受理号：CXSS2400023、CXSS2400024、CXSS2400025、CXSS2400026 证书编号：2025S03097、2025S03098、2025S03099、2025S03100 本公司董事会及全体董事保证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。 近日，厦门特宝生物工程股份有限公司（以下简称"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（以下简称"增加适应症"）上市许可申请获得批准。现将有关情况公告如下： 一、药品基本情况 药品名称：派格宾? 通用名称：聚乙二醇干扰素α-2b注射液 申请事项：药品注册（境内生产） 我国2022版《慢性乙型肝炎防治指南》中指出："对于部分适合条件的患者，应追求临床治愈（又称功 能性治愈）"，即停止所有治疗药物6个月或更长时间HBsAg持续清除伴HBV DNA持续抑制。HBsAg持 续清除是一个重要的临床治疗目标，目前被认为是获得HBV功能性治愈的标志。本次派格宾获批增加 适应症是基于一 ...

Core Viewpoint - The approval of the expanded indication for Pegbiv, a drug developed by Xiamen Tebao Biological Engineering Co., Ltd., marks a significant advancement in the treatment of chronic hepatitis B, enhancing its market competitiveness and potential for clinical cure [1][5]. Drug Basic Information - Drug Name: Pegbiv - Generic Name: Pegylated Interferon α-2b Injection - Application: Drug registration (domestic production) - Approval Conclusion: The drug is approved for use in adults with chronic hepatitis B for HBsAg clearance when used in combination with nucleos(t)ide analogs [1][2]. Drug Background - Pegbiv is the company's core product and the world's first 40kD pegylated long-acting interferon α-2b injection, classified as a Category 1 new drug in China. It was first approved for chronic hepatitis C in October 2016 and for chronic hepatitis B in September 2017 [2]. Chronic Hepatitis B Context - Chronic hepatitis B is a significant public health issue in China, with an estimated 75 million infected individuals as of 2020. The prevalence of HBsAg has decreased from 9.72% in 1992 to 5.86% in 2020 [3]. The disease poses risks of liver failure, cirrhosis, and liver cancer [3]. Clinical Cure Concept - The 2022 Chronic Hepatitis B Prevention and Treatment Guidelines in China emphasize the pursuit of clinical cure, defined as sustained HBsAg clearance and HBV DNA suppression after stopping all treatment for six months or longer [4]. The approval of Pegbiv's expanded indication is based on clinical trial results demonstrating its efficacy in achieving these treatment goals [4][5]. Clinical Trial Results - In a clinical trial, 31.4% of patients achieved HBsAg clearance and sustained HBV DNA suppression 24 weeks after treatment cessation, providing strong evidence for Pegbiv's role in achieving clinical cure for chronic hepatitis B [5].

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。 特宝生物(688278.SH)发布公告，近日，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(简 称"增加适应症")上市许可申请获得批准。 ...

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。 ...

证券代码：688278 证券简称：特宝生物 公告编号：2025-038 厦门特宝生物工程股份有限公司 关于派格宾增加适应症上市许可申请获得批准的公告 本公司董事会及全体董事保证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。 近日，厦门特宝生物工程股份有限公司（以下简称"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（以下简称"增加适应 症"）上市许可申请获得批准。现将有关情况公告如下： 一、药品基本情况 药品名称：派格宾® 通用名称：聚乙二醇干扰素α-2b注射液 二、药品其他相关情况 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。 慢性乙型肝炎是我国面临的重要公共卫生问题，根据 2024 年中国肝炎防 ...

Investment Rating - The report maintains a strong confidence in the pharmaceutical sector's potential for a reversal in 2025, particularly focusing on innovative drugs and the recovery of left-side sectors as the biggest investment opportunities for the year [5][14]. Core Insights - The innovative drug sector is expected to continue its upward trend, with BD (business development) activities anticipated to catalyze market movements. The upcoming ESMO conference (October 17-21) is highlighted as a key event for clinical data disclosures from domestic innovative drug companies [2][13]. - The report emphasizes the importance of recent Nobel Prize discoveries related to peripheral immune tolerance, which are relevant to the development of new therapies in oncology and autoimmune diseases. This underscores the significance of innovation in these fields [40][50]. - The report notes that the CXO industry in China is entering a recovery phase, with improvements expected in industry orders, capacity utilization, and performance metrics due to enhanced domestic investment and financing data [2][5]. Summary by Sections Innovative Drugs - The innovative drug sector has seen a recent pullback, but the long-term upward trend remains intact. The report suggests that the market is awaiting further BD catalysts and highlights the importance of upcoming clinical data from the ESMO conference [2][13]. - The report indicates that the overall sentiment in the innovative drug sector is still positive, with a focus on potential breakthroughs in cancer and autoimmune therapies following the recent Nobel Prize discoveries [40][50]. Biologics - Novo Nordisk announced an agreement to acquire Akero for $4.7 billion, with Akero's FGF21 analog EFX showing promise as a leading therapy for metabolic dysfunction-related fatty liver disease (MASH) [3][51]. - The report suggests that EFX is the only drug in Phase 2 trials demonstrating significant fibrosis regression in F4 patients, highlighting the need for continued attention to developments in this area [51][57]. Medical Devices - The commercialization of innovative products is accelerating, with domestic replacements making significant progress. For instance, MicroPort's Tumi laparoscopic surgical robot has surpassed 100 global orders and is leading the domestic market share [4][58]. - The report notes that the Tumi robot has received market access in over 60 countries and regions, with a strong presence in high-end markets such as Europe [60][62]. Traditional Chinese Medicine - There has been a continuous increase in new drug IND and NDA applications for traditional Chinese medicine, with 92 new IND applications and 42 NDA applications reported in the first nine months of 2025 [3][64]. - The report highlights ongoing policy support for traditional Chinese medicine, which is expected to drive further innovation and development in this sector [64][65].

Group 1 - The core point of the article highlights the recent trading activities of Te Bao Biological Engineering Co., Ltd., including significant block trades and stock performance metrics [2] - On September 30, 2023, there were 2 block trades totaling 155,000 shares with a transaction value of 13.03 million yuan, at a price of 84.05 yuan per share [2] - Over the past three months, the stock has seen a total of 12 block trades with a cumulative transaction value of 85.11 million yuan [2] Group 2 - The closing price of Te Bao Biological on the same day was 84.05 yuan, reflecting a 0.32% increase, with a daily turnover rate of 0.57% and a total trading volume of 195 million yuan [2] - The net inflow of main funds for the day was 15.30 million yuan, and the stock has increased by 6.69% over the past five days, with a total net inflow of 13.13 million yuan [2] - The latest margin financing balance for the stock is 1.46 billion yuan, which has decreased by 8.99 million yuan over the past five days, representing a decline of 0.61% [2] Group 3 - Te Bao Biological was established on August 7, 1996, with a registered capital of 406.80 million yuan [2] - The block trades on September 30 involved two transactions of 77,500 shares each, both at a price of 84.05 yuan, with no premium over the closing price [2] - The buying and selling parties involved various branches of Guangfa Securities and Guotai Junan Securities [2]

责任编辑：小浪快报 9月30日，特宝生物收涨0.32%，收盘价为84.05元，发生2笔大宗交易，合计成交量15.5万股，成交金额 1302.78万元。 第2笔成交价格为84.05元，成交7.75万股，成交金额651.39万元，溢价率为0.00%，买方营业部为广发证 券股份有限公司深圳高新南一道证券营业部，卖方营业部为国泰海通证券股份有限公司总部。 炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 进一步统计，近3个月内该股累计发生12笔大宗交易，合计成交金额为8511.37万元。该股近5个交易日 累计上涨6.69%，主力资金合计净流入2396.44万元。 第1笔成交价格为84.05元，成交7.75万股，成交金额651.39万元，溢价率为0.00%，买方营业部为广发证 券股份有限公司广州康王中路证券营业部，卖方营业部为国泰海通证券股份有限公司总部。 ...

| 交易日期 | 证券調核 | 证券代码 | 成交价(元) 成交金额(万元) 成交量(*) 买入营业部 | | | 类出管业部 | 是否为专场 | | --- | --- | --- | --- | --- | --- | --- | --- | | 2025-09-30 | 特宝生物 | 688278 84.05 | 651.39 | 7.75 | 巴里是亚博 | 用意要通過發驗的 | 客 | | 2025-09-30 | 特宝生物 | 688278 84.05 | 651.39 | 7.75 | 公司员会发展 | 用意透過甚至股份 | Ka | 9月30日，特宝生物大宗交易成交15.5万股，成交额1302.78万元，占当日总成交额的6.28%，成交价 84.05元，较市场收盘价84.05元持平。 ...