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天境生物電(IMAB.O)話會議紀要及解讀
uSMART盈立智投 12-22 15:17

總結:

1.頂尖的腫瘤權威臨牀專家朱秀軒博士加入公司,曾領導和參與了晚期肝癌的K藥(KEYNOTE-224)和雷莫蘆單抗(REACH-2)研究,成功開發首款治療膽管癌的IDH-1抑制劑(Ivosidenib);朱博士對公司管線高度認可,並與臧博士理念相近。

2.研發方面,預計2022年有望在全球同時推進20個臨牀研究,其中15個爲後期臨牀,4個註冊臨牀,雙抗和超級抗體將進入關鍵的臨牀前階段。菲澤妥單抗註冊臨牀達到了所有主要和次要終點,驗證了差異化優勢,現已準備好了文件並於監管部門溝通,爭取年底前提交NDA。

3.兩地上市進展上,目前基本明確了港股上市時間表,公司希望在2022年底前完成雙重上市安排。

Q&A:

Q:朱秀軒博士背景?

①全球頂尖的腫瘤權威臨牀專家,曾任美國哈佛大學醫學院教授及哈佛醫學院麻省總醫院肝癌研究中心主任,領導組建了麻省總醫院多學科肝癌中心;②與默沙東、禮來、羅氏、拜爾等海外大藥企有合作經驗,領導和參與了晚期肝癌的帕博利珠單抗(KEYNOTE-224)和雷莫蘆單抗(REACH-2)研究,成功開發首款治療膽管癌的IDH-1抑制劑(Ivosidenib);③有在國內腫瘤領域開發的經驗,2019年起先後擔任嘉會國際醫院國際腫瘤中心主任及嘉會醫療首席科學官。

Q朱秀軒博士加入公司的時點選擇

①對公司管線的創新性有比較高的認可度;②公司的管線發展到了關鍵時刻,從早期走向關鍵驗證,對提高臨牀成功率有需求;③朱博士和臧博士有相似的目標和研發理念;④有意願服務國內廣大的肝膽腫瘤患者,並期待將國內創新藥推向全球。

Q:公司管線階段

預計2022年有望在全球同時推進20個臨牀研究,其中15個爲後期臨牀,4個註冊臨牀,雙抗和超級抗體將進入關鍵的臨牀前階段。

Q:美國臨牀研究數據的看法

①全球臨牀研究需要在每個地區有適當的代表;②公司的研發主要爲美國團隊牽頭,優先在美國開啓臨牀,在得到初步數據後(安全性、療效信號、差異化驗證等)推進國內平行加速申報和全球研發,因此公司的數據是全球的,且這一策略帶來階段性的管線價值兌現和現金流。

Q:菲澤妥單抗(CD38)研發進展

註冊臨牀達到了所有主要和次要終點,驗證了差異化優勢,現已準備好了文件並於監管部門溝通,爭取年底前提交NDA。

Q:兩地上市進展

①明確了雙重主要上市(DualPrimaryListing)策略,降低地緣政治風險;②基本明確港股上市時間表,期待2022年底前完成雙重上市安排。

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