Company Update - The company announced that its self-developed Bcl-2 selective inhibitor, APG-2575 (also known as Lisangtuo), received conditional approval from the National Medical Products Administration of China for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor [1] - Lisangtuo is the first Bcl-2 inhibitor approved in China for the treatment of CLL/SLL and the second globally, following AbbVie's venetoclax [1] Clinical Value and Research - The approval of Lisangtuo is based on a pivotal Phase II clinical study (APG2575CC201) that demonstrated an overall response rate (ORR) meeting the predefined endpoint for patients who failed BTK inhibitors and/or immunochemotherapy, with a favorable safety profile [2] - The drug has been included in the "CSCO Lymphoma Diagnosis and Treatment Guidelines 2025" as of April 2025 [2] - The company is conducting four global Phase III clinical studies to further explore Lisangtuo's indications, including studies for treated CLL/SLL patients and newly diagnosed acute myeloid leukemia (AML) patients [2] Profit Forecast and Valuation - The company maintains its net profit forecast for 2025 and 2026 at a loss of 1.09 billion yuan and 320 million yuan, respectively [2] - Given the approval of Lisangtuo and the potential for global indication expansion, the company maintains an outperform rating and raises the target price by 27.5% to 88 HKD, indicating a 15.3% upside from the current stock price [2]
亚盛医药-B(06855.HK):中国首个原创BCL-2抑制剂利生妥获批上市