Favipiravir (Avigan) has become a centerpiece to the Chinese response to COVID-19. Of course, good practices such as enforced lockdowns, masks, and strict social distancing rules all fall under the formula for success possibly combined with a more authoritarian governmental structure, which is used to enforce the pandemic rules. But the broad-spectrum antiviral agent that inhibits the RNA-dependent RNA polymerase of RNA viruses certainly is helping according to recent press. As TrialSite News has reported, this drug has been approved in India, Russia and China, and the U.S. government via the Department of Defense (DOC) contributed over $200 million to its research and development. Why aren’t Americans benefiting from that investment?
As recently as 2015, the U.S. DOD funded a Phase 3 clinical trial to determine if a 5-day regimen of favipiravir reduced the time to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects with uncomplicated influenza compared to no treatment.
Zhejiang Hisun Pharmaceutical Co., Ltd (HISUN) secured a license to this now generic antiviral from Japanese maker FUJIFILM Toyama Chemical Co., Ltd.. (Toyama). The Chinese pharma companies reports no evident adverse reactions have been found since on the market. TrialSIte News has not been able to verify this data point although has a number of inquiries looking into its use. The company reports that the drug can directly prevent the virus from replicating itself in cells, with a mechanism of action similar to Remdesivir. However, Favipiravir can be taken orally while Remdesivir requires intravenous administration in a health care setting.
Zhejiang Hisun Pharma Not the Only Player in Town
The drug was approved as a Japanese stockpile in 2016. By 2016, Zhejiang Hisun Pharmaceutical Co., Ltd (HISUN), which collaborated with CMAM to develop and launch Favipiravir tablets to the Chinese market in February 2020, touts that the patent was exclusively franchised to itself. Perhaps this is true for China but Toyama is conducting clinical trials directly in the United States and elsewhere. Moreover, as the product went generic in 2016 now Russia has developed its own patented version. And in India, Glenmark Pharmaceuticals developed it own version based on the generic substance.
Chinese Government Activity
The Chinese company reported that China’s Ministry of Science and Technology at a COVID-19 themed press conference in March indicated the drug evidenced solid clinical efficacy against the novel coronavirus. The Chinese government included the drug in its Major Anti-pandemic Materials. Moreover, the government there has unified allocation of Favipiravir supplies. In China, all Favipiravir supplies are produced by HISUN, which was recently honored as an “Ordnance Factory” in response to the pandemic.
The recent HISUN press release showcases study results such as that of the No. 3 People’s Hospital of Shenzhen’s Favipiravir versus Kaletra trial findings which revealed regarding recovery from fever in 2 days, 72.4% in Favipiravir group versus 26.30% in the Kaletra group; regarding time for patients turning negative in viral nucleic acid tests, 4 days versus 11 days; regarding improvement rate in chest imaging, 91.43% versus 62.22%; regarding adverse reaction rate, 11.43% versus 55.56%.
Additionally HISUN showcased evidence from Zhongan Hospital of Wuhan University’s clinical trial involving Arbidol as a control group found ordinary Favipiravir-treated patients experienced a higher clinical recovery rate at the end of the treatment (71.43%), comparing with 55.86% in the control group. The auxiliary oxygen therapy or noninvasive mechanical ventilation rate was 8.16% in the Favipiravir group and 17.12% in the Arbidol group. HISUN reports coughing symptoms improved within 4.57 days, 1.41 days shorted than Arbidol-treated patients.
Who is HISUN?
Zhejiang Hisun Pharmaceutical Co., Ltd is a China-based company, principally engaged in the research and development, manufacture and distribution of specialty bulk pharmaceutical chemicals and preparation products. The company also has an American operation in Bridgewater, New Jersey.
The parent company was established in 1956 and is based in Taizhou, China, with over 7,000 employees. They purport themselves to be one of the largest Active Pharmaceutical Ingredient (API) manufacturers in China. Their API products are shipped to their partners throughout the world. The company also manufacturers finished dosage pharmaceuticals—capsules, tablets and parenterals—for Anti-Infective, Cardiovascular, Oncology, CNS, Animal Health and other therapeutic areas. They also have Antibody Drug Conjugate (ADC) and biosimilar production facilities. The company is positioning itself for growth within the United States.
Call to Action: TrialSite News needs to verify some of the claims in regards to Favipiravir. It is notable that China, Russia and India have approved the drug to treat COVID-19. Given the U.S. DOD invested over $200 million into Favipiravir clinical trials, it would appear that the American government saw promise with the drug.