Important Note:
Recently, Beijing SinoCellTech Biotechnology Co., Ltd. (hereinafter referred to as the "Company"), a controlling subsidiary of Beijing SinoCellTech Biotechnology Group, has received a Notice of Approval for Drug Clinical Trial from the National Medical Products Administration (hereinafter referred to as the "NMPA"), agreeing that the Company's self-developed product, SCTB35 Injection, should be carried out in CD20-positive B-cell non-Hodgkin's lymphoma indications. 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 time thereof 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:
I. Basic product information
1. Product name: SCTB35 injection
2. Acceptance No.: CXSL2300900
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 SCTB35 Injection submitted by the applicant meets the relevant requirements for drug registration, and the applicant agrees to carry out the clinical trial for the indication of CD20-positive B-cell non-Hodgkin's lymphoma.

II. Other relevant information of the product
SCTB35 is a CD20xCD3 bispecific antibody injection independently developed by the Company with the goal of differentiating its competitive advantages, which can achieve effective T-cell activation and tumor cell killing by mediating the formation of immune synapses between T-cells and tumor cells.
The clinical trial protocol submitted herein is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of SCTB35 in patients with relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma.

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 and implementation of clinical studies are subject to a variety of uncertainties, and the specific clinical study protocols 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 will be less than expected or even that the clinical studies will fail. In addition, there is uncertainty as to whether SCTB35 will obtain marketing authorization and the timing of obtaining marketing authorization.

2. In order to ensure the smooth conduct of the clinical study, the Company will need to continue to incur expenses for the related clinical trial. Other than that, it is not expected to have 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.

This announcement is hereby made.

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责编: editor