重磅!全球首个登上国际顶级期刊JAMA的小细胞肺(2)
SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases. Both limited stage SCLC (LS-SCLC) and ES-SCLC exhibit high malignancy, strong invasiveness, early metastasis, fast disease progression, and a poor prognosis. The advent of immune checkpoint inhibitors has brought new hope to patients with ES-SCLC. At present, anti-PD-L1 mAbs combined with chemotherapy have been recommended by clinical practice guidelines at home and abroad as the first-line treatment for ES-SCLC. Compared with chemotherapy, the overall survival (OS) of patients with SCLC has been prolonged to a certain extent, but the improvements were still modest, suggesting the need for more effective treatments in this patient population.
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; 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 NDA 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 over 20 clinical studies for 13 products and 11 combination therapies, expanding its presence in major markets as well as emerging markets.
Looking forward, Henlius will actively improving efficiency through innovations, focusing on unmet medical needs to bring more high-quality and affordable therapies to patients worldwide.
JAMA是同行评审的国际综合性医学期刊,以促进医学的科学与艺术以及改善公共卫生为主要目标。自1883年连续出版以来,JAMA已成为医学和科学领域最具影响力的期刊之一,目前影响因子为157.3。JAMA也是世界上发行最广泛的综合性医学类期刊,印刷版订阅数超过29万,网络订阅数超过160万,期刊网站的年访问量超过3800万,具有强大的社交媒体影响力和国际新闻媒体的曝光率。
未来,复宏汉霖将持续加码创新,以临床需求为先导,继续高效地为全球患者提供更多可负担、疗效更好的治疗方案。
关于复宏汉霖
Prof. Ying Cheng, the corresponding author and first author, as well as the leading principal investigator of the study, from Jilin Cancer Hospital, said, “In the ASTRUM-005 trial, serplulimab combined with chemotherapy achieved by far the longest OS in first-line immunotherapy for ES-SCLC. Compared with chemotherapy, the treatment prolonged median OS by 4.5 months and had the lowest HR of 0.63. In addition, the study showed good safety and consistent efficacy over time. ASTRUM-005 is the first study to demonstrate that PD-1 inhibitors plus chemotherapy can improve survival for patients with ES-SCLC. It is also the first international multi-centre phase 3 clinical study led by Chinese researchers to employ immunotherapy for ES-SCLC treatment, showcasing the expertise and excellence of Chinese researchers. I would like to thank all patients and their families, as well as researchers who contributed to this study. It opens a new chapter in first-line ES-SCLC immunotherapy, which will benefit a large number of patients."
About Henlius
AboutJAMA
JAMA, published continuously since 1883, is an international peer-reviewed general medical journal aiming to promote the science and art of medicine and the betterment of the public health. JAMA (impact factor of 157.3, one of the highest in medicine and science) is the most widely circulated general medical journal in the world, with more than 290,000 recipients of the print journal, more than 1.6 million recipients of electronic tables of contents and alerts, and over 38 million annual visits to the journal's website. JAMA's reach includes a growing social media presence and vast international news media exposure.
本文源自金融界资讯
H药 汉斯状?为重组人源化抗PD-1单抗注射液(通用名:斯鲁利单抗注射液),是复宏汉霖首个自主研发的创新型单抗,目前1项适应症获批上市,3项适应症上市申请获受理,11项临床试验同步在全球开展。
2022年3月,H药正式获批用于治疗微卫星高度不稳定(MSI-H)实体瘤。围绕H药,复宏汉霖积极推进其与公司其他产品的协同以及与创新疗法的联合,相继获得中国、美国、欧盟等国家及地区的临床试验许可,在全球同步开展11项肿瘤免疫联合疗法临床试验,广泛覆盖肺癌、食管癌、头颈鳞癌和胃癌等适应症,全面覆盖肺癌一线治疗。截至目前,H药已于中国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超3100人,其中2项国际多中心临床试验入组白人的比例超过30%,是拥有国际临床数据较多的抗PD-1单抗之一。H药联合化疗一线治疗鳞状非小细胞肺癌(sqNSCLC)、广泛期小细胞肺癌(ES-SCLC)和食管鳞状细胞癌(ESCC)的NDA已获得NMPA受理,H药有望成为全球首个一线治疗SCLC的抗PD-1单抗。此外,该药入选《2022 CSCO小细胞肺癌诊疗指南》作为ES-SCLC治疗推荐,针对ES-SCLC的国际多中心临床研究ASTRUM-005成为全球首个登上JAMA的小细胞肺癌免疫治疗临床研究,其治疗小细胞肺癌(SCLC)也已获得美国FDA孤儿药资格认定。
文章来源:《世界临床药物》 网址: http://www.sjlcywzz.cn/zonghexinwen/2022/1009/2057.html