Domestic "Peier" coming soon

Medical Network November 22 The latest day, Sun Qing, the director of human resources and director of the president office of Watson Bio, said in public that his heavy-weight 13-valent pneumonia vaccine will soon be on the market. At that time, Watson Bio will become the domestic company with the world's best-selling vaccine species.
It is understood that Streptococcus pneumoniae is the main pathogen causing acute respiratory infections in infants and the elderly. It is the most common bacterial respiratory infection. Infants and young children are suffering from pneumococcal infection due to immature immune system development and elderly immune function degradation. High-risk population, which can lead to multi-system invasive diseases clinically, including pneumonia, meningitis, sepsis, etc. According to WHO estimates, 1.6 million people worldwide die from pneumococcal infections each year, of which 460,000 are infants and young children; China Approximately 1.74 million children develop severe pneumococcal infections each year, and 30,000 of them die (equivalent to one child dying every 17 minutes).
The original 13-valent pneumonia vaccine (Peyer 13® vaccine) was developed by Pfizer to prevent pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F. Invasive diseases (including bacteremia pneumonia, meningitis, sepsis, and bacteremia, etc.), which were approved by the FDA in 2010. After the introduction of the 13-valent pneumonia vaccine in the United States, the incidence of diplococcal pneumonia decreased from 80 / 100,000 in 1998 to 3 / 100,000 in 2012, which is not very protective. In 2014, the FDA approved the expansion of the population of 13-valent pneumonia vaccine to people aged 50 and over. In November 2016, Peier was approved by the former State Food and Drug Administration to officially enter the Chinese market to help 6 weeks of age to 15 months. Infants and young children to prevent related invasive diseases caused by 13 pneumococcal serotypes.
In the global market, the 13-valent Peer vaccine has always been the best-selling vaccine variety, and has repeatedly ranked among the world's best-selling drugs TOP10. For Pfizer, Peer is more a "profit cow". In Pfizer's income structure, 13-valent pneumonia The contribution of the vaccine has gradually increased. In 2018, the vaccine's global sales reached 5.802 billion US dollars.
As the company that has made the fastest progress in 13-valent pneumonia vaccine research in China, the applicable population of 13-valent pneumonia vaccine and the immunization procedures declared by Watson Bio are: infants from 6 weeks to 15 months; basic immunization at 2, 4, and 6 months3 One dose of booster immunization at 12-15 months of age, that is, a total of 4 doses are needed for infants and young children. Previously, Watson Bio has disclosed the development of its 13-valent pneumonia vaccine several times. In January 2018, the vaccine completed clinical trials; in February of the same year, Watson Bio announced that the 13-valent pneumonia vaccine market application was accepted by the State Food and Drug Administration. There are reports that Watson Bio 13-valent pneumonia vaccine and Pfizer 13-valent vaccine in the United States Non-inferiority control clinical data of Pfizer 7-valent pneumonia vaccine was selected for comparison. The test results showed that the clinical trials of Watson 13-valent pneumonia vaccine reached the international advanced level in many aspects such as vaccine characteristics, clinical design, evaluation standards and test results. The standards and data results are even better than Pfizer's 13-valent pneumonia vaccine. In March 2018, Watson Bio 13-valent pneumonia vaccine was listed as a priority review procedure for drug registration applications. In September 2018, the technical review was completed and approved. The program also entered the end stage; in September 2019, Watson Bio completed and passed the registered production site inspection and GMP certification inspection of the breed.
According to industry insiders, Watson 13-valent pneumonia combined vaccine is expected to be approved for sale this year, and it will compete with Pfizer Peer. Based on the current policy market environment and overall competition pattern, Watson 13-valent pneumonia combined vaccine is expected to be marketed. Quickly monopolize the domestic market and become the largest vaccine variety in China. Combining Pfizer's original research product, Peer, the previous bid price was 698 yuan / support. Some analysts believe that if domestic pricing is assumed to be 500 yuan / support, 12 million newborns will be born in China each year With a medium penetration rate of 20%, the market demand is 9.6 million and the market size is 4.8 billion yuan.
At the same time, domestically, in addition to Watson Bio, Minhai Bio, Beijing Kexing Zhongwei, Lanzhou Bio Kangtai Bio have all obtained clinical approval for 13-valent pneumococcal vaccine.
In addition, Watson Bio has 9-valent HPV vaccine (currently in Phase I clinical trials, Watson Bio 2-valent HPV vaccine is currently in the final stage of Phase III clinical trial case collection and analysis, and industrial production workshops have been completed). latest progress. On November 7, Watson Bio announced that Shanghai Zerun, the company's controlling subsidiary, signed an agreement with the Bill and Melinda Gates Foundation (hereinafter referred to as the "Gates Foundation"), and Shanghai Zerun was awarded the Gates Fund. The US $ 2.5 million project fund will be used to accelerate the clinical research and industrialization of the 9-valent HPV vaccine.
Watson Bio said that the signing of this agreement shows that Shanghai Zerun and its 9-valent HPV vaccine project have been recognized by international organizations. After the 9-valent HPV vaccine has been pre-certified by WHO (WHO pre-certification is based on international quality, safety and performance The standard system for the evaluation of pharmaceuticals and diagnostic products) will enter the bulk procurement of international organizations, paving the way for Shanghai Zerun to enter the international market.