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2023年12月27日淌影，復(fù)宏漢霖（2696.HK）宣布击喂，基于與宜聯(lián)生物的合作触创，公司開發(fā)的EGFR靶向抗體偶聯(lián)藥物（antibody-drug-conjugate, ADC）注射用HLX42獲得美國食品和藥物監(jiān)督管理局（FDA）授予快速通道資格（fast track designation, FTD），用于治療經(jīng)第三代EGFR酪氨酸激酶抑制劑治療后疾病進(jìn)展的EGFR突變的晚期/轉(zhuǎn)移性非小細(xì)胞肺癌（NSCLC）婿失。此前价烘，HLX42用于治療晚期/轉(zhuǎn)移性實(shí)體瘤治療的臨床試驗(yàn)申請(qǐng)已經(jīng)相繼獲得中國國家藥品監(jiān)督管理局（NMPA）汇鞭、美國FDA許可耘沼。

復(fù)宏漢霖全球創(chuàng)新中心總經(jīng)理單永強(qiáng)博士

很高興我們?cè)贏DC開發(fā)領(lǐng)域接連取得重要進(jìn)展。此次HLX42獲得FDA授予快速通道資格盅藻，標(biāo)志著其在治療重大疾病和未滿足臨床需求中的潛力得到認(rèn)可购桑。未來，復(fù)宏漢霖也將持續(xù)聚焦未滿足的臨床需求氏淑，加速更多創(chuàng)新產(chǎn)品的研發(fā)步伐勃蜘，讓更多、更好的治療方案早日惠及全球患者夸政。

FDA授予的快速通道資格認(rèn)定適用于有潛力治療嚴(yán)重疾病及解決重要未滿足臨床需求的藥物元旬，并給予促進(jìn)開發(fā)和加快審評(píng)的政策支持，包括但不限于（1）獲得與FDA更多會(huì)議討論守问、書面溝通的機(jī)會(huì)，從而在藥物研發(fā)坑资、臨床試驗(yàn)設(shè)計(jì)等方面獲得更加密切的指導(dǎo)耗帕；（2）在符合相關(guān)標(biāo)準(zhǔn)條件時(shí)獲得優(yōu)先審評(píng)和加速批準(zhǔn)；（3）可通過滾動(dòng)審評(píng)方式遞交新藥上市申報(bào)材料爹故。

據(jù)GLOBOCAN 2020數(shù)據(jù)顯示番艳，肺癌是全球發(fā)病率第二大、死亡率第一的惡性腫瘤妹茬，2020年全球約有超過220萬新發(fā)肺癌病例尚和，占癌癥新發(fā)病例的11.4%[1]。NSCLC約占所有肺癌的80%-85%[2]泳唇，其中EGFR突變比例在亞裔NSCLC患者中高達(dá)50%十吐，在高加索人群中約占10%[3]。目前夜勋，包括EGFR酪氨酸激酶抑制劑（TKI）在內(nèi)的EGFR靶向治療是EGFR突變的晚期NSCLC患者的標(biāo)準(zhǔn)一線治療曼舟，然而經(jīng)治療后出現(xiàn)疾病進(jìn)展的患者，在后續(xù)治療中選擇有限聚伤，存在巨大未被滿足的臨床需求[4,5]嗤积。

HLX42為一款靶向表皮生長(zhǎng)因子受體（EGFR）的新型ADC候選藥物虱怖，是復(fù)宏漢霖首批進(jìn)入臨床階段的ADC產(chǎn)品之一。兼具抗體分子的高度靶向性和細(xì)胞毒素的強(qiáng)大殺傷力夯秃，HLX42已經(jīng)在臨床前藥效研究座咆、藥代動(dòng)力學(xué)研究及安全性評(píng)價(jià)中展現(xiàn)出良好的抗腫瘤活性和安全性。在第三代EGFR TKI（奧希替尼）或抗EGFR單克隆抗體（西妥昔單抗）耐藥的非小細(xì)胞肺癌仓洼、結(jié)直腸癌等腫瘤模型中箫措，HLX42顯示出良好的腫瘤殺傷效果，有望克服現(xiàn)有靶向EGFR治療的耐藥機(jī)制衬潦，填補(bǔ)更多晚期/轉(zhuǎn)移性實(shí)體瘤患者未滿足的臨床需求斤蔓。公司也計(jì)劃啟動(dòng)一項(xiàng)I期臨床研究，評(píng)估HLX42在晚期/轉(zhuǎn)移性實(shí)體瘤患者中的安全性镀岛、耐受性及藥代動(dòng)力學(xué)特征弦牡。

此外，基于公司豐富的多元化產(chǎn)品管線和具備差異化優(yōu)勢(shì)的免疫基石產(chǎn)品H藥漢斯?fàn)?（抗PD-1單抗）漂羊，HLX42的開發(fā)也將為公司開展ADC聯(lián)合免疫治療驾锰，突破現(xiàn)有藥物的治療瓶頸提供更多可能。未來走越，復(fù)宏漢霖也將持續(xù)立足于未滿足的臨床需求椭豫，以抗體技術(shù)為核心，加速釋放新型偶聯(lián)技術(shù)發(fā)展動(dòng)能旨指，積極探索新靶點(diǎn)宛殉、新機(jī)制，不斷拓展疾病領(lǐng)域和新藥物分子類型抽雇，為全球患者帶來更多高質(zhì)量希镶、可負(fù)擔(dān)的創(chuàng)新治療方案。

關(guān)于HLX42

HLX42為一款靶向表皮生長(zhǎng)因子受體（EGFR）的新型ADC候選藥物剖冒，由高度特異性的人源化lgG1 EGFR抗體分子欲返、可裂解的新型連接子-荷載毒素偶聯(lián)制備而成，其藥物抗體比（drug-to-antibody ratio, DAR）約為8卓邓。HLX42的荷載毒素為一種新型DNA拓?fù)洚悩?gòu)酶I（Topoisomerase I）小分子抑制劑欧纬，通過造成DNA雙鏈斷裂，阻斷DNA復(fù)制铁蒋，從而導(dǎo)致腫瘤細(xì)胞凋亡祭啸。靜脈輸注后，HLX42的連接子-毒素能夠在腫瘤微環(huán)境中特異性裂解釋放轨充，具備較強(qiáng)的旁觀者殺傷效應(yīng)荞看，獨(dú)特的作用機(jī)制使得HLX42較同類ADC產(chǎn)品具有更大的治療窗口，增強(qiáng)ADC在實(shí)體腫瘤中的治療效果蜂筹。

關(guān)于復(fù)宏漢霖

復(fù)宏漢霖（2696.HK）是一家國際化的創(chuàng)新生物制藥公司需纳，致力于為全球患者提供可負(fù)擔(dān)的高品質(zhì)生物藥芦倒，產(chǎn)品覆蓋腫瘤、自身免疫疾病不翩、眼科疾病等領(lǐng)域兵扬，已在中國上市5款產(chǎn)品，在國際上市1款產(chǎn)品口蝠，19項(xiàng)適應(yīng)癥獲批器钟，3個(gè)上市申請(qǐng)分別獲中國NMPA、美國FDA和歐盟EMA受理妙蔗。自2010年成立以來傲霸，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)眉反、生產(chǎn)及商業(yè)運(yùn)營全產(chǎn)業(yè)鏈昙啄。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)量管控寸五，不斷夯實(shí)一體化綜合生產(chǎn)平臺(tái)梳凛，其中，上海徐匯基地和松江基地（一）均已獲得中國和歐盟GMP認(rèn)證涉爆。

復(fù)宏漢霖前瞻性布局了一個(gè)多元化旷吱、高質(zhì)量的產(chǎn)品管線，涵蓋20多種創(chuàng)新單克隆抗體层阎，并全面推進(jìn)基于自有抗PD-1單抗H藥漢斯?fàn)?的腫瘤免疫聯(lián)合療法舰范。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)?（曲妥珠單抗掀尊，歐洲商品名：Zercepac?芥斋，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）相繼獲批上市玩猿，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、鱗狀非小細(xì)胞肺癌盈械、廣泛期小細(xì)胞肺癌和食管鱗狀細(xì)胞癌魄恭，并成為全球首個(gè)獲批一線治療小細(xì)胞肺癌的抗PD-1單抗。公司亦同步就16個(gè)產(chǎn)品在全球范圍內(nèi)開展30多項(xiàng)臨床試驗(yàn)案贩，對(duì)外授權(quán)全面覆蓋歐美主流生物藥市場(chǎng)和眾多新興市場(chǎng)揣褂。

FDA Grants Fast Track Designation to Henlius’ EGFR-Targeting ADC HLX42 for NSCLC Patients with Disease Progression on EGFR Targeted Therapies

Shanghai, China, December 27, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation(FTD) for HLX42, an investigational EGFR-Targeting ADC that developed by the company based on the collaboration with MediLink Therapeutics, for the treatment of patients with advanced or metastatic EGFR-mutated non-small cell lung cancer whose disease has progressed on a 3rd-generation EGFR tyrosine kinase inhibitor. ?Previously, HLX42 was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and FDA.

Yongqiang Shan, general manager of Henlius’ Global Innovation Center, said: “I am glad to see the continuous progress we have made in advancing our ADC portfolio. The grant of FTD represents FDA's recognition of HLX42's potential in addressing serious diseases that filled unmet medical needs. In the future, Henlius will maintain our focus on areas of unmet medical needs and accelerate the development and delivery of innovative treatments, providing safe and effective care for patients worldwide.”

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. According to the FDA, a drug that receives Fast Track designation is eligible for certain policy support, including but not limited to: 1) more opportunities for meetings and written communication with FDA to obtain closer guidance in drug development, clinical trial design, etc.; 2) eligibility for Accelerated Approval and Priority Review if relevant criteria are met; 3) accelerate path to FDA submission through Rolling Review.

According to GLOBOCAN data, lung cancer (LC) is the second commonly diagnosed cancer globally with the highest mortality rate. It is estimated that there are more than 2,200,000 new cases with LC and accounts for 11.4% of the global cancer incidence in 2020[1]. About 80%-85% of LC are NSCLC[2], and EGFR mutations are found in approximately 10% of white patients with NSCLC and up to 50% of Asian patients[3]. At present, EGFR targeted therapies, including EGFR tyrosine kinase inhibitors (TKIs), are the first-line treatment for advanced NSCLC patients with EGFR mutations, yet patients who experience disease progression after treatment have limited options for subsequent therapies[4,5]. Therefore, an great unmet medical need exists and new therapeutic approaches are required.

HLX42 is a novel antibody-drug conjugate (ADC) candidate that targeting epidermal growth factor receptor (EGFR) and being one of the first ADC products of Henlius to enter into clinical development. Combining the selectivity of targeted mAb with the highly potent cytotoxic agent, HLX42 has exhibited good anti-tumour effects and a favorable safety profile in preclinical efficacy studies, pharmacokinetic studies and safety evaluation. Meanwhile, HLX42 has shown potent tumour suppression in several CDX and PDX models that were EGFR TKIs or cetuximab resistant, which is expected to overcome the resistance of existing EGFR targeted therapies and fill the unmet clinical needs of more patients with advanced/metastatic solid tumours. And a phase 1 clinical trial will be initiated to evaluate the safety, tolerance and pharmacokinetics of HLX42 in patients with advanced/metastatic solid tumours.

With Henlius’ diversified portfolio and cornerstone product HANSIZHUANG, the company will further explore the potential of ADCs combining immunotherapies to provide more effective treatment options to fulfill the unmet clinical needs. Looking forward, Henlius will further take efforts to promote the layout of our innovative portfolio by focusing on antibody and novel conjugating technologies, bringing more high-quality and affordable therapeutics for patients worldwide.

About HLX42

HLX42 is a novel EGFR-targeting ADC candidate, comprised of a high-affinity humanised IgG1 mAb targeting EGFR conjugated with a novel cytotoxic payload through cleavable linkers, with the drug-to-antibody ratio is about 8. The cytotoxic payload of HLX42 is a novel DNA topoisomerase-I inhibitor which can cause double-strand breaks (DSBs) of DNA, block the replication machinery, thus trigger cancer cell apoptosis. When injected intravenously into the body, HLX42 linker-payload will be cleaved and released in tumour microenvironment (TME) with strong bystander killing effects. This unique mechanism of TME activation and payload release allows HLX42 to possess a higher therapeutic index and potency for treatment of solid tumours.

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, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. 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 commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Facility and Songjiang First Plant, both certificated by China and the EU GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, 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, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

【參考文獻(xiàn)】

[1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249.

[2] About Lung Cancer. American Cancer Society. https://www.cancer.org/content/dam/CRC/PDF/Public/8703.00

[3] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines?). Non-Small Cell Lung Cancer. Version 3.2023

[4] Cooper, A.J., Sequist, L.V. & Lin, J.J. Third-generation EGFR and ALK inhibitors: mechanisms of resistance and management. Nat Rev Clin Oncol 19, 499–514 (2022).

[5] Ricordel, C., et al. "Molecular mechanisms of acquired resistance to third-generation EGFR-TKIs in EGFR T790M-mutant lung cancer." Annals of Oncology 29 (2018): i28-i37.