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Vcanbio Receives NMPA Approval for Stem Cell Therapy VUM02 Clinical Trial
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China-based biotechnology firm Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind, placebo-controlled Phase I/II study. The study will assess the efficacy and safety of its innovative product VUM02, a…
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SciClone Pharmaceuticals Gains FDA Nod for Thymalfasin COVID-19 Vaccine Booster Study
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SciClone Pharmaceuticals Inc. (HKG: 6600), formerly a US-based and Nasdaq-listed company, has announced that it has received approval from the US FDA to conduct a clinical study for its drug thymalfasin as a booster for COVID-19 mRNA vaccines. This marks a significant step in exploring new ways to enhance the…
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Sichuan Huiyu Pharmaceutical’s HYP2090PTSA Gains NMPA Approval for KRAS G12C Solid Tumors
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HYP2090PTSA. This small molecule KRAS G12C/PI3K inhibitor is intended for the treatment of advanced solid tumors with KRAS G12C…
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RemeGen Secures NMPA Approval for Phase II Study of Disitamab Vedotin in Breast Cancer
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China-based biopharma RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with breast cancer. First Home-Grown ADC with Conditional Approvals Disitamab vedotin stands…
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Ascentage Pharma Initiates Phase III Study for APG-2575 and Calquence in CLL/SLL
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced the approval to commence a global multi-center, randomized, open-label pivotal Phase III clinical trial evaluating the efficacy and safety of APG-2575 combined with Calquence (acalabrutinib) in untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients. Earlier this year, the drug received clearance for a…
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Kintor Pharmaceutical Secures NMPA Approval for Phase II Study of GT1708F in Idiopathic Pulmonary Fibrosis
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its Hedgehog/SMO inhibitor, GT1708F, targeting idiopathic pulmonary fibrosis (IPF). Understanding the Role of Hedgehog Signaling in IPF Recent research has highlighted the…
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Yiling Pharmaceutical Secures NMPA Approval for Phase I Study of G201-Na in Premenopausal Women
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a single-center, randomized, double-blind, placebo-controlled Phase I clinical study. This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of G201-Na in premenopausal healthy adult women. G201-Na:…
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Roche’s Forimtamig Receives Tacit Approval for Multiple Myeloma Clinical Trials
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The Center for Drug Evaluation (CDE) has indicated that Swiss pharmaceutical giant Roche (SWX: ROG) has secured tacit clinical trial approval for its Category 1 biologic product, forimtamig (RG6234), in the treatment of multiple myeloma (MM). Promising Efficacy in Phase I Trials Forimtamig is a bispecific antibody (BsAb) designed to…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Anti-Tumor Drug Candidate SHR-2022
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug candidate, SHR-2022 injection. This marks a significant step forward in the development of a new approach…
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Atom Bioscience Initiates Global Phase III Clinical Study for Gout Drug ABP-671
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China-based Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd) has announced the enrollment of the first patient in a global pivotal clinical study for its pipeline candidate, ABP-671. This small molecule inhibitor of the urate transporter 1 (URAT1) protein plays a crucial role in the reabsorption of uric acid…
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GluBio Pharmaceutical’s GLB-002 Receives NMPA Approval for Clinical Trials in Hematological Tumors
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GluBio Pharmaceutical Co., Ltd, a specialist in molecular glue targeted protein degradation (TPD) based in Zhejiang, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its molecular glue degrading agent, GLB-002. The drug is indicated for the treatment of non-Hodgkin’s lymphoma (NHL)…
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Sichuan Biokin’s IZalontamab Gets US FDA Greenlight for NSCLC Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its innovative biologic drug, izalontamab (SI-B001). The trial will focus on assessing the efficacy of izalontamab in combination…
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Transcenta Secures FDA Approval for Phase III Trial of Osemitamab
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China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate the global Phase III pivotal TranStar study for its pipeline candidate, osemitamab (TST001). This clinical trial will evaluate the efficacy of osemitamab in combination with nivolumab and…
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Elpiscience Biopharmaceuticals Initiates Phase I Trial for Anti-LILRB2 Antibody ES009
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Elpiscience Biopharmaceuticals, a China-based biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical trial in Australia for its pipeline candidate, ES009. This investigational drug is an anti-LILRB2 (ILT4) monoclonal antibody developed to target cancers, marking a significant step in the company’s oncology research…
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Tasly Pharmaceuticals Gets NMPA Approval for B1344 Clinical Study in NASH
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Tasly Pharmaceuticals (SHA: 600535), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its human fibroblast growth factor 21 injection, B1344, in patients with non-alcoholic steatohepatitis (NASH). This development marks a significant step in the…
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ImmuneOnco Initiates Phase I Trial for CD24-Targeted Monoclonal Antibody IMM47
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the first patient dosing in a Phase I clinical study in Australia for its investigational drug, IMM47, a first-in-class CD24-targeted monoclonal antibody (mAb). This marks a significant step in the development of a novel immunotherapy approach for cancer treatment. IMM47’s Mechanism…
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Mabwell Bioscience Initiates Phase Ib/II Study for Nectin-4 Targeting ADC 9MW2821
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced the first patient dosing in a Phase Ib/II clinical study for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The study is designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of 9MW2821 in combination with…
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LEO Pharma Initiates Phase III Clinical Trial for Delgocitinib in China
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Denmark-based LEO Pharma A/S has announced the commencement of a China Phase III clinical study with the enrollment and dosing of the first patient for its delgocitinib cream, marking the first clinical study for the product in China. This milestone signifies the company’s efforts to address moderate to severe adult…
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United Laboratories Receives FDA Approval for Clinical Study of UBT251 for Obesity Treatment
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United Laboratories International Holdings Ltd (HKG: 3933), a Hong Kong-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 drug candidate, UBT251, for the treatment of overweight and obesity. UBT251: A Triple Agonist…
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BioTroy Therapeutics Receives US FDA IND Approval for Anti-Tumor Drug BT02
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BioTroy Therapeutics, a Shanghai-based developer of cancer immunotherapies, has announced the receipt of Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its innovative anti-tumor drug, BT02. This monoclonal antibody (mAb) targets solid tumors with a novel mechanism, representing a significant step forward in cancer…
