Two new drugs targeted at apoptosis have been designated by the FDA for orphan drugs.

Ascentage Pharma has announced that the U.S. Food and Drug Administration (FDA) has awarded two of its death inhibitors the "Orphan Drug Title (ODD)."
one inhibitor, MDM2-p53, APG-115, is used to treat acute myeloid leukemia (AML) and the other is Bcl-2/Bcl-xL inhibitor APG-1252 for the treatment of small cell lung cancer (SCLC).
MDM2-p53 inhibitor APG-115 (Source: Assin Pharma) APG-115 is an oral MDM2 selective small molecule inhibitor.
APG-115 has a strong affinity for MDM2, activating the anti-tumor activity of p53 by blocking the interaction between the MDM2-p53 protein and the protein (PPI).
APG-115 is the first MDM2-P53 inhibitor to enter clinical practice in China and is currently being evaluated in several solid and hematoma clinical trials in China and the United States, according to AAST.
Bcl-2/Bcl-xL inhibitor APG-1252 (Assin Medicine) APG-1252 is a new small molecule candidate that selectively inhibits both Bcl-2 and Bcl-xL proteins to restore apoptosis.
is currently conducting Phase I dose incremental studies in patients with advanced cancer in the United States and Australia, and phase IB/II studies of APG-1252 combined with yew alcohol in patients with relapsed/refr?curable SCLC in the United States.
clinical data from APG-1252 to date have shown good safety and initial efficacy in SCLC and other patients with advanced solid tumors.
AML and SCLC are both devastating and life-threatening diseases with high clinical requirements worldwide," said Dr. Yifan Yan, Chief Medical Officer, Ascentage Pharma, a professor of medicine.
this is the second time the APG-115 has been awarded ODD by the FDA, and the APG-1252 is the first time it has been awarded.
all ODD-related support policies in the United States will help us accelerate the global clinical development and commercialization of these two drug candidates and benefit more patients as quickly as possible.
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