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[Featured Stock] Celltrion Jumps Over 4% on News of Streamlined Clinical Trial Approval

On the 11th, Celltrion was up more than 4% following news that the clinical trial process for its biosimilar in Europe has been simplified.


As of 12:03 p.m. that day, Celltrion was trading at 238,500 won on the Korea Exchange, up 4.84% from the previous session.


[Featured Stock] Celltrion Jumps Over 4% on News of Streamlined Clinical Trial Approval

Investor sentiment appears to have improved on expectations that Celltrion’s global clinical trial streamlining will shorten clinical timelines and reduce development costs.


Earlier, on the 9th (local time), Celltrion announced that it had received approval from the European Medicines Agency (EMA) for an amendment to the investigational new drug (IND) application related to the global Phase 3 clinical trial of CT-P55, a biosimilar of Cosentyx (ingredient name: secukinumab).


Under the amended plan, the number of patients to be enrolled in the global Phase 3 trial will be reduced from 375 to 153. Celltrion expects to cut development costs and shorten the overall clinical trial period by reducing both the target enrollment and the number of enrolled patients. As a result, the company explained that the cost of development is also expected to decrease significantly.


Celltrion is currently conducting a global Phase 3 clinical trial in patients with plaque psoriasis to demonstrate the efficacy, safety, and equivalence between the original drug Cosentyx and CT-P55. Cosentyx is an interleukin (IL)-17A inhibitor used as a treatment for autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis. Its global sales last year were approximately 6.668 billion dollars (about 9.3352 trillion won). The substance patent is scheduled to expire in January 2029 in the United States and in July 2030 in Europe.


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