【SHANGHAI, China, November 6, 2026】Shanghai Allist Pharmaceuticals Co., Ltd (hereinafter referred to as "Allist" or the "Company"; stock code: 688578.SH) today announced that AST1001 for Injection (hereinafter referred to as "AST1001"), independently developed by the Company, has been approved by the National Medical Products Administration (NMPA) of China (acceptance number: CXSL2601080; approval notice number: 2026LP03414) to conduct clinical trials as monotherapy in patients with locally advanced or metastatic solid tumors.

In October 2026, AST1001 received clinical trial (Investigational New Drug, IND) approval from the U.S. Food and Drug Administration (FDA) (IND number: 183542) for the treatment of adult patients with locally advanced or metastatic solid tumors who have failed prior standard-of-care therapy. With these approvals, AST1001 has been cleared to enter clinical development in both China and the United States, becoming Allist's first in-house antibody-drug conjugate (ADC) to enter the clinical stage. This milestone marks the formal transition of the Company's biologics R&D from early-stage platform development into clinical validation, and represents a substantive step for Allist in expanding beyond its established focus on small-molecule targeted therapy for lung cancer into the broader treatment landscape of solid tumors.

About AST1001

AST1001 is an antibody-drug conjugate (ADC) independently developed by Allist with full proprietary intellectual property rights. It consists of a bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (c-MET), conjugated to a Topoisomerase I (Topo-I) inhibitor payload-linker independently developed by the Company. AST1001 is intended for the treatment of locally advanced or metastatic solid tumors after failure of standard-of-care therapy.

EGFR mutation is currently one of the key tumor therapeutic targets of clinical interest and is relatively common in epithelial-derived tumors such as non-small cell lung cancer (NSCLC), gastrointestinal cancers and squamous cell carcinoma of the head and neck. The dual-target therapeutic strategy combining EGFR and c-MET inhibition represents an important research direction at present. Multiple clinical studies have demonstrated the substantial potential of EGFR/c-MET bispecific ADCs in patients with advanced solid tumors, which may bring more treatment options to patients.

Chairman's Statement

Mr. Du Jinhao, Chairman and General Manager of Allist, commented: "AST1001 is the first in-house ADC of Allist to enter the clinical stage. Since establishing our biologics R&D team in July 2024, we have completed the entire chain — from platform construction and molecule design to IND filings in both China and the U.S. — in just over two years, which is a testament to Allist's independent R&D capabilities and efficiency. The Company will adhere to its 'small molecule + large molecule' dual-drive strategy, steadily advance its subsequent pipeline, and rigorously validate the clinical value of AST1001 through well-designed clinical studies, with the aim of providing patients with new treatment options."

About Allist

Shanghai Allist Pharmaceuticals Co., Ltd, founded in March, 2004, is an innovative pharmaceutical company with a fully integrated system for research and development, manufacturing, and commercialization of novel oncology drugs with a purpose to meet with medical needs across the globe. In accordance with its development concept “Advancing Long Life with Innovation of Science and Technology”, Allist is dedicated to self-develop First-in-class and Best-in-class drug candidates. After more than 20 years of endeavor, Allist has independently discovered and launched multiple approved innovative drugs and built comprehensive capabilities to continuously develop proprietary anti-tumor therapies with proven clinical efficacy. On December 2nd, 2020, Shanghai Allist Pharmaceuticals Co., Ltd. was officially listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange (stock number: 688578). 

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