聯康生物科技集團(00690.HK):Uni-PTH液體注射劑臨試申請(IND)獲NMPA批准
格隆匯 9 月 4日丨聯康生物科技集團(00690.HK)發佈公告,Uni-PTH(預灌封注射筆劑型)或“第二代Uni-PTH”已成功獲國家藥品監督管理局(“NMPA”)批准進行臨牀試驗,接納編號為CXSL2000138。該批准允許公司開始進行橋接臨牀試驗,這將加速第二代Uni-PTH的推出,預期最快於2022年推出市場。
Uni-PTH為全球治療骨質疏鬆及骨痛的唯一合成代謝(骨骼生長)劑。其治療機制與市場上已有的產品大不相同。Uni-PTH獲證實可有效刺激靜止骨表面的新骨生成,而不是抑制骨吸收。通過刺激新骨生成,Uni-PTH可在治療後6個月內迅速改善骨質及增加骨密度,從而減少骨折發生率及骨痛,尤其有助治療中重度骨質疏鬆及骨痛患者。此外,第二代Uni-PTH在第一代Uni-PTH製劑的基礎上更方便患者。2020年5月5日,公司宣佈與瑞士自我護理巨頭Yposmed進行戰略合作,開發與YpsoPen®相容的第二代Uni-PTH,YpsoPen®是一款具備獨一無二的劑量精確度及微乎其微的注射疼痛感的先進注射筆。連同YpsoPen®,第二代Uni-PTH旨在為骨質疏鬆及骨痛患者提供更安全的長期自我護理解決方案。
目前,預期中國的骨質疏鬆市場價值達人民幣155億元(約為全球骨質疏鬆市場的五分之一),且將持續快速增長,其原因為女性及老年人口中骨質疏鬆症病發率上升、生活水平提高及骨骼健康意識加強。與其他品牌推出的化學合成藥物相比,Uni-PTH為少數全生物表達製劑之一,在中國市場的競爭非常有限,因此具有龐大的市場潛力。
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