证券代码：688266 证券简称：泽璟制药 公告编号：2026-004 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZG005 与含铂化疗联用 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与含铂化疗联合用于晚期鼻咽癌和食管鳞癌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。 由于医药产品具有高科技、高风险、高附加值的特点，药品前期研发以及产 品从研制、临床试验、报批到投产的周期长、环节多，容易受到一些不确定性因 素的影响，存在无法获批上市销售的风险。公司将按国家有关法规的规定积极推 进上述研发项目，并及时对项目后续进展情况履行信息披露义务，敬请广大投资 者谨慎 ...

ZG005拥有双靶向阻断PD-1和TIGIT的作用，既可以通过有效阻断PD-1与其配体PD-L1的信号通路，进 而促进T细胞的活化和增殖；又可以有效阻断TIGIT与其配体PVR等的信号通路，促使PVR结合CD226产 生共刺激激活信号，进而促进T细胞和NK细胞的活化和增殖，并产生两个靶点被同时阻断后的协同增 强免疫系统杀伤肿瘤细胞的能力。 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1月22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与含铂化疗联合用于晚期鼻咽癌和食管鳞癌的临床试验获得批准。 ...

人民财讯1月22日电，泽璟制药(688266)1月22日公告，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与含铂化疗联合用于晚期鼻咽癌和食管鳞癌的临床试验获 得批准。 ...

1月22日，A股市场震荡，沪指收涨0.14%。创新药板块承压，截至15:00，科创创新药ETF汇添富(589120)收跌1.51%。从资金净流入方面来看，科创创新药 ETF汇添富近3天获得连续资金净流入，合计"吸金"2773.61万元，越跌越买趋势明显！ | 序号 | 代码 | 名称 | 申万一级行业 | 涨跌幅 | 估算权重 ▼ | | --- | --- | --- | --- | --- | --- | | 1 | 688235 | J-Z**KD | 医药生物 | -1.77% | 10.42% | | 2 | 688578 | 艾力斯 | 矢药生物 | -1.22% | 8.92% | | 3 | 688506 | 百利天恒 | 医药生物 | -3.72% | 8.34% | | র্ব | 688180 | 君实生物-U | 医药生物 | -0.43% | 6.31% | | 5 | 688331 | 荣昌生物 | 医药生物 | -4.04% | 6.13% | | 6 | 688266 | 泽揚制药-U | 医药生物 | -2.71% | 5.44% | | 7 | 688166 | 博瑞医药 ...

Group 1 - Zhongyuan Neipei plans to acquire 59% stake in Zhongyuan Jikean for 143 million yuan, making it a wholly-owned subsidiary [1] - HNA Holding reports a 2.8% year-on-year increase in passenger transport volume for December 2025, with international passenger transport volume up by 21.95% [2] - Haolai Ke expects a net profit decrease of 75.16% to 83.23% for 2025, projecting a profit of 13.5 million to 20 million yuan [3] Group 2 - Chengdu Investment Holdings reports a 71.41% year-on-year decrease in signed sales amount for Q4 2025, totaling 2.318 billion yuan [4] - Zhong Rare Metals signs a strategic cooperation agreement with Xian Dao Group to enhance market share in rare metals [5] - Bofei Electric plans to invest 23.38 million yuan in Haining Qiyuan alongside its controlling shareholder [6] Group 3 - Rongchang Bio plans to increase the maximum repurchase price to 116 yuan per share [7] - Filihua's controlling shareholders and executives plan to reduce their holdings by up to 1.05% of the company's shares [8] - Jiu Zhi Tang's general manager plans to reduce holdings by up to 2% of the company's shares [10] Group 4 - Aerospace Development's controlling shareholder reduced 12.26 million shares during stock trading fluctuations [11] - Nong Shang Environment's subsidiary faces delays in a computing infrastructure project due to funding issues [12] - Xinhua Department Store denies rumors of injecting semiconductor assets into the company [13] Group 5 - Jin Ao Bo expects a net profit increase of 40.24% to 59.58% for 2025, projecting a profit of 174 million to 198 million yuan [21] - Zhejing Pharmaceutical receives approval for clinical trials of ZGGS18 and ZG005 for advanced solid tumors [22] - Guangdong Hongtu anticipates a net profit decrease of 7.99% to 17.87% for 2025, projecting a profit of 341 million to 382 million yuan [23] Group 6 - Aijian Group expects to report a net loss for 2025 [24] - Shuangliang Energy also anticipates a net loss for 2025 [25] - Jia Mei Packaging announces early redemption of convertible bonds due to stock price conditions [26] Group 7 - Jindao Technology plans to issue convertible bonds to raise up to 306 million yuan for various projects [27] - Xinlei Co. extends the lock-up period for shares held by its controlling shareholder and actual controllers until January 19, 2027 [28] - Genesis expects a net profit decrease of 30% to 45% for 2025, projecting a profit of 131 million to 166 million yuan [29] Group 8 - Defu Technology plans to repurchase shares for employee stock ownership plans, with a budget of 75 million to 150 million yuan [30] - Huasheng Tiancheng states that AI-related revenue is currently a small portion of overall revenue [32] - Hongchuan Wisdom's shareholder plans to reduce holdings by up to 2% of the company's shares [33] Group 9 - Century Huatong's subsidiary plans to invest 50 million yuan in a financial development fund [34] - Liou shares will be suspended for trading due to significant stock price fluctuations [35] - Golden Dragon Fish plans to transfer stakes in two subsidiaries to Mars China for a total of 60 million USD [36] Group 10 - Mountain Outside Mountain's shareholder plans to reduce holdings by up to 1% of the company's shares [37] - Keheng Co. plans to sign a cooperation framework agreement with Gree Supply Chain for procurement [38] - Tian Sheng New Materials announces a change in actual controller and resumes trading [40] Group 11 - Xinghua New Materials plans to acquire at least 51% of Tian Kuan Technology for cash [41] - Rongbai Technology continues to delay responses to the Shanghai Stock Exchange's inquiries, leading to ongoing stock suspension [42] - Longxin Zhongke's shareholders plan to reduce holdings by up to 3.03% of the company's shares [43]

Group 1 - The core point of the article is that Zai Lab (stock code: 688266) has received approval from the National Medical Products Administration for clinical trials of its drugs ZGGS18 and ZG005 in combination with chemotherapy for advanced solid tumors [1] Group 2 - The approved clinical trial will focus on the use of ZGGS18 and ZG005 in treating patients with advanced solid tumors [1] - This approval marks a significant step for the company in advancing its oncology pipeline [1] - The combination therapy aims to enhance treatment efficacy for patients suffering from late-stage cancer [1]

证券代码：688266 证券简称：泽璟制药 公告编号：2026-003 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZGGS18 与注射用 ZG005 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 ZGGS18 与注射用 ZG005 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 注射用 ZGGS18 ZG005 | | --- | --- | | 剂型 | 粉针剂 粉针剂 | | 规格 | 50mg/瓶 100mg/瓶 | | 申请人 | 苏州泽璟生物制药股份有限公司、上海泽璟医 ...

Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its innovative biopharmaceuticals ZGGS18 and ZG005 in combination with chemotherapy for advanced solid tumors [1][2] Group 1: ZGGS18 - ZGGS18 is a recombinant humanized anti-VEGF/TGF-β bifunctional antibody fusion protein classified as a Class 1 therapeutic biological product, expected to be an innovative treatment for solid tumors [1] - ZGGS18 specifically binds to vascular endothelial growth factor (VEGF) and captures transforming growth factor-β (TGF-β), inhibiting tumor angiogenesis and reducing metastasis, thereby exerting multiple synergistic effects on tumor growth suppression [1] - ZGGS18 can also improve and regulate the tumor microenvironment, enhancing the efficacy of tumor immunotherapy drugs such as anti-PD-1/L1 antibodies and the dual-specific antibody ZG005 currently undergoing clinical research [1] Group 2: ZG005 - ZG005 is a recombinant humanized dual-specific antibody targeting PD-1 and TIGIT, classified as a Class 1 innovative tumor immunotherapy biological product, with potential applications in treating various solid tumors [2] - 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 [2] - ZG005 effectively blocks both PD-1 and TIGIT signaling pathways, promoting T cell activation and proliferation, and enhancing the immune system's ability to kill tumor cells through simultaneous blockade of both targets [2]

Group 1 - The company has received approval from the National Medical Products Administration for the clinical trial of ZGGS18 and ZG005 in combination with chemotherapy for advanced solid tumors [1]

Core Viewpoint - On December 31, the company announced a deep global collaboration with AbbVie regarding ZG006, with an upfront payment of $100 million and a total deal value of $1.235 billion. The initial clinical data presented at the ESMO Asia conference showed excellent clinical response rates and good durability in SCLC indications, indicating that this collaboration may accelerate ZG006's advancement in overseas oncology indications and maximize the value of the product pipeline, suggesting a promising future for the company [1][3]. Group 1: Collaboration Details - The company has entered into a global strategic collaboration and licensing option agreement with AbbVie for the development and commercialization rights of ZG006, receiving an upfront payment of $100 million, with potential milestone payments based on clinical progress and licensing options totaling up to $60 million. If AbbVie exercises the licensing option, the company could receive up to $1.075 billion in milestone payments [2][3]. Group 2: Clinical Data and Product Pipeline - ZG006 has shown promising early clinical data in small cell lung cancer (SCLC) at the ESMO Asia conference, with overall response rates (ORR) of 60.0% and 66.7% for the 10 mg Q2W and 30 mg Q2W groups, respectively. The confirmed response rates were 53.3% and 56.7%, with disease control rates (DCR) of 73.3% for both groups. The median progression-free survival (mPFS) was 7.03 months and 5.59 months, while the median duration of response (mDoR) rates at 6 months were 71.8% and 69.5% [4]. Group 3: Commercialization Progress - The company has made breakthroughs in commercialization, with the JAK inhibitor, Jika Xini, expected to be approved by the National Medical Products Administration in May 2025, becoming the first domestically approved JAK inhibitor for treating high-risk myelofibrosis. The product has shown rapid sales growth since its launch in June and has been included in the CSCO guidelines [5]. - The recombinant human thrombin injection is set to launch in 2024, with significant efficacy demonstrated in clinical trials, and is expected to become a core growth driver for revenue [5]. Group 4: Future Catalysts - The company has a clear timeline for key catalysts in 2026, including the continued rollout of insurance policies for the recombinant thrombin and Jika Xini, which are expected to drive sales growth. Additionally, further clinical data for ZG005 and ZG006 is anticipated, along with the ongoing collaboration with AbbVie to advance overseas clinical trials [8]. Group 5: Financial Projections - The company’s revenue projections for 2025-2027 are estimated at 712 million, 1.54 billion, and 2.5 billion yuan, with net profits of -127 million, -77 million, and 147 million yuan, respectively, maintaining a "buy" rating [9].