Zelgen(688266)
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11月17日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-17 10:20
Group 1 - Yongtai Technology's wholly-owned subsidiary has received approval for trial production of a lithium battery additive project with an annual capacity of 5,000 tons, set to begin trial production [1] - Mengke Pharmaceutical has decided to terminate its plan to issue shares to a specific entity due to ongoing disagreements among major shareholders, which could impact the company's stable operations [1] - Anhui Construction's subsidiary has been approved to register and issue debt financing tools totaling 15 billion yuan, including 5 billion yuan in short-term financing notes and 10 billion yuan in medium-term notes [2] Group 2 - Koli'er plans to repurchase shares worth between 10 million and 20 million yuan, with a maximum repurchase price of 20.94 yuan per share, to implement an employee stock ownership plan [2] - Xinhua Pharmaceutical has received approval for the production of fumaric acid volnoral raw materials, which are used to treat gastroesophageal reflux disease [3] - Lianhuan Pharmaceutical has received approval for additional specifications of tadalafil tablets, expanding its product offerings for treating erectile dysfunction and benign prostatic hyperplasia [5] Group 3 - Greenland Holdings reported an increase of 1,834 lawsuits with a total amount of 6.587 billion yuan from October 21 to November 13, 2025 [7] - Lianke Technology plans to invest up to 600 million yuan of idle funds in low-risk financial products [8] - Yinglian Co. signed a strategic procurement contract for 5,000 million square meters of composite aluminum foil with a leading new energy technology company [10] Group 4 - China Eastern Airlines reported a 10.58% year-on-year increase in passenger turnover for October, with a capacity increase of 6.84% [12] - China National Airlines reported an 8.7% year-on-year increase in passenger turnover for October, with domestic and international capacity also showing growth [15] - Oupai Home plans to use 320 million yuan of idle funds to purchase structured deposits with expected annual yields between 0.65% and 2.50% [16] Group 5 - Tianwei Food has submitted H-share issuance application materials to the Hong Kong Stock Exchange, which have been accepted by the China Securities Regulatory Commission [18] - Guizhou Aviation plans to establish a subsidiary focused on the research, production, and market expansion of intelligent automotive components, with initial operating funds of 40 million yuan [20] - Daimai Co. plans to invest 100 million yuan to establish a wholly-owned subsidiary in Shanghai focused on robotics technology [22] Group 6 - Founder Securities has received approval to issue company bonds totaling up to 30 billion yuan [24] - Hengrui Medicine has received clinical trial approvals for multiple drugs, indicating ongoing research and development efforts [26] - Zhaojing Pharmaceutical's product ZG006 has received orphan drug designation from the FDA, providing various benefits for its development in the U.S. market [39]
泽璟制药筹划港股上市
Zhong Guo Zheng Quan Bao· 2025-11-17 08:20
Core Viewpoint - The company is planning to issue H-shares and list on the Hong Kong Stock Exchange to enhance its international brand recognition and competitiveness [2] Group 1: Financial Adjustments and Investments - The company announced adjustments to investment amounts for certain sub-projects under the "New Drug Research and Development Project" from its 2021 A-share issuance, including a reduction of 92 million yuan for the III phase clinical trial of "Jackatinib Tablets" for moderate to severe atopic dermatitis and a reduction of 123 million yuan for the III phase clinical trial for ankylosing spondylitis [3] - New projects include a planned investment of 165 million yuan for a III phase clinical study on the efficacy and safety of "ZG006" in patients with recurrent small cell lung cancer, along with an additional 50 million yuan for working capital [3] Group 2: Business Operations and Financial Performance - The company primarily focuses on the research, production, and sales of chemical and biological new drugs, with ongoing development of multiple anti-tumor multi-target antibody drugs and small molecule targeted drugs [3] - The company reported a revenue of approximately 593 million yuan for the first three quarters, representing a year-on-year increase of 54.49%, but also recorded a net loss of approximately 93.42 million yuan [4] - The company relies heavily on external financing for its working capital, which poses risks to its product development and commercialization progress if operational expenses exceed available financing [4] Group 3: Market Performance - On November 17, the company's stock closed at 100.9 yuan per share, reflecting a decline of 4.72% [5]
泽璟制药股价跌5.08%,中金基金旗下1只基金重仓,持有2.95万股浮亏损失15.86万元
Xin Lang Cai Jing· 2025-11-17 06:56
11月17日,泽璟制药跌5.08%,截至发稿,报100.52元/股,成交2.64亿元,换手率0.97%,总市值266.08 亿元。 风险提示:市场有风险,投资需谨慎。本文为AI大模型自动发布,任何在本文出现的信息(包括但不 限于个股、评论、预测、图表、指标、理论、任何形式的表述等)均只作为参考,不构成个人投资建 议。 责任编辑:小浪快报 中金新医药A(006981)成立日期2019年5月14日,最新规模8375.56万。今年以来收益27.08%,同类排 名1961/4217;近一年收益21.06%,同类排名2033/3957;成立以来收益66.73%。 中金新医药A(006981)基金经理为丁天宇。 截至发稿,丁天宇累计任职时间4年324天,现任基金资产总规模2.31亿元,任职期间最佳基金回报 12.67%, 任职期间最差基金回报-19.7%。 资料显示,苏州泽璟生物制药股份有限公司位于江苏省昆山市玉山镇晨丰路262号,成立日期2009年3月 18日,上市日期2020年1月23日,公司主营业务涉及化学新药及生物新药的研发、生产及销售。主营业 务收入构成为:药品99.97%,医药中间体及原辅料0.02%,资产租 ...
泽璟制药股价跌5.08%,东方阿尔法基金旗下1只基金重仓,持有5.98万股浮亏损失32.19万元
Xin Lang Cai Jing· 2025-11-17 06:56
11月17日,泽璟制药跌5.08%,截至发稿,报100.52元/股,成交2.65亿元,换手率0.97%,总市值266.08 亿元。 资料显示,苏州泽璟生物制药股份有限公司位于江苏省昆山市玉山镇晨丰路262号,成立日期2009年3月 18日,上市日期2020年1月23日,公司主营业务涉及化学新药及生物新药的研发、生产及销售。主营业 务收入构成为:药品99.97%,医药中间体及原辅料0.02%,资产租赁0.00%。 从基金十大重仓股角度 东方阿尔法医疗健康混合发起A(014841)基金经理为孟昱。 截至发稿,孟昱累计任职时间1年355天,现任基金资产总规模3.06亿元,任职期间最佳基金回报 26.56%, 任职期间最差基金回报3.69%。 风险提示:市场有风险,投资需谨慎。本文为AI大模型自动发布,任何在本文出现的信息(包括但不 限于个股、评论、预测、图表、指标、理论、任何形式的表述等)均只作为参考,不构成个人投资建 议。 责任编辑:小浪快报 数据显示,东方阿尔法基金旗下1只基金重仓泽璟制药。东方阿尔法医疗健康混合发起A(014841)三 季度减持3.96万股,持有股数5.98万股,占基金净值比例为4.02%,位 ...
泽璟制药,宣布赴香港IPO,冲刺A+H | A股公司香港上市
Xin Lang Cai Jing· 2025-11-17 06:00
Group 1 - Zejing Pharmaceutical (688266.SH) plans to issue overseas listed shares (H-shares) and apply for listing on the Hong Kong Stock Exchange to enhance its international brand recognition and competitiveness [1][2] - The company is currently in discussions with relevant intermediaries regarding the issuance and listing, with specific details yet to be finalized [1] - As of November 17, 2025, Zejing Pharmaceutical's total market capitalization is approximately 27.133 billion RMB [2] Group 2 - Established in 2009, Zejing Pharmaceutical has five subsidiaries and focuses on the independent research, production, and commercialization of innovative drugs [2] - The company aims to become a leader in the development and production of new drugs for oncology, bleeding and blood diseases, and immune-inflammatory diseases [2] - Zejing Pharmaceutical has developed two core technology platforms for small molecule drug research and complex recombinant protein new drugs, covering various cancers and treatment areas [2]
苏州泽璟生物制药股份有限公司关于自愿披露注射用ZG006用于治疗神经内分泌癌获得FDA孤儿药资格认定的公告
Shang Hai Zheng Quan Bao· 2025-11-16 18:17
Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. announced that its injectable ZG006 has received Orphan-drug Designation from the FDA for the treatment of neuroendocrine cancer, which may provide certain policy support for its subsequent development and commercialization in the U.S. [2][5] Group 1: Drug Information - ZG006 (INN name: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody platform, and it has received clinical trial approval from both the FDA and China's NMPA [3]. - ZG006 is the first-in-class molecule targeting DLL3, with potential to become a best-in-class drug, as it connects tumor cells and T cells to enhance tumor cell killing [3]. Group 2: Regulatory and Development Implications - The Orphan-drug Designation allows ZG006 to benefit from various policy supports, including tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity [5]. - The company must still engage with the FDA regarding subsequent clinical trials and registration plans, with the success of these efforts remaining uncertain [2][6]. Group 3: Clinical Research Updates - The company presented clinical research data for ZG006 and ZG005 at the 2025 European Society for Medical Oncology (ESMO) annual meeting, indicating ongoing progress in its clinical development [4].
泽璟制药:注射用ZG006获FDA孤儿药资格认定
Zheng Quan Ri Bao Zhi Sheng· 2025-11-16 12:11
Core Viewpoint - Zai Jian Pharmaceutical announced that its investigational product ZG006 has received orphan drug designation from the FDA for the treatment of neuroendocrine cancer, marking it as the first trispecific antibody targeting the DLL3 antigen with potential to be a best-in-class molecule [1] Group 1: Product Development - ZG006 is the first trispecific antibody targeting the DLL3 antigen globally [1] - The orphan drug designation will provide ZG006 with policy support for further research, registration, and commercialization in the U.S. [1] Group 2: Benefits of Orphan Drug Designation - The designation includes benefits such as tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity [1]
泽璟制药注射用ZG006获得FDA孤儿药资格认定
Bei Jing Shang Bao· 2025-11-16 08:51
Core Viewpoint - ZaiJing Pharmaceutical (688266) has received orphan drug designation from the FDA for its investigational product ZG006, intended for the treatment of neuroendocrine cancer, which will facilitate its subsequent research, registration, and commercialization in the U.S. [1] Group 1 - The orphan drug designation provides ZaiJing Pharmaceutical with various policy supports, including tax credits for clinical trial costs [1] - The company will be exempt from new drug application fees as a result of this designation [1] - ZG006 will enjoy seven years of market exclusivity, independent of patent considerations [1]
泽璟制药(688266) - 泽璟制药关于自愿披露注射用ZG006用于治疗神经内分泌癌获得FDA孤儿药资格认定的公告
2025-11-16 08:00
证券代码:688266 证券简称:泽璟制药 公告编号:2025-052 苏州泽璟生物制药股份有限公司 关于自愿披露注射用 ZG006 用于治疗神经内分泌癌 获得 FDA 孤儿药资格认定的公告 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 ZG006 获得美国食品药品监督管理局(以下简称"FDA")颁发孤儿药资格认定 (Orphan-drug Designation),用于治疗神经内分泌癌。 本次获得孤儿药资格认定后,公司仍需就注射用ZG006用于治疗神经内分泌 癌的后续临床试验、注册申报方案等与FDA进行沟通与协商,最终能否成功完成 临床试验、获得FDA上市许可及上市时间均具有不确定性。本次获得孤儿药资格 认定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。 现将具体情况公告如下: 一、药品基本情况 | 药品名称 | 注射用 ...
泽璟制药(688266.SH):注射用ZG006用于治疗神经内分泌癌获FDA孤儿药资格认定
智通财经网· 2025-11-16 07:55
Core Viewpoint - Zai Jian Pharmaceutical (688266.SH) announced that its investigational product ZG006 injection has received orphan drug designation from the FDA for the treatment of neuroendocrine cancer [1] Group 1: Regulatory Approval - The orphan drug designation allows for potential benefits such as tax credits and market exclusivity, which could enhance the product's commercial viability [1] - The company will need to continue discussions and negotiations with the FDA regarding subsequent clinical trials and registration application plans for ZG006 [1] Group 2: Uncertainties - There remains uncertainty regarding the successful completion of clinical trials, obtaining FDA marketing approval, and the timeline for market entry [1]