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长森药业B+轮融资数亿元,加速推进核心管线临床研究与全球化布局
Cai Jing Wang· 2025-10-29 04:56
Core Viewpoint - Changsen Pharmaceutical has completed a multi-hundred million RMB B+ round financing, led by Qiming Venture Partners, aimed at advancing key clinical research and global expansion [1] Company Overview - Changsen Pharmaceutical was founded in 2012 by renowned chemical drug research expert Wang Zhe, focusing on innovative drug development and commercialization in the fields of antiviral immunity, autoimmune diseases, and tumor immunotherapy [1] - The company has multiple indications entering clinical phases II and III, with core product clinical data reaching international leading levels [1] Product Highlights - The dual-functional, dual-target hepatitis B cure drug LW231 and the new generation autoimmune disease drug LW402 are expected to significantly meet clinical needs in their respective fields and may represent major breakthrough achievements [1]
天辰生物拟港股上市 中国证监会要求补充说明全额行使超额配售权后的预计募集资金量等事项
Zhi Tong Cai Jing· 2025-10-19 23:02
Core Viewpoint - The China Securities Regulatory Commission (CSRC) has requested Tianchen Biopharma to provide supplementary information regarding its overseas listing application, focusing on fundraising estimates and shareholder transparency [1][2] Group 1: Regulatory Requirements - CSRC requires Tianchen Biopharma to clarify the expected fundraising amount after the full exercise of the over-allotment option [1][2] - The company must disclose the situation regarding its shareholders, specifically OFC Bohui Fund and OFC Jiazi Fund, after upward penetration [1] - Legal opinions are required to confirm the company's compliance with foreign investment policies and necessary qualifications for its business operations [1] Group 2: Company Overview - Tianchen Biopharma is a clinical-stage biopharmaceutical company focused on the development of innovative drugs for allergic and autoimmune diseases [2] - The company has established a comprehensive pipeline of biopharmaceutical products targeting various medical fields, including otolaryngology, dermatology, respiratory, hematology, nephrology, and other autoimmune diseases [2] - The growth of the global and Chinese markets for autoimmune and allergic diseases supports Tianchen Biopharma's ongoing reliance on its expertise in innovative drug development and strong R&D capabilities [2]
轩竹生物开始招股 主要聚焦肿瘤、消化创新药
Jing Ji Guan Cha Wang· 2025-10-07 02:59
经观健康 于2023年、2024年以及截至2024年及2025年3月31日止三个月,公司的研发开支分别为人民币239.06百 万元、人民币186.40百万元、人民币38.89百万元及人民币53.04百万元。 该公司处于亏损状况。于2023年、2024年以及截至2024年及2025年6月30日止六个月,亏损净额分别为 人民币300.6百万元、人民币556.4百万元、人民币111.0百万元及人民币110.9百万元,主要归因于商业化 战略处于初期阶段及于往绩记录期间产生经营开支。 经济观察网 据港交所信息,轩竹生物-B(02575.HK)2025年10月6日至10月10日招股,该公司拟全球发售 6733.35万股,其中香港发售占10%,国际发售占90%,另有15%超额配股权,每股发售价11.6港元。每 手500股,预期股份将于2025年10月15日在联交所开始买卖。 免责声明:本文观点仅代表作者本人,供参考、交流,不构成任何建议。 轩竹生物是国内极少的同时具备小分子化药、大分子生物药开发及产业化、商业化能力的高新生物医药 科技企业,主要聚焦肿瘤、消化、NASH等领域的创新药开发,目前有超过十种药物资产在积极开发 中 ...
希玛医疗:希华医药与Gilead及韩美就encequidar订立三方全球授权及合作协议
Zhi Tong Cai Jing· 2025-09-29 11:57
Group 1 - The core announcement involves a tripartite global licensing and collaboration agreement between a subsidiary of Hema Medical, Gilead Sciences, Inc., and Hanmi Pharmaceutical for the first P-glycoprotein inhibitor, encequidar, in the field of virology [1] - Hema Medical and Hanmi will grant Gilead global exclusive rights to encequidar in the virology field, while also providing drug supply, sharing technical knowledge, and participating as key partners in the project [1] - Upon meeting certain conditions and milestones during the agreement period, Hema Medical will receive an upfront payment of $10 million, with potential future payments reaching up to approximately $72.5 million, along with a low single-digit royalty on net sales [1] Group 2 - Hema Medical is primarily engaged in the development of innovative drugs in the oncology field and is currently researching oral formulations of encequidar [2] - The company is preparing to initiate a Phase 3 global clinical study for the treatment of metastatic breast cancer using oral paclitaxel combined with encequidar, aiming to replace intravenous administration of paclitaxel in chemotherapy [2] - The clinical study is planned to commence by the end of 2025 across multiple centers in the United States, Hong Kong, and New Zealand [2]
希玛医疗(03309.HK)附属与Gilead及韩美就“P-gp”抑制剂encequidar订立三方全球授权及合作协议
Ge Long Hui· 2025-09-29 11:18
Group 1 - The core point of the news is that Hema Medical (希华医药) has entered into a global licensing and collaboration agreement with Gilead Sciences and Hanmi Pharmaceutical for the P-glycoprotein inhibitor encequidar, which Hema Medical holds exclusive global rights outside of South Korea [1] - Under the agreement, Hema Medical and Hanmi will grant Gilead exclusive global rights to encequidar in the field of virology, and they will also provide drug supply and share technical knowledge [1] - Hema Medical is set to receive an initial payment of $10 million, with potential future payments reaching up to approximately $72.5 million, along with a low single-digit royalty on net sales [1] Group 2 - Hema Medical is primarily focused on innovative drug development in the oncology field and is currently researching oral formulations of encequidar [2] - The company is preparing to initiate a Phase 3 global clinical study for the treatment of metastatic breast cancer using oral paclitaxel combined with encequidar, which aims to replace intravenous administration of paclitaxel in chemotherapy [2] - The clinical study is planned to commence by the end of 2025 across multiple centers in the United States, Hong Kong, and New Zealand [2]
希玛医疗(03309) - 自愿性公告最新业务进展
2025-09-29 11:02
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責,對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明,並 明 確 表 示,概 不 對 因 本 公 告 全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 (股份代號:3309) (於開曼群島註冊成立之有限公司) 自願性公告 最新業務進展 希 瑪 醫 療 控 股 有 限 公 司(「本公司」,連 同 其 附 屬 公 司 統 稱「本集團」)董 事 會(「董 事 會」)欣 然 宣 佈,於2025年9月29日,希 華 醫 藥 有 限 公 司(「希華醫藥」)的 一 間 附 屬公司與Gilead Sciences, Inc.(「Gilead」)及 韓 美 藥 品 工 業 株 式 会 社(「韓 美」)就 病 毒 學領域首款P-糖 蛋 白(「P-gp」)抑 制 劑encequidar(希 華 醫 藥 擁 有 該 款 藥 物 在 韓 國 以 外 的 全 球 獨 家 權 利)訂 立 三 方 全 球 授 權 及 合 作 協 議。 根 據 協 議,希 華 醫 藥 及 韓 美 會 將encequidar在病毒學領域的全球獨家權 ...
浙江海正药业股份有限公司第十届董事会第七次会议决议公告
Core Viewpoint - Zhejiang Haizheng Pharmaceutical Co., Ltd. has signed an exclusive licensing and strategic cooperation agreement with Shenzhen Aixin Dawei Pharmaceutical Technology Co., Ltd. to enhance its innovation drug development capabilities and create new value growth points [1][3]. Group 1: Licensing Agreement - The agreement grants Haizheng exclusive rights to the globally innovative small molecule prodrug AST-3424 within the specified regions, including mainland China, Hong Kong, and Macau [1]. - Haizheng is authorized to research, develop, register, produce, and commercialize the licensed product, and will be the sole applicant for market approval in the cooperation area [1][3]. - A non-competition clause prohibits Aixin Dawei and its affiliates from engaging in competitive activities in the cooperation area during the agreement's term [2]. Group 2: Financial Terms - Haizheng will pay an upfront fee and milestone payments totaling no more than 240 million RMB based on the achievement of development milestones [3]. - Upon the product's first approval for sale in the cooperation area, Haizheng will pay annual royalties based on a percentage of net sales and milestone bonuses based on annual sales performance [4]. Group 3: Strategic Cooperation on AKR1C3 Enzyme Activation Platform - The agreement includes a strategic cooperation on Aixin Dawei's AKR1C3 enzyme activation platform, with a two-year option period for Haizheng to exercise its rights [5]. - Aixin Dawei is responsible for developing specified drugs using the AKR1C3 platform and advancing them to obtain clinical trial approval in mainland China [5]. - Any intellectual property developed during the cooperation will be exclusively owned or licensed to Haizheng [5][6]. Group 4: Charitable Donation - Haizheng's subsidiary, Huizheng (Shanghai) Pharmaceutical Technology Co., Ltd., will donate 200,000 RMB to support a prostate screening charity project in Nanjing [7]. - The donation is made from the company's own funds and does not significantly impact current or future performance [7].
新股消息 | 轩竹生物港股IPO及境内未上市股份“全流通”获中国证监会备案
智通财经网· 2025-08-29 12:05
Group 1 - The China Securities Regulatory Commission has approved XuanZhu Biotechnology Co., Ltd. to issue up to 77,433,500 overseas listed ordinary shares and list them on the Hong Kong Stock Exchange [1] - A total of 17 shareholders plan to convert 93,368,496 shares of unlisted domestic shares into overseas listed shares for circulation on the Hong Kong Stock Exchange [1] Group 2 - XuanZhu Biotechnology is a Chinese biopharmaceutical company with over ten drug assets actively under development, focusing on diseases with significant unmet medical needs, including gastrointestinal diseases, tumors, and non-alcoholic fatty liver disease (NASH) [3][4] - The company has three core products: KBP-3571 (NDA approved for gastrointestinal diseases), XZP-3287 (NDA approved for targeted breast cancer), and XZP-3621 (NDA submitted for targeted non-small cell lung cancer) [3][4] - The company employs a phased development strategy for each key indication, with KBP-3571 currently expanding its indication coverage to include gastroesophageal reflux disease after completing Phase II clinical trials [4]
天辰生物医药递表港交所 自主研发针对过敏性疾病及自身免疫性疾病创新药
Zhi Tong Cai Jing· 2025-08-21 13:29
Core Viewpoint - Tianchen Biopharmaceuticals (Suzhou) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with Guotai Junan Securities (Hong Kong) as the sole sponsor [1] Company Overview - Tianchen Biopharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of innovative drugs targeting allergic and autoimmune diseases, with a comprehensive pipeline of biological products across various medical fields [3] - The company has established two proprietary research and development platforms: a high-affinity antibody discovery platform and a bifunctional antibody development platform [3] Market Potential - The global autoimmune disease drug market is projected to grow from $138.9 billion in 2024 to $176.7 billion by 2030, with a compound annual growth rate (CAGR) of 4.1% [3] - The Chinese autoimmune disease drug market is expected to increase from $5.1 billion in 2024 to $19 billion by 2030, with a CAGR of 24.5% [3] - The global allergy disease drug market is anticipated to grow from $42.8 billion in 2018 to $68.8 billion in 2024, with a CAGR of 8.2%, reaching $111.4 billion by 2030 [3] Key Products - The core product, LP-003, is a next-generation anti-IgE antibody designed to treat allergic diseases, with the fastest clinical development progress among global candidates [4] - The key product, LP-005, is a bifunctional antibody fusion protein targeting C5 and C3b complement, aimed at treating various complement-mediated diseases [4] Clinical Development - LP-003 has received IND approval in China for multiple indications, including allergic rhinitis (AR) and chronic spontaneous urticaria (CSU), with ongoing Phase III trials for seasonal AR [5] - LP-005 is currently undergoing a Phase II clinical trial for treating paroxysmal nocturnal hemoglobinuria (PNH) and plans to initiate trials for other complement-mediated kidney diseases [5] Financial Overview - Tianchen Biopharmaceuticals reported other income and revenue of approximately RMB 2.23 million, RMB 3.07 million, RMB 1.38 million, and RMB 0.88 million for the fiscal years 2023, 2024, and the first half of 2025, respectively [6] - The company incurred total losses of approximately RMB 95.78 million, RMB 137.32 million, RMB 58.93 million, and RMB 94.21 million during the same periods [6][7]
新股消息 | 天辰生物医药递表港交所 自主研发针对过敏性疾病及自身免疫性疾病创新药
智通财经网· 2025-08-21 13:27
Core Viewpoint - Tianchen Biopharmaceuticals (Suzhou) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with Guotai Junan Securities (Hong Kong) as the sole sponsor [1][3]. Company Overview - Tianchen Biopharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of innovative drugs targeting allergic and autoimmune diseases, with a comprehensive pipeline of biological products across various medical fields [3][4]. Market Potential - The global autoimmune disease drug market is projected to grow from $138.9 billion in 2024 to $176.7 billion by 2030, with a compound annual growth rate (CAGR) of 4.1%. In China, the market is expected to increase from $5.1 billion in 2024 to $19 billion by 2030, with a CAGR of 24.5% [3]. - The global allergy disease drug market is anticipated to rise from $42.8 billion in 2018 to $68.8 billion by 2024, with a CAGR of 8.2%, and is expected to reach $111.4 billion by 2030, reflecting a CAGR of 8.4% during this period [3]. Product Pipeline - The core product, LP-003, is a next-generation anti-IgE antibody designed to treat allergic diseases, including allergic rhinitis (AR) and chronic spontaneous urticaria (CSU). It is noted for being the fastest in clinical development among next-generation anti-IgE biological candidates globally [4][5]. - The key product, LP-005, is a dual-function antibody fusion protein targeting C5 and C3b complement, aimed at treating paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated kidney diseases [4][6]. Clinical Development - LP-003 has received IND approval for multiple indications in China and is currently undergoing a Phase III clinical trial for seasonal AR, with plans to submit a BLA to the National Medical Products Administration by Q3 2026. A head-to-head Phase II trial against omalizumab for CSU is also in progress [5]. - For LP-005, IND approvals have been obtained for various indications, and a Phase II clinical trial is currently evaluating its efficacy in treating PNH [6]. Financial Overview - For the fiscal years ending December 31 and the six months ending June 30, Tianchen Biopharmaceuticals reported other income and revenue of approximately RMB 2.23 million, RMB 3.07 million, RMB 1.38 million, and RMB 0.879 million, respectively. The total loss for the same periods was approximately RMB 95.78 million, RMB 137.32 million, RMB 58.93 million, and RMB 94.21 million [6][7].