Core Viewpoint - Sapu003 aims to overcome the limitations of Afinitor (FDA-approved oral Everolimus) by providing full efficacy delivery through intravenous injection, enhancing treatment for breast cancer patients [1][2]. Group 1: Product Development - Sapu Nano has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate patient recruitment for Phase I clinical trials of Sapu003, an injectable formulation of Everolimus for breast cancer treatment [1]. - The proprietary Deciparticle™ technology allows Sapu003 to deliver 100% of the drug into the bloodstream, compared to only about 10% absorption with the oral tablet form [2]. - The Phase I clinical trial aims to determine the optimal dosing for future studies, including Phase III trials, addressing the unmet need for next-generation mTOR inhibitors [2][3]. Group 2: Market Implications - The new delivery method of Sapu003 is expected to significantly improve tumor shrinkage compared to existing oral formulations, which have limited efficacy [2][3]. - The development of Sapu003 represents a milestone in cancer treatment, potentially offering breast cancer patients more effective and longer-lasting therapeutic options [2][3].
Sapu Nano 的 Sapu003 进入人体临床试验 —— 革新给药方式,实现 Everolimus 全生物利用度,造福乳腺癌患者
Globenewswire·2025-09-30 00:00