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特宝生物自研1类新药长效生长激素益佩生纳入医保
Zheng Quan Ri Bao Wang· 2025-12-09 07:10
Group 1 - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have announced the inclusion of the new drug Yipeisheng (generic name: Yipei Growth Hormone Injection) developed by TeBao Bioengineering Co., Ltd. in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025 Edition), effective from January 1, 2026, which will enhance drug accessibility and reduce the medication burden for a wider range of patients with dwarfism [1][2] - The prevalence of dwarfism among children in China is approximately 3%, corresponding to about 7.6 million patients, but the standardized treatment rate is less than 5%, with traditional treatment options being a significant limiting factor [1] - Yipeisheng is the world's first Y-type 40kD polyethylene glycol long-acting growth hormone, primarily used for treating growth retardation due to growth hormone deficiency in children aged 3 and above, featuring a structural modification that preserves biological activity and allows for weekly administration [1] Group 2 - TeBao Bio has focused on the research and development of long-acting protein drugs, particularly excelling in polyethylene glycol modification technology, establishing itself as a leading enterprise in the domestic long-acting protein field after nearly 30 years of technological accumulation [2] - In the first three quarters of 2025, the company's R&D investment reached 312 million yuan, a year-on-year increase of 38.53%, providing strong support for continuous innovation [2] - The company aims to continue increasing R&D efforts to launch more high-quality and accessible innovative treatment solutions, contributing to the standardized diagnosis and treatment of dwarfism and benefiting more children and families, aligning with the "Healthy China 2030" strategy [2]
医保目录公布,新增50种创新药!科创创新药ETF汇添富(589120)一度涨超1%,资金小跑进场!创新药出海2.0,下一轮行情的关键
Sou Hu Cai Jing· 2025-12-09 03:20
Group 1 - The A-share market experienced fluctuations with the innovative drug sector showing a rebound before retreating, as evidenced by the performance of the Science and Technology Innovation Drug ETF Huatai (589120) which was flat after initially rising over 1% [1] - The Science and Technology Innovation Drug ETF Huatai (589120) has seen net inflows exceeding 9.39 million yuan over the past five days, with funds entering the market intermittently [1] - The component stocks of the ETF showed mixed performance, with stocks like Ailisi and Baili Tianheng rising over 1%, while others like Maiwei Biology fell over 2% [3][4] Group 2 - The 2025 National Basic Medical Insurance Drug Directory has been adjusted, adding 114 new drugs, including 50 first-class innovative drugs, which reflects ongoing support for innovation in the pharmaceutical sector [5][6] - The adjustment of the drug directory aims to encourage innovation while ensuring basic healthcare needs, with a focus on "true innovation" and "differentiated innovation" [6] - The commercial insurance directory has included 19 drugs, including CAR-T and treatments for Alzheimer's disease, indicating a significant step towards expanding commercial medical insurance in China [6] Group 3 - The innovative drug sector is expected to maintain a high level of activity, with a focus on "data validation" and "value reassessment" as key investment themes [6][7] - The industry is entering an internationalization phase, with business development (BD) becoming a regular practice, and the verification of global product value being crucial for future growth [7] - The Science and Technology Innovation Drug ETF Huatai (589120) focuses on leading innovative drug companies, providing a higher degree of exposure to the opportunities presented by the rise of innovative drugs in China [7]
特宝生物益佩生纳入医保 以差异化创新兑现临床价值
Zhong Zheng Wang· 2025-12-09 01:57
在乙肝领域,特宝生物支持的"珠峰项目"为无数患者带来了临床治愈的希望;在儿科领域,益佩生®同 样承载着这样的使命——让更多矮小症患儿不仅能"用得起"长效生长激素,更能"用得好、用得安全"。 此次益佩生®纳入医保,将显著提升药物的可及性,降低患者家庭经济负担,让高品质创新药"飞入寻 常百姓家"。而企业对高标准、无防腐剂等生产工艺的坚守,则确保了药品在可及性提升的同时,始终 保持安全可靠的品质和疗效。这种"可及性"与"高质量"的统一,正是特宝生物"以患者为中心"承诺的最 佳注脚。 展望2026年,随着新版医保目录的落地执行,益佩生®有望继派格宾®之后,成为驱动特宝生物业绩增 长的第二引擎。而对于资本市场而言,一家始终将技术创新聚焦于解决实际临床问题的公司,其长期成 长逻辑已然清晰可见。 此次进入医保,对于特宝生物而言意义深远,不仅标志着产品获得国家级市场准入资格,更在医保谈 判"保基本"的大背景下,验证了一个核心商业命题:具备显著临床优势和更高安全性的差异化创新药, 才能获得认可与支持。 益佩生®能够顺利入局,得益于其扎实的"品质硬实力",尤其是其在分子设计层面的突破性创新和安全 性升级,为产品构建了难以复制的差 ...
特宝生物益佩生®纳入医保 以差异化创新兑现临床价值
Zhong Guo Zheng Quan Bao· 2025-12-09 01:47
Core Viewpoint - The successful inclusion of Teva Biopharma's long-acting growth hormone, Yipei Growth Hormone Injection (brand name: Yipei®), into the medical insurance directory signifies a major milestone for the company, highlighting the importance of differentiated innovative drugs with significant clinical advantages and higher safety in gaining recognition and support [1][2] Group 1 - The inclusion of Yipei® in the medical insurance directory marks national market access for the product, validating the company's core business proposition [1] - Yipei®'s successful entry is attributed to its strong "quality hard power," particularly breakthroughs in molecular design and safety upgrades, creating a difficult-to-replicate competitive advantage [1] - Teva Biopharma has focused on high-barrier biotechnological advancements, translating them into clinical benefits that address user pain points [1] Group 2 - The "Zhu Feng Project" supported by Teva Biopharma has provided clinical cure hope for numerous hepatitis B patients, while Yipei® aims to ensure that more children with growth disorders can access and safely use long-acting growth hormones [2] - The inclusion of Yipei® in the medical insurance directory is expected to significantly enhance drug accessibility and reduce the financial burden on patients' families, allowing high-quality innovative drugs to reach ordinary households [2] - By adhering to high standards and preservative-free production processes, the company ensures that increased accessibility does not compromise the safety and efficacy of its products [2]
特宝生物益佩生 纳入医保 以差异化创新兑现临床价值
Zhong Zheng Wang· 2025-12-09 01:43
Core Insights - The successful negotiation for the inclusion of Teabo Bio's long-acting growth hormone, Yipei Growth Hormone Injection, into the medical insurance directory marks a significant milestone for the company, indicating national market access and validating the importance of differentiated innovative drugs with clinical advantages and higher safety [1][2] Group 1: Product Development and Innovation - Yipei Growth Hormone's entry into the insurance directory is attributed to its strong "quality hard power," particularly breakthroughs in molecular design and safety upgrades, creating a unique competitive advantage [1] - Teabo Bio has focused on high-barrier biotechnological advancements, translating them into clinical benefits that address user pain points, exemplified by its journey from Hepatitis B treatment to pediatric growth support [1] Group 2: Market Impact and Accessibility - The inclusion of Yipei Growth Hormone in the insurance directory is expected to enhance drug accessibility, reduce the economic burden on families of affected children, and ensure that high-quality innovative drugs are available to the general public [2] - The company's commitment to high standards and preservative-free production processes ensures that increased accessibility does not compromise the safety and efficacy of the drug, aligning with its patient-centered approach [2] Group 3: Future Growth Potential - Looking ahead to 2026, Yipei Growth Hormone is anticipated to become a second growth engine for Teabo Bio, following the success of its Hepatitis B treatment, indicating a clear long-term growth trajectory for the company in the capital market [2]
特宝生物的喜与忧
Sou Hu Cai Jing· 2025-12-08 11:22
Core Viewpoint - The approval of Pegbivac for the treatment of chronic hepatitis B marks a significant milestone for the company, Teva Biopharma, establishing it as a leader in the antiviral drug market and paving the way for clinical cures for hepatitis B [1] Financial Performance - Teva Biopharma's revenue grew from 280 million to 2.8 billion yuan from 2016 to 2024, with operating profit increasing from 30 million to 970 million yuan [2] - In the first three quarters of 2025, the company's revenue increased by 26.85% year-on-year, and operating profit rose by 16.11%, while net profit attributable to shareholders grew by 20.21% [2] - The company's return on equity has remained above 10% since 2019, with a debt-to-asset ratio of only 20.52% as of the first three quarters of 2025 [2] Product Portfolio and Growth Drivers - The company has three main product segments: antiviral drugs (Pegbivac), blood/tumor drugs (Peijin, Telin, Telkin), and endocrine drugs (Yipeisheng) [3] - Pegbivac, as the core product, is expected to account for 86.85% of the company's total revenue in 2024 [3] - The antiviral drug segment generated 2.447 billion yuan in revenue in 2024, a year-on-year increase of 36.72%, with a gross margin of 96.22% [6] - The blood/tumor drug segment contributed 12.87% to total revenue in 2024, with Peijin becoming a key growth driver after its listing in 2023 [8] Market Position and Competitive Landscape - Teva Biopharma is positioned in the second tier of the hepatitis treatment market, competing with companies like Kain Technology and others [9] - The company has gained market share due to the exit of imported brands and competitive pricing strategies [8] Industry Demand and Growth Potential - There are approximately 75 million HBV infected individuals in China, with only 17.33% currently receiving antiviral treatment, indicating significant growth potential [11] - The demand for tumor auxiliary drugs is also expected to grow, with the number of cancer cases projected to reach 5.81 million by 2030 [11] Challenges and Risks - The normalization of centralized procurement may pressure product prices and gross margins, with Pegbivac's price dropping by 14.28% in recent procurement rounds [13] - The company’s reliance on core products poses a risk, especially with Pegbivac's patent expiring in September 2027 [15] - The company is actively investing in new product development to mitigate dependency on a few key products [15][17] Research and Development - In 2024, the company invested 342 million yuan in R&D, representing 12.16% of its revenue, with a new growth hormone product approved for market [17] - Ongoing projects include Y-type PEG recombinant human erythropoietin, which is in clinical research, indicating a commitment to innovation despite the inherent risks of biopharmaceutical development [18]
价格降超50% 长效生长激素益佩生 纳入医保
Zhong Guo Jing Ji Wang· 2025-12-08 07:56
Core Insights - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security of China have jointly issued the new National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug List (2025), which includes the long-acting growth hormone, Yipeisheng, developed by Tebao Biologics [1] - Approximately 7 million children in China suffer from growth hormone deficiency, and the number of cases is on the rise, highlighting the critical need for effective treatment options [1] - The inclusion of Yipeisheng in the new drug list is expected to alleviate the challenges faced in the pediatric growth hormone treatment sector, such as adherence issues with daily injections of short-acting formulations and the high cost and limited options of long-acting drugs [1] - The new drug list will take effect on January 1, 2026 [1] Pricing and Accessibility - Following its inclusion in the new drug list, the price of Yipeisheng will decrease by over 50%, significantly reducing the financial burden on patients and improving treatment accessibility [2]
助力儿童健康生长 特宝生物益佩生纳入医保
Zheng Quan Shi Bao Wang· 2025-12-08 07:33
Core Insights - The 2025 Innovation Drug High-Quality Development Conference will be held on December 7 in Guangzhou, where the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Directory will be released, including the long-acting growth hormone Yipeisheng developed by TEBIO [1] Group 1: Product Development and Market Impact - Yipeisheng is the first globally approved Y-type 40kD polyethylene glycol long-acting growth hormone, reducing the injection frequency from daily to weekly, significantly alleviating the psychological burden on children [2] - The product is preservative-free and features a "single-use" design, greatly reducing the risk of microbial contamination and cross-infection [2] - The accompanying smart electronic injection pen "Yushida" addresses children's fear of injections with an innovative needle-hidden design, allowing for self-administration by older children and enhancing treatment adherence [2] Group 2: Social Responsibility and Public Health - TEBIO is actively engaged in social responsibility through donations to the "Little Bamboo Shoot" children's health care project, focusing on early screening, diagnosis, and standardized treatment of growth disorders [3] - The inclusion of Yipeisheng in the national medical insurance directory is expected to significantly improve accessibility to this innovative drug, reducing the economic burden on families and promoting sustainable treatment options for children's growth disorders [3]
特宝生物(688278) - 特宝生物:独立董事专门会议工作制度
2025-12-02 11:47
厦门特宝生物工程股份有限公司 独立董事专门会议工作制度 厦门特宝生物工程股份有限公司 独立董事专门会议工作制度 第一章 总则 第一条 为进一步完善厦门特宝生物工程股份有限公司(以下简称"公司") 治理结构,促进公司规范运作,维护公司整体利益,根据《上市公司独立董事管理 办法》《上海证券交易所科创板股票上市规则》《上海证券交易所科创板上市公司 自律监管指引第1号——规范运作》等国家有关法律、法规、规范性文件以及《厦 门特宝生物工程股份有限公司章程》(以下简称"公司章程")的规定,制定本制 度。 第二条 独立董事专门会议是指全部由公司独立董事参加的会议。 第三条 独立董事对公司及全体股东负有忠实义务与勤勉义务。独立董事应当 按照有关法律法规、《公司章程》和本制度的要求,认真履行职责,在董事会中发 挥参与决策、监督制衡、专业咨询作用,维护公司整体利益,保护中小股东合法权 益。 第二章 职责权限 第四条 独立董事行使下列特别职权: 独立董事行使前款第(一)项至第(三)项所列职权的,应当经全体独立董事 过半数同意。独立董事行使第(一)款所列职权的,公司应当及时披露。上述职权 不能正常行使的,公司应当披露具体情况和理由。 ...
特宝生物(688278) - 特宝生物:股东会议事规则(2025年12月)
2025-12-02 11:47
股东会议事规则 第一章 总 则 第一条 为规范厦门特宝生物工程股份有限公司(以下简称"公司"或"本 公司")行为,保证股东会依法行使职权,根据《中华人民共和国公司法》(以 下简称"《公司法》")、《中华人民共和国证券法》(以下简称"《证券法》")、 《上市公司股东会规则》(以下简称"《股东会规则》")、《上海证券交易所 科创板股票上市规则》(以下简称"《科创板股票上市规则》")及《厦门特宝 生物工程股份有限公司章程》(以下简称"《公司章程》")及其他有关法律、 法规和规范性文件的规定,特制订本规则。 第二条 公司应当严格按照法律、法规、规范性文件、《公司章程》及本 规则的相关规定召开股东会,保证股东能够依法行使权利。 公司董事会应当切实履行职责,认真、按时组织股东会。 公司全体董事应当勤勉尽责,确保股东会正常召开和依法行使职权。 厦门特宝生物工程股份有限公司 股东会议 事规则 厦门特宝生物工程股份有限公司 第三条 股东会应当在《公司法》和《公司章程》规定的范围内行使职权。 第四条 股东会分为年度股东会和临时股东会。年度股东会每年召开一次, 应当于上一会计年度结束后的 6 个月内举行。临时股东会不定期召开,出现 ...