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聯康生物科技集團(00690.HK):正在與NMPA和潛在合作伙伴進行談判,以將Uni-GLP擴展到新領域
格隆匯 09-18 17:40

格隆匯 9 月 18日丨聯康生物科技集團(00690.HK)披露Uni-GLP在治療2019冠狀病毒病和其他適應症方面的發展。

Uni-GLP是一種胰高血糖素樣肽-1受體激動劑("GLP-1RAs"),通過增加胰島素和減少葡萄糖分泌起到降低高血糖的作用,可有效治療二型糖尿病。GLP-1RAs的優勢在於其腸促胰島素的效果,可以降低低血糖發生的風險。此外,GLP-1RAs是唯一一類能減輕體重的抗糖尿病藥物。Uni-GLP水針已於2020年7月14日獲國家藥品監督管理局("NMPA")批准臨牀試驗。目前,集團的專家和技術人員正在努力準備臨牀試驗相關工作。

基於科學界的新數據,GLP-1 RAs可以治療許多高價值的適應症,比如肥胖症、心血管疾病("CVD")、非酒精性脂肪肝病("NAFLD")和非酒精性脂性肝炎("NASH")、阿爾茲海默症("AD")以及2019新型冠狀病毒病("COVID-19";由嚴重急性呼吸綜合症冠狀病毒2"SARS-CoV-2"引起),該等適應症有龐大的臨牀需求。

肥胖常見於二型糖尿病,GLP-1RAs適用於肥胖的二型糖尿病患者,而根據IMS初步研究,接近30%的中國糖尿病患者出現肥胖。而且,GLP-1RAs進一步被證明對心血管功能有益,而不依賴其在外周血血糖控制中的作用,其通過增加心肌葡萄糖攝取,在缺血損傷後保持心肌功能。此外,有數據顯示NAFLD和NASH(NAFLD的加重形式,可導致肝硬化和肝癌)患者的GLP-1分泌功能受損,突顯出GLP-1RAs治療NAFLD的潛力。而且,越來越多的證據表明,AD,由大腦"飢餓"引起,與胰島素抵抗有關。當大腦因為胰島素抵抗無法消耗葡萄糖,會導致水腫、斑塊沉積以及神經纖維纏結。然而,GLP-1RAs可以防止大腦葡萄糖消耗的下降,引起新突觸和神經形成,從而改善記憶行為。

最近,鑑於GLP-1RAs對過度炎症引起的急性肺損傷具有多種有益作用,GLP-1RAs被認為是治療伴或不伴有T2DM的COVID-19患者的優秀候選藥物。多個在小鼠和大鼠進行實驗誘導肺損傷的臨牀前研究表明,GLP-1RAs能減少肺部炎症的發生,由於其干擾核因子活化B細胞κ輕鏈增強子("NF-κB")信號通路,抑制細胞因子釋放。最近,幾項研究已經證明GLP-1RAs通過直接刺激血管緊張素轉換酶2("ACE2"),提高ACE2血管緊張素(1–7)("A(1–7)")Mas受體("MasR")軸的表達,培養抗血栓和抗炎的環境,有助於減少炎症和血栓形成過程的進展,而這些過程往往與SARS-CoV-2感染的不良預後有關。肺部損傷和炎症出現在較嚴重的COVID-19感染患者中,是導致COVID-19相關死亡的主要原因。與疫苗相比,GLP-1RAs的優勢在於其能在冠狀病毒發生突變時保護肺功能。

董事會對於Uni-GLP在新的治療領域的發展潛力保持樂觀態度。本集團已經和中國的幾所大學合作,開展Uni-GLP治療肥胖症的臨牀前研究,以及開發創新口服劑型或者第三代Uni-GLP。有了GLP-1RAs在CVD、NAFLD、NASH、AD和COVID-19治療中的最新數據,集團目前正在與NMPA和潛在合作伙伴進行談判,以將Uni-GLP擴展到這些新的領域。

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