Acquisition adds dersimelagon to LEO Pharma’s rare dermatology pipeline

收购为利奥制药的罕见皮肤病管线增添dersimelagon

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LEO Pharma, a global leader in medical dermatology delivering innovative solutions for skin disease, has entered into an agreement to acquire worldwide rights to dersimelagon from Japan-based Tanabe Pharma. Dersimelagon is an oral, once-daily small MC1R agonist being developed for erythropoietic protoporphyria (EPP) and X-linked proto-porphyria (XLP)..

全球医学皮肤科领域领导者、致力于提供皮肤疾病创新解决方案的利奥制药（LEO Pharma）已与日本田边制药（Tanabe Pharma）达成协议，收购dersimelagon的全球权益。Dersimelagon是一种每日一次口服的小分子MC1R激动剂，目前正针对红细胞生成性原卟啉症（EPP）和X连锁原卟啉症（XLP）进行开发。

EPP and XLP are rare and severe genetic diseases that cause severe sunlight-induced skin damage and can significantly limit patients’ ability to spend time outdoors.

EPP 和 XLP 是罕见且严重的遗传性疾病，会导致严重的日光性皮肤损伤，并可能显著限制患者户外活动的 ability。

The acquisition reflects LEO Pharma’s strategy to continue to strengthen its medical dermatology portfolio through targeted partnerships, acquisitions, and external innovation, with rare dermatology as a key focus area. Building on the 2025 partnership with Boehringer Ingelheim for Spevigo® (spesolimab) and the recent acquisition of Replay’s next-generation HSV gene therapy platform, LEO Pharma continues to pursue opportunities in rare skin diseases with high unmet need..

此次收购体现了LEO Pharma通过有针对性的合作伙伴关系、收购和外部创新，持续加强其医学皮肤科产品组合的战略，并将罕见皮肤病作为关键重点领域。继2025年与勃林格殷格翰就Spevigo®（spesolimab）达成合作，以及最近收购Replay的下一代HSV基因治疗平台之后，LEO Pharma继续寻求在存在高度未满足需求的罕见皮肤疾病领域的机会。

Dersimelagon has been granted both US FDA Fast Track Designation and Orphan Drug Designation, and an NDA for the treatment of EPP and XLP was submitted to the US FDA for regulatory review in June 2026, but has not yet been approved by the FDA or any other regulatory agency. Dersimelagon’s safety and efficacy have not been established by any regulatory authority..

Dersimelagon 已获得美国食品药品监督管理局（FDA）的快速通道认定和孤儿药认定，用于治疗红细胞生成性原卟啉症（EPP）和 X 连锁原卟啉症（XLP）的新药申请（NDA）已于 2026 年 6 月提交给美国 FDA 进行监管审评，但尚未获得 FDA 或任何其他监管机构的批准。Dersimelagon 的安全性和有效性尚未得到任何监管机构的确认。

If approved, dersimelagon would represent the first oral therapy for the treatment of EPP and XLP and help address an area of significant unmet need.

如果获得批准，Dersimelagon 将成为首个用于治疗红细胞生成性原卟啉症（EPP）和 X 连锁原卟啉症（XLP）的口服疗法，有助于满足这一领域巨大的未竟医疗需求。

Under the terms of the agreement, LEO Pharma will acquire worldwide rights to dersimelagon from Tanabe Pharma for up to $435 million in up front and near-term milestone payments together with potential downstream milestones and tiered royalties on net sales.

根据协议条款，LEO Pharma 将从田边制药收购 dersimelagon 的全球权利，支付高达4.35亿美元的首付款和近期里程碑付款，以及潜在的后续里程碑付款和基于净销售额的分级特许权使用费。