A private Chinese pharmaceutical company founded by an America-educated biologist is joining forces with the Chinese military to research, trial and roll out a homegrown messenger ribonucleic acid (mRNA) Covid-19 vaccine.
The move comes amid a surge in Covid-19 cases caused by the highly contagious Delta strain and as questions arise about the efficacy of the Sinovac and Sinopharm’s traditional inactivated vaccines already administered to over 1.1 billion Chinese against new viral variants.
It also comes as much of the developing world lacks access to Western-made mRNA vaccines such as Moderna and Pfizer-BioNTech, which are proving more effective against the disease than traditionally produced vaccine shots.
Abogen Biosciences, a startup based in the eastern city of Suzhou, has been leading the charge in vaccine research and development since early 2020.
Chinese state media recently quoted Abogen founder Ying Bo saying that third-phase human trials of China’s indigenous mRNA prototype have been underway in Mexico, Columbia and Pakistan since the end of May.
He added that the People’s Liberation Army’s (PLA) Academy of Military Medical Sciences in Beijing had also lent talent and poured in resources for the project.
Mexican Foreign Minister Marcelo Ebrard confirmed to reporters in May the launch of trials of a Chinese mRNA vaccine involving about 6,000 volunteers. The novel technology makes human cells produce proteins that mimic part of the coronavirus and trigger an immune response.
Ying told a China Central Television (CCTV) news program that initial output from a proposed manufacturing base in Yuxi in southwestern Yunnan province could hit 120 million doses a year if China’s drug watchdog fast-tracks procedures and clears it for emergency use and mass production.
An Abogen statement said it was a “discovery stage” biotechnology company focused on developing nucleic acid-based (RNA and DNA) therapeutics for the treatment of infectious diseases and cancer.
It stressed that the vaccine would come from a “rapidly expanding and versatile pipeline” of candidates and formulas that would help China edge close to and even potentially pass the West in vaccine development.
Abogen received 600 million yuan ($92.9 million) in its B round fundraising in April and now counts venture funds operated by state-owned insurer PICC and the State Development and Investment Corp as its backers.
Chinese media reported that Ying is a member of the Communist Party with a doctorate in bioengineering from Northeastern University in Boston. Ying said he acquired his knowledge of the frontier sector during his 13-year stint in the US working at several medical and drug startups developing mRNA drugs.
He was also the president of the Chinese-American BioMedical Association registered in Massachusetts and was reportedly backed and partially funded by Beijing’s embassy in Washington for exchange programs for professionals from both countries.
Abogen disclosed in a stock exchange filing from its key manufacturing partner Yunnan Walvax Biotechnology that initial lab and clinical assessments of the mRNA shot, named ARCoV, had shown “promising effectiveness results” that could be “ranked alongside” Germany’s BioNTech and America’s Moderna vaccines.
The latter two have a widely recognized overall protection rate of over 90% against most Covid-19 infections, though the emergence of Delta has raised questions about their efficacy against new, more contagious variants.
The PLA’s medical science academy, meanwhile, reportedly evaluated the heat endurance of the Chinese drug. Western mRNA formulas are known for their low thermal stability.
A related paper in the July 2020 issue of the American scientific journal Cell revealed that the intramuscular immunization of ARCoV could elicit “robust neutralizing antibodies and T cell response” against the coronavirus in mice and primates and that two doses of ARCoV immunization in mice would confer “complete protection” against the virus’s mouse-adapted strain.
Titled A Thermostable mRNA Vaccine against Covid-19, the paper also said ARCoV would be manufactured as a liquid formulation and could be stored at “room temperature for at least a week.”
“Because cold chain transportation is not available in many Covid-19 epidemic areas, a vaccine that can be stored at room temperature is highly desirable…Storage at 37°C for 7 days only resulted in an about 13% reduction in relative photon flux, indicating high thermostability of the ARCoV vaccine,” the paper said.
If further trial and assessment results confirm these claims, then the much less stringent temperature requirement may help the Chinese shot stand out from the competition and achieve a swift roll-out in the developing world.
By contrast, guidelines issued by the United States Center for Disease Control stipulate that unpunctured vials of the Moderna vaccine should be stored in a freezer between -50°C and -15°C (-58°F and 5°F), while the BioNTech drug must be chilled to -70°C during transport.
Chinese CDC chief Gao Fu has hailed the virtues of mRNA technology, suggesting it may be included in the current national immunization drive as booster shots to augment the protection of the two doses of traditional inactivated jabs from Sinovac and Sinopharm. The Chinese CDC has recommended extra doses to better protect against the spread of new strains.
Shanghai Fosun Pharma, a research and marketing partner of BioNTech with the exclusive right to supply the latter’s mRNA vaccine to mainland China, Hong Kong, Macau and Taiwan, has also applied to China’s drug regulator to import the drug from Germany, with localized bottling and packing being planned.
Gao and other CDC experts told CCTV last week that there would be a “quick turnaround” from regulators for new drugs and formulas proven to be effective overseas to enter China and help battle any viral resurgences.