Aachen Pharmaceutical Bcl-2 inhibitor APG-2575 was qualified as an orphan drug

Yassin Pharma (6855. HK) announced today that the U.S. Food and Drug Administration (FDA) has awarded the company the qualification of the original innovative drug Bcl-2 inhibitor APG-2575 orphan drug for the treatment of fable lymphoma (FL).
This is the fifth FDA-granted orphan drug qualification for APG-2575 following Fahrenheit globulinemia (WM), chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML) adaptation.
to date, as a total of 4 in the research of new drugs to obtain 10 FDA orphan drug certification.
"orphan medicine", also known as rare drugs, refers to the prevention, treatment, diagnosis of rare diseases of drugs.
, rare diseases are those that affect fewer than 200,000 people.
since 1983, the United States has adopted the Orphan Drugs Act to provide policy support to businesses to encourage the development of drugs for rare diseases.
This APG-2575 FDA-granted orphan drug qualification will help the drug enjoy certain policy support in the U.S. in the areas of follow-up research and development and commercialization, including access to clinical trial fee tax relief, exemption from NDA filing fees, access to research and development grants, and in particular, approval of the U.S. market after 7 years of exclusive ownership.
FL is a heterogeneic disease that is the second most common type of non-Hodgkin's lymphoma (NHL) in the United States, accounting for about 20 percent of all NHL cases.
FL is the most common inert B-cell lymphoma, caused by the malignant proliferation of B-cells in the birth center.
although current treatments have significantly improved the overall survival of FL patients, FL is still considered an incurable malignant tumor.
most patients have a recurrence or progressity after initial treatment and experience multiple relapses that require follow-up cross-line treatment.
Although there are a variety of treatment options for initial and relapse/refractic FL, there are still significant clinical needs that remain unsatisfying for FL patients with high risk, early recurrence, histological transformation, recurrence from existing treatment options, or inability to with existing treatments.
APG-2575 is a new oral Bcl-2 selective small molecule inhibitor developed by Asaan Pharmaceuticals to restore the tumor cell procedural death mechanism (apoptosis) by selectively inhibiting the Bcl-2 protein, thereby killing tumors, intended to be used to treat a variety of blood malignancies.
APG-2575 is the first locally developed Bcl-2 selective inhibitor to enter the clinical phase in China.
APG-2575 is currently licensed for multiple Phase Ib/II clinical trials in the United States, China and Australia and is advancing the clinical development of multiple blood tumor adaptations worldwide simultaneously.