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

1. Product name: SCTC21C Injection
2. Acceptance No.: CXSL2300778
3. Application matters: drug clinical trial
4. Applicant: SinoCellTech Cell Engineering Co.

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.

Risk Reminder

1. Pharmaceutical products are characterized by high technology, high risk and high value-added. After obtaining the clinical trial license, the pharmaceutical products still need to carry out clinical trials, obtain safety and efficacy data and be approved by the State Drug Administration before they can be marketed. The enrollment of the clinical studies and the implementation of the study programs are subject to a variety of uncertainties, and the specific clinical study programs and study cycles may be adjusted accordingly in light of the actual situation, and there is a risk that the results of the clinical studies may not be as expected or even that the clinical studies may fail. In addition, there is uncertainty as to whether SCTC21C will obtain marketing authorization and the timing of such authorization.
2. In order to ensure the smooth implementation of the clinical research, the Company will need to continue to spend the relevant clinical trial expenses, in addition to this, it is expected that there will not be a significant impact on the operating results of the Company in the short term. The Company will actively promote the aforesaid research and development project and carry out the subsequent related work in accordance with the relevant national regulations. Investors are advised to make decisions with caution and pay attention to investment risks.