Aceh Pharmaceutical Bcl-2 inhibitor APG-2575 has been approved by the FDA orphan drug for the treatment of chronic lymphocytic leukemia.

Introduction: Aceh Pharmaceutical Bcl-2 inhibitor APG-2575 has been qualified by the FDA orphan drug for the treatment of chronic lymphocytic leukemia (CLL).
, Suzhou, China, and Rockville, Md., September 7, 2020 /ATA/ -- AXA Pharma (6855. HK) today announced 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 chronic lymphocytic leukemia (CLL).
this is the second FDA-granted orphan drug qualification for APG-2575.
July, the FDA awarded APG-2575 the first orphan drug to be qualified as Fahrenheit globulinemia (WM).
"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 some 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 market access to the U.S. market for 7 years exclusive rights.
CLL is an adult leukemia characterized by a large number of cloned B lymphocytes in lymphatic tissues such as perennity blood, bone marrow, spleen and lymph nodes.
2020, there will be about 21,040 new cases of CLL in the United States and about 4,060 deaths from the disease, according to the American Cancer Society.
, according to the latest SEER data, there will be fewer than 200,000 CLL patients in the U.S. by 2020.
The development of existing Bruton tyrosine protein kinase (BTK) inhibitors and Bcl-2 inhibitors has improved the prognostication of CLL patients, but there is still a medical need for safer and more effective treatment options that achieve deep remission in short-term treatments and are chemotherapy-free.
APG-2575 is a new oral Bcl-2 selective small molecule inhibitor developed by Asaan Pharmaceuticals to restore the tumor cell programmed death mechanism (apoptosis) by selectively inhibiting Bcl-2 protein, thereby killing tumors and 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 has been licensed for several 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.
a global phase Ib/II clinical study of relapses/difficult CLL/SLL (small lymphocyte lymphoma) as a single drug or joint treatment is under way and is being recruited in the United States and Australia.
, Chief Medical Officer of Aceh Pharmaceuticals, said: "CLL's treatment is a clinical requirement that is not yet fully met at the global level.
as an important clinical development variety of the company's apoptosis product pipeline, APG-2575, after WM adaptation, quickly obtained the FDA's second orphan drug qualification, is a high degree of recognition and encouragement to us.
we will accelerate the global clinical development and product launch of this drug, supported by orphan drug-related policies, and provide more treatment options for CLL patients at an early age.
" Reference: 1. Cancer Statistics 2020, American Cancer Society 2. 2020 Cancer Cancer Data, Surveillance, And End Results Program, National Cancer Institute.