Clinical Study of Fluzopalil Combined With Apatinib for Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer

Thirty-seven women aged 18-75 years with recurrent ovarian cancer were enrolled

开始日期2024-12-01

申办/合作机构

厦门大学附属第一医院（厦门市第一医院、厦门市红十字会医院、厦门市糖尿病研究所）

NCT06308575 / Not yet recruiting临床2期

A Phase II Study of Rivoceranib for Patients With Recurrent or Metastatic Olfactory Neuroblastoma

To learn if rivoceranib can help to control olfactory neuroblastoma. The safety of this drug in participants with olfactory neuroblastoma will also be studied.

开始日期2024-09-30

申办/合作机构

Elevar Therapeutics, Inc.

NCT06200233 / Not yet recruiting临床2期

A Phase II, Open-label, Single-arm, Multi-center Clinical Trial of Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor

PURPOSE: To evaluate the efficacy and safety of Rivoceranib in patients with metastatic thymic epithelial tumors who developed resistance on first-line therapy.
Study Design: Patients with histologically confirmed metastatic thymic epithelial tumors who meet the inclusion/exclusion criteria will be enrolled in this study. In Stage 1, 18 subjects will be enrolled to receive study medication. If a tumor response is observed in at least 5 of these subjects, the study will proceed to Stage 2 to enroll the remaining subjects, or the study will be stopped early due to lack of clinical benefit of the investigational product. The trial will be considered clinically valid if a response is observed in 11 or more subjects out of a total of 33 subjects. Investigational product(Rivoceraniv 700 mg) will be administered until disease progression, development of intolerable adverse events, death, withdrawal of consent by the subject, or when, in the opinion of the principal investigator, it is inappropriate or impossible to continue the study. Imaging studies (CT or MRI) will be performed every 8 weeks (+,- 1 week) for C1D1 through 12 months and every 12 weeks (+,- 1 week) after 12 months, and the results will be used to assess tumor response according to RECIST v1.1 criteria. Safety will be assessed at C1D1, C1D7, and each scheduled visit thereafter.

开始日期2024-05-01

申办/合作机构

Samsung Medical Center

100 项与甲磺酸阿帕替尼相关的临床结果

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100 项与甲磺酸阿帕替尼相关的转化医学

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100 项与甲磺酸阿帕替尼相关的专利（医药）

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1,204

项与甲磺酸阿帕替尼相关的文献（医药）

2024-05-01·Recent Patents on Anti-Cancer Drug Discovery

A Synergistic Combination of Oleanolic Acid and Apatinib to Enhance Antitumor Effect on Liver Cancer Cells and Protect against Hepatic Injury

Article

作者: Cui, Qingrong ; Raza, Faisal ; Ren, Juan ; Wan, Haopeng ; Li, Haiyang ; Zafar, Hajra ; Wang, Xiangqi ; Chen, Xue ; Yan, Jun

Background::

As a pentacyclic triterpenoid, OA (oleanolic acid) has exhibited antiinflammatory, immunomodulatory and antitumor effects. VEGFR-2 (vascular endothelial cells receptor-2) tyrosine kinase activity could be inhibited by apatinib, a small-molecule antiangiogenic agent.

Objective::

Thus, this study sought to investigate the mechanism underlying the synergistic antitumor activity of combined OA and apatinib patent.

Methods::

Through CCK8 (Cell counting kit 8 assay), flow cytometric and western blotting techniques, we conducted in vitro studies on apatinib and OA effects on cell proliferation and apoptosis in H22 cell line. H22 tumor-burdened mice model was established in vivo, while the related signaling pathways were studied via pathological examination, western blotting and qPCR (quantitative polymerase chain reaction).

Results::

Growth of H22 cells in vitro and in vivo could be inhibited effectively by apatinib and OA. Thus, OA repaired liver function and inhibited oxidative stress induced by apatinib.

Conclusion::

OA can treat apatinib induced liver injury in H22 Tumor-burdened mice by enhancing the suppresssive effect of apatinib on the growth of tumor.

2024-03-01·Toxicology in Vitro

Inhibitory effects of the main metabolites of Apatinib on CYP450 isozymes in human and rat liver microsomes

Article

作者: Chen, Zhe ; Zhang, Bo-Wen ; Pang, Ni-Hong ; Xu, Ren-Ai ; Hu, Guo-Xin ; Chen, Lian-Guo

PURPOSE:

The inhibitory effect of Apatinib on cytochrome P450 (CYP450) enzymes has been studied. However, it is unknown whether the inhibition is related to the major metabolites, M1-1, M1-2 and M1-6.

METHODS:

A 5-in-1 cocktail system composed of CYP2B6/Cyp2b1, CYP2C9/Cyp2c11, CYP2E1/Cyp2e1, CYP2D6/Cyp2d1 and CYP3A/Cyp3a2 was used in this study. Firstly, the effects of APA and its main metabolites on the activities of HLMs, RLMs and recombinant isoforms were examined. The reaction mixture included HLMs, RLMs or recombinant isoforms (CYP3A4.1, CYP2D6.1, CYP2D6.10 or CYP2C9.1), analyte (APA, M1-1, M1-2 or M1-6), probe substrates. The reactions were pre-incubated for 5 min at 37 °C, followed by the addition of NAPDH to initiate the reactions, which continued for 40 min. Secondly, IC₅₀ experiments were conducted to determine if the inhibitions were reversible. The reaction mixture of the "+ NADPH Group" included HLMs or RLMs, 0 to 100 of μM M1-1 or M1-2, probe substrates. The reactions were pre-incubated for 5 min at 37 °C, and then NAPDH was added to initiate reactions, which proceeded for 40 min. The reaction mixture of the "- NADPH Group" included HLMs or RLMs, probe substrates, NAPDH. The reactions were pre-incubated for 30 min at 37 °C, and then 0 to 100 μM of M1-1 or M1-2 was added to initiate the reactions, which proceeded for 40 min. Finally, the reversible inhibition of M1-1 and M1-2 on isozymes was determined. The reaction mixture included HLMs or RLMs, 0 to 10 μM of M1-1 or M1-2, probe substrates with concentrations ranging from 0.25K_m to 2K_m.

RESULTS:

Under the influence of M1-6, the activity of CYP2B6, 2C9, 2E1 and 3A4/5 was increased to 193.92%, 210.82%, 235.67% and 380.12% respectively; the activity of CYP2D6 was reduced to 92.61%. The inhibitory effects of M1-1 on CYP3A4/5 in HLMs and on Cyp2d1 in RLMs, as well as the effect of M1-2 on CYP3A in HLMs, were determined to be noncompetitive inhibition, with the K_i values equal to 1.340 μM, 1.151 μM and 1.829 μM, respectively. The inhibitory effect of M1-1 on CYP2B6 and CYP2D6 in HLMs, as well as the effect of M1-2 on CYP2C9 and CYP2D6 in HLMs, were determined to be competitive inhibition, with the K_i values equal to 12.280 μM, 2.046 μM, 0.560 μM and 4.377 μM, respectively. The inhibitory effects of M1-1 on CYP2C9 in HLMs and M1-2 on Cyp2d1 in RLMs were determined to be mixed-type, with the K_i values equal to 0.998 μM and 0.884 μM. The parameters could not be obtained due to the atypical kinetics of CYP2E1 in HLMs under the impact of M1-2.

CONCLUSIONS:

M1-1 and M1-2 exhibited inhibition for several CYP450 isozymes, especially CYP2B6, 2C9, 2D6 and 3A4/5. This observation may uncover potential drug-drug interactions and provide valuable insights for the clinical application of APA.

2024-02-14·ACS Applied Materials & Interfaces

Biomimetic Responsive Nanoconverters with Immune Checkpoint Blockade Plus Antiangiogenesis for Advanced Hepatocellular Carcinoma Treatment

Article

作者: Zhong, Aoxue ; Liu, Jingfeng ; Liu, Xiaolong ; Li, Yonghao ; Cao, Yanbing ; Zhang, Yuting ; Min, Juan ; Fu, Jinghao ; Tu, Haibin ; Wang, Jianmin ; Yang, Yong ; Wu, Ming

The first-line treatment for advanced hepatocellular carcinoma (HCC) combines immune checkpoint inhibitors and antiangiogenesis agents to prolong patient survival. Nonetheless, this approach has several limitations, including stringent inclusion criteria and suboptimal response rates that stem from the severe off-tumor side effects and the unfavorable pharmacodynamics and pharmacokinetics of different drugs delivered systemically. Herein, we propose a single-agent smart nanomedicine-based approach that mimics the therapeutic schedule in a targeted and biocompatible manner to elicit robust antitumor immunity in advanced HCC. Our strategy employed pH-responsive carriers, poly(ethylene glycol)-poly(β-amino esters) amphiphilic block copolymer (PEG-PAEs), for delivering apatinib (an angiogenesis inhibitor), that were surface-coated with plasma membrane derived from engineered cells overexpressing PD-1 proteins (an immune checkpoint inhibitor to block PD-L1). In an advanced HCC mouse model with metastasis, these biomimetic responsive nanoconverters induced significant tumor regression (5/9), liver function recovery, and complete suppression of lung metastasis. Examination of the tumor microenvironment revealed an increased infiltration of immune effector cells (CD8⁺ and CD4⁺ T cells) and reduced immunosuppressive cells (myeloid-derived suppressor cells and T regulatory cells) in treated tumors. Importantly, our nanomedicine selectively accumulated in both small and large HCC occupying >50% of the liver volume to exert therapeutic effects with minimal systemic side effects. Overall, these findings highlight the potential of such multifunctional nanoconverters to effectively reshape the tumor microenvironment for advanced HCC treatment.

595

项与甲磺酸阿帕替尼相关的新闻（医药）

2024-04-25

·药研发

【药研发0426】常山生化GLP-1R激动剂报产 | 和誉肝癌新药获孤儿药资格...

「本文共：17条资讯，阅读时长约：3分钟」今日头条常山生化GLP-1R激动剂报产。河北常山生化药业旗下常山凯捷健生物提交的艾本那肽注射液上市申请获CDE受理，拟用于在饮食控制和运动基础上改善2型糖尿病患者的血糖控制。艾本那肽注射液是一款长效GLP-1受体激动剂，此前已在中国2型糖尿病患者中开展的III期临床研究中达到了主要终点和关键次要终点。患者接受艾本那肽注射液治疗24周后，其血糖水平显著降低，且疗效维持长达52周。国内药讯1.君实PD-1单抗在香港报产。君实生物PD-1抑制剂特瑞普利单抗向香港卫生署药物办公室（DO）提交上市申请并获得受理，拟联合顺铂/吉西他滨一线治疗转移性或复发性局部晚期鼻咽癌成人患者，以及单药治疗复发性、不可切除或转移性鼻咽癌。在Ⅲ期临床JUPITER-02中，特瑞普利单抗联合化疗使患者的疾病进展或死亡风险降低48%，死亡风险降低37%。2.科伦博泰ADC亮相ASCO。科伦博泰宣布将在ASCO2024年会上口头报告Trop2 ADC新药SKB264两项临床研究的最新数据。这两项临床分别为：SKB264用于治疗局部复发性或转移性三阴乳腺癌经治患者的Ⅲ期临床OptiTROP-Breast01；SKB264联合PD-L1单抗KL-A167一线治疗晚期非小细胞肺癌患者的Ⅱ期临床OptiTROP-Lung01。SKB264是科伦博泰采用专有毒素-连接子策略研发的一款创新ADC，抗体药物偶联比（DAR）平均值高达7.4。3.和誉肝癌新药获孤儿药资格。和誉医药自主研发的小分子FGFR4抑制剂依帕戈替尼（irpagratinib/ABSK011）获FDA授予孤儿药资格，用于治疗肝细胞癌（HCC）。在具有过表达FGF19的HCC细胞中，ABSK011可以通过抑制FGFR4的自身磷酸化并阻断FGFR4向下游通路活化的信号转导，最终抑制HCC患者的肿瘤。临床数据显示，ABSK011（每日两次）治疗的客观缓解率（ORR）达40.7%。4.康方双抗实体瘤早期临床积极。康方生物PD-1/VEGF双抗依沃西（AK112/SMT112）在治疗晚期实体瘤（包括卵巢浆液性癌、MSS结直肠癌和其他癌症）的Ⅰa期临床中获积极结果。中位随访为12.8个月时，依沃西在这类被认为对单药免疫治疗缺乏响应的肿瘤患者中达到了25.5%的客观缓解率（ORR），疾病控制率（DCR）为63.8%，且具有良好的安全性。详细数据已发表于《癌症免疫治疗杂志》（JITC）期刊上。5.通化东宝双靶点减肥药获批临床。通化东宝1类化药注射用THDBH120获国家药监局临床试验默示许可，拟开发用于超重/肥胖患者的长期体重管理。THDBH120是一款GLP-1/GIP双靶点激动剂，通过分子设计将GLP-1和GIP这两种促胰岛素的作用整合至一个多肽分子中，同时提高了代谢稳定性，从而改善血糖控制。去年年底，该新药已获批开展用于治疗2型糖尿病的临床研究。6.迈诺威病理性瘢痕新药获批IND。迈诺威医药拟用于预防和治疗病理性瘢痕的创新药MI151凝胶获FDA临床许可。MI151可抑制成纤维细胞增殖和TGF-β1的产生，同时可以影响TNF-α、IL-1β等炎症细胞因子和粘附分子的产生以及基质重塑因子的表达，有望通过抗炎和抗纤维化的双重作用来治疗瘢痕。在临床前研究中，MI151已显示出积极治疗效果；且具有良好的安全性。7.蓝纳成生物完成3亿元B+轮融资。东诚药业宣布，旗下蓝纳成生物已完成B+轮融资金额3亿元，将适时开展IPO融资上市。蓝纳成由东诚药业与国际分子影像及纳米医学领域专家陈小元教授联合创立。目前，该公司多个用于癌症的1类诊疗一体化创新药物已进入临床阶段，包括：靶向PSMA的放射性体内治疗药物177Lu-LNC1003注射液、用于前列腺癌诊断的1类创新核药氟[18F]思睿肽注射液、伴随诊断试剂68Ga-FAPI-46注射液、靶向FAP的放射性体内诊断药物氟[18F]纤抑素注射液、靶向FAP的放射性体内治疗药物177Lu-LNC1004注射液等。国际药讯1.Utility公司创新抗生素获批上市。Utility公司口服β-内酰胺抗生素pivmecillinam（商品名为Pivya）获FDA批准上市，用于治疗由大肠杆菌、奇异变形杆菌和腐生葡萄球菌引起的非复杂性尿路感染（UTIs）。Pivmecillinam是mecilinam的前体化合物，它通过干扰细菌细胞壁的合成来杀死细菌。在临床试验中，Pivya治疗相比安慰剂提高了患者的综合反应率（62%vs10%）；与布洛芬相比，Pivya组患者的综合反应率也显著提高（66%vs22%）。2.诺华放射性配体疗法获批用于儿童。诺华放射性配体疗法Lutathera（Lu 177 dotatate）获FDA批准扩展适用范围，用于治疗生长抑素受体阳性（SSTR+）胃肠胰神经内分泌肿瘤（GEP-NET）的儿童（12-18岁）患者。Lutathera是首款FDA批准的放射性配体疗法，能结合肿瘤细胞表面的生长抑素受体进入细胞，通过放射性对肿瘤细胞造成损伤。2018年，FDA已批准该药物用于治疗经治SSTR阳性的GEP-NET患者。3.安斯泰来前列腺癌新药获批新适应症。安斯泰来AR抑制剂恩扎卢胺（enzalutamide）获欧盟委员会（EC）批准新适应症，单药或与雄激素剥夺治疗（ADT）联合，用于不适合挽救性放疗的高风险生化复发性（BCR）、非转移性激素敏感性前列腺癌（nmHSPC）成年男性。在Ⅲ期EMBARK试验中，与亮丙瑞林相比，恩扎卢胺单药或与亮丙瑞林联合用药分别降低了36.9%和57.6%的癌症扩散或死亡的风险。4.Endeavor公司融资开发肺纤维化新药。Endeavor公司宣布完成1.325亿美元的C轮融资，以用于加速其小分子抑制剂ENV-101以及HER3靶向抗体偶联药物（ADC）ENV-501的临床开发。ENV-101旨在通过抑制过度激活的Hedgehog（Hh）信号通路来提高患者的肺功能，并逆转特发性肺纤维化（IPF）和进行性肺纤维化（PPF）患者肺部的纤维化，该新药目前已处于Ⅱ期临床阶段。此外，Endeavor也计划在今年启动ENV-501的Ⅰ/Ⅱ期临床试验。5.癌症小分子药物公司Flindr完成A轮融资。Flindr Therapeutics宣布完成2000万欧元的A轮融资，主要用于加速其靶向RNF31的潜在“first-in-class”小分子抑制剂的开发，应用于实体瘤和血液恶性肿瘤的治疗。在临床前研究中，该候选药物已在卵巢癌和B细胞淋巴瘤模型中显示出抗肿瘤活性，并识别相关生物标记。此轮融资还将用于该公司使用ImmunoGram药物发现引擎拓宽其产品管线。6.罕见皮肤病创新基因疗法被FDA拒批。Abeona公司基因疗法prademagene zamikeracel（pz-cel）用于治疗隐性营养不良性大疱性表皮松解症（RDEB）的上市申请收到FDA发出的完整回复函（CRL）。FDA要求Abeona必须在申请获得批准之前，“令人满意地解决”CMC问题，提供额外CMC信息。pz-cel是一款自体、COL7A1基因校正表皮片，利用逆转录病毒载体将产生胶原蛋白的功能性COL7A1基因送入患者自身的皮肤细胞。医药热点1.湘雅二医院将建设国家紧急医学救援基地。4月24日，国家卫健委官网发布了关于中南大学湘雅二医院国家紧急医学救援基地建设工程可行性研究报告的批复。国家卫健委原则同意中南大学湘雅二医院国家紧急医学救援基地建设工程可行性研究报告。据批复，该院主要建设内容为批量伤员救治、立体救治转运、应急指挥、培训演练、物资仓储等紧急医学救援相关业务用房及配套设施，建筑面积为81470平方米。其中，地上建筑面积55470平方米，地下建筑面积26000平方米。2.苏大附一院日间手术中心启用。近日，苏州大学附属第一医院正式启用日间手术中心。日间手术设有普外科的疝气胆囊专科、眼科、介入科、骨科、妇产科、耳鼻喉科、甲乳外科、超声科等多个学科领域，眼科的斜视矫正术、介入科的大隐静脉曲张手术、血透中心的动静脉造瘘术、妇科的宫腔镜手术等均能在日间手术中心完成。患者在入院前完成术前检查、麻醉评估、手术预约，手术当天办理住院；术后经过严密观察，当天或24小时后患者即可出院回家。3.今年北京市将新建10所社区医院。近日，北京市卫健委、市中医局联合发布《北京市“优质服务基层行”活动和社区医院建设三年行动方案》，北京市将着力改善基层医疗卫生机构中医药服务条件，今年将新建成10所社区医院。到2025年，社区卫生服务中心（乡镇卫生院）将全部设置中医馆、配备中医医师，能够规范开展10项以上中医药适宜技术。评审动态 1. CDE新药受理情况（04月25日) 2. FDA新药获批情况（北美04月24日）股市资讯上个交易日 A 股医药板块 -0.01%+0.61%涨幅前三跌幅前三常山药业+19.98% ST 吉药 -5.23%康弘药业+10.00% *ST 太安 -5.00%舒泰神 +8.60% 江苏吴中 -4.16%【恒瑞医药]1)公司产品“氟唑帕利胶囊”、“甲磺酸阿帕替尼片”上市许可申请获国家药监局得受理，并被纳入优先审评品种公示名单;2)公司产品“门冬胰岛素注射液”获得临床试验批准。【达安基因]公司产品“甲型流感病毒，乙型流感病毒和新型冠状病毒(2019-nCoV)核酸检测试剂盒(PCR-荧光探针法)”获得器械注册证。【金城医药]公司产品“磷酸奥司他韦”获得上市申请批准。- The End -戳“阅读原文”，了解更多医药研发及股市资讯。

孤儿药临床3期抗体药物偶联物ASCO会议免疫疗法

2024-04-25

·BiG生物创新社

ASCO 2024丨这些中国临床专家，将分享最新重磅研究

2024年美国临床肿瘤学会(ASCO)年会将于5月31日到6月4日在芝加哥举办，是世界上规模最大、学术水平最高、最具权威性的临床肿瘤学会议，会议汇集了全球肿瘤学医生和专业人士、患者倡导者、工业界代表和主要媒体，共同探讨当前国际最前沿的研究发现和临床试验成果。ASCO成立于1964年,是世界上最大、最具影响力的肿瘤专业学术组织,致力于癌症的预防、治疗及改善对患者的护理。ASCO在全球150多个国家和地区拥有超过45,000名成员。4月24日晚，ASCO官网公布了本次大会的研究标题，几十余名中国专家将在世界舞台上展示其研究成果，报告涵盖了多个瘤种的最新治疗策略和技术，展示了中国在全球癌症研究中的重要地位和贡献。世易编辑团队精心整理了中国专家们的研究报告，供您参考。全体大会报告Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. Abstract: LBA4 · Suresh S. Ramalingam教授，美国埃默里大学Winship癌症研究所· 陆舜教授，上海交通大学附属胸科医院口头报告Lung Cancer—Non-Small Cell MetastaticSacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. Abstract: 8502 · 方文峰教授，中山大学肿瘤防治中心 Ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor treatment (HARMONi-A): A randomized, double-blind, multi-center, phase 3 trial. Abstract: 8508 · 张力教授，中山大学肿瘤防治中心 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Adjuvant icotinib of 12 months or 6 months versus observation following adjuvant chemotherapy for resected EGFR-mutated stage II–IIIA non-small-cell lung cancer (ICTAN, GASTO1002): A randomized phase 3 trial. Abstract: 8004 ·王思愚教授，中山大学肿瘤防治中心 A phase II randomized trial evaluating consolidative nivolumab in locally advanced non-small cell lung cancer post neoadjuvant chemotherapy plus nivolumab and concurrent chemoradiotherapy (GASTO-1091). Abstract: 8008 · 刘慧教授，中山大学肿瘤防治中心 Taiwan national lung cancer early detection program for heavy smokers and non-smokers with family history of lung cancer. Abstract: 8009 · Pan-Chyr Yang, MD, PhD，台湾大学医学院 Gastrointestinal Cancer—Colorectal and Anal Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: Results from a randomized, open-labeled, phase Ib study. Abstract: 3505 · 徐瑞华教授，中山大学肿瘤防治中心 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Phase I study of CN201, a novel CD3xCD19 IgG4 bispecific antibody, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Abstract: 6505 · 王迎教授，中国医学科学院血液病医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia CLAMP: A phase II prospective study of camrelizumab combined with pegaspargase, etoposide, and high-dose methotrexate in patients with natural killer (NK)/T-cell lymphoma. Abstract: 7002 · 刘涛教授，华中科技大学同济医学院附属协和医院 Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study. Abstract: LBA7003 · 赵维莅教授，上海交通大学医学院附属瑞金医院 Hematologic Malignancies—Plasma Cell DyscrasiaPhase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ). Abstract: 7500 ·Thierry Facon, MD，University of Lille, CHU Lille·刘卓刚教授，中国医科大学附属盛京医院Central Nervous System Tumors Efficacy and safety of the vebreltinib in patients with previously treated, secondary glioblastoma/IDH mutant glioblastoma with PTPRZ1-METFUsion GENe (FUGEN): A randomised, multicentre, open-label, phase II/III trial. Abstract: 2003 · Zhaoshi Bao, MD, PhD，首都医科大学附属北京天坛医院 High-dose almonertinib in treatment-naïve EGFR-mutated NSCLC with CNS metastases: Efficacy and biomarker analysis. Abstract: 2007 · 范云教授，浙江省肿瘤医院 SarcomaUpdated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST) and paraganglioma. Abstract: 11502 · 邱海波教授，中山大学肿瘤防治中心 Sintilimab, doxorubicin and ifosfamide (AI) as first-line treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS), synovial sarcoma (SS), myxoid liposarcoma (MLPS) and de-differentiated liposarcoma (DDLPS): A single-arm phase 2 trial. Abstract: 11505 · 罗志国教授，复旦大学附属肿瘤医院 ARTEMIS-002: Phase 2 study of HS-20093 in patients with relapsed or refractory osteosarcoma. Abstract: 11507 · 谢璐教授，北京大学人民医院 Head and Neck Cancer Adjuvant PD-1 blockade with camrelizumab in high-risk locoregionally advanced nasopharyngeal carcinoma (DIPPER): A multicenter, open-label, phase 3, randomized controlled trial. Abstract: LBA6000 · 刘需教授，中山大学肿瘤防治中心 Tislelizumab versus placebo combined with induction chemotherapy followed by concurrent chemoradiotherapy and adjuvant tislelizumab or placebo for locoregionally advanced nasopharyngeal carcinoma: Interim analysis of a multicenter, randomized, placebo-controlled, double-blind, phase 3 trial. Abstract: 6001 · 陈秋燕教授，中山大学肿瘤防治中心 Endostar combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma (LA-NPC): A phase III, prospective, randomised-controlled, multicenter clinical trial. Abstract: 6002 · 康敏教授，广西医科大学第一附属医院 Developmental Therapeutics—ImmunotherapyClaudin18.2-targeted chimeric antigen receptor T cell-therapy for patients with gastrointestinal cancers: Final results of CT041-CG4006 phase 1 trial. Abstract: 2501 · 齐长松教授，北京大学肿瘤医院 A potential best-in-class BCMA-CD19 bispecific CART with advanced safety by self-inhibiting IFNG signaling during CRS. Abstract: 2502 · Lei Xue Efficacy and safety of LM-108, an anti-CCR8 monoclonal antibody, in combination with an anti-PD-1 antibody in patients with gastric cancer: Results from phase 1/2 studies. Abstract: 2504 · Chang Liu, MD，北京大学肿瘤医院Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Phase I/II first-in-human study to evaluate the safety and efficacy of tissue factor-ADC MRG004A in patients with solid tumors.Abstract: 3002· Wungki Park, MD, MS，美国纪念斯隆凯瑟琳癌症中心· 张剑教授，复旦大学附属肿瘤医院Updated safety and efficacy data of combined KRAS G12C inhibitor (glecirasib, JAB-21822) and SHP2 inhibitor (JAB-3312) in patients with KRAS p.G12C mutated solid tumors. Abstract: 3008 · 赵军教授，北京大学肿瘤医院快速口头摘要报告 Lung Cancer—Non-Small Cell Metastatic A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. Abstract: 8513 · James Chih-Hsin Yang 教授，台大肿瘤中心 Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non–small cell lung cancer: The phase 2 TRUST-I study. Abstract: 8520 · 李玮教授，同济大学附属上海市肺科医院 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Overall survival of adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. Abstract: 8014 · 陈大卫教授，山东省肿瘤医院 Breast Cancer—Metastatic ACE-Breast-02: A pivotal phase II/III trial of ARX788, a novel anti-HER2 antibody-drug conjugate (ADC), versus lapatinib plus capecitabine for HER2+ advanced breast cancer (ABC). Abstract: 1020 · 胡夕春教授，复旦大学附属肿瘤医院 Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial. Abstract: 4012 · 张小田教授，北京大学肿瘤医院 Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC). Abstract: 4019 · 章琦教授，浙江大学医学院附属第一医院肝胆胰外科 Gastrointestinal Cancer—Colorectal and Anal Total neoadjuvant treatment with long-course radiotherapy versus concurrent chemoradiotherapy in local advanced rectal cancer with high risk factors (TNTCRT): A multicenter, randomized, open-label, phase 3 trial. Abstract: LBA3511 · Xin Wang, MD，四川大学华西医院 Phase I trial of hypoxia-responsive CEA CAR-T cell therapy in patients with heavily pretreated solid tumor via intraperitoneal or intravenous transfusion. Abstract: 3514 · Hangyu Zhang，浙江大学医学院第一附属医院 Three-year disease-free survival after transanal vs. laparoscopic total mesorectal excision for rectal cancer (TaLaR): A randomized clinical trial. Abstract: 3516 · 康亮教授，中山大学附属第六医院 Genitourinary Cancer—Kidney and Bladder Camrelizumab plus apatinib for previously treated advanced adrenocortical carcinoma: A single-arm, open-label, phase 2 trial. Abstract: 4511 · Zhigong Wei，四川大学华西医院 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Latest results of a phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). Abstract: 6510 · Wei Yang，中国医科大学附属盛京医院 Safety and efficacy of CD7-CAR-T cell in patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma: Phase I dose-escalation/dose-expansion study. Abstract: 6515 · Lijuan Hu, MD, 北京大学人民医院 Hematologic Malignancies—Plasma Cell Dyscrasia OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS). Abstract: 7511 · Shan Fu，浙江大学医学院附属第一医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Timdarpacept (IMM01) in combination with tislelizumab in prior anti-PD-1 failed classical Hodgkin lymphoma: An open label, multicenter, phase II study (IMM01-04) evaluating safety as well as preliminary anti-tumor activity. Abstract: 7017 · Zhenjiu Wang, MD Gynecologic Cancer Efficacy and safety of sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer: A phase II trial. Abstract: 5512 ·刘继红教授，中山大学肿瘤防治中心 Nimotuzumab plus concurrent chemoradiotherapy for locally advanced cervical squamous cell carcinoma: The randomized, phase 3 CC3 study. Abstract: 5514 ·王俊杰教授，北京大学第三人民医院 A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES). Abstract: LBA5516 · 袁光文教授，中国医学科学院肿瘤医院 Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): A final overall survival analysis of a multicenter, open-label, randomized, phase 3 trial. Abstract: 5520 · 臧荣余教授，复旦大学附属中山医院 Head and Neck Cancer Preliminary results of phase I/II study to evaluate safety and efficacy of combination pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in patients with EGFR positive solid tumors. Abstract: 6013 · 阮丹云教授，中山大学肿瘤防治中心 Covalent FAPI PET enables accurate management of medullary thyroid carcinoma: a prospective single-arm comparative clinical trial. Abstract: LBA6018 · Ziren Kong, MD, 中国医学科学院北京协和医学院 Sarcoma A phase II study of anlotinib and an anti-PDL1 antibody in patients with alveolar soft part sarcoma: Results of expansion cohorts. Abstract: 11515 · 刘佳勇教授，北京大学肿瘤医院 Phase 1 study of NB003, a broad-spectrum KIT/PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST). Abstract: 11518 · 李健教授，北京大学肿瘤医院 Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Results of a phase 1/2 study of MHB088C: A novel B7H3 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in recurrent or metastatic solid tumors. Abstract: 3012 · 沈琳教授，北京大学肿瘤医院 9MW2821, a nectin-4 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1/2a study. Abstract: 3013 · 张剑教授，复旦大学附属肿瘤医院 Developmental Therapeutics—Immunotherapy Phase I study of GUCY2C CAR-T therapy IM96 in patients with metastatic colorectal cancer. Abstract: 2518 · 齐长松教授，北京大学肿瘤医院 Safety and preliminary efficacy results of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: A phase 1 dose escalation and expansion study. Abstract: 2519 · 郑莉教授，四川大学华西医院 Symptom Science and Palliative Care Effect of nurse-led multi-disciplinary treatment on patients with head and neck tumors: A randomized controlled trial. Abstract: 12013 · Jingjing Wang, MD，四川大学华西医院肿瘤中心临床科学研讨会A phase 1/2 study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors: Cervical cancer cohort. Abstract: 5509 · Hui Xie，德琪医药有限公司临床研发部 KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. Abstract: LBA8509 · Tony S. K. Mok 教授，香港大学 Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. Abstract: 104 · 樊英教授，中国医学科学院肿瘤医院 Efficacy of disitamab vedotin (RC48) plus tislelizumab and S-1 as first-line therapy for HER2-overexpressing advanced stomach or gastroesophageal junction adenocarcinoma: A multicenter, single-arm, phase II trial (RCTS). Abstract: 4009 · 刘联教授，山东大学齐鲁医院 A novel and uniquely designed bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients with advanced malignant tumors and neuroendocrine carcinoma: A report of safety and robust efficacy of LBL-024 monotherapy in phase I/II, first-in-human, open-label, multicenter, dose escalation/expansion study. Abstract: 4010 · 张盼盼医生，北京大学肿瘤医院 Safety and efficacy of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with advanced pancreatic ductal adenocarcinoma: Preliminary results from a phase 1 study. Abstract: 4011 · 郝继辉教授，天津医科大学肿瘤医院 Neoadjuvant sintilimab and platinum-doublet chemotherapy followed by transoral robotic surgery for HPV-associated resectable oropharyngeal cancer: Single-arm, phase II trial. Abstract: 6011 · 宋明教授，中山大学肿瘤防治中心 BiG 十周年预告本次BiG十周年庆典，将首次分为国内和国际篇章，以原创科学和临床需求为出发点，讨论创新技术平台和创新疗法（PROTACT/分子胶、双抗/ADC、siRNA/ASO、CGT、AI制药）的重大进展和发展前景，十年一药曙光现，大浪淘沙始见金！▼报名参会会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先biotech/Pharma、临床、院校科学家共建Biomedical创新生态圈！如何加入BiG会员？

ASCO会议临床结果

2024-04-24

·药渡Daily

【药渡药闻报告-创新药篇】-2024年第15期/总第136期

全球药物批准/研发动态01全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）全球（不含中国）共有8个新药获批上市。其中，NDA批准1个，BLA批准1个，新适应症批准5个，新剂型批准1个。与上个统计周期相比，本增加4个批准新药。4月16日，Teva宣布FDA已批准SELARSDI（Ustekinumab-aekn）注射液皮下使用，作为Stelara的生物类似药，用于治疗成人和6岁及以上成人和儿童患者的中度至重度斑块状银屑病和活动性银屑病关节炎。Ustekinumab 是一种人源单克隆抗体（mAb），可选择性靶向p40蛋白，p40蛋白是白细胞介素（IL）-12 和 IL-23 细胞因子的共同成分，在治疗免疫介导的疾病（如银屑病和银屑病关节炎）中起着至关重要的作用。4月18日，Genentech宣布FDA已批准Alecensa（Alectinib）用于肿瘤切除后的辅助治疗，用于间变性淋巴瘤激酶（ALK）阳性非小细胞肺癌（NSCLC）（肿瘤≥4厘米或淋巴结阳性）患者。Alecensa是目前第一个也是唯一一个被批准用于接受手术切除肿瘤的ALK阳性早期NSCLC患者的ALK抑制剂。ALINA的III期研究显示Alecensa将ALK NSCLC患者的疾病复发或死亡风险降低了76%。全球（不含中国）新药批准情况（部分）02全球新药申报进展本周暂无相关药物申报。根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）全球（不含中国）共有7个药物获监管机构特殊资格认定。其中，化学药2个，生物药5个。与上次统计周期相比，本次减少2个获监管机构特殊资格认定的药物。4月17日，加科思药业宣布其自主研发的KRAS G12C抑制剂Glecirasib胰腺癌适应症被FDA授予了孤儿药资格认定。此前，Glecirasib已被CDE授予用于KRAS G12C突变的二线或以上胰腺癌患者治疗的突破性治疗药物认定。此前在2024年美国临床肿瘤学会胃肠癌研讨会年会（2024 ASCO GI）以口头报告形式公布了二线及以上的KRAS G12C突变胰腺癌患者数据，确认客观缓解率为41.9%（13/31），疾病控制率为93.5%（29/31），中位无进展生存期（mPFS）为5.6个月，中位总生存期（mOS）为10.7个月。4月18日，恒瑞医药宣布其自主研发的Nectin-4抗体偶联药物（Antibody-drug-conjugate, ADC）注射用SHR-A2102获FDA授予快速通道资格，用于治疗晚期尿路上皮癌。SHR-A2102是靶向Nectin-4的抗体药物偶联物（ADC），其有效载荷是拓扑异构酶抑制剂（TOPi），多种研究表明Nectin-4在肿瘤中的高表达与肿瘤的发展和不良预后密切相关。特殊资格认定情况（部分）03全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）全球（不含中国）新药临床研发状态更新共计44条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、精神疾病、神经疾病以及眼部疾病等共计12个领域。其中，神经疾病领域临床进展更新居各领域之首，涉及化学药3条，生物药5条，细胞疗法2条。4月19日，劲方医药宣布KRAS G12C抑制剂GFH925单药疗法获得FDA临床试验许可，可针对KRAS G12C突变型难治、转移性结直肠癌患者开展一项多中心、开放标签、随机对照III期试验。这是全球首个临床获批的KRAS G12C抑制剂单药治疗结直肠癌III期试验，GFH925也是国内首个获得晚期结直肠癌突破性疗法认定的KRAS G12C抑制剂。。同日，丹码生物宣布在DM919的一项首次在人体中进行的I期的临床试验中, 首例受试者在美国已完成入组。DM919是D2M 自主研发的、靶向MICA/B蛋白的人源化单克隆抗体，通过恢复和促进T细胞和自然杀伤（NK）细胞的抗肿瘤反应，用于治疗晚期实体肿瘤。此外，当DM919与抗PD1药物联合应用时，已经表现出了显著的协同抗肿瘤效果。全球新药研发进展详情（部分）04全球医药交易事件本次统计周期（2024.04.13-04.19）全球（含中国）医药交易时间共计12起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分）国内药物批准/研发动态01国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有1个新药获NMPA批准上市。其中， NDA批准1个。与上次统计周期相比，本次减少5个NMPA批准新药。4月16日，康哲药业宣布澳门特别行政区批准磷酸芦可替尼乳膏新药上市申请，用于治疗12岁及以上青少年和成人患者伴面部受累的非节段型白癜风。该产品是第一种也是唯一一种在美国获批使用的局部JAK抑制剂，用于12岁及以上非节段型白癜风患者的局部治疗，以及传统外用处方疗法不可取或不能充分控制病情之12岁及以上成人和儿童非免疫功能低下的轻中度特应性皮炎（AD）患者的短期和非持续性慢性治疗。两项国际多中心（包含美国和欧洲中心）关键临床研究显示：治疗24周后，与赋形剂组相比，芦可替尼乳膏治疗组患者面部和全身皮损有显著复色；52周数据表明，随着治疗时间的延长，患者皮损持续复色。中国新药批准情况（部分）02国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有43个新药获临床默示许可，涉及70个受理号。其中，化学药20个，治疗用生物制品21个，预防用生物制品2个。与上个统计周期相比，本次增加17个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分）03国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有4个新药申报上市，涉及6个受理号。其中，化学药2个，治疗用生物制品2个。与上个统计周期相比，本次减少8个新药申报上市受理号。国内新药申报上市情况（部分）根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有43个新药申报临床，涉及68个受理号。其中，化学药23个，治疗用生物制品17个，预防用生物制品3个。与上个统计周期相比，本次增加12个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内共有3个药物获NMPA特殊资格认定。其中，化学药3个。与上个统计周期相比，本次增加1个获监管机构特殊资格认定的药物。4月19日， CDE官网公示，恒瑞医药两款创新药拟纳入优先审评，针对适应症为：氟唑帕利胶囊单药或联合甲磺酸阿帕替尼用于伴有胚系BRCA突变（gBRCAm）的HER2阴性乳腺癌患者的治疗。值得一提的是，这两款药针对该适应症的申请已于今年3月被CDE纳入突破性治疗品种。氟唑帕利是恒瑞医药研发的1类创新药，为一种新型口服PARP抑制剂。该药已经在中国获批用于胚系BRCA1/2（gBRCA1/2）突变的铂敏感复发性卵巢癌治疗，以及铂类敏感复发性卵巢癌维持治疗，无论胚系BRCA1/2突变状态如何。阿帕替尼是恒瑞医药研发一种高选择性的靶向血管内皮细胞生长因子受体2（VEGFR2）的抗血管生成药物，已经在中国获批单药治疗晚期胃腺癌或胃-食管结合部腺癌、晚期肝细胞癌，以及联合卡瑞利珠单抗治疗不可切除或转移性肝细胞癌。NMPA特殊资格认定情况（部分）04国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.04.13-04.19）国内新药临床研发状态更新共计2条，涉及肿瘤、血液和淋巴疾病共计2个领域。其中，化学药2个。4月17日，诺诚健华布鲁顿酪氨酸激酶（BTK）抑制剂奥布替尼治疗慢性原发性血小板减少症（ITP）患者的II期临床研究结果。该研究旨在评估奥布替尼治疗慢性ITP成人患者的疗效和安全性。结果显示，奥布替尼有望为ITP患者提供安全有效的治疗方案。此次研究的主要终点是血小板计数至少连续两周达到≥50×109/L（前4周内未使用补救药物）的患者比例。总共入组33例患者。在每天一次口服50毫克和30毫克的奥布替尼治疗ITP患者的两个组别中，奥布替尼都展现了良好的安全性。奥布替尼治疗ITP患者的III期注册临床正加速推进中，预计2024年年底完成患者入组。国内新药研发进展情况05国内新药研发领域政策法规动态国家药监局药审中心关于发布《药审中心关于已上市药品说明书增加儿童用药信息工作细则（试行）》的通知（药审业〔2024〕162号）为落实《已上市药品说明书增加儿童用药信息工作程序（试行）》中药品审评中心制定品种遴选范围、说明书修订与审核流程，以及品种申报程序等相关配套文件的要求，我中心制定了《药审中心关于已上市药品说明书增加儿童用药信息工作细则（试行）》（见附件），经国家药品监督管理局审核同意，现予发布，自发布之日起施行。06国内新药研发领域热点新闻Novartis超10亿美元押注PROTAC---蛋白水解靶向嵌合体诺华于本周四（4月11日）与Arvinas建立独家战略合作伙伴关系，推进前列腺癌的口服蛋白降解剂（PROteolysis TArgeting Chimera，PROTAC）。诺华公司将支付给Arvinas1.5亿美元的预付款，并承诺在开发、监管和商业里程碑上支付超过10亿美元的费用，外加分级特许权使用费。根据上述协议，诺华公司将负责ARV-766的全球临床开发和商业化。该交易还包括销售Arvinas在mCRPC中的临床前AR-V7项目（针对全长AR及其剪接变体AR-V7的下一代蛋白质降解剂）。诺华将拥有AR-V7项目的所有研究、开发、制造和商业化权利。更多资讯，请阅读原文TYK2：家族“异类”，大有可为进入2024年以来，三家Biotech的多轮融资将酪氨酸激酶2（TYK2）靶点的热度再次点燃。2024年1月，Sudo Biosciences宣布完成了第二次B轮融资，并在2月额外筹集了3000万美元，使这家TYK2开发公司的B轮融资额达到了1.47亿美元。同样在1月份，TYK2公司Myrobalan Therapeutics宣布完成2400万美元的A轮融资，用于开发口服神经修复疗法，包括用于减少神经炎症的TYK2变构抑制剂。更多资讯，请阅读原文聚焦抗病毒，凯因生物「赢得市场」在新冠疫情之前，抗病毒药物一直未得到充分的重视，全球抗病毒药物研发相比癌症、慢性病领域少之又少。近年来，新冠病毒的全球流行让抗病毒药物研发得到大量关注，资本快速流入，相关研发项目加速上马。同样在1月份，TYK2公司Myrobalan Therapeutics宣布完成2400万美元的A轮融资，用于开发口服神经修复疗法，包括用于减少神经炎症的TYK2变构抑制剂。更多资讯，请阅读原文喜大普奔！恒瑞医药终于营利双增重回正轨终于止跌回升，恒瑞医药的拐点要来了。根据最新年报显示，2023年，恒瑞医药总营收228.2亿元，同比增长7.26%；净利润43.02亿元，增长10.14%；归母扣非净利润41.41亿元，增长21.46%。在连续两年总营收和净利润下跌之后，恒瑞医药终于再度雄起，强势扭转下滑趋势，回到增长正轨。虽然这是恒瑞医药一家药企的喜讯，但作为最能代表中国制药行业的风向标，也昭示着集采对整个制药行业的影响基本出清，历史包袱已经卸下。长风破浪会有时，直挂云帆济沧海。更多资讯，请阅读原文不只有八因子，神州细胞还有秘密武器近日，神州细胞公布最新年报数据，2023年，其总营收18.87亿元，同比增长84.46%；净亏损3.96亿元，同比缩小23.70%；归母扣非净亏损6368.05万元，同比缩小83.91%。随着八因子的大爆量，以这样的增长速度进行下去，神州细胞很快就要实现扭亏为盈，实在不易。但这是意料之中的事，毕竟其八因子实在过于强悍。但与开挂式的营收增长趋势不符，神州细胞在资本市场的表现实在不能令人满意。不过在另一“爆款”即将浮现之际，或许神州细胞将会再展雄风。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“0424创新药周报”，即可下载。

上市批准孤儿药快速通道ASCO会议临床3期

100 项与甲磺酸阿帕替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲磺酸阿帕替尼	L01XE	DB14765

研发状态

适应症	最高研发状态	国家/地区	公司
肝细胞癌	批准上市	中国更多	江苏恒瑞医药股份有限公司更多
晚期肝细胞癌	临床3期	中国更多	江苏恒瑞医药股份有限公司更多
胆道肿瘤	临床2期	中国更多	Sun Yat-Sen Memorial Hospital 更多
胃腺癌	无进展	美国更多	Elevar Therapeutics, Inc. 更多
转移性胃癌	无进展	德国更多	Elevar Therapeutics, Inc. 更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ChiCTR2000034109 (SPACE, Literature) 人工标引	临床1期	晚期胃癌一线	34	Camrelizumab+apatinib+chemotherapy	艱齋繭窪鏇鑰蓋鹹蓋鑰(遞壓襯鹽窪醖獵鹽觸範) = not identified 構艱窪襯繭壓鹽醖鹽憲 (製觸鏇鏇鬱簾壓蓋艱構 ) 更多	积极	2024-03-25
ChiCTR2300076887 (ESMO_SRC2024) 人工标引	N/A	神经内分泌肿瘤一线	12	Camrelizumab + apatinib mesylate	遞鏇醖鬱築構夢構鏇淵(衊襯獵鬱窪夢蓋餘憲窪) = 膚顧製繭鬱鹽鑰選願繭鹹觸襯壓廠積鬱鏇糧簾 (網鑰範壓艱醖壓繭願夢 ) 更多	积极	2024-03-15
NCT04190745 (Pubmed)	临床2期	晚期胃癌二线	-	Apatinib plus Toripalimab	鹹構觸餘蓋艱選壓壓憲(鹽選衊憲膚網築壓製淵) = 夢選築蓋繭獵繭淵選鹽觸選鏇鬱憲範製鬱網繭 (鬱窪醖壓艱積範鑰廠醖 ) 更多	不佳	2024-02-16
				Physician's choice of chemotherapy	鹹構觸餘蓋艱選壓壓憲(鹽選衊憲膚網築壓製淵) = 糧鏇壓鏇簾繭築鏇蓋獵觸選鏇鬱憲範製鬱網繭 (鬱窪醖壓艱積範鑰廠醖 ) 更多
NCT03764293 (CTgov)	临床3期	肝细胞癌	543	Rivoceranib+Camrelizumab (Camrelizumab+Rivoceranib Arm)	鹹齋積壓築構遞淵願襯(壓獵膚廠積蓋蓋衊齋蓋) = 範遞獵繭鬱憲簾艱壓願網繭窪糧簾鬱艱淵壓簾 (鹽鑰築鑰製廠壓淵餘選, 鑰簾鹽築糧夢繭鹹夢選 ~ 襯窪獵鹽鹽廠壓觸廠積) 更多	-	2024-02-06
				Sorafenib (Sorafenib Arm)	鹹齋積壓築構遞淵願襯(壓獵膚廠積蓋蓋衊齋蓋) = 願衊積製齋顧壓糧糧積網繭窪糧簾鬱艱淵壓簾 (鹽鑰築鑰製廠壓淵餘選, 憲膚鑰鹹觸膚艱憲餘製 ~ 醖範糧鏇憲構構齋鬱淵) 更多
NCT02329860 (CTgov)	临床3期	肝细胞癌	400	Apatinib (Apatinib)	鬱餘襯鏇衊憲窪構壓鹽(餘襯觸鹹鏇糧衊餘構壓) = 廠憲積鑰蓋蓋鬱顧構顧鑰積窪鬱鹹鑰鏇鬱衊鏇 (簾鹽鹹衊簾繭積齋淵網, 餘膚淵築願糧襯醖艱築 ~ 壓鏇夢膚衊齋鏇齋鹽鹹) 更多	-	2024-01-22
				Placebo (Placebo)	鬱餘襯鏇衊憲窪構壓鹽(餘襯觸鹹鏇糧衊餘構壓) = 簾餘繭簾淵鬱廠願鹹壓鑰積窪鬱鹹鑰鏇鬱衊鏇 (簾鹽鹹衊簾繭積齋淵網, 壓鹽蓋遞壓願構鏇願夢 ~ 網簾積淵醖淵範憲糧醖) 更多
Pubmed	临床1/2期	晚期恶性实体瘤	61	Rivoceranib 685 mg	繭選夢願觸鏇壓顧製鹽(糧齋遞鹽醖膚鹽顧憲鹹) = grade 3 febrile neutropenia decreased appetite, and fatigue 獵衊繭襯選觸鑰淵繭齋 (願積膚廠鏇鏇衊願範糧 ) 更多	-	2024-01-18
				Rivoceranib 805 mg
NCT03472365 (CTgov)	临床2期	腺癌 \| 晚期胃癌 \| 胃食管交界处恶性肿瘤	67	Apatinib+oxaliplatin+SHR-1210+Capecitabine (Cohort 1)	願淵夢獵繭遞餘淵積觸(廠積鏇鹹淵餘觸蓋繭遞) = 壓窪積襯簾夢鏇鑰積積膚夢網醖簾醖網憲窪憲 (鏇餘選觸簾願壓淵鑰糧, 鏇蓋繭淵齋製簾窪鑰簾 ~ 廠構積鏇醖襯壓憲鹹繭) 更多	-	2024-01-11
				Apatinib+SHR-1210 (Cohort 2)	願淵夢獵繭遞餘淵積觸(廠積鏇鹹淵餘觸蓋繭遞) = 淵顧壓衊範選簾製襯壓膚夢網醖簾醖網憲窪憲 (鏇餘選觸簾願壓淵鑰糧, 鹽網簾鹹顧顧製範窪夢 ~ 鬱膚獵衊鹹觸壓鹽網顧) 更多
NCT04191889 (TRIPLET, Pubmed) 人工标引	临床2期	肝细胞癌	35	Camrelizumab+apatinib+HAIC-FOLFOX	醖餘鹽窪簾鏇網鏇鑰廠(艱膚積糧願廠製蓋築顧) = 願鏇壓醖醖鹽襯夢壓壓製鬱鬱艱製選構願鹹願 (淵網遞衊築鏇窪憲範願, 59.9 ~ 89.6) 更多	积极	2023-10-27
ChiCTR2000033588 (ESMO2023) 人工标引	临床2期	非小细胞肺癌新辅助 PD-L1 expression	78	Camrelizumab+ apatinib	築鹹窪壓構餘餘顧醖鹽(夢醖顧遞艱製鏇廠齋膚) = 築襯範夢蓋簾願觸築膚獵獵糧願遞壓齋壓繭膚 (積鹽齋簾獵鏇簾糧壓壓, 71.4-89.3) 更多	积极	2023-10-21
				Camrelizumab+ apatinib (stage II)	築鹹窪壓構餘餘顧醖鹽(夢醖顧遞艱製鏇廠齋膚) = 膚積顧鹹艱獵構選膚壓獵獵糧願遞壓齋壓繭膚 (積鹽齋簾獵鏇簾糧壓壓, 69.9-94.0) 更多
ESMO2023	N/A	三阴性乳腺癌	163	Low-dose apatinib (250mg/day) plus chemotherapy	廠襯構憲膚淵鹹艱廠願(選願窪餘襯鹽襯餘鏇夢) = 簾築艱壓構衊蓋繭構鏇獵衊鏇顧觸鏇積鏇積糧 (夢蓋襯壓衊廠蓋網築網 ) 更多	积极	2023-10-21
				Chemotherapy alone	廠襯構憲膚淵鹹艱廠願(選願窪餘襯鹽襯餘鏇夢) = 糧網繭繭醖觸蓋餘蓋夢獵衊鏇顧觸鏇積鏇積糧 (夢蓋襯壓衊廠蓋網築網 ) 更多