May 23, the flying creatures, according to the announcement on May 22 afternoon, it receives notice in writing of Merck (China) company, on September 27, 2012, with the MSD "supply, distribution and mutual promotion agreement" signed in the products - tetravalent human papilloma virus vaccine (hereinafter referred to as the "quadrivalent HPV vaccine") to obtain the approval of the CFDA. 

 

The announcement of the announcement meant that the HPV, which was the sole agency of the intellectual and biological protocols, had been waiting for five years to make a meaningful difference. According to the agreement signed with the United States Merck, Merck after licensing the quadrivalent HPV vaccine listed, will supply the product to intellectual biological exclusive, and permits the exclusive distributor in the area of the agreement, the joint promotion of the product. The basic procurement plan for the two countries was about 1.14 billion yuan in the first year, about 1.48 billion yuan in the second year and about 18.53 billion yuan in the third year. 

 

And according to the CFDA, the jadu is in the process of "approval and approval". If approved, this would be the second domestically listed cervical cancer vaccine to be approved by glaxosmithkline (GSK) on July 18 last year. 

 

Two multinational giants both feet into the bureau, in 2017 will be a formal break up this piece of virgin land, GSK chose to do with his new team, while the MSD chose flying creatures to speakers. How big is the market for cervical cancer in China? As a heavy product in China, can you shine? Who will succeed first? 

 

100 billion markets? 

 

Cervical cancer is the sixth most common malignancies in women, the second most common gynecologic cancer after breast cancer. The death rate is as high as 50 percent, with nearly 600,000 new cases worldwide each year. The number of new cases in China is about 150,000 a year, killing about 80,000. The advent of the HPV vaccine has changed the status quo, making it the second largest vaccine for global sales after pneumococcal conjugate vaccines. 

 

At present, there are three products listed on the global market, including four in the east and the nine in the same price, and the GSK's Cervarix price. The four-price HPV vaccine developed in the eastern part of the city was launched in 2006, with the use of yeast to express system production and prevent cervical cancer by 70%. GSK's 2valent HPV vaccine, which was launched in 2008, USES an insect cell expression system to prevent 70 per cent of cervical cancer. The nine-price HPV vaccine was approved by the end of 2014, preventing cervical cancer by 97%. Currently, HPV vaccines have been sold in more than 120 countries around the world, global vaccination demand more than 37 million doses, in 2014, Gardsil sales reached 1.83 billion us dollars, the Cervarix has reached us $269 million. 

 

And a larger domestic market, according to foresight research data shows that: from the point of market demand, according to the current global overall, recommended vaccination aged 9 ~ 45 (the recommended age of the United States is 9 ~ 26 years old), with reference to the global overall scope, according to the 10% market penetration, China's potential demand of the HPV vaccine crowd around 44 million, according to the expected price 2000 yuan of injection, the domestic market demand will reach 88 billion yuan, total according to 30% of the permeability, the market demand amount more than $260 billion. 

 

Theory, of course, the market is big, but the market is not a virgin land reclamation, although some women go to Hong Kong, but, after all, is one of the few, the market still need to develop, market cultivation, from the overall perspective, Merck and GSK into education require upfront costs for market, so don't compete in terms of the next two to three years. And it is important to note that although GSK approed, but so far no sales, investigate its reason is vaccine production sales and other drugs is not the same, also need the related process, and so does MSD. As a result, the official sale of HPV is expected to wait a while. 

 

Domestic r&d acceleration 

 

With the approval of the two big multinational companies, the HPV vaccine, local developers are also feeling the crisis and are speeding up the development of the HPV vaccine. 

 

So far, the research and development of HPV in domestic enterprises is mainly the chengdu institute of biological products, xiamen wantai the sea biotechnology company, Shanghai ZeRun biological technology co., LTD., Shanghai Po wei biological technology co., LTD., jiangsu rico biological technology co., LTD., and other five companies of six stages of product application in clinical trials. 

 

Among them, the Watson biological subsidiary, Shanghai zeyun technologies, is thought to be the fastest growing company in the country, with clinical trials being launched in November 2014. The other three clinical trials were conducted by the xiamen wantai sea. However, according to industry analysts believe that due to the xiamen wantai expressed in prokaryotic cells, and Merck compared with GSK are all integrated representation system needs to do more testing. Others were relatively slow, all in the first phase of the clinic. 

 

For research and development of biological subsidiary Shanghai ZeRun Watson have previously been industry forecast may be approved in 2017, but in terms of the current progress, may be delayed. According to E drug managers, Watson has already begun construction of the HPV production base in yunnan. 

 

From the point of the HPV vaccine market development, although the current domestic enterprise accelerating on HPV vaccine research and development, but with GSK and MSD compared to the two giants in the short term to get to the market is not easy. Moreover, there is a certain amount of uncertainty about the development of local companies. 

 

After the listing is not completely, of course, is not good, because the HPV vaccine market in China is not a mature market, so the multinational pharmaceutical companies as a starting the first need to invest a lot of money and resources to market cultivation, during which the amount will not soon, this is left to the local drug companies to accelerate time to market, there can be listed after the following strategy, at a low price way backwardness to system is not impossible.