The clinical trial application of the long-term biological pan-FGFR kinase inhibitor KIN-3248 was approved

Recently, Jingjiu Biologics announced that the clinical trial application of KIN-3248, a new generation of FGFR inhibitor, has obtained the implied license of the Center for Drug Review (CDE) of the National Medical Products Administration, and intends to carry out clinical research
in Chinese mainland.
The study is an international multi-center Phase I clinical study approved by the US FDA in January 2022 to evaluate the efficacy and safety
of KIN-3248 in advanced solid tumors carrying FGFR2/3 gene modification.

As a new generation of irreversible small molecule pan-FGFR inhibitor, KIN-3248 has the characteristics
of high selectivity, irreversible and potency.
KIN-3248 is planned to be developed for the treatment of primary FGFR2/3 gene alterations as well as for the treatment
of solid tumors resistant to FGFR2/3 targeted therapy.

With four subtypes (FGFR1/2/3/4), FGFR is one of the hot targets of "pan-tumor therapy", and abnormalities
including FGFR gene mutation, fusion and amplification have been found in a variety of malignancies such as intrahepatic cholangiocarcinoma, gastric cancer, urothelial cancer, endometrial cancer, and breast cancer.
In China, about 32% [1], 14% [2], 11% ^[3] of patients with urothelial carcinoma, intrahepatic cholangiocarcinoma and gastric cancer were found to have abnormal
FGFR2/³ genes.
For FGFR kinase inhibitors that have been approved for marketing, secondary drug resistance greatly limits the clinical benefit of such drugs, and there is still a huge unmet clinical need, and a new generation of FGFR kinase inhibitors that can overcome FGFR-targeted therapy resistance is urgently needed to change this situation
。 In non-clinical studies, KIN-3248 not only demonstrated significant anti-tumor activity for tumors carrying primary FGFR2/3 gene modifications, but also has significant anti-tumor activity for tumors carrying FGFR2/3 secondary drug-resistant mutations, which is expected to become a best-in-class drug in the future, bringing new therapeutic hope
to patients.

Mr.
Tian Feng, CEO and Executive Director of Evergreen, said, "KIN-3248 is expected to bring substantial clinical benefits to patients with solid tumors with FGFR gene modifications; Long-term Biologics will continue to explore more precision cancer treatment options to provide more possibilities
for solving the unmet clinical needs of cancer patients.
"

       Reference

[1] Zhang R, et al.
J Urol.
2021 Oct; 206(4):873-884.

[2] Dong L, et al.
Cancer Cell.
2022 Jan 10; 40(1):70-87.
e15.

[3] Gu W, et al.
Am J Cancer Res.
2021 Aug 15; 11(8):3893-3906.