January 24, 2024 Source: https://mp.weixin.qq.com/s/kGdV5hX3S2pN8s5z6zQhSA 197
SinoCellTech (hereinafter referred to as the "Company") has received the Notice of Approval for Drug Clinical Trial issued by the State Drug Administration (hereinafter referred to as the "SDA"), agreeing that the Company's self-developed product, SCTC21C Injection, could be used in clinical trials for the treatment of CD38+ hematologic malignancies. (hereinafter referred to as the "Company") received a Notice of Approval for Clinical Trial of Drugs from the State Drug Administration (hereinafter referred to as the "SDA"), agreeing to carry out a clinical trial of the Company's self-developed product, SCTC21C Injection, for the treatment of CD38+ hematologic malignancies. As there are many unpredictable factors in the process of clinical trial of drugs, the results of clinical trial, review and approval as well as the timing are subject to a certain degree of uncertainty, we respectfully request investors to make decisions cautiously and pay attention to the prevention of investment risks.
The relevant information is announced as follows:
Basic information
Approval Conclusion: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after examination, the SCTC21C Injection submitted by the applicant meets the relevant requirements for drug registration, and it is agreed to carry out the clinical trial of CD38+ hematologic malignancies.
Other relevant information of the product
CD38 is a transmembrane glycoprotein expressed on the surface of hematopoietic cells, which is commonly expressed on the surface of various hematopoietic cells (plasma cells, NK cells, B cells, T cells and granulocytes, etc.), and the expression level in malignant hematopoietic cells is significantly higher than that of corresponding normal cells, and it is an important target for the treatment of CD38+ hematological tumors.
SCTC21C product is a monoclonal antibody injection targeting CD38 developed by the company.SCTC21C can enhance the killing effect on CD38+ tumor cells by modifying the Fc segment. Preclinical studies have shown that SCTC21C has favorable preclinical pharmacokinetic and safety results.
The clinical trial protocol submitted herein is a Phase I clinical study evaluating the safety and efficacy of SCTC21C in subjects with CD38+ hematologic tumors.
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