Henlius Announces Second TIGIT Antibody Drug Application

On April 26, according to CDE's official website, Henlius' Class 1 new drug HLX53 was submitted for clinical application. HLX53 is an anti-TIGIT monoclonal antibody independently developed by Henlius. This is the first clinical application of this drug in China.

TIGIT, the full name of T cell immunoglobulin and ITIM domain protein, belongs to the poliovirus receptor (PVR)-like protein family and is a protein mainly expressed on the surface of immune cells (T cells) and natural killer cells (NK cells). Immune checkpoint proteins that inhibit the functioning of these immune cells.

Henlius has developed more than one drug for TIGIT targets. In addition to HLX53, Henlius has also developed PD-L1/TIGIT dual antibody HLX301. The drug was first announced for clinical use overseas in September 2021. It was first declared for clinical use in China on January 6 this year, and was just approved for clinical use on March 15 for advanced tumors. According to the 2021 annual report of Fosun Pharma, HLX301 has completed the first subject dosing in the Phase I clinical study in Australia in February this year. Globally, the project has carried out clinical trials for multiple indications, including non-small cell lung cancer, gastric cancer, gastroesophageal junction cancer, lymphoma, etc.

TIGIT is a relatively young immune checkpoint, but its research and development fever has remained high in recent years. According to the Insight database, there are 55 TIGIT antibody drugs under development worldwide, including 37 monoclonal antibodies and 14 double antibodies. Four drug candidates have progressed to Phase III clinical trials, of which Roche's Tiragolumab is the fastest.

According to the Insight database, there are currently 17 TIGIT antibody projects in the clinical stage in China, including 11 monoclonal antibodies and 6 double antibodies. Judging from the distribution of applications, in 2021, the number of domestic applications and the number of clinical projects initiated reached a peak.

From the perspective of the distribution of research and development progress, there are currently only 3 projects in phase III clinical trials in China. Among them, BeiGene's TIGIT monoclonal antibody Ociperlimab is not only the fastest progressing domestic project, but also ranks first in the world. BeiGene has launched a number of clinical trials in China, covering indications including esophageal squamous cell carcinoma, NSCLC, LS-SCLC, and large B-cell lymphoma.

Judging from the distribution of TIGIT targets, both Bio-Tech and Cinda have deployed more than one project. Bio-Tech's BAT6021 and BAT6005 are both TIGIT monoclonal antibodies, both of which were approved for clinical use in July last year, and both projects will be advanced to Phase I clinical research within 3 months. Innovent has developed both monoclonal antibodies and dual antibodies. The monoclonal antibody IBI939 was first launched in April 2020, while the PD-1/TIGIT dual antibody IBI321 was launched in May 2021.

In addition, there are more domestic companies deploying TIGIT target related products. For example, ZG005, which was deployed by Zejing Pharmaceuticals, was approved for clinical use for the first time in December last year and is currently conducting Phase II clinical research. Junshi's JS006, Huahui Anjian (Beijing) Bio's HH-101, and Primis Bio's PM1022 have also entered Phase 1 clinical trials. Several are still in preclinical research.