The pharmaceutical company CansinoBIO (06185) has announced that its ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector), known as MCV4 and marketed under the brand name Menhaxin®, has received a registration certificate from Argentina's National Administration of Drugs, Food and Medical Devices.

In China, Menhaxin® has already been approved for use in children aged from 3 months to 6 years (83 months). The vaccine works by stimulating the body's immune system to produce immunity against ACYW135 group Neisseria meningitidis, thereby preventing epidemic cerebrospinal meningitis caused by this bacterial group. Clinical trials conducted in China have demonstrated the vaccine's favorable safety profile and immunogenicity, offering a superior solution for preventing meningococcal disease in children aged 6 years and under.

A clinical study to extend the vaccine's use to individuals aged 7 to 59 years has been completed, with the clinical summary report obtained. Preparations for a supplemental application are currently underway.

Initial Step for Global Strategy

Securing this registration certificate in Argentina represents a significant achievement for the product's internationalization strategy and is expected to enhance the company's global recognition.

Regarding its international development plans, the company stated it will continue to concentrate on key overseas markets, with a focus on Southeast Asia, the Middle East, and Latin America. It aims to leverage the product's competitive advantages in these markets and advance foreign cooperation and product supply through various means, including technology transfer and the provision of intermediate or finished products.

The specific timing for commercial sales of MCV4 in Argentina and the associated sales revenue remain subject to some uncertainty and will depend on market demand within the approved target population.