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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
10月18日,中国证监会公布《境外发行上市备案补充材料要求(2025年10月12日—2025年10月17日)》。 其中,证监会要求天辰生物补充说明全额行使超额配售权后的预计募集资金量、公司股东OFC博晖基金 及OFC交子基金向上穿透后的情况等事项。据悉,天辰生物已于2025年8月21日向港交所主板提交上市 申请,国金证券(香港)为独家保荐人。 证监会请天辰生物补充说明以下事项,请律师核查并出具明确的法律意见: 三、请说明常熟东南、山证创新投资国有股东标识办理进展。 四、关于本次发行上市及"全流通":(1)请说明全额行使超额配售权后的预计募集资金量;(2)请说明本 次拟参与"全流通"股东所持股份是否存在被质押、冻结或其他权利瑕疵的情形。 据招股书,天辰生物医药是一家致力于创新药开发的临床阶段生物制药公司,主要专注于针对过敏性及 自身免疫性疾病的生物药物的自主发现与开发。天辰生物医药已构建针对鼻科、皮肤科、呼吸科、血液 科、肾脏科及其他自身免疫性疾病的综合性生物制剂产品管线。 基于全球及中国自身免疫性疾病和过敏性疾病市场的预期增长,天辰生物医药已经并将继续依托(i)在开 发创新药方面的专业知识;(ii)两个自主研 ...
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
根据协议,希华医药及韩美会将encequidar在病毒学领域的全球独家权利授予 Gilead。此外,希华医药 及韩美亦将提供药物供应、分享技术知识,并以主要伙伴身份参与项目。待于协议期内达成若干条件及 里程碑后,希华医药将获支付1000万美元首付款,日后有权获得的潜在价款可达最高约7250万美元,并 可按低个位数比率在销售净额中抽取使用权费。 希玛医疗(03309)发布公告,于2025年9月29日,希华医药有限公司的一间附属公司与Gilead Sciences, Inc.及韩美药品工业株式会社就病毒学领域首款P-糖蛋白抑制剂encequidar(希华医药拥有该款药物在韩 国以外的全球独家权利)订立三方全球授权及合作协议。 希华医药主要从事肿瘤学领域的创新药开发项目,目前正在多个领域研究以 encequidar开发口服药配 方。希华医药正研究在肿瘤学领域以口服紫杉醇结合 encequidar治疗转移性乳癌,以取代在化疗中经静 脉注射紫杉醇,是该公司最前沿的项目。希华医药正准备就口服紫杉醇结合encequidar的转移性乳癌疗 程展开第3阶段全球临床研究,有关研究计划于2025年底在美国、香港及纽西兰的多个中心进 ...
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
格隆汇9月29日丨希玛医疗(03309.HK)宣布,于2025年9月29日,希华医药有限公司的一间附属公司与 Gilead Sciences,Inc. "Gilead"及韩美药品工业株式会社"韩美"就病毒学领域首款P-糖蛋白"P-gp"抑制剂 encequidar(希华医药拥有该款药物在韩国以外的全球独家权利)订立三方全球授权及合作协议。 根据协议,希华医药及韩美会将encequidar在病毒学领域的全球独家权利授予Gilead。此外,希华医药 及韩美亦将提供药物供应、分享技术知识,并以主要伙伴身份参与项目。待于协议期内达成若干条件及 里程碑后,希华医药将获支付1000万美元首付款,日后有权获得的潜在价款可达最高约7250万美元,并 可按低个位数比率在销售净额中抽取使用权费。 希华医药主要从事肿瘤学领域的创新药开发项目,目前正在多个领域研究以encequidar开发口服药配 方。希华医药正研究在肿瘤学领域以口服紫杉醇结合encequidar治疗转移性乳癌,以取代在化疗中经静 脉注射紫杉醇,是该公司最前沿的项目。希华医药正准备就口服紫杉醇结合encequidar的转移性乳癌疗 程展开第3阶段全球临床研究,有关研 ...
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
Shang Hai Zheng Quan Bao· 2025-09-16 20:38
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].
重药控股:内生外延齐发力 上半年净利润双位数增长
Zheng Quan Shi Bao Wang· 2025-08-20 13:39
Core Insights - The company reported a revenue of 41.188 billion yuan for the first half of 2025, representing a year-on-year growth of 3.54% [1] - The net profit attributable to shareholders was approximately 282 million yuan, with a year-on-year increase of 18.56% [1] - The basic earnings per share reached 0.16 yuan, reflecting a growth of 14.29% year-on-year [1] Business Overview - The company is a national wholesale enterprise for narcotic drugs and Class I psychotropic drugs, and it operates in the pharmaceutical and medical device sectors [1] - The main business segments include pharmaceutical commercial operations, covering drug sales, medical devices, traditional Chinese medicine, health products, and supply chain services [1] - The company has expanded its market presence, achieving coverage in all 31 provinces and 164 prefecture-level cities in China [1] Pharmaceutical Wholesale Business - The pharmaceutical wholesale segment generated revenue of 39.052 billion yuan, accounting for over 95% of total revenue, serving more than 8,000 medical institutions [2] - The company is enhancing its "pharmaceutical + internet" strategy, with the online platform "Zhongyao Cloud Business" achieving a transaction volume of approximately 1 billion yuan, a year-on-year increase of 72% [2] Retail Business - The retail segment achieved revenue of 1.947 billion yuan, with brands like "Heping Pharmacy" covering over 850 stores across 22 provinces [2] - The company has opened 616 stores offering outpatient coordination services, improving patient access to medication and health management [2] Product and Service Diversification - The company operates over 280,000 product specifications, with pharmaceutical revenue reaching 33.668 billion yuan and traditional Chinese medicine revenue at 7.210 billion yuan [2] - The company has established standardized planting bases for traditional Chinese medicine and enhanced production capabilities through modern workshops and AI technology [2] Medical Device and Specialty Drugs - The medical device segment generated revenue of 6.884 billion yuan, with 41 SPD projects implemented to improve hospital supply chain management [3] - Revenue from narcotic drugs and Class I psychotropic drugs was 1.736 billion yuan, ensuring stable supply and efficient distribution [3] Innovation and Development - The company is focusing on high-end generic drugs, specialty traditional Chinese medicine, and innovative drug development [3] - Four products, including Mirabegron sustained-release tablets, were approved during the reporting period, with three already in commercial production [3]