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2020年5月31日，復(fù)宏漢霖（2696.HK）聯(lián)合合作伙伴Accord Healthcare Limited（“Accord”）共同宣布，歐洲藥品管理局（European Medicines Agency, EMA）人用醫(yī)藥產(chǎn)品委員會(huì)（Committee for Medicinal Products for Human Use, CHMP）發(fā)布積極審評(píng)意見(jiàn)，建議批準(zhǔn)HLX02（注射用曲妥珠單抗）用于治療HER2陽(yáng)性早期乳腺癌、HER2陽(yáng)性轉(zhuǎn)移性乳腺癌，以及未經(jīng)治療的HER2陽(yáng)性轉(zhuǎn)移性胃癌或胃/食管交界處腺癌的上市銷售許可申請(qǐng)（Marketing Authorisation Application, MAA）。根據(jù)EMA CHMP的積極審評(píng)意見(jiàn)，“HLX02與參照藥赫賽汀（曲妥珠單抗）高度相似，研究數(shù)據(jù)支持HLX02在質(zhì)量、安全性與療效等方面與赫賽汀均無(wú)顯著差異?！?/strong> HLX02是由復(fù)宏漢霖按照歐盟和中國(guó)生物類似藥相關(guān)指導(dǎo)自主開(kāi)發(fā)和生產(chǎn)的生物類似藥，其歐盟MAA由復(fù)宏漢霖與合作伙伴Accord共同推動(dòng)，未來(lái)HLX02在歐洲的商業(yè)化將由Accord負(fù)責(zé)。根據(jù)審評(píng)流程，CHMP的積極審評(píng)意見(jiàn)將被遞交至歐盟委員會(huì)（European Commission, EC），EC將參考CHMP的審評(píng)意見(jiàn)并在未來(lái)2-3個(gè)月做出最終決定。若獲得批準(zhǔn)，HLX02即可在全部歐盟成員國(guó)以及歐洲經(jīng)濟(jì)區(qū)國(guó)家挪威、冰島和列支敦士登上市銷售，成為進(jìn)入歐洲市場(chǎng)的第一個(gè)“中國(guó)籍”單抗生物類似藥，參與生物藥的“世界杯”比賽。 歐盟是世界上最早制定生物類似藥指導(dǎo)原則的地區(qū)。早在2004年，EMA就發(fā)布了《生物類似藥指南（草案）》，開(kāi)創(chuàng)了全球生物類似藥新時(shí)代。自2006年批準(zhǔn)首個(gè)生物類似藥以來(lái)，歐盟已成為全球生物類似藥最主要的成熟市場(chǎng)。根據(jù)IQVIA MIDASTM數(shù)據(jù)估計(jì)，2019年原研曲妥珠單抗及其生物類似藥于歐盟及挪威、冰島和列支敦士登的銷售額達(dá)到了13.7億美金。  復(fù)宏漢霖聯(lián)合創(chuàng)始人、首席執(zhí)行官劉世高博士表示： HLX02能夠獲得EMA的積極審評(píng)意見(jiàn)，我們感到非常驕傲。這意味著我們已經(jīng)成功通過(guò)了EMA的嚴(yán)格審評(píng)，在生物藥研發(fā)和生產(chǎn)方面的質(zhì)量獲得了國(guó)際權(quán)威藥監(jiān)機(jī)構(gòu)的認(rèn)可。HLX02有望于今年8月獲歐盟批準(zhǔn)，非常期待它能夠早日上市，為HER2陽(yáng)性乳腺癌和胃癌患者提供新的質(zhì)高價(jià)優(yōu)的治療選擇。復(fù)宏漢霖始終秉持以優(yōu)質(zhì)生物藥造福全球病患的使命，未來(lái)我們將繼續(xù)與合作伙伴Accord攜手不斷提升HLX02在歐洲及其他地區(qū)的可及性，努力惠及全球患者。 Accord執(zhí)行副總裁（歐洲和MENA地區(qū)）James Burt博士表示： 我們致力于不斷提高安全、有效、經(jīng)濟(jì)的抗腫瘤藥物的可及性。Accord在抗腫瘤領(lǐng)域已積累的豐富經(jīng)驗(yàn)為此次我們獲得CHMP積極審評(píng)意見(jiàn)提供了助力。Accord與復(fù)宏漢霖的合作印證了我們長(zhǎng)期致力于生物制藥研發(fā)與生產(chǎn)的戰(zhàn)略。 完整證據(jù)支持與原研高度相似， 國(guó)際質(zhì)量奠定成功基石 此次EMA的積極意見(jiàn)主要是基于對(duì)HLX02一系列研究數(shù)據(jù)的審評(píng)，包括質(zhì)量對(duì)比研究、臨床前研究及臨床研究。這些數(shù)據(jù)都證明了HLX02與參照藥（赫賽汀?）高度相似，在產(chǎn)品質(zhì)量、藥理學(xué)、藥代動(dòng)力學(xué)、藥效動(dòng)力學(xué)、毒理學(xué)、免疫原性、安全性和有效性等方面與參照藥沒(méi)有臨床意義上的顯著差異。其中，比較HLX02與歐洲市售原研曲妥珠單抗的3期臨床研究為一項(xiàng)隨機(jī)、雙盲、國(guó)際多中心3期臨床試驗(yàn)，HLX02也由此成為國(guó)內(nèi)首個(gè)進(jìn)行國(guó)際多中心3期臨床研究同時(shí)也是首個(gè)進(jìn)行中歐同步申報(bào)的生物類似藥。該研究共入組了來(lái)自中國(guó)、菲律賓、波蘭、烏克蘭89個(gè)研究中心的649例既往未接受治療的HER2陽(yáng)性復(fù)發(fā)性或轉(zhuǎn)移性乳腺癌患者。研究結(jié)果進(jìn)一步證實(shí)HLX02與歐洲市售原研曲妥珠單抗在療效與安全性上無(wú)臨床意義上的顯著差異。 HLX02在此前已通過(guò)了EMA的GMP現(xiàn)場(chǎng)檢查和GCP檢查，并于2020年4月獲得歐盟GMP認(rèn)證，表明復(fù)宏漢霖已經(jīng)具備了符合歐盟標(biāo)準(zhǔn)的商業(yè)化生產(chǎn)基地和質(zhì)量管理體系。復(fù)宏漢霖成立之初即以惠及全球更多病患作為出發(fā)點(diǎn)，在制定HLX02產(chǎn)品研發(fā)策略之初便放眼全球，創(chuàng)新性地同時(shí)按照中國(guó)和歐盟的生物類似藥指導(dǎo)原則進(jìn)行開(kāi)發(fā)和生產(chǎn)，為HLX02國(guó)際化戰(zhàn)略的成功實(shí)施打下了堅(jiān)實(shí)基礎(chǔ)。 前瞻性國(guó)際化布局，造福中國(guó)與全球病患 HLX02在中國(guó)的上市申請(qǐng)已于2019年4月獲國(guó)家藥品監(jiān)督管理局受理并已被納入優(yōu)先審評(píng)審批名單，也有望在2020年上市惠及中國(guó)患者，未來(lái)在中國(guó)的營(yíng)銷將由復(fù)宏漢霖已建立完善的自主商業(yè)化團(tuán)隊(duì)負(fù)責(zé)。 為滿足全球患者對(duì)高質(zhì)量、可負(fù)擔(dān)藥物的用藥需求，復(fù)宏漢霖針對(duì)HLX02前瞻性地開(kāi)展了國(guó)際商業(yè)化布局，積極開(kāi)拓海外市場(chǎng)。除授予Accord在歐洲、中東、北非地區(qū)和部分獨(dú)聯(lián)體國(guó)家共計(jì)70余個(gè)國(guó)家的HLX02獨(dú)家商業(yè)化權(quán)利之外，公司與Cipla、Mabxience和雅各臣藥業(yè)等國(guó)際一流的生物制藥企業(yè)也達(dá)成合作，持續(xù)推動(dòng)HLX02在全球多個(gè)國(guó)家和地區(qū)的商業(yè)化進(jìn)程。 未來(lái)，復(fù)宏漢霖將持續(xù)踐行“可負(fù)擔(dān)的創(chuàng)新·值得信賴的品質(zhì)”的核心理念，拓展更多產(chǎn)品的國(guó)際化布局，深耕腫瘤治療領(lǐng)域，同時(shí)積極推動(dòng)創(chuàng)新生物藥和生產(chǎn)工藝的開(kāi)發(fā)，讓全球病患不但用得到也用得起我們研發(fā)和生產(chǎn)的生物藥，成為全球最受信賴和景仰的創(chuàng)新生物醫(yī)藥公司。 關(guān)于HER2陽(yáng)性乳腺癌及胃癌 乳腺癌是女性中發(fā)病率和致死率最高的惡性腫瘤，嚴(yán)重威脅著全世界女性的健康。據(jù)GLOBOCAN數(shù)據(jù)估計(jì)，全球每年新增乳腺癌病例數(shù)超過(guò)200萬(wàn)，死亡病例數(shù)超過(guò)60萬(wàn)。HER2陽(yáng)性乳腺癌患者腫瘤細(xì)胞表面的HER2表達(dá)水平高于正常水平，約占全部乳腺癌患者的25%[1]，是乳腺癌中的主要亞型之一。HER2（人表皮生長(zhǎng)因子受體2）是一種受體酪氨酸激酶，能夠促進(jìn)細(xì)胞生長(zhǎng)和增殖，是乳腺癌患者的重要預(yù)后指標(biāo)，也是抗HER2藥物治療的主要預(yù)測(cè)指標(biāo)[2]。曲妥珠單抗能夠特異性地與HER2結(jié)合從而抑制腫瘤細(xì)胞生長(zhǎng)，同時(shí)能夠誘導(dǎo)抗體依賴型細(xì)胞毒作用（ADCC）殺傷腫瘤細(xì)胞，已被國(guó)內(nèi)外乳腺癌診療指南推薦用于HER2陽(yáng)性乳腺癌患者各階段的治療，成為HER2陽(yáng)性乳腺癌患者全程規(guī)范化治療公認(rèn)的“金標(biāo)準(zhǔn)”用藥。除乳腺癌外，HER2過(guò)表達(dá)的情況也常出現(xiàn)在胃癌或胃/食管交界處腺癌中。大約22%轉(zhuǎn)移性胃癌患者為HER2陽(yáng)性[3]。曲妥珠單抗聯(lián)合化療能夠顯著降低HER2陽(yáng)性轉(zhuǎn)移性胃癌患者的死亡風(fēng)險(xiǎn)，延長(zhǎng)患者的總生存期，亦已成為HER2陽(yáng)性轉(zhuǎn)移性胃癌一線治療的基石。 關(guān)于Accord Healthcare Accord總部位于英國(guó)，是歐洲增長(zhǎng)最快的制藥公司之一。Accord廣闊的市場(chǎng)覆蓋在歐洲仿制藥與生物類似藥公司中處于領(lǐng)先地位，營(yíng)銷和分銷網(wǎng)絡(luò)已覆蓋全球80多個(gè)國(guó)家。 廣闊的全球布局使得Accord得以為不同國(guó)家的衛(wèi)生系統(tǒng)提供重要且可負(fù)擔(dān)的藥物供給，幫助全世界的醫(yī)生改善患者的生活。通過(guò)采取靈活創(chuàng)新的商業(yè)模式，Accord不斷追求產(chǎn)品質(zhì)量與可及性的提升并將始終力求為全世界患者帶來(lái)更多獲益。 關(guān)于復(fù)宏漢霖 復(fù)宏漢霖（2696.HK）是一家國(guó)際化的創(chuàng)新生物制藥公司，致力于為全球患者提供質(zhì)高價(jià)優(yōu)的創(chuàng)新生物藥，產(chǎn)品覆蓋腫瘤、自身免疫疾病等領(lǐng)域。自2010年成立以來(lái)，復(fù)宏漢霖已建成一體化生物制藥平臺(tái)，高效及創(chuàng)新的自主核心能力貫穿研發(fā)、生產(chǎn)及商業(yè)運(yùn)營(yíng)全產(chǎn)業(yè)鏈。公司在中國(guó)上海、中國(guó)臺(tái)北和美國(guó)加州均設(shè)有研發(fā)中心，按照國(guó)際GMP標(biāo)準(zhǔn)進(jìn)行生產(chǎn)和質(zhì)量管控，位于上海徐匯的生產(chǎn)基地已獲得中國(guó)和歐盟GMP認(rèn)證。 復(fù)宏漢霖前瞻性布局了一個(gè)多元化、高質(zhì)量的產(chǎn)品管線，涵蓋20多種創(chuàng)新單克隆抗體，并全面推進(jìn)基于自有抗PD-1單抗HLX10的腫瘤免疫聯(lián)合療法。截至目前，公司已成功上市國(guó)內(nèi)首個(gè)生物類似藥漢利康?（利妥昔單抗），2個(gè)產(chǎn)品（HLX02曲妥珠單抗、HLX03阿達(dá)木單抗）上市申請(qǐng)正在審評(píng)中，并獲得優(yōu)先審評(píng)審批資格，有望于今年上市，并同步就10個(gè)產(chǎn)品、8個(gè)聯(lián)合治療方案于全球范圍內(nèi)開(kāi)展20多項(xiàng)臨床試驗(yàn)，產(chǎn)品對(duì)外授權(quán)覆蓋全球近100個(gè)國(guó)家和地區(qū)。此外，公司聯(lián)合商業(yè)合作伙伴Accord推動(dòng)HLX02向歐洲藥品管理局遞交上市申請(qǐng)，于2020年4月通過(guò)歐盟GMP現(xiàn)場(chǎng)核查，有望成為首個(gè)在歐盟上市的國(guó)產(chǎn)生物類似藥。 Henlius and Accord Receive Positive CHMP Opinion for Oncology Biosimilar, HLX02 (Trastuzumab) Shanghai, China, May 31, 2020 – Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) jointly announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for biosimilar HLX02 (trastuzumab for injection), for the treatment of HER2 positive early breast cancer, HER2 positive metastatic breast cancer and previously untreated HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction. According to the EMA CHMP summary of positive opinion，HLX02 is highly similar to the reference product Herceptin (trastuzumab). Data show that HLX02 has comparable quality, safety and efficacy to Herceptin. HLX02 is a biosimilar monoclonal antibody (mAb), that was developed and manufactured by Henlius in accordance with biosimilar guidelines, and will be distributed and marketed across Europe by Accord. The CHMP’s opinion will now be reviewed by the European Commission (EC), with a regulatory decision anticipated in the next 2-3 months. Once approved, a centralised marketing authorisation will be granted for all EU Member States, Iceland, Norway and Liechtenstein. Dr. Scott Liu, co-founder and CEO of Henlius, said, “We are very proud to receive CHMP positive opinion for HLX02 and that Henlius’ quality in the development and manufacture of biologics has been recognized by an international drug regulatory agency. We look forward to launching HLX02 to provide an alternative high-quality and affordable treatment option for patients with HER2 positive breast cancer and gastric cancer. We will continue to work with Accord to improve the accessibility of HLX02 in Europe and other regions and strive to benefit patients all over the world.” Dr. James Burt, Executive Vice President, Accord, Europe and MENA said, “We are committed to ensuring oncology patients get access to safe, cost effective medicines and this CHMP positive opinion builds on our established expertise and extensive oncology treatment portfolio. Our agreement with Henlius reflects our strategy of long-standing commitment to biopharmaceutical development, research and manufacturing.” About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has three R&D facilities in Shanghai, Taipei and California and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP). Henlius has proactively built a diversified and high-quality product pipeline covering over 20 innovative monocolonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Up to date, in addition to 漢利康? (HLX01, rituximab) launched commercially and two products (HLX02 trastuzumab and HLX03 adalimumab) under New Drug Application (NDA) review to be potentially launched within 2020, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. Products have been licensed out to nearly 100 countries and regions. About Accord Healthcare Headquartered in the United Kingdom (UK), Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve our products and patients’ access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide. 參考文獻(xiàn) [1] Menard S, Casalini P, Campiglio M, et al. HER2 overexpression in various tumor types, focussing on its relationship to the development of invasive breast cancer[J]. Annals of oncology, 2001, 12: S15-S19. [2]《人表皮生長(zhǎng)因子受體2陽(yáng)性乳腺癌臨床診療專家共識(shí)2016》. [3] Bang Y, Chung H, Sawaki A, et al. HER2-positivity rates in advanced gastric cancer (GC): results from a large international phase III trial[J]. Journal of Clinical Oncology, 2008, 26(15_suppl): 4526-4526. 聯(lián)系我們 媒體：PR@Henlius.com 投資者：IR@Henlius.com |
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