The core variety of Yasheng Medicine, HQP1351, was qualified as an FDA orphan drug

, 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 today that the U.S. Food and Drug Administration (FDA) has awarded the company's core HQP1351 orphan drug qualification for the treatment of chronic myeloid leukemia (CML). This is the first orphan drug qualification obtained by Asaan Pharmaceuticals.“ Orphan medicine" is also known as a rare drug, refers to the prevention, treatment, diagnosis of rare diseases of drugs. In the United States, rare diseases are those that affect fewer than 200,000 people. Since 1983, the United States has supported corporate policies to encourage the development of drugs for rare diseases through the implementation of the Orphan Drugs Act. This HQP1351 fdanation of orphan drugs will help the drug to enjoy certain policy support in the U.S. in the areas of follow-up research and development and commercialization, including 50% tax relief on clinical trial costs, exemption from NDA filing fees, FDA research and development funding, and in particular, approval of the U.S. market after 7 years of exclusive ownership.CML is a rare malignant blood disease with an annual incidence rate of about 19 per 100,000 people in the United States. With the launch of Tyrosine kinase inhibitors (TKI) targeted at BCR-ABL, CML has revolutionized the way it is treated. Although the first generation of BCR-ABL inhibitor imatinib (Grewe ®) and several subsequent second-generation drugs have significant clinical benefits for the treatment of CML, access to resistance has been a major challenge in the treatment of CML. BCR-ABL kinase region mutation is one of the important mechanisms of obtainive resistance, of which T315I mutation is one of the common drug-resistant mutation types, the occurrence rate in drug-resistant CML can reach about 25%. CML patients with T315I mutations are resistant to all current generation and second generation BCR-ABL inhibitors, so there is a clinical need for a third generation BCR-ABL inhibitor that can effectively treat T315I mutation CML.HQP1351 is a new class 1 drug developed by Asaan Pharmaceuticals, an oral third-generation BCR-ABL inhibitor, 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. Last July, the species was approved for FDA clinical trials and went directly to Phase I clinical studies. HQP1351, China's first third-generation BCR-ABL targeted drug-resistant CML treatment, is currently in the critical Phase II clinical trial phase and plans to submit a new drug listing application (NDA) this year. It is worth mentioning that the progress of HQP1351's Clinical Phase I trial in China has been included in the annual meeting of the American Society of Hematology (ASH) for two consecutive years since 2018 and was nominated for the 2019 ASH "Best Research" award."CML's treatment is a clinical requirement that is not yet fully met at the global level," said Dr. Dajun Yang, Chairman and CEO of Asason Pharmaceuticals. The FDA Orphan Drug Qualification is an important milestone in the development and commercialization of HQP1351 products, and support for policies will help us accelerate the global clinical development and launch of this drug. In view of the positive clinical safety and ability data previously available, we will accelerate development in the hope that HQP1351 will reach patients around the world as soon as possible. " about Asaan PharmaceuticalsAsaan Pharmaceuticals is a China-based, global clinical stage of the original innovative drug research and development enterprises, committed to the treatment of cancer, hepatitis B and aging-related diseases and other therapeutic areas of innovative drugs. The company has its own research and development of protein-protein interaction targeted drug design platform. On October 28, 2019, AXA Pharma was successfully listed on the Main Board of the Hong Kong Stock Exchange.Asasin Pharmaceuticals' product pipeline focuses on inhibitors of key proteins in the apoptosis pathway, restarting apoptosis procedures for tumor cells by inhibiting BCL-2, IAP or MDM2-p53, and second- and third-generation inhibitors for kinase mutants in cancer treatment. The company currently has 8 class 1 new drugs have entered the clinical development stage, is in China, the United States and Australia to carry out more than 30 I/II clinical trials. (
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