Heavy weight! The first domestic product! Zhifei Biotechnology's application for the launch of the 15 valent pneumonia vaccine has been accepted, benchmarking against Merck PCV15!
On June 5th, there was exciting news in the field of medicine and health: the marketing application for the 15 valent pneumococcal conjugate vaccine (PCV15) developed by Beijing Zhifei Green Bamboo Biopharmaceutical Co., Ltd. has been successfully accepted by the Drug Evaluation Center of the National Medical Products Administration, with the acceptance number CXSS2500059.
The 15 valent pneumococcal conjugate vaccine launched by Zhifei Green Bamboo utilizes Zhifei Biotechnology's advanced polysaccharide protein binding technology platform to scientifically cover 15 serotypes with high detection rates in Asia, including 3, 22F, and 33F, which are highly prevalent and pathogenic strains in China.
It can build a strong immune defense line for infants and young children at 2 months of age (minimum 6 weeks of age) and 3 months of age, effectively resisting the invasion of invasive diseases caused by 15 serotypes of pneumococcal 2, 12F, 23F, etc.
Streptococcus pneumoniae is an important culprit causing acute respiratory infections in infants, young children, and the elderly. As early as 2008, the World Health Organization (WHO) included pneumococcal disease on the list of diseases that require "extremely high priority" vaccine prevention.
Currently, in China's pneumonia vaccine market, 13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine dominate.
If Zhifei Biotechnology's PCV15 vaccine is successfully launched, it will fill the gap in the domestic 15 valent pneumonia conjugate vaccine field and form strong competition with Merck's similar PCV15 vaccine.
In 2024, Merck's PCV15 vaccine sales reached $665 million. In addition, Zhifei Biotechnology has a rich research and development pipeline in the field of pneumococcal vaccines.
In addition to the PCV15 vaccine applied for market this time, the 23 valent pneumococcal polysaccharide vaccine developed by it has been approved for market on August 29, 2023, and the 26 valent pneumococcal conjugate vaccine is also in phase I/II clinical trials.
With the application for listing of PCV15, Zhifei Biotechnology has established a comprehensive layout in the field of pneumonia vaccines, characterized by synergy between polysaccharide vaccines and conjugate vaccines, and complementarity between low and high priced vaccines.
By implementing a differentiated immunization strategy of administering the 15 valent PCV vaccine to infants and the 23 valent PPV vaccine to the elderly, Zhifei Biotechnology is expected to achieve health protection for the entire life cycle of pneumonia vaccines.
At present, there are nearly 20 domestic enterprises involved in the research and development of pneumococcal vaccines. Among them, the PCV13 vaccine of CanSino and Emmy vaccines has been submitted for market application.
In addition, there are several companies whose related vaccine products are in the Phase III clinical stage, including Sinovac Biotech's 13 valent pneumococcal polysaccharide conjugate vaccine, Emmy's 23 valent pneumococcal polysaccharide vaccine, and Fosun Antkin's 13 valent pneumococcal conjugate vaccine.
