三特异性抗体药物

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泽璟制药(688266.SH):注射用ZGGS34获得药物临床试验批准
智通财经网· 2025-09-17 08:19
Core Viewpoint - The company Zai Lab (688266.SH) has received approval from the National Medical Products Administration for the clinical trial of its drug ZGGS34, which targets MUC17-positive advanced solid tumors [1] Group 1: Drug Development - ZGGS34 is a trispecific antibody drug developed by the company, classified as a trispecific T cell engager (TriTE) [2] - The drug targets CD3, CD28 on T cells, and the tumor-associated antigen (TAA) MUC17, which is highly expressed in various gastrointestinal cancers [2] - ZGGS34 connects tumor cells and T cells, activating T cells to produce perforin, granzyme, and cytokines to kill tumor cells [2] Group 2: Mechanism of Action - The inclusion of a CD28 agonistic antibody in ZGGS34 enhances T cell activation, proliferation, and survival, making it more effective than typical BiTE molecules [2] - CD28 lowers the activation threshold of TCR, enhancing T cell proliferation, metabolism, and anti-apoptotic capabilities [2] Group 3: Preclinical Results - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression in various tumor models, indicating its strong tumor-killing capability [3] - Toxicology studies in non-human primates have demonstrated good safety characteristics for ZGGS34 [3]
泽璟制药:注射用ZGGS34获得药物临床试验批准
Zhi Tong Cai Jing· 2025-09-17 08:16
Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its drug ZGGS34, targeting MUC17-positive advanced solid tumors [1] Group 1: Drug Development - ZGGS34 is a trispecific antibody drug, classified as a trispecific T cell engager (TriTE), targeting CD3, CD28 on T cells, and the tumor-associated antigen MUC17 [2] - MUC17 is a transmembrane mucin highly expressed in gastric cancer, gastroesophageal junction cancer, pancreatic cancer, and colorectal cancer, making it a popular target for gastrointestinal tumor diagnosis and treatment [2] - ZGGS34 connects tumor cells and T cells, activating T cells to produce perforin, granzyme, and cytokines to kill tumor cells [2] Group 2: Mechanism of Action - The inclusion of a CD28 agonistic antibody in ZGGS34 enhances T cell activation, proliferation, and survival, providing stronger T cell activation capabilities compared to typical BiTE molecules [2] - CD28 binding lowers the T cell receptor activation threshold, enhancing T cell proliferation, metabolism, and anti-apoptotic abilities, thereby improving anti-tumor immune response [2] Group 3: Preclinical Results - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression in various tumor models, indicating its potent tumor-killing effects [3] - Toxicology studies in non-human primates have demonstrated good safety characteristics for ZGGS34 [3]
苏州泽璟生物制药股份有限公司关于自愿披露注射用ZG006开展关键性临床试验并完成首例受试者入组的公告
Shang Hai Zheng Quan Bao· 2025-09-16 20:15
Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received conditional approval from the National Medical Products Administration (NMPA) to conduct pivotal clinical trials for its investigational drug ZG006, with the first subject enrolled in the trial [1][2]. Drug Information - ZG006 (INN: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody research platform, and it has received clinical trial approval from both the U.S. FDA and China's NMPA [1][2]. - ZG006 targets two different DLL3 epitopes and CD3, acting as a T-cell engager to connect T-cells with tumor cells, demonstrating significant tumor suppression in preclinical studies [2]. Clinical Trial Details - The pivotal clinical trial for ZG006 is actively being advanced, with the first subject enrolled recently. The company plans to continue progressing the trial and will apply for conditional marketing approval if the trial results meet expectations [1][2]. Impact on the Company - The initiation of the pivotal clinical trial and the enrollment of the first subject are not expected to have a significant impact on the company's recent performance. The drug must complete clinical trials and receive regulatory approval before it can be marketed [2][3].
苏州泽璟生物制药股份有限公司关于自愿披露注射用ZGGS34临床试验申请获得FDA批准的公告
Shang Hai Zheng Quan Bao· 2025-08-19 19:59
Core Viewpoint - Suzhou Zaiqian Biopharmaceutical Co., Ltd. has received FDA approval for the clinical trial application of its product ZGGS34, aimed at treating advanced solid tumors [2][3] Group 1: Drug Information - ZGGS34 is a trispecific antibody drug developed by the company and its subsidiary Gensun Biopharma Inc., utilizing a dual/multi-specific antibody research platform [3] - The drug targets T-cell markers CD3 and CD28, as well as the tumor-associated antigen MUC17, which is highly expressed in various gastrointestinal cancers [3] - ZGGS34 connects tumor cells and T-cells, activating T-cells to produce perforin, granzyme, and cytokines to kill tumor cells, demonstrating enhanced anti-tumor immune effects compared to typical BiTE molecules [3] Group 2: Preclinical Research Results - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression effects across various tumor models, indicating its strong tumor-killing capability [4] - Toxicology studies in non-human primates have demonstrated controllable side effects and good safety characteristics for ZGGS34 [4] Group 3: Financial Impact - The FDA approval of the clinical trial application for ZGGS34 is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development [2][5]
泽璟制药:注射用ZGGS34临床试验申请获得FDA批准
Zhi Tong Cai Jing· 2025-08-19 08:53
Core Viewpoint - Zai Jian Pharmaceutical (688266.SH) has received FDA approval for its investigational product ZGGS34, which is intended for the treatment of advanced solid tumors [1] Group 1: Product Development - ZGGS34 is a trispecific antibody drug developed by the company and its subsidiary Gensun Biopharma Inc. through its bispecific/multispecific antibody research platform [1] - The drug targets CD3 and CD28 on T cells, as well as the tumor-associated antigen (TAA) MUC17, making it a trispecific T cell engager (TriTE) [1] Group 2: Clinical Research - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression effects across various tumor models, leading to tumor regression, indicating its potent tumor-killing capabilities [1] - Toxicology studies conducted in non-human primates have demonstrated that ZGGS34 has controllable side effects and good safety characteristics [1]