復星醫藥(02196.HK)關於Car-T近期紀要
總結:
1.細胞基因療法相比傳統療法已經體現出卓越的療效。公司 是復星醫藥投資50% ,然後Kite通過技術投資50%從而構建的企業,成立於2017年。通過4年的努力,公司目前已經建立了全流程開發生產平臺,並且已經完成第一款產品的商業化。公司目前的管線覆蓋了實體瘤和血液瘤。
2.CMC方面,國際上的CAR-T生產濃度標準1.0×106/kg ,而公司製備的濃度可以達到1.5x106/kg , 主要是因爲細胞長得更快而且長得更好。
3.支付方面公司也一直在努力讓更多人能夠用上,目前蘇州 和長沙惠民寶已經把公司產品加入計劃,能賠付70%。
Q&A:
Q:公司阿基侖賽注射液上市以來的銷售情況?有多少例患者已經用上公司產品?
公司主要選擇覆蓋60-70家省級醫院,目前已經有5-6例患者完成回輸,進展很順利。
Q:公司完成的醫院資質認證主要是僅針對自己這一款產品嗎?還是可以包括其他產品和細胞治療?
因爲不同產品對於單採或者回輸的標準可能是不一樣的,所以培訓和資質認證主要還是針對公司這款產品。
Q:公司產品的成本情況?
療法最大的成本是個體化,一批次只能生產一名患者。公司使用的原輔料和國際標準一樣,考慮到進口等因素,公司的生產成本高於Kite ,但定價又更低,所以整體成本還是比較有壓力。但是未來伴隨使用藥物的患者人數增加,成本會進一步降低。
Q:公司目前的產能情況?
現在大概生產1000人左右,生產週期約2周。
Q:公司在CMC優化的具體細節?對成本的影響?
1)公司製備時間短,相比其他廠家短50% ;2 )公司製備的濃度可以達到1.5x106/kg ,比同行都要高。
Q:如果患者在完成產品支付之後出現不適合回輸的情況, 公司怎麼解決這個問題?
會全部退款,所以公司製備速度快的優勢在這裏也體現出來了。
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