SinoCellTech Voluntarily Discloses Notice of Drug Clinical Trial Approval for SCTC21C, a Product of its Controlling Subsidiary

January 21, 2024  Source: drugdu 95

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Important Note: Recently, Beijing Shenzhou Cell Biotechnology Group Co.
(hereinafter referred to as the "Company") has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the "SDA"), agreeing that the Company's self-developed product, SCTC21C Injection, can be used for the treatment of CD38+. (the "Company") received a Notice of Approval for Clinical Trial of Drugs from the State Drug Administration (the "SDA"), agreeing to carry out clinical trials for the treatment of CD38+ hematologic malignancies for the Company's self-developed product SCTC21C Injection. As there are many unpredictable factors in the process of clinical trials of pharmaceutical products, the results and timing of clinical trials, review and approval are subject to certain uncertainties, investors are advised to make decisions with caution and take precautions against investment risks. The relevant information is announced as follows:

I. Basic Product Information
1. Product name: SCTC21C Injection
2. Acceptance No.: CXSL2300778
3. Application: Drug clinical trial
4. Applicant: SinoCellTech Cell Engineering Co.
Conclusion of Approval: According to the Drug Administration Law of the People's Republic of China and relevant regulations, after examination, the applicant submitted SCTC21C injection.
SCTC21C Injection meets the requirements for drug registration and is approved to conduct clinical trials for CD38+ hematologic malignancies.
malignant tumors.

II. 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 level of expression in malignant hematopoietic cells is significantly higher than that of the corresponding normal cells, and it is an important target for the treatment of CD38+ hematological tumors. SCTC21C is a monoclonal antibody injection developed by the company to target CD38. 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. This submission is for a Phase I clinical study to evaluate the safety and efficacy of SCTC21C in subjects with CD38+ hematologic tumors.

http://www.cninfo.com.cn/new/disclosure/detail?stockCode=688520&announcementId=1218945148&orgId=9900040621&announcementTime=2024-01-19

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