Watson Bio's Bivalent HPV Vaccine Approved

On March 24, the website of the State Food and Drug Administration showed that Watson Bio's recombinant bivalent human papillomavirus (HPV) vaccine was approved for marketing.

This is the second domestic HPV vaccine approved for marketing after Wantai Bio's bivalent HPV vaccine was approved for marketing. So far, the number of HPV vaccines approved for marketing in my country has increased to 5.

Due to capacity constraints, HPV vaccines have been in short supply for a long time. As more domestic vaccines come on the market, production capacity is gradually released, and it is expected to usher in a market of 100 billion yuan.

The production workshop has been built

The HPV vaccine is commonly known as the cervical cancer vaccine. At present, there are three types of HPV vaccines on the market globally: bivalent, quadrivalent and 9-valent.

Watson Bio's approved bivalent HPV vaccine was developed by its holding subsidiary Shanghai Zerun for the prevention of cervical cancer caused by HPV16 and 18 virus infection. The vaccine will be industrialized by Yuxi Zerun, a wholly-owned subsidiary of Shanghai Zerun.

Previously, four HPV vaccines have been approved for marketing in my country. Among them, Wantai Bio's bivalent HPV vaccine Xin Ke Ning is the first domestic HPV vaccine approved for marketing.

The other three are imported products, namely the bivalent HPV vaccine produced by GlaxoSmithKline, the quadrivalent HPV vaccine and the nine-valent HPV vaccine produced by Merck & Co. The two vaccines produced by Merck are exclusively represented by A-share listed company Zhifei Biological.

Watson Biology recently announced that Shanghai Zerun plans to increase the capital of Yuxi Zerun in cash, with a capital increase of 330 million yuan, which will be mainly used for Yuxi Zerun's capital needs such as purchasing raw materials and paying payables. This capital increase will further enhance Yuxi Zerun's operational capabilities, improve its anti-risk capabilities, and promote the launch of bivalent HPV vaccine products.

In terms of industrialization, the company's bivalent HPV vaccine production workshop has been built, and the product can be put into production after it is approved. The company expects that the bivalent HPV vaccine will be available for sale in the second half of 2022.

The research activity information disclosed by Watson Bio in November 2021 shows that the company will fully consider factors such as the market price of currently listed products, the company's product positioning, pricing strategy, and synergy with the subsequent nine-valent HPV vaccine, and determine the bivalent HPV vaccine. market price.

The designed production capacity of the currently built bivalent HPV vaccine production workshop is about 15 million doses.