The R&D and application of vaccine is one of the greatest achievements in the public health sector in the 20th century, its emergence has provided a powerful weapon for human beings to prevent and control the infectious diseases.

 

By virtue of its favorable social and economic benefits, vaccine industry has gradually become an important branch in the biomedicine industry, showing strong growth momentum in commercial development. Both the phenomenon of "hard to get a shot" of HPV vaccine in the past two years and the outbreak of COVID-19 this year have raised consideration concern about the vaccine R&D, many domestic pharmaceutical companies have got ready with overall arrangement, in an attempt to break up the monopoly of imported vaccine and to accelerate the rise of domestic vaccine.

 

For this issue, we invite Dr. Chen Dexiang, the Founder of Chengdu MaxHealth Biotech LLC (hereinafter referred to as "MaxHealth"), to introduce the development difference of domestic and foreign vaccine industry, the development history of Chinese vaccine industry, the R&D bottleneck as well as the future development layout of MaxHealth.

Graduated from University of Mississippi, with 25 years of experience in the vaccine R&D at Pfizer, Powder Ject, Novartis and other multinational corporations and the international public health institution PATH successively, Dr. Chen Dexiang has presided over and participated in the research and development of vaccine products for over 20 infectious diseases, including pneumococcal vaccine, meningitis vaccine, rotavirus vaccine, influenza vaccine and combined vaccine for children already on the market.

 

He has published more than 60 vaccine-related academic papers in Science, Nature Medicine and other world-class academic journals.

At present, domestic innovative multivalent vaccine varieties are relatively scarce, showing a remarkable gap with foreign countries, however, supported by national policy, innovative varieties like 13-valent pneumococcal conjugate vaccine, HPV vaccine and multiple vaccine are expected to come into the market at an accelerated pace.

Talking about the difference with foreign vaccine R&D, Chen Dexiang indicated that, foreign vaccine enterprises are small in number, large in scale and high in market share, for example, four established giants, GSK, Pfizer, Sanofi and MSD, have taken up more than half of global vaccine market shares. While vaccine enterprises in China feature large quantity and small scale, areas involved are rather scattered.

 

Currently, there are 45 vaccine manufacturers in China, of which, over 30 enterprises have received the certificate for release previously, moreover, with scattered R&D resources universally and an investment that can't be compared with foreign companies, domestic vaccine manufacturers are subject to market demand and lack strategic vision in respect of long-term layout. Besides, only a few enterprises in China possess the independent R&D capacity in vaccine field, delivering more of homogenized products and mapping the pipeline layout in a less profound way.

 

In contrast, novel vaccine R&D results in foreign countries are often originated in research institutes, universities and other frontline institutions, their original research results are favored by the capital. Hence, there is no lack of capital injection when enterprises are transforming such achievements. While China maintains an investment environment that is different from foreign countries, in spite of strong originality in these innovative achievements, the risks associated with investment are rather significant, making it hard to attract the attention of domestic investors.

According to Chen Dexiang, the development of vaccine industrialization in China has experienced three main stages since the founding of the nation.

 

In the first stage, against the backdrop of national planned economy, through government's layout and zoning, 6 state operated vaccine institutes were established nationwide, with duties of radiating the area under administration and solving immunity demands. The vaccine industry in China just took the first step here.

 

The second stage started from the late 1980s, and extended to around 2010. At this stage, supported by funds of original vaccine sales agencies, large quantities of private medical enterprises emerged and divided the domestic vaccine market by taking the talents and technology of original state-owned vaccine enterprises as the productive forces.

 

After 2010, China stepped into the third stage, which is a golden stage for the development of vaccine industry, a great deal of experts capable of vaccine R&D popped up at home and abroad, the vaccine R&D teams under their leadership not only possessed R&D capabilities geared to international standards, but also maintained rich R&D experience and advanced development concept, which injected vitality into Chinese vaccine industry and narrowed the gap between China and international level.

 

Statistics show that, among 100 vaccine projects from entering preclinical stage to being approved for marketing, only one or two can achieve success in the research and development. Of which, the success rate of projects entering clinical stage was only 10%, and in the most critical phase III trials, up to 50% of projects failed.

Meanwhile, the cycle of vaccine from project approval to the market is long -- no less than 10 years on average, and it costs much -- the average investment is not lower than RMB 500 million, it is thus clear that the vaccine R&D is very tough, testing the courage and patience of investors.

 

Vaccine industry in China still needs to gain momentum in catching up in order to align truly with international standards. Among domestic vaccine pipelines, pneumococcal conjugate vaccine manufactured by foreign enterprises hit the market a decade or more ago, the cervical cancer vaccine appeared 10 years ago, while domestic products have not come into the market until recently.

 

The gap between China and foreign countries is narrowing down. This year, Herpes Zoster Vaccine for the elderly manufactured by GSK is approved for sales in China, Chen Dexiang anticipated that domestic products are expected to be put on the market in 5 years. China has been constantly enhancing its vaccine R&D capability, and unremittingly catching up the international products, according to Chen Dexiang, it is not an extravagant hope for Chinese products to come into the market in synchronization with international products in the coming days.

When talking about the technical bottleneck of vaccine R&D, Chen Dexiang repeated such a term as "vaccine adjuvant".

 

With the sufficient in-depth exploration of conventional vaccine technology, the remaining technical bottlenecks for the moment are a hard nut to crack. Vaccine adjuvant is a kind of chemical or biological material added into vaccine as an ingredient, playing a key role in the effect of vaccine, such as the frequently used aluminium hydroxide adjuvant.

 

MaxHealth, by taking novel adjuvant as its core technology, has developed a COVID-19 adjuvant, and supplied it to 8 vaccine companies for pre-clinical evaluation. From the experimental results, the novel adjuvant showed two great advantages: first, the addition of adjuvant can reduce the dosage of COVID-19 antigen and greatly boost the capacity of emergency vaccine. Second, the addition of novel adjuvant can significantly improve the immune effect of vaccine and reduce the times of vaccination, which is vitally important for the control of new and emergent infectious diseases.

 

At present, novel adjuvant is rarely used in domestic vaccines, while about 10 vaccines abroad already adopted the novel adjuvant. Partly because China adopted a relatively conservative attitude towards drug supervision and administration in the part, and has not released corresponding guidelines and incentives to promote the development and application of novel adjuvant.

 

Furthermore, there are very few enterprises engaged in the R&D of novel adjuvant in China, the product market is almost blank. To this day, the state starts to encourage the novel adjuvant-based vaccine development, for the moment, there are novel adjuvant-based vaccines succeeding in applying for clinical trial.

Adjuvant technology is the great impetus for innovative vaccine R&D, and may be used as a platform driving innovation and industrialization potential.

 

Chen Dexiang has total confidence in the core adjuvant technology of MaxHealth which is domestically advanced and internationally aligned, meanwhile, he also puts a high value on the collaborative innovation with Sichuan enterprises, such as FANXI, Antejin, etc., he expects that MaxHealth will, by virtue of its core technology of adjuvant, assist Chengdu in creating a national vaccine R&D innovation and industrialization base, so as to boost the development of vaccine industry in China.

 

In 2017, Chen Dexiang made several on-the-spot investigations in first- and second-tier cities in China successively, and finally chose to settle MaxHealth in Chengdu. In the eyes of Chen Dexiang, Chengdu has a good ecological environment for the industrialization of medicine, Chengdu Hi-Tech Industrial Development Zone also offers very tempting and lucrative support policy for innovation-oriented enterprises. Moreover, Chengdu gathers talents specialized in the vaccine related industrialization and maintains a pleasant living environment.

 

 

With many years' experience in adjuvant R&D, Chen Dexiang knows full well the design and production process of raw materials of novel adjuvant.

 

Since the end of 2017 when Chen Dexiang founded MaxHealth in Tianfu Life Science Park, now the Company has maintained a remarkable team comprising more than 50 professionals and technical staff.

With regard to the experience in corporate operation and management, he indicated that three jobs abroad have endowed him the capability and confidence as an enterprise manager.

 

At first stage, Chen Dexiang served as vaccine related project manager at Pfizer;

 

For the second stage, he assumed the office of middle management, being engaged in the technical management related to R&D and clinical trial;

 

At third stage, he worked on biological and vaccine products specific to less developed countries at PATH which is an international public health institution.

 

As an expert in vaccine study field, Chen Dexiang has a clear understanding of public health needs of varied countries and regions, a profound investigation of technological resources for vaccine development globally, and a thorough knowledge of the whole development process of vaccine.

 

On such basis, by integrating global technology and making independent innovations, MaxHealth cooperates with vaccine company in developing innovative vaccines by virtue of such a core platform technology as adjuvant, and opens up product market with the help of its capability of industrialization. In the future, MaxHealth will also develop independent and innovative vaccine products, and work out a pipeline layout covering the whole value chain of vaccines.

Since its establishment, MaxHealth has obtained multiple rounds of financing, when talking about factors attracting the capital injection, Chen Dexiang mentioned three points:

 

♦ vaccine industry has a broad prospect, favorable national policy and rapid development speed.

 

♦ the R&D team of MaxHealth has a "very down to earth" background, with both international vaccine industrialization background and rich domestic vaccine industrialization experience;

 

♦ Either from technical field or market perspective, products developed by MaxHealth are forward-looking on the market.

 

On April 16, 2020, MaxHealth announced the completion of Pre-A round of financing of nearly RMB100 million, pushing multiple novel vaccine lines into clinical trial. (Click here to view details)

 

Currently, MaxHealth has built production and pilot plant covering 6,000 square meters in Tianfu International Bio Town and is expected to settle down there at the end of August. In the future, MaxHealth will continue its cooperation with Hi-tech Zone and Tianfu International Bio Town, kick off the construction of vaccine industrialization base, and plan to launch series A financing at the beginning of next year for the construction of such base and the advance of clinical trials.

 

Chengdu MaxHealth Biotech LLC

 

MaxHealth, founded by a senior expert team of 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 technology, MaxHealth has established R&D pipelines targeting at multiple innovative vaccines, covering the prevention against a series of diseases like rotavirus, herpes zoster, novel coronavirus pneumonia 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-certification of WHO, so as to ensure the quality of vaccines and meet the demands of domestic and international markets.

 

MaxHealth maintains a 50+ member vaccine R&D team representing international level, 5 patents for invention 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.