主要目的：评估AK104联合西奥罗尼治疗一线含铂化疗联合PD1/PDL1抑制剂治疗方案失败的广泛期小细胞肺癌（Extensive stage small cell lung cancer，ES-SCLC）的有效性和安全性。次要目的：评估AK104、西奥罗尼的药代动力学（Pharmacokinetics, PK）；评估AK104联合治疗的免疫原性。探索性目的：探索外周血中ATRX基因突变与疗效的相关性；探索肿瘤组织样本中其他潜在的生物标志物与疗效的相关性。

开始日期2022-11-22

申办/合作机构

康方药业有限公司

[+1]

NCT05271292 / Recruiting临床1/2期

A Phase 1b/2, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced Solid Tumors and Relapsed/Refractory SCLC

This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages:
Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods)
Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with no interruption between cycles.

开始日期2022-08-26

申办/合作机构

深圳微芯生物科技股份有限公司

100 项与西奥罗尼相关的临床结果

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100 项与西奥罗尼相关的转化医学

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100 项与西奥罗尼相关的专利（医药）

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项与西奥罗尼相关的文献（医药）

2023-05-09·Cell death & disease

Inhibition of extranodal NK/T-cell lymphoma by Chiauranib through an AIF-dependent pathway and its synergy with L-asparaginase.

Article

作者: Gao, Guoquan ; Huang, Jieye ; Fan, Wei ; Zhou, Ti ; Yang, Xia ; Xie, Jinye ; Huang, Jiajia ; Li, Zhiming ; Yin, Haofan ; Gao, Tianxiao

Extranodal NK/T-cell lymphoma (NKTL) is a rare and aggressive form of extranodal lymphoma with a poor prognosis. Currently, there are very limited treatment options for patients with advanced-stage disease or those with relapsed/recurrent disease. Here we show that Chiauranib, an orally small molecule inhibitor of select serine-threonine kinases (aurora B, VEGFRs, PDGFR, CSF1R, c-Kit), inhibited NKTL cell proliferation, induced cell cycle arrest, as well as suppressed the microvessel density in vitro and in vivo similar as in other types of cancer cells. Surprisingly, Chiauranib unfolded a new effect to induce apoptosis of NKTL cells by triggering AIF-dependent apoptosis other than the traditional cyt-c/caspase mitochondrial apoptosis pathway. The knockdown of AIF in vitro and in vivo dramatically blocked the efficacy of Chiauranib on NKTL. Mechanistically, the release of AIF from mitochondria is due to the upregulation of VDAC1 by the AKT-GSK3β pathway and activation of calcium-dependent m-calpain, which promotes the cleavage of VDAC1 and therefore permits the release of AIF. Notably, the low expression of Bax in both NKTL cells and patient tissues restrained the cyt-c release. It resulted in the inhibition of cyt-c/caspase mitochondrial pathway, suggesting that drugs targeting this traditional pathway may not be effective in NKTL. Furthermore, we found that L-asparaginase triggered CD95 (Fas/Apo-1)-caspase 8-caspase 3 apoptotic pathway in NKTL cells, and combination of Chiauranib and L-asparaginase exhibited a synergistic effect, suggesting a feasibility to combine these two drugs for effective treatment of NKTL. This study demonstrates Chiauranib's positive efficacy toward NKTL through the activation of the AIF-dependent apoptosis pathway for the first time. The novel and multi-targets of Chiauranib and the synergistic effect with L-asparaginase may provide a promising therapy for NKTL patients.

2023-01-01·Exploration of targeted anti-tumor therapy

In silico targeting of colony-stimulating factor-1 receptor: delineating immunotherapy in cancer.

Article

作者: Grose, Richard P ; Raza, Zohaib ; Raza, Afsheen ; Azhar, Zahra

Aim:

Delineate structure-based inhibition of colony-stimulating factor-1 receptor (CSF1R) by small molecule CSF1R inhibitors in clinical development for target identification and potential lead optimization in cancer therapeutics since CSF1R is a novel predictive biomarker for immunotherapy in cancer.

Methods:

Compounds were in silico modelled by induced fit docking protocol in a molecular operating environment (MOE, MOE.v.2015). The 3-dimensional (3D) X-ray crystallized structure of CSF1R kinase (Protein Databank, ID 4R7H) was obtained from Research Collaboratory for Structural Bioinformatics (RSCB) Protein Databank. The 3D conformers of edicotinib, DCC-3014, ARRY-382, BLZ-945, chiauranib, dovitinib, and sorafenib were obtained from PubChem Database. These structures were modelled in Amber10:EHT molecular force field, and quick prep application was used to correct and optimize the structures for missing residues, H-counts, termini capping, and alternates. The binding site was defined within the vicinity of the co-crystallized ligand of CSF1R kinase. The compounds were docked by the triangular matcher placement method and ranked by the London dG scoring function. The docked poses were further refined by the induced fit method. The pose with the lowest binding score (ΔG) was used to model the ligand interaction profile in Discovery Studio Visualizer v17.2. The co-crystallized ligand was docked in its apo conformation, and root-mean-square deviation was computed to validate the docking protocol.

Results:

All 7 CSF1R inhibitors interact with residue Met637 exhibiting selectivity except for edicotinib. The inhibitors maintain CSF1R in an auto-inhibitory conformation by interacting with Asp797 of the Asp-Phe-Gly (DFG) motif and/or hindering the conserved salt bridge formed between Glu633 and Lys616 thus stabilizing the activation loop, or interacting with tryptophan residue (Trp550) in the juxtamembrane domain. DCC-3014, ARRY-382, BLZ-945, and sorafenib bind with the lowest binding energy with CSF1R kinase.

Conclusions:

Pyrimidines are potent inhibitors that interact with CSF1R residues. DCC-3014 and ARRY-382 exhibit exceptional pharmaceutical potential exhibiting great structural stability and affinity.

2020-01-01·American journal of cancer research

Chiauranib selectively inhibits colorectal cancer with KRAS wild-type by modulation of ROS through activating the p53 signaling pathway.

Article

作者: Ma, Caiqi ; Jiang, Ping ; Xie, Jinye ; Luo, Zhaofan ; Yin, Haofan ; Duan, Deyu ; Hong, Honghai ; Jiang, Xi ; Qi, Junhua

Colorectal cancer (CRC) is one of the top three most deadly cancers despite using chemotherapy based on oxaliplatin or irinotecan combined with targeted therapy. Chiauranib has recently been identified to be a promising anticancer candidate with impressive efficacy and safety. However, the role and molecular mechanisms of Chiauranib in the treatment of CRC remain to be elucidated. Our study shows that Chiauranib inhibits cell proliferation and induces apoptosis in KRAS wild-type CRC cells in a dose- and time-dependent manner, but not mutation ones. Meanwhile, Chiauranib increases ROS production in KRAS wild-type CRC cells. Moreover, Chiauranib selectively suppresses KRAS wild-type CRC cells growth in vivo. Mechanistically, Chiauranib inhibits KRAS wild-type CRC cells by triggering ROS production via activating the p53 signaling pathway. Further, KRAS mutation CRC cells are resistant to Chiauranib by increasing Nrf2 to stably elevate the basal antioxidant program and thereby lower intracellular ROS induced by Chiauranib. Our findings provide the rationale for further clinical evaluation of Chiauranib as a therapeutic agent in treating KRAS wild-type CRC.

项与西奥罗尼相关的新闻（医药）

2024-03-29

·美通社

微芯生物发布2023年报及首份ESG报告，展示稳健经营与可持续发展成果

深圳 2024年3月29日 /美通社/ -- 3月29日，微芯生物（688321.SH）正式发布2023年度报告以及首份环境、社会和治理（ESG）报告，向公众全面展示了公司在过去一年的经营业绩以及在可持续发展方面的努力和成果。报告显示，微芯生物在2023年度业绩稳健，并在研发领域取得了显著成绩，在社会责任和环境保护方面积极贡献，为公司长期发展奠定了坚实的基础。业绩稳健，治疗 2 型糖尿病原创新药西格列他钠放量迅速报告期内，公司在业务领域稳健发展，实现营业收入52,371.02万元，归母净利润8,883.85万；报告期内公司主要产品西达本胺两项适应症实现销售收入4.67亿，治疗2型糖尿病原创新药双洛平 ® （西格列他钠）放量迅速，实现销售收入4224.79万元，同比增长167.04%，销量同比增长760.38%。（ 1 ）西达本胺西达本胺是公司独家发现的新分子实体药物，机制新颖，是全球首个亚型选择性组蛋白去乙酰化酶（HDAC）抑制剂和全球首个获批治疗外周T细胞淋巴瘤及晚期激素阳性乳腺癌的口服治疗药物，属于表观遗传调控剂类药物。西达本胺作用于表观遗传相关靶点—组蛋白去乙酰化酶（第I类的1、2、3亚型和第IIb类的10亚型）。组蛋白去乙酰化酶（HDAC）是一类对染色体的结构修饰和基因表达调控发挥重要作用的蛋白酶，西达本胺作为HDAC抑制剂，通过抑制HDAC的生物学活性产生作用，并由此产生针对肿瘤发生的多条信号传递通路基因表达的改变（即表观遗传改变）。具体而言，西达本胺的一般性作用机理主要包括：①直接抑制肿瘤细胞周期并诱导细胞凋亡；②诱导和激活自然杀伤细胞（NK）和抗原特异性细胞毒T细胞（CTL）介导的肿瘤杀伤作用；③抑制肿瘤细胞的表型转化及微环境的促耐药/促转移活性。全球范围商业化情况： 2014年12月，中国获批用于既往至少接受过一次全身化疗的复发或难治的外周T细胞淋巴瘤（PTCL）患者； 2019年11月，中国获批用于联合芳香化酶抑制剂治疗雌激素受体阳性、人表皮生长因子受体-2阴性、绝经后、经内分泌治疗复发或进展的局部晚期或转移性乳腺癌患者； 2021年6月，日本获批用于单一疗法治疗复发性或难治性（R/R）成人T细胞白血病（ATL）； 2021年12月，日本获批用于单药治疗复发性或难治性（R/R）外周T细胞淋巴瘤（PTCL）； 2023年3月，中国台湾获批用于荷尔蒙受体阳性且第二型人类表皮生长因子接受体（HER2）阴性，且经内分泌治疗后复发或恶化之停经后局部晚期或转移性乳腺癌妇女（联合依西美坦）。全球范围其他适应症探索情况： 2023年7月，西达本胺联合R-CHOP一线治疗弥漫大B细胞淋巴瘤上市申请获受理并纳入优先审评，目前正在审批上市过程中； 2023年11月，西达本胺联合替雷利珠单抗治疗非小细胞肺癌II期临床试验完成入组。西达本胺除正在开展全球多中心一线黑色素瘤三期临床试验外，正在中国及国际开展联合不同抗肿瘤免疫治疗的多项临床试验研究。 2024年3月4日，由中山大学肿瘤防治中心徐瑞华教授、王峰教授牵头开展的CAPability-01研究荣登全球顶尖学术期刊Nature Medicine（IF=82.9），作为Nature旗下最具含金量的子刊之一，Nature Medicine的发表体现了学术权威对于CAPability-01研究的认可。该研究表明，对于微卫星稳定/错配修复功能完整（MSS/pMMR）型转移性结直肠癌（mCRC）患者，三药方案西达本胺+信迪利单抗+贝伐珠单抗进行三线及以上治疗，18周PFS率达64.0%，ORR达44.0%，中位PFS达7.3个月，被认为是MSS/pMMR晚期CRC患者极具前景的治疗选择。（ 2 ）西格列他钠西格列他钠是公司自主研发的全新机制胰岛素增敏剂，用于二型糖尿病及代谢综合征，属于全新化学分子体的国家1类新药及国家 "重大新药创制"专项成果，也是全球第一个获批治疗2型糖尿病的PPAR全激动剂。西格列他钠所针对的是胰岛素抵抗这一T2DM发生和发展的核心机制，通过适度激活PPAR三个受体，使得糖、脂、能量和蛋白代谢达到动态平衡。前期临床综合研究结果显示，西格列他钠具有良好的安全性和药代、药效动力学特征，在T2DM患者的血糖、血脂及能量调控上显示了明确的疗效。商业化及其他适应症探索情况： 2021年10月，西格列他钠获批用于2型糖尿病。2023年1月，西格列他钠被纳入国家医保目录。 2023年6月，西格列他钠联合二甲双胍治疗经二甲双胍单药控制不佳的2型糖尿病的补充适应症已递交上市申请。 2023年8月，西格列他钠单药治疗非酒精性脂肪性肝炎（NASH）II期临床试验完成入组。研发成果显著，临床试验取得重大进展在研发方面，公司继续加大投入，取得了显著的成绩。微芯生物坚持以患者未满足的临床需求为核心，应用基于AI辅助设计和化学基因组学的整合式技术平台，不断发现具有差异化治疗获益的原创新药。在报告期内，公司不仅成功提交了两个新适应症的上市申请，还完成了多个关键和重要的临床试验，包括西奥罗尼治疗小细胞肺癌的关键Ⅲ期临床试验，以及西达本胺和西格列他钠两项新适应症的重要Ⅱ期临床试验的入组工作。此外，公司还有两个新分子实体新药获批进入临床阶段，进一步丰富了公司的产品线。（ 1 ）早期研发项目：深圳和成都小分子早期研发中心完成了2个候选分子CS23546（小分子PD-1抑制剂）和CS32582（Tyk2抑制剂）的临床试验申请并获得批准； CS231295（多靶点激酶抑制剂）和CS12088（HBV核衣壳蛋白抑制剂）完成了大部分临床前研究工作，其他项目正在先导分子发现或候选分子评估阶段。目前还在早期阶段的项目包括肿瘤领域（9项）、抗病毒（1项）、中枢神经系统疾病（1项）和代谢性疾病（2项），其中多个项目已经获得了活性先导分子，正在进一步的优化过程中，为扩充早期研发管线提供持续支撑。（ 2 ）重要临床试验进展： 2 项上市申请递交：西格列他钠联合二甲双胍治疗2型糖尿病的上市申请获得受理西达本胺联合R-CHOP用于弥漫大B细胞淋巴瘤的上市申请获得受理并纳入优先审评 2 项临床试验申请获准： CS23546（口服PD-L1抑制剂）治疗晚期肿瘤的I期临床试验获批，完成首家中心启动 CS32582（TYK2）胶囊用于治疗银屑病的临床试验申请获得批准 3 项临床试验完成入组：西格列他钠NASH适应症的II期临床试验完成入组西奥罗尼单药治疗小细胞肺癌III期研究完成入组西达本胺+PD-1 一线治疗非小细胞肺癌II期临床试验完成入组（ 3 ）国际临床进展：西奥罗尼（美国）小细胞肺癌的1b/II期临床试验，12个临床研究中心启动工作已按计划完成，剂量递增爬坡进展顺利专利成果丰硕，西达本胺项目获深圳市技术发明奖一等奖公司致力于原创新药的发现与开发，已在全球范围内累计申请663项发明专利，累计获得授权180项；2023年，公司新申请发明专利124项，获得授权33项。这些发明专利不仅保障了公司研发工作的顺利推进，也为公司在生物医药领域的竞争地位提供了有力支撑。2023年6月，公司"新颖表观遗传调控剂抗肿瘤原创新药西达本胺的研发及应用"项目获批2022年度深圳市技术发明奖一等奖。践行 ESG 理念，推动可持续发展微芯生物始终坚持原创、安全、优效、中国的理念，在公司治理、员工权益保护、产品安全、绿色运营、投资者回报、人才培养、社会公益、关注社会用药、医学知识科普需求等方面均作出贡献, 以实际行动积极推进社会和自身的可持续发展，获得政府、公众媒体和研究机构的认可。公司在连续两年发布了社会责任报告后，首次发布环境、社会及治理(ESG)报告，反映公司在环境、社会及治理(以下简称"ESG")方面的表现。公司聚焦深刻践行卓越治理，致力于打造更具综合实力和可持续发展的创新型现代生物制药企业。坚持规范运作、科学决策，将ESG 理念融入公司业务发展与运营管理全过程，全面提升治理水平，创新运营管理模式，持续保持公司信息高质量披露，多维度强化与投资者间的沟通交流，增进投资者对公司的了解和认同，助力企业可持续发展。公司聚焦环境管理绿色发展，积极响应联合国可持续发展目标(SDGs)。将绿色低碳发展融入企业发展和产品全生命周期管理，从研发、生产到销售各个环节全面贯彻绿色发展理念。我们积极推行清洁生产、节能减排，降低资源消耗和碳排放，确保生产过程符合环保要求;倡导低碳办公和绿色出行，提高资源利用效率，努力实现与环境和谐共生。微芯生物董事长鲁先平表示，2023年是公司发展的重要一年，公司经营稳健，研发方面均取得了显著成果。展望未来，公司将继续坚持源头创新，积极拓展市场，加强国际合作，以原创、差异化药物造福全球患者。同时，公司也将持续深化履行信息披露、社会责任和可持续发展的理念，为实现公司的长期可持续发展奠定坚实基础。关于微芯生物：微芯生物是一家以核心技术驱动，构建具有全球竞争力产品线的原创新药企业。作为中国原创新药领域的先行者，秉持"原创、安全、优效、中国"的理念，致力于为患者提供临床亟需的、具有革命性疗效的创新机制药物。公司已形成从早期探索性发现到商业化的完整产业链布局，为全球患者提供中国原创新药。微芯生物通过基于中国早期研究的全球开发策略，凭借深圳小分子早期研发中心和成都小分子早期研发中心汇聚的相关领域具有资深经验的顶尖科学家和团队，应用基于AI辅助设计和化学基因组学的整合式技术平台，打通了从基础研究到临床转化的全过程。已成功开发出了全球首创（First-in-class）且同类最优（Best-in-class）的原创新药，目前在中国有2个药3个适应症上市销售，在日本有2个适应症上市销售以及在中国台湾有一个适应症上市销售；且在肿瘤、代谢病和中枢神经系统疾病等领域布局了多个具有差异化优势和全球竞争力的研发项目。目前，微芯生物拥有以深圳总部/研发中心/GMP生产基地全资子公司深圳微芯药业有限责任公司、成都区域总部/研发中心/创新药生产基地全资子公司成都微芯药业有限公司、北京分公司（临床研究中心）、上海分公司（商业中心）及微芯生物科技（美国）有限公司的全球化产业布局。同时，作为国家首批"创新药物孵化基地"，国家高新技术企业，公司独立承担数十项国家"863"、"十五"、"十一五"、"十二五"及"十三五"国家重大科技专项及"重大新药创制"项目。累计申请境内外发明专利663项，180项已获授权。更多资讯，请访问： https://www.chipscreen.com/

财报高管变更

2024-03-20

·美通社

西格列他钠单药治疗非酒精性脂肪性肝炎的II期临床试验（CGZ203研究）达成首要疗效终点

2024年3月18日，深圳微芯生物科技股份有限公司（以下简称"微芯生物"，股票代码：688321.SH）宣布，西格列他钠单药治疗非酒精性脂肪性肝炎（NASH）的II期临床试验（CGZ203研究）于2024年2月22日顺利完成了数据清理并锁库，试验首要疗效终点达成，进一步的数据分析工作正在进行中。中国普通人群的非酒精性脂肪性肝病（NAFLD）或代谢相关脂肪性肝病（MAFLD）发生率超过25%，其中约25%会进展为NASH，在代谢综合征患者中这一比例更高，全球目前仅有一款甲状腺激素受体β（TRβ）激动剂药物获批用于治疗NASH。 CGZ203研究是一项随机、双盲、安慰剂平行对照、多中心II期临床试验，旨在评价西格列他钠单药针对NASH人群的安全性和初步有效性。CGZ203研究由首都医科大学附属北京友谊医院牵头，在全国24家临床中心开展。初步结果显示，在试验设定的首要疗效终点（18周治疗后经MRI-PDFF评估的肝脂肪含量相比基线的变化比例）上，相比安慰剂对照，西格列他钠两个剂量组均具有统计学显著意义且剂量依赖的降低；在次要疗效终点如肝脂肪含量下降超过30%的患者比例、肝细胞损伤、炎症和纤维化等无创性指标上，西格列他钠两个剂量也具有统计学显著意义的或剂量依赖趋势性的改善。试验总体安全性良好。西格列他钠（双洛平®）是微芯生物独家发现的具有全球专利保护的新分子实体药物，是过氧化物酶增殖体活化相关受体（PPAR）全激动剂，2021年10月在中国获批用于运动饮食无法有效控制的2型糖尿病患者的临床治疗，也是全球首个获批的PPAR全激动剂药物。西格列他钠在国内还完成了联合二甲双胍治疗二甲双胍单药控制不佳的2型糖尿病患者的III期试验（RECAM研究）以及本次针对NASH人群的II期临床试验（CGZ203）。 CGZ203是一项在NASH患者中开展治疗的无创性临床II期探索研究，试验设计为随机、双盲、安慰剂对照的多中心临床试验，入组患者为临床诊断的非酒精性脂肪性肝炎并伴有肝纤维化，按照2:2:1的比例随机入组分别接受每天一次口服西格列他钠48 mg、64 mg和安慰剂治疗，治疗周期为18周。试验的首要疗效终点为治疗18周后经磁共振质子密度脂肪分数（MRI-PDFF）评估的肝脏脂肪含量（LFC）相比基线变化的比例，次要终点包括LFC变化的绝对值、LFC下降超过30%的人群比例、其它肝细胞损伤、炎症、纤维化无创性指标的变化，同时观察评估试验期间患者的安全性。微芯生物是由资深留美归国团队于2001年创立的现代生物医药企业。公司专长于原创新分子实体药物研发，致力于为患者提供价格可承受的、临床亟需的、具有革命性疗效的创新机制药物。凭借自主创建的国际先进的"基于化学基因组学的集成式药物发现及早期评价平台"，微芯生物在肿瘤、代谢性疾病、自身免疫性疾病、中枢神经性疾病等重大疾病领域已开发出包括西达本胺（已上市）、西格列他钠（已上市）、西奥罗尼（临床Ⅲ期）、CS12192(临床Ⅰ期)、CS23546（临床I期）、CS32582（临床I期）在内的多个原创新药产品线。目前，微芯生物拥有以深圳总部/研发中心/GMP生产基地全资子公司深圳微芯药业有限责任公司、成都区域总部/研发中心/创新药生产基地全资子公司成都微芯药业有限公司、北京分公司（临床研究中心）、上海分公司（商业中心）及微芯生物科技（美国）有限公司的全球化产业布局。同时，作为国家首批"创新药物孵化基地"，国家高新技术企业，公司独立承担数十项国家"863"、"十五"、"十一五"、"十二五"及"十三五"国家重大科技专项及"重大新药创制"项目。累计申请境内外发明专利600余项，160余项已获授权。内容来源于网络，如有侵权，请联系删除。

临床3期ASH会议

2024-03-18

·PRNewswire

Positive results from Phase II clinical trial (CGZ203 study) of Chiglitazar monotherapy for non-alcoholic steatohepatitis

SHENZHEN, China, March 18, 2024 /PRNewswire/ -- On March 18 2024, Shenzhen chipscreen biosciences Co., Ltd. (hereinafter referred to as "chipscreen biosciences", stock code: 688321. SH) announced that the Phase II clinical trial (CGZ203 study) of chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH) was successfully completed with data cleaning and database locking on February 22, 2024. The primary efficacy endpoint of the trial has been achieved, and further data analysis is currently underway. The incidence of non-alcoholic fatty liver disease (NAFLD) or metabolic associated fatty liver disease (MAFLD) in the general population of China exceeds 25%, of which about 25% will progress to NASH, and this proportion is even higher in patients with metabolic syndrome. Currently, there is only one thyroid receptor β (TRβ) agonist approved worldwide. The CGZ203 study is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial aimed to evaluate the safety and preliminary efficacy of chiglitazar monotherapy in diagnosed NASH patients. The CGZ203 study was led by Beijing Friendship Hospital affiliated to Capital Medical University and conducted in 24 clinical sites nationwide. Preliminary results showed that both dose groups of chiglitazar produced significant and dose-dependent reductions at the primary efficacy endpoint (the proportion of changes from baseline in liver fat content evaluated by MRI-PDFF after 18 weeks of treatment), compared to placebo control group. In terms of secondary efficacy endpoints such as the proportion of patients with an over 30% decrease in liver fat content, non-invasive indicators related to hepatocyte damage, inflammation, and fibrosis and so on, both dose groups of chiglitazar also showed significant or dose-dependent trend of improvements. The overall safety is good. The detailed research results will be presented on an upcoming scientific conference or in research article. About Chiglitazar: Chiglitazar (Carfloglitazar) is a novel peroxisome proliferator activation related receptor (PPAR) pan-agonist, independently discovered and developed by Shenzhen chipscreen biosciences with global patent protection. It was firstly approved in China in October 2021, for clinical treatment of type 2 diabetes patients who cannot be effectively controlled by exercise and diet control. It is also the first approved PPAR pan-agonist in the world. Chiglitazar has already completed a phase III trial of combination with metformin to treat type 2 diabetes patients (RECAM study) and the current phase II trial in NASH patients (CGZ203) in China. About CGZ203: CGZ203 is an exploratory phase II trial aimed at treating NASH patients. It was designed as a randomized, double-blind, placebo-controlled multicenter clinical trial. The clinically diagnosed NASH patients were randomly enrolled in a ratio of 2:2:1 to receive oral administration of chiglitazar 48 mg, 64 mg, and placebo once a day respectively, with a treatment period of 18 weeks. The primary efficacy endpoint is the percentage of changes from baseline in liver fat content (LFC) evaluated by magnetic resonance proton density fat fraction (MRI-PDFF) after 18 weeks of treatment. Secondary endpoints include the absolute value of LFC changes, the proportion of people with a decrease of more than 30% in LFC, changes in other non-invasive indicators of liver cell damage, inflammation, and fibrosis, and the patient safety during the trial period. About Chipscreen: Shenzhen Chipscreen biosciences is a modern biopharmaceutical enterprise founded by a senior overseas Returnees team in 2001. The company specializes in the discovery and development of original new molecular entity drugs, focus on five major disease fields of cancer, metabolic diseases, autoimmune diseases, central nervous system diseases. With the independently created "integrated drug discovery and early evaluation platform based on chemical genomics", chipscreen has developed multiple original new drugs including two marketed products Chidamide (Tucidinostat) and Chiglitazar (Carfloglitazar), several clinical stage drug candidates Chiauranib (phase III), CS12192 (phase I), CS23546 (phase I), and CS32582 (Phase I). Till now, chipscreen has established a global industrial layout consisting of its headquarters, R&D center, a wholly-owned subsidiary of GMP production base (Shenzhen chipscreen Pharmaceutical Co., Ltd.) in Shenzhen, a wholly-owned subsidiary of its Chengdu regional headquarters/R&D center/innovative drug production base (Chengdu chipscreen Pharmaceutical Co., Ltd.) in Chengdu, Beijing branch (clinical research center), Shanghai branch (commercial center), and chipscreen Biosciences (USA) Co., Ltd. Chipscreen is one of the first batch of national "innovative drug incubation bases" and a national high-tech enterprise, independently undertakes dozens of national "863", "10th/11th/12th/13th five year plan of major scientific and technological special projects", and "major new drug creation" projects. A total of over 600 domestic and foreign invention patents have been applied, and over 160 have been authorized. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

临床2期临床结果上市批准临床3期

100 项与西奥罗尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16124

研发状态

适应症	最高研发状态	国家/地区	公司
肝细胞癌	临床2期	中国更多	深圳微芯生物科技股份有限公司更多
小细胞肺癌复发	临床2期	美国更多	深圳微芯生物科技股份有限公司更多
晚期恶性实体瘤	临床2期	美国更多	深圳微芯生物科技股份有限公司更多
软组织肉瘤	临床2期	中国更多	深圳微芯生物科技股份有限公司更多
复发性卵巢癌	无进展	中国更多	深圳微芯生物科技股份有限公司更多

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临床结果

适应症

分期

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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


NCT03216343 (AACR2021) 人工标引	临床2期	小细胞肺癌三线	28	Chiauranib	夢觸壓醖鏇膚廠夢積鹽(醖淵鑰窪淵選積鑰鹹衊) = 廠艱遞鹹簾簾膚餘淵醖遞糧網繭艱淵簾簾積簾 (鬱膚膚網廠糧淵獵艱鹹, 6.06 ~ 36.89) 更多	积极	2021-04-10
NCT02122809 (Pubmed \| J Hematol Oncol) 人工标引	临床1期	HR阳性/HER2低表达实体瘤	18	chiauranib	顧醖構壓獵鏇窪築窪窪(餘製鏇艱繭構壓選鹽襯) = grade 3 hypertension occurred in two patients at 65 mg/day 網餘鏇觸願廠淵願艱鬱 (遞蓋醖蓋齋鏇壓構範選 ) 更多	积极	2019-01-14