Group 1 - The core viewpoint of the news is that Zai Lab's stock has increased by 5% to 110.38 CNY per share, with a trading volume of 252 million CNY and a market capitalization of 29.218 billion CNY as of September 18 [1] - Zai Lab, established on March 18, 2009, is located in Kunshan, Jiangsu Province, and was listed on January 23, 2020. The company focuses on the research, production, and sales of chemical and biological new drugs, with 99.97% of its revenue coming from pharmaceuticals [1] Group 2 - From the perspective of fund holdings, Zai Lab is a significant investment for Huafu Fund, with its Huafu Health and Entertainment Flexible Allocation Mixed A Fund (001563) holding 40,000 shares, representing 5.81% of the fund's net value, making it the eighth-largest holding [2] - The Huafu Health and Entertainment Flexible Allocation Mixed A Fund has achieved a year-to-date return of 62.99% and a one-year return of 68.36%, ranking 452 out of 8172 and 1856 out of 7980 in its category, respectively [2]

Group 1 - The core point of the article is that Zai Lab has received approval from the National Medical Products Administration for the clinical trial of ZGGS34, which is intended for MUC17 positive advanced solid tumors [2] Group 2 - The approval signifies a significant step forward for Zai Lab in its oncology pipeline, potentially enhancing its market position in the treatment of advanced solid tumors [2]

重要内容提示： 证券代码：688266 证券简称：泽璟制药 公告编号：2025-039 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZGGS34 获得药物临床试验 批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 三、风险提示 根据国家药品注册相关的法律法规要求，药品在获得《药物临床试验批准通 知书》后，尚需开展临床试验，并经国家药监局批准后方可上市销售。本次注射 用 ZGGS34 用于 MUC17 阳性晚期实体瘤的临床试验获批事项对公司近期业绩不 会产生重大影响。 一、药品基本情况 | 药品名称 | 注射用 ZGGS34 | | --- | --- | | 剂型 | 注射用冻干制剂 | | 规格 | 10mg/瓶 | | 申请人 | 苏州泽璟生物制药股份有限公司、上海泽璟医药技术有限公司 | | 申请事项 | 境内生产药品注册临床试验 | | 年 7 审批结论 | 根据《中华人民共和国药品管理法》及有关规定，经审查，2025 月 日受理的注射用 临床试验申请符合药品注册 8 ZGGS34 | | | ...

Core Viewpoint - Zai Lab has received approval from the National Medical Products Administration for clinical trials of ZGGS34, a drug targeting MUC17-positive advanced solid tumors, indicating progress in its oncology pipeline [1] Group 1: Drug Approval and Clinical Trials - The company has obtained the Clinical Trial Approval Notice for ZGGS34, which is intended for use in MUC17-positive advanced solid tumors [1] - The approval marks a significant step in the development of ZGGS34, allowing the company to proceed with clinical trials [1] Group 2: Preclinical Research Findings - Preclinical studies have demonstrated that ZGGS34 exhibits significant tumor suppression effects across various tumor models, leading to tumor regression [1] - The drug has shown strong tumor-killing properties, suggesting its potential efficacy in treating advanced solid tumors [1] - Toxicology studies conducted in non-human primates indicate that ZGGS34 possesses favorable safety characteristics [1]

Group 1 - The core point of the article is that Zai Lab (688266) has received approval from the National Medical Products Administration for a clinical trial of its drug ZGGS34, which is intended for MUC17 positive advanced solid tumors [1] Group 2 - The clinical trial approval signifies a potential advancement in treatment options for patients with MUC17 positive advanced solid tumors [1]

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]

Core Viewpoint - Zai Jian Pharmaceutical (688266.SH) has received approval from the National Medical Products Administration for clinical trials of its injection ZGGS34, targeting MUC17 positive advanced solid tumors, indicating a significant advancement in its drug development pipeline [1] Company Summary - The drug ZGGS34 is a trispecific antibody with strong tumor-killing effects and good safety characteristics, highlighting its potential in cancer treatment [1]

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]

Core Insights - Zai Jian Pharmaceutical (688266.SH) reported a revenue of 376 million CNY in the first half of 2025, marking a year-on-year increase of 56.07% [1][2] - The company recorded a net loss attributable to shareholders of 72.8 million CNY, and a net loss of 103 million CNY after excluding non-recurring items [1][2] - The net cash flow from operating activities was negative at 17 million CNY, a significant decline compared to the previous year [2] Financial Performance - Revenue for the first half of 2025 was 376.65 million CNY, up from 240.70 million CNY in the same period last year, reflecting a growth of 56.07% [2] - Total profit for the period was -77.41 million CNY, slightly improved from -79.49 million CNY year-on-year [2] - The net profit attributable to shareholders was -72.80 million CNY, compared to -66.54 million CNY in the previous year [2] - The net profit after excluding non-recurring items was -102.64 million CNY, worsening from -72.37 million CNY year-on-year [2] - The net cash flow from operating activities was -17.02 million CNY, a decline of 115.12% from a positive cash flow of 112.55 million CNY in the previous year [2] Historical Performance - From 2016 to 2024, the net profit attributable to shareholders showed consistent losses, with figures ranging from -1.28 billion CNY to -4.57 billion CNY [2] - The company has faced ongoing challenges in achieving profitability, with net losses persisting over the years [2] Capital Raising - Zai Jian Pharmaceutical raised a total of 202.56 million CNY through its initial public offering, with a net amount of 190.82 million CNY after expenses [5] - The company initially planned to raise 238.39 million CNY for new drug development and operational reserves, but the final amount was lower than expected [5] - The company conducted a secondary offering in April 2023, raising approximately 1.18 billion CNY after expenses [6]

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].