Zheng Quan Zhi Xing·2025-09-02 12:23Core Viewpoint - Shanghai Junshi Biosciences has received approval for clinical trials of JT118, a vaccine aimed at preventing monkeypox virus infection, marking a significant step in the company's vaccine development efforts [1][2]. Group 1: Drug Information - The drug JT118 is a "two-in-one" recombinant protein vaccine composed of monkeypox virus antigens A35 and M1, designed primarily for the prevention of monkeypox virus infection [2]. - Preclinical studies have shown that JT118 can generate high levels of neutralizing antibodies and activate cellular immunity in animal models, demonstrating significant protective effects against monkeypox virus infections [2]. Group 2: Regulatory Approval - The clinical trial application for JT118 was approved by the National Medical Products Administration, allowing the company to proceed with the necessary clinical trials [1]. - The approval was based on compliance with the relevant requirements of the Drug Administration Law and the Vaccine Administration Law of the People's Republic of China [1]. Group 3: Collaboration and Market Context - The company has established a collaboration with Beihang University to jointly develop the monkeypox recombinant protein vaccine [2]. - As of the date of this announcement, there are no approved vaccines for the prevention of monkeypox virus infection in China, indicating a potential market opportunity for JT118 [2].