On 1 December 2023, Livzon MABPharm Inc. received a letter from the relevant national authorities that, upon the recommendation by the National Health Commission, the National Medical Products Administration (the "NMPA") conducted the expert review and approved the inclusion of the Recombinant SARS-COV-2 Bivalent (Original/Omicron XBB) Fusion Protein Vaccine (CHO Cell) (the "Product"), developed and produced by Livzon MAB, for emergency use. The Product is the second SARS-CoV-2 vaccine product developed by the Company to be included in the national emergency use, following the Recombinant SARS -CoV-2 Fusion Protein Vaccine (Zhong Zu Xin Xing Guan Zhuang Bing Du Rong He Dan Bai Yi Miao) ("LIKANG V-01"). Clinical trials for the Product have been conducted according to the clinical protocol approved by the NMPA.

Up to now, the enrolment of all subjects (a total of 4,750 subjects, including 2,002 elderly subjects) has been completed, successfully achieving the primary endpoints predefined for the clinical study. The clinical trial results reveal a rapid elevation in neutralizing antibody titers on Day 7 after the vaccination of the Product, with peak levels reached on Day 14 and a comparable level sustained on Day 28. The neutralizing antibody titer against the XBB.1.9.1 live virus is 407.9, demonstrating a significant superiority compared to the prototype vaccine V-01.

Moreover, the neutralizing antibody titers in the elderly group are equivalent to those observed in the adult group. Meanwhile, the Product demonstrates a broad-spectrum neutralizing effect against multiple prevalent variants, such as EG.5.1, XBB.1.9, XBB.1.16, and XBB.1.5, highlighting its robust protective effects against the predominant strains. The Product has promising safety profile, with adverse events predominantly characterized as mild and commonly observed.

The overall incidence is low, and the incidence of adverse events in the elderly group is lower than that in the adult group. No new risks have been identified in the Product when compared to the prototype vaccine V the01.