On February 25, the Hong Kong stock price of CanSino Biologics (06185.HK, share price of HK$37.35, market value of HK$9.2 billion) once soared by more than 15%. On the news front, the company issued an announcement the day before, saying that the adsorbed acellular pertussis (component) Haemophilus influenzae type b (combined)-ACYW135 group meningococcal (combined) combined vaccine (DTcP-Hib-MCV4) has been approved for drug clinical trials.

This is a pentavalent vaccine that prevents multiple diseases at the same time. It has three components: the first Asian quadrivalent meningococcal conjugate vaccine "Manhaixin" that has been approved for marketing, the second is the adsorbed acellular diphtheria (component) pertussis combined vaccine for infants and young children in the phase III clinical stage, and the third is the Hib vaccine (Haemophilus influenzae type b vaccine) in the phase I clinical stage.

It is worth noting that this is the first domestic pentavalent vaccine to reach the clinical stage. On February 25, CanSino told the reporter of "Daily Economic News" that the research and development of multi-unit vaccines is more difficult and the production process is more complicated, but it can relieve the pressure of 6-month-old babies to discharge vaccines, which is the development direction of children's vaccines.

The first domestic pentavalent vaccine approved for clinical trials

When it comes to pentavalent vaccines, new parents will first think of the pentavalent vaccine Sanofi Pasteur "Pentaxin" that has been on the market for more than 10 years. It reduces the 12 doses of vaccines that infants and young children originally need to be vaccinated to 4 doses, and can prevent five diseases at the same time, including diphtheria, pertussis, tetanus, poliomyelitis and infections caused by Haemophilus influenzae type b.

Although it is a "pentavalent vaccine" like "Pentaxin", the components of DTcP-Hib-MCV4 are different. They mainly include MCV4, the first meningococcal quadrivalent conjugate vaccine product in China, adsorbed acellular diphtheria-pertussis combined vaccine for infants and young children, and Hib vaccine. In addition, the five diseases it can prevent are also different. It does not include poliomyelitis, but epidemic cerebrospinal meningitis.

CanSino told reporters that the country has included meningococcal vaccines in the immunization plan, stipulating that children should receive a dose of group A meningococcal vaccine at 6 and 9 months old. The "Manhaixin" in the company's pentavalent vaccine covers four serogroups: A, C, W135, and Y. It is suitable for children aged 3 months to 3 years old (47 months old). It is the third meningococcal vaccine in the world that can be used for infants under 6 months old. It can not only protect children earlier at 3 months old, but also choose to be vaccinated at 6 months old. However, if it can be vaccinated at 3 months old, it can be vaccinated early and protected early, and it can also avoid "collision" with other vaccinations in June, affecting the timely vaccination rate.

As for why polio is not covered, the person said that the polio vaccine deployed by the company is based on virus-like particles (VLP). Compared with traditional OPV (oral attenuated live polio vaccine) and IPV (inactivated polio vaccine), this non-infectious polio vaccine does not rely on live viruses during the production process and is expected to have good safety and immunogenicity.

The reporter noted that in October last year, CanSino Biologics signed an agreement with the Gates Foundation again, and will continue to receive funding for its recombinant polio vaccine project, while also adding support for the combined vaccine project that includes the recombinant polio vaccine.

Domestic multi-unit vaccines are scarce, and Zhifei Biologics' quadruple vaccine has also been approved for clinical trials

According to the "2024 Vaccine Industry Tracking Report" released by Southwest Securities, the multi-unit vaccines that have been approved in China are all exclusive varieties of each company, such as the trivalent vaccine produced by Zhifei Biologics (300122.SZ, stock price 26.1 yuan, market value 62.478 billion yuan) - group A and group C meningococcal (combined) influenzae type b Haemophilus influenzae (combined) combined vaccine, the quadruple vaccine produced by Kangtai Biologics (300601.SZ, stock price 15.38 yuan, market value 17.178 billion yuan) - acellular diphtheria, tetanus, and pertussis Haemophilus influenzae type b combined vaccine, and the pentavalent vaccine produced by Sanofi Pasteur.

Judging from the batch data of batch issuance, since Zhifei Biotech failed to pass the re-registration of the trivalent vaccine, there has been no batch issuance record since the fourth quarter of 2019; in 2024, the batch issuance batches of the quadrivalent vaccine and pentavalent vaccine were 27 and 100, respectively, an increase of 17% and 10% year-on-year.

CanSino told reporters that multi-unit vaccines need to mix multiple antigens together, and the interaction between different antigens must be considered during the research and development process, and safety must be ensured while ensuring effectiveness. Moreover, when domestic companies produce combined vaccines containing the same antigen components, they need to obtain independent approval for monovalent vaccines first, and the research and development front is also extended.

However, with the increasing number of children's vaccine products, the competition among vaccine manufacturers to "grab arms" is becoming increasingly fierce, and multi-unit and multivalent vaccines have become a hot spot for research and development of domestic and foreign companies. For example, a few days before CanSino announced that its pentavalent vaccine had been approved for clinical trials, Zhifei Bio also announced that its subsidiary's application for clinical trials of a component diphtheria, pertussis, and Hib quadrivalent vaccine had been accepted, which is expected to become the first diphtheria, pertussis, and Hib quadrivalent vaccine in China based on component technology. The vaccine can prevent pertussis, diphtheria, tetanus, and diseases caused by Haemophilus influenzae type b infection.

However, the challenges faced by domestic multi-component vaccines cannot be ignored. Li Jiuling, a researcher in health systems and policies at the Global Health Research Center of Duke Kunshan University, once said that the three major reasons that restrict China's current promotion of combined vaccines are that the immunization plan has not been adjusted, the supportive policies have been slow to take effect, and the research and development technology is lagging behind.

Cui Fuqiang, a professor at the School of Public Health of Peking University, also suggested that the enthusiasm of enterprises for research and development should start from the demand side to ensure that combined vaccines can develop sustainably: on the one hand, to improve the public's awareness and recognition of combined vaccines, on the other hand, to update the immunization mechanism in a timely manner, and solve the connection problem between combined vaccines and other vaccinations in routine immunization to alleviate "vaccine hesitation".

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