Yunding Tech's shares rose nearly 3% as its Lysol NDA was accepted by CED, marking the first time a drug target in China has been achieved, according to an agency.
1min read Yunding Tech (Yunding Tech) rose nearly 3% as of the time of writing, up 2.67% to HK$42.25, with a turnover of HK$49.06 million.
On November 17, Yunding Tech-B announced that its new drug application (NDA) for APG-2575 (tentative Chinese generic name: Lysol-Cladina), a newly developed selective Bcl-2 inhibitor, had been accepted for review by the National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) and recommended for priority review for the treatment of relapsed or refractory (r/r) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first domestic NDA for a locally developed original Bcl-2 inhibitor and has the potential to become the second Bcl-2 inhibitor to be approved globally. CICC pointed out that APG-2575 is currently conducting global multi-regional phase III clinical trials and has the potential to expand its overseas market space.
CICC continued that Bcl-2i brings innovation to the treatment of r/r CLL/SLL, and there are no approved Bcl-2i in China. According to the company's announcement, CLL/SLL is the most common type of leukemia in developed countries, with more than 100,000 new cases each year. There is a large unmet clinical need for patients who relapse or become refractory after 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 and thus achieves the effect of treating tumors. According to the company's announcement, due to the high drug development difficulty of Bcl-2i, the target has been discovered for nearly 40 years since its discovery, and only Venclexta, an approved Bcl-2i by AbbVie, has been approved globally. There are no approved Bcl-2i in China.
