2023年9月9日至12日，由國際肺癌研究協會(hui) （IASLC）主辦的2023年世界肺癌大會(hui) （World Conference on Lung Cancer, WCLC）將於(yu) 新加坡舉(ju) 行。H藥漢斯狀^®（斯魯利單抗）聯合化療用於(yu) 一線治療不可手術切除的局部晚期或轉移性鱗狀非小細胞肺癌（sqNSCLC）的注冊(ce) 性臨(lin) 床試驗ASTRUM-004研究的無進展生存期（PFS）、總生存期（OS）等療效和安全性的最終分析結果將由牽頭主要研究者、上海市肺科醫院周彩存教授以口頭報告的形式在此次會(hui) 議上首次公布。

關(guan) 於(yu) IASLC WCLC

國際肺癌研究協會(hui) (IASLC) 成立於(yu) 1972 年，是一個(ge) 由來自100多個(ge) 國家的8,000多名肺癌專(zhuan) 家組成的國際組織。IASLC成員致力於(yu) 發展和促進肺癌的病因學、流行病學、預防、診斷、治療和所有其他方麵的研究。IASLC的使命是加強科學家、醫學界成員和公眾(zhong) 對肺癌的了解和教育。

由IASLC主辦的世界肺癌會(hui) 議 (WCLC) 是全球規模最大的肺癌和胸部腫瘤學領域會(hui) 議。WCLC雲(yun) 集一流的科學研究和知名專(zhuan) 家，重點關(guan) 注胸部腫瘤學和肺癌領域最先進的治療、臨(lin) 床試驗和研究。

關(guan) 於(yu) H藥

H藥 漢斯狀^®為(wei) 重組人源化抗PD-1單抗注射液（通用名：斯魯利單抗注射液），是全球首個(ge) 獲批一線治療小細胞肺癌的抗PD-1單抗，目前已有3項適應症獲批上市，2項適應症上市申請分別在中國和歐盟獲受理，10餘(yu) 項臨(lin) 床試驗同步在全球開展。

2022年3月，H藥正式獲批上市，目前可用於(yu) 治療微衛星高度不穩定（MSI-H）實體(ti) 瘤、鱗狀非小細胞肺癌（sqNSCLC）及廣泛期小細胞肺癌（ES-SCLC）。H藥聯合化療一線治療食管鱗狀細胞癌（ESCC）和一線治療廣泛期小細胞肺癌（ES-SCLC）的上市申請也分別獲得中國NMPA和歐盟EMA受理。聚焦肺癌和消化道腫瘤，複宏漢霖積極推進H藥與(yu) 公司其他產(chan) 品的協同以及與(yu) 創新療法的聯合，相繼獲得中國、美國、歐盟等國家及地區的臨(lin) 床試驗許可，在全球同步開展10餘(yu) 項腫瘤免疫聯合療法臨(lin) 床試驗。截至目前，H藥已於(yu) 中國、美國、土耳其、波蘭(lan) 、格魯吉亞(ya) 等國家和地區累計入組超3600人，其中2項國際多中心臨(lin) 床試驗入組白人的比例超過30%，是擁有國際臨(lin) 床數據較多的抗PD-1單抗之一。H藥的3項關(guan) 鍵性臨(lin) 床研究結果分別發表於(yu) 知名期刊《美國醫學會(hui) 雜誌》（JAMA）、《自然-醫學》（Nature Medicine）和British Journal of Cancer。此外，H藥還榮獲《CSCO 小細胞肺癌診療指南》、《CSCO非小細胞肺癌診療指南》、《CSCO 食管癌診療指南》、《CSCO結直腸癌診療指南》、《CSCO免疫檢查點抑製劑臨(lin) 床應用指南》和《中國食管癌放射治療指南》等多部權威指南推薦，為(wei) 腫瘤臨(lin) 床診療提供重要參考。海外方麵，H藥治療SCLC也已獲得美國FDA和歐盟EC的孤兒(er) 藥資格認定，並在美國啟動了一項H藥對比一線標準治療阿替利珠單抗的頭對頭橋接試驗。

關(guan) 於(yu) 複宏漢霖

複宏漢霖（2696.HK）是一家國際化的創新生物製藥公司，致力於(yu) 為(wei) 全球患者提供可負擔的高品質生物藥，產(chan) 品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域，已在中國上市5款產(chan) 品，在國際上市1款產(chan) 品，18項適應症獲批，3個(ge) 上市申請分別獲中國藥監局、美國FDA和歐盟EMA受理。自2010年成立以來，複宏漢霖已建成一體(ti) 化生物製藥平台，高效及創新的自主核心能力貫穿研發、生產(chan) 及商業(ye) 運營全產(chan) 業(ye) 鏈。公司已建立完善高效的全球創新中心，按照國際藥品生產(chan) 質量管理規範（GMP）標準進行生產(chan) 和質量管控，不斷夯實一體(ti) 化綜合生產(chan) 平台，其中，上海徐匯基地已獲得中國和歐盟GMP認證，鬆江基地（一）也已獲得中國GMP認證。

複宏漢霖前瞻性布局了一個(ge) 多元化、高質量的產(chan) 品管線，涵蓋20多種創新單克隆抗體(ti) ，並全麵推進基於(yu) 自有抗PD-1單抗H藥漢斯狀^®的腫瘤免疫聯合療法。繼國內(nei) 首個(ge) 生物類似藥漢利康^®（利妥昔單抗）、中國首個(ge) 自主研發的中歐雙批單抗藥物漢曲優(you) ^®（曲妥珠單抗，歐洲商品名：Zercepac^®，澳大利亞(ya) 商品名：Tuzucip^®和Trastucip^®）、漢達遠^®（阿達木單抗）和漢貝泰^®（貝伐珠單抗）相繼獲批上市，創新產(chan) 品漢斯狀^®（斯魯利單抗）已獲批用於(yu) 治療微衛星高度不穩定（MSI-H）實體(ti) 瘤、鱗狀非小細胞肺癌和廣泛期小細胞肺癌，成為(wei) 全球首個(ge) 獲批一線治療小細胞肺癌的抗PD-1單抗，其食管鱗狀細胞癌適應症的上市注冊(ce) 申請也正在審評中。公司亦同步就16個(ge) 產(chan) 品在全球範圍內(nei) 開展30多項臨(lin) 床試驗，對外授權全麵覆蓋歐美主流生物藥市場和眾(zhong) 多新興(xing) 市場。

About IASLC WCLC

Founded in 1972, the International Association for the Study of Lung Cancer (IASLC) is an international organization of more than 8,000 lung cancer specialists from 100+ countries. IASLC members work towards developing and promoting the study of etiology, epidemiology, prevention, diagnosis, treatment, and all other aspects of lung cancer. IASLC’s mission is to enhance the understanding and education of lung cancer to scientists, members of the medical community and the public. In addition to the annual meeting, the IASLC publishes the Journal of Thoracic Oncology, a prized resource for medical specialists and scientists who focus on the detection, prevention, diagnosis, and treatment of lung cancer.

The IASLC World Conference on Lung Cancer (WCLC) is the largest international gathering in the field of lung cancer and thoracic oncology. With a stellar scientific program and well-known faculty, WCLC highlights the most advanced treatments, clinical trials and studies in thoracic oncology and lung cancer.

About HANSIZHUANG

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 3 indications are approved for marketing in China, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC). The marketing applications of the first-line treatment for esophageal squamous cell carcinoma (ESCC) and ES-SCLC are under review by the NMPA and the EMA, respectively. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial approvals in China, the U.S., the EU and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine and the British Journal of Cancer, respectively. Furthermore, HASIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the  CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

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, 18 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 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 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 biosesimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac^®; trade names in Australia: Tuzucip^® and Trastucip^®, the first China-developed mAb biosesimilar 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 tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.