CanSino Biologics Inc. announced that its Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine (CRM197), marketed as Menhycia®, has received a drug registration certificate from Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT).
The product is already approved in China for children aged 3 months to 6 years (up to 83 months), where clinical trials demonstrated favorable safety and immunogenicity against Group ACYW135 Neisseria meningitidis. A clinical summary for an age-expansion study covering individuals aged 7 to 59 years has been completed, and a supplemental application is in preparation.
Management regards the Argentine approval as an important milestone in the vaccine’s international rollout, enhancing brand recognition and supporting the company’s broader overseas roadmap focused on Southeast Asia, the Middle East and Latin America. Future sales volumes and timing in Argentina will depend on market demand within the approved population.
The board advises shareholders and potential investors to exercise caution when dealing in the company’s shares.