Tigermed a leading clinical contract research organization (CRO) in China, has conducted clinical trials for a variety of biopharma therapies and gained significant experience and knowledge about how to efficiently conduct them in both metropolitan locations and rural areas with less established infrastructure.
So, when the coronavirus spread, Tigermed was uniquely positioned by virtue of its experience and networks to be the partner of choice for the some of the vaccine developers. As such, Tigermed played a key role in safely and efficiently developing and bringing to market China’s COVID-19 vaccine.
CROs, like Tigermed, enable biopharmaceutical companies to efficiently carry out high-quality clinical trials and can help shorten the time it takes for a company to bring a new drug to market.
Tigermed participated in and supported the phase III clinical study of the Ad5-nCoV vaccine, which was co-developed by CanSino Biologics and Professor Wei Chen. Tigermed was responsible for cross-country coordination of the study and operations. These efforts included project management, data management, biometrics, and oversight of third-party auditing. This was the first China-initiated phase III clinical study of a vaccine that covered multiple continents, including Asia, Europe, and Latin America, in countries including Pakistan, Mexico, Russia, Chile, and Argentina.
A High Success Rate
More than 40,000 subjects were vaccinated, and the interim data were analyzed. Data showed that the vaccine had an efficacy rate of 90.07 percent at preventing severe disease 28 days after single-dose vaccination and 95.47 percent at preventing severe disease 14 days after single-dose vaccination.1 The data also demonstrated that Ad5-nCoV efficacy met the technical standards set forth by the World Health Organization.
The CanSino vaccine uses a cold-causing adenovirus as a vector, similar to the vaccines developed by Johnson & Johnson and AstraZeneca. While the rollout of J&J’s and AstraZeneca’s vaccines was temporarily halted in Europe because of concerns about possible adverse effects, no worrisome side effects were detected with the CanSino vaccine. It and other Chinese vaccines were administered to 60,000 patients in pivotal-stage trials.2
A Coordinated Effort to Ensure Safety and Efficacy
To verify the safety and efficacy of this COVID-19 vaccine in the clinical trials, Tigermed partnered with CanSino to deploy scientists and clinical experts in regions that were gravely affected by the pandemic. The firm also worked with local researchers to accelerate the study and to ensure that it was conducted efficiently and was compliant with international regulatory standards.
Tigermed led and supported local centers to establish a process for continuous screening and high-volume sample enrollment. One week after arriving in Pakistan, for example, Tigermed helped to quickly initiate the first site and patient enrollment. Tigermed completed the start-up of multiple centers within a month and finished the enrollment of 10,000 subjects ahead of schedule.3
At the same time, Tigermed’s China teams of Biometrics, Medical Affairs, Pharmacovigilance and other supporting units collaborated with international teams to ensure the quality of data and results, thereby laying the groundwork for the completion of the trial and subsequent launch of the vaccine.
Helping to Oversee the Trial of an mRNA Vaccine
Tigermed also helped oversee the phase III trial of ARCoV, China’s first mRNA vaccine (similar to the Pfizer and Moderna vaccines) that was jointly developed by China’s Suzhou Abogen Biosciences, the Institute of Military Medicine and Walvax Biotechnology.
In total, an estimated 28,000 people were enrolled in ARCoV phase III trials across China, Mexico, and Indonesia. The production of ARCoV, which started in the third quarter of 2021, is expected to provide an annual capacity of 120 million doses.
Sustainable Development Goals
The Sands Capital six investment criteria lead us to businesses that are innovators or vital facilitators of change in industries undergoing significant transformation. Tigermed is one of many portfolio businesses that create impact by addressing at least one major social or environmental challenge identified by the United Nations Sustainable Development Goals (SDGs). With its support of COVID-19 vaccine development, Tigermed contributed to SDG 3, Good Health and Well-Being.