Stock code: 688578 Stock abbreviation: Allist Announcement No.: 2025-001

Shanghai Allist Pharmaceutical Technology Co., Ltd. voluntarily disclosed its information about furmetinib

Announcement of the approval of the drug clinical trial for the new indication

The board of directors and all directors of the company guarantee that there are no false records, misleading statements or material omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content in accordance with the law.

Important Content Notes:

Shanghai Allist Pharmaceutical Technology Co., Ltd. (hereinafter referred to as the "Company") recently received the "Drug Clinical Trial Approval Notice" approved and issued by the State Medical Products Administration (hereinafter referred to as the "State Food and Drug Administration"), and the clinical study of the new indication of Furmetinib Mesylate Tablets (hereinafter referred to as "Vormetinib") has been approved for drug clinical trials. The relevant information is hereby announced as follows:

1. Relevant information on the approval of clinical trials

Name of the drug: Vormetinib mesylate tablets

Name of Applicant: Shanghai Allist Pharmaceutical Technology Co., Ltd

Acceptance number CXHL2401238

Notice No. 2025LP00167

One to evaluate furmetinib versus placebo adjuvant therapy with nonmenstrual epidermal growth factor receptors

Specific Clinical Trials Stage IB-IIIB with canonical mutations and after radical resection with or without adjuvant chemotherapy is not small

A randomized, controlled, double-blind, global multicenter III of efficacy and safety in subjects with cellular lung cancer

Phase of the study

The MD Anderson Cancer Center team in the United States published a study in the authoritative journal Nature in 2021

The study analyzed the molecular biology of tens of thousands of patients with EGFR-mutated NSCLC, of which 30.8% had non-classical EGFR mutations and 2.2% had both non-classical mutations and other mutations.

Approximately 30% of patients with NSCLC are diagnosed with stage I-IIIB resectable NSCLC, which is surgically curative

Excision is the treatment of choice. Although the prognosis of patients treated with radical surgery is better than that of patients with advanced disease, the 5-year survival rate for patients treated with surgery alone remains low.

Currently, there are no EGFR-TKI drugs approved for surgery in patients with non-classical EGFR-mutant NSCLC

There is an unmet clinical need for post-adjuvant therapy, and there is an urgent need for more effective and safe treatment options. Based on previous preclinical and clinical data from Furmetinib, this study aims to evaluate the efficacy and safety of Furmetinib compared with placebo adjuvant in the treatment of subjects with stage IB-IIIB non-small cell lung cancer (NSCLC) who harbor non-classical epidermal growth factor receptor mutations and undergo radical resection with or without adjuvant chemotherapy, and this study is expected to provide a new drug treatment option for this population.

Second, the relevant situation of drugs

Furmetinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), a Class 1 small molecule targeted drug independently developed by the Company. Furmetinib is a highly selective and irreversible third-generation EGFR-TKI, mainly used for the treatment of EGFR-mutated non-small cell lung cancer, with differentiated competitive advantages of "brain conversion, excellent efficacy, good safety and wide treatment window", and its second-line and first-line indications have been included in the "National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalogue".

3. Risk Warning

Due to the characteristics of innovative drugs such as high-tech, high-risk, and high value-added, the drug has a long cycle and many links from early research and development, clinical trial approval, clinical trial development to drug approval, and its process is affected by a variety of uncertain factors, the specific clinical research plan and research cycle will be adjusted accordingly according to the actual situation, the company will actively carry out the above research and development projects in accordance with the requirements of relevant national laws and regulations, and timely fulfill the obligation of information disclosure.

The announcement is hereby made.

Board of Directors of Shanghai Allist Pharmaceutical Technology Co., Ltd

January 18, 2025