德琪醫藥-B(06996.HK)公佈中期業績 產品管線取得重大進展 將繼續建設商業團隊
於2021年8月20日晚間,德琪醫藥-B(06996.HK)公佈中期業績,截至2021年6月30日止6個月,公司其他收入及收益為人民幣1813.5萬元,研發成本為1.35億元。
2021年,公司的管線資產取得穩步進展,已於澳大利亞、韓國、新加坡及台灣提交塞利尼索治療復發/難治性多發性骨髓瘤和復發/難治性瀰漫大B細胞淋巴瘤及於中國內地及香港提交塞利尼索治療復發/難治性多發性骨髓瘤的NDA。
截至2021年7月31日,公司有十五項正在中國內地、韓國、台灣和澳大利亞進行的臨牀研究,其中五項管線資產,包括ATG-010(塞利尼索,XPO1抑制劑)、ATG-008(onatasertib,mTORC1/2抑制劑)、ATG-016(eltanexor,XPO1抑制劑)、ATG-019(PAK4/NAMPT雙靶點抑制劑)及ATG-017(ERK1/2抑制劑)。公司已完成針對復發/難治性多發性骨髓瘤患者的II期註冊臨牀研究的患者招募,並正在啟動和招募患者參與在中國內地分別開展的針對復發/難治性多發性骨髓瘤、復發/難治性瀰漫大B細胞淋巴瘤及子宮內膜癌的四項II期或III期註冊研究。公司亦就ATG-010(塞利尼索)向國家藥監局(中國內地)、藥品管理局(澳大利亞)、MFDS(韓國)、衞生科學局(新加坡)、香港衞生署及TFDA(台灣)提交NDA申請。
展望2021年下半年,公司已於2021年7月29日獲得韓國食品藥品安全部(MFDS)的NDA批准,且進一步預期塞利尼索 (ATG-010)於中國內地、澳大利亞、韓國、香港及新加坡等其他五個市場提交的NDA將在2021年第四季度至2022年第一季度期間獲得批准。我們亦將有兩項臨牀前新型資產推進到IND階段。
憑藉上述預期的NDA批准,在公司的核心商業領導團隊過去於全球、亞太地區及中國多次成功推出頂級血液學產品的經驗基礎上,公司將繼續建設商業團隊,為塞利尼索在大中華地區及其他亞太地區的同類首發做足準備,從而解決公司地區內未獲滿足的醫療需求。公司預計到年底將建設一支約200人的商業團隊,其中包括擁有優異往績記錄及在血液腫瘤學方面擁有深厚地區專業知識的專門內部營銷、外勤、定價及市場準入團隊以及醫學事務團隊。
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