Aachen Pharmaceutical Bcl-2 inhibitor APG-2575 has been re-qualified as an FDA orphan drug.

Introduction: For the treatment of chronic lymphocytic leukemia! SEPTEMBER 7, 2020 /AP/ -- Asathe Pharmaceuticals, a clinically advanced research and development company dedicated to the development of innovative drugs in the fields of cancer, hepatitis B and aging-related diseases, announced that the U.S. Food and Drug Administration (FDA) has awarded the company the qualification of 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 Incidence Data, Surveillance, Admiration, and End Results Program, National Cancer Institute On APG-2575APG-2575 is a new oral Bcl-2 selective inhibitor developed by Asaan Pharmaceuticals to restore the programed death mechanism (apoptosis) of tumor cells by selectively inhibiting Bcl-2 proteins, which is intended to kill tumors and is intended to treat a variety of blood malignancies.
previously launched single-drug Phase I clinical trials in the United States, Australia and China.
Since March this year, APG-2575 has been licensed for a number of Phase Ib/II clinical trials in the United States and China, and is simultaneously advancing clinical development of a number of blood tumor adaptations, including relapsed/difficult-to-treat chronic lymphoblastic leukemia/small lymphocyte lymphoma, Fahrenheit globulinemia, recurring/difficult-to-treat acute myeloid leukemia, and more.
APG-2575 has two adaptive disorders have been approved by the FDA for orphan drug qualification, respectively, Fahrenheit globulinemia and chronic lymphocytic leukemia.
About Asah Pharmaceuticals Asah Pharmaceuticals is a China-based, global-oriented research and development company in the clinical development stage of the original innovative pharmaceutical research and development enterprises, is committed to the cancer, hepatitis B and aging-related diseases and other therapeutic areas of the development of innovative drugs.
October 28, 2019, Asah Pharmaceuticals was listed on the Main Board of the Hong Kong Stock Exchange under the stock code: 6855. HK.
assus Pharmaceuticals has an independently constructed protein-protein interaction targeting drug design platform, which is at the forefront of new drug research and development in the apoptosis path.
has established eight pipelines of class 1 small molecule new drug products that have entered clinical development, including inhibitors that inhibit apoptotic pathway-critical proteins such as Bcl-2, IAP or MDM2-p53, and a new generation of inhibitors for kinase mutants in cancer treatment, the only innovative company in the world with clinically developed varieties in the field of apoptosis-critical proteins.
currently conducting more than 40 Phase I/II clinical trials in China, the United States and Australia.
HQP1351, the core variety used to treat drug-resistant chronic myeloid leukemia, has submitted an application for the listing of a new drug in China, which has been certified as an FDA-reviewed fast-track and orphan drug.
another important variety of APG-2575 recently received two FDA orphan drug certifications.
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