Ascent Pharmaceuticals Nectinib is included in the proposed breakthrough treatment, and it is China's first BCR-ABL targeted CML drug

On March 22, the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that Guangzhou Shunjian Biomedical Technology Co.
, Ltd.
, a wholly-owned subsidiary of Ascent Pharmaceuticals, used Bcr-Abl T3151 kinase for the treatment of chronic myeloid leukemia (CML).
The inhibitor nectinib (HQP1351) is planned to be included in the list of species to be breakthrough treatment.

Screenshot source: CDE official website HQP1351 is an original Class 1 new drug under research by Ascent Pharmaceuticals, a new third-generation BCR-ABL tyrosine kinase inhibitor (Tyrosine Kinase Inhibitor, TKI), used to treat first- and second-generation TKI resistance Chronic Myelogenous Leukemia (CML), especially for CML patients with T315I mutation, has a good effect.

It is China's first three-generation BCR-ABL targeted drug resistant chronic myelogenous leukemia (CML) treatment.

In July 2019, HQP1351 was approved by the U.
S.
Food and Drug Administration (FDA) for clinical trials and directly entered phase Ib clinical trials.

In May 2020, the drug has successively obtained the orphan drug qualification and the fast-track review qualification granted by the US FDA.

In addition, HQP1351 submitted a new drug listing application in China in June 2020, which is also the first NDA since the establishment of Yasheng Pharmaceutical.

In October 2020, HQP1351 was included in the priority review and approval procedure by CDE.

Screenshot source: CDE official website.
With the release of the movie "I'm Not the God of Medicine", chronic myelogenous leukemia (CML) is well known to everyone.
It is a rare malignant hematological disease, accounting for 15% of adult leukemia, with a global incidence of 1.
6- 2/100,000, the epidemiological survey in several regions of our country shows that it is 0.
39-0.
55/100,000.

The median survival time of patients in the chronic phase is 3 to 5 years.
Once they become acute leukemia, they will die in a short period of time.The advent of the sky-high price drug "Gleevec" has brought new hope to patients, but clinical results show that about 10% of patients with chronic myeloid leukemia may have T315I mutations and develop resistance to the drug.

The emergence of Niketinib may alleviate this situation and bring new hope to patients with chronic myelogenous leukemia.

It is reported that the Phase II clinical study of Nectinib included a total of 41 CML-CP patients with a median follow-up time of 7.
9 months.

The results of the study showed that the 3-month progression-free survival rate (PFS) of patients was 100%, the 6-month PFS was 96.
7%, and the major cytogenetic response (MCyR) rate was 75.
6%, of which 65.
9% obtained a complete cytogenetic response ( CCyR), 48.
8% of patients achieved major molecular biological remission (MMR).

This indicates that HQP1351 has good efficacy and tolerability in TKI-resistant CML-CP and CML-AP patients with T315I mutation, and with the extension of treatment time, the remission rate and depth of remission will further increase.

So far, in addition to Gleevec (Imatinib), targeted drugs for the treatment of myeloid leukemia include Dasatinib (Dasatinib) and Nilotinib (Nilotinib) from Novartis Pharma Stein AG.
, Wyeth's Bosutinib (Bosutinib), ARIAD's Ponatinib (Ponatinib).

I hope that in the future, Niketinib can break through the barriers and bring new surprises to patients with myeloid leukemia.

End reference materials: [1] Yasheng Pharmaceutical's official website