HK Stock Market Move | ASCENTAGE-B (06855) rose nearly 3%, surpassing Kala NDA for CED acceptance. Institutions point to the difficulty of becoming a drug target for the first time in China.

ASCENTAGE-B (06855) rose nearly 3%, as of press time, up 2.67% to 42.25 Hong Kong dollars, with a turnover of 49.0676 million Hong Kong dollars. On the news front, on November 17, ASCENTAGE-B announced that the new drug application (NDA) for the company's independently developed novel selective Bcl-2 inhibitor APG-2575 (proposed Chinese common name: Lisheng Kelapian) has been accepted by the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) and recommended for priority review, for the treatment of refractory or relapsed (r/r) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first domestically developed original Bcl-2 inhibitor to submit an NDA in China, and is expected to become the second Bcl-2 inhibitor to be marketed globally. CICC pointed out that APG-2575 is currently undergoing multiple Phase III clinical trials globally, with potential to expand its overseas market. CICC continued to point out that Bcl-2i brings innovation to the treatment of r/r CLL/SLL, and there are currently no approved Bcl-2i in China. According to the company's announcement, CLL/SLL is the most common type of adult leukemia in Western countries, with over 100,000 new cases each year, and there is a significant unmet clinical need for patients who do not respond well to existing therapies. Bcl-2 is highly expressed in various malignant hematological tumors and is an important mechanism for tumor cells to evade apoptosis. Bcl-2i restores the apoptosis process of tumor cells, thereby achieving the effect of treating tumors. According to the company's announcement, due to the high difficulty of developing Bcl-2i drugs, the discovery of this target has been for nearly 40 years, and the only globally approved Bcl-2i is AbbVie's Venetoclax, with no Bcl-2i currently approved in China.