After the outbreak of COVID-19 this year, Chengdu Hi-tech Industrial Development Zone immediately issued the Measures to Strengthen the Scientific and Technological Breakthrough and Material Support for COVID-19 Prevention and Control, helping enterprises with "actual deeds" and precise services. In March, the policy of the first batch of projects was implemented, including Chengdu MaxHealth Biotech LLC in the Tianfu Life Science Park, and the term "vaccine adjuvant" also appeared in the public view.
MaxHealth has developed a COVID-19 vaccine adjuvant based on the core technology of new adjuvant. According to the current experimental results, it cannot only significantly reduce the antigen dosage of a novel coronavirus, but also improve the immune effect of vaccine, and reduce the inoculation times, which is crucial for the control of emerging infectious diseases. It is reported that the vaccine with this adjuvant is expected to be available early next year.
Chen Dexiang (middle) and the research personnel
Different from other manufacturing enterprises, vaccine production is the only industry with the whole chain not allowed to be outsourced. The average capital investment is no less than RMB 500 million, and any change in any link will affect the whole industry, making it a veritable "asset-heavy" industry.
According to data, only one or two out of 100 vaccine projects could be successful from entering the preclinical stage to receiving approval for marketing, of which, the success rate of projects entering the clinical stage was only 10%, and in the most critical phase III trials, up to 50% of projects failed.
Furthermore, the cycle of vaccines from project approval to marketing is long -- no less than 10 years on average, which thus shows that vaccine R&D is very tough, highly testing the courage and patience of entrepreneurs and investors.
Then, where did Chen Dexiang get the courage?
Dr. Chen Dexiang graduated from Mississippi State University, with 25 years of experience in vaccine R&D successively at multinational companies such as Pfizer, PowderJect, and Novartis, and the global public health organization PATH. He has mastered international cutting-edge vaccine and adjuvant technologies and possesses rich industrialization experience. He participated in and led the development of more than 20 infectious disease vaccines and therapeutic vaccines, including the marketed pneumococcal vaccine, meningitis vaccine, rotavirus vaccine and influenza vaccine.
As a result, he wanted to return to China to exercise his faculty to promote the development of the vaccine industry in China. (Review of the exclusive interview with Chen Dexiang)
Conventional vaccine technology has been explored sufficiently, and now the remaining technical bottlenecks are hard nuts to crack, with vaccine adjuvants being one of those nuts.
Vaccine adjuvants are chemical or biological materials added as excipients to vaccines and play a key role in the effectiveness of the vaccines. The commonly used adjuvant was aluminum hydroxide in the past, however, as vaccine technology continues to be explored deeply, aluminum hydroxide can no longer meet today's needs, and more and better "novel adjuvants" are needed to improve the effectiveness of vaccines.
Vaccines produced in China rarely use novel adjuvants at present, and there are very few enterprises engaged in the R&D of novel adjuvant in China, therefore, the product market is almost blank.
To this day, the state has started to encourage the novel adjuvant-based vaccine development, and for the moment, there are novel adjuvant-based vaccines succeeding in applying for clinical trials.
MaxHealth, by taking novel adjuvants as its core technology, has developed a COVID-19 vaccine adjuvant and supplied it to eight vaccine companies for pre-clinical evaluation.
From the experimental results, the novel adjuvant showed two great advantages: first, the addition of adjuvant could reduce the dosage of COVID-19 antigen and greatly boost the capacity of emergency vaccine; second, the addition of novel adjuvant could significantly improve the immune effect of vaccine and reduce the times of vaccination, which is crucial for the control of new and emergent infectious diseases.
MaxHealth Biotech, after three years of incubation in the Tianfu Life Science Park, has more than 10 international cutting-edge technologies and more than 20 invention patents and has three core vaccine pipelines and three reserve vaccine pipelines in place, which cover hepatitis B, cancer and other areas. It has also built 6,000-square-meter production and pilot plants in Tianfu International Biotown and is expected to be settled there at the end of August.
This April, MaxHealth announced the completion of a PRE-A round of financing of nearly RMB 100 million, used to advance the senile herpes zoster vaccine pipeline and novel rotavirus vaccine pipeline into clinical trials. (Review of the financing details)
New vaccine for herpes zoster in the elderly
The average effective rate of the first generation of herpes zoster vaccines is only 50% in people aged above 50 and almost ineffective in people aged above 80. The new vaccine of MaxHealth for herpes zoster in the elderly is expected to fill in this gap.
With the aid of the adjuvant, the new herpes zoster vaccine of MaxHealth Biotech can effectively improve the therapeutic effect by 20% to 30%, leading to an effective rate of over 90% in vaccinated people aged above 50 and also benefits for people aged above 80.
Novel rotavirus vaccine
As one of the main pathogens causing diarrhea in infants and children, rotavirus mainly infects the intestinal epithelial cells in children to thus cause diarrhea. The traditional first-generation rotavirus vaccines are administered orally, which has the disadvantage of causing serious intestinal side effects in children at a rate of about 1 in 100,000, and their efficacy is questionable.
The new rotavirus vaccine MaxHealth Biotech is currently developing is administered to children through a new injection method that can improve the effectiveness of the vaccine while alleviating side effects.
Tianfu Life Science Park (Phase I)
In 2017, Chen Dexiang, who is from Shandong, investigated first- and second-tier cities in China many times and eventually chose to settle down in Chengdu Hi-tech Industrial Development Zone Tianfu Life Science Park. According to him, Chengdu has a good ecological environment for medicine industrialization and the government's generous support policies for innovative enterprises are very attractive; moreover, Chengdu gathers talents specialized in vaccine-related industrialization and maintains a pleasant living environment.
Chengdu MaxHealth Biotech LLC
MaxHealth, founded by a senior expert team with international innovative vaccine R&D experience, is specialized in the R&D, production and sales of innovative vaccines and novel adjuvants. Through self-innovation, Sino-foreign collaboration and many other modes, MaxHealth will provide high-quality, safe and effective vaccines to serve the Chinese and global public health.
MaxHealth has several internationally advanced and domestically pioneering adjuvant technologies, meanwhile, it has set up platforms for multiple technologies such as the expression of recombinant proteins, the evaluation of novel adjuvants, and the preparation of drugs. With many vaccine-related core intellectual property rights and proprietary technologies, MaxHealth has established R&D pipelines targeting multiple innovative vaccines, covering the prevention against a series of diseases like rotavirus, herpes zoster, COVID-19, and bacterial pneumonia, as well as the treatment of hepatitis B, allergic diseases, cancers, and other diseases. The Company plans to have all products pass the pre-qualification of the WHO, so as to ensure the quality of vaccines and meet the demands of domestic and international markets.
MaxHealth maintains a vaccine R&D team with 50+ members at international levels, five invention patents in relation to vaccine products and technology, as well as facilities and premises for the R&D and production of vaccines and adjuvants, including pilot plant and production plant.
Source: Sichuan Online
Park WeiChart