醫(yī)藥行業(yè)創(chuàng)新藥月報(bào)egfr靶點(diǎn)詳解,大適應(yīng)癥大市場(chǎng),首個(gè)國(guó)產(chǎn)三代tki申報(bào)上市_第1頁(yè)
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1、若出現(xiàn)排版,錯(cuò)誤,數(shù)據(jù)顯示不全等情況,可加微信535600147,憑購(gòu)買(mǎi)下載記錄獲取PDF版本目錄1.重要靶點(diǎn)系列分重要靶點(diǎn)系列分析之一:之一:EGFR(表皮生長(zhǎng)因子受體)表皮生長(zhǎng)因子受體)....................................................................................................................51.1EGFR概

2、覽:抗腫瘤治療成熟靶點(diǎn):抗腫瘤治療成熟靶點(diǎn)............................................................................................................................................51.2EGFR靶點(diǎn):大分子、小分子適應(yīng)癥各有側(cè)重,聯(lián)合:大分子、小分子適應(yīng)癥各有側(cè)重,聯(lián)合治療為未來(lái)突破方向療為未來(lái)

3、突破方向........................................................................51.3EGFR單抗概覽:結(jié)直腸癌靶向治療王者,適應(yīng)癥多概覽:結(jié)直腸癌靶向治療王者,適應(yīng)癥多領(lǐng)域銳意探索域銳意探索....................................................................................71.

4、3.1獲批適應(yīng)癥涵蓋大小病種、臨獲批適應(yīng)癥涵蓋大小病種、臨床推薦優(yōu)先級(jí)高推薦優(yōu)先級(jí)高............................................................................................................71.3.2EGFR單抗現(xiàn)有適應(yīng)癥現(xiàn)有適應(yīng)癥................................................

5、......................................................................................................81.3.3EGFR單抗適應(yīng)癥擴(kuò)展:在研擴(kuò)展豐富,聚焦聯(lián)合適應(yīng)癥擴(kuò)展:在研擴(kuò)展豐富,聚焦聯(lián)合治療......................................................................

6、......................131.3.4EGFR單抗國(guó)內(nèi)外市場(chǎng)速覽:適應(yīng)癥與療效決定上國(guó)內(nèi)外市場(chǎng)速覽:適應(yīng)癥與療效決定上限,多因素影響規(guī)模,多因素影響規(guī)模................................................................161.3.5國(guó)內(nèi)國(guó)內(nèi)EGFR單抗在研抗在研產(chǎn)品:西妥昔面臨專(zhuān)利懸崖,國(guó)產(chǎn)品:西妥昔面臨專(zhuān)利懸崖,國(guó)產(chǎn)EGFR單抗大幅擴(kuò)軍抗大幅擴(kuò)軍....

7、................................................191.4EGFR小分子靶向:子靶向:EGFR陽(yáng)性NSCLC突破療法,三代破療法,三代TKI競(jìng)爭(zhēng)競(jìng)爭(zhēng)激烈..........................................................................201.4.1大癌種大市場(chǎng),大癌種大市場(chǎng),EGFR陽(yáng)性NSCLC首選藥物選藥物.......

8、...................................................................................................201.4.2臨床療效一覽:顯著優(yōu)于傳統(tǒng)臨床療效一覽:顯著優(yōu)于傳統(tǒng)化療,各代療,各代TKI競(jìng)爭(zhēng)激烈競(jìng)爭(zhēng)激烈....................................................................

9、......................211.4.3適應(yīng)癥擴(kuò)展:適應(yīng)癥擴(kuò)展:NSCLC聯(lián)合治療為主,尋求適應(yīng)癥突破治療為主,尋求適應(yīng)癥突破............................................................................................251.4.4國(guó)內(nèi)外市場(chǎng)速覽:初代國(guó)內(nèi)外市場(chǎng)速覽:初代TKI具備先發(fā)優(yōu)勢(shì),差異化或成為關(guān)鍵備先發(fā)優(yōu)勢(shì),差異化或成

10、為關(guān)鍵..............................................................................261.4.5在研產(chǎn)品:國(guó)外重磅藥物呼之在研產(chǎn)品:國(guó)外重磅藥物呼之欲出,國(guó)內(nèi)仿制藥出,國(guó)內(nèi)仿制藥BE試驗(yàn)如火如荼驗(yàn)如火如荼......................................................................292.非上市明

11、星公司非上市明星公司系列之列之一信達(dá)生物:仿創(chuàng)結(jié)合的信達(dá)生物:仿創(chuàng)結(jié)合的BIOTECH型藥企,藥企,未來(lái)13年在研管線迎來(lái)收獲期年在研管線迎來(lái)收獲期..............................302.1管理團(tuán)隊(duì):具備豐富的產(chǎn)業(yè)化管理團(tuán)隊(duì):具備豐富的產(chǎn)業(yè)化經(jīng)驗(yàn)與國(guó)際化視野驗(yàn)與國(guó)際化視野......................................................................

12、............................................312.2融資情況:已獲得五輪融資,融資情況:已獲得五輪融資,或?qū)⒏案凵鲜袑⒏案凵鲜?.........................................................................................................................312.3在研管線:以仿

13、創(chuàng)為主,預(yù)計(jì)在研管線:以仿創(chuàng)為主,預(yù)計(jì)未來(lái)3年將迎來(lái)年將迎來(lái)收獲期獲期..........................................................................................................313.創(chuàng)新藥上市公司創(chuàng)新藥上市公司系列研究之列研究之一科倫藥業(yè):仿制帶動(dòng)創(chuàng)新,科倫藥業(yè):仿制帶動(dòng)創(chuàng)新,2020年即將步入收獲期年即將步入收獲期.......

14、.........................................................343.1產(chǎn)業(yè)升級(jí),原料藥、輸液、制產(chǎn)業(yè)升級(jí),原料藥、輸液、制劑板塊三箭齊發(fā)板塊三箭齊發(fā)......................................................................................................................3

15、43.2深耕研發(fā),仿制深耕研發(fā),仿制藥創(chuàng)新藥迎來(lái)創(chuàng)新藥迎來(lái)成熟收獲期熟收獲期............................................................................................................................343.2.1輸液板塊:腸外營(yíng)養(yǎng)未來(lái)輸液板塊:腸外營(yíng)養(yǎng)未來(lái)23年銷(xiāo)售額有望突破年銷(xiāo)售額有望突破10億........

16、....................................................................................353.2.2特色專(zhuān)科藥:涵蓋治療領(lǐng)域豐特色專(zhuān)科藥:涵蓋治療領(lǐng)域豐富,各領(lǐng)域均有看點(diǎn),各領(lǐng)域均有看點(diǎn)......................................................................................

17、............364.2018年6月創(chuàng)新藥新聞月創(chuàng)新藥新聞........................................................................................................................................................................405.風(fēng)險(xiǎn)提示風(fēng)險(xiǎn)提示......

18、..........................................................................................................................................................................................43若出現(xiàn)排版,錯(cuò)誤,數(shù)據(jù)顯示不全等情況,可加微信535600147

19、,憑購(gòu)買(mǎi)下載記錄獲取PDF版本東興證券專(zhuān)題報(bào)告東興證券專(zhuān)題報(bào)告行業(yè)選擇醫(yī)藥創(chuàng)新藥月報(bào)20180624:EGFR靶點(diǎn)詳解:大適應(yīng)癥大市場(chǎng),首個(gè)國(guó)產(chǎn)三代TKI申報(bào)上市DONGXINGSECURITIES插圖目錄插圖目錄圖1:EGFR受體通路示意圖體通路示意圖.............................................................................................

20、.........................................................................5圖2:EGFR靶點(diǎn)大分子小點(diǎn)大分子小分子藥物作用機(jī)制圖子藥物作用機(jī)制圖...............................................................................................................

21、.......................6圖3:轉(zhuǎn)移性結(jié)腸癌現(xiàn)有治療方案轉(zhuǎn)移性結(jié)腸癌現(xiàn)有治療方案..............................................................................................................................................................8圖4:西妥昔單抗、帕

22、尼單抗臨床數(shù)據(jù)西妥昔單抗、帕尼單抗臨床數(shù)據(jù)......................................................................................................................................................9圖5:西妥昔單抗、帕尼單抗西妥昔單抗、帕尼單抗R數(shù)據(jù)......................

23、........................................9圖6:西妥昔單抗頭頸部腫瘤臨床數(shù)據(jù)西妥昔單抗頭頸部腫瘤臨床數(shù)據(jù)....................................................................................................................................................

24、10圖7:復(fù)發(fā)性頭頸部鱗癌西妥昔單抗復(fù)發(fā)性頭頸部鱗癌西妥昔單抗OS數(shù)據(jù)數(shù)據(jù)........................................................................................................................................10圖8:復(fù)發(fā)性頭頸部鱗癌西妥昔單抗復(fù)發(fā)性頭頸部鱗癌西妥昔單抗PFS數(shù)據(jù)...........

25、.............................................10圖9:耐昔妥珠單抗耐昔妥珠單抗OS&PFS數(shù)據(jù)..................................................................11圖10:尼妥珠單抗妥珠單抗CR數(shù)據(jù)數(shù)據(jù)...............................................................

26、.......................................................................................................12圖11:NCCN中國(guó)版頭頸部腫瘤治療國(guó)版頭頸部腫瘤治療........................................................................................

27、............................................................12圖12:西妥昔單抗聯(lián)用適應(yīng)癥拓展試驗(yàn)數(shù)妥昔單抗聯(lián)用適應(yīng)癥拓展試驗(yàn)數(shù).............................................................................................................................

28、.................14圖13:帕尼單抗聯(lián)用適應(yīng)癥拓展試驗(yàn)數(shù)尼單抗聯(lián)用適應(yīng)癥拓展試驗(yàn)數(shù)................................................................................................................................................14圖14:海外EGFR單抗銷(xiāo)售數(shù)據(jù)抗銷(xiāo)售數(shù)據(jù)...

29、.........................................................................................................................................................16圖15:西妥昔單抗國(guó)內(nèi)樣本醫(yī)院銷(xiāo)售數(shù)據(jù)妥昔單抗國(guó)內(nèi)樣本醫(yī)院銷(xiāo)售數(shù)據(jù)................................

30、..............................................................................................................17圖16:尼妥珠單抗國(guó)內(nèi)樣本醫(yī)院銷(xiāo)售數(shù)據(jù)妥珠單抗國(guó)內(nèi)樣本醫(yī)院銷(xiāo)售數(shù)據(jù)...........................................................................

31、.................................................................17圖17:尼妥珠單抗樣本醫(yī)院放量曲線妥珠單抗樣本醫(yī)院放量曲線............................................................................................................................

32、..........................18圖18:EGFR的非小細(xì)胞肺非小細(xì)胞肺癌(NSCLC)治療流程治療流程..........................................................................................................................20圖19:吉非替尼非替尼VS??颂婺岚?颂婺?...........

33、......................................................................................................................................................22圖20:吉非替尼非替尼VS厄洛替尼厄洛替尼...............................................

34、...................................................................................................................22圖21:??颂婺崮X轉(zhuǎn)移患者數(shù)據(jù)克替尼腦轉(zhuǎn)移患者數(shù)據(jù)..............................................................................

35、................................................................................23圖22:二代TKI數(shù)據(jù)數(shù)據(jù).............................................................................................................................

36、.....................................................23圖23:EGFRT790M位點(diǎn)........................................................................24圖24:三代TKIPFS數(shù)據(jù)..............................................................

37、..........25圖25:腦轉(zhuǎn)移患者三代轉(zhuǎn)移患者三代TKIPFS數(shù)據(jù)...............................................................25圖26:TKI適應(yīng)癥拓展情況應(yīng)癥拓展情況..................................................................................................

38、....................................................................26圖27:TKI研究類(lèi)型數(shù)量概覽究類(lèi)型數(shù)量概覽................................................................................................................................

39、..................................26圖28:海外TKI銷(xiāo)售數(shù)據(jù)銷(xiāo)售數(shù)據(jù).......................................................................................................................................................................

40、...27圖29:國(guó)內(nèi)TKI樣本醫(yī)院終端數(shù)據(jù)樣本醫(yī)院終端數(shù)據(jù)..........................................................................................................................................................28圖30:達(dá)克替尼臨床數(shù)據(jù)克替尼臨床數(shù)據(jù)...............

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