12月29日，国家药监局官网信息显示，合肥天汇生物的重组人胰岛素肠溶胶囊（ORMD-0801）未获批 准。公司随后回应称，此次注册终止为"主动撤回"，属于公司整体战略调整。然而，结合其国内外临床 试验波折、合资计划流产及近期频现的经营风险，这家曾试图撬动全球口服胰岛素市场的企业，正面临 前所未有的压力。 一、核心管线受阻，口服胰岛素前景蒙尘 ORMD-0801曾被视作天汇生物的关键增长点。作为全球尚未有产品获批的口服胰岛素，该药若成功上 市，将极大提升糖尿病患者用药便利性，市场潜力显著。 然而，该药物的研发路径并不平坦： 2023年1月，合作伙伴Oramed宣布其在美国的3期临床试验未达到主要终点与次要终点。尽管天汇生物 强调国内外试验方案不同，且国内3期临床已于2022年完成，但国际试验的失败仍影响了业界对该药效 的信心。 同时，双方的合资计划落空。2023年双方曾计划成立合资公司OraTech，共同推进全球注册，却因天汇 生物"无法满足财务交割条件"而在2025年10月终止。 口服胰岛素技术门槛高，依赖复杂的递送系统保护药物在肠道吸收，至今全球无一成功上市案例，诺和 诺德等巨头也曾终止类似项目。天汇生物引 ...

Company Overview - The company, Leading Pharmaceutical Biotechnology (00399.HK), closed at HKD 0.39 per share, marking a 39.29% increase with a trading volume of 113 million shares and a turnover of HKD 38.66 million, reflecting a volatility of 39.29% [1] - Over the past month, Leading Pharmaceutical Biotechnology has seen a cumulative increase of 36.59%, and a year-to-date increase of 34.62%, outperforming the Hang Seng Index by 20.65% [1] Financial Performance - As of March 31, 2025, Leading Pharmaceutical Biotechnology reported total revenue of HKD 1.9296 million, a decrease of 68.28% year-on-year [1] - The company recorded a net profit attributable to shareholders of -HKD 319 million, a significant decline of 434.55% year-on-year [1] - The gross profit margin stood at 8.99%, with a debt-to-asset ratio of 97.66% [1] Industry Valuation - Currently, there are no institutional investment ratings for Leading Pharmaceutical Biotechnology [2] - The average price-to-earnings (P/E) ratio for the consumer retail sector (TTM) is -0.32x, with a median of 2.04x; Leading Pharmaceutical Biotechnology has a P/E ratio of -1.49x, ranking 13th in the industry [2] - Comparatively, other companies in the sector have P/E ratios such as Minghui International (4.36x), Youpin 360 (7.76x), Hengan International (10.97x), Jiangsu Hongxin (12.35x), and China Jindian Group (17.15x) [2] Business Segments - Leading Pharmaceutical Biotechnology's operations are primarily divided into two segments: research and development of pharmaceutical products and trade of beauty instruments and products [2] - The company is currently focused on developing oral insulin products and aims to acquire more commercially viable pharmaceutical products to expand its R&D scope [2] - Previously known as United Gene Technology Group, the company primarily provided genetic testing services, health management services, and distribution of biotechnology products [2]