targets Adjuvant Breast Cancer

Shenzhen Salubris Wins NMPA Approval for SAL0150 – Oral Long-Acting Diabetes/Obesity Drug Targets Weekly Dosing Regimen

Qilu Pharma’s QLS1317 Wins NMPA Approval – First‑in‑Class MSI‑H Targeted Therapy Enters Solid Tumor Clinical Trials

Henlius Biotech’s HLX18 Wins NMPA Approval – Nivolumab Biosimilar Enters Phase I Solid Tumor Trials in China

Lepu Biopharma Wins NMPA Approval for Perioperative HNSCC Trial – First‑in‑World EGFR ADC + PD‑1 Combination Advances to Clinic

Biokin Pharma’s BL‑ARC002 Wins NMPA Approval – First‑in‑Class Antibody‑Radionuclide Conjugate Enters Solid Tumor Trials

Hansoh Pharma Wins NMPA Approval for Two Category 1 Drugs – HS‑20152 and HS‑10587 Enter Clinical Trials in Rare Disease and Oncology

Hengrui Pharma’s SHR-3836 Wins NMPA Approval for Multiple Myeloma – First-in-Class Anti-Tumor Agent Enters Clinical Development

Innovent Biologics Doses First Patient in Phase 3 Tigulixostat Study – Next‑Gen Xanthine Oxidase Inhibitor Targets Gout Market

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Hengrui Pharma’s HRS9531 Wins NMPA Approval for Cardiovascular Outcomes Trial – Dual GIPR/GLP-1R Agonist Targets MACE Reduction

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