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Article source: Medical Rubik's Cube Info
Author: Shi Bei
On November 1, the clinical application of the bispecific antibody HLX35 targeting EGFR and 4-1BB dual targets by Henlius was officially accepted by the State Food and Drug Administration
.
This is the first domestic EGFR/4-1BB double antibody to be declared clinically
Data from pre-clinical animal experiments show that HLX35 can effectively combine the advantages of two targets.
It can bind to EGFR molecules on the tumor surface, block tumor signal transduction pathways, and kill tumor cells
.
It can also be combined with 4-1BB immune activation molecules on the surface of immune cells (T cells and NK cells) to make more immune cells gather around the tumor and stimulate the activity of immune cells in the tumor microenvironment, thereby synergistically killing tumor cells , Improve curative effect
In November 2020, Henlius and Binacea signed a license and joint development agreement, granting Binacea the global development, production and commercialization rights of HLX35 excluding Mainland China, Hong Kong, Macau and Taiwan
.
The down payment is 5 million U.
According to the NextPharma database of Medicine Rubik’s Cube, there are 5 bispecific antibodies in Henlius’ pipeline, including HLX35 (EGFR/4-1BB double antibody), HLX301 (PD-L1/TIGIT double antibody), HLX31 (HER2/CD3 Double antibodies), HLX304, HLX36
.
Among them, HLX35 is the company's first dual-antibody product to be declared for clinical use
There are 10 domestic companies that have declared 4-1B monoclonal antibody, including Tianyan Pharmaceutical, Dingkang Biological, Huaaotai Biological, Lijin Biological and so on
.
In addition, 4-1BB/PDL1 double antibodies such as Kewang Biology, Weilizhibo Biology, Qilu Pharmaceutical have been approved for clinical use
