Another domestic third-generation EGFR inhibitor applied for listing and CSPC obtained exclusive authorization

Side effects: 8% of patients had serious adverse reactions related to grade 3-4 drugs, mainly skin rash, anemia, and neutropenia
.

Currently, BPI-7711 is advancing phase II and phase III clinical trials at full speed
.

The above three domestic third-generation EGFR-TKIs have no overall survival data, but osimertinib has been proven to significantly prolong the survival of lung cancer patients
.
Moreover, Osimertinib has successfully captured the first-line treatment of lung cancer
.

 Fierce competition in the domestic third-generation EGFR-TKI market

In addition to Ametinib, Vometinib, and BPI-771, there are currently 13 domestic third-generation EGFR inhibitors in the clinical stage, targeting first-line and second-line treatments for non-small cell lung cancer
.
Among them, Yifang Bio's second-line befortinib treatment has been declared and marketed, and the first-line treatment has entered clinical phase III.
Aisen Medicine's Avitinib has been sent to the title of "the first domestic third-generation EGFR-TKI", but it has been issued many times.
It has not yet been listed, and has been overtaken by Hausen and Ellis.
Now its clinical trials for first-line non-small cell lung cancer are in the phase III clinical research phase
.

In addition, ASK120067 from Osaikon and Oritinib from Nanjing Shenghe have also entered clinical phase III
.
If it can be successfully listed, it will further change the market structure of China's third-generation EGFR-TKI drugs and expand the market scale of the industry
.

It is worth mentioning that both osimertinib and ametinib are currently included in the national medical insurance
.
Among them, the price of Ametinib was reduced from the original price of 9800/box/55mg*20 tablets to 176 yuan/55mg tablets, a decrease of 64.
08%
.
AstraZeneca’s osimertinib, as the fastest imported new anti-cancer drug in China, was approved for listing in China in 2017 and was included in the national medical insurance in 2018.
The medical insurance negotiation will be renewed in 2020.
The medical insurance payment price is 5580 yuan/box (original price) 15300 yuan/box), the price reduction rate reaches 63.
5%
.

Since the IPASS study of the first generation of EGFR TKI gefitinib came out in 2005, targeted therapy has occupied a dominant position in the treatment of advanced NSCLC with positive driver genes
.
Targeted therapy has undergone rapid development in the past 15 years, which is surprising and exciting
.
In recent years, the drug R&D of China's local pharmaceutical companies has also entered a new period of rapid development, providing Chinese patients with new treatment options
.
In the future, as China's local pharmaceutical companies continue to improve their R&D capabilities, Chinese patients will also be able to enjoy drug treatments comparable to or even better than the international advanced level at relatively low prices
.

 Reference source:

1.
Analysis of resistance mechanisms to abivertinib, a third-generation EGFR tyrosinekinase inhibitor, in patients with EGFR T790M-positive non-small cell lungcancer from a phase I trial.
EBioMedicine.
2019 May;43:180-187.

2.
https://ascopubs.
org/doi/abs/10.
1200/JCO.
2019.
37.
15_suppl.
9091.

3.
https://