Tianjin, 29 September 2025—CanSino Biologics Inc. (CanSinoBIO) has shipped iPneucia® (PCV13i), an innovative 13-valent pneumococcal conjugate vaccine, to the domestic market, alongside Menhycia® (MCV4), Asia's first quadrivalent meningococcal conjugate vaccine, to overseas markets. This milestone underscores the company's continuous achievements in providing high-quality, innovative products and marks a significant step forward in expanding its global commercial presence.

Dr. Yu Xuefeng, Chairman and CEO of CanSinoBIO, stated: "The successful domestic launch of iPneucia® and the international rollout of Menhycia® will provide a solid foundation for building immunological protection and strengthening life-saving immunity. CanSinoBIO has established a robust vaccine pipeline covering the full lifecycle and will continue to advance multiple innovative products pioneered in China to market in the future."

iPneucia®: Innovation to Provide Enhanced Protection to Children in China

Pneumococcal disease is one of the world's most serious public health challenges. According to the World Health Organization (WHO), pneumococcal infections cause approximately 1.6 million deaths globally each year, primarily among infants, young children, and the elderly^[i]. Streptococcus pneumoniae is the main pathogen responsible for severe illnesses in children, including pneumonia, meningitis, and bacteremia, and is also a common cause of acute otitis media and sinusitis. In China, there are an estimated 550,000 cases of pneumococcal pneumonia each year among children under five^[ii], with severe pneumococcal pneumonia accounting for up to 93% of all severe pneumonia cases in this age group^[iii]. A growing challenge is the increasing antimicrobial resistance of streptococcus pneumoniae due to widespread antibiotic use. Surveillance in China shows that multidrug-resistant strains have reached 83.3%^[iv]. Vaccination remains the most cost-effective and efficient way to prevent pneumococcal diseases^[v].

After more than a decade of dedicated research, CanSinoBIO's iPneucia®, a 13-valent pneumococcal conjugate vaccine, was officially approved by China's National Medical Products Administration in June this year. It is the first pneumococcal conjugate vaccine to use both CRM197, a non-toxic diphtheria toxin mutant, and tetanus toxoid (TT) as carriers in China.

iPneucia® is designed with improved characteristics compared to other marketed products domestically, effectively avoiding potential adverse effects associated with overuse of a single carrier, reducing immune interference when co-administered with other vaccines, and enhancing immunogenicity^[vi]. The vaccine also offers stronger protection^[vii] against the four serotypes (19F, 19A, 7F, and 3) that contribute most heavily to the pneumococcal disease burden in Chinese children.

As the peak season for respiratory diseases approaches, the successful launch of iPneucia® will offer enhanced protection for children in China. In 2026, iPneucia® is expected to reach a larger domestic market, with plans underway for expansion into overseas markets as well.

Menhycia®: China's Contribution to Achieving a World Without Epidemics

Coinciding with the domestic launch of iPneucia®, Asia's first ACYW135 meningococcal conjugate vaccine Menhycia® also departed from Tianjin, heading to Indonesia. This marks CanSinoBIO's next vaccine export since its COVID-19 vaccine.

Meningococcal meningitis is a serious infectious disease caused by Neisseria meningitidis^[viii], with high fatality rates and severe aftereffects, particularly in children under five. Vaccination remains the most effective way to control and prevent its spread. In its "Defeating Meningitis by 2030: Global Road Map" , WHO has called for the elimination of bacterial meningitis epidemics, aiming to reduce cases of vaccine-preventable bacterial meningitis by 50% and deaths by 70%^[ix].

Leveraging CanSinoBIO's synthetic biology and formulation technology platforms, Menhycia®, launched in 2021, covers a broader age range and serogroups, providing more protection for children aged 3 months to 3 years (47 months). Currently, a supplemental application for the vaccine has been accepted by China's National Medical Products Administration, proposing an expanded age range of 3 months to 6 years (83 months), aiming to offer even broader protection for children.

As China's first and the world's third quadrivalent meningococcal conjugate vaccine suitable for infants under six months, Menhycia® is steadily advancing its international rollout. The vaccine was approved in Indonesia in December 2024 and received Halal certification from Indonesian authorities in February this year. In addition, the company is conducting clinical trials in Indonesia to evaluate the safety and immunogenicity of Menhycia® in individuals aged 18–55, aiming to expand the vaccine's target population.

Beyond advancing its presence in the Indonesian market, CanSinoBIO signed a formal vaccine cooperation agreement with a Saudi Arabian partner in March this year. The collaboration is intended to expedite the introduction of Menhycia® across Saudi Arabia and other markets in the Middle East and North Africa, while advancing joint research and development and establishing localized manufacturing capabilities.

With the mission of "To provide innovative, high-quality and affordable vaccines", CanSinoBIO will continue advancing the development and global rollout of more pioneering vaccines, making sustained contributions to global public health.

About CanSinoBIO
Founded in 2009, CanSinoBIO (SSE: 688185, HKEX: 06185) develops and manufactures high-quality, innovative, and affordable vaccines for global public health. It possesses five integrated platform technologies, supporting a diverse portfolio of vaccines preventing more than 10 diseases, including Asia's only vaccine for Ebola virus disease, Ad5-EBOV; the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Convidecia®, approved in over 10 countries and granted Emergency Use Listing (EUL) by the WHO; Asia's first Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) Menhycia®; the Group A and Group C Meningococcal Conjugate Vaccine (CRM197) Menphecia®, approved by China's NMPA; and China's first 13-Valent pneumococcal polysaccharide conjugate vaccine (CRM197/TT) iPneucia® (PCV13i).

References：

[i] WHO. Meeting of the Immunization strategic Advisory Group of Experts, November2007-conclusions and recommendations [J]. weekly Epidemiology Record, 2008,83(1): 1-15.

[ii] 衛(wèi)生策略研究簡報，肺炎鏈球菌結合疫苗接種的現(xiàn)況、挑戰(zhàn)及建議[EB/OL]. https://mp.weixin.qq.com/s/KJi7KN-S-8aAI9I8OyUerg.

[iii] Lai X, Wahl B, Yu W, et al. National, regional, and provincial disease burden attributed to Streptococcus pneumoniae and Haemophilus influenzae type b in children in China: Modelled estimates for 2010-17 [J]. Lancet Reg Health West Pac. 2022 Mar 16;22:100430.

[iv] Wang CY, Chen YH, et al. Antibiotic resistance profiles and multidrug resistance patterns of Streptococcus pneumoniae in pediatrics: A multicenter retrospective study in mainland China[J].Medicine (Baltimore). 2019 Jun;98(24):e15942.doi:10.1097/MD.0000000000015942.

[v]China CDC https://icdc.chinacdc.cn/zxxx/hydt/202412/t20241217_303327.html

[vi] Ladhani SN, Andrews NJ, Waight P, et al. Interchangeability of meningococcal group C conjugate vaccines with different carrier proteins in the United Kingdom infant immunisation schedule [J]. Vaccine 2015; 33:648-55.

[vii] "Stronger protection": According to current clinical data, the GMC level of iPneucia® is higher than that of the control group.

[viii] https://www.nhc.gov.cn/ylyjs/gzdt/202312/7553bd72c9934f4ca72327b361d111be/files/1734003068133_63694.pdf

[ix] https://www.who.int/initiatives/defeating-meningitis-by-2030