Clinical trial approval / initiation

Company Drug

Huiyu Pharma Receives NMPA Clinical Trial Approval for HY-1016 Extended-Release Dienogest Injection – Novel Formulation Aims to Transform Endometriosis Treatment Adherence

Sichuan Huiyu Pharmaceutical Co., Ltd. (SHA: 688553) announced today that it has received clinical trial...

Company Drug

CSPC Innovation Launches Phase III Trial of SYS6010 ADC-PD-1 Combo in Resected NSCLC – Novel EGFR-Targeted Antibody-Drug Conjugate Enters Adjuvant Setting

Fineline Cube Jul 1, 2026

CSPC Innovation Pharmaceutical Co., Ltd. (SHE: 300765) announced today the initiation and public registration of...

Company Drug

Shanghai Bao Pharmaceuticals Secures NMPA IND Approval for BJ044 Recombinant Ulinastatin – First Synthetic Biology-Derived Therapy for Critical Care Indications

Fineline Cube Jun 30, 2026

Shanghai Bao Pharmaceuticals Co., Ltd. (HKG: 2659) announced that the National Medical Products Administration (NMPA)...

Company Drug

Mabwell Bioscience Secures NMPA Approval for 9MW5211 Clinical Trial in Multiple Sclerosis – Expanding Autoimmune Pipeline

Fineline Cube Jun 25, 2026

Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced that China’s National Medical Products Administration (NMPA)...

Company Drug

Mabwell Secures NMPA Clinical Trial Approval for 6MW5311 Bispecific Antibody – Dual US-China Authorization for Hematological Malignancies

Fineline Cube Jun 24, 2026

Mabwell Bioscience Co., Ltd. (HKG: 2493) announced that China’s National Medical Products Administration (NMPA) has...

Company Drug

Ab&B Bio-Tech Secures NMPA Clinical Trial Approval for mRNA Mpox Vaccine – First Dual-Approved Candidate Globally

Fineline Cube Jun 24, 2026

Ab&B Bio-Tech Co., Ltd. (HKG: 2627) announced that China’s National Medical Products Administration (NMPA) has...

Company Drug

Innovent Biologics Doses First Patient in Pivotal Phase III Trial for IBI3003 Trispecific Antibody in Relapsed/Refractory Multiple Myeloma

Fineline Cube Jun 22, 2026

Innovent Biologics (HKG: 1801) announced the first subject dosing in the pivotal Phase III TriadicMM-1...

Company Drug

CureGene Pharmaceutical Initiates Pivotal US Clinical Trial for Evategrel, World’s First Dual-Formulation P2Y12 Inhibitor Addressing Clopidogrel Resistance

Fineline Cube Jun 22, 2026

Shanghai CureGene Pharmaceutical Co., Ltd. announced the enrollment of the first patient in a pivotal...

Company Drug

CSPC Pharmaceutical Secures FDA Clearance for SYHX2008 Octreotide Biosimilar Clinical Trials in US Market

Fineline Cube Jun 22, 2026

CSPC Pharmaceutical Group (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has...

Company Drug

Hotgen Biotech Secures NMPA Approval for SGT003 Bispecific Antibody Targeting Tumor Microenvironment

Fineline Cube Jun 18, 2026

Hotgen Biotech Co., Ltd (SHA: 688068) announced that China’s National Medical Products Administration (NMPA) has...

Company Drug

Shanghai Henlius Biotech Secures NMPA Approval for Phase I Trial of HLX3902 Trispecific Antibody in Advanced Solid Tumors

Fineline Cube Jun 18, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...

Company Drug

Hopstem Biotechnology Secures FDA Clearance for hNPC01 Neural Progenitor Cell Therapy in Hemorrhagic Stroke Motor Dysfunction

Fineline Cube Jun 18, 2026

Hopstem Biotechnology Co., Ltd., a neural stem cell specialist founded by neuroscientists and stem-cell biologists...

Company Drug

Insilico Medicine’s NLRP3 Inhibitor ISM8969 Achieves First-in-Human Milestone in Phase I Trial for CNS Disorders

Fineline Cube Jun 17, 2026

Insilico Medicine (HKG: 3696) announced that ISM8969, jointly developed with Hygtia Therapeutics Co., Ltd., has...

Company Drug

Hengrui Pharmaceuticals Receives NMPA Clinical Approvals for Two Novel Anti-Tumor Candidates SHR-6914 and HRS-7525, Addressing Unmet Needs in Prostate Cancer and Solid Tumors

Fineline Cube Jun 17, 2026

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received separate clinical...

Company Drug

Shanghai Henlius Biotech Receives Australian Clearance for Phase II Study of PD-L1 ADC HLX43 Combined with Hansizhuang in NSCLC Neoadjuvant Therapy

Fineline Cube Jun 17, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received regulatory clearance in Australia to...

Company Drug

Shanghai Leadingtac Secures NMPA Approval for LT-010391 – China’s First Clinical-Stage Oral KRAS-G12D Degrader

Fineline Cube Jun 16, 2026

Shanghai Leadingtac Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...

Company Drug

Simcere Pharmaceutical Secures NMPA Approval for SIM0689 Bispecific Antibody Targeting PD-1 and VEGF in Solid Tumors

Fineline Cube Jun 15, 2026

Simcere Pharmaceutical Group (HKG: 2096) announced that SIM0689, a novel bispecific antibody (BsAb) targeting both...

Company Drug

Mabwell Bioscience Secures FDA Approval for 6MW5311 Bispecific Antibody Trial in Hematologic Malignancies

Fineline Cube Jun 15, 2026

Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced that the U.S. Food and Drug Administration...

Company Drug

Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed/Refractory AML

Fineline Cube Jun 11, 2026

Yipinhong Pharmacy Co., Ltd. (SHE: 300723) announced it has received Investigational New Drug (IND) clearance...

Company Drug

Imviva Biotech Receives FDA Clearance for Phase 1b Basket Trial of CTA313 Allogeneic CAR-T Therapy in B Cell-Mediated Autoimmune Diseases

Fineline Cube Jun 11, 2026

Imviva Biotech announced it has received Investigational New Drug (IND) clearance from the U.S. Food...

Clinical trial approval / initiation

Huiyu Pharma Receives NMPA Clinical Trial Approval for HY-1016 Extended-Release Dienogest Injection – Novel Formulation Aims to Transform Endometriosis Treatment Adherence

CSPC Innovation Launches Phase III Trial of SYS6010 ADC-PD-1 Combo in Resected NSCLC – Novel EGFR-Targeted Antibody-Drug Conjugate Enters Adjuvant Setting

Shanghai Bao Pharmaceuticals Secures NMPA IND Approval for BJ044 Recombinant Ulinastatin – First Synthetic Biology-Derived Therapy for Critical Care Indications

Mabwell Bioscience Secures NMPA Approval for 9MW5211 Clinical Trial in Multiple Sclerosis – Expanding Autoimmune Pipeline

Mabwell Secures NMPA Clinical Trial Approval for 6MW5311 Bispecific Antibody – Dual US-China Authorization for Hematological Malignancies

Ab&B Bio-Tech Secures NMPA Clinical Trial Approval for mRNA Mpox Vaccine – First Dual-Approved Candidate Globally

Innovent Biologics Doses First Patient in Pivotal Phase III Trial for IBI3003 Trispecific Antibody in Relapsed/Refractory Multiple Myeloma

CureGene Pharmaceutical Initiates Pivotal US Clinical Trial for Evategrel, World’s First Dual-Formulation P2Y12 Inhibitor Addressing Clopidogrel Resistance

CSPC Pharmaceutical Secures FDA Clearance for SYHX2008 Octreotide Biosimilar Clinical Trials in US Market

Hotgen Biotech Secures NMPA Approval for SGT003 Bispecific Antibody Targeting Tumor Microenvironment

Shanghai Henlius Biotech Secures NMPA Approval for Phase I Trial of HLX3902 Trispecific Antibody in Advanced Solid Tumors

Hopstem Biotechnology Secures FDA Clearance for hNPC01 Neural Progenitor Cell Therapy in Hemorrhagic Stroke Motor Dysfunction

Insilico Medicine’s NLRP3 Inhibitor ISM8969 Achieves First-in-Human Milestone in Phase I Trial for CNS Disorders

Hengrui Pharmaceuticals Receives NMPA Clinical Approvals for Two Novel Anti-Tumor Candidates SHR-6914 and HRS-7525, Addressing Unmet Needs in Prostate Cancer and Solid Tumors

Shanghai Henlius Biotech Receives Australian Clearance for Phase II Study of PD-L1 ADC HLX43 Combined with Hansizhuang in NSCLC Neoadjuvant Therapy

Shanghai Leadingtac Secures NMPA Approval for LT-010391 – China’s First Clinical-Stage Oral KRAS-G12D Degrader

Simcere Pharmaceutical Secures NMPA Approval for SIM0689 Bispecific Antibody Targeting PD-1 and VEGF in Solid Tumors

Mabwell Bioscience Secures FDA Approval for 6MW5311 Bispecific Antibody Trial in Hematologic Malignancies

Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed/Refractory AML

Imviva Biotech Receives FDA Clearance for Phase 1b Basket Trial of CTA313 Allogeneic CAR-T Therapy in B Cell-Mediated Autoimmune Diseases

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Huiyu Pharma Receives NMPA Clinical Trial Approval for HY-1016 Extended-Release Dienogest Injection – Novel Formulation Aims to Transform Endometriosis Treatment Adherence

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