A Multicenter, Randomized, Open-label, Active-controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer

To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

开始日期2024-05-31

申办/合作机构

和黄医药（中国）有限公司

NCT06313554 / Not yet recruitingN/AIIT

A Single-center, Single-arm, Open-label Clinical Study of Surufatinib Combined With Toripalimab and HAIC in Patients With Inoperable or Metastatic Intrahepatic Cholangiocarcinoma

This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma.
The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes.

开始日期2024-05-20

申办/合作机构

复旦大学

100 项与索凡替尼相关的临床结果

登录后查看更多信息

100 项与索凡替尼相关的转化医学

登录后查看更多信息

100 项与索凡替尼相关的专利（医药）

登录后查看更多信息

项与索凡替尼相关的文献（医药）

2024-03-01·European Journal of Cancer

Surufatinib plus toripalimab in patients with advanced neuroendocrine tumours and neuroendocrine carcinomas: An open-label, single-arm, multi-cohort phase II trial

Article

作者: Zhang, Xing ; Shi, Si ; Cheng, Ying ; Zhang, Panpan ; Yin, Fei ; Song, Lijie ; Xu, Qian ; Weng, Desheng ; Fan, Songhua ; Tan, Panfeng ; Ma, Yue ; Ye, Feng ; Zhang, Yanqiao ; Gao, Heli ; Zhao, Yaqin ; Chen, Zhendong ; Yang, Minjie ; Chen, Wei ; Su, Weiguo ; Li, Zhiping ; Yin, Xiaolei ; Li, Yi ; Sheng, Wang ; Wu, Chunjiao ; Ji, Dongmei ; Shen, Lin ; Lu, Ming ; Shi, Michael ; Shen, Weina ; Xu, Jianming

BACKGROUND:

The programmed death 1 inhibitor toripalimab plus the angio-immuno kinase inhibitor surufatinib revealed a tolerable safety profile and preliminary efficacy in patients with advanced solid tumours in a phase I study.

PATIENTS AND METHODS:

This was an open-label, single-arm, multi-cohort phase II study in China. Patients with advanced neuroendocrine tumours (NETs) or neuroendocrine carcinomas (NECs) or mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs) who had failed or were intolerable of standard treatment were given surufatinib (250 mg orally, once daily) plus toripalimab (240 mg intravenously, once every 3 weeks). Primary end-point was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary end-points included duration of response (DoR), disease control rate, progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

Forty patients were enrolled into two cohorts by tumour types (NET, n = 19; NEC-MiNEN, n = 21). ORRs (95% CIs) were 21.1% (6.1-45.6) and 23.8% (8.2-47.2) in the NET and NEC-MiNEN cohorts, respectively. Median DoR was 7.1 months (6.9-not evaluable [NE]) and 4.1 months (3.0-NE), respectively. Median PFS was 9.6 months (4.1-NE) and 4.1 months (1.5-5.5); median OS was 27.3 (15.3-NE) and 10.9 months (9.1-14.6), respectively. Overall, grade ≥ 3 treatment-related adverse events occurred in 18 (45.0%) patients.

CONCLUSIONS:

Surufatinib plus toripalimab showed antitumour activity and a tolerable safety profile in patients with previously treated NETs/NECs/MiNENs. Further study of this combination regimen is ongoing for advanced NECs, for which current therapeutic options remain limited.

CLINICALTRIALS:

gov: NCT04169672.

2023-11-27·Open Life Sciences

Favorable response to surufatinib in a patient with necrolytic migratory erythema: A case report

作者: Li, Guiling ; Guo, Shuang ; Zhang, Peng ; Qin, You ; Hu, Feng ; Liu, Zhongan

Abstract:

Necrolytic migratory erythema (NME) is usually associated with paraneoplastic syndrome caused by functional pancreatic neuroendocrine tumor (PNET). Accurate diagnosis and effective treatment of NET-related NME is challenging due to its rarity and lack of typical clinical symptoms and specific pathological manifestations. Here we report a rare case of PNET with NME as the initial manifestation. 68Ga-DOTA-TATE PET/MR was used to detect the primary pancreatic and metastatic liver tumors. Finally, the patient was diagnosed as PNET via liver biopsy. After four cycles of standard capecitabine plus temozolomide chemotherapy combined with long-acting octreotide, the patient’s skin lesions on both lower extremities improved only slightly, while tumors remained stable and unchanged in size. Then the patient was treated with surufatinib. Two months later, the skin lesions healed completely, and tumors responded significantly. This rare case suggests that surufatinib may be a promising therapy for patients with PNET-associated NME.

2023-11-01·Annals of surgical oncology

The Efficacy and Safety of Surufatinib Combined with Anti PD-1 Antibody Toripalimab in Neoadjuvant Treatment of Locally Advanced Differentiated Thyroid Cancer: A Phase II Study.

Article

作者: Chen, Jia-Ying ; Huang, Nai-Si ; Hu, Jia-Qian ; Wang, Yu ; Wang, Yu-Long ; Cao, Yi-Ming ; Wei, Wen-Jun ; Shen, Qiang ; Ji, Qing-Hai ; Lu, Zhong-Wu

BACKGROUND:

Surgery is the primary treatment for locally advanced differentiated thyroid cancer (DTC). However, some locally advanced patients are not candidates for R0/1 resection. There is limited evidence of neoadjuvant treatment in locally advanced DTC. Surufatinib targets multiple kinases, which is efficient, tolerable, and safe in patients with radioiodine-refractory DTC. In addition, surufatinib plus toripalimab (an anti-PD-1 antibody) showed encouraging antitumor activity in advanced solid tumors. This study was designed to evaluate the efficacy and safety of surufatinib plus toripalimab in locally advanced DTC in the neoadjuvant setting.

METHODS:

In this single-arm, phase II study, patients with pathologically confirmed unresectable or borderline resectable DTC were eligible and received a combination of 250 mg of surufatinib (orally daily) with 240 mg of toripalimab (intravenous, every 3 weeks). Treatment continued until satisfied for curative surgery, disease progression, withdrawal of consent, unacceptable toxicity, or investigator decision. Primary endpoint was objective response rate (ORR). Secondary endpoints included R0/1 resection rate, adverse events (AEs), etc. RESULTS: Ten patients were enrolled and received at least 4 cycles of treatment. The ORR was 60%. Nine patients received R0/1 resections after neoadjuvant treatment. The median best percentage change in the sum of the target lesion diameter was 32%. Most adverse events (AEs) were grade 1 or 2.

CONCLUSIONS:

Surufatinib in combination with toripalimab as neoadjuvant therapy for locally advanced DTC was feasible, and the majority of patients achieved R0/1 resection. It represents a new option for locally advanced DTC and needs further investigation.

145

项与索凡替尼相关的新闻（医药）

2024-04-22

·同写意

癌王“杀手”浮出水面？

本次培训针对CGT企业或研发机构有一定CMC基础的工艺和质量主管进阶提升，讲述工艺与治疗关键点，给与尽可能多的避坑指南，帮助其成为独当一面的CMC专家。信吗？被称为“癌中之王”的胰腺癌的城池，正在不断被攻破。4月4日，在公布CAN-2409联合伐昔洛韦和化疗用于交界性可切除胰腺癌获得积极的II期研究数据后，Candel Therapeutics股价飙升约281%。稀缺造就爆炒。股价暴涨背后，是由于胰腺癌药物市场仍缺乏有效的靶向或免疫疗法。存在巨大的临床未满足需求。此次在胰腺癌中取得突破的溶瘤病毒疗法，是肿瘤治疗领域的新热点，机构预测其市场空间可达数百亿美元，媲美双抗、ADC的市场规模。国内药企中，乐普生物已抢占溶瘤病毒疗法的先机。此外，还有多种药物在积极攻克胰腺癌这块“硬骨头”，包括NALIRIFOX化疗新方案、PARP抑制剂、双抗和Claudin18.2靶向药物等。一场关于胰腺癌的攻坚战正在打响。1Candel股价暴涨背后Candel Therapeutics成立于1999年，是一家主攻溶瘤病毒疗法的癌症生物技术公司，于2021年在纳斯达克上市，目前已布局多款溶瘤病毒疗法管线，其中进展最快的便是前文提到的CAN-2409。目前，CAN-2409正在开展针对前列腺癌、非小细胞肺癌和胰腺癌的临床试验。其中，前列腺癌适应症已进入Ⅲ期阶段，其余两个均处于Ⅱ期阶段。Candel Therapeutics的研发管线图片来源：公司官网Candel股价单日暴涨280.95%，正是由于CAN-2409在非转移性胰腺癌随机II期临床试验中取得了积极的中期数据：截至2024年3月29日数据，在边缘性可切除胰腺导管腺癌（PDAC）中，使用CAN-2409进行实验治疗后，预估中位总生存期显著改善，mOS为28.8个月，而对照组仅为12.5个月；24个月时，接受CAN-2409治疗的患者生存率为71.4%，而对照组的生存率为16.7%；36个月时，CAN-2409组的生存率为47.6%，而对照组为16.7%。CAN-2409还显示出良好的耐受性，没有显著的额外局部或全身毒性。正如Candel总裁兼首席执行官Paul Peter Tak博士所言：“传统免疫疗法未能改善胰腺癌的治疗效果，原因在于高度免疫抑制的肿瘤微环境，其中很大程度上缺乏免疫细胞。”实际上，胰腺癌既诊断困难又极难攻克，一直缺乏有效的靶向或免疫疗法，因而被称为“癌中之王”，存在巨大的临床未满足需求。这也是刺激Candel股价暴涨的重要外因。胰腺癌是一种非常具有挑战性的癌症，早期发现率仅5%-7%，多数患者在发现时已进入晚期，且治疗手段有限，导致胰腺癌患者的总生存期较短，仅为6-9个月。据NCCN指南资料显示，一线治疗晚期胰腺癌的ORR一般不超过30%，mPFS低于6个月，mOS低于10个月；在接受二线治疗后，ORR约为7.7%，mPFS约为3个月，mOS约为6个月。不过，溶瘤病毒疗法作为肿瘤治疗领域新热点，又在胰腺癌中显示出治疗潜力，无疑能获得资本市场的青睐。另一家主攻溶瘤病毒疗法的CG Oncology公司，上市首日股价即暴涨近100%。这不免让人好奇，溶瘤病毒疗法这个半路杀出的“黑马”，究竟是“何方神圣”？2溶瘤病毒疗法“何方神圣”？乐普生物抢占先机溶瘤病毒疗法是一种利用病毒来治疗癌症的方法，主要通过裂解肿瘤细胞和激活机体的免疫反应两种原理来杀伤肿瘤细胞，具备高靶向性、肿瘤杀伤途径多、不良反应小等优势。在治疗过程中，这些溶瘤病毒会进入癌症患者的体内，然后寻找并感染癌细胞，一旦成功感染，就会在癌细胞内部大量复制，就像病毒在癌细胞里“安营扎寨”并“招兵买马”。随着病毒数量的增多，它们会破坏癌细胞的内部结构，最终导致癌细胞裂解和死亡。另外，溶瘤病毒还能激活患者自身的免疫系统来一起对抗癌症。当溶瘤病毒杀死癌细胞时，会释放出一些特殊的物质，这些物质就像是“信号弹”，吸引人体的免疫细胞前来攻击更多的癌细胞。目前，全球在研溶瘤病毒药物的病毒种类，主要以腺病毒、单纯疱疹病毒、痘苗病毒为主，适应症覆盖黑色素瘤、结直肠癌、胰腺癌、非小细胞肺癌、肝细胞癌、头颈部鳞状细胞癌、胶质瘤、卵巢癌等。抗肿瘤机制独特且可针对诸多实体瘤，溶瘤病毒疗法的市场潜力必然不容小觑。根据弗若斯特沙利文数据，2021年全球溶瘤病毒治疗药物市场总额达0.6亿美元，预计到2025年、2030年将分别达到67.9亿美元、247.9亿美元。2017-2030E全球溶瘤病毒治疗药物市场规模资料来源：弗若斯特沙利文，太平洋证券整理目前，全球已有3款溶瘤药物获批上市，包括第一三共Delytact（针对恶性胶质瘤）、安进Imlygic（针对黑色素瘤）、三维生物的安柯瑞（联用化疗治疗鼻咽癌），其中前两款的病毒类型为单纯疱疹病毒，后者为腺病毒。更重要的是，溶瘤病毒疗法不仅能单药治疗，还可与放疗、化疗药物、靶向疗法、细胞疗法和免疫检查点抑制剂等联合应用，技术优势显著。例如，CG Oncology公司研发的CG0070正在开展两项Ⅲ期临床试验，包括一项高危、卡介苗（BCG）无反应的非肌层浸润性膀胱癌（NMIBC）试验和一项中风险NMIBC试验，以及一项联合Pembrolizumab（Keytruda，K药）治疗高危、BCG无反应NMIBC疾病的II期试验。从临床数据看，CG0070针对高危、BCG无反应NMIBC患者的完全缓解（CR）率达到75.7%，单药治疗的有效性和安全性表现优于K药和基因疗法Adstiladrin，而且小样本的临床II期试验CORE-001显示CG0070联用PD-1有望进一步提升疗效。K药于2017年获FDA批准治疗MSI-H或dMMR实体瘤（包括胰腺癌）患者，之后又于2020年获批应用于高肿瘤突变负荷的癌症患者（包括胰腺癌）。CG0070与K药的联用，已经擦出了火花。2019年，乐普生物从CG Oncology引进了CG0070的大中华区权益，目前正在开展用于BCG无应答NMIBC的I期临床试验，后续有望开展桥接试验，快速实现上市。此外，以PD-1单抗为基石药物的乐普生物，也开展了自身核心产品普特利单抗联用CG0070治疗BCG无应答NMIBC的临床试验，颇有看点。3“癌王”攻坚战正在打响春风得意马蹄疾，一日看尽长安花。现阶段，胰腺癌治疗药物已取得许多新的突破，包括化疗方案的迭代和靶向药物的获批。由于多数胰腺癌患者在发现时已进入晚期，失去手术机会，化疗成为主要治疗方案，包括FOLFIRINOX方案（氟尿嘧啶+亚叶酸钙+伊立替康+奥沙利铂）、Gem+NabP方案（紫杉醇+吉西他滨）和S-IROX方案（替吉奥+伊立替康+奥沙利铂）。其中，Gem+NabP方案是胰腺癌一线标准治疗方案。然而，法国公司益普生（Ipsen）研发的NALIRIFOX方案（伊立替康脂质体+5-氟尿嘧啶/亚叶酸+奥沙利铂），不仅在头对头试验中打败了Gem+NabP方案，还于今年2月获美国FDA批准用于转移性胰腺癌患者的一线治疗。根据Ⅲ期研究NAPOLI 3结果显示，NALIRIFOX方案、Gem+NabP方案一线治疗转移性胰腺癌患者的中位总生存期（OS）分别为11.1个月、9.2个月，中位无进展生存期（PFS）分别为7.4个月、5.6个月，客观缓解率（ORR）分别为41.8%、36.2%。此外，还有一些靶向药物也成功获批治疗胰腺癌，包括Erlotinib（厄洛替尼）、Lynparza（奥拉帕利）、Larotrectinib（Vitrakvi）和Entrectinib（Rozlytrek）等。其中，阿斯利康研发的奥拉帕利，是全球首款获批上市的PARP抑制剂，自2014年以来已相继获批卵巢癌、乳腺癌、去势抵抗性前列腺癌和胰腺癌等多项适应症，2023年销售额高达28.11亿美元。据研究结果显示：与对照组相比，奥拉帕利使gBRCAm转移性胰腺癌患者的无进展生存期延长了近一倍（中位PFS：7.4个月 vs 3.8个月）、疾病进展或死亡风险显著降低了47%。国内药企方面，和黄医药布局了索凡替尼+卡瑞利珠单抗+白蛋白结合型紫杉醇+S-1（NASCA方案），相较AG方案（吉西他滨+白蛋白紫杉醇）带来更多获益；再鼎医药也针对PARP1/2抑制剂尼拉帕利开展了二线治疗晚期胰腺癌的临床研究。值得一提的是，康宁杰瑞研发的PD-L1/CTLA-4双抗KN046联合化疗一线治疗胰腺癌，已推进至临床Ⅲ期阶段。尤其在胰腺癌中高表达的Claudin18.2靶点，吸引了不少国内外药企争相布局，涉及单抗、ADC和CAR-T疗法等各种药物类型。Claudin18.2 ADC竞争格局（注：仅包含进入临床的管线品种）资料来源：华泰证券研报Claudin18.2单抗方面，包括安斯泰来Zolbetuximab（IMAB326）、创胜集团TST001；靶向Claudin18.2的ADC药物，包括礼来LM-302、康诺亚/乐普生物CMG901、君实生物JS-107和信达生物的IBI343等；靶向Claudin18.2的CAR-T疗法，科济药业布局了两款（CT041、CT048），传奇生物布局了LB-1904，均有开展针对胰腺癌的临床试验。此外，乐普生物研发的MRG004A，是国内首个申报临床的TF ADC，目前正在美国及中国进行Ⅰ/Ⅱ期临床研究，并已在胰腺癌、三阴性乳腺癌及宫颈癌中观察到抗肿瘤活性信号，且FDA已授予MRG004A用于治疗胰腺癌的孤儿药资格认定和快速通道资格。在TF ADC药物市场，全球仅有Seagen的Tivdak获批上市，获批适应症为宫颈癌、卵巢癌，未来或将有望拿下胰腺癌，再鼎医药拥有该药的中国权益。— 总结 — 可以看到，这场关于“癌王”胰腺癌的攻坚战，覆盖了各种各样的药物类型，打得可谓相当精彩。尤其Claudin18.2靶向药物，参与者众多，当前已进入竞争的白热化阶段，期待国产药企能从中突围。参考文献：1.各家公司的财报、公告、官网2.《20240225-生物医药Ⅱ行业周报：溶瘤病毒疗法初显峥嵘，乐普生物布局领先》，太平洋证券3.《攻克癌王的机会》，瞪羚社，2023-11-204.《CG Oncology首日大涨96%：核心产品溶瘤病毒疗法CG0070，乐普生物拥有大中华区权益》，医药笔记，2024-01-265.《显著延长“癌症之王”生存期！FDA批准一线治疗晚期胰腺癌的新疗法》，厚朴方舟，2024-02-18更多优质内容，欢迎关注↓↓↓

免疫疗法抗体药物偶联物临床3期临床2期

2024-04-05

·BioSpace

HUTCHMED Highlights Data to be Presented at AACR Congress 2024

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California. Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia. Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models. Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo. The investigational drug candidate displayed favorable pharmacokinetic pro high selectivity and low risk of cardiac toxicity. A Phase I study of HMPL-506 is planned for the second half of 2024. Initial preclinical data will also be presented for HMPL-A067 (HMA800067), a novel CD38-targeting antibody-drug conjugate (ADC) in which daratumumab was conjugated with cytotoxic payload Monomethyl auristatin E (MMAE) via a novel linker. It demonstrated significant superior anti-tumor activity to daratumumab, including in several B-cell malignancies models with resistance to daratumumab treatment. Other presentations include preclinical data on the ERK 1/2 inhibitor, HMPL-295; early clinical data on the Syk inhibitor, sovleplenib, in lymphoma patients; additional clinical data from global studies of VEGFR inhibitor, fruquintinib, and MET inhibitor, savolitinib; and several investigator-initiated studies of fruquintinib and VEGFR/CSF-1R/FGFR inhibitor, surufatinib. Details of the presentations are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of MLL-rearranged and NPM1mutant acute leukemia in preclinical models Min Cheng, HUTCHMED, Shanghai, China #2113 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 HMPL-A067 (HMA800067), a novel CD38-targeting antibody-drug conjugate (ADC), demonstrated superior anti-tumor activity to daratumumab in preclinical B-cell malignancies models Yan Xu, HUTCHMED, Shanghai, China #1890 Poster Session (PO.ET01.02 - Antibody-Drug Conjugates and Bispectific Antibodies) Monday, April 8, 2024 Preclinical characterization of HMPL-295, a potent and selective ERK1/2 inhibitor Jia Hu, HUTCHMED, Shanghai, China #1661 Poster Session (PO.MCB03.01 - Cell Signaling Components as Therapeutic Targets) Monday, April 8, 2024 Targeting YAP1/TEAD signaling re-sensitizes MAPK/ERK pathway inhibitors in KRAS-driven cancer cells Xianwen Yang, HUTCHMED, Shanghai, China #1931 Poster Session (PO.ET03.04 - Drug Resistance 2: Ras GTPase) Monday, April 8, 2024 Safety and Efficacy of Sovleplenib (HMPL-523), a Syk Inhibitor, in Patients with Relapsed or Refractory Lymphoma Paolo Strati, The University of Texas MD Anderson Cancer Center, USA #CT144 Poster Session (PO.CT01.03 - Phase 0 and Phase I Clinical Trials) Monday, April 8, 2024 Early carcinoembryonic antigen (CEA) dynamics to predict the efficacy of fruquintinib (F) + best supportive care (BSC) in patients with metastatic colorectal cancer (mCRC) enrolled in FRESCO-2 Stefano Lonardi, Veneto Institute of Oncology IOV-IRCCS Padua, Italy #6408 Poster Session (PO.CL01.10 - Predictive Biomarkers 5) Tuesday, April 9, 2024 Savolitinib (savo) + osimertinib (osi) vs savo + placebo (PBO) in patients (pts) with EGFR-mutated (EGFRm), MET-amplified advanced NSCLC with progression on osi James Chih-Hsin Yang, National Taiwan University Hospital and National Taiwan University Cancer Centre, Taipei, Taiwan #CT251 Poster Session (PO.CL01.10 - Predictive Biomarkers 5) Tuesday, April 9, 2024 INVESTIGATOR-INITIATED STUDIES Enhanced anticancer efficacy via ROS-dependent ferroptosis: synergy between surufatinib and cisplatin in small cell lung cancer Xiaolin Li, First Affiliated Hospital of Nanjing Medical University, Nanjing, China #2122 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Efficacy and underlying mechanisms of surufatinib in non-small cell lung cancer treatment Yanfang Zheng, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, China #2126 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Enhancing Radiosensitivity in Biliary Tract Cancer: The Dual Role of Surufatinib in Tumor Suppression and Macrophage Reprogramming Hong Ma, Wuhan Union Hospital, Wuhan, China #2127 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Surufatinib treatment in pancreatic cancer: unveiling the role of GPR34 in TAMs and enhancing immunotherapy efficacy Jihui Hao / Song Gao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China #2128 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Efficacy and Underlying Mechanisms of Surufatinib Combined with PD-1 Monoclonal Antibody and Chemotherapy in Pancreatic Cancer Guanghai Dai / Ru Jia, Chinese PLA General Hospital (CPLAGH), Beijing, China #2129 Poster Session (PO.ET07.02 - Pharmacodynamic Biomarkers of Drug Response) Monday, April 8, 2024 Optimizing the treatment schedule of radiotherapy combined with VEGFR-TKIs and PD-(L) 1 inhibitors in metastatic colorectal cancer Tao Zhang / Zhenyu Lin, Cancer Center, Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China #3827 Poster Session (PO.CL10.04 - Outcome Investigation with Real World Data) Monday, April 8, 2024 Clinical and epidemiological pro neuroendocrine differentiation- A hospital-based retrospective study Susheng Shi / Yaru Wen, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China #4630 Poster Session (PO.ET06.04 - Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes) Tuesday, April 9, 2024 Epidemiological characteristics and treatment strategies of gastric cancer with neuroendocrine differentiation (NED) Jun Zhang, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China #4864 Poster Session (PO.PS01.08 - Descriptive Epidemiology and Statistical and Epidemiological Methodology) Tuesday, April 9, 2024 Initial efficacy of surufatinib plus sintilimab and IBI310 for patients with high-grade advanced-neuroendocrine neoplasm: A multicenter, single arm phase 2 study Lin Shen / Ming Lu, Peking University Cancer Hospital and Institute, Beijing, China #CT266 Poster Session (PO.CT02.02 - Phase II Clinical Trials 2) Tuesday, April 9, 2024 About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067, the further clinical development for fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067, its expectations as to whether any studies on fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067 would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, savolitinib, surufatinib, sovleplenib, HMPL-295, HMPL-506 and HMA800067 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of nab-paclitaxel, sintilimab, toripalimab, pemetrexed, platinum, etoposide or cisplatin as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon +44 (20) 7886 2500

临床1期免疫疗法AACR会议临床2期

2024-03-23

·CPHI制药在线

中国生物利妥昔单抗生物类似药获批上市；荃信生物正式在港交所上市 | 制药在线一周药闻复盘

博华出品友情推荐上方扫码👆提前注册🎁免排队免费领票！距2024 HOTELEX上海展还有 4 天******友情推荐↑↑今日正文↓↓本周，有不少热点值得关注。首先是审评审批方面，多个药物获批临床以及一些药物获批，最值得一提的就是中国生物的利妥昔单抗生物类似药获批上市；其次是研发方面，多个药物启动关键临床以及不少药物研发进展取得好结果，比如，阿斯利康启动了ALXN1850的关键Ⅲ期临床等；再次是交易及投融资方面，这几天国内外发生了不少交易，阿斯利康24亿美元收购核药公司Fusion；最后是上市方面，荃信生物正式在港交所上市。本周盘点包括审评审批、研发、交易及投融资和上市四大板块，统计时间为3.18-3.22，包含23条信息。审评审批NMPA上市批准1、3月22日，NMPA官网显示，中国生物上海生物制品研究所的利妥昔单抗注射液生物类似药获批上市，用于非霍奇金淋巴瘤（滤泡性非霍奇金淋巴瘤、CD20阳性弥漫大B细胞性非霍奇金淋巴瘤）、慢性淋巴瘤细胞白血病（CLL）的治疗。利妥昔单抗是一种抗CD20单抗，原研产品为罗氏的美罗华。申请2、3月22日，CDE官网显示，Albireo和益普生的odevixibat胶囊申报上市。Odevixibat是一种强效、非体循环回肠胆汁酸转运蛋白（IBAT）抑制剂，已被CDE纳入优先审评，用于治疗6个月或以上患者的进行性家族性肝内胆汁淤积症（PFIC）。2023年3月，益普生收购Albireo，获得该疗法。临床批准 3、3月18日，CDE官网显示，石药集团1类新药SYH2039片获批临床，拟用于治疗晚期恶性肿瘤。SYH2039正是一种高活性MAT2A抑制剂，可选择性杀伤MTAP缺失型肿瘤细胞，同时对正常细胞的影响较小。4、3月19日，CDE官网显示，信达生物的IBI130获批临床，拟开发用于不可切除的局部晚期或转移性实体瘤。IBI130是一款靶向TROP2的抗体偶联药物（ADC），拟开发用于治疗肿瘤。目前，该药已在全球范围内进入到Ⅰ期临床试验阶段。5、3月20日，CDE官网显示，贝达药业1类新药BPI-520105片获批临床，拟用于治疗携带EGFR突变的实体瘤患者。BPI-520105是一种新型强效、高选择性的针对多种EGFR突变的泛表皮生长因子受体（Pan-EGFR）抑制剂。临床前研究显示，BPI-520105能够高效抑制多种EGFR突变，包括EGFR常见及罕见的单突变、携带T790M和/或C797S的双突变和三突变等。6、3月21日，CDE官网显示，康朴生物的1类新药KPG-818胶囊获批临床，拟用于治疗系统性红斑狼疮（SLE）。KPG-818是康朴生物的新一代口服分子胶免疫调节药物，归属E3泛素连接酶复合物CRL4-CRBN调节剂，对靶点CRBN显示出极高的亲和力。优先审评7、3月18日，CDE官网显示，辉瑞的CD3/BCMA双抗Elranatamab（Elrexfio）拟纳入优先审评，用于治疗既往接受过至少三种治疗（含一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体）的复发或难治性多发性骨髓瘤（R/RMM）成人患者。突破性疗法8、3月18日，CDE官网显示，特瑞思的1类治疗用生物制品注射用TRS005拟纳入突破性疗法，用于治疗至少经过2次标准治疗的复发或难治性CD20阳性弥漫大B细胞淋巴瘤（DLBCL）。该产品是首个申请突破性疗法的CD20ADC。FDA上市批准9、3月19日，FDA官网显示，武田的Ponatinib（Iclusig）补充新药申请（sNDA）获加速批准，联合化疗一线治疗新诊断费城染色体阳性急性淋巴细胞白血病（Ph+ALL）成年患者。Ponatinib是一款三代Bcr-abl激酶抑制剂，最早于2012年12月在美国上市。孤儿药资格10、3月18日，FDA官网显示，华昊中天的优替德隆口服胶囊（UTD2）获孤儿药资格，用于治疗胃癌。优替德隆为一种基于合成生物学技术成功研发上市的化疗新分子，其与紫杉类作用机制相似，已于2021年在中国获批上市，用于治疗既往接受过至少一种蒽环类或紫杉类药物化疗方案的复发或转移性乳腺癌患者。11、3月21日，FDA官网显示，睿健医药的NouvSight001获孤儿药资格，针对视网膜色素变性系列适应症。NouvSight001是睿健医药团队依托“AI+化学诱导”平台开发的诱导多能干细胞（iPSC）来源的眼科通用型细胞治疗产品。研发临床状态12、3月18日，药物临床试验登记与信息公示平台显示，和黄医药启动了索凡替尼联合卡瑞利珠单抗、白蛋白结合型紫杉醇、吉西他滨治疗转移性胰腺癌的Ⅱ/Ⅲ期临床研究。索凡替尼是和黄医药自主研发的一种新型口服酪氨酸激酶抑制剂，具有抗血管生成和免疫调节双重活性。13、3月18日，药物临床试验登记与信息公示平台显示，阿斯利康启动了两项ALXN1850注射液的国际多中心（含中国）Ⅲ期临床研究，分别用于治疗2~12岁低磷酸酯酶症儿童受试者、≥12岁的青少年和成人低磷酸酯酶症受试者。ALXN1850（重组碱性磷酸酶）属于新一代组织非特异性碱性磷酸酶酶替代疗法（ERT）。14、3月18日，药物临床试验登记与信息公示平台显示，百利天恒启动了BL-B01D1的Ⅲ期临床，在既往经PD-1/PD-L1单抗联合含铂化疗治疗失败的复发性或转移性食管鳞癌患者中对比BL-B01D1与医生选择的化疗方案（二线）。BL-B01D1（伦康依隆妥单抗）是一种基于双特异性拓扑异构酶抑制剂的ADC。15、3月18日，药物临床试验登记与信息公示平台显示，华东医药启动了HDM1005的临床。HDM1005是华东医药自主研发的1类新药，属于GLP-1R/GIPR双靶点长效多肽类激动剂，2023年12月首次申报临床，于2024年3月获批。16、3月22日，药物临床试验登记与信息公示平台显示，Bellus启动了一项国际多中心（含中国）Ⅲ期临床研究，以评估BLU-5937治疗难治性慢性咳嗽（包括不明原因的慢性咳嗽）的安全性和有效性。BLU-5937是一款选择性口服P2X3受体拮抗剂。2023年4月，GSK以总额约为20亿美元收购Bellus，获得该疗法。临床数据17、3月18日，微芯生物宣布，西格列他钠（双洛平）单药治疗非酒精性脂肪性肝炎（NASH）的Ⅱ期CGZ203临床试验达到首要疗效终点。西格列他钠属于过氧化物酶增殖体活化相关受体（PPAR）全激动剂，于2021年10月在国内获批用于运动饮食无法有效控制的2型糖尿病患者，该药物也是全球首个获批的PPAR全激动剂药物。18、3月19日，信达生物宣布，重组人血管内皮生长因子受体（VEGFR）-抗体-人补体受体1(CR1)融合蛋白Efdamrofuspalfa注射液（IBI302）在中国新生血管性年龄相关性黄斑变性（nAMD）受试者中开展的第二项Ⅱ期临床研究（高剂量）达到主要终点。19、3月21日，罗氏合作伙伴Chugai制药（中外制药）公布了萨特利珠单抗（Enspryng）治疗全身型重症肌无力（gMG）的Ⅲ期LUMINESCE结果。虽在其主要终点观察到具有统计学意义的数据，但结果没有达到对临床获益程度的预期。萨特利珠单抗是一种运用SMARTTM再循环技术开发的人源化IgG2单抗，靶向IL-6受体。交易及投融资20、3月18日，百奥泰生物宣布，已与Stein签署授权许可与商业化协议，将其在研生物类似药BAT2506（戈利木单抗）和BAT2606（美泊利珠单抗）在巴西以及其余拉丁美洲地区市场独占的产品商业化权益有偿许可给Stein。该协议首付款及里程碑款总金额最高至600万美元。21、3月19日，阿斯利康宣布，已与Fusion达成最终协议，将以每股21美元的价格收购Fusion所有流通股，预计总交易金额约24亿美元。Fusion核心产品为FPI-2265，这是一款用于转移性去势抵抗性前列腺癌（mCRPC）的新疗法，靶向前列腺特异性膜抗原（PSMA）。目前该产品正处于Ⅱ期临床开发阶段。22、3月22日，健康元宣布，已与拜耳就一项小分子抑制剂在中国的开发、商业化和生产的独家许可签署协议。本次合作涉及的产品是拜耳开发的一种针对慢性阻塞性肺疾病（COPD）的创新型口服药物，已在欧洲完成Ⅰ期临床试验。该小分子化合物通过抑制脯氨酰内肽酶（PREP）活性，有效阻止了COPD炎症介质的产生。上市23、3月20日，荃信生物在港交所正式上市。荃信生物创办于2015年，专注于开发治疗自身免疫性疾病及过敏性疾病的生物疗法，有两个核心产品—IL-17A抑制剂QX002N、抗IL-4Rα单抗QX005N，它们目前分别处于Ⅲ期和Ⅱ期临床研究阶段。【企业推荐】【智药研习社近期课程预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

并购临床3期抗体药物偶联物上市批准生物类似药

100 项与索凡替尼相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11885	-	L01XX	DB15106

研发状态

适应症	最高研发状态	国家/地区	公司
实体瘤	申请上市	欧盟更多	和黄医药（中国）有限公司更多
神经内分泌癌	申请上市	中国更多	和黄医药（中国）有限公司更多
胃神经内分泌肿瘤	临床2期	西班牙更多	和黄医药（中国）有限公司更多
晚期恶性实体瘤	临床2期	中国更多	和记黄埔医药（上海）有限公司更多
肺神经内分泌肿瘤	临床2期	法国更多	和黄医药（中国）有限公司更多

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


CT266 (AACR2024)	临床2期	晚期神经内分泌肿瘤	14	Surufatinib (SUR)	醖簾憲憲壓簾衊選積鬱(廠艱艱築繭築鏇壓鹹觸) = 鏇積襯構廠鑰壓網鏇餘遞憲鬱網網蓋簾繭顧窪 (願鹽鹹夢構淵構積鬱簾 ) 更多	积极	2024-04-05
NCT05839275 (ESMO_SRC2024) 人工标引	临床1/2期	软组织肉瘤	6	Radiotherapy+Surufatinib+ Sintilimab	糧選鹹築顧鑰築膚構構(網壓繭網簾顧積襯鹽遞) = 鹹繭餘簾製蓋艱顧網鹹積糧鹽鏇窪簾蓋鏇鑰齋 (淵鏇顧餘觸積鏇窪窪夢 ) 更多	积极	2024-03-15
NCT04169672 (Pubmed)	临床2期	晚期神经内分泌肿瘤 \| 神经内分泌癌	40	Surufatinib plus toripalimab	觸顧獵鹹鹹襯選鬱廠獵(夢糧獵醖鹹齋糧淵積襯) = 網壓膚廠蓋夢繭鏇製窪願選鑰鬱繭鹹製構窪艱 (糧鬱顧遞鏇襯襯夢遞蓋, 6.1 ~ 45.6) 更多	-	2024-03-01
ChiCTR2200063336 (ASCO_GI2024) 人工标引	临床2期	晚期胃癌 HER2 Negative	15	paclitaxel or irinotecan +surufatinib	鹽憲壓構廠範蓋積選製(築壓廠鏇夢夢艱繭糧蓋) = 製顧夢簾醖襯獵壓觸鹹顧顧網繭廠範範範膚鑰 (憲廠顧淵壓窪衊獵鑰觸, 11.8~61.6) 更多	积极	2024-01-18
NCT05235906 (ASCO_GI2024) 人工标引	临床2期	进展期胃腺癌 \| 晚期胃食管交界处腺癌二线 HER2 Negative	16	Surufatinib 250mg + Sintilimab 200mg	遞壓鬱醖製蓋願範觸淵(艱艱顧範獵餘醖鑰簾蓋) = 鏇構鹹觸製廠願衊鹹淵壓糧鹹獵夢憲廠構衊壓 (構襯網襯遞選淵願壓構, 15.2 ~ 64.6) 更多	积极	2024-01-18
NCT05064852 (ASCO_GI2024) 人工标引	N/A	胆道肿瘤一线	56	Surufatinib	糧築鹽觸構選蓋醖鹹網(獵鬱獵淵遞選鬱觸鑰製) = 築鏇膚襯醖願鑰簾廠蓋糧廠簾艱膚餘範願網願 (構淵築淵築獵膚鹽遞鹹 ) 更多	积极	2024-01-18
NCT05218889 (ASCO_GI2024) 人工标引	临床1/2期	转移性胰腺腺癌一线	49	Surufatinib + Camrelizumab + Nab-paclitaxel + S-1	憲製醖構鬱範糧壓鬱範(鏇衊鏇糧積夢齋壓願選) = 壓膚淵憲壓簾獵願鏇鑰夢顧夢構顧膚夢築繭鑰 (蓋窪艱獵網淵窪膚築醖, 35.8 ~ 70.5) 更多	积极	2024-01-18
NCT05218889 (ASCO_GI2024) 人工标引	临床1/2期	转移性胰腺腺癌一线	49	Nab-paclitaxel + Gemcitabine	憲製醖構鬱範糧壓鬱範(鏇衊鏇糧積夢齋壓願選) = 繭醖繭觸醖廠糧憲齋顧夢顧夢構顧膚夢築繭鑰 (蓋窪艱獵網淵窪膚築醖, 5.2 ~ 36.0) 更多	积极	2024-01-18
NCT04996771 (ESMO_IO2023)	临床1/2期	小细胞肺癌一线	39	Surufatinib plus toripalimab	憲齋餘願鏇構衊膚築醖(襯鏇憲艱廠鬱範遞築顧) = 顧網蓋廠廠餘鹽範構選願製夢壓製願顧積鏇鑰 (襯鹽壓鑰願簾餘襯餘遞, 4.7 ~ 7.3) 更多	积极	2023-12-07
NCT05003037 (ESMO_IO2023)	临床2期	晚期肺非鳞状非小细胞癌 EGFR \| HER2 \| MET	40	Surufatinib + Toripalimab + chemotherapy (AP)	簾願選醖鹽製簾範憲醖(簾襯簾窪鹹窪鹹夢選廠) = 艱膚餘衊醖鬱衊餘餘願獵廠顧壓廠憲遞遞願觸 (醖顧鹽襯願遞齋艱顧夢 ) 更多	积极	2023-12-07
NCT05652283 (ESMO2023) 人工标引	临床2期	卵巢癌新辅助 myChoice HRD Positive \| BRCA1 mutations \| BRCA2 mutations	20	Pamiparib+ Surufatinib	觸憲簾鹹構憲積獵襯範(製窪淵願襯顧鹽選壓夢) = 遞鹽壓築願壓餘鏇夢齋鹹獵鹹鹽鏇構積構製顧 (蓋醖憲獵蓋築觸鬱夢獵 )	积极	2023-10-22
NCT05652283 (ESMO2023) 人工标引	临床2期		20	Pamiparib+ Surufatinib (completed NAT)	願膚遞繭艱艱鬱積壓遞(製網糧繭繭蓋夢餘糧網) = 積簾製艱襯艱構構築餘獵憲獵襯繭觸壓餘淵鹹 (醖憲願壓窪膚顧鏇壓窪 ) 更多	积极	2023-10-22