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Yasheng Pharmaceutical News Frequent-Won 9 U.S. FDA Orphan Drug Qualification Certifications

Release time:

2021-01-08 15:12

2021.1.8

“Orphan Drug”Also known as rare disease drugs, refers to drugs used to prevent, treat and diagnose rare diseases. In the United States, a rare disease is one in which the number of people with the disease is less20diseases of thousands of people. From1983Since the implementation of the Orphan Drug Act, the United States has given enterprises relevant policy support to encourage the research and development of rare disease drugs and obtain the United States.FDAOrphan drug qualification means that the drug will enjoy tax deductions and exemptions for clinical trial costs.NDAApplication fees, access to research and development grants, etc., especially if the drug is approved for the U.S. market for this indication.7years of exclusive rights, thus gainingFDAOrphan drug identification has been regarded as one of the important indicators of global innovation strength.

In recent years, China's biomedical innovation power is rising day by day, and as a leader in global innovation-Yasheng Pharmaceuticals, since2020Since the year, good news has been reported frequently, and it has been continuously obtained.9The United StatesFDAOrphan drug qualification certification has become a leader in China's biomedical enterprises.

Up to now:

FDAPredictionHQP1351one itemOrphan drug qualification, indication for chronic myeloid leukemia (CML）。HQP1351Is a new oral third-generationBCR-ABLinhibitors, yes.BCR-ABLas well as includingT315IA variety of mutations.BCR-ABLMutants have outstanding effects for the treatment of first and second generationsTAKESdrug-resistantCMLPatients.

FDAPredictionAPG-2575four itemsOrphan Drug Eligibility, Indications for Fahrenheit Macroglobulinemia(WM)Chronic lymphocytic leukemia(CLL), multiple myeloma (MM) And acute myeloid leukemia (AML）。APG-2575is a paragraphBcl-2selective small molecule inhibitors, by selectively inhibitingBcl-2proteins to restore the tumor cell programmed death mechanism (apoptosis).

FDAPredictionAPG-115three itemsOrphan drug qualification, indications for gastric cancer, acute myeloid leukemia (AML) and soft tissue sarcomas (STS）。APG-115is an oral, highly selective small moleculeMDM2inhibitors, yes.MDM2with high binding affinity, by blockingMDM2-p53interaction to restorep53tumor suppressor activity.

FDAPredictionAPG-1252one itemOrphan drug qualification, indicated for small cell lung cancer (SCLC）。APG-1252A new high-efficiency small molecule drug independently developed for Yasheng Pharmaceuticals, which can be selectively inhibited.Bcl-2andBcl-xLProtein repair apoptosis.

TheseCML,WM,CLL,MMThe treatment of rare diseases such as rare diseases is a clinical need that has not been fully met at the global level. Therefore, it is hoped that in obtainingFDAThe support of relevant policies after orphan drug qualification can help Yasheng Pharmaceutical Company to accelerate the global clinical development and product launch of these drugs, and benefit more patients with rare diseases as soon as possible.

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