据悉，替恩戈替尼是一款自主研发、注册性临床阶段的创新多靶点小分子激酶抑制剂，通过靶向肿瘤细 胞和改善肿瘤微环境发挥抗肿瘤作用。目前，替恩戈替尼已经在中美两地开展了多项针对胆管癌、前列 腺癌、乳腺癌等实体瘤的临床试验，并获得了美国FDA授予的用于治疗胆管癌的"孤儿药认证"(ODD) 及"快速通道资格认证"，中国NMPA批准纳入突破性治疗品种名单及优先审评品种名单，欧洲EMA授予 的用于治疗胆道癌的孤儿药认证(ODD)。 消息面上，据药捷安康官微消息，近日，公司宣布，核心产品替恩戈替尼在美国开展的针对胆管癌的探 索性临床2期结果在《柳叶刀，胃肠病和肝病学》(影响因子38.6)上发表。为此，德克萨斯大学MD安德 森癌症中心研究人员评论："我们正在寻找针对耐药的下一代FGFR2抑制剂。替恩戈替尼作为下一代 FGFR抑制剂，以独特机制靶向FGFR。在这项2期研究中，替恩戈替尼在胆管癌患者中展现出持久缓解 和生存期延长。这些令人瞩目的数据支持启动3期注册试验。" 药捷安康-B(02617)拉升近14%，截至发稿，涨13.85%，报166.1港元，成交额1.12亿港元。 ...

Policy Developments - Jiangxi Province has introduced 13 measures to promote the high-quality development of the pharmaceutical retail chain industry, including support for enterprise integration, simplified approval processes, and encouragement of innovative business models [1] - The new policies aim to address industry pain points, such as supporting mergers and acquisitions, and promoting health service extensions like chronic disease management [1] Medical Device Approvals - The National Medical Products Administration has approved two innovative medical devices: a proton therapy system for treating malignant tumors and a deep brain stimulation system for opioid addiction treatment [2] Clinical Trials - Haikang announced that its subsidiary received clinical trial approval for four innovative drugs targeting inflammatory bowel disease, respiratory diseases, acute pain, and muscular dystrophy [3] Capital Market Developments - Changchun High-tech signed an exclusive licensing agreement for the GenSci098 injection project, potentially earning up to $1.365 billion in milestone payments [4][5] Industry Collaborations - Sunshine Nuohuo has partnered with Peking University to establish a joint laboratory focused on innovative drug development, particularly in cell and gene therapy [7] Regulatory Actions - The Shanghai Consumer Protection Committee has addressed issues related to Antarctic krill oil products from Beijing Tongrentang, highlighting quality control failures and potential misrepresentation [10][11]

Group 1 - The first invasive brain-computer interface product for treating drug addiction has been approved in China, marking a significant milestone in the field of mental health treatment [1] - The product is designed for severe opioid addiction patients and provides a new option for treatment, filling a technological gap in physical interventions for opioid addiction [1] - The approval indicates that China's brain-computer interface products are at the forefront of global applications in treating mental illnesses, although long-term safety and commercial performance remain to be observed [1] Group 2 - Four new class 1 innovative drugs from a subsidiary of Haikang have received clinical trial approval, showcasing the breadth of the company's research and development pipeline [2] - The approval of multiple new drugs in a short period reflects the company's commitment to innovation, but the long and complex drug development cycle poses high risks and uncertainties [2] - Investors are advised to monitor the clinical progress of these new drugs closely due to the inherent uncertainties in the drug development process [2] Group 3 - Sunshine Nuohua has announced a collaboration with Peking University to establish a joint laboratory focused on innovative drug development, particularly in cell and gene therapy [3] - This partnership aims to enhance research depth and technological foresight, aligning with the industry trend of integrating production, education, and research in innovative drug development [3] - The collaboration is expected to contribute to long-term capability building, although immediate performance impacts may not be realized [3]

Group 1 - The first invasive brain-machine interface product for treating drug addiction has been approved in China, marking a significant milestone in the field of mental health treatment [1] - The product is designed for patients with severe opioid addiction and provides a new option for relapse prevention through deep brain stimulation [1] - This approval highlights China's leading position in the application of brain-machine interface technology for treating mental disorders [1] Group 2 - A subsidiary of Haikang has received clinical trial approval for four innovative chemical drugs, indicating a broad research and development pipeline [2] - The approval of multiple first-class new drugs reflects the company's commitment to innovation, although the long and complex drug development process carries inherent risks [2] - Investors are advised to monitor the clinical progress of these new drugs due to potential uncertainties [2] Group 3 - Sunshine Nuohua has announced a collaboration with Peking University to establish a joint laboratory focused on innovative drug development [3] - The partnership aims to enhance research capabilities in cutting-edge fields such as cell and gene therapy, aligning with industry trends of integrating academia and industry [3] - This collaboration is expected to contribute to long-term capacity building in drug development, although immediate financial returns may not be realized [3]

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Core Viewpoint - The company, Haikang (002653.SZ), announced that its subsidiary, Shanghai Haikang Shennuo Pharmaceutical Technology Co., Ltd., has received clinical trial approval for four innovative drugs from the National Medical Products Administration of China [2] Group 1: Drug Approvals - The approved drugs include HSK45019 tablets, HSK50042 tablets, injectable HSK55718, and HSK36357 capsules [2] - These drugs are intended for the treatment of inflammatory bowel disease, respiratory diseases, acute pain, and muscular dystrophy [2] - All drugs are classified as Class 1 chemical drugs and possess independent intellectual property rights [2] Group 2: R&D Considerations - The company has highlighted that the research and development of innovative drugs involves long cycles, multiple stages, and high risks, indicating the uncertainties involved [2]

摘要 一品红出售安硕环球资产，获得总计 15 亿美元收益，包括 9.5 亿美元 首付款和 5.5 亿美元里程碑付款，同时保留 AR882 在大中华区的全部 权益和全球供应权，预计 Sobi 对 AR882 的销售峰值预估为 30 亿美元。 AR882 海外定价预计为每年 7 万美元，国内市场定价预期在 2 至 3 万元 之间，一品红拥有原料药和制剂生产的优先供应权，预计通过直接供应 而非按股份比例分成将带来更高收益。 一品红因 ODI 政策限制未能参与安硕公司最后一轮增资，并非针对中小 股东的不公平行为，而是受客观条件所限，安硕公司资金需求紧迫，每 月支出超过 1,000 万美元。 国内 AR882 三期临床已完成入组，预计 2026 年上半年完成全部试验， 中国市场痛风石患者约 2000 万人，高尿酸血症患者 1.8 亿人，市场潜 力巨大，不亚于美国市场。 AR882 在美国主要针对痛风石患者，定位二线用药，定价约 7 万美元， 美国痛风石患者约 180 万人，美国专利到期时间为 2039 年，中国专利 到期时间为 2042 年。 Q&A 请介绍一下此次一品红与 Sobi 的交易情况及其条款细节。 此次交易 ...

过去十年，中国医药产业竞争力大幅提升，实现了从"跟跑"到"并跑"甚至"领跑"的跨越。目前，我国医 药产业规模位居全球第二。多位业内人士指出，未来5年中国制药一定会站在世界制药舞台的核心，而 这期间，不仅需要完成从"中国新"到"全球新"的创新跨越，更需要树立国产制药品牌药品高质量的行业 标准和标杆。 其中，以齐鲁制药为代表的民族药企秉持着"大医精诚、家国天下"的情怀，为助推中国医药产业高质量 发展提供了强劲动能。近日，一场聚焦国产药高质量发展的调研行与专题研讨会在山东济南举办，齐鲁 制药从科研攻坚、质量严控、国际品质、好药可及等多个视角全方位展示了民族药企的丰硕实践成果， 以期大众能够加深对民族药企的了解，以此在国产好药与大众之间构建起长期信任。 "质量源于设计"，国产高质量好药可高于原研标准 何为高质量好药？一颗药在研发、设计、生产、甚至改良的全生命周期对"质量"这个词在不同阶段有着 不同的定义。 最直观的是生产环节。先进的生产装备和技术工艺是高品质产品的保障，更是核心竞争力。目前齐鲁制 药拥有全球最优质、最先进的生产设备和检测设备，装备了世界上首台商业化生产的德国双组分气流分 装机、意大利伊玛洗烘灌联动线、 ...

Group 1 - The company is currently advancing its innovative drug development as planned [2] - The Xinlikang capsule, used for treating cancer-related fatigue, received approval for clinical trials from the drug regulatory authority in October 2025 [2]

Core Viewpoint - Shanghai Pharmaceuticals has received approval for its innovative drug, Suojirolin, aimed at treating primary hypertension, marking a significant achievement in its commitment to independent innovation in the pharmaceutical industry [1][2]. Group 1: Product Approval and Clinical Significance - The National Medical Products Administration (NMPA) has officially approved Suojirolin (brand name: Xintuoan), a first-class innovative drug for the treatment of primary hypertension [1]. - Suojirolin is a new generation of oral non-peptide small molecule renin inhibitors, designed to meet unmet clinical needs, providing a new treatment option for over 300 million patients with primary hypertension in China [1]. - Clinical trials have shown that Suojirolin demonstrates good efficacy and safety, with its Phase II trial results published in the authoritative journal "Hypertension Research," indicating growing global academic interest in Chinese innovative drugs [1]. Group 2: Research and Development Strategy - Shanghai Pharmaceuticals has positioned research and development (R&D) innovation at its strategic core, with a planned R&D investment of 2.818 billion yuan for 2024, leading the industry in investment intensity [2]. - As of the end of Q3 2025, the company has submitted 57 new drug applications for clinical trials, including 45 innovative drug pipelines, establishing a comprehensive and tiered R&D team [2]. - The company has several innovative drugs in advanced clinical stages, including a CD20 injection for neuromyelitis optica and a traditional Chinese medicine for cervical spondylosis, indicating a robust pipeline [2]. Group 3: Collaborative Innovation and Market Strategy - Shanghai Pharmaceuticals has established the Shanghai Frontier Biomedical Innovation Center to foster an open innovation ecosystem by collaborating with top universities and research institutions [3]. - The company has created a comprehensive distribution network covering over 80,000 medical institutions across 25 provinces and municipalities in China, ensuring effective market access for Suojirolin [3]. - The integration of online and offline pharmaceutical services enhances the company's ability to reach patients quickly and efficiently [3].