MaxVax Biotechnology Breaks Through Novel Adjuvant Technology Barriers with Differentiated Vaccine Pipeline

Vaccines are considered one of the greatest achievements in the history of human medicine and serve as a crucial weapon against infectious diseases; smallpox, poliomyelitis, and other diseases have been eradicated thanks to vaccines.

China is the world’s second-largest vaccine market, accounting for more than one-fifth of the global market, with substantial growth potential. However, China’s vaccine market has been commercialized for less than 20 years, and there remains a significant gap in product technology compared with international counterparts, particularly against the backdrop of an oligopolistic structure in the global vaccine market.

Dr. Chen Dexiang, Founder of MaxvaxIt is believed that, first, China’s vaccine industry is relatively fragmented and lacks the capacity for innovation and explosive growth. In the future, the industry will experience rapid growth, and through market consolidation driven by survival of the fittest, a few leading vaccine enterprises will ultimately emerge.

Secondly, as China has joined the ICH, vaccine quality is becoming increasingly aligned with international standards. Stricter quality regulation will significantly drive improvements in vaccine quality.

Finally, Chinese vaccine manufacturers previously operated under a self-production and self-distribution model; the COVID-19 pandemic has propelled them to expand globally. Currently, domestically produced COVID-19 vaccines have been deployed in over 100 countries, and the internationalization of vaccine products represents a significant future trend.

Maxvax is a company dedicated to the research and development of innovative vaccines and novel adjuvants. Leveraging its leading innovative adjuvant technology platform and recombinant protein expression platform, Maxvax has established a pipeline of more than ten innovative vaccine candidates, including preventive vaccines for major infectious diseases, as well as therapeutic vaccines for allergic diseases and cancer.

After obtaining his Ph.D. in the United States in 1991, Chen Dexiang entered the U.S. vaccine industry, successively serving as Project Manager at Pfizer Vaccines, Director of R&D at Novartis Vaccines, and Vaccine Technology Director at PATH (Program for Appropriate Technology in Health), where he engaged in the development of vaccines and adjuvants.

During his 25 years in the overseas vaccine industry, Dr. Chen Dexiang participated in and led the development of more than 20 vaccines for infectious diseases, six of which have been launched globally, including pneumococcal vaccines, meningococcal vaccines, rotavirus vaccines, and influenza vaccines.

According to Dr. Chen Dexiang, vaccines represent a low-cost intervention with the greatest social benefit; however, many countries have yet to reap the benefits of vaccination. This is partly due to vaccine pricing and partly because global vaccine production capacity fails to meet the demands of the overall population.

Currently, vaccines are not yet available for many infectious diseases, such as HIV/AIDS and certain sexually transmitted infections, leaving substantial room for further development.

Furthermore, Dr. Chen Dexiang stated that in developed countries, the leading cause of human death is no longer infectious diseases, but chronic conditions such as cancer and diabetes. These non-communicable diseases may also be addressed through vaccination.

Drawing on years of technological expertise and a profound understanding of vaccines, Dr. Chen Dexiang decided to return to China to launch a startup, leveraging his technical know-how to develop innovative vaccines that address needs in the fields of infectious diseases, cancer, and allergic disorders. Thus, Maxvax was born.

In 2016, Maxvax was officially established, with its headquarters in Chengdu. The company has R&D centers or production bases in Chengdu, Shanghai, and Hangzhou, and has set up business and clinical centers in Seattle, USA. Currently, the company has more than 200 employees. The core management team, led by Dr. Chen Dexiang, has an average of over 20 years of experience in vaccine research and development and industrialization.

Maxvax’s core technologies are its internationally leading, China-first novel adjuvant technology platform and recombinant protein production platform.

The production of novel adjuvants presents significant challenges, requiring advanced manufacturing technologies and adherence to stricter regulatory standards. The vast majority of vaccine companies lack the commercial-scale production capacity for novel adjuvants and must therefore partner with firms such as GSK to secure adjuvant supplies. Adjuvant development has become a critical "chokepoint" technology for China’s vaccine industry.

According to Dr. Chen Dexiang, adjuvant technology is actually the scarcest, most challenging, and highest-value niche segment within the vaccine industry. The core technologies of adjuvants includeRaw Materials, FormulationsandQualityThree Aspects.

Maxvax holds a unique advantage in the development of novel adjuvants, stemming from Dr. Chen Dexiang’s over 30 years of deep expertise and accumulation in the vaccine field.

First, it possessesNearly 20Raw Materials, with the majority independently designed and manufactured, and a small portion introduced from domestic and international sources, we have broken through intellectual property barriers, controlled costs and quality, ensured stable supply, and achieved the number one position globally in terms of volume. Second, we have builtThree mature delivery systems, featuring over 10 composite formulations, thirdly,Mature Process, complying with domestic and international quality standards and demonstrating superior quality compared to foreign benchmark products. These technologies are also being applied to the development of preventive and therapeutic vaccine projects.

Leveraging innovative adjuvant raw materials, formulations, manufacturing processes, and a comprehensive quality system, Maxvax has developed a series of adjuvant products, including optimized aluminum adjuvants, nanoemulsion adjuvants, combination adjuvants, and molecular adjuvants.

Maxvax’s recombinant protein production platform includes both prokaryotic and eukaryotic expression systems. Leveraging its technological advantages and the strength of its industrialization team, Maxvax has established a presence in9 Class 1 New Drug Pipeline Products, of which three have entered the IND stage and two have already entered clinical trials. In the next 6–8 months, three additional products will be submitted for clinical trial approval.

Regarding pipeline strategy, Maxvax has its own considerations. “We aim to rapidly advance our early-stage products to market to generate initial revenue, thereby laying the groundwork for deploying truly leading, breakthrough innovations on the global stage,” said Dr. Chen Dexiang.

MaxvaxClassify the pipeline into three categories based on risk level.. The Phase I product portfolio includes a recombinant rotavirus vaccine and a herpes zoster vaccine; their underlying technological platforms have been validated, indicating a very high probability of success, and they are currently the most advanced products in development.

Traditional first-generation rotavirus vaccines are administered orally and may cause severe intestinal adverse reactions in children, with an incidence rate of approximately one in 100,000; their efficacy also remains debatable. Maxvax’s recombinant rotavirus vaccine is administered to children via injection, which can mitigate side effects while enhancing vaccine effectiveness. It has currently entered Phase II clinical trials, marking the fastest progress among similar domestic products.

The second product, the shingles vaccine, has just entered Phase I clinical trials. The first-generation shingles vaccine had an average efficacy of only 50% in individuals aged 50 and above, and was nearly ineffective in adults over 80. Maxvax’s novel shingles vaccine can effectively improve therapeutic efficacy by 20% to 30%, raising the vaccine effectiveness rate to over 90% in people aged 50 and older, and enabling adults over 80 to also benefit from this new vaccine.

Phase II products are in the regulatory filing stage, including therapeutic vaccines for cervical cancer and varicella-zoster virus vaccines, which carry certain risks but have a relatively high probability of success.

Cervical cancer is one of the most common gynecological malignancies, with a substantial number of patient deaths occurring annually. According to data from the International Agency for Research on Cancer (IARC), in 2020, there were 340,000 cervical cancer-related deaths and 600,000 new cases worldwide. Vaccination against human papillomavirus (HPV) is currently one of the primary measures for preventing cervical cancer, driving significant market demand.

The third-stage product is another cancer therapeutic vaccine, which will be submitted for clinical trial approval next year. “The production cost of cancer vaccines is very low, allowing for mass production similar to conventional vaccines. However, this also entails significant challenges and risks. We are confident that by leveraging our unique technology platform, we can identify novel adjuvants and develop promising cancer vaccines, thereby benefiting more people,” said Dr. Chen Dexiang.

Since its establishment over four years ago, Maxvax has transitioned from a biotech startup to clinical development and is now advancing toward industrialization.

In May this year, Maxvax established a business and clinical center in Seattle, USA. Regarding this development, Dr. Chen Dexiang stated that adjuvant platforms are also a scarce resource for foreign vaccine companies. He expressed the hope that, through collaboration, Maxvax can provide comprehensive adjuvant technology solutions to jointly develop more innovative products, while also promoting the company’s cervical cancer vaccine, shingles vaccine, and other products to the international market.

Looking ahead, Maxvax will increase its investment in clinical development, accelerate the construction of its industrialization base, and cultivate a team of professional managers with entrepreneurial spirit and a sense of mission for public health. These efforts will drive the company’s sustained growth and enable it to make meaningful contributions to public health in China and around the world.