South Korea’s pharma major Celltrion Inc. will unveil the results of the second-phase clinical trial of its Covid-19 antibody treatment (CT-P59) next week to address to transparency in data disclosure of the drug that is under review for conditional approval of emergency use.

According to multiple sources from the pharmaceutical and bio industries on Tuesday, Celltrion has decided to disclose the results of the global clinical second-phase test of its Covid-19 treatment CT-P59 (regdanvimab) at the High 1 New Drug Development Symposia to be hosted by the Pharmaceutical Society of Korea on Jan. 13. It will be the first time for Celltrion to unveil detailed data of CT-P59’s second clinical trial.

Celltrion has already applied for a conditional authorization for the Covid-19 antibody treatment with Korea’s Ministry of Food and Drug Safety after completing its global second-phase trial late last year It had not disclosed the test results upon agreement with the ministry, given public’s excessive attention over a Covid-19 treatment.

Celltrion has obtained a go-head from the ministry to share the findings on confidence that its drug has sufficient elements for it to be approved by experts from home and abroad for its outstanding efficacy and safety as a Covid-19 treatment.

An unnamed official from Celltrion said that the antibody treatment – when injected to mild and secondary patients – significantly lowers the ratio of them developing into serious conditions.

The second-phase trial has been carried out on 327 Covid-19 patients including those in Korea, Romania, Spain, and the United States. The drugmaker completed final injections on Nov. 25 and applied for a conditional approval with the food and drug safety ministry on Dec. 29.

Apart from the conditional authorization, Celltrion plans to launch third-phase clinical trial in 10 countries.

Shares of Celltrion were trading 0.58 percent lower at 345,500 won ($317.9) on Tuesday.

Celltrion’s founder and Chairman Seo Jung-jin is intent on seeing through the antibody release before his retirement in March.

After his retirement, Seo will remain as honorary chairman and focus on grooming digital healthcare startups using his knowhow of nurturing Celltrion from a minor biosimilar producer to the country’s most valuable bio-tech company.

Under Seo’s leadership, Celltrion made its name in the 1 trillion won club in 2019 with 1.13 trillion won in revenue, significantly up from 141.1 billion won in 2009. In the first nine months of last year, the drugmaker raised 547.4 billion won in operating profit on sales of 1.36 trillion won and it is poised to become Korea’s largest pharma and bio company in sales, according to Financial Supervisory Service.

The company aims to become one of world’s top 10 pharmaceutical firms by 2030.

By Kim Byung-ho and Lee Eun-joo

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