On June 29, 2023, Shenzhen Aixindawei Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Aixindawei" or "the Company") reported that the company’s independently developed small molecule conjugated new drug (project number: AST-006) based on the "hypoxia activation" prodrug technology platform has obtained NMPA’s implicit clinical trial approval (acceptance number CXHL2300416), and its indication is BRCA1/2 mutant malignant tumors (Press release, Ascentawits Pharmaceuticals, JUN 29, 2023, View Source [SID1234650301]). This is another major milestone in the company’s development after the company’s first project AST-3424 and the second project AST-001 entered clinical trials.
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Dr. Jianxin Duan, founder and chairman of Aixindawei Pharmaceuticals, said: "We are very pleased that our third independently developed small molecule conjugate new drug, AST-006 project, has obtained implicit approval for clinical trials from NMPA. Multiple preclinical in vitro and in vivo studies have demonstrated that AST-006 has good safety and broad-spectrum anti-tumor activity. It is expected that AST-006 can achieve more effective anti-tumor effects for BRCA1/2 mutant malignant tumors, especially tumors resistant to PARP inhibitors. We are very much looking forward to the clinical performance of AST-006, which will bring more effective treatment options for patients with BRCA1/2 mutant malignant tumors and contribute to Healthy China."
About AST-006
AST-006 is a Class 1 small molecule conjugate drug independently developed by the company based on the "hypoxia activation" technology platform. AST-006 cannot be selectively activated under normoxic conditions, so it has less toxicity to normoxic tissues and organs. Most tumors are accompanied by the production of a hypoxic tumor microenvironment, and AST-006 is activated in the hypoxic area to produce the active metabolite Br-IPM, leading to tumor cell death. This hypoxia-selective activation mode is completely different from the non-selective mechanism of action of traditional alkylating agents (such as cyclophosphamide and ifosfamide). Since hypoxia is a common feature of most tumors, it means that AST-006 has the potential to become a broad-spectrum, highly selective anti-tumor drug.