Samchundang to start oral insulin clinical trial this year

Holds IR event and brief current status, “Eylea biosimilar to complete clinical trial April next year”

Samchundang Pharm announced its plan to start clinical trial on 'oral insulin' within this year.

 

Also the South Korean company explained that four vaccines were added to the pipeline of the 'S-Pass' platform, a technology converting injection into oral drug.

 

In the case of Eylea (aflibercept) biosimilar, the company expects to complete a global Phase III clinical trial in April next year.

 

With the trial data, the South Korean company is to initiate marketing in the U.S.

 

and Japan from 2023.

 

On Mar.

 

25, Samchundang Pharm convened an investor relations event for institutional investors and individual stockholders, and briefed about the S-Pass platform and the progress in Eylea biosimilar clinical trial.

 

Samchundang Pharm predicts the global clinical trials for oral insulin will begin this year.

 

The company is developing oral drugs such as insulin, vaccine, and TNF inhibitor using a formulation conversion technology platform named S-Pass.

 

Among these, the company is pushing the oral insulin the strongest.

 

Samchundang Pharm explained that its oral insulin under investigation showed almost the same level of efficacy and safety as injections.

 

Based on the outcome, the company is to kick off clinical trials.

 

The trials would be conducted in the U.S.

 

and China scheduled to finish in 2024.

 

Moreover, Samchundang Pharm announced that it has expanded the S-Pass platform pipelines.

 

In addition to oral insulin, the company is developing GLP-1 diabetes treatment Victoza, TNF inhibitor Enbrel, and growth hormone drug Zinotropin.

 

On top of them, the company added four types of vaccines—influenza, COVID-19, cervical cancer and pneumococcus—on the pipeline.

 

The company also reported the development status of Eylea biosimilar, undergoing global Phase III clinical trials at the moment.

 

Investigated under the name 'SCD411,' the Eylea biosimilar is expected to complete the global Phase III clinical trial in April next year.

 

The goal is to apply for a market authorization to the U.S.

 

Food and Drug Administration (FDA) by December of that year when the Phase III clinical trial is completed in April of next year.

 

He explained that it plans to start marketing the drug in the U.S.

 

and Japan from 2023.

 

Samchundang Pharm started its first clinical administration in 15 countries including the U.S.

 

in August last year.

 

155 clinical institutions worldwide and 560 patients are participating in the trial.

 

It has already obtained related patents in the U.S., Europe and Japan.

 

Samchundang Pharm explained that the local partners have been selected for Eylea biosimilars global sales.

 

In Japan, it has already signed an exclusive sales and supply contract with SENjU.

 

In the U.S., Europe, and China, the partners have been selected.

 

And it reported that the terms of the contract are being discussed.

 

It would be highly likely that the profit distribution would be 50-50 in Japan, the U.S., Europe, and China.

 

Eylea is a macular degeneration treatment developed by the U.S.-based Regeneron.

 

The blockbuster drug has made 8.5 trillion won worldwide as of 2019.

 

Given that the Eylea patent expiration is approaching but would still maintain high growth for the time being, many pharmaceutical companies home and abroad are jumping in to the biosimilar development.

 

Besides Samchundang Pharm, Celltrion, Samsung Bioepis, and Alteogen are conducting clinical trials in Eylea biosimilars.