According to the NMPA official website on March 24, the recombinant human papillomavirus bivalent (type 16/18) vaccine of Yuxi Zerun Bio, a subsidiary of Watson Bio, was approved for marketing.
The bivalent HPV vaccine developed by Shanghai Zerun is used to prevent cervical cancer caused by HPV types 16 and 18. At present, the HPV vaccines that have been marketed around the world include the bivalent HPV vaccine of GlaxoSmithKline (GSK) of the United Kingdom, the quadrivalent HPV vaccine and the nine-valent HPV vaccine of Merck & Co. of the United States, and the bivalent HPV vaccine of Xiamen Wantai Canghai Biotechnology Co., Ltd. HPV vaccine.
The HPV vaccine to be approved this time is produced by the Pichia pastoris expression system, which has many advantages, such as the high expression level of the yeast, which is conducive to separation and purification; the expression can be strictly controlled; the expression product has high stability . In addition to the bivalent HPV vaccine, Runze Bio’s product pipeline also includes a nine-valent HPV vaccine, a recombinant enterovirus 71 (EV71) virus-like particle vaccine, and a new coronavirus vaccine.
According to the official website of Runze Biology
At present, there are 4 HPV vaccines on the market in China, namely Merck’s 4-valent and 9-valent vaccine, GSK’s bi-valent vaccine, and Wantai Bio’s bi-valent vaccine (trade name: Xin Ke Ning). It is reported that Xin Ke Ning’s sales in China in 2020 will be approximately RMB 693 million. In 2021, GSK’s bivalent vaccine sales will be $138 million, and Merck’s quadrivalent and nine-valent vaccine (Gardasil/Gardasil 9) sales will reach $5.673 billion, a year-on-year increase of 44%. (Liu Yingqi)