雙成藥業(002693.SZ)：已有多個多肽品種(包括原料藥和製劑)在發達國家獲批，並上市銷售
格隆匯1月31日丨有投資者於投資者互動平台向雙成藥業(002693.SZ)提問，“公司是否有專業的肽類製劑研發能力？還是隻是代工？並不具備研發能力”，公司回覆稱，公司聚焦於多肽產品的研發、生產和銷售，已有多個多肽品種(包括原料藥和製劑)在發達國家獲批，並上市銷售，生產場地也通過美國FDA和歐盟的GMP檢查。公司擁有豐富的化學合成多肽藥物研發、註冊申報、生產和市場營銷經驗，已成功開發了多個化學合成多肽藥物和20個其他各種治療類藥物，其中多肽類藥物主要有：注射用胸腺法新(“基泰”)系增強免疫藥物，主要用於慢性乙型肝炎、腫瘤、老年科及感染類疾病等的治療及肌體免疫力提高，同時，該產品已通過國家藥品監督管理局注射劑仿製藥質量和療效一致性評價以及獲得意大利藥品管理局頒發的上市許可證；注射用生長抑素，用於嚴重急性食道靜脈曲張出血、嚴重急性胃或十二指腸潰瘍出血、糖尿病酮症酸中毒等的治療,該產品同樣通過國家藥品監督管理局注射劑仿製藥質量和療效一致性評價，同時，生長抑素原料藥獲得CEP(歐洲藥典適用性)證書，標誌着公司生長抑素原料藥在安全性和有效性上達到了國際水平；注射用比伐蘆定，獲得美國FDA和國家藥品監督管理局的上市許可，主要應用於預防血管成型介入治療不穩定性心絞痛,前後的缺血性併發症，是直接凝血酶抑制劑的一線用藥；依替巴肽注射液，用於急性冠狀動脈綜合徵(不穩定型心絞痛/非ST段抬高性心肌梗死)患者。依替巴肽注射液ANDA通過美國FDA上市許可批准。
公司在多肽產品研發方面有着紮實的基礎和長期的生產經驗，多肽產品是公司的主要產品。公司的多肽原料藥研發實驗室設備先進、管理科學、人才齊備，在國際化過程中多肽品種自然成為研發項目的重點。近年來公司研發多肽產品近10個，這些品種多具有市場大、合成難度高的特點，報吿期內這些項目分別處於獲批上市和研發的不同階段。
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