Shanghai Fosun Pharmaceutical (02196) responds to the acquisition of LvGu Pharmaceutical: The confirmatory clinical research on mannitol sodium capsules has been recognized by the Drug Evaluation Center, with a total of 580 cases enrolled.

On the evening of December 22, Shanghai Fosun Pharmaceutical (600196.SH, 02196) issued an announcement in response to the regulatory work letter from the Shanghai Stock Exchange regarding the investment in Lugu Pharmaceutical, disclosing details about the specific transaction method, clinical progress, and subsequent integration. The acquisition in this instance adopts a combination of "acquisition of existing equity + subscription of new registered capital". Shanghai Fosun Pharmaceutical will hold a 51% equity stake in the target company, achieving controlling interest. The transaction amount will be paid in installments, with a total of 1.269 billion yuan in subscription funds, of which 635 million yuan will be paid on the delivery date; the remaining 634 million yuan will be paid within 3 years from the completion of the first payment, based on the subsequent research and development progress of the target company. This design aims to control the actual investment progress based on the stage achievements of clinical trials, in order to dynamically manage clinical and investment risks. In addition, the entity controlled by the founder of the target company will pledge 10% of the equity held after this acquisition as a guarantee for potential risks that may cause losses to the company. This transaction is a controlling acquisition, providing the necessary funds for the subsequent clinical trials of Galantamine Capsules, as well as support and assurance for the clinical trials, approval, and commercialization of the drug, including capabilities and resources in clinical operation organization, registration, and commercialization. Galantamine Capsules will also be included in Shanghai Fosun Pharmaceutical's innovative drug pipeline, and the company will conduct standardized management in clinical, registration, product quality, drug vigilance, production, and commercialization aspects of this drug. Regarding the subsequent clinical progress, Shanghai Fosun Pharmaceutical stated that according to the "Alzheimer's Disease Drug Clinical Trial Technical Guidance Principles (Trial)" issued by the Drug Evaluation Center of the National Medical Products Administration in May 2025, after communicating with the Drug Evaluation Center of the National Medical Products Administration in October 2025, the post-marketing confirmatory clinical trial plan was revised to extend the double-blind treatment period from 36 weeks to 48 weeks and increase the sample size from 1,312 to 1,950 cases. The revised post-marketing confirmatory clinical trial design meets the requirements of the "Alzheimer's Disease Drug Clinical Trial Technical Guidance Principles (Trial)" issued in May 2025 for the confirmatory clinical trial of disease-modifying Alzheimer's disease (AD) drugs, including the recommendation of randomized, double-blind, placebo-controlled trials; this trial design has been approved by the Drug Evaluation Center of the National Medical Products Administration. As of December 15, 2025, a total of 580 participants have been enrolled in the clinical study. Based on the estimated clinical research plan, all subjects are expected to complete enrollment by the end of 2027, relevant research and data reading by early 2029, and the submission of a clinical trial summary report to the National Medical Products Administration in the first half of 2029. Shanghai Fosun Pharmaceutical continues to focus on the field of central nervous system degenerative diseases, enriching its product portfolio. It has already established a "drug + device" collaborative innovation model through products such as Opicapone, AR1001, Galantamine Capsules, and CyberKnife. This acquisition is another step taken by the company to address unmet clinical needs in this field, aiming to further enrich the drug pipeline in this treatment area, enhance the innovative product pipeline matrix, and continuously improve market layout.