CanSino Biologics Inc. (“CanSinoBIO”) (SSE: 688185, HKEX: 06185) announced that the National Medical Products Administration of China (“NMPA”) granted approval for its ACYW135 Meningococcal Conjugate Vaccine (CRM197) (“MCV4”, trade name: Menhycia™), making it the first of its kind to be authorized in China.
Leveraging CanSinoBIO’s industry-leading synthetic biotechnology and formulation technology platform, Menhycia™ covalently binds common pathogenic meningococcal serogroups A, C, W135 and Y to the carrier protein CRM197. Currently, Menhycia™ is the initial vaccine product containing these four serogroups in China. In December 2019, the NMPA had granted Menhycia™ priority review status, making it the first MCV4 to be included on the priority review list in China.
The approval marks an important step in accelerating the development of China’s meningococcal vaccine immunization strategy. Menhycia™ provides protection for a wide range of age groups, including for children aged 3 months to 3 years old (47 months), by inducing strong T cell immune responses and immunological memory for immunized children.
Dr. Xuefeng YU, Chairman and CEO of CanSinoBIO, said, "We are committed to contributing to disease prevention and control in China through innovation. Menhycia™ provides a cutting-edge solution in the prevention of meningococcal disease, and we are pleased to contribute to the advancement of the prevention and control capabilities of meningococcal disease in China.”
Currently, meningitis remains a serious challenge to global public health management. The World Health Organization's "Defeating Meningitis by 2030" plan aims to eliminate bacterial meningitis epidemics and reduce vaccine-preventable bacterial meningitis cases by 50% and deaths by 70%1.
The cause of meningococcal meningitis is Neisseria meningitides (Lta), which is transmitted through the respiratory tract and invades blood circulation from the nasopharynx, and settling in the meninges and spinal cord membranes, forming a purulent inflammation. Measuring the onset of meningitis can be difficult and initial symptoms may be similar to a cold or flu, making it difficult to diagnose. However, the disease can develop to be life-threatening within 24 hours of onset without treatment. In addition, patients may experience serious long-term complications, such as mental retardation, hearing impairment and amputation even after treatment.
Vaccination is the most effective way to prevent meningitis. MCV4 was not previously available in China, and the national immunization system had historically administered a polysaccharide vaccine to prevent the diseases. Now, Menhycia™ can help provide stronger and broader protection in China.
1 Source: WHO: Defeating meningitis by 2030