Core Viewpoint - The article discusses the divestment of a 17.87% stake in Tianmai Biotechnology by China Resources Pharmaceutical, marking a significant shift in strategy after a decade of investment in oral insulin, which has faced multiple setbacks and challenges in commercialization [5][9]. Group 1: Company Background and Investment History - China Resources Pharmaceutical began its investment in Tianmai Biotechnology in 2016, focusing on the development and commercialization of insulin and its analogs, particularly oral insulin [5]. - The initial optimism surrounding oral insulin was based on its potential to improve patient compliance by replacing injections with oral administration, thus expanding the user base [5][6]. Group 2: Challenges Faced - The development of oral insulin has proven to be extremely challenging due to the instability of insulin in the gastrointestinal tract and the difficulty in achieving stable bioavailability [6]. - Tianmai faced delays in obtaining necessary approvals for injectable insulin, and the introduction of centralized procurement in China significantly altered the market dynamics, leading to price reductions and increased competition from larger players [6][7]. Group 3: Recent Developments and Strategic Shift - In 2023, Oramed's failure to meet primary and secondary endpoints in Phase III trials for ORM-0801 posed a significant setback for the oral insulin narrative, leading to diminished investor confidence and uncertainty regarding future funding [9]. - Following these developments, China Resources Pharmaceutical opted to divest its stake in Tianmai, indicating a strategic pivot towards more certain and commercially viable products, such as a partnership with Borui Pharmaceutical for BGM0504 [10]. Group 4: Market Context and Future Outlook - The divestment reflects a broader trend in the pharmaceutical industry where large companies are increasingly focused on maximizing returns on capital and minimizing exposure to high-risk projects [11]. - Despite the withdrawal from oral insulin, the article suggests that there may still be potential for value in Tianmai, as the company explores new avenues such as GLP-1 analogs, although the competitive landscape has become significantly more challenging [10][11].

来源：市场资讯 （来源：动脉新医药） 也许正是看到天麦生物聚焦的巨大的糖尿病市场，以及其口服胰岛素可能带来的巨大突破，2016年，华 润医药与天麦生物签署战略合作协议并完成投资，但公开资料中未明确披露此次投资的具体金额。根据 后续公开信息，华润医药通过此次投资成为天麦生物重要股东，持股比例一度达20%。 但2017年底，华润医药将所持天麦生物14.12%股权以约11.47亿港元的公允价值出售。这一操作是基于 当时华润医药与天麦生物主要股东签订的股份认购协议中的相关条款，因天麦生物在2017年12月31日仍 未取得GMP证书，触发了股权出售条件。后续该股权通过产权交易所进行了公开转让程序。不过在 2020年，华润医药曾发文显示，还持有天麦生物23.75%股份，推测是其2017年出售股份后又增持了。 2月9日，华润医药公告，其全资附属公司华润医药投资已启动潜在出售华润医药投资及其附属公司所持 有天麦生物的约17.87%股权，其将通过上海联合产权交易所进行公开挂牌，挂牌底价约为人民币14.2亿 元。 天眼查数据显示，天麦生物股权结构较为多元，共涉及21家股东。其中，华润医药投资直接持有天麦生 物20%股权，实缴出资 ...

Core Viewpoint - The withdrawal of ORMD-0801 by Tianhui Biotech highlights the long-term uncertainty surrounding the oral insulin market, which is considered a high-difficulty area in the pharmaceutical industry [6][12]. Group 1: Product Development and Market Potential - ORMD-0801 aims to address a long-standing challenge in medicine by enabling oral administration of insulin, which offers advantages in patient compliance and long-term treatment experience compared to injectable forms [7]. - The global diabetes patient population is large, making the insulin market attractive, especially for type 2 diabetes patients who often rely on exogenous insulin due to the depletion of their own pancreatic beta-cell function [7][8]. Group 2: Technological and Strategic Background - ORMD-0801 is not a homegrown product but was introduced to Tianhui Biotech from the Israeli company Oramed in 2015, which specializes in oral delivery technology for proteins [9]. - Oramed's POD™ technology aims to protect insulin from gastric acid and facilitate its absorption in the intestines, a challenge that many pharmaceutical companies have faced [9]. Group 3: Clinical Trials and Regulatory Challenges - ORMD-0801 completed its Phase III clinical trial in China in 2022 and was submitted for approval in April 2023, but faced controversy due to the failure of a similar trial in the U.S. [10]. - Despite the U.S. trial's failure, Tianhui Biotech maintained that the differences in clinical trial designs would not affect expectations in China, although this raised regulatory scrutiny [10]. Group 4: Financial and Operational Issues - In August 2023, Oramed and Tianhui Biotech announced plans to establish a joint venture, OraTech, to focus on global registration of the oral insulin pipeline, with both parties investing significant amounts [11]. - However, the joint venture was terminated in October 2025 due to Tianhui Biotech's failure to meet financial conditions, limiting its ability to participate in global expansion [11]. Group 5: Industry Trends and Future Outlook - Tianhui Biotech faces operational challenges, including tax issues and contract disputes, raising concerns about its stability [12]. - The approval of long-acting insulin products by competitors, such as Novo Nordisk, is reducing the urgency for oral insulin solutions, indicating a shift in the market landscape [12]. - The withdrawal of ORMD-0801 does not signify the end of oral insulin development but underscores the high investment and failure rates in this challenging field [13].

2025.12. 29 本文字数：973，阅读时长大约1.5分钟 作者 | 第一财经 林志吟 12月29日，国家药监局网站公布的药品通知件送达信息显示，合肥天汇生物科技有限公司（下称天 汇生物）申请的重组人胰岛素肠溶胶囊位于其中。 一般而言，拿到药品通知件，有可能是药品上市申请"不予批准"，或者是企业因预判无法过审而主动 撤回上市申请。 第一财经记者亦向天汇生物方面了解这款药上市申请未能成功原因，截至发稿之际，还未获得回复。 之所以重组人胰岛素肠溶胶囊备受关注，原因在于它是全球范围第一个申报上市的口服胰岛素，最早 于2023年4月在中国申报上市，用于治疗口服降糖药疗效不佳的2型糖尿病患者。 天汇生物的这款重组人胰岛素肠溶胶囊，也是一款引进产品，来自于以色列Oramed公司。 | 序榜 | 受刑导 | 药品名称。 | 申请人 | 签发日期 | | --- | --- | --- | --- | --- | | | CXSS2300021 | 重组人胰岛素肠溶胶養 | 合肥天汇生物科技有限公司 | 2025年12月26日 | | 2 | CYHS2303584 | 丙戊酸钠缓释片(Ⅰ) | 上海暖谷药业有限公司 ...

曾是全球范围第一个申报上市的口服胰岛素。 12月29日，国家药监局网站公布的药品通知件送达信息显示，合肥天汇生物科技有限公司（下称天汇生 物）申请的重组人胰岛素肠溶胶囊位于其中。 一般而言，拿到药品通知件，有可能是药品上市申请"不予批准"，或者是企业因预判无法过审而主动撤 回上市申请。 | 2024年5月1日起。行政相对人可登录国家药品监督管理局政务服务门户 -- 我的办件中重看电子文书,按照相关提示目行打印。 | | --- | | 序号 | 受刑与 | 药品名称 | 申请人 | 签发日期 | | --- | --- | --- | --- | --- | | | CXSS2300021 | 重组人胰岛素肠溶胶囊 | 合肥天汇生物科技有限公司 | 2025年12月26日 | | 2 | CYHS2303584 | 丙戊酸钠缓释片(I) | 上海曜谷药业有限公司 | 2025年12月29日 | | ਤੇ | CYHS2400416 | 色甘酸钠滴眼液 | 中山万汉制药有限公司 | 2025年12月29日 | | 4 | CYHS2400417 | 色甘酸钠滴眼液 | 中山万汉制药有限公司 | 2025年12月 ...