Yasheng Pharmaceuticals has won six FDA orphan drug qualifications.

“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.

Yasheng Pharmaceuticals, as a company aimed at targeting Chinese and global patients.“No medicine to cure, not yet satisfied”of clinical needs, R & D has“First-in-Class”and“Best-in-Class”Potential international new original small molecule drugs to fill the domestic gap and enter the international high-end pharmaceutical market of original new drug research and development enterprises, so far, Yasheng Pharmaceutical has a total4A new drug is being developed.6ItemFDAOrphan Drug Eligibility.

In May this year, the third generation of Yasheng MedicineBCR-ABLinhibitorsHQP1351ObtainFDAOrphan Drug Eligibility, IndicationsChronic myeloid leukemia (CML);7Months and9The month,FDAPredictionAPG-2575Two Orphan Drug Eligibility, Indications for Fahrenheit Macroglobulinemia(WM)And chronic lymphocytic leukemia(CLL);9The month,FDAPredictionMDM2-p53inhibitorsAPG-115Orphan drug qualification for the treatment of gastric cancer;10Month9On the same day, Yasheng Pharmaceuticals announced that it had won two more.FDAOrphan Drug Certification:FDAGrant its apoptosis pipeline in the development of new drugs.MDM2-p53inhibitorsAPG-115,Bcl-2/Bcl-xLinhibitorsAPG-1252Two orphan drug qualifications for the treatment of acute myeloid leukemia (AML) and small cell lung cancer (SCLC）。

HQP1351Yasheng Medicine is researching the original1Class of new drugs, for 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. Last year7In January, the variety was awarded to the U. S.FDAClinical trial permission, direct entryIbPhase clinical studies.HQP1351The first three generations of ChinaBCR-ABLtargeted drug resistanceCMLTherapeutic drugs are now in criticalIIIn the phase of clinical trials, it is planned to submit a new drug listing application this year (NDA）。

APG-2575It is a new type of oral administration under research by Yasheng Medicine.Bcl-2selective small molecule inhibitors,Has been the United States, China, Australia, a numberIb/IIThe clinical trial license is advancing the clinical development of multiple blood tumor indications globally. which as monotherapy or combination therapy for relapses/refractoryCLL/SLL (small lymphocytic lymphoma)a globalIb/IIPhase I clinical studies are ongoing and patient recruitment is ongoing in the United States and Australia.

APG-115is an oral, highly selective small moleculeMDM2inhibitors, yes.MDM2with high binding affinity, by blockingMDM2-p53interaction to restorep53tumor suppressor activity.APG-115It is also the first to enter the clinical stage in China.MDM2-p53A number of clinical studies for the treatment of solid tumors and hematological tumors have been carried out in China and the United States.

APG-1252A new high-efficiency small molecule drug independently developed for Yasheng Pharmaceuticals, which can be selectively inhibited.Bcl-2andBcl-xLProtein repair apoptosis. Clinical for patients with advanced cancer is ongoing in the United States and AustraliaIPhase dose ramp-up trial in the United States for combination paclitaxel treatment of relapsed refractorySCLCThe patient'sIb/IIperiod trials, and conducted in China againstSCLCPatients with single-drug clinicalIPhase dose climbing test. Clinical data show that,APG-1252InSCLCand other advanced solid tumor patients with good safety, and preliminary showed efficacy.

Chronic myeloid leukemia (CML), Fahrenheit macroglobulinemia(WM)And chronic lymphocytic leukemia(CLL)Gastric cancer, acute myeloid leukemia (AML) and small cell lung cancer (SCLC) and other diseases are clinical needs that are not yet fully met at the global level.. ObtainFDAOrphan Drug EligibilityidentifiedHQP1351,APG-2575,APG-115andAPG-1252Important milestones in product development and commercializationIt fully illustrates the United States.FDAThe recognition of the quality and clinical effect of Yasheng Pharmaceutical products, and the support of relevant policies will also help Yasheng Pharmaceutical Company to speed up this.severalGlobal clinical development and product launch of drugs, which can benefit more early.rare diseasePatients.