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<p>Sobi (SOBI.ST) 宣佈，歐洲藥品管理局人用藥品委員會已採納積極意見，推薦 Aspaveli 或 pegcetacoplan 的市場授權，用於治療成人和青少年 C3 腎小管病或原發性免疫複合體增生性腎小管炎患者。CHMP 的推薦基於第三階段 VALIANT 研究的積極結果。</p>
<p>該公司表示，歐洲委員會的批准決定預計將在 2026 年第一季度作出。Sobi 及其合作伙伴 Apellis Pharmaceuticals, Inc.擁有系統性 pegcetacoplan 的全球共同開發權。</p>
<p>欲獲取更多健康新聞，請訪問 rttnews.com。</p>
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<p>Sobi 宣佈，歐洲藥品管理局的 CHMP 已對 Aspaveli（pegcetacoplan）用於治療 C3 腎小管病和原發性免疫複合物膜增生性腎小管炎的市場授權給予了積極意見。該決定基於第三階段 VALIANT 研究的結果，預計歐洲委員會將在 2026 年第一季度批准。Sobi 和 Apellis Pharmaceuticals 擁有該藥物的全球共同開發權</p>

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</div><p>Sobi (SOBI.ST) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli or pegcetacoplan for the treatment of adult and adolescent patients with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis. The CHMP recommendation is based on positive results from the Phase 3 VALIANT study.</p>
<div class="lb-trans"><p>Sobi (SOBI.ST) 宣佈，歐洲藥品管理局人用藥品委員會已採納積極意見，推薦 Aspaveli 或 pegcetacoplan 的市場授權，用於治療成人和青少年 C3 腎小管病或原發性免疫複合體增生性腎小管炎患者。CHMP 的推薦基於第三階段 VALIANT 研究的積極結果。</p>
</div><p>The company said the approval decision by European Commission is expected in the first quarter of 2026. Sobi and its partner Apellis Pharmaceuticals, Inc. have global co-development rights for systemic pegcetacoplan.</p>
<div class="lb-trans"><p>該公司表示，歐洲委員會的批准決定預計將在 2026 年第一季度作出。Sobi 及其合作伙伴 Apellis Pharmaceuticals, Inc.擁有系統性 pegcetacoplan 的全球共同開發權。</p>
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Sobi 宣佈 CHMP 對 Aspaveli 持積極意見