On January 28, 2022, Shenzhen Aixindawei Pharmaceutical Technology Co., Ltd. (hereinafter referred to as: "Aixindawei" or "the Company") reported that the company’s independently developed small molecule targeted conjugate new drug (project number: AST-001) based on the AKR1C3 enzyme-activated prodrug platform has obtained NMPA’s implicit approval to enter clinical trials (acceptance number CXHL2101680) (Press release, Ascentawits Pharmaceuticals, JAN 28, 2022, View Source [SID1234650302]). The indication is malignant solid tumors. This is another major milestone in the company’s development after the company’s first project AST-3424 obtained NMPA’s implicit approval to enter clinical trials on June 13, 2019.

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Dr. Jianxin Duan, founder and chairman of Aixindawei Pharmaceuticals, said: "We are very pleased that the AST-001 project, another small molecule targeted conjugate new drug independently developed based on the AKR1C3 enzyme-activated prodrug platform, has obtained implicit approval for clinical trials from the NMPA. Multiple preclinical in vitro and in vivo studies have demonstrated that AST-001 has good safety and broad-spectrum anti-tumor activity. In addition, AST-001 has shown encouraging pharmacodynamic effects in multiple in vivo tumor models with high expression of AKR1C3 and KRAS G12D mutations. We are very much looking forward to the clinical performance of AST-001, which will bring more effective and more beneficial treatment options to patients with different tumor types and contribute to a healthy China."