Carelink is a pharmaceutical company that is actively engaged in developing new drugs by making use of their staff that have ample global experiences in Japan, Asia, Europe and the U.S., as well as extensive clinical development expertise and track records, with the aim of broadly supplying high-quality pharmaceuticals not only in China but to the entire world. At present, Carelink has expanded its area of development to infectious diseases as well as lifestyle diseases, and is working to develop antiviral drugs. In addition, with pharmaceuticals that have already been approved in Europe and the U.S., the company collaborates with partner corporations both inside and outside China to promote clinical drug development and submit applications for their approval as imported drugs.
FUJIFILM Toyama Chemical has partnered with Carelink towards the deployment of Avigan in China, and signed a memorandum to grant Carelink the exclusive right to submit an application for imported drug approval. Going forward, Carelink plans to make use of Avigan’s nonclinical and clinical data that FUJIFILM Toyama Chemical has accumulated so far (Targets: Influenza and novel coronavirus infections), and work to submit an application to obtain imported drug approval in China.
Furthermore, to expand therapeutic options using Avigan, FUJIFILM Toyama Chemical will develop an injectable form of Avigan jointly with Carelink.
Avigan, approved for manufacture and sale in Japan as an influenza antiviral drug, selectively inhibits RNA polymerase necessary for influenza virus replication. Due to this mechanism of action, it has been expected that Avigan may have an antiviral effect on the novel coronavirus, as they are RNA viruses of the same type as influenza viruses. FUJIFILM Toyama Chemical conducted phase III clinical trial in Japan in March of this year for COVID-19 patients with non-serious pneumonia. After confirming, with a statistically significant difference, the efficacy and safety of Avigan, the company filed on October 16th an application for Partial Changes to manufacturing and marketing approval items to add indication, as well as dosage and administration, relating to COVID-19.
By tapping into its leading-edge proprietary technologies and expertise, the Fujifilm Group will work to provide the market with pharmaceuticals that will help improve and maintain people’s health, contributing to the resolution of various societal issues.
Avigan is not approved for distribution in the U.S.
<Overview of Carelink Pharmaceutical Co., Ltd.>
| Company name | Carelink Pharmaceutical Co., Ltd. |
| President and CEO (General Manager) | Qian Kang |
| Location | Shanghai, China |
| Established | 2018 |
| Capital | 12.5 million yuan |
|
###