Yasheng Pharmaceutical-B: Original 1 new medicine Nishik was allowed to conduct clinical trials in Canada

On July 22, 2022, Yasheng Pharmaceutical-B (06855.HK) announced that the company's 1-type new medicine Nishiki (O'rabatinib) has recently obtained the clinical trial of the Canadian Ministry of Health. IB clinical research on patients with chronic myeloblast leukemia (CML) and Philadelphia chromosomal positive acute lymphocyte leukemia (PH+ALL). This will be the first clinical study of Yasheng Pharmaceutical in Canada.

This study is a phase IB global clinical trial that is open label, multi -center, and randomly enrolled. Chronic period (CP), acceleration period (AP), and emergency change period (BP) patients and patients with PH+ALL are subject to the safety, effectiveness, pharmacokinetic characteristics (PK), and phase II clinical research recommendation dosage ( RP2D).

CML is a malignant tumor related to white blood cells. With the listing of TKI drugs targeting BCR-ABL, the treatment of CML has been innovated, but the obtaining TKL resistance has always been the main challenge of CML treatment, and the mutation of BCR-ABL kinase region is an important mechanism for obtaining drug resistance. one. At present, a new generation of drugs that need to be safe and effective clinically.

Orebatinib is a new drug of Yasheng Medicine. It is the third-generation BCR-ABL inhibitor orally for the treatment of CML for the first and second-generation TKI drugs. The mutant has a prominent effect. As of the date of this announcement, Orebatini has obtained a total of 1 FDA review of fast channel qualifications; 3 American FDA orphan drug qualifications are identified, and the indications are CML, ALL, and acute myeloid leukemia (AML); One orphan drug qualification is determined that the indication is CML.

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