Kexing 23-valent pneumococcal polysaccharide vaccine approved
Kexing 23-valent pneumococcal polysaccharide vaccine approved. The 23-valent pneumococcal polysaccharide vaccine developed by Beijing Kexing Biotechnology (SINOVA Bio) was approved in China.
December 9, 2020, Beijing-Kexing Holdings Biotechnology Co., Ltd. (NASDAQ: SVA, hereinafter referred to as “Kexing Holdings” or the “Company”), a leading biopharmaceutical company in China, announced today , The 23-valent pneumococcal polysaccharide vaccine developed by its subsidiary, Beijing Kexing Biological Products Co., Ltd., has obtained the “Drug Registration Approval Document” (approval number: S20200027) issued by the State Drug Administration on December 2. Listed.
The 23-valent pneumococcal polysaccharide vaccine is the first bacterial vaccine product approved by Beijing Kexing Biological Products Co., Ltd., which not only broadens the company’s product line, but also marks the development and industrialization technology of the bacterial vaccine project by Kexing Holdings. A new step has been reached on the platform. The vaccine does not contain preservatives and is the second 23-valent pneumococcal polysaccharide vaccine in the world with two dosage forms: a prefilled syringe and a vial.
The 23-valent pneumococcal polysaccharide vaccine uses 23 widely prevalent and aggressive serotypes of pneumococcal, including serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F), respectively, through culture, inactivation and purification of 23 serotypes of pneumococcal capsular polysaccharide antigens, and then mixed and packaged. All quality standards of the vaccine meet or exceed the standards of the Chinese Pharmacopoeia and the European Pharmacopoeia.
The 23-valent pneumococcal polysaccharide vaccine project of Beijing Kexing Biological Products Co., Ltd. was launched in 2009, and the Phase III clinical study was completed in April 2017. Clinical research results show that the vaccine has good immunogenicity and safety. This vaccine is suitable for people aged 2 years and older with an increased risk of pneumococcal infection, and is used to prevent infectious diseases caused by the above 23 serotypes of pneumococcal bacteria.
Respiratory tract infectious diseases have similar symptoms. In the current situation where the global COVID-19 epidemic continues to be high, timely vaccination of pneumococcal vaccine and influenza vaccine can effectively prevent other respiratory diseases and reduce worries.
In June 2020, the quadrivalent influenza virus split vaccine developed by Beijing Kexing Biological Products Co., Ltd. was approved for marketing, and together with the trivalent influenza vaccine Anerlaifu®️, it helped the prevention and control of influenza epidemics in the northern hemisphere.
The new coronavirus inactivated vaccine Kellyf™ ️ developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd. is successively carrying out Phase III clinical studies in Brazil, Indonesia, Turkey, Chile and other countries. The new coronavirus vaccine production line has been built and put into use. The production capacity is over 300 million doses. After the second production line, which is planned to be completed before the end of 2020, is put into use, the annual production capacity of Kellife™️ will be increased to over 600 million doses.
According to market demand and available funds, the company may further expand its production capacity in the future in order to make greater contributions to the availability and affordability of the global COVID-19 vaccine.
About pneumococcal disease
There are multiple serotypes of pneumococcus, spread from person to person as droplets, and colonize the human nasopharynx. Pneumococcal bacteria are commonly carried in healthy people, and winter and early spring are the high incidence periods of disease. Pneumococcal infection can cause a variety of invasive and non-invasive diseases, including pneumonia, meningitis, bacteremia and otitis media, with high incidence of mild cases and dangerous severe cases. In addition, mixed infection is a potential hazard of pneumococcal disease. It is documented that pneumococcus may be co-infected with chlamydia, mycoplasma, other bacteria, and viruses.
About pneumococcal vaccine
The “Expert Consensus on the Prevention of Pneumococcal Diseases (2020 Edition)” recommends that the use of pneumococcal vaccines to prevent pneumococcal diseases is necessary and urgent. The 23-valent pneumococcal polysaccharide vaccine can cover more than 85% of the pathogenic serotypes. It is the most widely protected pneumococcal vaccine among the products currently on the market.
Based on China’s years of experience in the application of 23-valent pneumococcal polysaccharide vaccines, it is recommended that people who are 2 years old and above susceptible to pneumococcal, especially the following key populations, should be vaccinated:
- The elderly;
- Those with normal immune function but suffering from chronic diseases;
- People with low immune function, such as splenectomy or splenic insufficiency, sickle cell disease, Hodgkin’s disease, lymphoma, multiple myeloma, chronic renal failure, nephrotic syndrome, and organ transplant;
- Asymptomatic people living with HIV and AIDS;
- Patients with cerebrospinal fluid leakage;
- Special populations: densely populated residents or staff in high-risk environments where pneumococcal infection or its complications occur (such as long-term hospitalized elderly, welfare agency personnel, etc.)
About Kexing Holdings Biotechnology Co., Ltd.
Sinovac Biotech Ltd. (Sinovac Biotech Ltd.) is a high-tech biotechnology company headquartered in Beijing, currently listed on the Nasdaq Global Select Market (NasdaqGS: SVA). The company owns Beijing Kexing Biological Products Co., Ltd., Kexing (Dalian) Vaccine Technology Co., Ltd., Beijing Kexing Zhongwei Biotechnology Co., Ltd., and Kexing Holdings (Singapore) Co., Ltd. through its wholly-owned subsidiary Kexing Holdings (Hong Kong) Co., Ltd. The company and Beijing Kexing Zhongyi Bio-Pharmaceutical Co., Ltd. have five enterprises and have four industrial bases in Haidian, Changping, Daxing in Beijing and Dalian in Liaoning.
With the mission of “providing vaccines for humans to eliminate diseases”, Kexing Holdings is committed to the research, development, production and sales of human vaccines and related products, and provides services for disease prevention and control. Currently the company’s listed products mainly include:
- A new class 1 preventive biological product-Enterovirus 71 inactivated vaccine (Yierlaifu®),
- China’s first inactivated hepatitis A vaccine (Haierlaifu®) pre-certified by WHO,
- Influenza virus split vaccine (Anerlaifu®),
- Quadrivalent influenza virus split vaccine,
- Live attenuated varicella vaccine,
- Combined hepatitis A and B vaccine (Bellife®),
- 23-valent pneumococcal polysaccharide vaccine
- Live attenuated mumps vaccine, etc.
In addition, the company has successively developed the world’s first SARS virus inactivated vaccine (completed phase I clinical), China’s first pandemic influenza (H5N1) vaccine (Panerlaifu®) and the world’s first influenza A H1N1 vaccine The vaccine (Panerlaifu.1®) has contributed to disease prevention and control in China and even the world.
The Sabin strain polio vaccine developed by the company has completed production site inspections and GMP compliance inspections. Many vaccine projects are in clinical or preclinical research phases. Among them, the new coronavirus inactivated vaccine Kellyf™️ is currently in Brazil and Indonesia. , Turkey, Chile and other countries to carry out Phase III clinical studies.
Kexing Holdings mainly sells vaccines in the Chinese market, while also continuously exploring opportunities in the international market. The company is registering and exporting vaccines in more than 30 countries.