凱因科技(688687.SH):培集成干擾素α-2注射液III期臨牀試驗首例受試者成功入組
格隆匯12月28日丨凱因科技(688687.SH)公佈,公司研發的創新型生物製品培集成干擾素α-2注射液治療低複製期慢性HBV感染III期臨牀試驗首例受試者於2021年12月28日成功入組。
培集成干擾素α-2注射液是經PEG修飾的重組集成干擾素,其中重組集成幹擾素是通過對14種天然α-干擾素亞型進行序列同源性比對,遵循同源序列最高原則分析集成獲得,活性比一般α型干擾素更高,半衰期長,適合一週一次給藥,具有較好的便利性,其兼備抗病毒、免疫調節作用,是追求慢性病毒性乙型肝炎臨牀治癒的藥物之一。
培集成干擾素α-2注射液乙肝適應症已完成I期、II期臨牀試驗,II期臨牀試驗結果表明培集成干擾素α-2注射液的療效和安全性與進口藥物相當。
公司目前開展的培集成干擾素α-2注射液III期臨牀研究為多中心、隨機、雙盲、安慰劑對照臨牀試驗,由吉林大學第一醫院主導,以評價培集成干擾素α-2注射液治療低複製期慢性HBV感染者的療效及安全性。本研究以未被滿足的臨牀治療需求為導向,突破乙肝既往固定的疾病分期和治療理念,將為更多能獲得臨牀治癒的潛在人羣提供臨牀循證依據。2021年12月28日,首例受試者成功完成了入組。
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