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2022年10月28日，復(fù)宏漢霖(2696.HK)宣布，公司自主研制的帕妥珠單抗生物類似藥HLX11(重組抗HER2結(jié)構(gòu)域II人源化單克隆抗體注射液)的臨床試驗(yàn)申請(qǐng)?jiān)跉W盟國家西班牙獲批開展國際多中心III期臨床研究，擬用于HER2陽性且HR陰性的早期或局部晚期乳腺癌新輔助治療。目前，HLX11的III期臨床研究(HLX11-BC301)已于中國完成首例受試者給藥。與此同時(shí)，公司已陸續(xù)向波蘭、保加利亞、匈牙利、捷克等其他歐盟國家遞交了HLX11的臨床試驗(yàn)申請(qǐng)，預(yù)計(jì)將于近期陸續(xù)獲批。

HLX11為復(fù)宏漢霖遵照中國及歐盟生物類似藥相關(guān)法規(guī)自主開發(fā)的帕妥珠單抗生物類似藥，其潛在適應(yīng)癥主要包括聯(lián)合曲妥珠單抗和化療用于HER2陽性早期乳腺癌的新輔助治療和輔助治療，以及聯(lián)合曲妥珠單抗和多西他賽治療HER2陽性轉(zhuǎn)移性或不可切除的局部復(fù)發(fā)性乳腺癌患者。HLX11可與HER2的細(xì)胞外二聚化結(jié)構(gòu)域(亞結(jié)構(gòu)域II)發(fā)生特異性結(jié)合，從而阻斷HER2與其他HER家族成員(包括EGFR、HER3和HER4)生成配體依賴型異源二聚體，進(jìn)而抑制配體啟動(dòng)的細(xì)胞內(nèi)信號(hào)轉(zhuǎn)導(dǎo)，導(dǎo)致腫瘤細(xì)胞生長停滯和細(xì)胞凋亡，同時(shí)通過抗體依賴性細(xì)胞介導(dǎo)的細(xì)胞毒性作用(ADCC)達(dá)到增強(qiáng)免疫細(xì)胞對(duì)腫瘤細(xì)胞的殺傷能力。

復(fù)宏漢霖深耕抗HER2治療領(lǐng)域，積累了豐富的研究成果與經(jīng)驗(yàn)，公司自主開發(fā)的豐富管線覆蓋多款靶向HER2的抗體生物藥，也為相關(guān)雙特異性抗體、抗體偶聯(lián)藥物(ADC)產(chǎn)品等新型抗體的研發(fā)奠定了扎實(shí)的基礎(chǔ)。其中，復(fù)宏漢霖自主開發(fā)與生產(chǎn)的曲妥珠單抗?jié)h曲優(yōu)(歐洲商品名：Zercepac，澳大利亞商品名：Tuzucip和Trastucip)是中國首個(gè)自主研發(fā)的中歐雙批單抗藥物，目前已在全球30多個(gè)國家獲批上市，為全球HER2陽性乳腺癌及胃癌患者的“金標(biāo)準(zhǔn)”治療方案增添了新的選擇。公司正處于II期臨床研究階段的創(chuàng)新型產(chǎn)品HLX22(一款針對(duì)HER2靶點(diǎn)開發(fā)的人源化lgG1單克隆抗體注射液)也有望進(jìn)一步提升HER2陽性乳腺癌及胃癌患者的治療效果，帶給患者更大的生存獲益。HLX11也有潛力與漢曲優(yōu)、HLX22聯(lián)合應(yīng)用，助力復(fù)宏漢霖打造更高效的治療方案。

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未來，公司將持續(xù)推動(dòng)HLX11相關(guān)研究在全球范圍的臨床布局，并以不斷的創(chuàng)新與突破為全球病患帶來更多質(zhì)高價(jià)優(yōu)的生物。

關(guān)于復(fù)宏漢霖

復(fù)宏漢霖(2696.HK)是一家國際化的創(chuàng)新生物制藥公司，致力于為全球患者提供可負(fù)擔(dān)的高品質(zhì)生物藥，產(chǎn)品覆蓋腫瘤、自身免疫疾病、眼科疾病等領(lǐng)域，已在中國上市5款產(chǎn)品，在國際上市1款產(chǎn)品，15項(xiàng)適應(yīng)癥獲批，5個(gè)上市注冊申請(qǐng)獲得中國藥監(jiān)局受理。自2010年成立以來，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)營全產(chǎn)業(yè)鏈。公司已建立完善高效的全球創(chuàng)新中心，按照國際藥品生產(chǎn)質(zhì)量管理規(guī)范(GMP)標(biāo)準(zhǔn)進(jìn)行生產(chǎn)和質(zhì)量管控，不斷夯實(shí)一體化綜合生產(chǎn)平臺(tái)，其中，上海徐匯基地已獲得中國和歐盟GMP認(rèn)證，松江基地(一)也已獲得中國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H藥漢斯?fàn)畹哪[瘤免疫聯(lián)合療法。繼國內(nèi)首個(gè)生物類似藥漢利康(利妥昔單抗)、中國首個(gè)自主研發(fā)的中歐雙批單抗藥物漢曲優(yōu)(曲妥珠單抗，歐洲商品名：Zercepac，澳大利亞商品名：Tuzucip和Trastucip)、漢達(dá)遠(yuǎn)(阿達(dá)木單抗)和漢貝泰(貝伐珠單抗)相繼獲批上市，創(chuàng)新產(chǎn)品漢斯?fàn)?斯魯利單抗)已獲批用于治療微衛(wèi)星高度不穩(wěn)定(MSI-H)實(shí)體瘤，其鱗狀非小細(xì)胞肺癌、廣泛期小細(xì)胞肺癌和食管鱗狀細(xì)胞癌3項(xiàng)適應(yīng)癥的上市注冊申請(qǐng)也正在審評(píng)中。公司亦同步就13個(gè)產(chǎn)品、11個(gè)免疫聯(lián)合治療方案在全球范圍內(nèi)開展20多項(xiàng)臨床試驗(yàn)，對(duì)外授權(quán)全面覆蓋歐美主流生物藥市場和眾多新興市場。

Henlius Pertuzumab Biosimilar HLX11Received Clinical Trial Approval in EU for the Phase3MRCT Shanghai,China,Oct,28th,2022-Shanghai Henlius Biotech,Inc.(2696.HK)announced that the international multicentre phase3clinical trial for the company’s pertuzumab biosimilar HLX11,a recombinant anti-human epidermal growth factor receptor2(HER2)subdomain II humanized monoclonal antibody injection,for the neoadjuvant therapy in patients with HER2-positive,HR-negative early or locally advanced breast cancer has been approved by the Spanish Agency of Medicines and Medical Devices(AEMPS).At present,the phase3clinical trial is currently underway for HLX11in China.Additionally,Henlius has submitted clinical trial applications for HLX11in other EU countries including Poland,Bulgaria,Hungary,and the Czech Republic,and such applications are expected to be approved soon.

HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China and the European Union(EU),which can be potentially used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2-positive early breast cancer and in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic or unresectable locally recurrent breast cancer patients.HLX11can specifically bind with the subdomain II of HER2extracellular domain and inhibit the heterodimerisation of HER2and other HER family receptors,i.e.,EGFR,HER3,and HER4.This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells.In the meantime,HLX11can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity.

With the accumulated results and experience from extensive anti-HER2research,Henlius has a well-established product pipeline in anti-HER2treatment and built a solid foundation for discovering and developing anti-HER2bispecific/multi-target antibodies and antibody-drug conjugates(ADC).Up to now,the company’s independently developed and manufactured trastuzumab biosimilar HANQUYOU(Zercepac,trade names in Australia:Tuzucip and Trastucip),the first Chinese mAb biosimilar entering both the EU and China market,has been successfully launched in more than30countries and regions,providing a new standard treatment option for global HER2positive breast and gastric cancer patients.Besides,HLX22,an anti-human epidermal growth factor receptor-2(HER2)humanized monoclonal antibody injection in phase2clinical trial,has the potential to further improve treatment outcomes for HER2positive breast cancer and gastric cancer patients.And HLX11also has the potential to be used in combination with HANQUYOU and HLX22to help Henlius to create more beneficial course of treatment for patients.

In the future,Henlius will continue to speed the launch of this clinical trial in more countries and regions,as well as innovate and seek breakthroughs to bring more affordable and quality biologics to patients around the globe.

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,autoimmune diseases and ophthalmic diseases.Up to date,5products have been launched in China,1approved for marketing in overseas markets,15indications approved worldwide,and5New Drug Applications(NDAs)accepted for review in China.Since its inception in2010,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 commercialization.It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice(GMP),including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over20innovative monoclonal antibodies(mAbs)and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG(anti-PD-1mAb)as backbone.Apart from the launched products HANLIKANG(rituximab),the first China-developed biosimilar,HANQUYOU(trastuzumab,trade name in Europe:Zercepac;trade names in Australia:Tuzucip and Trastucip,the first China-developed mAb biosimilar approved both in China and Europe,HANDAYUAN(adalimumab)and HANBEITAI(bevacizumab),the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDAs for the treatment of squamous non-small cell lung cancer(sqNSCLC),extensive-stage small cell lung cancer(ES-SCLC),and esophageal squamous cell carcinoma(ESCC)are under review.What's more,Henlius has conducted over20clinical studies for13products and11combination therapies.