Celltrion’s Regkirona approved for emergency use in Indonesia
Celltrion’s Regkirona Covid-19 treatment has received an emergency use authorization from regulators in Indonesia.
According to the bio company, the Indonesia National Agency of Drug and Food Control made an announcement on July 17 that it approved the emergency use of Regkirona for high risk and moderate risk Covid-19 patients.
Earlier in the week, Celltrion announced that animal tests of Regkirona have produced meaningful results confirming its effectiveness against the Delta variant. Regkirona will be a great help in preventing the further spread of Covid-19 cases in Indonesia, Celltrion said.
According to data from Worldometer, the number of Covid-19 cases in Indonesia total 2.91 million as of 1 p.m. Tuesday. The number of deaths total 74,920.
“As Regkirona has proved its effectiveness, it was able to win emergency use authorization from the Indonesia National Agency of Drug and Food Control,” said a spokesperson for Celltrion. “With the approval, we anticipate that the export of Regkirona will increase further and Celltrion will make all efforts for quick supply.”
Celltrion is working with Samsung Biologics, which manufactures Regkirona under a contract manufacturing organization (CMO) deal.
"Celltrion will manufacture Regkirona in our own plants, but signed a CMO contract with Samsung Biologics in order to avoid supply shortages in the future," Celltrion's spokesperson said.
Multiple media outlets reported that Celltrion has also applied for emergency use authorizations for Regkirona in many countries, including Malaysia, Saudi Arabia, India, Brazil and Mexico.
BY SARAH CHEA [firstname.lastname@example.org]