Zhifei biological tetravalent HPV vaccine obtained drug registration approval

[China Pharmaceutical network enterprise news] it is reported that recently, the product involved in the supply, distribution and joint promotion agreement signed by Zhifei biology and the company's affiliated company, Mercer East Pharmaceutical Co., Ltd., on September 27, 2012, was approved (picture source: Baidu picture) Zhifei biology announced in the morning that at 16:44 on May 22, 2017, the company received a written notice from MSD (China) Co., Ltd and the supply, marketing and joint promotion agreement signed by the company and MSD Pharmaceutical Co., Ltd., an affiliate of MSD Pharmaceutical Co., Ltd., on September 27, 2012 (for details, please refer to announcement 2012-60 issued by the company on October 8, 2012) The product involved - tetravalent human papillomavirus vaccine (Saccharomyces cerevisiae) (hereinafter referred to as "tetravalent HPV vaccine") - has been approved by the State Food and Drug Administration with the approval numbers of 2017s00251 and 2017s00252 According to the World Health Organization, cervical cancer is one of the most common gynecological malignancies, and the second highest incidence of cancer among women aged 15 to 44 in the world, the company said According to the 2015 China cancer statistics report, it is estimated that there were about 98900 new cases of cervical cancer in China in that year, and the death toll was about 30500 As a cancer with clear cause in human history, cervical cancer is caused by the persistent infection of high-risk HPV virus HPV16 and HPV18 are responsible for about 70% of cervical cancer worldwide Tetravalent HPV vaccine is one of cervical cancer vaccines in the world According to the approval of CFDA, the vaccine is used to vaccinate women aged 20 to 45 years old The three dose vaccination program is applicable to the prevention of cervical cancer, cervical intraepithelial neoplasia (cin1 / 2 / 3) and adenocarcinoma in situ (AIS) caused by human papillomavirus (HPV) 16 and 18 According to the agreement, MSD will supply the products to the company after obtaining the listing license in mainland China, and license the company to distribute and jointly promote the products in mainland China Vaccination is an effective way to prevent HPV infection and develop into cervical cancer Impact on the company 1 The four price HPV vaccine product of MSD is a global cancer vaccine Up to now, there is no official sale of HPV vaccine in mainland China, which fills the gap of domestic four price HPV vaccine, meets the demand of domestic market, further enriches the company's product line, strengthens the company's market position, enhances the company's influence and competitive strength in the vaccine industry, and conforms to the company's development strategy 2 A strong marketing network is one of the company's core competitiveness The listing of the product will expand the company's sales scale, increase the main business profits, and improve the company's operating performance and profitability; 3 The listing of the product is not expected to have a significant impact on the company's operating performance in 2017.