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科倫博泰與和鉑醫藥宣佈SKB575/HBM7575治療特應性皮炎的新藥臨床試驗申請獲NMPA批准
成都2026年3月9日 /美通社/ -- 2026年3月9日,四川科倫博泰生物醫藥股份有限公司(「科倫博泰」或「公司」,6990.HK)與和鉑醫藥(股票代碼:02142.HK)宣佈,雙方合作研發的靶向胸腺基質淋巴細胞生成素(TSLP)及一個未公開靶點的長效雙特異性抗體SKB575/HBM7575的新藥臨床試驗(IND)申請已獲中國國家藥品監督管理局(NMPA)批准,用於治療特應性皮炎。 特應性皮炎是一種慢性炎症性皮膚病,以持續性瘙癢、紅斑和皮膚刺激為主要特徵。全球範圍內,該病影響約20%的兒童及高達10%的成人[1]。雖不具傳染性,但其週期性發作與緩解的疾病特徵嚴重影響了患者的生活品質。當前的治療方案,包括外用皮質類固醇、生物製劑及JAK抑制劑,雖能為許多患者緩解症狀,但往往難以實現長期持續的疾病控制,尤其在中重度患者中更為明顯。因此,行業迫切需要探索更安全、更有效、更持久且能從疾病根本機制入手並改善患者長期預後的治療方案。 科倫博泰首席執行官葛均友博士表示:「很高興看到SKB575/HBM7575獲批開展針對特應性皮炎的臨床試驗,這標誌著我們在自身免疫疾病領域的佈局取得重要進展,可為特應性皮炎患者提供全新的治療選擇。作為一款兼具差異化創新機制與長半衰期優勢的雙特異性抗體,SKB575/HBM7575有望實現持久穩定的疾病控制,並通過降低給藥頻率改善患者的治療體驗。」 和鉑醫藥創始人、董事長兼首席執行官王勁松博士表示:「HBM7575/SKB575獲國家藥監局臨床試驗許可,標誌著我們在應對特應性皮炎等自身免疫疾病的重大臨床需求上,邁出了重要一步。通過靶向2型炎症反應的關鍵上游驅動因數TSLP及未公開靶點,HBM7575/SKB575有望成為該疾病領域同類最佳(best-in-class)的雙特異性抗體。我們期待推進這一在研療法的臨床開發,並相信其長效特性可為全球患者提供差異化的治療選擇。」 [1] https://www.atopicdermatitisatlas.org/en/atopic-dermatitis/how-common-is-atopic-dermatitis 關於SKB575/HBM7575 SKB575/HBM7575是一款靶向胸腺基質淋巴細胞生成素(TSLP)及一個未公開靶點的長效雙特異性抗體,具有雙重作用機制:一方面通過阻斷TSLP與其受體的相互作用,可抑制TSLP介導的信號通路以及Th2免疫細胞的啟動;另一方面,其針對另一未公開靶點的結合與阻斷可產生協同效應,克服TSLP單靶點抗體的耐藥問題。SKB575/HBM7575經過工程化設計,具有延長的半衰期以及良好的可開發性,可實現皮下給藥。基於臨床前半衰期推測,人體半衰期預期可支援3個月以上的給藥間隔,具備同類最佳的潛力。 根據公司與和鉑醫藥之間的合作協定,SKB575/HBM7575由科倫博泰主導設計與全球範圍內的開發及商業化,和鉑醫藥共同參與該專案投資與開發並將按約定共用收益。 關於科倫博泰 四川科倫博泰生物醫藥股份有限公司(簡稱「科倫博泰」,股票代碼:6990.HK)是科倫藥業控股子公司,專注于創新生物技術藥物及小分子藥物的研發、生產、商業化及國際合作。公司圍繞全球和中國未滿足的臨床需求,重點佈局腫瘤、自身免疫和代謝等重大疾病領域,建設國際化藥物研發與產業化平臺,致力於成為在創新藥物領域國際領先的企業。公司目前擁有30余個重點創新藥項目,其中4個項目8個適應症已獲批上市,1個專案處於NDA階段,10餘個專案正處於臨床階段。公司成功構建了享譽國際的專有ADC及新型偶聯藥物平臺OptiDCTM,已有2個ADC項目5個適應症獲批上市,多個ADC或新型偶聯藥物產品處於臨床或臨床前研究階段。 關於和鉑醫藥 和鉑醫藥(股票代碼:02142.HK)是一家專注於免疫性疾病及腫瘤領域創新藥研發的全球生物製藥企業。公司通過自主研發、聯合開發及多元化的國際合作模式快速拓展創新藥研發管線。 和鉑醫藥專有的抗體技術平臺Harbour Mice®能夠生成雙重、雙輕鏈(H2L2)和僅重鏈(HCAb)形式的全人源單克隆抗體。基於HCAb抗體平臺開發的免疫細胞銜接器(HBICE®)能夠實現傳統藥物聯合療法無法達到的抗腫瘤療效。同時,基於HCAb平臺開發的雙特異性免疫細胞拮抗劑(HBICATM)為免疫及炎症性疾病領域創新生物藥的研發提供了有力支援。Harbour Mice®、HBICE®、HBICATM與單B細胞克隆篩選平臺共同組成了和鉑的下一代創新治療性抗體研發引擎。更多資訊,請訪問:www.harbourbiomed.com。
2026-03-09 10:47:00

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成都2026年3月9日 /美通社/ -- 2026年3月9日,四川科倫博泰生物醫藥股份有限公司(「科倫博泰」或「公司」,6990.HK)與和鉑醫藥(股票代碼:02142.HK)宣佈,雙方合作研發的靶向胸腺基質淋巴細胞生成素(TSLP)及一個未公開靶點的長效雙特異性抗體SKB575...
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