Haisco Pharmaceutical Group (002653.SZ)The IND application for the innovative drug HSK46256 tablet has been accepted.

Haisco Pharmaceutical Group (002653.SZ) announced that its subsidiary, Shenyang Haisco Pharmaceutical Group Pharmaceutical Co., Ltd., recently received a "Notice of Acceptance" issued by the National Medical Products Administration for HSK46256, a new drug independently developed by the company with independent intellectual property rights for the treatment of advanced solid tumors. According to the announcement (No. 44, 2020) issued by the National Medical Products Administration regarding the classification of chemical drug registration and the requirements for application materials, this product belongs to Class 1 of chemical drugs. Preclinical studies have shown that HSK46256 demonstrates potential efficacy in multiple tumor cell lines and has strong anti-tumor activity in homologous recombination repair defect models, with potential for treating homologous recombination repair-deficient cancers, especially those associated with BRCA mutations, such as breast cancer, ovarian cancer, and prostate cancer. Additionally, HSK46256 has good brain penetration properties, effectively inhibiting intracranial tumor proliferation in intracranial tumor efficacy models and prolonging animal survival, making it a highly promising small molecule drug with development potential.