Innovent's 2 bispecific antibodies were approved for clinical use

Text|Pharmaceutical Mission Hills

On September 14, the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China announced that the two new class 1 biological drugs declared by Cinda Biologics have been approved for clinical use, namely the CD3/Claudin 18.

Screenshot source: CDE official website

According to public information, bispecific antibodies are one of Cinda's key research and development areas

Bispecific antibody therapy is another way to use T cells in the patient's immune system to kill tumors

(1) IBI389: CD3/Claudin 18.

It is reported that IBI389 is a bispecific antibody that can simultaneously target CD3 and Claudin 18.

Claudin protein is a tight junction (tight junction) molecule, and its function is mainly to adjust the permeability of the barrier structure

However, studies have found that Claudin 18.

(2) IBI322: CD47/PD-L1 bispecific antibody

Public information shows that IBI322 is a potential "first-in-class" recombinant anti-CD47/PD-L1 bispecific antibody developed by Cinda.

CD47 (recombinant fully human anti-differentiation antigen cluster 47) protein is an immunomodulatory molecule overexpressed on cancer cells.

By targeting the two pathways of CD47 and PD-L1, IBI322 is expected to enhance the body's ability to kill tumor cells

According to the announcement issued by Cinda Biologics, the product is a molecule with "first-in-class" potential, which is more compatible with tumor tissues, thereby reducing the toxicity of the target to normal tissues and delaying the occurrence of drug resistance.

In addition to the two products, bio-letter bispecific antibody product line further comprises an anti-PD-1 / PD-L1 double-antibody IBI318, anti-PD-1 / HER2 double antibody IBI315 the like

Reference materials:

[1] Center for Drug Evaluation of China National Medical Products Administration.