On February 2, 2018, Watson Biotech released the "Announcement on the Acceptance of Drug Registration Application for the Production of New Drugs by 13-Popular Pneumococcal Polysaccharide Combination Vaccine" (hereinafter referred to as the announcement), the announcement stated that the company's 13-valent pneumococcal polysaccharides were combined. The vaccine application for new drug production received the "Notice of Acceptance" issued by CFDA, the acceptance number: CXSS1800003, Watson Bio said that the application for the new drug production was accepted, indicating that it has entered the final drug production registration review and approval from the clinical research stage. stage. Pneumococcal disease is the leading cause of death among children under 5 years of age worldwide. There are 30,000 children under 5 years of age who die of pneumococcal disease every year in China. The direct beneficiary of 13-valent pneumococcal vaccine after listing is 2 months old (minimum 6 weeks) ) Children who are 5 years old (71 months old) can effectively prevent pneumococcal disease by inoculation of the vaccine, and indirectly reduce the release rate of pneumococcal disease in the elderly in the family. The 13-valent pneumococcal vaccine market is huge in scale and is the world's best-selling and most widely marketed vaccine variety. Currently, only Pfizer is exclusively produced and sold on the market. The sales of the vaccine in 2015 and 2016 were US$6.2 billion and 57 respectively. In the WHO catalogue of vaccines purchased by the WHO, pneumococcal conjugate vaccines are among the highest priority, and they are the most urgently needed vaccines in the world. Only GAVI's bulk purchases reach 200 million doses/year, and the international market is extremely large. Supply gap. According to Pfizer's latest 2017 report, in the fourth quarter of 2017, Prevnar 13's global revenue increased by 7%. Pei's 13 international market operating income increased by 27%, mainly due to the timing of some emerging market government procurement of infant and young vaccination, as well as some emerging markets in the fourth quarter of 2017 to put Pei 13 into the nationwide adult and children Additional immunization program. In 2017, Pei's 13 annual revenue was $5.6 billion. Jiang Runsheng, president and party secretary of Yunnan Watson Biotechnology Co., Ltd., said in an interview with Xinhuanet that Watson Bio has been developing a series of pneumococcal vaccines for more than ten years. After nearly three years of clinical research, the birth of a 13-valent pneumonia vaccine, Effectively reduce the incidence and mortality of pneumococcal disease in infants under 5 years old, and rewrite the history of pneumococcal disease prevention in children aged 2-5 years. “The 13-valent pneumococcal vaccine technology has a high threshold. The retail price of 13-valent pneumonia vaccine for foreign manufacturers is about 800 yuan/dose, and the 4-needle needs more than 3,000 yuan. The vaccine is only approved for use in China for 6 weeks to 15 months, and according to The conclusion of the phase III clinical summary report, the company's 13-valent pneumonia vaccine needs to be given 4 doses (3+1) for 2-6 months of age, only 3 doses (2+1) for 7-11 months of age, 12-23 months old. Only need to inoculate 2 doses, only need to inoculate 1 dose at 24-71 months of age. Thus, the 13-valent pneumonia vaccine is suitable for vaccination for all children between 2 months and 71 months of age." Jiang Runsheng introduced. In addition, Jiang Runsheng also revealed that after the listing of the 13-valent pneumonia vaccine, the sales price of the product will be determined according to the full cost of the vaccine, the estimated sales volume, the sales strategy, etc., to provide better quality products and services for Chinese children. Affordable product prices. According to the national drug registration management regulations, after the company's 13-valent pneumococcal conjugate vaccine application for new drug production is accepted, it also needs to go through technical review, clinical trial registration on-site verification, and production site inspection. After obtaining the drug registration certificate issued by CFDA and passing the GMP certification, the product production can be organized, and the product can be listed and sold after being approved by the batch. Watson Bio said that it is expected that it will take about 5 months for the 13-valent vaccine to get the production approval until the product is on the market, and it will be sold as soon as possible in 2019. Medical Equipment Disposal,Syringes Needles Sizes,Disposable Syringe,Insulin Syringe FOSHAN PHARMA CO., LTD. , https://www.pharmainjection.com