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Staidson’s STSP-0601 Begins Phase II Study for Hemophilia Treatment
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China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced the first subject dosing in a Phase II clinical study for its Category 1 biologic STSP-0601. The study aims to evaluate the drug as an on-demand treatment for bleeding in patients with hemophilia A or B without inhibitors. This marks…
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Hansoh’s HS-10517 Greenlit for COVID-19 Clinical Study by NMPA
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its HS-10517, a Category 1 anti-COVID-19 drug co-developed by the Global Health Drug Discovery Institute (GHDDI). The study will focus on mild to moderate COVID-19…
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Abbisko’s ABSK021 Gains NMPA Approval for Phase II Study in cGVHD
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib) in chronic graft versus host disease (cGVHD). This marks a significant step forward in the development of…
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Ascletis Pharma Initiates Dosing in Phase I Trial for COVID-19 Treatment ASC11
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced the dosing of four healthy subjects in the first cohort of a multi-dose escalation Phase I clinical study for its oral 3-chymotrypsin-like protease (3CLpro) inhibitor ASC11, in combination with 100 mg ritonavir tablets. The study aims to evaluate the safety, tolerability, and…
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Guangzhou’s Overseas Pharma Wins China Clinical Trial Approval for OPL-038
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Guangzhou-based Overseas Pharmaceuticals, Ltd has secured clinical trial approval in China for its sustained and controlled release drug OPL-038. The drug, filed as an Investigational New Drug (IND) under Category 2 (modified drug), aims to address the needs of adult patients with type 2 diabetes through a novel combination therapy.…
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Xinhua Pharma’s OAB-14 Receives NMPA Approval for Phase I Alzheimer’s Study
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China-based Shandong Xinhua Pharmaceutical Co., Ltd (SHE: 000756) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study of its innovative Alzheimer’s disease (AD) drug, OAB-14. The study will assess the safety and tolerability, pharmacokinetics, pharmacodynamics, and food effects of OAB-14 in…
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Konruns’ KC1036 Advances to Phase II Study for Lung Adenocarcinoma
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study of its Category 1 chemical drug KC1036. The study will assess the efficacy and safety of KC1036 in combination with docetaxel for the treatment of…
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Harbour BioMed’s HBM1020 Receives FDA Approval for US Phase I Study
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Harbour BioMed (HKG: 2142), a global biotech company operating in the Netherlands, the United States, and China, has announced receiving approval from the US Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I study of its monoclonal antibody (mAb) HBM1020. The study will assess the safety, tolerability,…
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Kexing Pharmaceutical Initiates Phase I Trial for IFN-Alpha-1b Inhalation Solution
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China-based Kexing Pharmaceutical (SHA: 688136) has announced the enrollment of the first subject and dosing in a Phase I clinical study for its interferon-alfa-1b (IFN-alpha-1b) solution for inhalation. The drug will be assessed for treating lower respiratory tract infections caused by respiratory syncytial virus (RSV) in children, including conditions such…
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CSPC’s Cleviprex Approved for Clinical Study by China’s NMPA
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its pipeline drug candidate cleviprex. The company’s first nanoemulsion, cleviprex, is a dihydropyridine calcium channel blocker being developed to treat hypertension when oral antihypertensive drugs are…
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Kelun-Biotech’s SKB264 Approved for Phase II Study in EGFR-Mutant NSCLC
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its drug candidate SKB264. The antibody-drug conjugate (ADC) targets trophoblast cell-surface antigen 2 (TROP2) and will be evaluated in combination with AstraZeneca’s (AZ, NASDAQ: AZN)…
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Konruns Initiates Phase II Study for KC1036 in Advanced Thymic Tumors
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced the initiation of a single-arm, open, multi-center Phase II clinical study to assess the efficacy and safety of its Category 1 chemical drug KC1036 in patients with advanced thymoma and thymic carcinoma. The study focuses on patients whose disease has progressed…
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HighTide Therapeutics Doses First Patient in Phase IIb Study for HTD1801 in NASH
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Shenzhen-based HighTide Therapeutics Inc. has announced that the first patient has been dosed in a Phase IIb clinical study for its pipeline candidate HTD1801 in non-alcoholic steatohepatitis (NASH). The randomized, double-blind, placebo-controlled study is designed to assess the histological improvement of HTD1801 compared with placebo in subjects with NASH and…
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Jiangsu Kanion’s KYS202002A Greenlit for Clinical Study in Multiple Myeloma
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its pipeline candidate KYS202002A in recurrent/refractory multiple myeloma (R/R MM). This marks a significant step forward in the development of this innovative therapy targeting a…
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Innovent Biologics Doses First Patient in Phase III Study for Mazdutide
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced that the first patient has been dosed in the multi-center, randomized, double-blind, placebo-controlled Phase III DREAMS-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being assessed for safety and efficacy in treating Chinese…
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Jiangxi Jemincare’s JMKX003142 Gets FDA Nod for Clinical Study
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China-based Jiangxi Jemincare Group has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its oral drug JMKX003142 in polycystic nephropathy. This marks a significant step forward in the development of a potential new treatment for this chronic kidney condition. Disease Background…
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Yantai Dongcheng Pharma Gets FDA Go-Ahead for 177Lu-LNC1004 Clinical Trial
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its 177Lu-LNC1004 in advanced fibroblast activation protein (FAP)-positive solid tumors. This marks a significant step in the development of this innovative…
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Jacobio Pharma Doses First Patient in US Phase I/IIa Study for JAB-2485
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China-based Jacobio Pharma (HKG: 1167) has announced that the first patient has been dosed in a Phase I/IIa clinical study being carried out in the United States for its Aurora A inhibitor JAB-2485. The initial indication for the study is general advanced solid tumors, marking a significant step in the…
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Dizal’s Sunvozertinib and Golidocitinib Combo Gets NMPA Approval for Phase II Study
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the safety, tolerability, and efficacy of its next-generation epidermal growth factor receptor (EGFR) inhibitor sunvozertinib (DZD9008) in combination with the JAK1 inhibitor golidocitinib (DZD4205).…
