The first in the world! Heji Pharmaceuticals ITK Inhibitor Approved for Clinical

October 26, 2021

On October 26, 2021, Heji Pharmaceuticals announced that the world’s first ITK inhibitor to enter the clinical development stage, the clinical trial application of CPI-818 for oral use has obtained the clinical trial approval of the NMPA Drug Approval Center, which is intended to be used for relapse/ Refractory T-cell lymphoma. Heji Pharmaceutical has the authority of CPI-818 Greater China. It is expected to bring new therapies to Chinese patients with T-cell lymphoma. This is also the first clinical trial approval obtained by Heji Pharmaceutical. CPI-818 is an inhibitor that can strongly inhibit ITK kinase. In the first human clinical trials conducted in the United States, South Korea, and Australia, it has shown definite efficacy and good safety and tolerability. As of February 17, 2021, a total of 25 patients worldwide (16 in the dose-escalation phase and 9 in the expansion phase) have received CPI-818 treatment. Preliminary clinical data suggest that CPI-818 has good safety and tolerability. No dose limiting toxicity (DLT) was observed during the dose escalation period. Among patients with primary cutaneous T-cell lymphoma (CTCL), one patient with CTCL-Sezary syndrome had reduced target lymph nodes and no FDG active lesions, and the lymph nodes reached complete remission (CR). During the dose escalation phase, of the 7 patients with PTCL-NOS who received CPI-818 ≥ 200 mg BID, 2 patients achieved remission. One patient with PTCL-NOS achieved complete remission (CR) lasting 15 months, and one patient had a confirmed partial remission (PR) lasting 5 months and successfully received allogeneic transplantation during PR. Dr. Richard Miller, co-founder and chairman of Heji Pharmaceutical, said: “I am very pleased that CPI-818 has been approved for clinical use in China. We will work with experts in the field of lymphoma in China to fully advance the progress of CPI-818 clinical trials, strive to be approved for listing in China as soon as possible, and bring revolutionary solutions to patients with relapsed/refractory T-cell lymphoma To meet urgent clinical needs." Professor Song Yuqin, director of the Chinese Society of Clinical Oncology (CSCO), Secretary-General of the Chinese Society of Clinical Oncology (CSCO) Anti-Lymphoma Alliance, and Professor Song Yuqin, Department of Lymphoma, Peking University Cancer Hospital, said: "Relapsed/Refractory T Cell lymphoma is a major problem in the clinical work of non-Hodgkin’s lymphoma. At present, the five-year survival rate of most patients is only 10-30%. We are very pleased to see that Heji Pharmaceutical has brought a new target of ITK inhibitors. Going to China, I hope that the clinical development of the product in the country will progress smoothly, and I look forward to the early launch of the product, which will bring good news to many patients with relapsed/refractory T-cell lymphoma."

About CPI-818

CPI-818 can strongly inhibit ITK kinase and is highly selective without affecting normal T cell proliferation and immune response. Interleukin-2 (IL-2) induces tyrosine kinase (ITK), which was first discovered in 1992, with a molecular weight of 72kDa protein kinase, which plays an essential role in the activation, differentiation and proliferation of Th2 cells. T-cell lymphoma is a rare subtype of non-Hodgkin's lymphoma, which is aggressive and heterogeneous. It has been confirmed that ITK plays a key role in the signal transduction, differentiation, development and cytokine production of T cells. Therefore, ITK has become a very potential target in the treatment of T lymphocyte proliferative diseases.

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