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Grand Pharma’s First-in-Class RDC ITM-11 Accepted for IND Review
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China-based Grand Pharmaceutical Group Ltd (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its first-in-class radionuclide drug conjugate (RDC) ITM-11 has been accepted for review. The intended indication for ITM-11 is gastroenteropancreatic neuroendocrine tumors (GEP-NETs), marking a significant step forward in the development of novel treatments…
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Mabwell’s IL-11 Monoclonal Antibody 9MW3811 Approved for Australian Clinical Trial
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving clinical trial approval from the Therapeutic Goods Administration (TGA) of Australia for its 9MW3811, an in-house developed IL-11 monoclonal antibody (mAb) for the treatment of various advanced malignant tumors and fibrotic diseases. This approval marks a significant step forward…
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InnoCare and Keymed Announce First Dosing of ICP-B05 Clinical Study
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China-based firms InnoCare Pharma (HKG: 9969, SHA: 688428) and Keymed Biosciences (HKG: 2162) have jointly announced the first subject dosing of a clinical study for ICP-B05 (CM369), an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody (mAb) developed by their joint venture, Tiannuojiancheng Pharma. This marks a significant milestone in the…
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Luye Pharma’s Paliperidone Palmitate Approved for European Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval in Europe for its paliperidone palmitate extended-release injectable suspension (LY03010). This approval marks a significant step forward in the development of this second-generation antipsychotic drug, which is designed for the treatment of schizophrenia and schizoaffective disorders. Paliperidone Palmitate:…
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Abbisko’s ABSK121 Greenlit for Phase I Clinical Study by NMPA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to carry out a Phase I clinical study for its ABSK121, a fibroblast growth factor receptor (FGFR) drug resistance and mutation inhibitor, in advanced solid tumors. This marks a significant…
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Shanghai Pharmaceuticals’ WST01 Receives FDA Clinical Clearance
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China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607) has announced receiving clinical clearance from the US FDA for its WST01, an oral micro-ecological live bacterial preparation for weight management. This marks a significant milestone in the development of innovative treatments for obesity. WST01: Product Profile and DevelopmentWST01, co-developed by the…
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Neurophth’s NR082 Gene Therapy Completes Phase III Enrollment
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced the completion of all-patient enrollment and dosing in a Phase III clinical study for its NR082 (rAAV2-ND4, NFS-01), a recombinant adeno-associated virus serotype 2 (rAAV2) therapy for ND4-mediated Leber’s hereditary optic neuropathy (ND4-LHON). This marks a significant milestone in the development…
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Insilico Medicine’s COVID-19 Drug ISM3312 Enters Clinical Trials
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China-based AI-powered drug discovery firm Insilico Medicine has announced that its ISM3312, an oral COVID-19 drug designed with the support of the firm’s Chemistry42 platform, has entered clinical trials after receiving approval from the National Medical Products Administration (NMPA). This marks a significant milestone in the development of innovative treatments…
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Chinagene Tech Initiates ZVS101e Gene Therapy Trial for Bietti’s Crystalline Dystrophy
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Beijing-based Chinagene Tech, a specialist in hereditary ophthalmopathy diagnosis and gene therapy, has announced the enrollment and dosing of the first subject in a Phase I/II clinical study for its ophthalmology gene therapy ZVS101e in Tianjin. This study marks the first potentially regulatory clinical trial for a gene therapy targeting…
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Biosyngen’s BRG01 Gets FDA Nod for NPC Clinical Study
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Cell and gene therapy (CGT) specialist Biosyngen Pte Ltd has announced receiving approval from the US FDA to initiate a Phase I/II clinical study for its BRG01, an autologous T cell therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC). This marks a significant milestone in the development of innovative…
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BRL Medicine Achieves First Cure of Thalassemia Major with BRL-101
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Shanghai-based BRL Medicine Inc. has announced a significant breakthrough in the treatment of thalassemia major. The company reported the first cure in a multi-center Phase clinical study assessing the safety and efficacy of its BRL-101, an autologous hematopoietic stem progenitor cell therapy. This marks a major milestone in the development…
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Immuno Cure BioTech Launches Phase I HIV/AIDS Vaccine Study
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China-based Immuno Cure BioTech has announced the initiation of a Phase I clinical study for its ICVAX, a therapeutic vaccine against HIV/AIDS, in Shenzhen. This marks a significant step forward in the development of innovative treatments for HIV/AIDS, a condition that affects millions of people globally. Study Design and ObjectivesThe…
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CSPC’s NBL-020 Gets NMPA Approval for Clinical Study in Advanced Solid Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate a clinical study for the antibody drug NBL-020. This marks a significant step forward in the development of new treatments for advanced solid tumors. NBL-020: Anti-Tumor Necrosis Factor Type…
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AIM Vaccine Gains Approvals for COVID-19 mRNA Vaccine Trials in Pakistan
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving separate approvals in Pakistan to initiate a Phase I clinical study for its mRNA vaccine against COVID-19 variants and a Phase III study for its mRNA vaccine against the COVID-19 prototype as a sequential booster. This marks a significant step…
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Innovent Biologics Initiates Phase III CLEAR Study for Picankibart in Psoriasis
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China-based Innovent Biologics (HKG: 1801) has announced the first subject dosing in the Phase III CLEAR study for its picankibart (IBI112), a recombinant anti-interleukin 23p19 subunit (IL23p19) antibody injection, in moderate-to-severe plaque psoriasis. This marks a significant advancement in the development of innovative treatments for this chronic skin condition. Phase…
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Hengrui Pharmaceuticals Gains NMPA Approval for SHR-A1921 Clinical Study
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to carry out an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921 combined with adebrelimab (SHR-1316) in advanced solid tumors. This marks a significant step in the development of…
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Innovent Biologics Initiates Phase II Study for IBI311 in Thyroid-Associated Ophthalmopathy
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China-based Innovent Biologics Inc., (HKG: 1801) has announced the first patient dosing in a Phase II clinical study for its IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in thyroid-associated ophthalmopathy (TAO). IBI311 is an IGF-1R-targeting monoclonal antibody independently developed by Innovent, marking a significant step in the…
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Kangtai Biological Begins Phase I Trial for Tetravalent Influenza Vaccine
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the first subject enrollment in a Phase I clinical study for its tetravalent influenza virus split vaccine. This marks a significant step in the development of a vaccine designed to provide broader protection against influenza, particularly for individuals aged…
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Beijing Wantai Initiates Phase I Study for 20-Valent Pneumonia Vaccine
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China-based Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced the initiation and first subject enrollment in a Phase I clinical study for its 20-valent pneumonia vaccine. This marks a significant step in the development of a vaccine designed to provide broader protection against pneumonia. Vaccine Development and…
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Gracell Biotechnologies Gains IND Approval for GC012F in China
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Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for its chimeric antigen receptor (CAR) T cell candidate GC012F. The dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step in the development…
