The progress of new drugs, the first three-generation Gleevec in China!

Yesterday, the latest NMPA approval showed that the third-generation BCR-ABL inhibitor Orebatinib (Nelic®) of Ascent Pharmaceuticals was approved to be marketed for the treatment of resistance to any tyrosine kinase inhibitor (TKI).
The fully validated detection method diagnoses adult patients with chronic myeloid leukemia (CML) in chronic phase (CP) or accelerated phase (AP) with T315I mutation
.

This is the first third-generation BCR-ABL inhibitor developed by a local Chinese company, and it is also the first innovative drug approved by Ascent Pharmaceuticals since its establishment more than ten years ago
.

The approval of Yasheng Pharmaceutical Nellig is mainly based on the data of two key registration phase II clinical studies, namely the HQP1351CC201 study and the HQP1351CC202 study
.

Clinical data shows that Nerlik has good efficacy and tolerability in TKI-resistant CML-CP and CML-AP patients with T315I mutations, and with the extension of treatment time, the remission rate and depth of remission will be improved.
Further increase
.

 Directly attacking drug resistance, Orebatinib can be expected in the future.
When it comes to Orebatinib, you have to mention the movie "I am not the god of medicine".
The prototype of the "magic medicine" Glenin in the movie is Gleevec.
One of the earliest drugs to turn cancer into a chronic disease, used to treat chronic myelogenous leukemia (CML) and malignant gastrointestinal stromal tumors, etc.
Orebatinib is another iteration of Gleevec
.

CML is a malignant tumor related to white blood cells, but studies have found that targeting drugs designed for the BCR-ABL gene on the chromosome can kill cancer cells.
As a result, the first generation of BCR-ABL inhibitors has become a treatment for CML.
"Lifesaving medicine"
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However, although the first-generation BCR-ABL inhibitors and several subsequent second-generation drugs have significant clinical benefits for the treatment of CML, acquired resistance has always been the main challenge for CML treatment
.

 Mutations in the kinase region of BCR-ABL are one of the important mechanisms of acquired drug resistance.
The currently confirmed mutation sites include four types: P-loop (phosphate-binding loop; M244, G252, Y253, E255), gatekeeper residues (Imatinib binding site; T315, F317), SH2 binding region and C-lobe (mutations near the catalytic domain; M351, F359), activation loop (H396)
.

Among them, T315I mutation is one of the common types of drug-resistant mutations, and the incidence rate in drug-resistant CML is as high as about 25%
.

CML patients with T315I mutations are resistant to all current first- and second-generation BCR-ABL inhibitors.
Under the dilemma that patients have no drugs available, there is an urgent need for effective new-generation therapeutic drugs in clinical practice
.

 At present, Nallik is the second third-generation BCR-ABL inhibitor to be marketed in the world.
In 2018, Orebatinib entered clinical trials.
In July 2019, this species was approved by the US FDA for clinical trials and directly entered phase Ib.
Clinical research
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In May 2020, Orebatinib successively obtained the orphan drug qualification and the fast-track qualification for review granted by the US FDA
.

In addition, Orebatinib has been selected as an oral report at the annual meeting of the American Society of Hematology (ASH) for four consecutive years
.

 In December 2020, at the 62nd ASH Annual Meeting, Ascent Pharmaceuticals announced the results of two key registration phase 2 clinical studies of HQP1351.
These two studies were respectively aimed at the chronic phase and the chronic phase of TKI-resistant CML with T315I mutation.
Accelerated patients
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At the 2021 ASH meeting to be held in December this year, Yasheng will present its latest data in the form of an oral report
.

 Focusing on the tens of billions market, the market for Orebatinib is expected to be considerable.
According to Zhitong Finance APP, from the perspective of market space, the global CML market for Orebatinib will increase to US$5.
8 billion in 2030, while in China The CML drug market is expected to grow to 14.
2 billion yuan by 2023
.

 Image source: Zhitong Finance From the perspective of market competition, domestic CML treatment has fewer drug choices than Western developed countries, and only imatinib, nilotinib and dasatinib are currently on the market
.

Other second-generation TKIs, such as Bosutinib, and the first third-generation TKI, Panatinib, are not currently on the market in China
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Especially for CML patients with drug resistance or poor efficacy or advanced stage, the third-generation TKI should be "just needed", but there is still a lack of such drugs in China
.

In other words, if it is successfully approved for listing in China, auribatinib will become the first third-generation BCR-ABL inhibitor to be marketed in China, with obvious market exclusivity
.

 At present, Yasheng Pharmaceutical has reached a strategic cooperation of up to 245 million U.
S.
dollars with Cinda Biotech in July this year.
One of the contents of the cooperation is that the two parties will jointly develop and commercialize Orebatinib in China
.

During the service trade fair held not long ago, Yasheng Pharmaceutical also announced that it has reached cooperation with genetic testing companies, Internet medical companies and other partners, looking forward to using precision testing, Internet hospital platforms, commercial insurance, etc.
to promote the precision and standardization of CML Treatment to improve the accessibility and affordability of oribatinib
.

End reference materials: [1]https://baijiahao.
baidu.
com/s?id=1717404489894891955&wfr=spider&for=pc[2]https://mp.
weixin.
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