February 24th, 2026, CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) announced that China's National Medical Products Administration ("NMPA") has granted approval for the supplemental application to expand the indicated population of its self-developed ACYW135 Meningococcal Conjugate Vaccine (CRM197) ("MCV4", trade name: Menhycia®). With this approval, Menhycia® now provides comprehensive protection for infants and children aged 3 months to 6 years old (83 months) against meningococcal meningitis caused by Neisseria meningitidis serogroups A, C, Y, and W135.

Meningococcal meningitis is an acute purulent meningitis caused by Neisseria meningitidis, characterized by sudden onset, rapid progression, high contagiousness, a high rate of asymptomatic infection, and elevated mortality and disability rates^1,2. Infants, Children from infancy through school age are one of the main groups at risk for morbidity and mortality due to meningococcal meningitis³. According to China's National Immunization Program requirements, children must complete the final dose of the meningococcal vaccine by age six². In recent years, China is confronting new challenges in the prevention and control of meningococcal meningitis. the number of meningococcal meningitis cases has increased annually, with the reported incidence in 2025 nearly doubling that of 2023—reaching the highest level since 20153. Furthermore, the prevalence of pathogenic serogroups is becoming increasingly diversified, with prevalent strains having shifted from serogroups A and C to a co-circulation of serogroups Y, W, and B^4,5. The current vaccines under the national immunization program only provide protection against serogroups A and AC, and thus fail to prevent infections caused by other serogroups^4,5.

Prof. Liang Xiaofeng, Vice Chairman of the Chinese Preventive Medicine Association 

Prof. Liang Xiaofeng, Vice Chairman of the Chinese Preventive Medicine Association, noted that meningococcal meningitis is acute, severe, and dangerous, with infants and adolescents identified as high-risk groups urgently in need of preventive protection. Vaccination remains the most cost-effective method for preventing meningococcal meningitis. According to China's current immunization schedule, the final dose of the meningococcal vaccine for school-aged children is administered at 6 years of age³. Children in this age group frequently engage in close contact within school settings, which facilitates the formation of transmission chains. Therefore, prevention efforts must address not only disease onset but also bacterial carriage and transmission. Studies have shown that during meningococcal epidemics, the nasopharyngeal carriage rate of Neisseria meningitidis in the population can reach 25%–50%, indicating a significant risk of infection². The MCV4 covers the four currently prevalent serogroups and is characterized by strong immune memory, durable protection, and the ability to reduce bacterial carriage. Expanding the age indication of the MCV4 to include 6-year-olds offers a new option for School-aged children entering campus life and is crucial for improving China's meningococcal immunization strategy and enhancing population immunity.

Prof. Shen Kunling, Beijing Children's Hospital, Capital Medical University & Shenzhen Children's Hospital

Prof. Shen Kunling from Beijing Children's Hospital, Capital Medical University & Shenzhen Children's Hospital, stated that meningococcal meningitis is an acute respiratory infectious disease that is often overlooked, with winter and spring being the peak incidence seasons^6,7. The number of reported meningococcal cases is increasing, and the circulating serogroups are becoming increasingly diverse, with the proportion of cases caused by Y, W and B serogroups rising³. Meningococcal meningitis progresses rapidly, with advancement from onset to severe stages in as little as a few hours. Clinical management is challenging, with a case fatality rate exceeding 10% (equivalent to 1 death per 10 infected individuals), and even among cured patients, approximately 10%–20% suffer lifelong disabilities^8,9. One study showed that among diseases preventable by National Immunization Program vaccines, meningococcal meningitis imposes the heaviest health and economic burden on individuals and families, with a total economic burden of up to RMB 73,361 per case¹⁰. Parents should prioritize this issue and actively choose multivalent conjugate vaccines for their children. These vaccines offer broader serogroup coverage and long-term immune protection, effectively reducing their children's infection risk and disease burden.

Prof. Ma Jun, Education Expert, Institute of Child and Adolescent Health of Peking University

Prof. Ma Jun, an education Expert from Institute of Child and Adolescent Health of Peking University, emphasized that 6-year-old children are about to enter primary school, where they will engage in more concentrated group living and thus become a susceptible population for respiratory infectious diseases such as meningococcal meningitis. Timely and full-course vaccination against meningococcal meningitis is recognized as the most effective measure for preventing the disease.In accordance with the national immunization schedule, children at the age of 6 are required to receive one dose of meningococcal meningitis vaccine to consolidate immune protection and safeguard their health throughout the entire school age². If conditions permit, under the principle of "informed consent and voluntary participation", parents may also choose conjugate vaccines for their children that offer broader serogroup coverage, better immunogenicity, and durable protection. Families and schools should jointly pay attention to children's health, implement protective measures, and ensure the healthy growth of children.

Dr. Yu Xuefeng, Chairman and Chief Executive Officer of CanSinoBIO

Dr. Yu Xuefeng, Chairman and Chief Executive Officer of CanSinoBIO, stated that as a China's first-in-class and first NDA approved MCV4 vaccine covering four serogroups, Menhycia® offers multiple advantages over all MPSV4 products, including broad protection coverage, stronger immune response, more durable protection, and reduced bacterial carriage^11-15. It not only reduces the risk of individual infection but also lowers pathogen transmission risk in the population. To date, the vaccine has cumulatively protected over 3 million children and has completed 12 clinical studies both domestically and internationally, with its immunogenicity and immune persistence fully validated. The expansion of Menhycia®'s indication age groups represents another significant milestone in CanSinoBIO's commitment to vaccine R&D innovation.This advancement will provide a valuable healthcare option for Chinese six-year-olds as they start primary school. In the future, CanSinoBIO will continue to collaborate with disease control agencies, healthcare providers, and educational institutions to promote awareness and increase coverage of meningococcal vaccination. This effort aims to reduce the burden of meningococcal meningitis and support the shared vision of "Towards a World Free of Meningitis" ¹⁶.

Disclaimer:

Shareholders and potential investors of the Company are advised to exercise caution when dealing in the shares of the Company.

References

1.https://www.chinacdc.cn/jkyj/mygh02/jbzt/xjxcrb/ln/202409/t20240925_301015.html

2.Chinese Preventive Medicine Association. Expert consensus on immunization with meningococcal vaccines in China(2023 version). Chin Prev Med, 2023, 24(2):81-92. [Chinese]

3.The 2nd Member Representative Conference of Vaccine and Immunization Branch of Yunnan Provincial Preventive Medicine Association, 2025, China.

4.Wang B, Santoreneos R, Giles L, et al. Case fatality rates of invasive meningococcal meningitis by serogroup and age: A systematic review and meta-analysis. Vaccine. 2019 May 9;37(21):2768-2782.

5.Zhou JJ, Li MS, Zhang Q, et al. Analysis on incidence trend of meningococcal meningitis and major pathogenic serogroups of Neisseria meningitidis in China, 1990-2023. Zhonghua Liu Xing Bing Xue Za Zhi. 2024 Sep 10;45(9):1197-1203.  [Chinese]

6.https://www.chinacdc.cn/jkyj/crb2/yl/lxxnjsmy/jswj_ln/202409/P020240909351424528632.pdf

7.https://www.hbqj.gov.cn/xwzx/ztbd/ggws/202304/t20230421_4633596.html

8.https://www.cqfd.gov.cn/sy_200/ztzl/mbfk/202302/t20230217_11618599.html

9/Chinese Preventive Medicine Association. Expert consensus on informed consent for vaccination(Part One). Pract Prev Med, 2021, 28(4):385-411. [Chinese]

10.Wang M, Zhang ZN, Shi JJ, et al. The economic burden of and quality of life with vaccine-preventable diseases targeted by Expanded Program on Immunization vaccines in several areas of China:a retrospective survey. Chin J Vaccines Immun, 2023(2). [Chinese]

11.Xu J, Yan DS, Xu L, et al. Research progress in global meningococcal polysaccharide conjugate vaccine. Chinese Journal of Microbiology and Immunology, 2024, 44(4):304-316.  [Chinese]

12.Johswich KO, McCaw SE, Islam E, et al. In vivo adaptation and persistence of Neisseria meningitidis within the nasopharyngeal mucosa. PLoS Pathog. 2013;9(7):e1003509.

13.Liu XY, Yang Y, Shi BZ, et al. Immune persistence of a domestic group ACYW135 meningococcal polysaccharide conjugate vaccine in children 4-6 years of age. Chin J Vaccines Immun, 2025, 31(5):538-544. [Chinese]

14.Burman C, Knuf M, Sáfadi MAP, Findlow J. Antibody persistence and revaccination recommendations of MenACWY-TT: a review of clinical studies assessing antibody persistence up to 10 years after vaccination. Expert Rev Vaccines. 2024 Jan-Dec;23(1):614-635.

15.Liu XY, Yang Y, Li WX, et al. Study on the safety and immunogenicity of ACYW135 meningococcal polysaccharide conjugate vaccine in children aged 4-6 years. Zhonghua Liu Xing Bing Xue Za Zhi. 2025 Dec 10;46(12):2225-2232. [Chinese]

16.https://www.who.int/zh/publications/i/item/9789240026407