China's 1st and the world's 2nd PCV13 got batch release

On March 30, the first batch of 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13, trade name: Walanxin (Woanheim)) produced by Yuxi Walvax, a subsidiary of Yunnan Walvax Biotechnology Co., Ltd., obtained the "Certificate for the Release of Biological Products" issued by the NMPA. Walanxin is China's first and the world's second approved 13-valent pneumococcal polysaccharide conjugate vaccine.

Walanxin is a product independently developed and produced by Walvax, which is mainly suitable for vaccinating infants and children from 6 weeks to 5 years old (before 6th birthday). It can be used to prevent infectious diseases caused by 13 serotypes (serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) of pneumococcus included in the vaccine.

Streptococcus pneumoniae is the most common cause of invasive diseases, pneumonia and upper respiratory tract infections, and it is also the pathogenic bacteria most likely to cause pneumonia in infants and children.S. pneumoniae infectious diseases are the leading cause of vaccine preventable deaths among children under 5 years of age in the world. About 30,000 children under 5 years of age die from S. pneumoniae infectious diseases in China every year. For S. pneumoniae infectious diseases, prevention is currently better than treatment. The World Health Organization (WHO) has listed S. pneumoniae infectious diseases as diseases requiring "very high priority" for vaccine prevention.

In the case of a 13-valent pneumococcal polysaccharide conjugate vaccine, chemical methods are used to covalently bind the polysaccharide to a protein carrier, and this protein carrier can induce immunity to promote long-term immune memory. More importantly, it can effectively produce antibodies for babies under 2 years old. As we all know, this is a very important vaccine, but R & D of which is extremely difficult.

Previously, 13-valent pneumococcal conjugate vaccines for infants and children are produced exclusively by Pfizer in the world. Pfizer'sPneumococcal conjugate vaccine Prevenar 13® was approved by the FDA in 2012 and was approved for marketing in China in 2016. Prevenar 13® has now been included in the immunization plan of many countries and regions in the world and Asia-Pacific. With global sales of 5.85 billion US dollars in 2019, it is firmly on the throne of "the best-selling vaccine in the world".

In mainland China, the number ofPrevenar 13® release annually has been increasing year by year since it was approved by CFDA (now NMPA) in 2016, and is 4.755 million in 2020. However, compared with the huge and growing market demand, this amount is a drop in the bucket. Prevenar 13® is frequently out of stock in the domestic market, leaving many parents who are intended to vaccinate their children helpless. The global market is also in great demand for 13-valent pneumococcal polysaccharide conjugate vaccines, and there is a large gap in supply.

Walanxin’s approval to market will break the monopoly of foreign pharmaceutical company Pfizer in the field of pneumococcal conjugate vaccines for infants and children, and will compete strongly against Pfizer. The person in charge of Walanxin project revealed that the future Walanxin annual production capacity can reach 30 million, which can effectively ease some market demand.

In terms of patents, an invention patent application titled "A 13-valent pneumococcal polysaccharide-protein conjugate composition and preparation method and use thereof" was filed by Yunnan Walvax Biotechnology Co., Ltd. on January 19, 2018, and was published on May 29, 2018, which patent is CN108079286A and is currently in the substantive examination stage.

Of course, in addition to Walvax, there are many pharmaceutical companies that are developing 13-valent pneumococcal conjugate vaccines. We look forward to more domestic pharmaceutical companies shining in the field of pneumococcal conjugate vaccines in the future.