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CanSinoBIO Initiates Phase Ⅲ Clinical Trial of Group ACYW135 Meningococcal Conjugate Vaccine Menhycia® in Indonesia

2024.03.25 来源:

Recently, CanSinoBIO initiated a Phase Ⅲ clinical trial of its Group ACYW135 Meningococcal Conjugate Vaccine (CRM197 Vector) Menhycia®, successfully enrolling its first participant in Indonesia. This trial aims to expand the applicable population, and evaluate the safety and immunogenicity of the vaccine in adults aged 18 to 55 years. As early as June 2022, Menhycia®, developed by CanSinoBIO, has been officially approved for market launch in China, targeting infants and young children under the age of 3.


Meningitis is a serious infection of the meninges, the membranes covering the brain and spinal cord. The most common symptoms of meningitis are high fever, severe headache and vomiting. According to World Health Organization, even with early diagnosis and adequate treatment, up to 10% of patients die, typically within 24 to 48 hours of symptom onset. About 10% to 20% of survivors have brain damage, hearing loss or learning disabilities. [1]


Meningococcal meningitis remains a public health issue of concern, with a high mortality rate and leading to serious long-term complications. Vaccination is the most affordable and effective method of prevention.


Statistics reveal that meningitis cases are present across in all age groups, with children under the age of 5 experiencing a higher incidence rate. Typically, as age increases, the rate of meningitis infection tends to decline, but there is a noticeable increase in infection rates among adolescents and the elderly. With an increased public awareness of the health prevention and vaccination, the adult vaccine market is expected to expand further. Menhycia®, the first quadrivalent meningococcal conjugate vaccine in Asia, is believed to provide better protection and has been chosen by hundreds of thousands of families in China.


Indonesia, the world's fourth most populous country with a population close to 300 million, urgently needs for more effective meningitis vaccination strategies to achieve stronger herd immunity. Meanwhile, as the country with the largest Muslim population globally, where approximately 87% of residents are followers of Islam, there is a significant demand for reliable vaccine apply. CanSinoBIO is poised to meet this need with its innovation and high-quality vaccine product, particularly for travelers embarking on the annual pilgrimage to Saudi Arabia.


In August 2023, the recombinant COVID-19 vaccine Convidecia® developed by CanSinoBIO has obtained the Halal Decree by the Assessment Institute for Foods, Drugs and Cosmetics of Majelis Ulama Indonesia (LPPOM MUI), becoming the only adenovirus vector COVID-19 vaccine in the world with Indonesian Halal Decree. Leveraging its world-leading vaccine technology platform, CanSinoBIO has the potential to obtain Halal Decree, which will help accelerate the company's internationalization process.


In recent years, CanSinoBIO has been actively collaborating with local organizations and enterprises in Indonesia. In November 2022, coinciding with the G20 Summit, CanSinoBIO and Etana, an leading Biopharmaceutical company in Indonesia, representing their respective nations, signed a cooperation agreement on inhaled vaccine technology and meningitis vaccines.


CanSinoBIO dedicated to providing global solutions for the prevention and treatment of infectious diseases. With the support of both countries, the company is committed to leveraging its industry-leading technology to continuously drive innovation and breakthroughs in meningitis vaccines, contributing to the construction of a shared future between China and Indonesia.

 

[1] World Health Organization (8 February 2023). Disease Outbreak News; Meningitis - Niger. Available at https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON439