Recently, Johnson & Johnson (J&J) submitted a marketing application to the U.S. Food and Drug Administration (FDA) for Icotrokinra (JNJ-2113), the world's first oral interleukin-23 (IL-23) receptor antagonist. This new drug, designed to liberate patients with moderate-to-severe plaque psoriasis from injections, not only carries the hopes of millions of patients longing to "bid farewell to needles" but is also seen as a pivotal move by J&J to revitalize its dominance in autoimmune diseases and challenge the throne of its long-time rival, AbbVie.

In the field of pharmaceutical R&D, the development of oral peptide drugs was once considered an "impossible mission." The successful breakthrough of Icotrokinra represents a technological "barrier-breaking" achievement. Its four pivotal Phase III clinical trials have yielded impressive data: the drug not only demonstrates robust overall efficacy but also shows significant advantages in traditionally challenging areas such as the scalp and genital regions. The convenience of taking one pill daily instead of undergoing frequent injections holds immense potential for improving long-term treatment adherence among patients.

As the "First-in-class" oral drug targeting this specific receptor, Icotrokinra, once approved, will undoubtedly reshape the landscape of psoriasis treatment. J&J's ambitions extend beyond this: Phase IIb studies have revealed promising signs of its efficacy in ulcerative colitis, indicating a clear roadmap for expanding its indications.

According to Ddu data, propelled by the strong performance of its post-Humira era pillars—the IL-23 monoclonal antibody Skyrizi and the JAK inhibitor Rinvoq—AbbVie's autoimmune business revenue approached 130 billion RMB in 2024, solidifying its position as the global leader. In contrast, J&J's autoimmune blockbuster, Stelara (ustekinumab), is facing the severe impact of the patent cliff, making the search for its next "cash cow" an urgent priority.

Notably, Chinese contributions are visible in the development chain of this global innovative drug. This not only serves as evidence of China's growing global competitiveness in pharmaceutical R&D outsourcing but also suggests that domestic companies are quietly transitioning from mere "participants" to more influential players in the global innovation ecosystem. However, the question of how to enable true root-based innovation to take hold and yield value in China remains a profound challenge that the entire industry must confront.

Source： https://news.yaozh.com/archive/45823.html