江苏恒瑞医药股份有限公司关于 获得药物临床试验批准通知书的公告

Group 1 - Jiangsu Hengrui Medicine Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for clinical trials of HRS-7535 tablets, which are intended for the treatment of hypertension combined with overweight or obesity [1][2] - HRS-7535 is a novel oral small molecule GLP-1 receptor agonist that promotes insulin secretion and reduces glucagon secretion, while also enhancing satiety and suppressing appetite, making it suitable for treating type 2 diabetes and weight loss [2] - The total R&D investment for HRS-7535 has reached approximately 36.94 million yuan [2] Group 2 - The company's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injectable SHR-1826 included in the list of breakthrough therapy drugs by the NMPA [5][6] - SHR-1826 is a therapeutic biological product targeting c-Met, intended for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer in patients who have failed at least one line of systemic therapy [6][7] - The total R&D investment for SHR-1826 has reached approximately 12.55 million yuan [7]