Emergency approval for the oral COVID-19 drug Zocova — and production started before it (2022)

Building the factory before the approval

They had begun building manufacturing equipment before the clinical trials started — the remark Teshirogi Isao made in October 2020 contains the whole of the Zocova judgement. Committing money to production before development succeeds or fails means that failure converts the plant directly into a loss. And yet, because it was built first, shipments to wholesalers could begin the day after approval came on 22 November 2022, and two million courses could be booked into a single quarter's revenue. That a manager who said he would not rush a vaccine on safety grounds acknowledged taking an unusual risk in manufacturing tells you something about how this company allocates resources.

The range in which that risk was repaid, however, is skewed toward the figures. Revenue and profit set records, but infectious-disease specialists did not raise the drug's place in their prescribing order, and the fact remains that a teratogenic drug was prescribed to 23 pregnant women. The nature of an emergency approval framework — deferring confirmation of efficacy in order to speed supply — became the dividing line in how the drug was judged. Being the first domestic drug to answer a national emergency procurement was both a case of policy design and corporate preparation meeting, and a demonstration that speed of approval does not necessarily bring the clinical front line along with it.