Core Viewpoint - The company Teva Biopharmaceuticals (688278.SH) has received approval from the National Medical Products Administration for the marketing application of its product Pegbinterferon, which is now indicated for the sustained clearance of HBsAg in adult patients with chronic hepatitis B [1] Group 1: Product Information - Pegbinterferon is the company's core product and is the world's first 40kD polyethylene glycol long-acting interferon α-2b injection [1] - It is classified as a Category 1 new drug for biological products in China and is the first domestically marketed PEG-modified interferon in the country [1] - Pegbinterferon was approved for marketing in October 2016 for the treatment of adult chronic hepatitis C and received approval for the indication of adult chronic hepatitis B in September 2017 [1]

北京商报讯（记者 丁宁）10月12日晚间，特宝生物（688278）发布公告称，公司收到国家药品监督管 理局核准签发的《药品注册证书》，公司产品派格宾联合核苷（酸）类似物用于成人慢性乙型肝炎患者 的HBsAg持续清除的增加适应症上市许可申请获得批准。 公告显示，派格宾是公司目前的核心产品，是公司自主研发的全球首个40kD聚乙二醇长效干扰素α-2b 注射液，是治疗用生物制品国家1类新药，是我国第一个国产上市的聚乙二醇（PEG）修饰干扰素品 种。派格宾于2016年10月获批上市，获批适应症为治疗成人慢性丙型肝炎；2017年9月获批成人慢性乙 型肝炎适应症。 ...

Core Insights - The Nobel Prize has increasingly recognized individuals from the industrial sector, indicating a growing fusion between science and industry [1][4] - Emerging biotechnology companies are becoming a significant force in the life sciences revolution, with Nobel laureates often being entrepreneurs [2][4] Biotechnology Companies - Sonoma Biotherapeutics, a biotechnology startup focused on regulatory T cell therapy, has raised over $330 million from investors including Eli Lilly and Arch Venture Partners [2] - The company has entered into a partnership with Regeneron to develop therapies for ulcerative colitis and Crohn's disease, receiving a $45 million milestone payment and a $75 million upfront payment [2] Market Trends - The recognition of regulatory T cell therapy by the Nobel Prize is expected to attract more capital, accelerating the clinical application of related therapies [3] - Over 200 clinical trials for regulatory T cell drugs are currently underway globally [3] Scientific Advancements - Recent advancements in regulatory T cells have revealed their roles beyond immune regulation, including involvement in tissue repair and metabolic regulation [3] - The mRNA technology, developed by Katalin Karikó from BioNTech, has laid the groundwork for COVID-19 vaccines and is being explored for cancer vaccines and CAR-T cell therapies [4] Investment Surge - The awarding of the Nobel Prize to CRISPR technology in 2020 led to a surge in investments in gene editing companies, significantly increasing the market capitalization of leading firms like CRISPR Therapeutics and Editas Medicine [5] - CRISPR Therapeutics' collaboration with Vertex for a gene therapy to treat sickle cell disease received FDA approval in 2023, marking a historic breakthrough for the field [5] Entrepreneurial Trends - The trend of scientists becoming entrepreneurs is growing, with many Nobel laureates having founded companies prior to their awards [6][9] - In the U.S., a mature ecosystem of private funding supports scientific research, facilitating the transition from research to commercial applications [7] Challenges in Commercialization - Despite the success stories, many scientific ventures do not succeed due to the inherent differences between scientific and business thinking [10][11] - Establishing a supportive ecosystem is crucial for scientists to focus on research while professional managers handle business operations [11]

Core Insights - The integration of scientific research and industry is accelerating, with Nobel Prize winners increasingly founding companies to commercialize their research [1][3][5] - Emerging biotechnology companies are becoming a significant force in the life sciences sector, particularly in the development of regulatory T cell therapies [3][4] Biotechnology Industry - Sonoma Biotherapeutics, a biotechnology startup focused on regulatory T cell therapy, has raised over $330 million from investors including Eli Lilly and Arch Venture Partners [3] - The company has entered into a partnership with Regeneron to develop therapies for ulcerative colitis and Crohn's disease, receiving a $45 million milestone payment and a $75 million upfront payment [3][4] - The market anticipates increased investment in regulatory T cell therapies following their recognition with a Nobel Prize, with over 200 clinical trials currently underway globally [4] mRNA Technology - Katalin Karikó, a Nobel Prize winner for mRNA technology, is associated with BioNTech, which is exploring the use of mRNA for cancer vaccines and CAR-T cell therapies [5][6] - BioNTech is actively investigating the combination of cancer vaccines with PD-1 inhibitors to enhance immune response against cancer cells [6] Gene Editing - The recognition of CRISPR Cas9 gene editing technology with the Nobel Prize in Chemistry in 2020 has led to a surge in investment and the emergence of numerous gene editing companies [6] - CRISPR Therapeutics, Editas Medicine, and Intellia Therapeutics have seen significant increases in market capitalization following the Nobel Prize announcement [6] - CRISPR Therapeutics and Vertex's collaboration on gene therapy for sickle cell disease and β-thalassemia received FDA approval in 2023, marking a significant milestone for the industry [6][7] Entrepreneurial Trends - The trend of scientists becoming entrepreneurs is growing, with many Nobel laureates already having established companies prior to their awards [9][10] - The Seattle biotech scene has produced multiple Nobel laureates, indicating a thriving ecosystem for scientific innovation and entrepreneurship [9] - In China, successful biotech companies founded by scientists, such as Innovent Biologics and BeiGene, have seen substantial market growth [11] Challenges in Scientific Entrepreneurship - Despite some success stories, many scientific ventures struggle due to the inherent differences between scientific and business thinking [12] - Establishing a supportive ecosystem is crucial for scientists to transition into successful entrepreneurs, with a clear division of responsibilities between scientific research and business management [12]

格隆汇10月11日｜有投资者在互动平台向华熙生物提问：请介绍合成生物平台复用性。麦角硫因/红景 天苷等研发中，平台能否快速复制至CDMO代工业务？(如为药企生产核苷酸)；或者国际技术授权(类似 Ginkgo的ADEPT模式)？ 华熙生物回复称，华熙生物的合成生物平台在基因编辑、菌株高效构建、代谢 路径优化、工艺开发等方面的技术成熟度较高，中试成果转化中心以模块化设计与柔性化生产为核心， 可快速实现工艺放大与产业化转移。华熙生物所积累的平台技术与经验，可赋能应用于功能糖、蛋白 质、多肽、氨基酸、核苷酸、天然活性物类这六大类物质的开发，实现技术模块跨品类复用并延伸至 CDMO代工，以受托生产的业务形式帮助客户降低研发成本，缩短周期。所储备的技术成果，也可以通 过技术授权转让与合作开发的形式，构建公司授权合作生态圈。 ...

此次获批使优时比在中国同时提供泽卢克布仑钠和罗泽利昔珠单抗两款创新药物，成为全球唯一可同时 覆盖两种靶向治疗方案的生物制药公司，为全身型重症肌无力患者带来更丰富、针对不同医疗需求的疾 病管理选择。 泽卢克布仑钠是全球首个且唯一经皮下注射、可自行给药并拥有双重抑制作用的新一代C5补体抑制 剂，用于治疗抗AChR抗体阳性的全身型重症肌无力患者。作为一款具备双重抑制作用机制的创新药 物，它能够有效阻断补体介导的神经肌肉接头损伤。患者在家中仅需5–8秒即可完成皮下注射。 经济观察网10月11日，全球生物制药公司优时比(UCB)宣布，中国国家药品监督管理局(NMPA)已批准 泽卢克布仑钠(商品名：卓倍可)上市许可，与常规治疗药物联合用于治疗抗乙酰胆碱受体(AChR)抗体阳 性的成人全身型重症肌无力患者。 ...

Core Viewpoint - The recent merger announcement by Barinthus with Clywedog Therapeutics is not expected to impact the development of the shingles vaccine by the company, which is currently in the clinical I phase and showing promising results in immune response [1] Group 1: Vaccine Development - The company has conducted clinical I trials for its shingles vaccine (adenovirus vector) and the results indicate that the candidate vaccine is expected to stimulate a good cellular immune response [1] - CD4 levels are comparable to the control vaccine, while CD8 levels show significant advantages [1] - Future project strategies will be considered based on the competitive landscape, R&D planning, and resource allocation, with updates provided on any significant progress [1] Group 2: Collaboration and Strategic Considerations - The company advises that any developments regarding its partner's strategic direction should be referenced from the partner's official disclosures [1]

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：688513 证券简称：苑东生物 公告编号：2025-073 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、准确性和完整性依法承担法律责任。 一、已披露的增资暨关联交易概述 为加快公司创新转型战略的实施步伐，推动公司从仿制药向创新全面转型，公司分别于2025年9月23日 召开第四届董事会第八次会议、于2025年10月9日召开2025年第二次临时股东大会，审议通过了《关于 向参股公司增资暨关联交易的议案》，由公司全资子公司苑东生物投资管理（上海）有限公司（以下简 称"上海投资公司"）作为投资主体以货币资金的形式对上海超阳实施增资，增资价格为2.27元/注册资 本，增资总金额8,571.00万元（对应上海超阳注册资本3,771.00万元），资金来源均为自有资金。本次增 资完成后，上海超阳的注册资本将由原8,800.00万元增加至12,571.00万元，公司间接持有上海超阳的股 权比例将由30.68%增加至51.48%，上海超阳将变更为公司控股子公司，纳入公司合并报表范围。 具体内容详见公司于2025 ...

Group 1 - The company expects a net profit attributable to shareholders of the parent company for Q3 2025 to be between 130 million and 140 million yuan, representing an increase of 6.91 million to 16.91 million yuan compared to the same period last year, with a year-on-year growth of 5.62% to 13.74% [3] - The expected net profit attributable to shareholders of the parent company after deducting non-recurring gains and losses is also projected to be between 130 million and 140 million yuan, with an increase of 4.71 million to 14.71 million yuan compared to the same period last year, reflecting a year-on-year growth of 3.76% to 11.74% [3] - The performance forecast is based on preliminary calculations by the company's financial department and has not been audited by registered accountants [4] Group 2 - In the same period last year, the company's total profit was 128.28 million yuan, with a net profit attributable to shareholders of the parent company of 123.09 million yuan, and a net profit after deducting non-recurring gains and losses of 125.29 million yuan, with basic earnings per share of 0.58 yuan [5] - The company has implemented a business philosophy of "time leading, technology leading," which has contributed to the steady growth of net profit during the reporting period [6]

【深圳商报讯】（记者 刘娥）近日，深圳华诺生物科技有限公司（以下简称"华诺生物"）宣布完成 A+轮融资，由国中资本领投，深产投跟投。本轮融资将主要用于基于自主研发的自愈合超分子技术平 台的产品管线扩充及核心产品的产能升级。 华诺生物创新性地将"自愈合超分子"技术用于可注射、可塑形的流体类植入耗材产品的开发，首款Ⅲ类 器械产品"科凝Colloidose 可吸收止血流体明胶"于2024年10月获得国家药监局批准的医疗器械证。 止血流体明胶产品被广泛用于不可压迫组织创面（脑、脊柱等）和微创手术的止血应用，全球止血流体 市场以强生和百特的流体明胶产品为主流。传统止血流体明胶产品以"明胶微米造粒"技术为主流，其中 强生的多孔造粒技术是微米造粒技术路线的代表。针对此，华诺生物自主研发"自愈合超分子"技术并开 发出全新的流体明胶技术路线，在保持微创注射特性的同时提升流体明胶的力学性能。 国中资本投资团队表示，华诺生物实现了高端止血材料的供应链国产化及生产工艺全流程的自主可控， 未来有望将该技术平台延伸至更多创新性医用耗材的开发与应用。 ...