Is the market value of the vaccine leader nearly 100 billion yuan in danger?

Article Liang Jian Zhifei biology, a leading domestic vaccine enterprise, issued a notice that the AC group meningococcal (combined) type B Haemophilus influenzae (combined) combined vaccine (hereinafter referred to as "AC Hib vaccine") produced by its wholly-owned subsidiary Beijing Zhifei green bamboo biopharmaceutical Co., Ltd (hereinafter referred to as "Zhifei green bamboo") received the approval opinion from Beijing Drug Administration on February 19, 2020: no further injection Volume The "AC Hib vaccine" independently developed and produced by Zhifei green bamboo is used to prevent group A and group C Neisseria meningitidis and infectious diseases such as meningitis, pneumonia, septicemia, cellulitis, arthritis and epiglottis caused by Haemophilus influenzae type B On April 2, 2014, AC Hib vaccine obtained the drug registration approval from the former State Food and Drug Administration (approval No.: 2014s00240), approved the product registration, and issued the drug approval number (gyzz s20140003), which is valid for 5 years On November 8, 2018, Zhifei green bamboo submitted the application for re registration of AC Hib vaccine to Beijing food and drug administration After 16 months of waiting, the application for re registration failed Beijing Drug Administration gave reasons for not re registration: the information provided by the applicant has not met the requirements of the approval conclusion of the original drug registration documents For the impact of this re registration failure, Zhifei biology said that the sales revenue of AC Hib vaccine in 2019 accounted for about 10% of the company's main business revenue, and the product did not obtain the re registration approval, which is expected to have a certain impact on the company's performance in 2020 It can be seen that the lack of approval of this AC Hib vaccine will greatly affect the performance of Zhifei biology in 2020 Of course, the power of this effect depends on the future R & D adjustment direction of Zhifei biology However, it also shows the disadvantages of Zhifei biology in R & D and sales, that is, too much dependence on a single variety is very likely to lead to unstable performance of the company, even if this is the case The next affected company is Zhifei biological's subsidiary Although its exclusive AC Hib vaccine has not been approved for re registration, Zhifei biology also said in the announcement that the company is stepping up the development of AC Hib vaccine freeze-dried dosage form and will timely fulfill the obligation of information disclosure according to the follow-up progress The implication of Zhifei biology is that in 2020, the company will focus on the research and development of AC Hib vaccine lyophilized dosage form In addition, Zhifei biology will mainly promote the upgraded AC combined vaccine and Hib vaccine products in 2020, which is also expected to promote the company's own varieties to achieve a steady growth of 20% Why is it not approved normally for two consecutive years? In fact, it is not the first time that the AC Hib vaccine has not been approved Almost in the same period last year, on April 1, 2019, Zhifei biology released a notice saying that its exclusive varieties have not received the re registration approval, which means that the production of AC Hib vaccine, which accounts for a large proportion of its profits, will be suspended As a result, the stock price of Zhifei biology will be suspended the next day What is the reason why the same product has not been approved for two consecutive years? According to the statement of Zhifei biology last year, the suspension of AC Hib vaccine is not due to quality problems, because in October 2018, before applying for registration, Zhifei biology was affected by the forgery of Changsheng biology, the exposure of bribery scandal and the urgent departure of the two shareholders, which caused Zhifei biology to stop under multiple profits More than that, it may be the impact of vaccine forgery, regulatory epidemic Miao registration may be tightened Last year's failure to get approval was due to the industry's increased supervision caused by Changchun Changsheng vaccine fraud, but this year's failure to get approval again Zhifei biology has not explained the reasons in the announcement Zhifei biology said that the sales revenue of AC Hib vaccine in 2019 accounted for about 10% of the company's main business revenue, and the product has not obtained the re registration approval, which is expected to produce the company's 2020 performance Make a certain impact The risk cannot be underestimated In fact, AC Hib vaccine is a project launched by Zhifei biology in 2011 Zhifei green bamboo, a wholly-owned subsidiary, is responsible for the implementation of AC Hib vaccine, with an investment of 307 million yuan Zhifei green bamboo is a subsidiary of Zhifei biology, which is mainly engaged in the R & D, production and sales of bacterial vaccine products mainly for the prevention of meningitis and pneumonia At present, its main performance growth point is the AC Hib triple vaccine According to the financial report of Zhifei biology, in 2016, Zhifei biology achieved a revenue of 450 million yuan and a net profit of 32.52 million yuan; Zhifei green bamboo achieved a revenue of 300 million yuan and a net profit of 93.187 million yuan; the annual batch issuance of AC Hib vaccines was 222000 In 2017, Zhifei's biological revenue was 1.34 billion, with a net profit of 430 million; Zhifei's green bamboo revenue was 990 million, with a net profit of 430 million; the annual batch issuance of AC Hib vaccines was 4.704 million In 2018, Zhifei biological revenue was 5.23 billion yuan, with a net profit of 1.45 billion yuan; Zhifei green bamboo revenue was 1.24 billion yuan, with a net profit of 530 million yuan; the annual batch issuance of AC Hib vaccine was 6.437 million pieces According to the 2019 performance forecast released by Zhifei biology a few days ago, in 2019, the annual performance is expected to achieve a net profit of 2.250-2.540 billion Based on this figure, the profit of Zhifei biology AC Hib vaccine last year will be 225-254 million In addition to the cooperation with MSD, the cooperation with MSD will be a bright spot in the future performance development of Zhifei biology In fact, in China, the cooperation between Zhifei biology and MSD has been for 7 years The strong sales and promotion ability of Zhifei biological vaccine is the advantage of mosadong According to the 2019 half year report of Zhifei biology, its marketing network can cover 31 provinces, autonomous regions and municipalities directly under the central government, including more than 300 cities, more than 2600 districts and counties, and more than 30000 grassroots health service points (township vaccination points, community clinics) At present, there are 1792 sales personnel in Zhifei biology In 2017 and 2018, Zhifei biology won the exclusive right to act on the 4 and 9 Price HPV vaccine of MSD In the past years, the growth rate of lukewarm performance ushered in qualitative change In 2018, the net profit reached 1.451 billion, surpassing the biopharmaceutical leader Changchun hi tech In the first three quarters of 2019, Zhifei biology achieved a business income of 7.666 billion yuan, a year-on-year increase of 119.35%, and a net profit attributable to its parent of 1.763 billion yuan, a year-on-year increase of 62.25% In 2019, Zhifei's annual performance is expected to achieve a net profit of 2.250-2.540 billion Zhifei has also said that at present, the four price HPV has won the bid in 29 provincial-level units nationwide, and the promotion and sales work are also actively carried out Since the signing of the supplementary agreement on May 1, 2018, the nine price HPV vaccine has won the bid in five provincial units, and the bidding, promotion and sales of the above products have been actively promoted as planned It can be seen that although the situation of approval of self-developed products is not clear, the support of MSD has given a boost to the performance of Zhifei biology last year However, as the cooperation agreement with MSD is about to expire, what Zhifei biology needs to consider at present is the R & D process of its own products According to the 2019 half year report, at present, there are 22 products under research and 17 products are in the clinical stage The rich R & D pipeline is also the capital and foundation for Zhifei to get rid of MSD After all, even if it acts as an agent for more products of others, when the other party finds a more suitable partner, it also has the spare power to support the next development 37