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On August 21, insight databases showed that Haizheng Pharmaceuticals had launched a domestic open Phase I clinic for the safety of the class 1 new drug "HS236 Capsules" in advanced solid tumors.
drug is mainly used for hepatocellular carcinoma and other advanced malignant solid tumors.
from: Insight database HS236 is a select inhibitor of fibrous growth factor subjectivity 4 (FGFR4).
FGFR4 is a member of the family of the ligand tyrosine kinase involved in regulating cell proliferation, differentiation, metastasis and angiogenesis, and its expression abnormalities have been shown to be associated with a variety of solid tumors such as liver cell liver cancer, breast cancer, transverse muscular tumors and melanomas.
, there are some domestic companies in the FGFR4 inhibitor research and development, adaptation is mostly hepatocellular carcinoma.
FGFR4-specific inhibitor class has not yet been marketed.
hepatocellular carcinoma as a domestic high incidence of cancer, there is no ideal treatment, the development of new target drugs to help provide a new treatment for hepatocellular carcinoma.
is submitting HS236's clinical registration application to NMPA in May 2020 and has been formally accepted by CDE, and was granted a clinical implied license on July 29 to begin Phase I clinical treatment within one month.
The main purpose of this clinical trial is to evaluate the safety and toerability of HS236 capsules in patients with advanced solid tumors and to explore the maximum to-dosage (MTD) of HS236 to determine the recommended dose (RP2D) for Phase II clinical trials.
researcher is Li Jin, director of Shanghai Oriental Hospital.
the number of participants in the test target group is 48.
, according to the company's announcement, as of July 31, the company has invested about 20.72 million yuan in the drug research and development project.
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