[Photo by Chong Kun Dang]
Shares of Chong Kun Dang Pharm tumbled after its acute pancreatitis drug Napabeltan (nafamostat mesylate) highly anticipated as the second potential coronavirus treatment in Korea has failed to get conditional approval for the new indication.
Its shares have nose-dived 21 percent to 154,000 won as of 1:55 p.m. Thursday.
An advisory board consisting of outside experts under the Ministry of Food and Drug Safety said that data from a Phase 2 study of the drug were not sufficient to support the drug’s efficacy and recommended a Phase 3 trial for regulatory clearance.
On Mar. 8, Chong Kun Dang submitted Phase 2 trial data to the ministry to seek approval on condition that the results from its Phase 3 trial will be submitted.
Chong Kun Dang and other pharmaceutical companies have joined a race to win approval for the country’s second Covid-19 cure after Celltrion’s Rekirona (regdanvimab) became the first homegrown treatment in February.
Eyes are still on who will win the second homegrown cure title in Korea where Gilead’s Veklury® (remdesivir) and Celltrion’s Rekirona are the only two approved coronavirus treatment.
Candidates include Chong Kun Dang, GC Pharma and Daewoong Pharm.
By Chung Ji-sung and Minu Kim
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]