On November 11, the old vaccine manufacturer “Kangtai Bio†issued an announcement announcing its signing of the vaccine project cooperation framework agreement with DESMONS CONSULTING SPRL on November 11, 2018. DESMONS CONSULTING SPRL will assist Kangtai Biotech to develop a new five-line vaccine (DTP-Hib-IPV) as a one-packed all-liquid vaccine according to the agreement. Kangtai Biotech will pay the project milestone to DESMONS CONSULTING SPRL according to the terms of the framework agreement. The Wulian vaccine pays the sales commission in the first five years after the domestic market.
DESMONS CONSULTING SPRL is a vaccine research and development company. Founder Pierre Desmons has more than 30 years of experience in internationally renowned vaccine companies, contributing to the marketing of some vaccine varieties, including DTP, Hib, pneumonia, HPV, and reorganization. Herpes zoster vaccine and combination vaccines such as quadruple vaccine, five vaccines, and six vaccines based on white blood.
Kangtai Biotechnology Co., Ltd. is one of the earliest companies engaged in the production of recombinant hepatitis B vaccine (Saccharomyces cerevisiae). It was founded in 1992 and successfully transformed into a listed company in 2017. The current market value is 23.4 billion yuan, and two of them are located in Nanshan District, Shenzhen. The production base of Science and Technology Industrial Park and Daxing Bio-pharmaceutical Industrial Base of Zhongguancun Science and Technology Park in Daxing District, Beijing, and the research and development production base of Kangtai Bio-light Bright Vaccine covering an area of ​​62,400 square meters are in trial production. At present, Kangtai Bio has listed products including recombinant hepatitis B vaccine (Saccharomyces cerevisiae) (10μg, 20μg, 60μg), Haemophilus influenzae type b conjugate vaccine, measles and rubella combined live attenuated vaccine, cell-free whitening A combination of Haemophilus influenzae type b vaccine.
Duo Miaocheng International R&D trend, with great market value
The most economical and effective measure for humans to control and prevent infectious diseases is vaccination. China has implemented immunization planning policies for 40 years, and the implementation of immunization programs has been continuously manifested. Vaccination has reduced the incidence of infectious diseases to the lowest level in history. The development of vaccine products requires three stages: preclinical research, clinical research and production license. The entire vaccine development cycle usually takes 7 to 15 years, and it is necessary to apply to the State Food and Drug Administration for clinical research, apply for drug registration approval, and accept the country. Strict review by relevant departments.
At present, the five vaccines (DTP-Hib-IPV) marketed in China are in two bottles, one bottle is a component of the polio vaccination vaccine (liquid), and the other bottle is a Hib conjugate vaccine (lyophilized), inoculated. The lyophilized Hib vaccine is dissolved in a blister polio vaccine combined with a liquid component.
The bottled all-liquid five-dose vaccine (DTP-Hib-IPV) developed by Kangtai Bio and DEMONS CONSULTING SPRL is more advanced than the two-packaged five-dose vaccine (DTP-Hib-IPV). It is produced, stored and transported. The use of the program is more convenient. The new five-line vaccine is in line with the current research and development trend of multi-lingual seedlings in the world and has great market value.
For Kangtai Bio, in addition to the four products already on the market, there are currently 25 research projects, of which one has obtained the GMP certification for the production workshop, and four have applied for the drug registration approval, 11 Clinical approvals have been obtained, one has applied for clinical studies, and eight have been in preclinical research. In other words, the signing and implementation of this framework agreement will further enrich the research and development projects of Kangtai Bio and improve the strength of Kangtai Bio-combined vaccine.
Withdrawal of drug registration application, net profit growth is affected
It is worth noting that just two days ago, Kangtai Biotech announced that its wholly-owned subsidiary Minhai Biotech had submitted the withdrawal of freezers to the Beijing Food and Drug Administration to avoid the repeated construction of the rabies vaccine GMP production workshop. Application for registration with rabies vaccine (MRC-5 cells) and approval.
Among the vaccination varieties used by Minhai Biological for the prevention of rabies are: freeze-dried human rabies vaccine (MRC-5 cells), freeze-dried human rabies vaccine (human diploid cells). The freeze-dried human rabies vaccine (MCR-5 cells) was introduced from the French Pasteur technology, and the freeze-dried human rabies vaccine (human diploid cells) is the basis for lyophilization of human rabies vaccine (MRC-5 cells). The project optimization process has the advantages of advanced production technology, stable quality, large output and low production cost, and greatly reduces the technical license fee paid to Pasteur. At present, freeze-dried human rabies vaccine (human diploid cells) has completed phase III clinical research, is in the stage of clinical research summary, all work is carried out smoothly, and it is expected to declare production in mid-2019.
The research and development progress of the rabies vaccine (human diploid cells) combined with freeze-dried human rabies vaccine, in order to avoid the repeated construction of the rabies vaccine GMP production workshop, concentrate the superior resources to promote the development of other heavy vaccines, and withdraw the freeze-dried human rabies Application for registration of vaccine (MRC-5 cells). The lyophilized human rabies vaccine (MRC-5 cell) production workshop and supporting facilities will be converted into a production workshop for freeze-dried human rabies vaccine (human diploid cells) in accordance with relevant regulations.
As of the announcement date of Kangtai Bio-release, the accumulated research and development capitalization amount of freeze-dried human rabies vaccine (MRC-5 cells) will be transferred to the current expenses. Although Kangtai Bio said that the withdrawal of this drug registration application will not affect Kangtai Bio's other research projects, according to China Securities Journal, market participants analyzed that the withdrawal of drug registration application will affect the profit of this year and next year, especially the company. More important product development. This year's profit will be reduced by 46 million yuan, and it is expected to be less next year.
Yitai Health reviewed the revenue and net profit growth of Kangtai Bio from 2013 to 2017 and found that its net profit maintained its growth. Kangtai Biotech realized revenue of RMB 1.5 billion from the beginning of the 2018 to the third quarter, a year-on-year increase of 88.82%; the net profit attributable to listed companies was 376 million yuan, a year-on-year increase of 140.60%.
It can be seen that Kangtai Bio's net profit as of the third quarter has far exceeded the net profit of 2017 by 215 million yuan. That is to say, even if Kangtai Biotech's net profit decreased by 46 million yuan due to withdrawal of drug registration application, its net profit in 2018 still showed an upward trend, but the growth rate would be slightly lower.
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