Asasin Pharma won the 10th FDA Orphan Drug Certification, and Bcl-2 inhibitor APG-2575 added one

Suzhou, China, And Rockville, Maryland, USA January 29, 2021 - AXA Pharmaceuticals (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.
, as of now, Asah Pharmaceuticals has obtained 10 FDA orphan drug certifications in the research of new drugs, the largest number of Chinese pharmaceutical companies.
"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% of all NHL cases1.
FL is the most common inert B-cell lymphoma, caused by the malignant proliferation of B-cells in the birth center 1,2.
the current treatment has significantly improved the overall survival of FL patients, FL is still considered an incurable malignant tumor2,3.
most patients have a recurrence or progressity after initial treatment and experience multiple recurrences that require follow-up cross-line treatment4.
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.
"This is the company's apoptosis pipeline important varieties Bcl-2 inhibitor APG-2575 obtained the 5th FDA awarded orphan drug qualification, for Assassin Pharmaceuticals won the 10th orphan drug certification, further solidified our 'creation of China's pharmaceutical orphan drug certification has always been the most' leading position, but also the company's global innovation ability and level of embodiment."
expects that, driven by the FDA's orphan drug policy, several companies, including APG-2575, will accelerate clinical development and early approval of varieties for the benefit of more patients more quickly.
" References 1.Kridel R, Sehn L, Gascoyne D. Pathogenesis of follicular lymphoma. J Clin Invest. 2012 Oct; 122(10):3424-31. 2.Huet S, Sujobert P, Salles G.From genetics to the clinic: a translational perspective on follicularlymphoma. Nat Rev Cancer. 2018 Apr; 18(4):224-239. 3.Carbone A, et al. Follicularlymphoma. Nat Rev Dis Primers. 2019 Dec 12; 5(1):83. 4.Matasar M, et al. FollicularLymphoma: Recent and Emerging Therapies, Treatment Strategies, and RemainingUnmet Needs. Oncologist. 2019 Nov; 24(11):e1236-e1250.About Asasin Pharma 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, committed to the treatment of cancer, hepatitis B and aging-related diseases and other therapeutic areas of innovative drugs.
October 28, 2019, Asasin Pharma was listed on the Main Board of the Hong Kong Stock Exchange under the stock code: 6855. HK。
Asheng Pharmaceuticals has an independently constructed protein-protein interaction targeting drug design platform, which is at the forefront of the global research and development of new drugs for apoptosis path.
has established eight pipelines of class 1 small molecule new pharmaceutical products that have entered the clinical development stage, including inhibitors that inhibit key proteins in apoptosis pathways such as Bcl-2, IAP or MDM2-p53;
is 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 a fast-track and orphan drug by the FDA.
, the company has a total of 4 new drugs in the study of 10 FDA orphan drug certification.