Group 1 - The core point of the article is that Zai Lab has received FDA approval for its investigational product ZGGS34 for the treatment of advanced solid tumors [2] Group 2 - The announcement was made on the evening of August 19 [2] - The approval is significant as it allows the company to proceed with clinical trials in the United States [2]

Core Viewpoint - Zai Jiang Pharmaceutical has received FDA approval for its investigational product ZGGS34, aimed at treating advanced solid tumors, which could enhance its market position and revenue potential [2] Company Summary - Zai Jiang Pharmaceutical's revenue composition for the year 2024 is heavily weighted towards pharmaceutical manufacturing, accounting for 99.73% of total revenue, with other business activities contributing only 0.27% [2]

证券代码：688266 证券简称：泽璟制药 公告编号：2025-029 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 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： 近日，苏州泽璟生物制药股份有限公司（以下简称"公司"）在研产品注射 用 ZGGS34 临床试验申请获得美国食品药品监督管理局（以下简称"FDA"）批 准，用于治疗晚期实体瘤。 本次注射用 ZGGS34 临床试验申请获得 FDA 批准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： 一、药品基本情况 | 药品名称 | 注射用 ZGGS34 | | --- | --- | | 剂型 | 注射用冻干制剂 | | 编号 | IND 177999 | | 适应症 | 晚期实体瘤 | 二、药品相关情况 ZGGS34 是公司及子公司 Gensun Biopharma ...

Group 1 - The core point of the article highlights the performance of the Huatai Fuhua Medical Service Flexible Allocation Mixed A Fund, which has shown significant returns over various time frames, including a 69.10% return over the past six months and a 65.45% return year-to-date, ranking first in its category [1] - The fund's latest net value is reported at 1.9920 yuan, reflecting a decrease of 0.75% [1] - The fund's top ten stock holdings account for a total of 68.66%, with notable investments in companies such as Heng Rui Pharmaceutical (9.90%) and Ke Lun Pharmaceutical (9.03%) [1] Group 2 - The Huatai Fuhua Medical Service Flexible Allocation Mixed A Fund was established on June 18, 2015, and as of June 30, 2025, it has a total scale of 2.915 billion yuan [1] - The fund manager, Zhang Wei, has a strong background in biomedical studies and extensive experience in the pharmaceutical sector, having held various positions in research and fund management [2]

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]

人民财讯8月19日电，泽璟制药(688266)8月19日晚间公告，近日，公司在研产品注射用ZGGS34临床试 验申请获得美国食品药品监督管理局(简称"FDA")批准，用于治疗晚期实体瘤。 ...

Core Viewpoint - ZaiJing Pharmaceutical's injectable ZGGS34 has received clinical trial approval from the FDA for the treatment of advanced solid tumors, but this approval will not have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development [1] Group 1 - The FDA has granted clinical trial approval for ZaiJing Pharmaceutical's injectable ZGGS34 [1] - The drug is intended for the treatment of advanced solid tumors [1] - The approval is not expected to significantly affect the company's recent performance [1] Group 2 - The drug development process is characterized by long cycles, multiple approval stages, and substantial research investment [1] - The company faces various uncertainties that could impact the drug's development [1]

格隆汇8月19日丨泽璟制药(688266.SH)公布，在研产品注射用ZGGS34临床试验申请获得美国食品药品 监督管理局（简称"FDA"）批准，用于治疗晚期实体瘤。临床前研究结果显示，ZGGS34在多种肿瘤模 型上具有显著的肿瘤抑制作用，可以导致肿瘤消退，说明ZGGS34具有强效的肿瘤杀伤作用。已完成的 ZGGS34在非人灵长类动物中毒理研究显示其具有毒副作用可控等良好的安全性特征。 ...

Group 1 - The core viewpoint of the article highlights the performance and holdings of the Agricultural Bank of China Healthcare Stock Fund, which has shown significant growth in recent months and years [1] - The fund's latest net value is 2.0003 yuan, reflecting a growth of 1.17% [1] - Over the past month, the fund has achieved a return of 4.93%, ranking 412 out of 1032 in its category [1] - In the last six months, the fund's return has been 50.76%, ranking 43 out of 993 [1] - Year-to-date, the fund has returned 46.69%, ranking 69 out of 983 [1] Group 2 - The top ten holdings of the Agricultural Bank of China Healthcare Stock Fund account for a total of 51.10%, with significant positions in companies such as Heng Rui Pharmaceutical (8.16%) and Zai Lab (7.99%) [1] - The fund was established on February 10, 2015, and as of June 30, 2025, it has a total size of 1.441 billion yuan [1] - The fund manager, Meng Yuan, has a master's degree and has held various positions in the financial industry, including roles at Bank of China Fund Management and Agricultural Bank of China Asset Management [1]

Core Insights - The core viewpoint of the news is the performance and holdings of the Agricultural Bank of China Healthcare Stock Fund, which has shown significant growth in recent months and has a diversified portfolio in the healthcare sector [1]. Fund Performance - The latest net value of the Agricultural Bank of China Healthcare Stock Fund is 1.9772 yuan, reflecting a growth of 1.81% [1]. - The fund's return over the past month is 9.64%, ranking 129 out of 328 in its category [1]. - Over the last six months, the fund has achieved a return of 47.35%, ranking 12 out of 316 [1]. - Year-to-date, the fund has a return of 45.00%, ranking 18 out of 316 [1]. Fund Holdings - The top ten holdings of the Agricultural Bank of China Healthcare Stock Fund account for a total of 51.10% of the portfolio, with the following key positions: - Heng Rui Medicine: 8.16% - Zai Lab: 7.99% - Xin Li Tai: 5.84% - Rejig Bio: 5.63% - Kelun Pharmaceutical: 5.02% - HAO OBO: 4.36% - BeiGene: 3.61% - Yifang Bio: 3.58% - Aosaikang: 3.52% - Bid Pharma: 3.39% [1]. Fund Background - The Agricultural Bank of China Healthcare Stock Fund was established on February 10, 2015, and as of June 30, 2025, it has a total scale of 1.441 billion yuan [1]. - The fund manager is Meng Yuan, who has a master's degree and has held various positions in the fund management industry, including roles at Bank of China Fund Management and Agricultural Bank of China Asset Management [1].