信達生物(01801.HK)：PARSACLISIB治療惰性淋巴瘤患者完成中國關鍵性臨牀試驗首例患者給藥
格隆匯4月28日丨信達生物－Ｂ(01801.HK)發佈公告，公司PI3Kδ特異性抑制劑parsaclisib (IBI-376) 的一項2期關鍵性註冊臨牀研究完成中國首例患者給藥。該研究的目的是評估parsaclisib在復發或難治的中國濾泡淋巴瘤(“FL”)╱邊緣區淋巴瘤(“MZL”)患者中的有效性和安全性。如果成功，該研究結果將用於支持parsaclisib在中國的新藥上市申請。
FL和MZL雖然是惰性淋巴瘤，當進展到復發或難治階段，有效的治療手段有限，急需新的治療方法。PI3Kδ抑制劑是近年來湧現的新的一類治療惰性淋巴瘤的療法。 Parsaclisib的早期臨牀試驗資料顯示，parsaclisib對治療復發或難治FL/MZL可能具有好的療效和耐受性。公司希望該研究結果可以使復發或難治的FL/MZL患者獲益，並有望為臨牀醫生給患者帶來更多治療選擇。
根據披露，Parsaclisib(IBI-376)是一種臨牀新型口服磷脂醯肌醇3-激酶δ亞型抑制劑(PI3Kδ)。 PI3Kδ信號通路是一個與惡性B細胞生長、存活和增殖有關的重要抗腫瘤靶點，在臨牀前研究中證明了其有效性和選擇性，具有治療惡性血液病如淋巴瘤的潛力。 CITADEL(靶向PI3Kδ抑制劑治療淋巴瘤的臨牀研究)臨牀試驗項目正在進行中，評估parsaclisib在幾項治療非霍奇金淋巴瘤(濾泡淋巴瘤，邊緣區淋巴瘤，套細胞淋巴瘤)的效果，目前均處於2期臨牀研究。Incyte Biosciences International Sàrl (「Incyte」)也正在進行parsaclisib的1期和2期試驗，作為骨髓纖維化、瀰漫性大B細胞淋巴瘤和自身免疫性溶血性貧血患者聯合治療的一部分。
2018年12月，Innovent Biologics (HK) Limited(公司的全資附屬公司)與Incyte包括就parsaclisib (PI3Kδ inhibitor)等三個Incyte發現並研發的處於臨牀試驗階段候選藥物達成戰略合作協定。根據協定條款，Innovent HK擁有parsaclisib 及其他兩個候選藥物在中國大陸、中國香港、中國澳門和中國台灣地區的開發和商業化權利。
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