近日，金賽藥業研發BD License-out負責人夏遠峰博士攜女性健康領域Gensci074和免疫領域GenSci120等創新管線亮相波士頓2025國際生物技術大會暨展覽會（BIO 2025）。

近日，金賽藥業研發BD License-out負責人夏遠峰博士攜女性健康領域Gensci074和免疫領域GenSci120等創新管線亮相波士頓2025國際生物技術大會暨展覽會（BIO 2025）。BIO作為全球規模最大、最具影響力的生物技術行業盛會之一，匯聚了來自全球優秀藥企、科研機構及行業領袖。金賽藥業此次參會，不僅彰顯了其國際化創新實力，更通過與全球同行的深度交流，進一步推動自主創新生物藥的發展。

本次大會金賽展示的Gensci074項目是一款用于治療絕經期女性中重度潮紅熱（VMS）的NK3R拮抗劑，該項目于2023年11月獲得中國IND臨床批件，2024年1月達成中國首例受試者入組，同期完成了澳洲一期臨床研究；2025年1月完成中國二期研究的末例入組。目前中國二期臨床研究的數據顯示，在第4周和12周，接受GenSci074治療患者的潮熱的頻次下降和嚴重程度改善相較于安慰劑組都存在統計學差異。安全性特征上，治療組和安慰劑組類似，在本研究觀察期內未報告與藥物相關的肝酶升高風險事件。GenSci074臨床前受體拮抗活性、臨床一期的PK/PD特征和臨床二期POC研究結果的數據均表現良好，有望成為治療絕經期女性中重度潮紅熱的“Best-in-class”治療手段。

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金賽藥業研發BD License-out負責人夏遠峰博士主題分享

數據顯示，VMS癥狀在女性的絕經期的發生率高達80%，而且平均的持續時間超過7年[1]。全球約有8.8億圍絕經期女性正經歷VMS癥狀，其中中國圍絕經期婦女達1.3億[2]。目前全球主流治療方案仍以激素治療為主，但長期使用可能增加腫瘤和心血管疾病風險[3]。Gensci074的研發有望為這一龐大患者群體提供更具突破性的治療選擇。

為女性提供全生命周期的健康守護

婦女兒童健康是全民健康的基石，金賽藥業一直重點關注婦女兒童健康領域，歷經多年的布局和深耕，金賽藥業在女性健康領域構建了全面而立體的布局，涵蓋了輔助生殖、婦科感染、婦科常見病、婦科腫瘤等方面，以滿足不同年齡段女性的健康需求。產品布局方面，金賽藥業聚焦女性健康臨床需求未被滿足的細分領域，通過引進優質BD產品快速提升商業化能力。代表性產品氯喹那多-普羅雌烯采用"殺菌+促菌"雙機制，用于治療除淋球菌感染外、各種感染性病因引起的白帶異常，旨在殺菌的同時促進有益菌生長，恢復陰道微生態平衡自研方面，金賽持續加大投入，目前公司在女性健康領域布局超過10款創新管線，覆蓋細菌性陰道炎、絕經期血管舒縮癥、子宮內膜異位癥等婦科常見病，同時在輔助生殖領域推進長效制劑研發，逐步構建具有高度競爭力的產品管線。

關于GenSci098 & GenSci120

除了Gensci 074項目，本次大會金賽也帶來了GenSci098和GenSci120的突破性進展。GenSci098是通過抑制促甲狀腺激素受體（TSHR）治療甲狀腺相關眼病（TED）的靶向療法，GenSci098目前在臨床一期階段，從一期的數據看，GenSci098表現出良好的安全性，顯示出起效和療效持續時間的積極信號，并呈現劑量依賴性。“我們將全力加速GenSci098的全球開發進程，GenSci098有望改寫TED治療格局，成為全球首個獲批的TSHR抑制劑。”夏遠峰博士強調。

GenSci120注射液是金賽藥業自主研發的一款人源化PD-1單抗,通過和PD-1結合并激活PD-1抑制性信號通路以及ADCC效應，從而抑制或殺傷致病性T細胞，發揮特異的靶向免疫抑制作用。臨床前及早期臨床研究顯示，GenSci120在包括類風濕關節炎(RA)、系統性紅斑狼瘡(SLE)、炎癥性腸病(IBD)等多種自身免疫性疾病中具有治療潛力，該項目此前已在國內獲批RA、SLE等四個自身免疫病的臨床試驗申請。同期，GenSci120注射液也獲得了美國食品藥品監督管理局（FDA）的針對RA的IND默示許可。

此次BIO 2025大會上，GenSci074等核心管線的披露，不僅展現了金賽成為全球婦兒健康領先品牌的決心，更彰顯了其以患者需求為核心的國際化布局。未來，金賽將持續加速創新療法開發，為全球患者提供更安全、更有效的治療選擇。

參考文獻

[1]El Khoudary, Samar R et al. “The menopause transition and women's health at midlife: a progress report from the Study of Women's Health Across the Nation (SWAN).”Menopause (New York, N.Y.)vol. 26,10 (2019): 1213-1227.

[2]張凡，張廣美.女性絕經綜合征的研究進展［J］.中國臨床研究，2017，30（8）：1131-1133，1137.

[3] Gartlehner, Gerald et al. “Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Women: Evidence Report and Systematic Review for the US Preventive Services Task Force.”JAMAvol. 318,22 (2017): 2234-2249.