Sinovac Biotech Ltd. (“Sinovac”) (Nasdaq: SVA), a Chinese biopharmaceutical company developing a COVID-19 vaccine candidate (CoronaVac), announced that its Brazilian partner Instituto Butantan, a producer of immunobiological products and vaccines, received approval from the Brazilian National Regulatory Agency, Anvisa, to proceed with the Phase 3 clinical trial to investigate the efficacy and safety of the inactivated vaccine candidate from Sinovac. A major milestone as this represents one of a few COVID-19 vaccine candidates that have made it all the way to Phase 3. But as TrialSite News reminded investors, the drama and intrigue associated with this company and its poison pill provision cannot be overlooked.
The Brazilian Review Process
First, it should be noted that Anvisa fast-tracked the Instituto Butantan application due to the public health emergency associated with COVID-19. In what could be a record for the Brazilian regulatory, the entire review process was completed in two weeks. The collaborators did remind the public in their press release that Anvisa’s review was of the highest standards: Anvisa is a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and qualified as a full functional regulatory agency for the World Health Organization (WHO) prequalification process.
The Phase 3 Clinical Trial
This planned pivotal study will recruit nearly 9,000 healthcare professionals working in COVID-19 specialized facilities in twelve clinical sites located in several Brazilian states. Now that the regulatory approval is out of the way, the sponsors now need ethical approval for each clinical site and then patient enrollment can commence: planned to start in July 2020. Note that China has far less COVID-19 cases so Chinese sponsors have been identifying deals elsewhere for major clinical trials.
Commenting on the milestone Dr. Dimas Covas, Director of Instituto Butantan, reported, “The Phase 3 clinical trial approval is a demonstration that Sinovac and Butantan partnership is an efficient collaboration to move forward offering hope to save lives worldwide.” Should this study produce positive results, it could lead to the world’s first licensed COVID-19 vaccine.
Sinovac LS initiated the development of an inactivated vaccine against COVID-19 (named CoronaVac) on January 28th, 2020. Preclinical study results were published in the peer-reviewed academic journal Science. On April 13th, 2020 the National Medical Products Administration (“NMPA”) granted approval to conduct phase I and II clinical trials in China. The phase I and II trials commenced on April 16, 2020 in Jiangsu Province. China. A group of healthy adults aged 18-59 years old were vaccinated with a 0, 14 day schedule. Preliminary phase I/II results were recently reported. There was no serious adverse event after vaccinating a total of 743 volunteers in the trials, demonstrating a good safety profile for the vaccine candidate. Over 90% seroconversion was observed in the phase II clinical trial 14 days after completion of a two-dose vaccination at day 0 and day 14. A Phase II study on elderly adults is being conducted which will be followed by child and adolescent groups. The phase II trial is expected to be completed at the end of 2020. The Company has partnered with several companies outside of China for phase III efficacy studies.
The Company Context
CoronaVac developer Sinovac Life Sciences Co. Ltd. (Sinovac LS) was previously known as Sinovac Research and Development Co. Ltd or “Sinovac R&D, a wholly owned subsidiary Sinovac in Brazil.
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, Quadrivalent Influenza vaccine (“QIV”), H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps. Healive, the hepatitis A vaccine manufactured by the Company, has passed the assessment under WHO prequalification procedures in 2017. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, and a SARS-CoV-2 (commonly referred to as COVID-19) vaccine. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company is registering its products in over 30 countries outside of China.
TrialSite News reported on challenges as the company had to recently secure a $15 million convertible debt deal. Back in 2019, the company instituted a rare “poison pill” to protect management from disgruntled shareholders. This whole affair was full of intrigue and drama.
Call to Action: Investors should be very careful with Sinovac due to issues associated with its poison pill affair.