Group 1 - The core point of the article is that Zai Lab has received approval from the National Medical Products Administration for a clinical trial of ZG005 in combination with Jikaxitinib and chemotherapy for advanced solid tumors [2] Group 2 - The clinical trial approval indicates a significant step forward for Zai Lab in its oncology pipeline, potentially enhancing its market position in cancer treatment [2]

证券代码：688266 证券简称：泽璟制药 公告编号：2025-030 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZG005 与盐酸吉卡昔替尼片及 化疗联用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。 重要内容提示： 苏州泽璟生物制药股份有限公司（以下简称"公司"）于近日收到国家药品监 督管理局（以下简称"国家药监局"）核准签发的《药物临床试验批准通知书》， 注射用 ZG005 与盐酸吉卡昔替尼片及化疗联合用于晚期实体瘤的临床试验获得 批准。 本次临床试验获批事项对公司近期业绩不会产生重大影响。由于药品的研发 周期长、审批环节多、研发投入大，容易受到一些不确定性因素的影响，敬请广 大投资者谨慎决策，注意防范投资风险。 现将相关情况公告如下： | 药品名称 | 注射用 盐酸吉卡昔替尼片 ZG005 | | --- | --- | | 剂型 | 粉针剂 片剂 | | 规格 | 100mg/瓶 50mg | | 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 | ...

智通财经APP讯，泽璟制药(688266.SH)公告，公司近日收到国家药品监督管理局核准签发的《药物临 床试验批准通知书》，注射用ZG005与盐酸吉卡昔替尼片及化疗联合用于晚期实体瘤的临床试验获得批 准。 ...

格隆汇8月20日丨泽璟制药(688266.SH)公布，公司于近日收到国家药品监督管理局核准签发的《药物临 床试验批准通知书》，注射用ZG005与盐酸吉卡昔替尼片及化疗联合用于晚期实体瘤的临床试验获得批 准。 ...

泽璟制药(688266.SH)公告，公司近日收到国家药品监督管理局核准签发的《药物临床试验批准通知 书》，注射用ZG005与盐酸吉卡昔替尼片及化疗联合用于晚期实体瘤的临床试验获得批准。 ...

每经AI快讯，8月20日，泽璟制药(688266.SH)公告称，公司近日收到国家药监局核准签发的《药物临床 试验批准通知书》，注射用ZG005与盐酸吉卡昔替尼片及化疗联合用于晚期实体瘤的临床试验获得批 准。本次临床试验获批事项对公司近期业绩不会产生重大影响。药品研发周期长、审批环节多，存在无 法获批上市销售的风险。 ...

近日，苏州泽璟生物制药股份有限公司收到国家药监局核准签发的《药物临床试验批准通知书》，注射 用ZG005与盐酸吉卡昔替尼片及化疗联合用于晚期实体瘤的临床试验获批。注射用ZG005是创新型肿瘤 免疫治疗生物制品，有望治疗多种实体瘤；盐酸吉卡昔替尼片是新型JAK和ACVR1双抑制剂类药物， 已有部分适应症获批或受理。不过，药品研发周期长、环节多，存在不确定性，获批事项对公司近期业 绩无重大影响，提醒投资者注意风险。 ...

Group 1 - The Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index decreased by 0.91% as of August 20, 2025, with mixed performance among constituent stocks [1] - Heartbeat Medical led the gains with an increase of 3.13%, while Yuandong Biological experienced the largest decline [1] - The market for the Sci-Tech Medical ETF managed by Harvest saw a turnover rate of 24.05% and a transaction volume of 62.637 million yuan, indicating active trading [3] Group 2 - The latest scale of the Sci-Tech Medical ETF reached 263 million yuan, marking a one-month high and ranking first among comparable funds [3] - The ETF has seen continuous net inflows over the past three days, with a maximum single-day net inflow of 6.157 million yuan, totaling 15.2382 million yuan [3] - The net value of the ETF increased by 56.59% over the past year, with the highest monthly return since inception being 23.29% [3] Group 3 - The total amount of business cooperation for innovative drugs in China is projected to reach 51.9 billion USD in 2024, with a record 1.25 billion USD upfront payment transaction between 3SBio and Pfizer in 2025 [4] - The Chinese innovative drug sector has seen a 25.02% increase year-to-date, ranking fourth among 31 industries, with a current PE ratio of 31.31 times [4] - The National Healthcare Security Administration has introduced a temporary management method for disease-based payment, promoting payment reform in the healthcare sector [4] Group 4 - As of July 31, 2025, the top ten weighted stocks in the Sci-Tech Innovation Board Biopharmaceutical Index accounted for 49.14% of the index, with leading companies including United Imaging and BeiGene [4][6] - The performance of individual stocks varied, with United Imaging down by 0.26% and BeiGene up by 0.95% [6] - Investors without stock accounts can access the Sci-Tech Medical ETF through the Harvest Sci-Tech Medical ETF linked fund [6]

Group 1 - Yiling Pharmaceutical's new drug application for "Children's Lianhua Qingwen Granules" has been accepted by the National Medical Products Administration, indicating the company's efforts to expand its respiratory product line [1] - During the COVID-19 pandemic, Yiling Pharmaceutical experienced significant revenue growth due to Lianhua Qingwen, but performance has normalized as demand decreased [1] Group 2 - East China Pharmaceutical reported a revenue of 21.675 billion yuan for the first half of 2025, a year-on-year increase of 3.39%, and a net profit attributable to shareholders of 1.815 billion yuan, up 7.01% [2] - The company is focusing on innovation in weight loss, oncology, and autoimmune disease sectors, which may lead to a valuation shift from "stable" to "growth" as new products are launched [2] Group 3 - Innovent Biologics reported a revenue of 731 million yuan for the first half of 2025, a 74.26% increase year-on-year, but incurred a net loss of 30.0914 million yuan, an improvement from a loss of 262 million yuan in the same period last year [3] - The strong growth in revenue is attributed to increased sales of its core product, Aobutini, which reached 637 million yuan, a 52.84% year-on-year increase [3] - Future sales growth is expected as the indications for Aobutini expand [3] Group 4 - Zai Lab announced that its investigational product ZGGS34 has received FDA approval for clinical trials aimed at treating advanced solid tumors, marking a significant step in the company's international innovation efforts [4] - Preclinical studies have shown that ZGGS34 exhibits significant tumor suppression effects across various cancer models [4] - However, ZGGS34 is still in the early stages of clinical development, and the path to market remains lengthy, with inherent risks associated with drug development [4]

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]