Mei Kai three times! Asasin Pharma's 3rd product is eligible for FDA orphan drugs.

Asasin Pharma's FDA Orphan Drug is also known as a rare drug, which is used to prevent, treat, and diagnose rare diseases.
, rare diseases are those that affect fewer than 200,000 people.
Since 1983, the United States has passed the Orphan Drugs Act, and projects that have been eligible for orphan drugs can enjoy certain policy support in the areas of follow-up research and development, registration and commercialization, including: 1) tax credits.
50% of the cost of subsequent clinical trials for orphan drugs can be used as a tax credit, extending forward by 3 years and back by 15 years.
2) free of new drug listing application (NDA) fees.
3) Market exclusive rights.
certified orphan drug is subject to 7 years of market exclusive rights after being approved for market listing by the U.S. FDA and is not subject to patents.
of treating stomach cancer with APG-115 showed great differences in eastern and western countries.
2017, there were 116,525 cases of stomach cancer in the United States, according to the latest SEER (Surveillance And End Results Program) data, which is considered a rare disease.
the incidence of stomach cancer is higher in Asian countries such as China and Japan.
, stomach cancer has the third highest mortality rate of malignant tumors in the world, after lung cancer and colorectal cancer.
1/12 of all cancer-causing deaths can be attributed to stomach cancer.
based on the 2020 National Comprehensive Cancer Network (NCCN) Clinical Practice Guide for Gastric Cancer, a multidisciplinary integrated treatment model is currently recommended to treat patients with advanced metastatic gastric cancer that cannot be removed.
however, for patients with progressing diseases receiving second-line treatment, treatment options are few and the prognosis is poor, so new and effective treatments are urgently needed to improve disease progress and reduce mortality.
APG-115 is an oral bioavailable, highly selective small molecule MDM2 inhibitor developed by Aachen Pharmaceuticals, which has a high binding affinity for MDM2 and restores p53 tumor inhibition activity by blocking MDM2-p53 interactions.
APG-115 is the first MDM2-p53 inhibitor to enter the clinical phase in China, and has conducted a number of clinical studies in China and the United States to treat solid and blood tumors, and has shown considerable potential in preclinical studies to treat stomach cancer.
APG-2575 treatment of chronic lymphocytic leukemia CLL is an adult leukemia characterized by a large number of cloned B lymphocytes in lymphatic tissues such as 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 free of chemotherapy.
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.
A global phase Ib/II clinical study of relapsed/difficult-to-treat CLL/SLL (small lymphocyte lymphoma) is under way and is being recruited in the United States and Australia.
APG-2575 treatment of Fahrenheit globulinemia WM is a lymphocyte tumor characterized by lymphatic plasma cells soaking the bone marrow, accompanied by a blood list clone immunoglobulin M (IgM) increase.
is a rare disease that accounts for less than 2% of non-Hodgkin's lymphoma patients in the United States.
The objective remission rate (ORR) of the WM treatment recommended in the current guidelines can reach 80%, but the deeper remission rate above the good partial remission (VGPR) is very low (about 20% or less), and more patients will eventually relapse or progress.
, the middle age of WM is around 70 years old, and the patient's physical condition is often insatiable with intense treatment.
the improvement of WM therapeutic effect is an urgent clinical problem to be solved.
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 world's rare Bcl-2 selective inhibitor to enter the clinical development phase after VENCLEXTA® (venetoclax) and 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 clinical development of multiple blood tumor adaptations globally, including an ongoing global multi-center Phase Ib/II clinical study to assess the safety, resistance and effectiveness of APG-2575 monodring or joint ibrutinib/rituximab treatment of WM patients.
treatment of chronic myeloid leukemia CML with HQP1351 is a rare malignant blood disease with an annual incidence rate of about 1.9 per 100,000 people in the United States.
with the launch of tyrosine kinase inhibitors (TKI) targeted at BCR-ABL, CML treatments have been revolutionized.
Although the first generation of BCR-ABL inhibitor imatinib and several subsequent second-generation drugs have significant clinical benefits for the treatment of CML, access resistance has been a major challenge for CML treatment.
BCR-ABL kinase region mutation is one of the important mechanisms of obtainive resistance, of which T315I mutation is one of the common drug resistance mutation types, the occurrence rate in drug-resistant CML can reach about 25%.
CML patients with T315I mutations are currently resistant to all current generation and second-generation BCR-ABL inhibitors, there is an urgent clinical need for a third-generation BCR-ABL inhibitor that can effectively treat T315I mutation CML.
HQP1351 is an oral third-generation BCR-ABL inhibitor developed by Asaan Pharmaceuticals, which has outstanding effects on BCR-ABL and a variety of BCR-ABL mutants, including T315I mutations, for the treatment of first- and second-generation TKI-resistant CML patients.
May 7, the FDA also granted HQP1351 Fast Track the right to treat patients with chronic myeloid leukemia (CML) who fail to treat a specific gene mutation in an existing tyrosine kinase inhibitor (TKI).
In June this year, ASIO Pharmaceuticals submitted an application for the listing of HQP1351 (NDA) to the National Drug Administration (NMPA) New Drug Review Center (CDE) for the treatment of chronic myeloid leukemia (CML) chronic and accelerated patients with T315I mutations, based on the results of two key registered clinical studies.
is the first new drug to be marketed since the creation of Asaan Pharmaceuticals, and is expected to become the first third-generation BCR-ABL inhibitor to go on sale in China.
References: 2020 Cancer Calleds Data, Surveillance, Executy, and End Results Program, National Cancer Institute , Rawla, P., and Barsouk, A. (2019). Appy of gastric cancer: global trends, risk factors and prevention. Gastric Cancer, NCCN Clinical Practice Guidelines in Oncology, National Comprehensive Cancer Nerwork 2020. Cancer Statistics 2020, American Cancer Society ( 5 ) Datamonitor, Market Spotlight: WM Published on April 17, 2020.