30/01/2026
📢最新消息!News Alert
仁新醫藥於27日代子公司Belite Bio, Inc公告,旗下LBS-008(Tinlarebant)針對青少年斯特格病變(STGD1)之DRAGON II第二/三期臨床試驗已於日本、美國及英國完成60位受試者收案,其中有15位為日本人受試者,日本受試者數據將有助於未來在日本的新藥上市申請及後續商業化安排。Belite並規劃於2026年上半年先向美國FDA遞交新藥上市申請(NDA)。
仁新表示,LBS-008為全球首款證實具STGD1臨床療效之治療候選藥物,其在關鍵的DRAGON臨床三期試驗解盲數據亮眼,主要療效指標顯示病灶增長速度降低了36%(p=0.0033),展現LBS-008在罕病眼疾治療領域之潛力。隨著DRAGON解盲成功,Belite將以最高效率推動新藥上市與後續全球市場佈局,讓臨床成果真正轉化為實際市場價值。
Belite Bio, Inc., a subsidiary of Lin Bioscience, announced on January 27 the completion of enrollment of 60 subjects in the Phase 2/3 DRAGON II clinical trial evaluating Tinlarebant for the treatment of Stargardt disease type 1 (STGD1). Across Japan, the United States, and the United Kingdom, the trial had a targeted enrollment of 60 adolescent subjects, including 15 Japanese subjects, whose data are expected to support future new drug application efforts and subsequent commercialization in Japan. Belite Bio plans to file its first NDA with the US FDA in 1H 2026.
Lin BioScience stated that LBS-008 is the world’s first therapeutic candidate to demonstrate clinical efficacy in Stargardt disease type 1 (STGD1), with compelling topline results from the pivotal Phase 3 DRAGON clinical trial showing a 36% reduction in lesion growth rate on the primary efficacy endpoint (p = 0.0033), highlighting the strong potential of LBS-008 in the treatment of rare retinal diseases. Belite Bio is positioned to efficiently advance the regulatory submissions and global commercialization strategies, aiming to transform its clinical achievements into tangible market value.
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仁新醫藥完整新聞👉 https://www.linbioscience.com/TW/IM/NewsDetail/87
Belite Bio News Release Details👉 https://investors.belitebio.com/news-releases/news-release-details/belite-bio-completes-enrollment-dragon-ii-clinical-trial
仁新醫藥(股票代碼:6696,以下簡稱”仁新”) 昨(27)日代子公司Belite Bio, Inc(那斯達克股票交易代碼:BLTE,以下簡稱”Belite”)公告,旗下LBS-008(Tinlarebant)針對青少年斯特格病變(STGD1)之DRAGON II第二/三期臨床試驗已.....