Recognizing Takeda's Entyvio as an official rival of Celltrion's Zymfentra, Celltrion Group Chairman Seo Jung-jin unveiled the company's plans to conduct a head-to-head comparison study.

Speaking at a press conference to discuss the recent approval of the company's merger by shareholders on Wednesday, Seo highlighted the recent FDA approval of Zymfentra, also known as Remsima SC outside the U.S., as a landmark event in Korean biopharmaceutical history.

Zymfentra, referencing the original drug Remicade, developed by Janssen, is designed to treat a range of conditions, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult Crohn's disease, and adult ulcerative colitis. Unlike the original medication, Zymfentra is administered subcutaneously, simplifying patient compliance.

"The company forecasts that Zymfentra will achieve annual revenue of over 600 billion won ($445.4 million) and potentially reach 3 trillion won in sales within three years," Seo said. "The company expects a stable mid-to-long-term revenue base as it can set a higher selling price for Zymfentra than existing biosimilars through the patent for the SC formulation and administration method that has been filed."

Seo emphasized that the company anticipates pricing Zymfentra similarly to Takeda's Entyvio, a biologic treatment for individuals with ulcerative colitis or Crohn's disease. The actual cost may vary depending on the patient's health insurance coverage. Notably, Entyvio is priced at approximately $4,380 per month in the U.S., according to the official website of the drug.

During the press conference, Seo said that he expects Entyvio will become the main competitor of Zymfentra in the U.S. Takeda has also recently won FDA approval for a subcutaneous version of Entyvio.

"While there is a head-to-head study comparing Entyvio against Humria, there is no study that compares Entyvio with Zymfentra, and there have been many requests from doctors to conduct such a head-to-head study," Seo said. "Therefore, we plan to conduct the study from next year."

Celltrion, Celltrion Healthcare merger to be completed by end of 2023

Seo also said he aims to successfully conclude the merger of Celltrion and Celltrion Healthcare by the end of the year.

"We have enough funds even if some shareholders exercise their appraisal right over 1 trillion won, which we had said that we would initially offer," Seo said. "As a result, appraisal right is no longer an uncertainty for the merger and not a point of concern for the company."

Seo stressed that he believes the merger will be successfully completed by the end of the year and will do his best to ensure that there are no hitches.

"After the merger, we expect revenues of 3.5 trillion won and earnings before interest, taxes, depreciation, and amortization (EBITA) of 1.7 trillion won next year," he said. "Both existing and future investors want this merger."

After this initial phase of the merger, Seo said that the company will begin the merger with Celltrion Pharma within six months and aim to leap forward as a multinational pharmaceutical company next year.

"We expect synergies in cost competitiveness and uncertainty resolution through the merger, in addition to our company's strengths in in-house development, in-house production, and direct sales in over 110 countries," Seo said.

Chairman Seo also mentioned the listing plans for Celltrion Holdings, in which he holds a 98 percent stake. He stated, "When Celltrion Holdings is listed, I plan to turn it into an investment company investing in bio healthcare."