甘李藥業(603087.SH)：糖尿病藥GZR4獲批臨牀試驗
格隆匯11月30日丨甘李藥業(603087.SH)公佈，近日，公司收到國家藥品監督管理局(“國家藥監局”、“NMPA”)下發的關於公司在研藥品GZR4臨牀研究申請的《受理通知書》(受理號：CXSL2101457國)，根據國家相關注冊法規規定，自受理之日起60個工作日內，如未收到國家藥監局藥品審評中心否定或質疑意見，則甘李藥業可以按照提交的方案開展臨牀試驗。
該藥品為每週皮下注射給藥一次的超長效胰島素周製劑，適應症為糖尿病。
根據國際糖尿病聯盟(International Diabetes Federation，IDF)全球糖尿病概覽第9版(2019)發佈的最新數據顯示，目前全球有4.63億成人(20-79 歲)患
有糖尿病。如不採取充分的應對措施，到2030年全球糖尿病患者將達到5.78億人，到2045年將達到7億人。中國是全球糖尿病第一大國，據2020年4月發表在BMJ雜誌最新中國成人流行病學數據顯示，中國成人糖尿病前期比例35.2%，中國成人糖尿病患病率高達12.8%，糖尿病患者總數達到1.298億。
在目前已上市的胰島素類藥物中，胰島素類似物因其相對良好的安全性和更低的免疫原性佔據着胰島素市場的主要份額。目前已上市的長效基礎胰島素類似物主要有甘精胰島素、地特胰島素和德谷胰島素。據Evaluate數據統計，2020年甘精胰島素(來得時)、地特胰島素和德谷胰島素的全球銷售額分別為53.92、10.39和13.27億美元，整個糖尿病市場至2026年預期將達到660億美元。
目前已上市的長效基礎胰島素類似物半衰期大約都在10~26小時，作用持續時間僅為一天左右。超長效胰島素周製劑具有半衰期更長、給藥頻率低、血藥濃度與藥效更加平穩，血糖日間變異小，低血糖風險更小等特點，成為了各主要糖尿病藥物研發企業目前新藥研發的重要方向之一。截止目前，全球範圍內尚未有胰島素周製劑產品被批准上市，目前進展最快的是處於III期臨牀研究的諾和諾德的胰島素周製劑Icodec（Insulin287）。
截至2021年9月30日，甘李藥業在該項目中累計投入研發費用3027萬元人民幣。
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