证券代码：600161 证券简称：天坛生物 公告编号：2025-048 北京天坛生物制品股份有限公司关于下属企业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、准确性和完整性承担法律责任。 近日，北京天坛生物制品股份有限公司下属国药集团昆明血液制品有限公司（以下简称"天坛昆明"）获 得国家药品监督管理局签发的《药物临床试验批准通知书》，同意天坛昆明开展"人纤维蛋白原"临床试 验。现将有关信息披露如下： 一、概况 （一）产品信息 ■ （二）产品主要市场情况 国内市场： 登录新浪财经APP 搜索【信披】查看更多考评等级 ■ *注：上述国内市场主要情况来自国家药品监督管理局官方网站（http://www.nmpa.gov.cn）。 国际市场： ■ 二、风险提示 天坛昆明"人纤维蛋白原"产品后续尚需完成开展临床试验、提交药品上市许可申请、通过国家药品监督 管理局药品审评中心审评及国家药品监督管理局审批、获得药品注册证书等审批程序，方可实现生产及 上市销售。药品的研发是一项长期工作，存在诸多内外部不确定因素，敬请广大投资者注意投资风 ...

Group 1 - The company has proposed to adjust the annual remuneration for independent directors from 180,000 RMB to 240,000 RMB, which aligns with industry standards and aims to enhance corporate governance [1][2] - The adjustment requires approval from the upcoming extraordinary general meeting of shareholders [1] Group 2 - The company plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its international presence and optimize its capital structure [3][4] - The issuance will comply with relevant laws and regulations and requires approval from regulatory bodies [4][5] - The company is currently discussing the issuance with relevant intermediaries, and specific details are yet to be finalized [4] Group 3 - The company has scheduled the extraordinary general meeting for October 17, 2025, to discuss the proposed H-share issuance and other matters [9][10] - Voting will be conducted through both on-site and online platforms [10][11] Group 4 - The company has appointed Crowe (Hong Kong) CPA Limited as the auditing firm for the H-share issuance [23][24] - The auditing firm has a strong track record and is expected to meet the company's needs for the H-share issuance [27][28] Group 5 - The board of directors has approved several resolutions regarding the H-share issuance, including the types of shares, issuance methods, and fundraising plans [31][34] - The proposed fundraising will be used for drug research and development, overseas commercialization, and working capital [62]

潜在交易额超20亿美元 诺诚健华达成重磅对外授权协议 ◎记者 张雪 奥布替尼被寄予厚望 潜在总交易金额超20亿美元 诺诚健华将获得1亿美元的首付款及近期里程碑付款，以及Zenas发行的700万股普通股。未来，诺诚健 华还有权获得潜在的研发及注册里程碑付款、商业化里程碑付款，并从授权产品的年度净销售额中收取 最高达百分之十几的特许权使用费，总交易金额或将超过20亿美元。 奥布替尼是全球首个进入Ⅲ期临床的中枢神经系统强渗透性BTK抑制剂，针对原发进展型多发性硬化症 （PPMS）的全球Ⅲ期试验已于2025年三季度启动，预计2026年一季度启动继发进展型（SPMS）试 验。此前Ⅱ期数据显示，其显著减少脑部炎症病灶，且安全性优异。 通过此次合作，Zenas将获得奥布替尼在多发性硬化领域的全球独家开发、生产和商业化权利，以及奥 布替尼在非肿瘤领域除大中华区及东南亚地区以外区域的权利。Zenas还将获得口服IL-17AA/AF抑制剂 除大中华区及东南亚地区外的独家开发、生产和商业化权利，以及透脑性口服TYK2抑制剂的全球权 利。"我们预计2026年将这两款抑制剂推向临床，并预计2027年获得口服IL-17AA/AF抑制剂的 ...

四环医药(00460.HK)旗下中国生物制药公司轩竹生物-B(02575.HK)10月6日至10月10日招股。截至周三 （8日）晚上10时多，轩竹生物获券商借出至少858亿港元孖展，较下午的350亿港元增1.5倍；以公开发 售起初集资额7811万港元计，超额认购1097.5倍。轩竹生物每手500股，一手入场费为5858.5港元，轩竹 生物预期将于10月15日挂牌买卖，中金公司为独家保荐人。 ...

Core Insights - The collaboration between Nocera Biopharma and Zenas BioPharma involves a global licensing agreement worth over $2 billion, focusing on the development of Orelabrutinib for multiple sclerosis and other autoimmune diseases [2][4]. Group 1: Agreement Details - Zenas will receive global exclusive rights for Orelabrutinib in the multiple sclerosis field and rights for non-oncology development and commercialization outside Greater China and Southeast Asia [4][5]. - Nocera Biopharma will receive an upfront payment of $100 million, milestone payments, and 7 million shares of common stock from Zenas, along with royalties of up to a percentage of annual net sales from licensed products [4][6]. Group 2: Product Potential - Orelabrutinib is the first highly permeable BTK inhibitor for the central nervous system to enter Phase III clinical trials, with trials for primary progressive multiple sclerosis (PPMS) starting in Q3 2025 and secondary progressive multiple sclerosis (SPMS) trials expected to begin in Q1 2026 [4][8]. - The drug has shown significant efficacy in reducing brain inflammation and has an excellent safety profile based on Phase II data [4][8]. Group 3: Strategic Focus - Nocera Biopharma retains global rights for Orelabrutinib in oncology and non-oncology rights in Greater China and Southeast Asia, indicating a strategic focus on dual therapeutic areas [6][8]. - The company aims to enhance its drug discovery platform to develop first-in-class and best-in-class therapies for autoimmune diseases, addressing unmet medical needs in China and globally [9].

Group 1 - The company Changjiang Life Sciences Technology (00775.HK) announced the sale of its melanoma vaccine business to TransCode Therapeutics for $125 million (approximately HKD 975 million) [1] - The transaction will be paid through the issuance of consideration shares by the buyer, with additional milestone payments of up to $95 million (approximately HKD 741 million) upon achieving certain milestones [1] - The seller will acquire approximately 9.1% of the buyer's ordinary shares after the issuance of payment shares, and up to approximately 90.7% after the conversion of preferred shares [1] Group 2 - The target company, Polynoma, is a Delaware limited liability company that focuses on the research, production, and commercialization of melanoma treatment drugs [2] - Polynoma's flagship candidate drug, seviprotimut-L, is a proprietary multi-valent melanoma cancer vaccine [2] - After the transaction, the seller will no longer hold any equity in the target company, which will cease to be a subsidiary of the seller [2] Group 3 - The merger between Polynoma and the buyer is expected to create synergies between their businesses, addressing significant unmet needs in oncology [3] - The buyer's product line includes TTX-MC138, currently in Phase I/II clinical trials, and other preclinical candidates, complementing Polynoma's advanced candidate [3] - The buyer, being a NASDAQ-listed entity, will enhance the market exposure of seviprotimut-L and improve fundraising and partnership opportunities for accelerated development [3]

Core Viewpoint - The transaction involves the sale of 100% equity interest in ABCJ, LLC, a subsidiary of Changjiang Life Sciences Technology, to TransCode Therapeutics, Inc. for a total consideration of $125 million, with additional milestone payments potentially reaching $95 million [1][2]. Group 1: Transaction Details - The seller, through its indirect wholly-owned subsidiary DEFJ, LLC, will sell 100% of the issued equity of the target company for $125 million, payable through the issuance of shares by the buyer [1]. - The buyer will also pay milestone payments up to $95 million upon achieving certain milestones [1]. - An investment agreement will see the seller purchase preferred shares from the buyer for approximately $25 million [1]. Group 2: Target Company Overview - The target company, ABCJ, LLC, owns 100% of Polynoma, which focuses on the research, production, and commercialization of treatments for melanoma [2]. - Polynoma's flagship candidate, seviprotimut-L, is a proprietary multi-valent melanoma cancer vaccine [2]. - Post-transaction, the target company will no longer be a subsidiary of the seller, and its financial performance will not be consolidated into the seller's accounts [2]. Group 3: Strategic Implications - The merger is expected to create synergies between Polynoma and the buyer's product line, which addresses metastatic cancer, a significant unmet need in oncology [2]. - The buyer's product portfolio includes TTX-MC138, currently in Phase I/II clinical trials, and other preclinical candidates [2]. - Being a Nasdaq-listed entity, the buyer will enhance market exposure for seviprotimut-L and improve fundraising capabilities [3].

Group 1 - The article highlights significant global market movements during the National Day holiday, including a government shutdown in the US, a surge in Japan's stock market, and gold prices reaching historical highs [1] - Japan's Nikkei 225 index broke the 48,000-point mark for the first time on October 6, becoming the best-performing major index globally, influenced by the election of a new president in the ruling Liberal Democratic Party [2] - The US stock market saw slight gains, with the Nasdaq up 0.57%, Dow Jones up 0.44%, and S&P 500 up 0.39%, driven by strong performance in the semiconductor sector due to a significant agreement between AMD and OpenAI [6] Group 2 - Gold prices surged, with spot gold breaking the $4,000 mark for the first time, reflecting a nearly $1,400/ounce increase this year, a rise of over 52% [8] - The People's Bank of China announced a 1.1 trillion yuan reverse repurchase operation to enhance liquidity, marking a significant policy move to support the market [10] - A new government procurement policy will provide a 20% price evaluation advantage for domestically produced products starting January 1, 2026, aimed at fostering a competitive procurement market [11] Group 3 - The electric vehicle and energy storage sectors saw increased activity, with record charging volumes and strong demand for energy storage cells, although BYD's September sales declined to 396,300 units [12] - Meta's AI glasses have sold out in retail stores, indicating strong market demand, with plans for increased sales points to meet supply [14] - Longfeng Pharmaceutical's stock surged over 230% on its debut, attracting investor attention despite a general market downturn [15] Group 4 - Private equity firms maintain an optimistic outlook for the A-share market post-holiday, focusing on technology growth as a core investment theme [16] - October's "golden stocks" list from brokers features nearly 200 stocks, with Zhaoyi Innovation receiving multiple recommendations, indicating a focus on technology and consumer recovery sectors [17]

协议主要条款 对公司影响与风险 本次协议签署将加快奥布替尼及其他管线产品全球开发和商业化进程，是国际化战略重要里程碑，预计 对未来业绩产生积极影响，不影响业务独立性，不会形成依赖。但新药研发风险高、周期长，本次交易 付款需满足条件，最终金额存在不确定性，投资者需谨慎决策。 来源：新浪财经-鹰眼工作室 market诺诚健华10月9日发布公告称，其全资子公司InnoCare Pharma Inc.与Zenas BioPharma, Inc.签署授 权许可协议，将奥布替尼及2项临床前资产有偿许可给Zenas，使其可开发、生产、商业化或以其他方式 利用该等产品。 交易详情 交易审议与双方情况 2025年10月7日，诺诚健华董事会审议通过本次交易，无需提交股东大会审议。主要许可产品：奥布替 尼是处于后期临床阶段、具潜在同类最佳优势的高中枢神经系统渗透性、选择性、不可逆口服小分子 BTK抑制剂。在多发性硬化症领域已启动相关III期临床试验；在自身免疫疾病领域，免疫性血小板减少 症三期注册临床完成患者入组，系统性红斑狼疮IIb期临床数据预计于2025年第四季度公布；在血液肿 瘤领域，自中国上市以来已取得显著临床认可及市场覆 ...

Core Viewpoint - InnoCare Pharma Inc. has entered into an exclusive licensing and subscription agreement with Zenas BioPharma, granting Zenas rights to develop, manufacture, and commercialize certain products, including the BTK inhibitor Orelabrutinib for multiple sclerosis and other preclinical assets [1][2]. Group 1: Licensing Agreement Details - The agreement allows Zenas exclusive rights to develop and commercialize Orelabrutinib for multiple sclerosis globally, while InnoCare retains rights in oncology and certain regions for non-oncology applications [1]. - Zenas will pay InnoCare up to $100 million in upfront and milestone payments, along with issuing up to 7 million shares of Zenas common stock [2]. - The total potential value of the transaction exceeds $2 billion, including tiered royalties based on annual net sales of the licensed products [2]. Group 2: Product Development and Clinical Trials - Orelabrutinib is a late-stage clinical candidate with potential best-in-class advantages, currently undergoing Phase III trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [3]. - InnoCare has completed patient enrollment for a Phase III trial for immune thrombocytopenia (ITP) and plans to submit a new drug application in mid-2026 [3]. - Zenas aims to lead in the development and commercialization of transformative therapies for autoimmune diseases, leveraging an experienced leadership team and a robust product pipeline [3].