Zhifei Bio makes $7.2 billion a year from its exclusive agent for the four-price HPV vaccine

Even after formulating a five-year sales period totaling more than 6.5 billion yuan of basic procurement plan, Chongqing Zhifei Bio's exclusive agent of the Merca East four-price HPV vaccine has finally been issued a certificate, up to tens of billions of market space will no longer be calm.
November 9, Chongqing Zhifei Biological Products Co., Ltd. issued a notice that its exclusive agent in the Chinese mainland region of the Merca East four-price human papillomavirus vaccine (brewing yeast) has now received the State Food and Drug Administration issued the "Biological Products Approval Certificate."
is a more substantial step towards the Chinese market since the four-price HPV vaccine was officially approved in September. According to the relevant provisions of the state, vaccine products must be mandatory testing, examination and approval of the qualified before the official sale. According to Zhifei Bio previously announced that from 2017 to 2021, the four-price HPV vaccine basic procurement plan has been completed, the total amount of more than 6.5 billion yuan.
the previous GSK has been the first to market the two-price HPV vaccine, the four-price HPV vaccine in Merca East officially entered the market circulation field, will undoubtedly make the already much-watched cervical cancer vaccine market re-opened.1, more than $6.5 billion procurement plan has been finalized
although the Merca East four-price HPV vaccine, which began registration in China as early as 2006, was officially approved in China a decade later, Zhifei's confidence in the vaccine never seems to have diminished. In its previously released third-quarter 2017 report, Zhifei Bio has revealed its basic procurement plans for the next few years.
specifically, the total amount of basic procurement plans from September 2017 to June 2021 exceeded RMB6.5 billion, of which approximately RMB542 million in 2017 and APPROXIMATEly RMB13 in 2018 72 million yuan, about 1.784 billion yuan in 2019, 2.230 billion yuan in 2020 and 617 million yuan in 2021.
fact, this is not the first time that Chifei has cooperated substantively with Mercedon. As early as April 25, 2011, Zhifei Bio jointly launched a marketing cooperation with Mercadon, responsible for the sale of Mercadon vaccine products in the Chinese mainland region, in 2011, Zhifei Bio purchased 110.534 million yuan from merca Dong designated importers, accounting for 37.15 percent of the company's total purchase of vaccine agents that year. On February 6, 2012, a strategic partnership was established, with products including the five-priced round-the-virus vaccine, the 23-price pneumonia polysaccharose vaccine, and the hepatitis A inactivated vaccine.
And according to public information, up to now, the four-price HPV vaccine has won the bid in six provinces (municipalities directly under the central government) such as Henan, Yunnan, Chongqing, Heilongjiang, Jiangxi and Hubei, while other provinces have submitted or are ready to submit relevant bidding materials according to the progress of bidding in each province. The zhifei biological announcement also said that the successful issuance of this batch of vaccine products will contribute to the active bidding work.
As the world's first and only cancer vaccine approved for use in the prevention of cervical cancer and pre-cancer lesions of reproductive organs caused by HPV6, 11, 16 and 18, Jiadasso is currently available in 124 countries and regions around the world, and there are currently two-price vaccines from GSK, also targeted at cervical cancer. Zhifei biological bulletin shows that according to China's possible applicable objects and vaccination procedures, the market capacity is expected to be about tens of millions of units / year. China-Thai Securities Research Report pointed out that this time Merca East approved four-price HPV vaccine, approved population of 20 to 45-year-old women, according to the corresponding group of 269 million people, according to the penetration rate of 5%, 2400 yuan / 3 needles price forecast, this market space can reach 32.3 billion yuan.
industry has pointed out that if the net interest rate is calculated at about 15%, the net profit will be about $360, or about $1.8 billion for 5 million people. Optimistically, after the introduction period of the market, the number of people vaccinated each year will increase, if the peak of 10 million to 20 million people per year vaccination, the annual net profit can reach 3.6 billion to 7.2 billion yuan., five years waiting, or an explosion of growth
from the initial signing of an exclusive agency agreement, to the final product was officially approved for sale, Zhifei Bio has been waiting for more than five years.
On September 27, 2012, Zhifei Bio signed the Supply, Distribution and Co-promotion Agreement with Merca East Pharmaceutical Co., Ltd. (an affiliate of Merca East Pharmaceutical Co., Ltd.) on the four-priced human papillomavirus recombinant vaccine, agreeing that after the product is listed, Zhifei Bio will be responsible for its import, promotion and sale in the Chinese mainland region. At that time, the vaccine was still in the clinical phase III trial stage.
Specifically, Mercedon will be responsible for the registration of jiadashu's medicines and obtain a listing license in the Chinese mainland region, after which the product will be exclusively supplied to Zhifei Bio and will be licensed to the exclusive distribution of Chifei Bio in the Chinese mainland region to jointly promote the product. Zhifei creatures should provide the necessary assistance and support in their process. In accordance with the agreed cooperation time at that time, the cooperation between the two sides from September 27, 2012 to the end of the three sales years. One year before the expiration of the term, if there is no objection between the two parties, Zhifei Bio may renew the agreement for 2 years after obtaining a written confirmation from Mercedon.
three-year basic procurement plan was also completed at that time, that is, about $1.14 billion in the first year, about $1.483 billion in the second year and about $1.853 billion in the third year. However, due to the difficult to predict the approval time of vaccine products, until the end of the three-year sales period, Jiadasso did not complete the registration and marketing process in China.
At the same time, with the outbreak of the 2016 Shandong vaccine series of cases, the relevant state regulatory authorities have also revised the "Vaccine Circulation and Vaccination Regulations" and a series of industry laws and regulations, in this change, on September 2, 2017 on the basis of the original agreement and the United States Merca East re-signed the "Supply, Distribution and Co-promotion Agreement Supplementary Agreement", clearly the cooperation will continue, and extend the cooperation period to June 30, 2021.
more than a decade of waiting, the four-price HPV vaccine was approved more quickly than expected.
From the time point of view, on May 22, 2017, Jiadasso was officially approved by the State Food and Drug Administration for drug registration, and on September 18, 2017, the first batch of vaccines obtained the "Import drug clearance document" issued by the Beijing Municipal Food and Drug Administration, and then sent to the Central Inspection Court for approval. Generally in accordance with the "Biological Products Approval Management Measures" provisions, the approval of the Central Inspection Court will be completed in about 60 working days, and the four-price HPV vaccine in Mercedon took less than 2 months, has exceeded market expectations.
Dongxing Securities analysis report shows that after the Shandong vaccine incident, Zhifei biological production and sales business has been fully restored, its main product triple seedling AC-Hib volume sales, 2017 is expected to sell about 4 million units, contributing profits of about 400 million yuan. Dongxing Securities believes that the rapid acquisition of the four-price HPV batch issue may foreshadow a period of outbreak in its performance. (E drug manager)