博安生物(06955)：成交量异常变动及地舒单抗(60MG)在玻利维亚获批上市

Core Viewpoint - The company, Luye Pharma Group, has announced an increase in trading volume of its H-shares and confirmed that it is unaware of any reasons for this change, aside from disclosed information regarding the issuance of exchangeable preferred shares [1][2]. Group 1: Share Issuance and Trading - Luye Pharma Group's wholly-owned subsidiary, Luye Geneora Holding Limited, issued exchangeable preferred shares on December 12, 2025, which allow holders to exchange these shares for existing H-shares held by Luye Pharma Group [1][2]. - Following the issuance of the exchangeable preferred shares, an agreement was made to transfer 100.5 million H-shares to a designated custody account to fulfill the exchange rights associated with these shares [2]. - On January 9, 2026, Luye Pharma Group arranged for its subsidiary, Shandong Luye Pharmaceutical Co., Ltd., to transfer 50 million H-shares to the issuer in the market [2]. Group 2: Product Development and Approval - The company's self-developed drug, BA6101 (60mg), has been approved for market launch by Bolivia's National Medicines and Health Technologies Authority (AGEMED) [2][3]. - BA6101 is a biosimilar to the reference drug Prolia®, widely used for the treatment of osteoporosis, and has the same indications as the reference drug [3]. - The development of BA6101 adheres to international guidelines and has demonstrated high similarity in quality, safety, and efficacy compared to the reference drug, with no clinically significant differences [3]. Group 3: Commercialization Strategy - The company plans to commercialize BA6101 in Bolivia and enhance the accessibility of the drug for patients, providing more treatment options [4]. - Strategic partnerships have been established for the commercialization of BA6101 in other Latin American markets, the United States, Southeast Asia, Hong Kong, and Macau [4]. - The company aims to accelerate its international strategy by offering high-quality domestic biopharmaceuticals, including BA6101, to meet global patient treatment needs [4].