Chengdu Clover Biopharma received a manufacturing permit for its S-Trimer COVID-19 vaccine candidate at its Changxing facility. Clover is currently testing the vaccine in a global pivotal Phase II/III trial as a combination of the SCB-2019 antigen (a stabilized trimeric form of the S-protein) and two adjuvants. It is based on the original strain of the SARS-CoV-2 virus. Clover plans to submit for conditional approval of SCB-2019 in China and the EU, plus WHO, with a launch as early as year-end 2021. At peak capacity, the Changxing facility will be able to produce more than one billion doses of antigen per year.

To produce the vaccine, Clover's SCB-2019 antigen is combined with two adjuvants: Dynavax's CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

Clover's in-house, commercial-ready Changxing biologics facility is a part of Zhejiang Clover Biopharmaceutical, a wholly owned Clover subsidiary. It has a centrally-automated and flexible start-to-finish platform based on single-use technologies. The  facility was designed to adhere to current Good Manufacturing Practices (cGMP) standards in accordance with NMPA, FDA, and EMA regulations.

SCB-2019 (CpG 1018/Alum), Clover's COVID-19 vaccine candidate, could be one of the first protein-based COVID-19 vaccines commercialized globally through the COVAX Facility.

Clover uses its Trimer-Tag™ technology platform to develop novel vaccines and biologic therapeutic candidates. In 2020, the company received a grant from the Coalition for Epidemic Preparedness Innovations (CEPI) for up to $328 million to support development of the COVID-19 vaccine.

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Disclosure: None.