French drugmaker Sanofi has abruptly scrapped plans to develop a next-generation atopic dermatitis drug to follow its blockbuster Dupixent, which generates 27 trillion won in annual sales. The move came after the phase 3 trial failed to prove differentiation that surpasses existing treatments. The industry says the decision could create new opportunities for Korea's corporations to target the "post-Dupixent" market.
According to the pharmaceutical and biotech industry on the 29th, Sanofi recently withdrew its plan to file for U.S. Food and Drug Administration (FDA) approval of its next-generation atopic dermatitis candidate "amlitelimab." As recently as six months ago, the company said it would pursue approval, but after the phase 3 results failed to show clear differentiation over existing therapies and a comprehensive review of market competitiveness after launch, it concluded the asset lacked sufficient commercial potential.
Dupixent is the world's first atopic dermatitis treatment, co-developed by Sanofi and U.S.-based Regeneron. To prepare for Dupixent's patent expiration in the early 2030s, Sanofi had been nurturing amlitelimab as the "next Dupixent." To that end, in 2021 it acquired U.K. biotech Kymab for about $1.1 billion (1.6 trillion won), securing amlitelimab and developing it as a next-generation growth driver.
In the global atopic dermatitis treatment market, Dupixent holds an overwhelming share, with Novartis' "XOLAIR" among the competitors. Global drugmakers are accelerating efforts to secure next-generation immunology pipelines not only through research and development but also via large mergers and acquisitions (M&A). In June, U.S.-based AbbVie jumped into the race by acquiring immunology drug developer Apogee for $10.9 billion (about 15.95 trillion won).
With this decision, Sanofi has effectively exited the race to develop the "next Dupixent," widening the window for latecomers at home and abroad to target the market. However, because big pharma prioritizes differentiation over mere clinical success, it is crucial for Korea's corporations to ultimately prove efficacy that surpasses existing treatments.
A representative corporation is Yuhan(000100). It is co-developing the atopic dermatitis treatment "Lesigercept (GI-301)," introduced in July 2020 from GI Innovation(358570). Lesigercept, now in global phase 2, is a key pipeline that Yuhan is nurturing as the "next Leclaza."
Yuhan said that results from the Lesigercept phase 1b trial released last month at the European Academy of Allergy and Clinical Immunology (EAACI) showed faster and more sustained suppression of free serum IgE than existing treatments.
GI Innovation is also moving to expand its follow-up pipeline by discovering artificial intelligence (AI)-based bispecific fusion protein candidates.
AprilBio(397030) is conducting a global phase 2b of "APB-R3," an autoinflammatory disease candidate licensed out to U.S.-based EvoMune last year in a deal worth about 650 billion won, as an atopic dermatitis treatment.
Shaperon, which is developing the atopic dermatitis treatment "NuGel," did not achieve statistical significance versus placebo on the primary endpoint of improvement in the Eczema Area and Severity Index (EASI) in global phase 2b results released last month. The company plans to review future development strategies based on additional analyses.
With Dupixent's patent expiration approaching, competition to develop biosimilars is also heating up. Subsidiary Samsung Bioepis of Samsung Epis Holdings(0126Z0) and Chong Kun Dang pharmaceutical(185750), Daewoong Pharmaceutical(069620), and Kyungdong Pharm(011040) are moving to develop Dupixent biosimilars (biosimilar), aiming to secure a lead in the next-generation market.
"It's no longer enough to simply succeed in clinical trials," an industry official said. "How much a new drug can surpass existing therapies has become the key criterion that determines success or failure."