Simplified Chinese
Minhai Biologics’ independently developed world’s first 13-valent pneumococcal polysaccharide–protein conjugate vaccine has been approved for market launch.
Release date:
2021-09-24
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Abstract
Pneumococcal disease is the leading cause of mortality among vaccine-preventable diseases worldwide, accounting for 5… It is a leading cause of morbidity and mortality among children under the age of five. In China, infants and young children constitute a high-risk group for invasive pneumococcal disease, with as many as 30,000 children under five dying annually from such infections. The 13-valent pneumococcal conjugate vaccine is the most effective means of preventing pneumococcal disease. The World Health Organization (WHO) has designated pneumococcal disease as a vaccine-preventable illness of extremely high priority and recommends that all countries worldwide include the 13-valent pneumococcal conjugate vaccine in their routine childhood immunization schedules.
Tight market supply and high prices
13 The pneumococcal vaccine market has enormous potential and is often referred to as a “gold-standard” product in the vaccine industry; the original 13‑valent formulation… The 13-valent pneumococcal vaccine, developed by Pfizer, was approved for market launch in 2010 and has since become one of the world’s best-selling vaccines, repeatedly ranking among the top 10 best-selling drugs globally. In 2018, Pfizer’s global sales of this vaccine reached approximately US$5.8 billion, making it the only vaccine to crack the top ten in worldwide pharmaceutical sales; in 2019, that figure neared US$6 billion, earning the 13-valent pneumococcal vaccine the reputation of being Pfizer’s “cash cow.” After nine years of near‑monopoly by Pfizer in the global market, Watson Bio’s 13-valent pneumococcal vaccine received approval at the end of 2019. According to statistics from the National Institute for Food and Drug Control, total batch releases of the 13-valent pneumococcal vaccine in 2020 amounted to 10.8886 million doses, with Pfizer accounting for 6.4235 million doses and Watson Bio for 4.4651 million doses. With roughly 16 million newborns each year in China, and assuming four doses per child—plus an additional cohort of infants under two—the annual demand for the 13-valent pneumococcal conjugate vaccine exceeds 80 million doses, leaving production capacity severely strained and hindering widespread access. The company’s designed production capacity for the 13-valent pneumococcal conjugate vaccine is approximately 30 million doses per year; at a price of RMB 400 per dose, annual revenue could reach around RMB 12 billion. As a result, the company’s performance has entered a phase of rapid growth, propelling its development onto a fast track.
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Our company in 2005 In [year], preclinical studies were initiated for a bivalent‑carrier 13‑valent pneumococcal vaccine. In 2019, the application for drug production approval was accepted by the National Medical Products Administration, and the product is expected to receive market authorization in 2021. To achieve a technological breakthrough, the company undertook major process reforms. First, it adopted an innovative approach by conjugating pneumococcal capsular polysaccharides with two distinct carrier proteins; this strategy mitigates carrier‑induced epitope suppression, resulting in enhanced immunogenicity and higher polysaccharide antigen content, thereby improving overall immunogenicity. The product’s stringent quality standards have laid a solid foundation for these advances. Second, the company implemented an advanced polysaccharide extraction process, ensuring state‑of‑the‑art manufacturing. Additionally, the formulation incorporates a novel adjuvant that exhibits improved safety and reduced toxicity. This bivalent‑carrier 13‑valent pneumococcal vaccine has been granted four authorized patents and has three patent applications pending. According to publicly available information from the Center for Drug Evaluation, the company’s first independently developed bivalent‑carrier 13‑valent pneumococcal conjugate vaccine, “Weiminfeibao,” has entered the final stage of regulatory review and is poised for market launch. With a designed production capacity of 30 million doses per year, this 13‑valent pneumococcal conjugate vaccine addresses an urgent market need.
Since the outbreak of the COVID‑19 pandemic, the message that “vaccination is the most effective and cost‑efficient means of preventing infectious diseases” has taken deep root in public consciousness. This dual‑vector 13‑valent vaccine, independently developed by our company… The pneumococcal polysaccharide conjugate vaccine, Vimenfeibao, is poised to become a powerful tool for preventing pneumococcal disease in infants and young children, benefiting the public and enhancing the overall competitiveness of China’s vaccine industry.
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