Tianjing Biotech's new dual-antibody TJ-CD4B for the treatment of gastric cancer received FDA orphan drug designation

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Dr.
Xiuxuan Zhu, President of IJBio, said: "We are very excited about the orphan drug designation granted by the FDA, which fully demonstrates the potential of TJ-CD4B as an innovative therapy for gastric cancer and its broad application prospects.

TJ-CD4B has an innovative role.

It has entered the clinical stage in both China and the United States

TJ-CD4B is the first innovative double antibody targeting tumor antigen claudin 18 spliceosome 2 (Claudin 18.
2) and T cell costimulatory molecule 4-1BB in clinical stage.
Increases lymphocytic tumor infiltration and exerts tumor-killing effect
.

Different from other Claudin 18.

TJ-CD4B is the key product of Tianjing Bio’s innovative dual-antibody pipeline, and is currently in Phase 1 in the United States and China for the treatment of various advanced solid tumors (including gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma and pancreatic duct adenocarcinoma).
Clinical trial ( NCT04900818 )
.

At present, its global clinical development has made a number of significant progress

Gastric cancer is the fifth most common cancer in the world and the third leading cause of death worldwide
.

Due to the mild symptoms of patients in the early stage, gastric cancer is usually diagnosed in the advanced stage, and the clinical prognosis is not optimistic

An orphan drug is a designation granted by the U.
S.
FDA for investigational new drugs and biologics developed to treat rare diseases (fewer than 200,000 patients in the U.
S.
), providing developers with a range of development incentives, including FDA approval Market exclusivity for 7 years post-marketing, tax credits for clinical trials, and waiver of FDA filing fees
.

[1] American Cancer Society.
Key Statistics about stomach cancer.
Available at: https://#:~:text=How%20common%20is %20stomach%20cancer,6%2C740%20men%20and%204%2C440%20women )

[2] Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A.
Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.
CA Cancer J Clin.
2018;68(6 ): 394–424.

About TJ-CD4B

TJ-CD4B/ABL111 was jointly developed by Tianjing Bio and South Korea’s ABL Bio (Kosdaq stock code: 298380 on the GEM market in South Korea).
Innovative bispecific antibody against the tumor antigen claudin 18 spliceosome 2 (Claudin 18.
2) and the T cell costimulatory molecule 4-1BB
.

The unique 4-1BB binding epitope of TJ-CD4B enables it to activate T cells only when it binds to Claudin 18.

About Tianjing Biology

IMAB (Nasdaq: IMAB) is an innovative international biotechnology company focusing on the research and development, production and commercialization of differentiated and innovative biological drugs in the field of tumor immunity
.

With the mission of "continuously developing innovative biological drugs to truly change the lives of patients", the company has rapidly established itself through diversified models such as independent research and development and global licensing cooperation, driven by the two-wheel strategy of "rapid product launch" and "rapid proof-of-concept".

Tianjing Biological Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including preclinical and clinical studies of TJ-CD4B, the potential impact of clinical trial data on patients, Tianjing Biological progress and expected clinical development plans, regulatory milestones and commercialization of TJ-CD4B
.

Actual results may differ materially from forward-looking statements as a result of various important factors

Tianjing Biological Contact
Long Jiang, Chief Financial Officer Feng Qi, Chief Communications Officer
IR@i-mabbiopharma.

com PR@i-mabbiopharma.
com                                       

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