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Avitinib, who was expected to win the title of "the first domestically produced third-generation EGFR-TKI", was overtaken by Amitinib and missed the first one.
At present, there are three third-generation EGFR-TKIs in China that have been declared for listing, namely Hausen’s Ametinib (formerly known as ometinib), Aisen’s Ivertinib and Iris’ vometinib.
(Source: NMPA official website)
Why is avitinib not approved for so long?
From the start of production in June 2018, to now it is almost three years, why has avitinib not been listed after repeated issuances? I guess the main reason is insufficient clinical data.
In June 2018, Avitinib was applied for the market with Phase II clinical data (registration number: CTR20161018).
(Source: Drug Clinical Trial Registration and Information Disclosure Platform)
In June 2019, Avitinib appeared at the 55th ASCO Annual Meeting and announced the results of the Phase II clinical study of Avitinib in the treatment of NSCLC.
Histogram of changes in target lesions of patients in different dose groups of avitinib
(From public information)
In terms of safety, the adverse events reported by subjects treated with Avitinib were mainly grade 1 or 2.
While the industry is curious about when avitinib will be listed, in May 2020, Aisen and Sorrento formally signed a cooperation agreement, and Sorrento obtained an exclusive license for avitinib maleate, which is applicable to all outside China For all indications in the region, the final terms of the license will be stated in the final agreement between the two parties.
(Source: Sorrento official website)
At present, the progress of Avitinib is still slow, and the road to market is full of unknowns.
Vometinib may become the second domestic third-generation EGFR-TKI to be marketed
In December 2019, Iris Vometinib (formerly known as Iflutinib) applied for listing and was subsequently included in the priority review.
(Source: Medicine Rubik's Cube)
Beda joins the battle
In February 2021, after the completion of the Phase II clinical trial of the third-generation EGFR-TKI BPI-D0316 of Betta, after a series of data management and statistical analysis work, a clinical trial summary report has been obtained.
However, there is no absolute limit.
Research and development progress of the third-generation EGFR-TKI
(Source: Insight database)
