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健康元:LZM012项目银屑病适应症预计本年内申报上市
Zheng Quan Ri Bao· 2025-11-18 13:41
Core Viewpoint - The company Health元 is preparing to submit a listing application for the LZM012 project for psoriasis indication within this year, having received consent for a priority review application from the CDE [2]. Group 1: Project Development - The LZM012 project is expected to have its listing application submitted by the end of this year [2]. - The company has communicated with the drug review center (CDE) regarding the priority review application and has received approval [2]. - The application for priority review will be submitted simultaneously with the drug listing application [2]. Group 2: Future Plans - The company is currently in discussions with relevant parties regarding the details of external authorization cooperation and is conducting due diligence [2]. - Any progress in these discussions will be announced in a timely manner [2].
丽珠集团:目前LZM012项目银屑病和强直性脊柱炎两个适应症均已完成III期临床
Zheng Quan Ri Bao Wang· 2025-10-27 08:09
Core Viewpoint - LIZHU Group has announced the completion of Phase III clinical trials for its LZM012 project targeting psoriasis and ankylosing spondylitis, with key data locked and read out, and plans to submit a formal application for market approval by the end of this year [1] Group 1: Clinical Development - Both indications for LZM012, psoriasis and ankylosing spondylitis, have completed Phase III clinical trials [1] - The key Phase III clinical data has been locked and read out [1] - The company is actively preparing relevant documentation for the upcoming market application [1] Group 2: Regulatory and Market Position - The company has received formal feedback from the CDE, indicating that LZM012 will be prioritized for review [1] - LZM012 is the first domestic Phase III study for psoriasis with PASI100 as the primary endpoint, demonstrating superior efficacy compared to secukinumab [1] Group 3: Business Development - The company is in deep discussions with relevant parties regarding external licensing cooperation details, including due diligence [1] - Any further developments in this area will be announced in a timely manner [1]