Inovio Pharmaceuticals Inc expects to start a late-stage US study of its experimental Covid-19 vaccine candidate in the second quarter of 2021, the drug developer’s chief executive officer said on Monday.

Inovio’s vaccine, INO-4800, is being tested in two trials – a mid-stage study in China in partnership with Advaccine Biopharmaceuticals Suzhou Co Ltd and a mid-to-late stage trial in the United States.

The company announced a licensing deal with Advaccine Biopharmaceuticals Suzhou Co. Ltd. for its Covid-19 vaccine candidate. As part of the agreement, the privately held Chinese biotech gains exclusive right to develop, manufacture, and commercialise the still-investigational vaccine in China, Hong Kong, Macao, and Taiwan.

Under the deal, Advaccine will get exclusive rights to Inovio’s vaccine candidate in China, and Inovio will receive an upfront payment of $3 million, an aggregate of $108 million upon achieving milestones, and will also be entitled to sales royalty.

The US Food and Drug Administration had put the Phase III portion of the study on hold in September, as the agency sought more information, including details of a delivery device used to inject INO-4800 into skin cells.

“We expect to complete mid-stage trials in March and project we will be able to start late-stage trials in second quarter of this year,” Dr. Kim said.

The regulatory delay has resulted in Inovio lagging behind other developers in the race to develop a vaccine, as shots from Pfizer-BioNTech and Moderna have already gained authorisation for emergency use in the United States.

Advaccine is scaling up its manufacturing capability and expects to produce 100 million doses of the vaccine this year for China, Inovio said.

Shares of Pennsylvania-based Inovio rose 6 per cent to $9.43 on Monday afternoon.