康緣藥業(600557.SH):九味疏風平喘顆粒獲批臨牀試驗
格隆匯12月2日丨康緣藥業(600557.SH)公佈,公司近日收到國家藥品監督管理局簽發的九味疏風平喘顆粒《藥物臨牀試驗批准通知書》。九味疏風平喘顆粒適應症擬用於支氣管哮喘慢性持續期、中醫辨證為風哮證的患者。
九味疏風平喘顆粒是根據國醫大師晁恩祥教授五十餘年臨牀診療經驗,在以往傳統中醫學有關哮喘病因、病機的基礎上,首次創新性地提出以“風哮”為病名,以“從風論治”的新思路,並闡明“風邪犯肺、氣道攣急”致哮的發病機理,在“風哮”理論指導下,開發出的治療風哮的新藥。其功能主治為疏風緩急,肅肺平喘。用於風邪犯肺,肅降失常所致氣道攣急。症見喘息憋悶,氣短、氣息急迫,喉中哮鳴有聲,或見咳嗽陣作,少痰或無痰,舌苔薄白;輕、中度支氣管哮喘反覆持續發作見上述證候者。
目前該產品已完成製備工藝、質量標準、穩定性及藥效、安評實驗等臨牀前研究。臨牀前藥效學研究顯示,九味疏風平喘顆粒具有較好的平喘、祛痰、止咳、調節免疫功能、抗炎、抗過敏作用,提示藥物臨牀可有效抑制哮喘的急慢性發作。毒理學研究結果顯示藥物安全性較好,有足夠的安全窗。
公司擁有該新藥獨立完整自主的知識產權。截至目前,九味疏風平喘顆粒公司累計研發投入約816.15萬元。
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