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2024年歐洲腫瘤內(nèi)科學(xué)會（ESMO）大會將于9月13日到17日在西班牙馬德里盛大召開。復(fù)宏漢霖首個創(chuàng)新型單抗 H藥 漢斯?fàn)?（斯魯利單抗）湾笛、中美歐三地獲批的曲妥珠單抗生物類似藥漢曲優(yōu)?的多項最新研究結(jié)果入選本次大會梭唆。

其中蟋真，由吉林省腫瘤醫(yī)院程穎教授擔(dān)任主要研究者牽頭開展的H藥針對廣泛期小細(xì)胞肺癌（ES-SCLC）III期臨床研究（ASTRUM-005）小細(xì)胞肺癌患者中吸煙相關(guān)突變的探索性研究踱陡，以及由同濟大學(xué)附屬東方醫(yī)院周彩存教授牽頭開展的H藥針對鱗狀非小細(xì)胞肺癌（sqNSCLC）的III期臨床研究（ASTRUM-004）的探索性生物標(biāo)志物分析結(jié)果將在大會上首次發(fā)布。

H藥為復(fù)宏漢霖自主研發(fā)的重組人源化抗PD-1單抗注射液酷它，也是全球首個獲批一線治療小細(xì)胞肺癌的抗PD-1單抗荸跃。以臨床需求為導(dǎo)向，公司圍繞H藥進(jìn)行了差異化悦阿、多維度的適應(yīng)癥布局柄露，廣泛覆蓋肺癌、消化道腫瘤等高發(fā)大癌種丝板。目前窒汤，H藥已在中國獲批用于治療微衛(wèi)星高度不穩(wěn)定（MSI-H）實體瘤、鱗狀非小細(xì)胞肺癌（sqNSCLC）吓篙、廣泛期小細(xì)胞肺癌（ES-SCLC）和食管鱗狀細(xì)胞癌（ESCC）盘瞧，惠及患者超過7萬人。此外柒浙，探索H藥在多項差異化適應(yīng)癥中療效的創(chuàng)新聯(lián)合療法正在進(jìn)行中膘掰，如H藥聯(lián)合貝伐珠單抗及化療一線治療轉(zhuǎn)移性結(jié)直腸癌（mCRC），聯(lián)合化療用于胃癌的新輔助/輔助治療佳遣，聯(lián)合化療同步放療治療局限期小細(xì)胞肺癌等识埋。

漢曲優(yōu)?（曲妥珠單抗，美國商品名：HERCESSI?零渐，歐洲商品名：Zercepac?）是復(fù)宏漢霖按照中國窒舟、歐盟和美國等生物類似藥法規(guī)自主研發(fā)的曲妥珠單抗，也是公司首個通過FDA批準(zhǔn)在美國開展商業(yè)化的產(chǎn)品诵盼，可用于治療HER2陽性早期乳腺癌惠豺、轉(zhuǎn)移性乳腺癌和轉(zhuǎn)移性胃癌，涵蓋原研已獲批準(zhǔn)的所有適應(yīng)癥风宁。目前洁墙，漢曲優(yōu)?已在全球47個國家和地區(qū)獲批上市，累計惠及200,000+患者戒财，為全球乳腺癌和胃癌患者帶來可負(fù)擔(dān)热监、高品質(zhì)的治療選擇。

以下為此次發(fā)布的詳細(xì)信息：

ASTRUM-005研究

場次：SCLC

論文題目：Smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study（ASTRUM-005小細(xì)胞肺癌患者中吸煙相關(guān)突變的探索性研究）

摘要編號：1796P

牽頭主要研究者：程穎

展示時間：2024年9月14日（中歐夏令時）

ASTRUM-004研究

場次：Biomarkers & translational research (agnostic)

論文題目：Exploratory biomarker analysis of phase 3 ASTRUM-004 study: serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer（斯魯利單抗聯(lián)合化療一線治療鱗狀非小細(xì)胞肺癌的關(guān)鍵III期臨床研究ASTRUM-004的探索性生物標(biāo)志物分析）

摘要編號：152P

牽頭主要研究者：周彩存

展示時間：2024年9月15日（中歐夏令時）

場次：SCLC

論文題目：Consolidation Serplulimab Following Concurrent Hypofractionated Chemoradiotherapy for Limited-stage SCLC: Preliminary Analysis of Phase II ASTRUM-LC01 Study（ASTRUM-LC01 II 期臨床試驗：局限期小細(xì)胞肺癌低劑量放化療后斯魯利單抗鞏固治療的初步分析）

摘要編號：1795P

主要研究者：畢楠

展示時間：2024年9月14日（中歐夏令時）

場次：NSCLC, early stage

論文題目：Perioperative serplulimab and chemotherapy in patients with resectable squamous non-small cell lung cancer: an open-label, single-arm, phase 2 trial（斯魯利單抗聯(lián)合化療圍術(shù)期治療可切除鱗狀非小細(xì)胞肺癌患者：一項開放標(biāo)簽的單臂II期臨床試驗）

摘要編號：1225P

主要研究者：陳海泉

展示時間：2024年9月14日（中歐夏令時）

場次：SCLC

論文題目：Efficacy and Safety of Integrating Consolidative Thoracic Radiotherapy with Immunochemotherapy in ES-SCLC: A Real-world Retrospective Analysis（廣泛期小細(xì)胞肺癌患者胸部放療聯(lián)合免疫療法鞏固治療：一項真實世界研究的回顧性分析）

摘要編號：1799P

主要研究者：劉成新

展示時間：2024年9月14日（中歐夏令時）

場次：Breast cancer, early stage

論文題目：Phase II study of pyrotinib plus albumin-bound paclitaxel and Trastuzumab (HLX02) as neoadjuvant treatment in HER2-positive, stage II-III breast cancer（吡咯替尼聯(lián)合白蛋白紫杉醇及曲妥珠單抗HLX02用于HER2 陽性 II-III 期乳腺癌新輔助治療的 II 期研究）

摘要編號：275P

主要研究者：羅婷

展示時間：2024年9月16日（中歐夏令時）

關(guān)于復(fù)宏漢霖

復(fù)宏漢霖（2696.HK）是一家國際化的創(chuàng)新生物制藥公司饮寞，致力于為全球患者提供可負(fù)擔(dān)的高品質(zhì)生物藥悬占，產(chǎn)品覆蓋腫瘤、自身免疫疾病拜岂、眼科疾病等領(lǐng)域邓秕，已在中國上市5款產(chǎn)品现碰，在國際獲批上市3款產(chǎn)品，23項適應(yīng)癥獲批轻江，3個上市申請分別獲中國藥監(jiān)局和歐盟EMA受理伐歇。自2010年成立以來，復(fù)宏漢霖已建成一體化生物制藥平臺廉旅，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)運營全產(chǎn)業(yè)鏈密梯。公司已建立完善高效的全球創(chuàng)新中心桌苔，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，不斷夯實一體化綜合生產(chǎn)平臺安影，其中腻喇，公司商業(yè)化生產(chǎn)基地已相繼獲得中國、歐盟和美國GMP認(rèn)證膏蚓。

復(fù)宏漢霖前瞻性布局了一個多元化瓢谢、高質(zhì)量的產(chǎn)品管線，涵蓋50多個分子驮瞧，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)合療法氓扛。繼國內(nèi)首個生物類似藥漢利康?（利妥昔單抗）、自主研發(fā)的中美歐三地獲批單抗生物類似藥漢曲優(yōu)?（曲妥珠單抗论笔，美國商品名：HERCESSI?采郎，歐洲商品名：Zercepac?）、漢達(dá)遠(yuǎn)?（阿達(dá)木單抗）和漢貝泰?（貝伐珠單抗）相繼獲批上市狂魔，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）實體瘤蒜埋、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)胞癌最楷，并成為全球首個獲批一線治療小細(xì)胞肺癌的抗PD-1單抗整份。公司亦同步就16個產(chǎn)品在全球范圍內(nèi)開展30多項臨床試驗，對外授權(quán)全面覆蓋歐美主流生物藥市場和眾多新興市場籽孙。

Henlius to Release Latest Results of HANSIZHUANG and HANQUYOU at ESMO Congress 2024

2024 European Society of Medical Oncology (ESMO) Congress will take place from September 13-17 in Madrid, Spain. During the conference, Henlius will release multiple results on its first innovative product HANSIZHUANG (serplulimab) as well as its trastuzumab biosimilar approved in China, Europe and U.S., HANQUYOU.

The results to be displayed include the smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study, a pivotal phase 3 clinical study of serplulimab for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) led by Professor Ying Cheng from Jilin Cancer Hospital, and the exploratory biomarker analysis of ASTRUM-004 study, a pivotal phase 3 clinical study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (sqNSCLC) led by Professor Caicun Zhou from Shanghai East Hospital, School of Medicine, Tongji University.

HANSIZHUANG (serplulimab) is a recombinant humanised anti-PD-1 monoclonal antibody（mAb）injection independently developed by Henlius, and the world's first anti-PD-1 mAb approved for the first-line treatment of SCLC. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications. Up to date, HANSIZHUANG has been approved by the National Medical Products Administration (NMPA) for the treatment of MSI-H solid tumours, sqNSCLC, ES-SCLC, and esophageal squamous cell carcinoma (ESCC), benefiting more than 70,000 patients. Moreover, a wide variety of clinical trials on immuno-oncology combination therapies in differentiated indications has been initiated by the company to further explore the efficacy of the product, such as HANSIZHUANG plus bevacizumab and chemotherapy as first-line treatment for patients with metastatic colorectal cancer (mCRC) , HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer (GC), and HANSIZHUANG plus chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC),etc.

HANQUYOU is the trastuzumab biosimilar independently developed by Henlius in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other international biosimilar guidelines. It is Henlius’ first FDA-approved product. HANQUYOU is indicated for the treatment of HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, which corresponds to all the approved indications of the trastuzumab originator. Up to date, HANQUYOU has been approved in 47 countries and regions, benefiting 200,000+ patients, bringing affordable and high-quality treatment options to breast cancer and gastric cancer patients worldwide.

Details of the presentation are as follows:

ASTRUM-005 Study

Session: SCLC

Title: Smoking-related genomic mutation patterns in patients with small cell lung cancer treated in ASTRUM-005 study

Presentation Number: 1796P

Leading PI: Ying Cheng

Onsite Poster display date: Saturday, 14 September 2024

ASTRUM-004 Study

Session: Biomarkers & translational research (agnostic)

Title: Exploratory biomarker analysis of phase 3 ASTRUM-004 study: serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer

Presentation Number: 152P

Leading PI: Caicun Zhou

Onsite Poster display date: Sunday, 15 September 2024

Session: SCLC

Title: Consolidation Serplulimab Following Concurrent Hypofractionated Chemoradiotherapy for Limited-stage SCLC: Preliminary Analysis of Phase II ASTRUM-LC01 Study

Presentation Number: 1795P

PI: Nan Bi

Onsite Poster display date: Saturday, 14 September 2024

Session: NSCLC, early stage

Title: Perioperative serplulimab and chemotherapy in patients with resectable squamous non-small cell lung cancer: an open-label, single-arm, phase 2 trial

Presentation Number: 1225P

PI: Haiquan Chen

Onsite Poster display date: Saturday, 14 September 2024

Session: SCLC

Title: Efficacy and Safety of Integrating Consolidative Thoracic Radiotherapy with Immunochemotherapy in ES-SCLC: A Real-world Retrospective Analysis

Presentation Number: 1799P

PI: Chengxin Liu

Onsite Poster display date: Saturday, 14 September 2024

Session: Breast cancer, early stage

Title: Phase II study of pyrotinib plus albumin-bound paclitaxel and Trastuzumab (HLX02) as neoadjuvant treatment in HER2-positive, stage II-III breast cancer

Presentation Number：275P

PI：Ting Luo

Onsite Poster display date: Monday, 16 September 2024

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, 3 have been approved for marketing in overseas markets, 23 indications are approved worldwide, and 3 marketing applications have been accepted for review in China 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules 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, trade name: HERCESSI? in the U.S., Zercepac? in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., 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), 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.