The IPO application of Yifang Bioscience Innovation Board was accepted, the third-generation EGFR-TKI entered the NDA, and the domestic competition was fierce

On April 16, the Shanghai Stock Exchange disclosed that it accepted the IPO application of Yifang Biotechnology (Shanghai) Co.
, Ltd.
(hereinafter referred to as: Yifang Bio).
The information showed that Yifang Biotechnology plans to raise 2.
409 billion yuan for the IPO.
New drug project research and development and headquarters base construction
.

Yifang Bio is an innovative drug research and development company with a global perspective based in China, focusing on major diseases such as tumors and metabolic diseases
.

With in-depth research and understanding of the mechanism of disease, the company selects potential drug targets, designs drugs based on the binding conformation of the compound and the target, and achieves precise treatment of diseases while ensuring excellent human safety

Yifang Biological Research Pipeline (picture from Yifang Biological Prospectus)

The prospectus shows that the third representative skin growth factor receptor (EGFR) tyrosine kinase inhibitor BPI-D0316, independently developed by Yifang Biological, can be used to treat EGFR mutation-positive non-small cell lung cancer (NSCLC)
.

At present, BPI-D0316 has completed the second-line registration clinical trial of NSCLC, and the new drug application (NDA) has been accepted by the National Medical Products Administration (NMPA) in March 2021, and it is expected to be approved for marketing in 2022

According to the results of the Phase 2 registration trial of BPI-D0316, the objective response rate of BPI-D0316 in the treatment of locally advanced or metastatic non-small cell lung cancer patients who have developed T790M mutations after resistance to EGFR inhibitors has been assessed by the Independent Review Committee (IRC) (ORR) is 64.
8%, and disease control rate (DCR) is 95.
2%
.

The objective intracranial response rate (iORR) was 52.

       At present, the domestic three-generation EGFR-TKI competition is fierce
.

Three drugs, AstraZeneca’s osimertinib, Hausen’s ametinib, and Iris Medical’s vometinib, have been approved for marketing

       In addition, Beierda's BPI-7711, ASK120067 from Osaikon, Avitinib from Aisen Medicine, and Auritinib 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

       Progress in clinical research on the first and second-line treatment of non-small cell lung cancer with third-generation EGFR-TKI drugs in China

       According to public information

       It can be seen from the above that the domestic competition of the third-generation EGFR-TKI is still very fierce, and most of the current third-generation new drugs are in the clinical research stage
.

Yifang Bio's BPI-D0316 marketing authorization application has been accepted, and we look forward to being approved for listing as soon as possible to benefit patients as soon as possible

       Founded in 2013, Yifang Bio is a biomedical technology company engaged in the research and development of innovative drugs
.

It mainly researches and develops independent innovative drugs for major diseases such as tumors and metabolic diseases .

       Reference source:

       1.
Yifang Bioscience Innovation Board IPO prospectus;

       2.
CDE official website
.