Chengdu Zenitar Biomedical Technology Co., Ltd. is committed to providing expanded access to the investigational drug Flonoltinib Maleate for patients with serious or life-threatening diseases who have no other satisfactory treatment options.

This policy is established in accordance with 21 U.S.C.§360bbb and relevant FDA guidance.

1. Conditions for Expanded Access

Expanded access will typically be considered only when all of the following conditions are met:

·The patient has a serious or life-threatening disease or condition;

·There is no comparable or satisfactory alternative therapy available;

·The patient is unable to participate in an ongoing clinical trial;

·The potential benefit justifies the risks of the treatment;

·Providing the drug will not interfere with the clinical trials supporting its marketing approval.

2. How to Submit a Request

Submitter: Requests for expanded access must be submitted by a licensed physician on behalf of the patient. We cannot directly accept applications from patients or their families.

Submission Content: Physicians should submit the following information to gangli@zenitar.cn/9^th Floor,Building E3,Frontier Medical Center,High-tech Zone,Chengdu,Sichuan Province,China]:

·Physician's name, affiliated institution, and contact information;

·Basic clinical information about the patient (disease diagnosis, stage, prior treatment history);

·The requested drug and intended indication;

·An explanation of why the patient cannot participate in a clinical trial or has no alternative treatment options.

3. Evaluation Criteria and Procedure

All requests will be reviewed by the Clinical Medicine Department. Evaluation is based on the following core factors:

·Whether the patient meets the applicable conditions above;

·Whether existing clinical data support the use of the drug for the requested indication;

·Whether the drug supply is sufficient and whether it would affect ongoing clinical trials;

·Ethical and compliance considerations.

4. Response Timeline

We will acknowledge receipt within 10 business days after receiving a complete application. An evaluation will then be initiated, and a decision will be communicated within a reasonable timeframe.

5. Clinical Trial Information

For clinical trial registration information regarding Flonoltinib Maleate, please visit ClinicalTrials.gov and search: NCT 07750574.

6. Contact Information

·Email: gangli@zenitar.cn

·Phone: +86-13574895515

Important Disclaimer: Flonoltinib Maleate has not been approved by the FDA for marketing, and its safety and efficacy have not been established. Provision of expanded access does not constitute a statement that the drug is safe or effective. The decision to provide the drug is at the sole discretion of Chengdu Zenitar Biomedical Technology Co., Ltd., and this policy may be modified at any time.