药品注册上市许可申请
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丽珠医药集团股份有限公司 关于A股股份回购结果暨股份 变动公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-25 01:17
Group 1: Share Buyback Announcement - The company approved a share buyback plan at the shareholder meetings held on December 24, 2024, and May 29, 2025, with a total amount not less than RMB 60 million and not exceeding RMB 100 million, at a price not exceeding RMB 45.00 per share [2][3] - As of December 23, 2025, the company completed the buyback of 16,193,259 A-shares, accounting for 1.79% of the total share capital, with a total expenditure of RMB 600,217,787.75 [3][4] - The repurchased shares will be fully canceled, leading to a reduction in registered capital, and the company will submit the cancellation application to the relevant authorities [3][6] Group 2: Compliance and Implementation - The buyback process complied with relevant regulations, and the total funds used, repurchase price, and number of shares repurchased were consistent with the approved plan [5][6] - The company did not engage in stock trading during sensitive periods, ensuring compliance with trading regulations [10][11] Group 3: New Drug Application - The company’s subsidiary received a notice from the National Medical Products Administration regarding the acceptance of the registration application for "Lai Kang Qi Ta Monoclonal Antibody Injection" [16][17] - This drug is a first-in-class IL-17A/F dual-target inhibitor for treating moderate to severe plaque psoriasis, with promising clinical trial results showing superior efficacy compared to the control group [18][20] - The total R&D investment for this drug has reached approximately RMB 20.4 million, and there are currently no approved products for the same indication in the domestic market [20]
人福医药:二甲磺酸利右苯丙胺胶囊上市许可申请获受理
Zheng Quan Shi Bao Wang· 2025-11-21 07:47
Group 1 - The core point of the article is that Yichang Renfu, a subsidiary of Renfu Pharmaceutical, has received approval from the National Medical Products Administration for the marketing authorization of Dexmethylphenidate hydrochloride capsules, which are used to treat ADHD and moderate to severe binge eating disorder [1] - Dexmethylphenidate hydrochloride capsules were first approved in the United States and are currently not available in the domestic market, with no related products approved for import [1]