Yassin 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 acute myeloid leukemia (AML).
This is the fourth FDA-granted orphan drug qualification for APG-2575, following Fahrenheit globulinemia (WM), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) adaptation.
, as of now, Asah Pharmaceuticals has obtained 9 FDA orphan drug certifications in research and development of new drugs, the largest number of Chinese enterprises.
AML is a highly heterogeneic malignant tumor of the blood system, and is mainly a disease of elderly patients, with a medium age of 68 years at the time of diagnosis1.
the latest SEER and End Results Program estimates from the National Cancer Institute that there will be 19,940 new AML cases in the United States by 2020 and 11,180 deaths from the disease.
although some progress has been made in the treatment of AML in recent years, the five-year survival rate of the disease is 25%-30%, so there is still an urgent need for safer, more lasting and effective treatment.
"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.
's FDA-granted orphan drug eligibility will help the drug enjoy some policy support in the U.S. in terms of follow-up research and development and commercialization, including tax breaks on clinical trial costs, exemptions from NDA filing fees, and access to research and development grants, especially if the drug is approved for seven years of exclusive ownership of the U.S. market.
with the rise of China's pharmaceutical innovation force, China's pharmaceutical companies in recent years, "going out to sea" trend is increasingly obvious, access to FDA orphan drug identification and other qualifications are also regarded as one of the important indicators of global innovation strength.
as a leader in global innovation, ASHENG Pharmaceuticals is undoubtedly one of the best.
, as of now, as of now, as a result of the four new drugs in the study of 9 FDA orphan drug certification (see table below).
public information shows that this number is the largest among Chinese companies.
drug target adaptation HQP1351BCR-ABL chronic myeloid leukemia APG-2575Bcl-2 Fahrenheit globulinemia chronic lymphocytic leukemia multiple myeloma acute myeloid leukemia APG-115MDM2 Public data on the number of innovative drugs approved by the FDA for acute myeloid leukemia soft tissue sarcoma APG-1252Bcl-2/Bcl-xL small cell lung cancer show that the proportion of FDA-approved orphan drugs in approved innovative therapies has gradually increased over the past 10 years.
more than 60 per cent of new drugs approved for the whole of 2020 will be eligible for orphan drugs, a 10-year high.
data show that the FDA's policy of qualification orphan drugs has a very practical incentive and impetus to accelerate the development and market of rare disease drugs.
Enter Title Enter Title In just one year, we have obtained 9 FDA orphan drug certifications, both in time and quantity, are the largest Chinese enterprises, even in the world should be the leading.
behind this data comes from our team's commitment to its mission to 'address the unseeded clinical needs of patients in China and around the world'.
hope that, driven by the FDA's orphan drug policy, our multiple drugs will accelerate clinical development and be approved at an early time, thereby benefiting more patients more quickly.
Yang Dajun, Chairman and CEO Reference DeSantis CE, Lin CC, Mariotto AB, et al. Cancer Treatment and Survivorship Statistics, 2014. CA Cancer J Clin 2014; 64:252-271. About Asaan 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, committed to the development of cancer, hepatitis B and aging-related diseases and other therapeutic areas 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。
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 clinical development, including inhibitors that inhibit apoptotic pathway-critical proteins 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 four new drugs in the study of 9 FDA orphan drug certification.
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