Menhycia? is a China first-in-class and first NDA approved MCV4 vaccine. Compared with existing products in this regard, Menhycia? has significantly improved and upgraded the process of current products by leveraging the Company’s advanced synthetic vaccine technology, along with the enhanced formulation and delivery technology. The commercialization of Menhycia? will not only bridge the gap between China and developed countries but also fulfil the demands for high-end vaccines in this field within China by filling the vacancy.

Menhycia? was granted NDA approval by the NMPA in December 2021, making it the first MCV4 vaccine approved in China. Save for Menhycia?, the current quadra-valent meningococcal vaccines in China are all MPSV4 products with a limited age indication. In contrast, our Menhycia? is applicable for children aged from 3 months to 3 years old (47 months), with good safety and immunogenicity profiles demonstrated in clinical trials. The Company has established the Commercial Operation Center (COC) with a comprehensive system to enable the Company’s commercialization team to develop and implement domestic and overseas promotion strategies and marketing operations for Menhycia?.

The Company obtained NDA approval from the NMPA in June 2021 for commercialization of Menphecia? in the PRC. Menhycia? have been successfully marketed in 30 provinces and cities in China, and their penetration rate continues to increase. 

the Company has obtained the Acceptance Notice issued by NMPA, pursuant to which, the supplemental application to expand the age range of applicable population of MCV4 from “children aged from 3 months to 3 years old (47 months)” to “children aged from 3 months to 6 years old (83 months)” has been accepted by NMPA. 

We have initiated the indication extension clinical trial in people aged 18–59 years old for MCV4 and all patient cases have been formally enrolled.