SEOUL, Dec. 7 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Tuesday its COVID-19 antibody treatment has won emergency approval from Australian authorities. The Therapeutic Goods Administration (TGA) granted provisional approval of Rekirona for the intravenous treatment of mild-to-moderate COVID-19 in adult patients. It is the fifth COVID-19 treatment to receive regulatory approval [...]
SEOUL, Nov. 30 (Korea Bizwire) — Celltrion Healthcare Co., an affiliate of South Korean biopharmaceutical giant Celltrion Inc., said Tuesday it has inked a series of deals to supply its COVID-19 antibody treatment to nine European countries. Under the agreement, Celltrion Healthcare — which handles overseas business operations for Celltrion Inc. — will deliver 150,000 [...]
SEOUL, Nov. 12 (Korea Bizwire) — The European Union’s drug agency has recommended the approval of a COVID-19 antibody treatment by Celltrion Inc., paving the way for its sales in the region, the South Korean pharmaceutical giant said Friday. The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency recommended the [...]
SEOUL, Oct. 25 (Korea Bizwire) — South Korean biopharmaceutical company Celltrion Inc. said Monday that its self-diagnostic kit for the novel coronavirus has won emergency approval from U.S. drug authorities. Celltrion DiaTrust COVID-19 Ag Home Test, co-developed by local healthcare business Humasis, received the U.S. Food and Drug Administration’s Emergency Use Authorization approval. The product [...]
SEOUL, June 14 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. said Monday that its COVID-19 antibody treatment has sharply reduced recovery time and the chance of a severe case. Celltrion announced top-line results from a global phase three clinical study of Rekirona, a pivotal part of the study to obtain more comprehensive safety [...]
SEOUL, May 10 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. has begun the global supply of its COVID-19 antibody treatment starting with Pakistan, according to the company’s affiliate on Monday. Celltrion Healthcare, which handles Celltrion’s overseas business, said it has signed a contract with a Pakistan state-run company to export 100,000 tablets of [...]
SEOUL, Feb. 20 (Korea Bizwire) — South Korean biopharmaceutical company Celltrion Inc. will supply its antibody treatment for COVID-19 without a profit margin in South Korea, its chairman has said. Celltrion’s CT-P59 won the South Korean drug safety agency’s conditional approval earlier this month, becoming the first locally made treatment for the virus. The drug [...]
SEOUL, Feb. 18 (Korea Bizwire) – Celltrion Inc. said Thursday that its anti-COVID-19 monoclonal antibody treatment has confirmed neutralizing potency against the British variant, and the South Korean pharmaceutical giant has also begun developing a neutralizing antibody cocktail treatment. CT-P59, an anti-COVID-19 monoclonal antibody treatment, won the country’s drug safety agency’s conditional approval earlier this [...]
SEOUL, Feb. 17 (Korea Bizwire) — South Korean pharmaceutical giant Celltrion Inc. began supplying its COVID-19 antibody treatment to medical institutions in the country Wednesday. CT-P59 won the drug safety agency’s conditional approval earlier this month, becoming the first locally made treatment for COVID-19. CT-P59 will be administered to COVID-19 patients at higher risk, referring [...]
SEOUL, Feb. 5 (Korea Bizwire) — South Korea’s drug safety agency said Friday it has approved pharmaceutical giant Celltrion Inc.’s COVID-19 treatment candidate on several conditions. The conditional marketing authorization of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, marks the country’s first homegrown COVID-19 treatment. The Korean Ministry of Food and Drug Safety said CT-P59 [...]