The Board of Directors of the Company has noted an increase in the trading volume of the Company's H shares on January 9, 2026. After making reasonable enquiries under the circumstances, the Board confirms that, other than the matters disclosed below, it is not aware of any reasons for such volume movement, any information that must be announced to avoid a false market in the Company's securities, or any inside information required to be disclosed under Part XIVA of the Securities and Futures Ordinance (Chapter 571 of Hong Kong Law).
The Board has been notified by its controlling shareholder, Luye Pharma Group Ltd. (together with its subsidiaries, the "Luye Pharma Group"), that on December 12, 2025, Luye Pharma's wholly-owned subsidiary, Luye Geneora Holding Limited (the "Issuer"), issued a number of exchangeable preference shares. These exchangeable preference shares grant their holders the right to exchange such shares for existing H shares of the Company held by the Luye Pharma Group.
As disclosed in the relevant announcements, Luye Pharma and the Issuer have agreed that, following the issuance of the exchangeable preference shares, they will facilitate the transfer of 100.5 million H shares into a designated custodian account of the Issuer. This transfer is intended to ensure the Issuer can fulfill its obligation to deliver H shares upon the exercise of the exchange rights attached to the exchangeable preference shares.
To comply with the relevant agreement, the Luye Pharma Group arranged for its wholly-owned subsidiary, Shandong Luye Pharmaceutical Co., Ltd., to transfer 50 million H shares on the market to the Issuer on January 9, 2026. As further disclosed in the announcements, the exchangeable preference shares are collectively exchangeable for a total of 100.5 million H shares.
The Luye Pharma Group has informed the Board that it will arrange for further transfers of H shares to the Issuer in accordance with the terms of the subscription agreement related to the exchangeable preference shares. The Board also confirms that there are currently no negotiations or agreements relating to intended acquisitions or realizations subject to disclosure under Rule 13.23 of the Hong Kong Listing Rules, nor is the Board aware of any matters discloseable under the general obligation set out in Rule 13.09 of the Listing Rules that are or may be of a price-sensitive nature.
The Board is pleased to announce that its self-developed Denosumab Injection (60mg) (code: BA6101) has been approved for marketing by the Bolivian National Agency for Medicines and Health Technologies (AGEMED). BA6101 is a biosimilar to the originator reference drug Prolia®, which is widely used globally for the treatment of osteoporosis. The indications for BA6101 are the same as those for the originator reference drug.
BA6101 was developed based on the Company's global R&D strategy and is planned for commercialization in multiple countries and regions worldwide. In 2022, BA6101 (Boyoubei®) was the first domestically produced Denosumab Injection to be approved for marketing in China. Currently, the marketing authorization application for BA6101 in the United Kingdom is under review, and the Company plans to submit applications in Europe, the United States, Japan, and other countries and regions.
The development process for BA6101 strictly followed the biosimilar-related guidelines of China, the US, the EU, and Japan, demonstrating its overall similarity to the originator reference drug through a series of analytical, non-clinical, human pharmacokinetic, and clinical studies. Specifically, BA6101 has been confirmed to be highly similar to the originator reference drug in terms of quality, safety, and efficacy, with no clinically meaningful differences.
Furthermore, the production of BA6101 adheres to the highest international standards, providing quality assurance for its overseas expansion. The Company will work with partners to advance the commercialization of BA6101 in Bolivia, actively improving the accessibility of denosumab in the local market and providing patients with more treatment options.
In addition to Bolivia, the Company has also established strategic collaborations for the commercialization of BA6101 in other Latin American markets such as Brazil, as well as in the United States, Southeast Asia, and the special administrative regions of Hong Kong and Macau in China. The Company will accelerate the advancement of its internationalization strategy by offering multiple high-quality domestic biologics, including BA6101, to meet the treatment needs of patients worldwide.
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