浩鼎 中國CFDA核准phase III (乳癌新藥Adagloxad Simolenin /OBI-822)

浩鼎:補充說明本公司OBI-822通過中國(CFDA)2017L00106核准進行第三期臨床試驗 鉅亨網新聞中心※來源：台灣證券交易所2017/01/26 12:000相關個股浩鼎295.5+2.43% 第二條第51款1.事實發生日:106/01/262.公司名稱:台灣浩鼎生技股份有限公司3.與公司關係(請輸入本公司或子公司):本公司4.相互持股比例:不適用5.傳播媒體名稱:不適用6.報導內容:不適用7.發生緣由:中國國家食品藥品監督管理總局(CFDA)核准本公司乳癌新藥Adagloxad Simolenin (OBI-822，又稱OPT-822) 亞洲多中心第三期臨床試驗，其適應症、試驗方式、受試人數，及試驗時程，將與OBI-822全球臨床試驗開發策略綜合考量後，進一步規畫並適度調整。8.因應措施:有關本公司財務業務及新藥研發進度等相關事宜，請依本公司於公開資訊觀測站揭露之資訊為準。9.其他應敘明事項:新藥開發時程長、投入經費高且並未保證能一定成功，此等可能使投資面臨風險，投資人應審慎判斷謹慎投資。

Adagloxad Simolenin (formerly OBI-822) is a new first-in-class, investigational anti-cancer treatment that belongs to a novel class of active immunotherapies which target the Globo Series antigens (Globo H, SSEA-3 and SSEA-4). Adagloxad Simolenin is a synthetic glycoprotein comprised of a Tumor-Associated Carbohydrate Antigen (TACA), Globo H, covalently bound to a carrier protein, Keyhole Limpet Hemocyanin. OBI-821 is a saponin-based adjuvant. Globo Series antigens are expressed in high levels on the surface of malignant tumors in many epithelial cancers, such as breast, prostate, gastric, lung, colon, pancreatic, and ovarian cancer, among others. The immunogenicity of the antigen is enhanced by conjugating Globo H to the KLH carrier protein to form Adagloxad Simolenin (Globo H-KLH), and then co-administering it with the adjuvant, OBI-821. OBI Pharma recently completed a Phase 2 International efficacy and safety study in 349 patients with Metastatic Breast Cancer. Adagloxad Simolenin is exclusively licensed to OBI Pharma from Memorial Sloan-Kettering Cancer Center (MSKCC).