每经AI快讯，8月29日，泽璟制药(688266.SH)公告称，公司在研产品注射用ZG005与注射用ZGGS18联 用的临床试验申请获得美国食品药品监督管理局批准，用于治疗晚期实体瘤。注射用ZG005有望用于治 疗多种实体瘤，根据公开查询，是全球率先进入临床研究的同靶点药物之一，目前全球范围内尚未有同 类机制药物获批上市；注射用ZGGS18有望成为治疗实体瘤的创新型生物制品。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。 ...

Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG005, ZGGS18, and JAK inhibitor Jika Xini tablets in combination for advanced solid tumors [2][3]. Group 1: Drug Information - Injectable ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody, classified as a Class 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][4]. - Injectable ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF and TGF-β, also classified as a Class 1 therapeutic biological product, expected to be an innovative treatment for solid tumors [4][5]. - JAK inhibitor Jika Xini tablets, developed by the company, are a new Class 1 drug with independent intellectual property rights. They have received NDA approval for treating high-risk myelofibrosis and are undergoing clinical trials for other indications [5][6]. Group 2: Clinical Trial Approval Impact - The approval for the clinical trial of the combination therapy is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development and approval processes [2][7]. - The company will actively promote the research projects in accordance with national regulations and fulfill information disclosure obligations regarding subsequent project developments [7][8].

登录新浪财经APP 搜索【信披】查看更多考评等级 | | | 8月21日重要公告摘要 | | --- | --- | --- | | 类型 | 公司 | 主要内容 | | 今日聚焦 | 达梦数据 | 公司董事兼高级副总经理被立案调查 | | | 吉视传媒 | 上半年净亏损2. 32亿元 | | | 万泰生物 | 九价HPV疫苗首次获得批签发证明 | | | 飞鹿股份 | 公司控制权或将变更 股票自8月22日起停牌 | | 投资&签约 | 帝欧家居 | 拟5亿元设立全资子公司拓展生成式人工智能领域 | | | 格林美 | 与蔚蓝锂芯签署战略合作协议 打造超高比能电池材料和固态电池创新联合 | | 股权变动 | 盟科药业 | 股东JSR和Best Idea拟询价转让2294.62万股股份 占总股本3.5% | | 增减持&回购 | 中银证券 | 江西铜业拟减持公司不超3%股份 | | 经营&业绩 | 三一重工 | 上半年净利润同比增长46% 拟每10股派3.1元 | | | 亿纬锂能 | 上半年净利润同比下降24.9% | | 获批&项目中标 | 长春高新 | 子公司注射用GenSci143注册临床试验申请获得受 ...

一、停牌 飞鹿股份：筹划公司控制权变更，公司股票停牌。 三、对外投资、日常经营 1、万泰生物：公司九价人乳头瘤病毒疫苗（大肠埃希菌）首次获得批签发证明。 2、翰宇药业：醋酸阿托西班注射液获得越南药品上市许可。 3、泽璟制药：注射用ZG005、注射用ZGGS18与盐酸吉卡昔替尼片联用获得药物临床试验批准通知书。 4、长春高新：子公司注射用 GenSci143 注册临床试验申请获受理。 二、定增、并购 1、云南铜业：拟购买凉山矿业40%股份申请文件获深交所受理。 2、征和工业：拟定增募资不超过8.18亿元，用于农机部件扩产项目、园林工具锯链刀具系统项目、微 型链系统软硬件一体化研发项目、补充流动资金。 3、科大讯飞：拟定增募资不超过40亿元，用于星火教育大模型及典型产品、补充流动资金；其中，公 司股东言知科技拟认购金额不低于2.5亿元且不超过3.5亿元。 5、金博股份：收到某头部主机厂的定点通知书，该主机厂选择公司作为其定点供应商，为其开发和供 应碳陶制动盘产品。 6、格林美：与蔚蓝锂芯签署战略合作协议，打造超高比能电池材料和固态电池创新联合体。 7、安源煤业：公司证券名称拟变更为"江钨装备"。 四、业绩变动 1 ...

智通财经APP讯，泽璟制药(688266.SH)发布公告，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、注射用ZGGS18与盐酸吉卡昔替尼 片联合用于晚期实体瘤的临床试验获得批准。 公告显示，注射用ZG005是重组人源化抗PD-1/TIGIT双特异性抗体，为创新型肿瘤免疫治疗生物制品， 注册分类为1类，有望用于治疗多种实体瘤。根据公开查询，ZG005是全球率先进入临床研究的同靶点 药物之一，目前全球范围内尚未有同类机制药物获批上市。注射用ZGGS18是一种重组人源化抗 VEGF/TGF-β的双功能抗体融合蛋白，注册分类为治疗用生物制品1类，有望成为治疗实体瘤的创新型 生物制品。盐酸吉卡昔替尼（曾用名：盐酸杰克替尼）是公司自主研发的一种新型JAK和ACVR1双抑 制剂类药物，属于1类新药，公司拥有该产品的自主知识产权。 ...

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]

每经AI快讯，8月21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、注射用ZGGS18与盐酸吉卡昔替尼片联合用于晚期实体瘤的临床试 验获得批准。注射用ZG005是重组人源化抗PD-1/TIGIT双特异性抗体，为创新型肿瘤免疫治疗生物制 品，注册分类为1类，有望用于治疗多种实体瘤。根据公开查询，ZG005是全球率先进入临床研究的同 靶点药物之一，目前全球范围内尚未有同类机制药物获批上市。 ...

格隆汇8月21日丨泽璟制药(688266.SH)公布，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、注射用ZGGS18与盐酸吉卡昔替尼片联合用于晚期实体瘤的临床试验 获得批准。 注射用ZG005是重组人源化抗PD-1/TIGIT双特异性抗体，为创新型肿瘤免疫治疗生物制品，注册分类为 1类，有望用于治疗多种实体瘤。根据公开查询，ZG005是全球率先进入临床研究的同靶点药物之一， 目前全球范围内尚未有同类机制药物获批上市。 注射用ZGGS18是一种重组人源化抗VEGF/TGF-β的双功能抗体融合蛋白，注册分类为治疗用生物制品1 类，有望成为治疗实体瘤的创新型生物制品。 盐酸吉卡昔替尼（曾用名：盐酸杰克替尼）是公司自主研发的一种新型JAK和ACVR1双抑制剂类药 物，属于1类新药，公司拥有该产品的自主知识产权。 ...

泽璟制药8月21日公告，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、注射用ZGGS18与盐酸吉卡昔替尼片联合用于晚期实体瘤的临床试验获得批准。注射用ZG005 是重组人源化抗PD-1/TIGIT双特异性抗体，为创新型肿瘤免疫治疗生物制品，注册分类为1类，有望用 于治疗多种实体瘤。根据公开查询，ZG005是全球率先进入临床研究的同靶点药物之一，目前全球范围 内尚未有同类机制药物获批上市。 ...

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].