On March 14, 2024 Shanghai Ailes Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Ailes") reported that its independently developed AST2169 liposome for injection (hereinafter referred to as "AST2169" ) has recently obtained the "Drug Clinical Trial" approved and issued by the State Food and Drug Administration (Press release, Allist Pharmaceuticals, MAR 14, 2024, https://www.allist.com.cn/newsd/101/2078.html [SID1234642112]). Approval Notice", approving its Phase I clinical study on safety, tolerability, pharmacokinetics and preliminary efficacy in patients with KRAS G12D mutated advanced solid tumors.
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AST2169 is a KRAS G12D selective inhibitor with global intellectual property rights independently developed by Alex . KRAS G12D mutation is a common subtype of KRAS mutation and is found in many types of cancers such as non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Although the role of KRAS mutations in human cancer has been known for decades, the development of anti-cancer therapies targeting KRAS mutations has been slow . Currently, no KRAS G12D inhibitors have been approved for marketing globally , and the growing clinical demand cannot Be satisfied.
According to statistics from the World Health Organization ( WHO ), there will be approximately 2.21 million new cases of lung cancer and 1.15 million new cases of colorectal cancer in the world in 2020 . In 2020 , there will be approximately 820,000 new cases of lung cancer and approximately 550,000 new cases of colorectal cancer in China . KRAS is a commonly mutated driver gene, and the incidence of KRAS mutations in cancer patients is 14%-30% . KRAS G12D is the predominant mutation subtype among KRAS mutations and is detected in approximately 30% of pancreatic cancers, 12% of colorectal cancers, and 4% of non-small cell lung cancers.
Mr. Du Jinhao, Chairman and General Manager of Ellis, said: "Alice has accumulated nearly 20 years of research and development experience in the field of oncology, and has been deeply involved in research and development, commercialization and other stages of precision treatment of lung cancer, aiming to continuously launch innovative products. , innovative solutions to meet the growing clinical needs of cancer patients and bring good news to cancer patients. "