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置疑:7777788888四肖四碼管家婆或新澳及香港天天開獎資料大全600,合理釋義、解釋與落實-規(guī)避不實的聲明

zhenzhi 2025-07-10 學(xué)習(xí)知識 22554 次瀏覽 0個評論

界面新聞記者 | 李科文

界面新聞編輯 | 謝欣

7月3日,迪哲醫(yī)藥宣布,舒沃替尼(ZEGFROVY,商品名:舒沃哲)的新藥上市申請(New Drug Application,NDA),正式獲得美國食品藥品監(jiān)督管理局(FDA)批準(zhǔn),用于既往經(jīng)含鉑化療治療時或治療后出現(xiàn)疾病進(jìn)展,并且經(jīng)FDA批準(zhǔn)的試劑盒檢測確認(rèn),存在表皮生長因子受體(EGFR)20號外顯子插入突變(exon20ins)的局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌(NSCLC)的成人患者。

舒沃替尼是迪哲醫(yī)藥首款商業(yè)化產(chǎn)品。其于2023年8月在國內(nèi)獲批,用于二線治療攜帶EGFR 20號外顯子插入突變(EGFR ex20ins)的非小細(xì)胞肺癌(NSCLC)。

截至目前,舒沃替尼也是全球首個且唯一在美獲批的EGFR exon20ins非小細(xì)胞肺癌創(chuàng)新藥。

7月3日,迪哲醫(yī)藥向界面新聞記者表示,舒沃替尼通過優(yōu)先審評程序獲得批準(zhǔn)上市,成為目前全球首個且唯一在美獲批的EGFR exon20ins非小細(xì)胞肺癌的創(chuàng)新藥。其在分子設(shè)計的源頭進(jìn)行了重大創(chuàng)新,突破難治靶點,是中國首個獨立研發(fā)在美獲批的全球首創(chuàng)新藥。

迪哲醫(yī)藥表示,此次通過優(yōu)先審評獲美國食品藥品監(jiān)督管理局批準(zhǔn),是基于舒沃替尼在國際多中心注冊臨床研究“悟空1B”(WU-KONG1B)中,針對經(jīng)治EGFR exon20ins非小細(xì)胞肺癌患者的療效和安全性數(shù)據(jù)。

置疑:7777788888四肖四碼管家婆或新澳及香港天天開獎資料大全600,合理釋義、解釋與落實-規(guī)避不實的聲明

迪哲醫(yī)藥表示,此前,一項于2023年歐洲內(nèi)科腫瘤學(xué)會(ESMO)年會公布的匯總分析顯示,舒沃替尼單藥一線治療EGFR exon20ins 非小細(xì)胞肺癌經(jīng)確認(rèn)的客觀緩解率(ORR)達(dá)78.6%,中位無進(jìn)展生存期(mPFS)為12.4個月。

EGFR exon20ins突變是非小細(xì)胞肺癌難治靶點,因其空間構(gòu)象特殊、突變亞型繁多、異質(zhì)性強(qiáng),導(dǎo)致傳統(tǒng)EGFR TKI對該靶點基本無效,中位無進(jìn)展生存期(mPFS)和中位總生存期(mOS)不及EGFR敏感突變型晚期NSCLC的一半。

中國與歐美在肺癌驅(qū)動基因圖譜上存在明顯差異。界面新聞記者查詢弗若斯特沙利文報告等發(fā)現(xiàn),EGFR exon20ins在美國的每年新發(fā)患者人群數(shù),不如國內(nèi)市場。

以2021年為例,中國EGFR EXON 20非小細(xì)胞肺癌新發(fā)患者約3.2萬人,而在美國EGFR EXON 20 非小細(xì)胞肺癌新發(fā)患者僅約5100人。

不過,中外新藥商業(yè)化路徑不盡相同。界面新聞記者根據(jù)報告分析,美國市場雖然患者人數(shù)少,但錢多、回報高,依舊是迪哲醫(yī)藥不可錯過的核心市場。

在高端腫瘤靶向治療領(lǐng)域,美國的自由定價機(jī)制、醫(yī)保覆蓋能力、以及孤兒藥政策等,允許企業(yè)即使面對小眾人群,也可能實現(xiàn)數(shù)十萬美元的年均單人收入。以PD-1為例,進(jìn)口原研藥在中國的實際平均價格僅有美國價格的15%左右。

特別是,EGFR exon20ins突變治療在美國市場的競爭并不激烈。武田制藥的莫博賽替尼于2023年宣布退市后,舒沃替尼成為唯二已獲批的藥物,另一產(chǎn)品是強(qiáng)生的EGFR/c-MET雙抗埃萬妥單抗。

截至目前,迪哲醫(yī)藥共有兩款商業(yè)化產(chǎn)品——舒沃替尼和JAK1抑制劑戈利昔替尼。其中,舒沃替尼實現(xiàn)中美兩地上市。

隨著兩款新藥上市,迪哲醫(yī)藥業(yè)績逐漸向扭虧靠近。

界面新聞統(tǒng)計迪哲醫(yī)藥年報數(shù)據(jù),2022年至2024年,迪哲醫(yī)藥實現(xiàn)營收0元、9129萬元和3.59億元,實現(xiàn)凈利潤-7.36億元、-11.08億元和-9.39億元。

置疑:7777788888四肖四碼管家婆或新澳及香港天天開獎資料大全600,合理釋義、解釋與落實-規(guī)避不實的聲明
界面新聞記者李科文制圖

舒沃替尼美國獲批后,迪哲醫(yī)藥業(yè)績扭虧的速度或能加快。

但舒沃替尼的海外商業(yè)化未來將如何推進(jìn)尚未有公開答案。此前,對于在出海問題,迪哲醫(yī)藥創(chuàng)始人、董事長兼CEO張小林在接受界面新聞記者采訪時表示,公司保持開放心態(tài),也在評估各種模式。

界面新聞記者從業(yè)內(nèi)獲悉,目前中國創(chuàng)新藥出海在商業(yè)化落地上主要有兩種路徑:其一是由企業(yè)自建銷售體系,實現(xiàn)本土自主銷售;其二則是通過對外授權(quán)(BD)等方式與海外藥企合作,由后者負(fù)責(zé)本地市場推廣。

前者是資金實力雄厚的跨國藥企慣常采用的模式,依托其成熟的產(chǎn)研銷一體化能力和廣泛的銷售網(wǎng)絡(luò),具備直接面向市場的基礎(chǔ)。

對于中國生物科技企業(yè)而言,自營團(tuán)隊出海雖理想,但現(xiàn)實挑戰(zhàn)重重。截至目前,真正實現(xiàn)自主出海商業(yè)化的中國藥企中,百濟(jì)神州是極少數(shù)的成功案例。類似的機(jī)遇也可遇不可求。

國內(nèi)某創(chuàng)新藥公司總裁曾向界面新聞記者表示,不可否認(rèn)的是,中國創(chuàng)新藥企要在海外建立自己的商業(yè)化體系,目前來看難度依舊很高。國內(nèi)企業(yè)在海外成功實現(xiàn)自主銷售的案例極少,其中百濟(jì)神州是一個極為突出的例子。百濟(jì)神州的成功在于其強(qiáng)大的資本運作能力,以及CEO歐雷強(qiáng)本人在中美資本市場的深度游走能力。他具備美方背景和強(qiáng)融資能力,使得百濟(jì)即便長期虧損,也能持續(xù)支撐其在美國建設(shè)商業(yè)化體系。

他向界面新聞記者舉例稱,相比之下,即使是在國內(nèi)擁有強(qiáng)大商業(yè)團(tuán)隊和盈利能力的傳統(tǒng)藥企如恒瑞醫(yī)藥,也沒有在美國建立起成熟的銷售體系。這說明海外商業(yè)化不僅僅是資源投入的問題,更是綜合能力與生態(tài)適應(yīng)的問題。

相比自建海外商業(yè)化體系所需的高投入與高門檻,大多數(shù)中國藥企更現(xiàn)實的選擇是通過對外授權(quán)(License out)或聯(lián)合開發(fā)等合作形式拓展國際市場。

考慮到當(dāng)前多數(shù)國內(nèi)藥企在海外仍缺乏完整銷售能力,對外授權(quán)不僅能在研發(fā)端實現(xiàn)資源互補(bǔ)、分?jǐn)傦L(fēng)險,還可借助跨國藥企成熟的銷售網(wǎng)絡(luò),加速國產(chǎn)創(chuàng)新藥在海外落地。

CIC灼識咨詢總監(jiān)盧李康向界面新聞記者表示,對于大多數(shù)中國創(chuàng)新藥企而言,對外授權(quán)仍是當(dāng)前拓展海外市場最具性價比的路徑。組建一支覆蓋全美的專業(yè)銷售、市場、醫(yī)學(xué)事務(wù)團(tuán)隊,人力成本極高,前期投入巨大,同時需要多年的積累才能建立起品牌,而對外授權(quán)合作將顯著降低這部分的投入負(fù)擔(dān),同時還有機(jī)會通過里程碑付款和銷售分成帶來持續(xù)現(xiàn)金流,從資金和運營效率上來講是更優(yōu)。

盧李康補(bǔ)充,合作方可利用在美國當(dāng)?shù)氐纳虡I(yè)化網(wǎng)絡(luò)快速推進(jìn)產(chǎn)品的市場準(zhǔn)入和的市場營銷,并且獲取跨國藥企的品牌背書,依靠合作方案的能力帶來產(chǎn)品的快速上市、準(zhǔn)入談判和醫(yī)生處方理念塑造。國內(nèi)生物科技公司可以專注研發(fā),持續(xù)產(chǎn)出創(chuàng)新成果,不斷帶來產(chǎn)品和管線組合的更新升級,發(fā)揮創(chuàng)新能力的最大價值。

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