复星医药：预计2029年完成上市后确证性临床试验

Core Viewpoint - Fosun Pharma is acquiring a controlling stake in Green Valley Pharmaceutical for approximately 14.12 billion yuan, despite the core product, Manzotai Capsules, being suspended from production and sales. The acquisition has raised concerns in the capital market regarding the timeline for the product's re-entry into the market [1][2]. Group 1: Acquisition Details - Fosun Pharma's acquisition will result in it holding 53% of Green Valley's shares through its subsidiary and a special purpose vehicle (SPV) [2]. - The acquisition involves a combination of stock transfer and subscription to new registered capital, with Fosun Pharma's subsidiary expected to hold 51% of Green Valley's shares [2]. - The payment for the acquisition will be made in installments, with an initial payment of 6.35 billion yuan on the closing date and the remaining amount contingent on Green Valley's future R&D progress [3]. Group 2: Clinical Trial Progress - The revised post-marketing confirmatory clinical trial for Manzotai Capsules has been approved by the National Medical Products Administration, with an estimated completion of subject enrollment by the end of 2027 and data readout in early 2029 [1][4]. - As of December 15, 2025, 580 subjects have been enrolled in the clinical study, with 1,370 more needed to complete the trial [4]. - The clinical trial design has been updated to extend the double-blind treatment period from 36 weeks to 48 weeks and increase the sample size from 1,312 to 1,950 [3]. Group 3: Financial and Compliance Aspects - Green Valley Pharmaceutical has faced administrative penalties for improper promotional practices, resulting in a fine of 400,000 yuan, but this has not significantly impacted its operations [6]. - An audit by Ernst & Young revealed no hidden large debts or misuse of funds within Green Valley, indicating a stable financial condition [6][7]. - The acquisition is not expected to have a significant impact on Fosun Pharma's consolidated profits in the short term, as Green Valley's assets and liabilities represent a small fraction of Fosun's total [7].