Rituximab biosimilar (Henlius Biotech)

近日，由美国胰腺学会/日本胰腺学会/中国胰腺病学会/国际胰腺病协会（APA/JPS/CAP/IAP）四大胰腺顶级学会联合举办的2024年第55届胰腺病学会年会在美国夏威夷成功举行，该会议是全球胰腺病学领域最具影响力的学术盛会之一。会上，四川大学华西医院曹丹教授团队口头报告了斯鲁利单抗联合化疗及放疗一线治疗胰腺癌的II期研究数据。 H药汉斯状®（通用名：斯鲁利单抗注射液）为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国和多个东南亚国家获批，惠及患者约9万人。此外，H药一线治疗广泛期小细胞肺癌（ES-SCLC）的上市申请也已获得欧盟EMA受理，有望于2025年获得批准。聚焦肺癌和消化道肿瘤等瘤种，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，在全球同步开展10余项肿瘤免疫联合疗法临床试验，于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超4600人。 消化道肿瘤是我国和全球范围内高发病率和高死亡率的瘤种，主要包括结直肠癌、胃癌、肝癌、食管癌、胰腺癌和胆囊胆管癌。根据2022年全球癌症统计数据，全球约有490万例新发消化道癌症病例和332万例死亡病例，占所有癌症发病例约25%，占癌症相关死亡的34%以上[1]。针对消化道肿瘤，H药联合化疗治疗不可切除局部晚期/复发或转移性食管鳞癌(ESCC)的一线治疗方案已于2023年9月获得中国国家药监局（NMPA）批准上市，为我国食管鳞癌患者带来了免疫治疗新选择。与此同时，该产品在胃癌新辅助/辅助方面已进入III期临床研究，有望使胃癌患者在前线便从肿瘤免疫疗法中获益。 以下为此次发布的详细信息： 论文题目：AG方案（白蛋白紫杉醇+吉西他滨）联合斯鲁利单抗及立体定向体放疗（SBRT）一线治疗局晚期及转移性胰腺癌的II期临床研究 牵头主要研究者：曹丹  四川大学华西医院 报告人：成科，四川大学华西医院 报告时间：2024年12月11日（夏威夷时间） 研究设计： 研究采用AG方案（白蛋白紫杉醇+吉西他滨）联合斯鲁利单抗及 SBRT （ICSBRT）作为 mPDAC（转移性胰腺导管腺癌） 的一线治疗方案。经筛选合格的受试者将接受吉西他滨、白蛋白紫杉醇联合斯鲁利单抗治疗，每21天为一个周期。第2周期将同步进行SBRT。白蛋白紫杉醇 125mg/m2，ivgtt，day1、8，每21天重复；吉西他滨 1000mg/m2，ivgtt，day1、8，每21天重复；斯鲁利单抗 200mg，ivgtt，day1，每21天重复；SBRT ：原发灶6.6Gy×5次，转移灶 8Gy×3次，从第 2 周期开始。主要终点是 6 个月无进展生存率 （6m-PFS%）。次要终点包括总生存期（OS） 、无进展生存期（PFS） 、客观缓解率（ORR） 、 疾病控制率（DCR） 和安全性等。 结果： 截至 2024 年10月，共纳入44名患者进行分析。研究的主要终点6个月的PFS率达74.48%；次要终点mPFS为8.6个月， mOS为15.5个月。  次要终点: 研究的ORR为75%，DCR为100%。 肿瘤目标病灶消退情况：N=44，所有患者在目标病灶上均出现肿瘤消退，33 例患者达到 PR/CR。 亚组生存分析：入组前是否接受过根治性切除手术，PFS和OS均无显著性差异。 安全性分析：研究中3级以上TEAEs发生率为79.55%，没有发生严重的TEAEs，常见的TEAEs为厌食，中性粒细胞减少，白细胞减少，疲劳，呕吐，皮疹和恶心。 结论： 这项 II 期研究的中期结果达到了研究预设的主要终点，6 个月PFS率为 74.48%，ORR 为 75%，DCR 为 100%，中位 PFS 为 8.6 个月，中位 OS 为 15.5 个月，安全性可控。 这是第一个报道 ICIs 联合 SBRT 联合化疗治疗一线 mPC 的良好临床疗效和安全性的机构。免疫联合放化疗（ICSBRT）显示出有希望的疗效，这支持将这种联合治疗作为 mPDAC 患者的一线治疗。 关于复宏汉霖 复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，3款产品在国际获批上市，25项适应症获批，4个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。 复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）以及汉奈佳®（奈拉替尼），此外，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌、食管鳞状细胞癌和非鳞状非小细胞肺癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 Latest Results of Serplulimab in The Field of Pancreatic Cancer Released In APA/JPS/CAP/IAP 2024 Annual Meeting in Oral Presentation Recently，one of the most distinguished meeting in the field of pancreatology—the APA/JPS/CAP/IAP 2024 Annual Meeting, jointly organized by the American Pancreatic Association (APA), the Japan Pancreas Society (JPS), the Chinese Pancreatic Association (CAP) and the International Association of Pancreatology (IAP), was successfully held in Hawaii, USA. At this congress, Professor Dan Cao’s team from West China Hospital of Sichuan University reported the results of a phase 2 clinical trial of serplulimab in combination with chemotherapy and radiotherapy for the first-line treatment of pancreatic cancer in oral presentations. HANSIZHUANG (serplulimab), Henlius’ first self-developed innovative Anti-PD-1 mAb, is the world’s first anti-PD-1 mAb for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Up to date, it has been approved in China and several Southeast Asian countries, benefiting over 90,000 patients. Furthermore，the marketing applications of the first-line treatment for ES-SCLC is under review by the European Medicines Agency (EMA), which is expected to be approved in 2025. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,600 subjects enrolled in China, the U.S., Turkey, Poland, Georgia and other countries and regions. Gastrointestinal tumors are characterized by high incidence and mortality rates both in China and globally. The main types include colorectal cancer, gastric cancer, liver cancer, esophageal cancer, pancreatic cancer, and gallbladder & bile duct cancer. According to global cancer statistics for 2022, there were approximately 4.90 million new cases and 3.32 million deaths due to gastrointestinal cancers worldwide, accounting for about 25% of all new cancer cases and more than 34% of cancer-related deaths[1]. In terms of gastrointestinal cancer, HANSIZHUANG in combination with chemotherapy for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC has been approved by the China National Medical Products Administration (NMPA) in September 2023, providing a new treatment option for patients with ESCC. Meanwhile, HANSIZHUANG has led the way with a phase 3 clinical study on neoadjuvant/adjuvant therapies for gastric cancer, striving to benefit gastric cancer patients from the early line of immunotherapy. The detailed results of the study released at APA/JPS/CAP/IAP 2024 Annual Meeting are as follows: Title: Phase II Trial of Gemcitabine plus nab-paclitaxel (GnP) Combined with Serplulimab and SBRT for Metastatic Pancreatic Cancer As the First-line Treatment Leading PI:  Dan Cao, West China Hospital of Sichuan University Presenter: Ke Cheng, West China Hospital of Sichuan University Study Design: Immunotherapy (Serplulimab), chemotherapy (GnP) plus SBRT (ICSBRT) as the first-line treatment for mPDAC. The eligible patients without previous treatment, will be administered gemcitabine 1000mg/m2 and nab-paclitaxel 125mg/m2 intravenously on day 1 and day 8 every 3 weeks. Serplulimab 200mg will be administered intravenously on day 1 every 3 weeks, and SBRT delivering 5 fractions of 6.6 Gy to primary tumor or 3 fractions of 8 Gy to metastatic lesion in cycle 2. The primary endpoint was 6-month progression free survival (PFS) rate. The secondary endpoints included overall survival (OS), PFS, ORR, DCR, and safety outcomes. Results: Follow up to October 2024, forty-four patients were enrolled. Primary endpoint：The 6-months PFS rate calculated through KM curve is 74.48%. Secondary endpoints: an mPFS of 8.6 months and an mOS of 15.5 months. Secondary endpoints: The ORR of the study was 75%, and the DCR was 100%. Tumor regression ratio: Waterfall plot of the best percent change in target lesion diameter from baseline, colored according to best of response (n=44). All patients experienced tumor regression in the target lesion, 33 patients achieved PR/CR. Subgroup survival analysis: according to whether received radical resection before enrollment. No significant difference was observed in PFS and OS. Safety analysis: the incidence of grade 3 or higher TEAEs was 79.55%, with no serious TEAEs occurring. The frequent TEAEs included anorexia, neutropenia, leukopenia, fatigue, vomiting, rash, and nausea. Conclusion: The interim results of this phase II study has met our preset primary endpoint with 74.48% in 6-month PFS rate, achieving ORR with 75%, DCR with 100%, median PFS with 8.6 months, median OS with 15.5 months, and manageable safety profile.  We are the first to report the favorable clinical efficacy and safety of ICIs plus SBRT combined with chemotherapy in first-line mPC. And ICSBRT presented promising efficacy, and this supported ongoing this combination as the first-line treatment in patients with mPDAC. 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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 25 indications are approved worldwide, and 4 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 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 the 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), esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancer (nsNSCLC), 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. 【参考文献】 [1] Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263.  联系方式 媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容 点击下方按钮·分享 ·收藏 ·点赞 ·在看