Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its innovative cancer immunotherapy products, ZG005 and ZGGS18, in combination with JAK and ACVR1 dual inhibitor, JAK inhibitor [1] Group 1 - ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody classified as a Class 1 innovative tumor immunotherapy biological product, expected to treat various solid tumors [1] - ZG005 is one of the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [1] - ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF/TGF-β, classified as a Class 1 therapeutic biological product, anticipated to be an innovative treatment for solid tumors [1] Group 2 - JAK inhibitor, also known as JAK and ACVR1 dual inhibitor, is a new Class 1 drug independently developed by the company, which holds the intellectual property rights for this product [1]

Core Viewpoint - Zai Jing Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of ZG005 and ZGGS18 in combination with Jikaxitinib for advanced solid tumors [2] Group 1: Company Developments - Zai Jing Pharmaceutical announced the approval of clinical trials for ZG005 and ZGGS18, indicating progress in its oncology pipeline [2] - The company's revenue composition for the year 2024 is projected to be 99.73% from pharmaceutical manufacturing and 0.27% from other businesses, highlighting its focus on the pharmaceutical sector [2]

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： 证券代码：688266 证券简称：泽璟制药 公告编号：2025-031 | 药品名称 | 注射用 ZG005 注射用 盐酸吉卡昔替尼片 | | ZGGS18 | | --- | --- | --- | --- | | 剂型 | 粉针剂 粉针剂 片剂 | | | | 规格 | 100mg/瓶 50mg/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 | | | | 申请事项 | 境内生产药品注册临床试验 | | | | 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， 符合药品注册的有关 | | | | | 年 日受理的注射用 2025 06 10 | 月 | ZG005 | | | 要求，同意注射用 联合注射用 和盐酸吉卡昔 ZG005 ZGGS18 | | | | | 替尼片在晚期实体瘤患者中开展临床试验。 | | | ...

Core Viewpoint - ZaiJing Pharmaceutical (688266.SH) has received approval from the National Medical Products Administration for clinical trials of its innovative cancer immunotherapy products, ZG005 and ZGGS18, in combination with a specific drug for advanced solid tumors [1] Company Summary - ZG005 is a recombinant humanized bispecific antibody targeting PD-1/TIGIT, classified as a Class 1 innovative biopharmaceutical, with potential applications in treating various solid tumors [1] - ZG005 is one of the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [1]

Group 1 - The company Zai Lab (688266.SH) has received approval from the National Medical Products Administration for clinical trials of ZG005 and ZGGS18 in combination with JAK inhibitor for advanced solid tumors [1] - ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody, classified as a Class 1 innovative tumor immunotherapy product, and is among the first in the world to enter clinical research for this target [1] - ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF/TGF-β, also classified as a Class 1 therapeutic biological product, with potential as an innovative treatment for solid tumors [1] Group 2 - The JAK inhibitor, previously known as JAK inhibitor, is a novel dual inhibitor of JAK and ACVR1 developed by the company, classified as a Class 1 new drug, with the company holding independent intellectual property rights for this product [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its innovative cancer immunotherapy products, ZG005 and ZGGS18, in combination with a specific drug for advanced solid tumors [1] Group 1: Product Information - ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody classified as a Class 1 innovative tumor immunotherapy biological product [1] - ZG005 is among the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [1] Group 2: Clinical Trial Approval - The clinical trial approval includes the use of ZG005 and ZGGS18 in conjunction with hydrochloride gicaxetine tablets for advanced solid tumors [1]

Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG005 combined with JAK inhibitor and chemotherapy for advanced solid tumors [2][5]. Group 1: Drug Information - Injectable ZG005 is a recombinant humanized dual-specificity antibody targeting PD-1 and TIGIT, classified as a Category 1 innovative tumor immunotherapy product, with potential applications for various solid tumors. It is one of the first drugs globally to enter clinical research targeting the same mechanism [3]. - ZG005 works by blocking both PD-1 and TIGIT pathways, enhancing T-cell activation and proliferation, thereby improving the immune system's ability to kill tumor cells [3]. - Hydrochloride JAK inhibitor (previously known as JAK inhibitor) is a new dual inhibitor developed by the company, classified as a Category 1 new drug, with independent intellectual property rights. It is the first domestic JAK inhibitor approved for treating myelofibrosis [4]. Group 2: Clinical Trial and Market Impact - The approval for the clinical trial of injectable ZG005 and JAK inhibitor combined with chemotherapy 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]. - The JAK inhibitor is also undergoing multiple key clinical studies for other immune-inflammatory diseases, including atopic dermatitis and ankylosing spondylitis, and has received support from national major new drug creation projects [4].

Group 1 - The core point of the article highlights the performance and holdings of the ICBC Frontier Medical Stock A fund, which has a recent net value of 3.4760 yuan and a decline of 0.52% [1] - The fund's one-month return is 1.67%, ranking 964 out of 1023 in its category; the six-month return is 30.63%, ranking 115 out of 984; and the year-to-date return is 32.12%, ranking 222 out of 974 [1] - The top ten holdings of the fund account for a total of 59.44%, with significant positions in companies such as Heng Rui Pharmaceutical (9.51%), Kelun Pharmaceutical (9.16%), and others [1] Group 2 - The ICBC Frontier Medical Stock A fund was established on February 3, 2016, and as of June 30, 2025, it has a total scale of 9.33 billion yuan [1] - The fund manager, Zhao Bei, has extensive experience in the healthcare sector, having held various positions since joining ICBC Credit Suisse in 2010 [2]

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 | ...