pharm edaily

[Shin-Min Joon, Edaily Reporter] South Korea’s First Blockbuster Drug is Born. Celltrion has successfully launched South Korea’s first blockbuster drug. The protagonist of this achievement is Remsima (infliximab), an autoimmune disease treatment.

On January 25 Celltrion announced its preliminary financial results for 2024, reporting annual revenue of 3.5573 trillion won and an operating profit of 492 billion won. Among these, Remsima generated 1.268 trillion won in revenue, accounting for 36% of the total sales. With its flagship product proving its competitive edge in the market, Celltrion aims to achieve annual revenue of 5 trillion won this year, with success in the U.S. market, the world‘s largest pharmaceutical market, being a key determinant.

Zymfentra. (Image=Celltrion)

Zymfentra’s Full-Scale Growth Begins with Pre-Established Preparations

Celltrion recorded over KRW 1 trillion in revenue from the North American market, including the U.S., last year. This was driven by the strong performance of existing products such as Remsima and Truxima, as well as the growth of follow-up products like Zymfentra (the U.S. version of Remsima SC), Yuflyma, and Vegzelma. As a result, the company achieved a 66% year-over-year increase in sales. To reach KRW 5 trillion in total revenue this year, Celltrion must generate KRW 1.5 trillion to KRW 2 trillion from the North American market alone. Zymfentra has been identified as the key product to achieve this target.

Celltrion has already laid the foundation for expanding Zymfentra prescriptions. The company has secured formulary listings with the three major pharmacy benefit managers (PBMs) in the U.S., which have significant influence over the pharmaceutical market, as well as with medium and small-sized insurance companies. As a result, Celltrion has achieved over 95% insurance coverage in the U.S. Additionally, since the end of last year, the company has launched a full-scale media advertising campaign via TV and YouTube. Celltrion has also been displaying advertisements in over 500 medical institutions to boost brand recognition and preference for Zymfentra. Securities analysts are optimistic about Zymfentra’s success.

Lee Hee-young a researcher at Daishin Securities stated “With the stabilization of the U.S. sales network and the expansion of Zymfentra’s formulary listings with insurance companies linked to PBMs, prescription volume and product shipments are on an upward trend.”

Kiwoom Securities researcher Heo Hye-min also commented “From the second half of this year, the number of products that can be marketed alongside Zymfentra will increase, which will enhance Celltrion’s negotiating power with insurers.”

Proactive Measures Against U.S. Drug Tariff Concerns and Consideration of Local Production Facilities

As former U.S. President Donald Trump’s tariff policies continue to fluctuate, attention is on Celltrion’s strategic approach, given its focus on the U.S. market. On January 18 (local time), Trump announced at a press conference in Mar-a-Lago, Florida, that he would impose tariffs on semiconductors and pharmaceuticals.

Celltrion has taken proactive steps to mitigate risks associated with U.S. tariff policies. The company has already transferred approximately nine months’ worth of inventory, including Zymfentra, to the U.S. market, minimizing any immediate impact regardless of potential tariff impositions.

Moreover, Celltrion primarily exports drug substances (DS), which are subject to significantly lower tariff burdens compared to finished pharmaceuticals (DP). The company is also utilizing local contract manufacturing organizations (CMOs) to produce finished pharmaceuticals. Depending on future tariff policy developments, Celltrion plans to expand local finished product manufacturing if necessary. Additionally the company is considering securing a local drug substance production facility in the U.S. as a long-term solution to mitigate trade protectionism risks.

Lee Myung-sun a researcher at DB Financial Investment noted “Despite Trump’s pharmaceutical tariff policies, Celltrion has preemptively stockpiled a significant amount of products in the U.S. to minimize initial tariff impacts. The company has also secured local raw material and finished product production facilities through contract manufacturing, and it is considering establishing its own local manufacturing facility.”