信達生物(01801.HK)：抗腫瘤藥物達伯華®在中國獲批上市
格隆匯 10 月 9日丨信達生物(01801.HK)宣佈，公司與禮來製藥("禮來")共同開發的重組人－鼠嵌合抗CD20單克隆抗體藥物達伯華®(利妥昔單抗生物類似藥，英文商標：HALPRYZA®)正式獲得國家藥品監督管理局("NMPA")在中國上市的批准，用於治療瀰漫性大B細胞淋巴瘤("DLBCL")，濾泡性淋巴瘤("FL")，及慢性淋巴細胞性白血病("CLL")。這是繼達伯舒®(信迪利單抗注射液)，達攸同®(貝伐珠單抗生物類似藥)及蘇立信®(阿達木單抗生物類似藥)之後，公司第四個獲得NMPA上市批准的單克隆抗體藥物。
惡性淋巴瘤是中國最常見的血液系統惡性腫瘤，是發病率和死亡率較高的十大惡性腫瘤之一，且近年來發病率呈上升的趨勢。利妥昔單抗的多個大型臨牀試驗數據充分地證實了其在CD20陽性的非霍奇金淋巴瘤("NHL")的臨牀療效和安全性，已成為CD20陽性的非霍奇金淋巴瘤的標準治療。原研藥利妥昔單抗注射液於1997年獲得美國食品藥品監督管理局("美國FDA")批准上市，用於治療NHL，CLL，類風濕性關節炎("RA")，血管炎肉芽腫("GPA")，顯微鏡下多血管炎("MPA")，中重度成人天皰瘡("PV")，利妥昔單抗的顯著療效和良好安全性已得到普遍認可。達伯華®(利妥昔單抗生物類似藥)是公司和禮來製藥共同研發的重組人－鼠嵌合抗CD20單克隆抗體注射液。達伯華®(利妥昔單抗生物類似藥)的上市將為中國患者提供高品質且更可負擔的利妥昔單抗注射液。
據悉，達伯華®為利妥昔單抗生物類似藥，為重組人－鼠嵌合抗CD20單克隆抗體藥物。利妥昔單抗可與B淋巴細胞表面的CD20抗原結合，介導補體依賴性細胞毒作用和抗體依賴性細胞介導的細胞毒作用，介導體內正常及惡性B細胞溶解，從而實現抗腫瘤治療效果。原研藥利妥昔單抗注射液於1997年獲得美國FDA批准上市，用於治療NHL，CLL，RA，GPA，MPA，中重度PV。目前在國內獲批的適應症為DLBCL，FL及CLL。其顯著療效和良好安全性已得到普遍認可。
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