A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Adolescent Patients With Moderate-to-severe Atopic Dermatitis

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.

开始日期2024-05-30

申办/合作机构

康诺亚生物医药科技（成都）有限公司

NCT06171048 / Not yet recruiting临床1期

A Pharmacokinetics Study of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

开始日期2024-04-30

申办/合作机构-

NCT06116565 / Not yet recruiting临床2期

An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis

This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.

开始日期2024-03-30

申办/合作机构

康诺亚生物医药科技（成都）有限公司

100 项与司普奇拜单抗相关的临床结果

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100 项与司普奇拜单抗相关的转化医学

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100 项与司普奇拜单抗相关的专利（医药）

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项与司普奇拜单抗相关的文献（医药）

2024-01-20·Chinese Medical Journal

Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial

Article

作者: Zhu, Xiaohong ; Li, Yumei ; Yang, Bin ; Zhang, Litao ; Chen, Bo ; Man, Xiaoyong ; Tao, Xiaohua ; Cheng, Hao ; Wang, Jinyan ; Diao, Qingchun ; Jia, Yingmin ; Zhao, Yan ; Lu, Jianyun ; Zhang, Furen ; Zhang, Jianzhong ; Zhao, Guoqing ; Li, Linfeng ; Xia, Xiujuan ; Yan, Jinchun ; Li, Fuqiu ; Ding, Yangfeng ; Wu, Liming ; Lu, Qianjin ; Li, Jingyi ; Zhang, Chunlei

Abstract:

Background::

Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.

Methods::

This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.

Results::

At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator's Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310.

Conclusion::

CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.

2023-07-03·Investigative ophthalmology & visual science

Blocking Th2 Signaling Pathway Alleviates the Clinical Symptoms and Inflammation in Allergic Conjunctivitis.

Article

作者: Yang, Yiliu ; Zhang, Libo ; Liu, Wei ; She, Kaiqin ; Chen, Qin ; Liang, Licong ; Chen, Xuhong ; Tao, Zhiyan ; Lu, Fang ; Song, Qin ; Zhao, Guoqing

Purpose:

To explore the role of Th2 signaling pathway in allergic conjunctivitis (AC).

Methods:

Serum Th2 cytokines IL-4 or IL-13 of patients with AC were detected using the Meso scale discovery assay to verify the correlation of Th2 immunity and AC pathogenesis. Wistar Han rats were intraperitoneally and subcutaneously injected with ovalbumin (OVA) to establish an experimental AC model and the Th2 signaling pathway was blocked by an investigational neutralizing antibody (CM310). Serum IgE and OVA-specific IgE were detected by ELISA. Conjunctivitis inflammation, infiltration of eosinophils, and mast cell degranulation were detected by histological examination. Immortalized human conjunctival epithelial cells, a conjunctival epithelial cell line, and peripheral blood mononuclear cells of patients with AC were used as the target cells to study the impact of IL-4 or IL-13 on AC progression. Finally, a STAT6 reporter gene system was constructed using immortalized human conjunctival epithelial cells to confirm whether the downstream signaling pathway activated by IL-4 or IL-13.

Results:

Serum IL-4 or IL-13 were increased in patients with AC versus healthy individuals. In an OVA-induced rat experimental AC model, blocking the Th2 signaling pathway with CM310, an investigational neutralizing antibody, alleviated the conjunctival symptoms, and decreased serum IgE, suppressed infiltration of eosinophils and mast cell degranulation. Further, an in vitro model showed CM310 suppressed the secretion of inflammatory cytokine from both immune cells and epithelial cells in both patients peripheral blood mononuclear cells and cell line.

Conclusions:

Blocking Th2 signaling pathway alleviates the clinical symptoms and inflammation in AC.

2023-07-01·EClinicalMedicine

Efficacy and safety of CM310 in severe eosinophilic chronic rhinosinusitis with nasal polyps (CROWNS-1): a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial.

Article

作者: Shi, Li ; Yang, Yucheng ; Wang, Chengshuo ; Yu, Shaoqing ; Jiang, Luyun ; Chen, Jianjun ; Chen, Bo ; Zhang, Yuan ; Tan, Guolin ; Liu, Feng ; Xu, Yu ; Li, Jiping ; Song, Xicheng ; Liu, Shengyang ; Yang, Yi ; Ye, Jing ; Yan, Bing ; Wang, Lin ; Wan, Lijia ; Zhang, Luo ; Zhang, Yu ; Shen, Shen ; Jiang, Yan ; Zhao, Changqing ; Yan, Hongyue ; Liu, Jinfeng ; Su, Lizhong ; Liu, Wei

Background:

Severe eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP) remains the most relapsed subtype of uncontrolled CRSwNP. CM310, a humanised anti-interleukin (IL)-4 receptor alpha monoclonal antibody, inhibits IL-4 and IL-13 signaling which underlying eosinophilic inflammation. This study aims to evaluate the efficacy and safety of CM310 in patients with severe ECRSwNP.

Methods:

A multicentre, randomised, double-blind, and placebo-controlled phase 2 clinical trial was conducted. 56 eligible adult patients with severe ECRSwNP were randomised 1:1 to receive subcutaneously either CM310 (300 mg) or placebo every 2 weeks under the background therapy of mometasone furoate nasal spray (MFNS) for 16 weeks, with 8 weeks of follow-up. Coprimary endpoints included the changes from baseline in nasal polyp score (NPS) and nasal congestion score (NCS) at week 16. Key secondary endpoints included sinus Lund-Mackay CT score, change in sinus volume occupied by disease, University of Pennsylvania Smell Identification Test score, 22-item Sino-nasal Outcome Test score, and total symptom score. Safety, pharmacodynamics, and changes in type 2 inflammation biomarkers were assessed. This study is registered with ClinicalTrials.gov, NCT04805398.

Findings:

Between April 6, 2021, and March 18, 2022, 27 patients respectively in both the CM310 and placebo groups completed the study. Findings suggested that CM310 improved the coprimary efficacy endpoints of decreasing nasal polyp size and alleviating nasal congestion compared with the placebo. Least squares (LS) mean differences (CM310 vs placebo) of change from baseline in NPS and NCS at week 16 were -2.1 (95% CI -2.9, -1.4; p < 0.0001) and -0.9 (95% CI -1.4, -0.5; p < 0.0001), respectively. Sinus CT scan revealed that Lund-Mackay CT score (LS mean difference [95% CI] -7.6, [-9.4, -5.8]; p < 0.0001) and sinus volume occupied by disease (LS mean difference [95% CI] -37%, [-47%, -28%]; p < 0.0001) were significantly improved with CM310 compared with placebo. In addition, CM310 significantly relieved the daily symptoms of patients with CRSwNP and improved their quality of life reflected by the improvements in the TSS (-2.6 [95% CI -3.5, -1.6]), UPSIT (10.4 [95% CI 6.8, 14.0]) and SNOT-22 score (-19.1 [95% CI -29.8, -8.5]). Compared with placebo, CM310 administration significantly reduced type 2-related biomarkers including the serum TARC and total IgE, and tissue eosinophils. The most common adverse events were upper respiratory tract infection, blood cholesterol increased, and tinnitus, but none were considered drug-related.

Interpretation:

These findings support CM310 as an effective additional treatment option to the standard of care in patients with severe ECRSwNP.

Funding:

KeyMed Biosciences (Chengdu) Limited.

项与司普奇拜单抗相关的新闻（医药）

2024-05-03

·医药观澜

4月中国申报上市新药一览，来自君实生物、康方生物、百时美施贵宝……

▎药明康德内容团队报道根据中国国家药监局药品审评中心（CDE）官网，在刚刚结束的4月份，有10多款新药上市申请（NDA）或新适应症上市申请获得CDE受理。通过梳理，这些新药涵盖了抗PCSK9单抗、抗IL-1β单抗、抗IL-4Rα单抗、PD-1/CTLA-4双抗、GLP-1受体激动剂等等，它们拟用于治疗结直肠癌、宫颈癌、乳腺癌等癌症，痛风性关节炎、季节性过敏性鼻炎等炎症性疾病，以及糖尿病、肢端肥大症等。本文将结合公开资料介绍部分产品的信息，看看它们有哪些特点，以及有望惠及哪些患者。君实生物：昂戈瑞西单抗注射液作用机制：抗PCSK9单抗适应症：高胆固醇血症、血脂异常等昂戈瑞西单抗是君实生物自主研发的注射用重组人源化抗PCSK9单克隆抗体。根据君实生物新闻稿，本次该产品2项新适应症上市申请获CDE受理，用于治疗：1）杂合子型家族性高胆固醇血症；2）他汀类药物不耐受或禁忌使用的原发性高胆固醇血症和混合型血脂异常。本次新适应症上市申请主要基于两项3期注册临床试验（JS002-005、JS002-007）。优锐医药等：注射用牛肺表面活性剂作用机制：吸入性药械联合产品适应症：新生儿呼吸窘迫综合征（NRDS）由优锐医药（Nuance Pharma）、Lyomark Pharma等联合申报的5.1类新药注射用牛肺表面活性剂上市申请获CDE受理。根据优锐医药公开资料，这是该公司引进的一款无创、吸入性药械联合产品AeroFact，该产品用于治疗新生儿呼吸窘迫综合征（NRDS）。NRDS是一种新生儿科的呼吸障碍，在早产儿中高发，并严重危及生命，临床已获批的疗法为肺表面活性剂器官插管治疗，具有较高的创伤风险。由于肺表面活性剂具有技术难度的物理特性，以及治疗早产儿患者的固有困难，以气雾形式将该药物通过早产儿鼻腔向肺输送非常具有挑战。AeroFact是一种经鼻吸入的牛肺表面活性剂给药系统，结合了成熟的牛肺表面活性剂Alveofact（Lyomark Pharma公司），以及采用Aerogen公司的新一代输送技术和经鼻输送系统，可以实现持续、高效给药。而及时无创、高效的治疗对于患儿未来一生的生活质量影响深远。AeroFact此前已经获得美国FDA授予的快速通道资格和孤儿药资格。金赛药业：注射用金纳单抗作用机制：抗IL-1β单抗适应症：急性痛风性关节炎根据长春高新公告，其子公司金赛药业申报的注射用金纳单抗上市申请获CDE受理，针对适应症为急性痛风性关节炎。金纳单抗是一种抗白介素1-β（IL-1β）全人源单克隆抗体，可以快速和特异性地阻断IL-1β与其受体的结合，从而阻断炎症发生。在骨关节炎患者中，IL-1β刺激多种金属蛋白酶的产生，导致结缔组织破裂，抑制胶原蛋白的产生，从而对关节软骨产生负面影响。此外，IL-1β对破骨细胞的成熟有直接及间接的刺激作用，从而介导关节炎中骨侵蚀的发展。IL-1拮抗剂目前已是临床常用的痛风性关节炎的治疗药物之一。锐康迪医药：注射用双羟萘酸帕瑞肽微球作用机制：第二代生长抑素类似物适应症：肢端肥大症Recordati集团中国全资子公司锐康迪医药申报的注射用双羟萘酸帕瑞肽微球上市申请获CDE受理。该产品还于今年3月被CDE纳入优先审评，拟用于治疗无法手术或手术后未治愈和通过另一种生长抑素类似物治疗控制不佳的成人肢端肥大症患者。公开资料显示，这是一款长效帕瑞肽产品（pasireotide pamoate），已经于2014年相继获得欧洲药品管理局（EMA）和FDA批准治疗成人肢端肥大症患者。此外，博鳌乐城维健罕见病临床医学中心已经引进该产品治疗肢端肥大症患者。长效帕瑞肽（即双羟萘酸帕瑞肽）为第二代生长抑素类似物（SRL）。与第一代SRL相比，长效帕瑞肽增强了生长抑素受体（SSTR）的结合谱，即对SSTR1、2、3和SSTR5亚型具有高亲和力，尤其对SSTR5的亲和力最高，具有更好的临床和生化控制率，且安全性良好。百时美施贵宝：伊匹木单抗+纳武利尤单抗作用机制：双免疫联合疗法适应症：结直肠癌百时美施贵宝申报的纳武利尤单抗联合伊匹木单抗上市申请获受理，同时被CDE纳入优先审评，针对适应症为一线治疗不可切除或转移性微卫星高度不稳定性（MSI-H）或错配修复缺陷型（dMMR）结直肠癌患者。伊匹木单抗是一款CTLA-4抗体，纳武利尤单抗是一款PD-1抑制剂。根据百时美施贵宝于今年1月公布的临床研究（CheckMate-8HW）数据，与化疗相比，两药联合疗法一线治疗MSI-H/dMMR表型的mCRC患者，将疾病进展或死亡风险降低了79%。此外，双免疫联合疗法组的PFS改善从大约三个月时就开始出现，并贯穿始终。恒瑞医药：氟唑帕利胶囊+阿帕替尼作用机制：PARP抑制剂+抗血管生成药物适应症：HER2阴性乳腺癌恒瑞医药两款创新药上市申请获CDE受理，并纳入优先审评，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。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；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。根据恒瑞医药新闻稿介绍，2023年12月，氟唑帕利单药及联合甲磺酸阿帕替尼治疗乳腺癌的3期FZPL-Ⅲ-303研究主要研究终点结果达到方案预设的优效标准。研究期中分析结果表明，与研究者选择化疗组相比，氟唑帕利联合甲磺酸阿帕替尼组及氟唑帕利单药组的无进展生存期均取得了显著的且有临床意义的改善。康方生物：卡度尼利作用机制：PD-1/CTLA-4双抗适应症：宫颈癌根据康方生物新闻稿，卡度尼利第3个适应症上市申请获CDE受理，拟加含铂化疗联合/不联合贝伐珠单抗对比安慰剂加含铂化疗联合/不联合贝伐珠单抗用于一线治疗持续、复发或转移性宫颈癌。卡度尼利为一款PD-1/CTLA-4双特异性抗体，此前已获得中国NMPA批准上市，单药治疗既往接受含铂化疗治疗失败的复发或转移性宫颈癌。此次新适应症上市申请获得受理是基于AK104-303研究，研究显示，卡度尼利在一线治疗晚期宫颈癌全人群中展现出突出疗效。常山药业：艾本那肽注射液作用机制：GLP-1受体激动剂适应症：2型糖尿病根据常山药业新闻稿，艾本那肽为其控股子公司常山凯捷健生物开发的GLP-1受体激动剂，本次申报的适应症为治疗2型糖尿病。艾本那肽注射液是一款长效胰高血糖素样肽-1（GLP-1）类药物，采用独特的药物亲和力偶合（DAC）技术，对GLP-1受体激动剂类药物Exendin-4进行化学修饰，通过抵抗快速降解和快速肾清除克服了天然Exendin-4较短血浆半衰期的缺点，达到一周给药1次的效果。临床研究显示，在2型糖尿病受试者中连续给药24周，艾本那肽注射液可显著降低受试者血糖水平，且起效较快，第5周即可观察到显著的有效性，治疗后第5~17周血糖持续降低，并在第17周趋于稳定，疗效可维持至52周。康诺亚：司普奇拜单抗注射液作用机制：抗IL-4Rα单抗适应症：季节性过敏性鼻炎根据康诺亚新闻稿，其1类创新药司普奇拜单抗治疗季节性过敏性鼻炎的新药上市许可申请已获CDE受理。司普奇拜单抗（CM310）是一种针对白介素4受体α亚基（IL-4Rα）的高效、人源化抗体，此前该产品已在中国递交治疗成人中重度特应性皮炎的上市申请，并被纳入优先审评。在针对对鼻用糖皮质激素或其他治疗方法控制不佳的成人季节性过敏性鼻炎患者的3期临床研究中，司普奇拜单抗组显著优于安慰剂组，具备高度显著的统计学差异，且安全性良好。除了上述新药，还有其他新药的上市申请于今年4月获CDE受理。限于篇幅，本文不再一一介绍。希望这些新药能早日在中国获批上市，造福患者！参考资料（可上下滑动查看）：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved Apr 30 , 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d[2] 君实生物宣布昂戈瑞西单抗2项新适应症上市申请获得国家药品监督管理局受理. Retrieved Apr 2 , 2024, from https://mp.weixin.qq.com/s/K4faNuVdjIuEy19ng5GJnA[3]优锐医药携手蔻德罕见病中心，助力中国罕见病领域研究发展 . Retrieved July 13 , 2022, from https://mp.weixin.qq.com/s/cz3M5QF8G6C5S28mmDPUrQ{4}长春高新关于子公司注射用金纳单抗上市申请获得受理的公告. Retrieved Apr 12 , 2024, from http://www.cninfo.com.cn/new/disclosure/detail?stockCode=000661&announcementId=1219583997&orgId=gssz0000661&announcementTime=2024-04-12[5]恒瑞氟唑帕利单药或联合阿帕替尼用于HER2阴性乳腺癌申报上市且拟被纳入优先审评. Retrieved Apr 12 , 2024, from https://mp.weixin.qq.com/s/J3GO-9B3T1sPXBF975iwUA[6]康方生物双抗卡度尼利一线治疗晚期宫颈癌全人群的sNDA获CDE受理. Retrieved Apr 24, 2024, from https://mp.weixin.qq.com/s/mxxYyUI8PGdbGZvDvhdUhw[7]艾本那肽注射液（GLP-1受体激动剂）新药上市申请获国家药品监督管理局正式受理. Retrieved Apr 24 2024, from https://mp.weixin.qq.com/s/eVAKxE3x3BoxBvgIRXbw1A[8]司普奇拜单抗治疗季节性过敏性鼻炎的药品上市许可申请获受理. Retrieved Apr 30, 2024, from https://mp.weixin.qq.com/s/2S57RdLpPNTpFWbMsLznGw本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

孤儿药申请上市临床3期

2024-05-01

·医药观澜

康诺亚「司普奇拜单抗」申报上市，治疗过敏性鼻炎

4月30日，康诺亚宣布，其自主研发的1类创新药司普奇拜单抗治疗季节性过敏性鼻炎的新药上市许可申请已获中国国家药监局药品审评中心（CDE）受理。与此同时，CDE官网于昨日公示，司普奇拜单抗注射液拟纳入优先审评，针对适应症为慢性鼻窦炎伴鼻息肉。司普奇拜单抗（CM310）是一种针对白介素4受体α亚基（IL-4Rα）的高效、人源化抗体，此前该产品已在中国递交治疗成人中重度特应性皮炎的上市申请，并被纳入优先审评。过敏性鼻炎（AR）是特应性个体暴露于过敏原后，主要由免疫球蛋白E（IgE）介导的鼻黏膜非感染性慢性炎性疾病，按过敏原可分为季节性（SAR，常见过敏原为花粉等季节性过敏原）和常年性（常见过敏原为尘螨等室内过敏原或职业性过敏原）。流行病学数据显示，近年来中国由花粉导致的SAR患病率高达32.4%[4]。SAR对患者的睡眠、活动、工作和学习有明显的不利影响，甚至会引发疲劳、情绪变化、焦虑和抑郁等心理症状，严重影响生活质量。鼻用糖皮质激素和抗组胺药是目前控制过敏性鼻炎症状的常见药物，但联合使用仍有62%的患者症状未控制[5]，且长期使用存在不良反应。慢性鼻窦炎合并鼻息肉（CRSwNP）是慢性鼻窦炎（CRS）的一个亚组，其特征是鼻腔和鼻旁内出现鼻息肉，被认为是由于慢性炎症而产生。CRSwNP的发病机制复杂，鼻塞、嗅觉减退和流涕等临床症状严重影响患者生活质量。根据流行病学数据，在中国，CRS的患病率高达8%，超过1亿人受到CRS的困扰[6]。长期以来，CRS的治疗主要依靠局部或全身广谱抗炎药物，药物疗效欠佳。内镜鼻窦手术是CRS药物治疗无效后首选的外科治疗手段，但高达90%以上嗜酸性粒细胞型CRSwNP患者会再次复发，目前仍缺乏有效药物治疗手段。 IL-4Rα是一种经过临床验证的靶点。司普奇拜单抗通过靶向IL-4Rα，可双重阻断白介素4 （IL-4）及白介素13 （IL-13）的信号传导，而IL-4及IL-13为引发2型炎症的两种关键细胞因子。在全球范围内，抗IL-4Rα单抗已获批用于治疗特应性皮炎、哮喘、CRSwN、慢性自发性荨麻疹、结节性痒疹、嗜酸性食管炎等一系列2型炎症性疾病。根据康诺亚新闻稿介绍，此次申报过敏性鼻炎适应症上市申请，是基于一项多中心、随机、双盲、安慰剂平行对照的3期研究，该研究旨在评估司普奇拜单抗治疗对鼻用糖皮质激素或其他治疗方法控制不佳的成人季节性过敏性鼻炎患者的有效性和安全性。研究结果显示，3期临床试验数据结果积极，主要终点完全达标，司普奇拜单抗组显著优于安慰剂组，具备高度显著的统计学差异，且安全性良好。 2023年12月，康诺亚宣布司普奇拜单抗治疗慢性鼻窦炎伴鼻息肉的3期临床研究已完成双盲治疗期数据揭盲及初步统计分析，临床数据达到主要终点。该3期临床试验数据结果积极，共同主要终点均完全达标，CM310组皆优于安慰剂组，具备高度显著的统计学差异，且安全性良好。康诺亚此前新闻稿表示，计划将于2024年内向CDE递交司普奇拜单抗治疗慢性鼻窦炎伴鼻息肉的上市许可申请。司普奇拜单抗此前针对针对慢性鼻窦炎伴鼻息肉2期临床研究也达到主要终点。本次研究共纳入了56名合格的受试者，以1:1的随机比例分别接受300mg司普奇拜单抗和安慰剂治疗，每2周一次，共8次。本次临床试验数据结果积极，两个主要疗效终点均完全达标，司普奇拜单抗组治疗16周双侧鼻内镜息肉评分（NPS）和鼻塞评分（NCS）较基线分别降低2.32和1.23，皆显著优于安慰剂组（分别降低0.19和0.30），具备显著的统计学差异。参考资料： [1]司普奇拜单抗治疗季节性过敏性鼻炎的药品上市许可申请获受理. Retrieved Apr 30, 2024, from https://mp.weixin.qq.com/s/2S57RdLpPNTpFWbMsLznGw [2]消息公告 | CM310治疗慢性鼻窦炎伴鼻息肉的III期临床试验达到主要终点. Retrieved Dec 27, 2023, from https://mp.weixin.qq.com/s/qlHXd7oOv94a8BUqx7tPyA [3]消息公告 | 康诺亚CM310针对慢性鼻窦炎伴鼻息肉的II期临床试验达主要终点. Retrieved Mar 30, 2022, from https://mp.weixin.qq.com/s/A_NKys_CWZz7hobxdS7JCw [4]Zhang Y, Lan F, Zhang L. Allergy. 2021 Nov;76(11):3383-3389. [5]White P, Smith H, et al. Clin Exp Allergy. 1998 Mar;28(3):266-70 [6]ShiJB, FuQL, ZhangH, et al. Epidemiology of chronic rhinosinusitis: results from a cross-sectional survey in seven Chinese cities[J]. Allergy, 2015, 70(5): 533-539. DOI: 10.1111/all.12577. 内容来源于网络，如有侵权，请联系删除。

优先审批申请上市

2024-04-30

·GBIHealth

康诺亚1类新药治疗过敏性鼻炎III期临试达主要终点；科兴制药与青峰医药达成奥拉帕利国际商业化合作

药械追踪No.1 /康诺亚司普奇拜单抗治疗过敏性鼻炎的III期临试达主要终点康诺亚近日宣布，1类新药CM310重组人源化单克隆抗体（司普奇拜单抗）注射液治疗季节性过敏性鼻炎（SAR）的III期临床研究已完成双盲治疗期数据揭盲及统计分析，临床数据达到主要终点。司普奇拜单抗已在过往多项临床试验中，显示了良好的安全性及令人鼓舞的疗效，其治疗成人中重度特应性皮炎的药品上市许可申请已于2023年12月7日获国家药品监督管理局受理，并纳入优先审评审批程序。->点击阅读原文，解锁完整双语新闻企业动态No.1 /科兴制药与青峰医药达成奥拉帕利国际商业化合作近日，科兴制药与青峰医药旗下子公司科睿药业达成了奥拉帕利片的国际商业化许可合作协议。科兴制药签下青峰医药奥拉帕利片在海外首批10个国家的商业化权益。此次合作的奥拉帕利为青峰药业子公司山香药业申报的仿制药，目前在上市申报阶段，受理号：CYHS2300238、CYHS2300239。->点击阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20年的深耕细作，GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ sylvia.hua@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

优先审批临床3期

100 项与司普奇拜单抗相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
季节性过敏性鼻炎	申请上市	中国更多	成都康诺行生物医药科技有限公司更多
哮喘	临床3期	中国更多	康诺亚生物医药科技（成都）有限公司更多
慢性鼻窦炎伴鼻息肉	临床3期	中国更多	康诺亚生物医药科技（成都）有限公司更多
慢性阻塞性肺疾病	临床申请批准	中国更多	康诺亚生物医药科技（成都）有限公司更多
阿尔茨海默症	无进展	中国更多	Keymed Bioscience Chengdu Co. Ltd. 更多

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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


NCT04805411 (CM310, Pubmed)	临床2期	特应性皮炎	120	CM310 300 mg	願築鏇襯簾遞選遞製壓(觸繭廠鹹築網鑰糧窪襯) = 艱襯淵製齋鹹顧艱構蓋鑰觸餘壓獵繭鬱構齋淵 (艱襯顧鬱艱鑰憲窪構襯 )	积极	2023-07-21
				CM310 150 mg	願築鏇襯簾遞選遞製壓(觸繭廠鹹築網鑰糧窪襯) = 衊築膚窪選構繭糧醖夢鑰觸餘壓獵繭鬱構齋淵 (艱襯顧鬱艱鑰憲窪構襯 )
NCT04805398 (CROWNS-1, Pubmed)	临床2期	慢性鼻窦炎伴鼻息肉	56	CM310 (300 mg)	繭鹹積齋廠廠鬱淵淵餘(衊齋繭窪鏇鏇齋淵膚鏇): LS mean difference = -7.6 (95% CI, -9.4 ~ -5.8)	积极	2023-07-01
				Placebo
CM310AD005 (Corporate Publications) 人工标引	临床3期	特应性皮炎	-	CM310	憲壓夢淵積遞鹹鏇簾積(選艱製網網夢淵壓餘夢) = 主要疗效终点均成功达到膚膚鹹獵鹽願製齋鹽構 (襯鑰構窪壓鹹繭齋糧窪 ) 达到更多	积极	2023-03-28
				安慰剂
NCT04805398 (CM310NP001, NEWS) 人工标引	临床2期	慢性鼻窦炎伴鼻息肉	56	CM310	壓遞網繭淵遞窪顧糧築(構積齋壓網鹹蓋選遞窪) = 鏇壓網願築觸遞顧壓積製鏇蓋夢積範遞築鹽蓋 (壓築壓蓋選憲鹽夢襯選 ) 更多	积极	2022-03-30
				Placebo	壓遞網繭淵遞窪顧糧築(構積齋壓網鹹蓋選遞窪) = 夢製糧築製膚醖積築衊製鏇蓋夢積範遞築鹽蓋 (壓築壓蓋選憲鹽夢襯選 ) 更多