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Allist Pharmaceuticals Gains NMPA Approval for Furmonertinib Clinical Study
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its furmonertinib as an adjuvant therapy for stage IB-IIIB non-small cell lung cancer (NSCLC) carrying non-classical epidermal growth factor receptor (EGFR) mutations. The study will evaluate the…
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Asieris’ USP1 Inhibitor APL-2302 Cleared for Clinical Trials
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its APL-2302 (ASN-3186) in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced cancer. APL-2302: Mechanism of ActionAPL-2302…
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Zhejiang Huahai’s HB0056 Approved for US Phase I Asthma Trial
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its HB0056. This injectable bispecific antibody (BsAb) targets thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11) and is now cleared to enter Phase I clinical study in asthma.…
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Hengrui’s HER2-Targeted ADC and Antibody Drug Combo Approved for Trials
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its SHR-A1811 combined with SHR-9839 in advanced solid tumors. This approval is a significant step forward in the development of innovative treatments for patients with advanced cancer. SHR-A1811:…
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CSPC’s SYS 6043 Receives FDA Approval for Clinical Trials
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its in-house developed SYS 6043 has obtained clinical trial approval from the US Food and Drug Administration (FDA). This approval marks a significant step forward in the development of innovative treatments for advanced/metastatic solid tumors. Clinical Trial Scope and ObjectivesThe…
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Wepon Medical’s WP107 Receives FDA Approval for gMG Clinical Trial
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China-based Wepon Medical Holding Group Co., Ltd. (SHE: 002082) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed WP107 (huperzine A). The acetylcholinesterase inhibitor is slated to enter a clinical study for the treatment of generalized myasthenia gravis (gMG). WP107: Preclinical…
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Fosun Pharma Initiates Phase II Study for Glomerular Disease Treatment
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II study for its Category I chemical drug, XH-S003, in glomerular diseases related to abnormal complement activation, such as IgA nephropathy in China. This marks a significant step forward in the development of…
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Hengrui’s SHR-9839 Receives NMPA Clearance for Advanced Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its SHR-9839 subcutaneous (SC) injection in advanced solid tumors. This clearance marks a significant step forward in the development of innovative treatments for patients with advanced malignant tumors. SHR-9839:…
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Huadong Medicine Gets FDA Nod for Phase I Study of HDM2006 in Solid Tumors
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study for its Category 1 chemical drug, HDM2006, in patients with advanced solid tumors. This marks a significant step forward in…
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Tonghua Dongbao Begins Phase II Trial for GLP-1/GIP Agonist THDBH120 in Weight Loss
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has announced a significant milestone in its clinical development program with the first patient dosing in the Phase II clinical study of THDBH120. This study is designed to assess the efficacy and safety of the GLP-1/GIP dual-targeted receptor agonist in weight loss applications. THDBH120…
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CSPC Pharmaceutical’s ADC Pipeline Advances with SYS 6041 Approval
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has reported significant progress in its antibody drug conjugate (ADC) pipeline. The company’s latest product, SYS 6041, has recently been cleared for study in advanced solid tumors in China. This approval marks a crucial step in the development of CSPC’s ADC portfolio,…
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Henlius Biotech Gains NMPA Clearance for HLX43 ADC Study
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) drug HLX43, combined with the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10), in patients with advanced/metastatic solid…
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Ucello Biotech’s UC101 Receives FDA IND Clearance for Anti-CD19 Therapy
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China-based Chengdu Ucello Biotechnology Co., Ltd., a developer of allogeneic universal chimeric antigen receptor (CAR)-T cell therapies, has announced receiving Investigational New Drug (IND) clearance from the US FDA for its anti-CD19 allogeneic universal T-cell therapy UC101. This clearance is a significant milestone in the development of UC101, paving the…
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Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1819 Phase II Study
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its investigational drug SHR-1819. This approval is a significant step forward in the development of SHR-1819, which is…
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Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4375 Clinical Trial
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic product SHR-4375. This approval is a significant milestone in the development of SHR-4375, which is designed to treat advanced malignant solid tumors.…
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Doma Biopharma Receives FDA Clearance for DM002 Phase I Study-Fineline Info & Tech
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China-based Doma Biopharmaceutical (Suzhou) Co., Ltd has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of its Category 1 drug DM002 in multiple solid tumors. This…
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CSPC Pharmaceutical Group Receives NMPA Approvals for ADC SYS6045 and PDE4B Inhibitor SYH2059
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SYS6045 and small molecule inhibitor SYH2059. These approvals mark significant milestones in the development of both drug candidates. SYS6045: Antibody…
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Simcere Zaiming’s SIM0505 Receives NMPA Approval for Clinical Trials in Advanced Solid Tumors
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SIM0505, which targets CDH6 in advanced solid tumors. Last month, the drug also received clearance for clinical trials…
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Amoytop Biotech’s Pegfilgrastim Gains NMPA Approval for Preeclampsia Clinical Trials
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Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pegfilgrastim (Y shape) to reduce the incidence of preeclampsia. This marks a significant milestone in the development of innovative therapies for pregnancy-related complications. Product Overview…
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MicuRx Pharmaceuticals’ MRX-5 Receives NMPA Approval for NTM Infections Clinical Study
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug MRX-5. The study will focus on infections caused by non-tuberculous Mycobacteria (NTM) that are sensitive to this product. MRX-5: A Promising…
