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润都股份:公司1类创新药盐酸去甲乌药碱注射液及其原料药的注册审评工作正在有序推进中
Zheng Quan Ri Bao· 2025-12-24 12:13
(文章来源:证券日报) 证券日报网讯 12月24日,润都股份在互动平台回答投资者提问时表示,公司1类创新药盐酸去甲乌药碱 注射液(规格:2ml:2.5mg)及其原料药的注册审评工作正在有序推进中。公司已完成药学补充研究 并于2025年4月提交资料(此次发补,无临床相关内容)。根据《国家药品监督管理局药品审评过程中 审评计时中止与恢复管理规范(试行)》(药审业〔2022〕614号)规定,药品审评存在多种审评计时 中止情形,中止期间所占时间不计入审评时限。当前该药品处于药学审评序列暂停阶段,属于审评流程 中的正常情况。后续如有重大进展,公司将严格遵循信息披露规定及时履行披露义务。 ...
太美医疗科技拟出资7000万元参设合伙企业
Zhi Tong Cai Jing· 2025-12-24 11:47
董事会相信,通过成立合伙企业公司可以深度参与创新药管线研究及开发,公司将能够将其数智化医药 研发解决方案标准化、模块化地输出给各个处于早期至成长阶段的创新药研发管线,从而有机会分享药 物研发成功的超额收益以及扩大公司的行业足迹;其次,通过合伙企业持有管线权益,参与早期临床试 验抢占行业价值链关键环节,避免传统股权投资的复杂性与长周期风险,通过转让或出售管线实现高效 退出,实现了资金的快速周转和价值兑现。 太美医疗科技(02576)公布,于2025年12月24日(交易时段后),公司(作为有限合伙人)、太美智研(作为有 限合伙人)、嘉兴产投(作为有限合伙人)、陆高峰先生(作为有限合伙人)、陆海啸女士(作为有限合伙 人)、陈国娟女士(作为有限合伙人)及凯风太美(作为普通合伙人)订立合伙企业协议,内容有关成立合伙 企业。所有合伙人向合伙企业的初始注资总额将为人民币22,727万元,其中该公司、太美智研、嘉兴产 投、陆高峰先生、陆海啸女士、陈国娟女士、及凯风太美将分别注资人民币7,000万元、人民币3,000万 元、人民币1亿元、人民币1,000万元、人民币500万元、人民币1,000万元及人民币227万元。合伙企业将 ...
太美医疗科技(02576.HK)拟成立合伙企业深度参与创新药管线研究及开发
Ge Long Hui· 2025-12-24 11:44
董事会相信,通过成立合伙企业公司可以深度参与创新药管线研究及开发,公司将能够将其数智化医药 研发解决方案标准化、模块化地输出给各个处于早期至成长阶段的创新药研发管线,从而有机会分享药 物研发成功的超额收益以及扩大公司的行业足迹;其次,通过合伙企业持有管线权益,参与早期临床试 验抢占行业价值链关键环节,避免传统股权投资的复杂性与长周期风险,通过转让或出售管线实现高效 退出,实现了资金的快速周转和价值兑现。 格隆汇12月24日丨太美医疗科技(02576.HK)公告,于2025年12月24日,公司(作为有限合伙人)、太美智 研(作为有限合伙人)、嘉兴产投(作为有限合伙人)、陆高峰(作为有限合伙人)、陆海啸(作为有限合伙 人)、陈国娟(作为有限合伙人)及凯风太美(作为普通合伙人)订立合伙企业协议,内容有关成立合伙企 业。所有合伙人向合伙企业的初始注资总额将为人民币22,727万元,其中公司、太美智研、嘉兴产投、 陆高峰、陆海啸、陈国娟、及凯风太美将分别注资人民币7,000万元、人民币3,000万元、人民币10,000 万元、人民币1,000万元、人民币500万元、人民币1,000万元及人民币227万元。 合伙企业的业 ...
国元国际:给予诺诚健华(09969)目标价16.81港元 评级“买入”
智通财经网· 2025-12-24 07:09
Core Viewpoint - Guoyuan International expects Nuo Cheng Jianhua (09969) to achieve revenues of RMB 2.01 billion, 2.06 billion, and 2.56 billion for the years 2025-2027, with net profits of RMB 117 million, 17 million, and 188 million respectively. The company holds approximately RMB 7.2 billion in cash and equivalents, sufficient for innovative research. The company is driven by scientific innovation and has strong product capabilities. A DCF model gives a target price of HKD 16.81, indicating a potential upside of 28% from the current price [1]. Group 1 - Acalabrutinib shows excellent performance in SLE IIb trials, with a SRI-4 response rate of 57.1% in the 75mg group, significantly higher than the placebo group at 34.4%. In subgroups with baseline BILAG≥1A or ≥2B, the response rate improved by 35%, and in those with BILAG≥1A or ≥2B and SLEDAI-2K score ≥4, it improved by 43%. The CDE has approved the initiation of Phase III clinical trials for Acalabrutinib in SLE, with the first patient expected to be enrolled in Q1 2026 [2]. Group 2 - The company has accelerated its product pipeline, with the new TYK2 inhibitor ICP-488 approved for Phase II clinical trials for cutaneous lupus erythematosus (CLE). ICP-488 specifically binds to the TYK2 JH2 domain, blocking the signaling of inflammatory cytokines such as IL-23, IL-12, and type I interferons. The NMPA has approved the company's Entrectinib (ICP-723) for treating adult and adolescent patients with NTRK fusion gene-positive solid tumors, showing high objective response rates (89.1%) and disease control rates (96.4%), with a 24-month PFS of 77.4% and OS of 90.8%, outperforming first-generation TRK inhibitors. Acalabrutinib's Phase III registration trial for immune thrombocytopenia (ITP) in China has completed patient enrollment, with plans to submit a new drug application in H1 2026 [3]. Group 3 - The company has made significant progress in business development, reaching an agreement with ZenasBio Pharma in October 2025. Zenas has been granted rights for Acalabrutinib for non-oncology indications outside Greater China and Southeast Asia, as well as global rights for multiple sclerosis; IL-17i rights are granted for regions outside Greater China and Southeast Asia, and global rights for CNS TYK2i. Zenas will pay a cash upfront of USD 100 million, with the total potential value of the deal exceeding USD 2 billion, which will significantly accelerate the overseas clinical development of products [4].
健康元(600380):首次覆盖报告:呼吸龙头再起航,创新+国际化开启成长新篇章
Western Securities· 2025-12-24 05:15
公司深度研究 | 健康元 呼吸龙头再起航,创新+国际化开启成长新篇章 健康元(600380.SH)首次覆盖报告 大型综合医药集团,创新+国际化开启新篇章。公司始创于 1992 年,保健品 业务起家,通过收并购不断开拓商业版图,经过 30 余年逐步发展为大型综 合医药集团。近年来,公司加快布局国际化及创新转型,一方面推动海外生 产基地建设,同时通过合作引进等方式快速丰富研发管线,聚焦呼吸常见疾 病,同时拓展镇痛、抗感染等领域布局。 制剂集采压力出清,新品放量助力主业拐点向上。近年来受艾普拉唑系列产 品、盐酸左沙丁胺醇吸入溶液等大单品降价影响,公司主业短暂承压,目前 核心产品降价压力基本出清,后续随着妥布霉素吸入溶液、玛帕西沙韦等新 品陆续放量,公司主业有望拐点向上。 加快创新管线布局,聚焦呼吸大适应症。多年深耕呼吸领域,近年来随着公 司创新转型进程加速推进,公司通过合作引进快速扩充在研管线,覆盖支气 管扩张、流感、COPD 等呼吸常见适应症。目前改良新药妥布霉素吸入溶液 以及流感新药玛帕西沙韦胶囊已获批,另外 TSLP 单抗、MABA 双靶点吸入 溶液、PREP 抑制剂等核心药物已进入 2 期临床。 丽珠集团: ...
翰思艾泰-B盘中涨近6% 创新药HX111获得国家药监局批准临床试验
Xin Lang Cai Jing· 2025-12-24 03:17
Core Viewpoint - The company Hansai Aitai-B (03378) has received approval from the National Medical Products Administration of China to conduct clinical trials for its innovative drug HX111, which is a first-in-class OX40-targeted antibody-drug conjugate (ADC) [1][4]. Group 1: Stock Performance - The stock price of Hansai Aitai-B increased by nearly 6% during trading, with a current price of 17.60 HKD, reflecting a 2.33% rise and a trading volume of 16.8885 million HKD [1][4]. Group 2: Product Development - HX111 is identified as a first-in-class OX40-targeted ADC, with preclinical studies indicating that OX40 is overexpressed in several malignant tumors compared to normal tissues, making it a suitable target for ADC [1][4]. - HX111 is the third first-in-class molecule to advance to clinical development, following the company's previous dual-specific antibody therapies HX009 and HX044 [1][4]. - The company aims to continue its efforts in clinical development to bring more innovative first-in-class drugs to market [1][4].
重磅!前中金研究所董事总经理带队,企业IPO申请火速获受理!董秘也来自中金!
Xin Lang Cai Jing· 2025-12-24 02:28
Core Viewpoint - Suzhou Xinnowei Pharmaceutical Technology Co., Ltd. has received acceptance for its IPO application on the Sci-Tech Innovation Board, with Guotai Junan Securities serving as the sponsor [1][31]. Company Overview - The company was established on May 17, 2017, with a registered capital of RMB 370.17 million [6][36]. - The actual controller of the company is Qiang Jing, who holds 47.0448% of the voting rights [32][28]. - The company focuses on innovative drug development to address significant unmet clinical needs globally, particularly in oncology and infectious diseases [7][29]. Business and Product Pipeline - The company has developed a pipeline of 10 innovative drugs targeting major diseases, including three drugs in the oncology field (XNW5004, XNW27011, XNW28012) currently in Phase III or critical clinical research stages [8][38]. - The drug XNW5004 is an EZH2 inhibitor, while XNW27011 and XNW28012 are targeted ADCs for treating various cancers [8][39]. - In the infectious disease sector, the injectable imipenem-cilastatin (XNW4107) is under review for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, with approval expected in 2026 [8][39]. Financial Data - As of June 30, 2025, the total assets of the company were RMB 1.12 billion, with a net loss of RMB 373.74 million for the first half of 2025 [17][47]. - The company has consistently reported losses, with net losses of RMB 46.26 million, RMB 42.69 million, and RMB 38.60 million for the years 2022, 2023, and 2024, respectively [30][47]. - The company has a high debt ratio, with a consolidated debt ratio of 89.05% as of June 30, 2025 [17][47]. Research and Development - The company has invested significantly in R&D, with a total of RMB 121.90 million in R&D expenditures over the last three years, representing a substantial portion of its revenue [14][44]. - R&D personnel constitute 73.67% of the total workforce, indicating a strong focus on innovation [14][44]. Future Plans and Fundraising - The company plans to raise approximately RMB 294 million through its IPO, with funds allocated primarily for new drug development and working capital [19][49]. - The company aims to enhance its R&D capabilities and expand its product offerings to meet clinical needs effectively [20][21].
翰思艾泰募资5.86亿港股上市 武汉光谷上市公司增至71家
Xin Lang Cai Jing· 2025-12-23 23:50
Group 1 - Hansi Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. successfully listed on the Hong Kong Stock Exchange on December 23, becoming the 71st listed company in the Optics Valley region [1] - The IPO involved a global offering of 18.321 million shares at an issue price of HKD 32 per share, raising a total of HKD 586 million, with a market capitalization of nearly HKD 4.4 billion [1] - Hansi Aitai focuses on developing innovative drugs for precise treatment of cancer and autoimmune diseases, with a pipeline of 10 candidate drugs, including 3 in clinical stages and 7 in preclinical stages [1] Group 2 - The founder of Hansi Aitai, Zhang Faming, is a professor and doctoral supervisor at Wuhan University School of Pharmacy, and has been an entrepreneur in the innovative drug field for 16 years [2] - The total number of listed companies in the Optics Valley region has reached 71, accounting for over 60% of the city's total and approximately one-third of the province's total [2] - In the life and health sector, there are currently 9 listed companies in the Optics Valley, with 6 companies undergoing listing review and 19 companies starting IPO counseling [2]
沙利文大中华区合伙人兼董事总经理毛化:中国创新药2026年迎升浪 加速国际化价值兑现
不过,谈及市场周期,沙利文大中华区合伙人兼董事总经理毛化在接受21世纪经济报道专访时,以"分 化与修复并存"概括当下态势。 "中国创新药行业已逐步走出底部,进入修复与分化并存的新阶段。"毛化指出,尽管当下医药市场有所 回暖,但周期是否"彻底结束"仍需理性看待。 近一年来,中国药企在国际舞台上频频亮相,国际社会对中国制药业的发展关注度持续攀升。 过去一年,中国生物科技企业的股价涨幅远超美国同类企业,这一切无不表明,全球生物医药创新长达 一个世纪的"西方主导"格局正悄然改变。 这一判断的背景是:2025年以来,创新药出海交易数据屡创新高,但资本寒冬的印记仍深,市场"冷热 不均"的特征十分显著。 一方面,融资层面寒意未消。数据显示,2025年上半年中国创新药公司完成134起融资,数量为近10年 同期最低;一级市场公开交易笔数与总金额呈逐月下降趋势。另一方面,海外授权交易热潮涌动,商业 拓展(BD)交易空前活跃,成为替代融资的"造血"生命线。 2026年的医药市场究竟会呈现怎样的态势? 拐点、重塑 2025年以来,创新药出海加快、一级市场融资回暖、海外基石投资者重返港股IPO,行业投融资活跃度 显著提升。当被问及市场 ...
三力制药:2亿元引进阿尔茨海默病新药
Cai Jing Wang· 2025-12-23 21:42
Core Viewpoint - Sanli Pharmaceutical has signed a technology transfer contract with Hainan University for the HXW2324 compound and related patent application rights, aiming to enhance its innovative drug product portfolio through collaboration with academic research [1] Group 1: Contract Details - The total transfer price for the HXW2324 compound is 200 million RMB, which includes a milestone payment of 20 million RMB and a sales commission of 180 million RMB [1] - The contract is designed to integrate the company's industrialization capabilities with university research resources to promote the transformation of innovative drug research results [1] Group 2: Product Information - The HXW2324 compound is a preclinical candidate for developing new treatments for Alzheimer's disease (AD) [1]