复星医药回应监管函,甘露特钠胶囊累计销售19.2亿元,2029年递交总结报告
Zhong Guo Jing Ying Bao·2025-12-23 09:19

Group 1 - The core product of the company, Ganluo Sodium Capsules, has achieved cumulative sales of 1.92 billion yuan and a total sales volume of 6.7711 million boxes since its approval for market launch in 2019 [1] - The company plans to invest 1.412 billion yuan to acquire a controlling stake in Green Valley Pharmaceutical, which is the manufacturer of Ganluo Sodium Capsules [1] - From November 2024, commercial production of Ganluo Sodium Capsules will cease, significantly impacting sales in 2025 [1] Group 2 - The post-marketing confirmatory clinical trial aims to enroll 1,950 patients, with 580 already enrolled as of December 15, 2025, leaving 1,370 more to be enrolled [2] - The clinical trial is expected to complete patient enrollment by the end of 2027, with data readout anticipated in early 2029, followed by submission of the clinical trial summary report to the National Medical Products Administration in the first half of 2029 [2]

FOSUNPHARMA-复星医药回应监管函,甘露特钠胶囊累计销售19.2亿元,2029年递交总结报告 - Reportify