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微芯生物(688321.SH):西奥罗尼胶囊治疗转移性胰腺导管腺癌临床试验申请获得受理
Ge Long Hui A P P· 2025-11-06 09:37
Core Viewpoint - Micron Biologics (688321.SH) has received the acceptance notice for the clinical trial application of its self-developed drug, Xioroni capsules, for the treatment of metastatic pancreatic ductal adenocarcinoma from the National Medical Products Administration (NMPA) [1] Group 1: Drug Development - Xioroni is a novel small molecule anti-tumor drug with a unique chemical structure, developed independently by the company and protected by global intellectual property rights [1] - The drug exhibits a multi-pathway anti-tumor mechanism by inhibiting multiple kinase targets, including Aurora B, CSF1R, and VEGFR/PDGFR/c-Kit, providing comprehensive anti-pancreatic cancer effects [1] - Xioroni has shown significant synergistic inhibitory effects on pancreatic cancer growth when used in combination with the chemotherapy drug Gemcitabine [1] Group 2: Clinical Trial Results - Phase II clinical follow-up data indicates that Xioroni combined with standard AG chemotherapy (albumin-bound paclitaxel and Gemcitabine) has better objective response rates, disease control rates, and progression-free survival compared to historical data of AG chemotherapy [2] - The safety and tolerability of Xioroni in patients are reported to be good [2] - The drug is expected to further improve clinical efficacy and extend survival time for patients with advanced pancreatic cancer when combined with PD-1 monoclonal antibodies and chemotherapy [2]