目前 ，公司圍繞HLX04-O在全球範圍內積極開展III期臨床钻研 ，現已在美國、中國、澳大利亞和歐盟实现首例患者給藥 ，並獲得蕴含新加坡在內的多個國家和地區的臨床試驗許可。復宏漢霖將攜手億勝生物持續推動HLX04-O在全球的臨床階段钻研 ，以期憑藉相關钻研結果實現HLX04-O在中國、澳大利亞、歐盟和美國等全球多個國家和地區上市 ，成為首批獲得核准用於眼科相關疾病治療的貝伐珠單抗 ，惠及全球眾多眼科疾病患者。未來 ，復宏漢霖將始終以臨床數據為沉 ，秉持「內表兼建」的開發战术 ，不斷拓展藥物大局 ，持續推進更多產品的臨床進程 ，打造更多更高效的治療规划。
年齡相關性黃斑變性（AMD）是造成老年人視力損害和不成逆失明的重要原因之一[1] ，根據世界衛生組織報告 ，全球約有3000萬AMD患者 ，每年約有50萬人因為AMD而致盲[2]。AMD致盲患者中 ，以脈絡膜新生血管（Choroidal neovascularization ，CNV）為特徵的濕性年齡相關性黃斑變性（wAMD）比例高達90%。隨着老年人丁比例的不斷上升 ，wAMD已經成為一個日益嚴沉的社會醫學問題 ，存在着巨大的未滿足的臨床需要[3]。隨着眼底治療步骤的突破與發展 ，抗VEGF藥物已成為wAMD的一線療法[4] ，貝伐珠單抗玻璃體注射治療wAMD的有效性和安全性也已在多項臨床钻研中得到驗證[5-11]。
【參考文獻】
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[7] Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ, Wordsworth S, Reeves BC. Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial. Ophthalmology. 2012 Jul;119(7):1399-411.
[8] Kodjikian L, Souied EH, Mimoun G, Mauget-Fa?sse M, Behar -Cohen F, Decullier E, Huot L, Aulagner G; GEFAL Study Group. Ranibizumab versus Bevacizumab for Neovascular Agerelated Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial. Ophthalmology. 2013 Nov;120(11):2300-9.
[9] Krebs I, Schmetterer L, Boltz A, Told R, Vécsei-Marlovits V, Egger S, Sch?nherr U, Haas A, Ansari-Shahrezaei S, Binder S; MANTA Research Group. A randomized double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration. Br J Ophthalmol. 2013 Mar;97(3):266-71.
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