Samsung Biologics Epix is leaping forward as a world-class company, achieving simultaneous growth in performance and novel drug development based on its global competitiveness in the biosimilar (biologic copy drug) sector. While continuing the trend of improved performance through expanded biosimilar sales, the company is also accelerating the expansion of its business areas, including the U.S. Food and Drug Administration (FDA) 'Fast Track' designation for an antibody-drug conjugate (ADC) novel drug candidate.
Bio investment holding company Samsung Epix Holdings announced on the 28th that its subsidiary, Samsung Biologics Epix, recorded Q3 revenue of 442.2 billion won and operating profit of 132.6 billion won. This represents a year-on-year increase of 0.3% and 2.8%, respectively. Compared to the previous quarter, revenue and operating profit increased by 13% (50 billion won) and 53% (46 billion won), respectively, maintaining growth momentum.
Samsung Biologics Epix achieved cumulative Q3 revenue of 1 trillion 289.3 billion won and operating profit of 363.2 billion won this year, already reaching 97% of last year's total operating profit (375.9 billion won). Rising global sales of the rare disease treatment Soliris biosimilar 'SB12' and the autoimmune disease treatment Stelara biosimilar 'SB17' are driving performance growth.
Following the successful commercialization of a total of 11 biosimilars in global markets including the United States, Samsung Biologics Epix has recently established an 'early collaboration model' with global pharmaceutical companies to diversify sales strategies by product and market. A representative example is the partnership agreement signed earlier this month with Teva Pharmaceutical Industries for two immunological disease biosimilar candidates (Fasenra (SB41) and Ilaris (SB44)). The strategy involves dividing development, production, and supply (Samsung Biologics Epix) from sales (Teva) from the initial stage to alleviate cost burdens and accelerate market entry.
A Samsung Biologics Epix official stated, "In addition to SB41 and SB44, we have expanded our follow-up biosimilar pipeline targeting blockbuster drugs nearing patent expiration to nine candidates." The official added, "In particular, after announcing the global Phase 3 clinical trial results for the Keytruda biosimilar candidate 'SB27' in June last year, demonstrating equivalence with the original drug, we entered the product approval process in Korea first among domestic companies in August."
Another growth pillar for Samsung Biologics Epix is novel drug development. The company set a goal earlier this year to add at least one novel drug clinical trial annually, going beyond biosimilars. Currently, based on 'open innovation' with domestic and international companies, it has secured two ADC (antibody-drug conjugate) anticancer drugs, 'SBE303' and 'SBE313', and a long-acting obesity treatment 'SBE501', accelerating research and development (R&D).
Among these, SBE303, the 'first novel drug,' is an ADC targeting 'nectin-4,' which is overexpressed in tumor cells. It entered global Phase 1 clinical trials in March last year for patients with locally advanced or metastatic urothelial cancer who had received existing targeted therapies. Following this, it was designated as a Fast Track drug by the FDA in mid-June to expand treatment access for patients with serious diseases, and development speed is expected to accelerate further.
The holding company, Samsung Epix Holdings, operates not only Samsung Biologics Epix but also bio platform developer 'Epix Nex Lab' and a China R&D center (Samsung Biologics Epix China) for novel drug technology development, exploring and pursuing new business opportunities in various fields. A Samsung Biologics Epix official stated, "It is significant that we are achieving solid growth through expanded global product sales, excluding one-time milestones." The official added, "We will maximize profitability through customized sales strategies while securing sustainable growth drivers by achieving results in follow-up biosimilars and next-generation novel drug development."
in THEBIO
