華東醫藥(000963.SZ)：注射用DR30303獲得藥物臨牀試驗批准通知書
格隆匯1月19日丨華東醫藥(000963.SZ)公佈，2022年1月18日，公司控股子公司浙江道爾生物科技有限公司(以下簡稱“道爾生物”)收到國家藥品監督管理局(NMPA)核准簽發的《藥物臨牀試驗批准通知書》，由道爾生物申報的生物製品1類新藥注射用DR30303的I期臨牀試驗申請獲得批准，旨在評估人源化Claudin18.2單克隆抗體-DR30303治療晚期實體瘤的安全性和耐受性、藥代動力學和初步療效。
2021年4月26日，公司全資子公司杭州中美華東製藥有限公司收購道爾生物75%股權，注射用DR30303是道爾生物的重點在研創新藥之一。
2021年11月，道爾生物向NMPA提交了注射用DR30303的臨牀試驗申請。DR30303是一種靶向Claudin18.2、經過Fc工程改造的人源化IgG1(免疫球蛋白G1)單克隆抗體，可特異性結合表達Claudin18.2的腫瘤細胞，並通過抗體依賴性的細胞介導的細胞毒作用(ADCC)和補體依賴性細胞毒性作用(CDC)誘導腫瘤細胞死亡，從而達到治療腫瘤的目的。
Claudins是一類存在於上皮和內皮緊密連接中的整合素膜蛋白，是緊密連接的重要組成部分。人類Claudin18基因可產生Claudin18.2蛋白亞型，多項研究指出Claudin18.2蛋白在分化的胃黏膜上皮細胞以外的其它正常組織中不表達，只在胃癌、胰腺癌、胃食管結合部癌和卵巢癌等多種腫瘤中異常表達。CLDN18.2的腫瘤特異性表達特性使其已成為腫瘤領域重要研發靶點。
目前全球尚無抗Claudin18.2類藥物上市，本次獲得注射用DR30303藥物臨牀試驗批准通知書，是道爾生物首個獲批的臨牀試驗申請，將豐富公司在腫瘤治療領域的產品儲備，增加公司在創新藥和腫瘤疾病治療領域用藥的覆蓋範圍，加速公司融入全球創新醫藥產業的步伐，進一步提升公司綜合競爭力。
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