Rising Star of International First-line Vaccine ▏AIM Vaccine MCV4 Obtained Clinical Approval
Another success of AIM Vaccine Co., Ltd.—its wholly-owned subsidiary AIM Vacin obtained the Notice of Approval for Drug Clinical Trial for its ACYW135 Meningococcus Conjugate Vaccine (MCV4) from the National Medical Products Administration on December 1, and will carry out clinical trials in accordance with the requirements in the Notice.
MCV4 is an industry-recognized international first-line innovative vaccine, and so far no similar product of its kind has obtained approval in China. As estimated by China Insights Consultancy, the market size of MCV4 will reach 4.4 billion yuan by 2030.
According to the data of China Insights Consultancy, epidemic cerebrospinal meningitis (DCSM) caused by meningococcus has the highest incidence rate in infants under 12 months. The MCV4 of AIM, which is soon entering the clinical trial stage, will hopefully induce immune response among children aged 2 and under. After obtaining approval for the market, this product will fill in the gap of quadrivalent meningococcus conjugate vaccines for children under 2 years of age in the Chinese market.
ACYW135 Meningococcus Polysaccharide Vaccine (MPSV4)—a commercialized product of AIM Vaccine—has used mature polysaccharide purification process, with key technical indicators including O-acetyl, phosphorus content, distribution of molecular sizes and bacterial toxoid all batter than the specifications in the Chinese Pharmacopoeia. Since the polysaccharides used in MCV4 are derived with the same process, this product is expected to maintain a high standard.
In addition, for the common pathogenic meningococcal polysaccharides including A, C, W135 and Y, the polyglycoprotein chemical coupling technique is adopted for covalent bonding with the carrier protein CRM197 respectively, so as to induce immune response among children under 2 years of age and thus provide protection.
In Defeating Meningitis by 2030, a plan released by the World Health Organization (WHO), the goals set out including “elimination of meningitis epidemics” and “reduction of cases of vaccine-preventable meningitis and deaths by 80%.” As of now, quadrivalent meningococcus conjugate vaccine has been listed in the national immunization program of 34 countries around the world.