A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation

开始日期2025-08-12

申办/合作机构

苏州康乃德生物医药有限公司

NCT06940141

/ Recruiting临床2期

A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Adult and Adolescent Participants With Asthma and Type 2 Inflammation

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

开始日期2025-08-08

申办/合作机构

苏州康乃德生物医药有限公司

NCT05917782

/ Completed临床1期

A Randomized, Open-Label, Parallel-Designed, Phase I Clinical Study to Evaluate the Pharmacokinetics Similarity of Single-Dose CBP-201 Injection With Different Dosage Forms and Strengths in Healthy Adult Chinese Subjects

This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity study.

开始日期2023-07-18

申办/合作机构

苏州康乃德生物医药有限公司

100 项与苏州康乃德生物医药有限公司相关的临床结果

登录后查看更多信息

0 项与苏州康乃德生物医药有限公司相关的专利（医药）

登录后查看更多信息

项与苏州康乃德生物医药有限公司相关的文献（医药）

2025-09-02·BRITISH JOURNAL OF DERMATOLOGY

Rademikibart monotherapy for moderate-to-severe atopic dermatitis in a 1-year, randomized, phase II trial (SEASIDE CHINA): initial two-week dosing, followed by two-week or four-week dosing.

Article

作者: Yun, Jili ; Collazo, Raúl ; Pan, Wuban ; Guo, Jiawang ; Wei, Zheng ; Silverberg, Jonathan I ; Zhang, Jianzhong

BACKGROUND:

Rademikibart (CBP-201) is a potent, next-generation, optimized IL-4Rα-targeting antibody.

OBJECTIVES:

To evaluate rademikibart efficacy and safety, initially dosed every other week (Q2W), and Q2W or every fourth week (Q4W) from Week 16, in Chinese adults/adolescents with moderate-to-severe atopic dermatitis (AD).

METHODS:

SEASIDE CHINA (NCT05017480) was a phase II trial: Stage 1 (16-week treatment period), Stage 2 (36-week treatment and 8-week follow-up periods). The primary endpoint was the proportion of patients with a vIGA score 0/1 and ≥2-point reduction from baseline at Week 16. Overall, 330 patients were randomized (2:1) double-blind to receive subcutaneous rademikibart, 600 mg on Day 1 and 300 mg Q2W from Week 2-14, or placebo. Pre-dose at Week 16, patients were assessed for minimally important change (≥50% Eczema Area and Severity Index score reduction, EASI-50) and re-randomized (1:1) double-blind to rademikibart 300 mg Q2W or Q4W.

RESULTS:

In Stage 1, 29.0% of patients attained vIGA0/1 and ≥2-point reduction with rademikibart Q2W (p<0.001; 5.9% with placebo) at Week 16, without plateauing. Rapid, significant improvements were also observed with all other rating scales in Stage 1, including EASI-75 (58.6% vs 22.6%) and PP-NRS ≥4-point reduction (36.3% vs 10.5%) with rademikibart Q2W vs placebo, respectively, at Week 16. In Stage 2, Week 16 EASI-50 responders from Stage 1 continued to improve through Week 52 when treated with rademikibart Q2W or Q4W, including vIGA0/1 (59.1%, 62.6%), EASI-75 (84.6%, 84.8%), and PP-NRS ≥4-point reduction (60.4%, 70.3%). Most patients with improvements during rademikibart Q2W therapy at Week 16 maintained these responses through Week 52 in both rademikibart Q2W and Q4W groups: vIGA0/1 (78.0%, 87.1%), EASI-75 (90.1%, 92.3%), PP-NRS ≥4-point reduction (85.3%, 94.8%). Injection site reactions were Grade 1 (mild). No serious TEAEs were treatment related. Three patients discontinued rademikibart due to TEAEs (AD flare, vitiligo, pregnancy).

CONCLUSIONS:

Rademikibart Q2W induced rapid improvements in AD lesions and pruritus during the initial 16 weeks, which were maintained/improved further with rademikibart Q2W or Q4W across an additional 36 weeks. Rademikibart Q2W and Q4W were similarly efficacious and well tolerated. These findings are compatible with those from the published WW001 international phase II rademikibart trial.

2025-05-01·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma: A Phase 2B Randomized Clinical Trial

Article

作者: Guo, Jiawang ; Adivikolanu, Radha ; Yun, Jili ; Wang, Junying ; Longphre, Malinda ; Kerwin, Edward ; Collazo, Raúl ; Su, Nan ; Yang, Ting ; Pan, Wuban ; Wei, Zheng

RATIONALE:

Rademikibart (formerly CBP-201) is an IL-4Rα-targeting antibody.

OBJECTIVES:

To evaluate rademikibart in adults with moderate-to-severe, persistent, uncontrolled asthma.

METHODS:

In this global phase 2b trial (NCT04773678), 322 patients were randomized 1:1:1 to two rademikibart groups (150 mg or 300 mg every other week, following a 600 mg loading dose) or placebo, administered subcutaneously, for 24 weeks.

MEASUREMENTS AND MAIN RESULTS:

Prebronchodilator (trough) forced expiratory volume in the first second of expiration (FEV₁) at Week 12 (primary endpoint) improved with rademikibart 150 mg and 300 mg: least squares mean changes (95% CI), above placebo, were +140 mL (+44-236 mL; p=0.005) and +189 mL (+92-286 mL; p<0.001), respectively. Prebronchodilator trough FEV₁ improvements occurred rapidly during Week 1, were sustained through Week 24, and greatest in patients with high baseline blood eosinophils (patients with ≥300 eosinophils/mL experienced placebo-adjusted FEV₁ improvement at Week 24 of +420 mL [95% CI, +239-600 mL] in the 300 mg group). Rapid and sustained statistically significant improvements were also observed in percent predicted FEV₁ and Asthma Control Questionnaire score across 24 weeks. Through Week 24, proportions of patients with ≥1 exacerbation were 7.5% (150 mg) and 9.3% (300 mg) vs 16.7% (placebo). 88% of patients completed treatment. Treatment-emergent adverse events (TEAEs) were generally similar to placebo, and no eosinophilia was observed. Injection site reactions were mostly mild. The most common TEAEs (10-12% of patients) were cough, COVID-19, and dyspnea.

CONCLUSIONS:

Rapid and sustained improvements in lung function and asthma control were gained across 24 weeks of rademikibart therapy. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/). Clinical trial registration available at www.

CLINICALTRIALS:

gov, ID: NCT04773678.

2023-07-31·Scientific reports

Preclinical immunological characterization of rademikibart (CBP-201), a next-generation human monoclonal antibody targeting IL-4Rα, for the treatment of Th2 inflammatory diseases.

Article

作者: Ding, Ying ; Yang, Xin ; Wei, Zheng ; Wang, Qingjian ; Zhang, Limin ; Pan, Wubin ; Smith, Paul A

Rademikibart (CBP-201) is a next-generation human monoclonal antibody targeting IL-4Rα, undergoing evaluation in Phase 2 clinical trials for the treatment of moderate-to-severe Th2 inflammatory diseases. We report the immunological characterization of rademikibart. Rademikibart and dupilumab were associated with K_D of 20.7 pM and 45.8 pM, respectively, when binding to distinct human IL-4Rα epitopes. Rademikibart did not bind to IL-4Rα from other species. Rademikibart inhibited IL-4 and IL-13-mediated STAT6 signaling (mean ± SD IC₅₀: 7.0 ± 2.5 and 6.6 ± 1.5 ng/mL, respectively), TF-1 cell proliferation (IC₅₀: 8.0 ± 1.6 and 9.7 ± 0.8 ng/mL, respectively) and TARC production in PBMCs (IC₅₀: 59.2 ± 3.9 and 13.5 ± 0.2 ng/mL, respectively). Rademikibart versus dupilumab was more potent in the STAT6 assays (IL-4, p < 0.01; IL-13, p = 0.03), with non-significant trends towards greater potency in the TF-1 cell assays (IL-4, p = 0.09; IL-13, p = 0.20), and similar potency in the TARC assays. In experiments with mice expressing human IL-4Rα and IL-4, rademikibart and dupilumab demonstrated similar potency; both monoclonal antibodies eliminated IL-4 (p < 0.0001) and IL-13 (p < 0.05) mediated B cell activation in vitro and ovalbumin-induced IgE (p < 0.01) and eosinophilic lung infiltration (p < 0.0001) in vivo. In Th2-stimulated human skin explants, rademikibart rapidly downregulated IL-4, IL-13, and TARC gene expression, with greater effectiveness than dupilumab for IL-4 (p < 0.01) and a non-significant trend towards superiority for IL-13. In summary, rademikibart bound to a distinct IL-4Rα epitope with high affinity and demonstrated reductions in Th2 inflammatory biomarkers with at least similar and potentially superior potency to dupilumab.

217

项与苏州康乃德生物医药有限公司相关的新闻（医药）

2025-10-01

·GlobeNewswire-Health Care

Connect Biopharma Presents Data Supporting Rademikibart at the European Respiratory Society Congress 2025

– Rademikibart demonstrated rapid and significant improvement in lung function and asthma control in patients, with greatest improvements observed in those with elevated baseline levels of key type 2 inflammatory markers – – Significant reduction in annualized exacerbations observed in patients with one or more elevated type 2 inflammatory markers at baseline – – Data supports ongoing Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD; expect to report topline data from both studies in 1H26 – Sept. 29, 2025 -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today presented data supporting rademikibart, the Company’s investigational, next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody, at the European Respiratory Society (ERS) Congress 2025, taking place September 27 – October 1, 2025, in Amsterdam, Netherlands and virtually. “We are excited to share additional analyses from our Phase 2b asthma study at ERS. These data continue to expand our data package for rademikibart and reinforce its potential to deliver best-in-class efficacy for patients with moderate to severe asthma and COPD,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “These data build on previously reported Phase 2b study outcomes demonstrating rapid and sustained lung function improvements, with the greatest outcomes being observed in patients with elevated levels of key type 2 inflammatory biomarkers. In addition, these analyses have helped to refine our clinical development plans and clinical site strategies for our ongoing Seabreeze STAT asthma and COPD studies. We look forward to reporting topline data from both in the first half of 2026.” Results from the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma were evaluated in a post-hoc analysis to investigate the efficacy of rademikibart in subgroups of patients with asthma based on baseline levels of type 2 inflammatory biomarkers, indicated by blood eosinophil counts (EOS) of Rademikibart treatment led to rapid and sustained improvement in lung function and asthma control in subgroups with elevated baseline markers of Type 2 inflammation, with greatest improvements observed in patients with both high EOS and high FeNO. At Week 24, treatment with rademikibart improved prebronchodilator FEV1 by 507 mL in patients with high EOS and high FeNO, 284 mL in patients with low EOS and high FeNO, 209 mL in patients with high EOS and low FeNO, and 108 mL in patients with low EOS and low FeNO. In addition to lung function and asthma control, a reduction in asthma exacerbations was observed in subgroups with at least one high type 2 inflammatory biomarker at baseline, with a 63% reduction in patients with high EOS and a 69% reduction in patients with high FeNO. These results highlight rademikibart’s potential to improve lung function and reduce asthma exacerbations, particularly in patients with elevated markers of Type 2 inflammation. A post-hoc analysis of the Company’s Phase 2b trial of rademikibart in moderate-to-severe asthma investigated the prespecified primary endpoint, absolute change in prebronchodilator FEV1 at Week 12, in subgroups of patients enrolled in Poland and in the Rest of the World (ROW). Rademikibart rapidly and significantly improved lung function in adults with asthma, with greater benefit observed in patients with higher baseline EOS, in both the overall trial population and ROW subgroup. In Poland, placebo response was greater and rademikibart response was less than in the ROW subgroup and overall trial population. Four patients in the placebo group demonstrated unusually large improvements in lung function, potentially related to baseline factors, such as EOS 1, and/or daily use of inhalers. In Poland, rademikibart-treated patients also had milder disease compared to the ROW subgroup, increased percent predicted FEV1, and despite similar FeNO levels, this baseline imbalance may have impacted treatment effects. These results underscore the importance of rigorous trial conduct and comprehensive patient guidance and have informed the Company’s ongoing Phase 2 Seabreeze STAT clinical site strategy. Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma. Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect also has an exclusive license and collaboration agreement for rademikibart with Simcere in China. The content above comes from the network. if any infringement, please contact us to modify.

临床结果引进/卖出

2025-09-30

·丁香园 Insight 数据库

爆发！31 款新药国内申报上市，来自恒瑞、科伦博泰、石药集团......

今年九月，国内新药申报上市迎来了大爆发。根据 Insight 数据库，截至 9 月 29 日，共计有 31 款新药在本月向 NMPA 递交了上市申请（含新适应症，不含原研地产化品种），数量为今年单月第 2 高。其中，国产药有 14 款，进口药有 17 款。药物类型上，化药有 14 款，生物药有 17 款。从国内注册信息来看，31 款药中，有 17 个新药是首次申报上市，其中包括 11 款 1 类新药。本文将对其中几款首次报产的新药信息做介绍。恒瑞医药：HRS9531 首个国产 GLP-1R/GIPR 双激动剂 9 月 2 日，恒瑞医药的 HRS9531 注射液上市申请获得受理，适应症为在控制饮食和增加运动的基础上用于成人的长期体重管理，患者的初始体重指数（BMI）需≥28 kg/m2（肥胖）或≥24 kg/m2（超重），并伴有至少一种体重相关合并症。截图来源：CDE 官网 HRS9531 是一种同时靶向 GLP-1R 和 GIPR 的双激动剂。2025 年 7 月，HRS9531 注射液 Ⅲ 期临床试验（HRS9531-301）取得成功。研究结果表明，在主要疗效终点和所有关键次要疗效终点上，HRS9531 组显著优于安慰剂组，HRS9531 高剂量组平均体重降低达 19.2%，其中 44.4% 的受试者体重降低≥20%，而且安全性和耐受性良好。 Insight 数据库显示，在 GLP-1R/GIPR 双靶点新药赛道，全球现仅有礼来的替尔泊肽获批上市。恒瑞的 HRS9531 是首个报上市的国产 GLP-1R/GIPR 双激动剂。此外，还有多款同靶点新药在国内进入了 Ⅲ 期，来自翰森制药、博瑞生物、安进、众生药业、华东医药。箕星药业/LENZ：盐酸醋克利定滴眼液首个老花眼滴眼液 9 月 9 日，箕星药业和 LENZ Therapeutics 联合递交的盐酸醋克利定滴眼液上市申请获得受理，适应症为老视（俗称老花眼）。截图来源：CDE 官网 LNZ100（盐酸醋克利定）是 LENZ 公司开发的一种以醋克利定为基础的滴眼液，主要用于改善老花眼患者的近视力。箕星药业拥有 LNZ100 在大中华区的开发和商业化独家权益。今年 7 月 31 日， LNZ100 已在美国获批上市，成为了首个获批的老花眼眼药水。在国内，LNZ100（1.75% 醋克利定）用于治疗中国老视患者的 III 期临床研究 JX07001 已取得成功。中国 Ⅲ 期研究数据显示，LNZ100 达到了主要终点和关键次要终点，最佳远矫正下的近视力 (BCDVA) 有三行或更佳的显著改善，并保持其最佳远视力（即视力下降不可超过 5 个字母）。而且大多数受试者在服用 LNZ100 后 30 分钟内就能起效，疗效可维持 10 个小时。康宁杰瑞/石药集团：安尼妥单抗首个国产 HER2 双抗 9 月 12 日，康宁杰瑞和石药集团津曼特生物申报的安尼妥单抗注射液上市申请获得受理，适应症为用于 HER2 阳性局部晚期、复发或转移性的胃/胃食管结合部腺癌二线治疗。该申请已被纳入优先审评。截图来源：CDE 官网 KN026 是康宁杰瑞自主研发的一种 HER2 双抗。2021 年 8 月，石药集团旗下津曼特生物与康宁杰瑞达成一项 10 亿元授权合作，获得了 KN026 在中国内地在乳腺癌、胃癌适应症上的排他性开发与独占性商业化许可权。 2024 年 ESMO 大会上公布的 II 期临床研究结果显示：KN026 联合化疗的客观缓解率为 40.0%，经独立评审委员会 (IRC) 评估的中位无进展生存期为 8.6 个月，中位总生存期为 13.2 个月。本次上市申请主要是基于一项关键 II/III 期临床试验（KC-WISE）。III 期研究首次期中分析结果显示：与目前的标准治疗相比，KN026 联合化疗可显著提高患者的临床疗效，延长 PFS 和 OS，且无新发安全性风险，心脏毒性发生率低，免疫原性低。根据 Insight 数据库，目前国内仅有百济神州从 Zymeworks 引进的泽尼达妥单抗一款 HER2 双抗获批上市，用于治疗胆道癌。康宁杰瑞和石药集团的 KN026 是首个报上市的国产 HER2 双抗，首发适应症为胃癌。科伦博泰：仑博替尼首个国产 RET 抑制剂 9 月 22 日，科伦博泰的富马酸仑博替尼胶囊上市申请获受理，适应症为用于治疗 RET 融合阳性局部晚期或转移性非小细胞肺癌 (NSCLC) 成人患者。此前，国内仅有两款进口 RET 抑制剂获批，仑博替尼是首个报上市的国产 RET 抑制剂。截图来源：CDE 官网仑博替尼（A400）是一款新型下一代选择性 RET 抑制剂，拟开发用于治疗 NSCLC、甲状腺髓样瘤以及其它 RET 变异的高患病率实体瘤，具有克服第一代选择性 RET 抑制剂耐药的潜力。本次上市申请是基于 KL400-I/II-01 研究中的两个关键 Ⅱ 期队列治疗一线和二线及以上 RET 融合阳性 NSCLC 的积极结果。数据显示，两个关键临床研究队列已达到主要有效性终点，RET+ NSCLC 一线治疗的 ORR 为 80.8%，二线以上晚期 RET+ NSCLC 的 ORR 为 69.7%。同时，仑博替尼还展示出了可管理的耐受性和安全性。 2021 年 3 月，科伦博泰已将仑博替尼在大中华区及部分亚洲国家之外的开发、制造及商业化独家权益授权给了英国 Ellipses Pharma 公司（研发代号为 EP0031）。在海外，仑博替尼已获得美国 FDA 授予快速通道资格，用于治疗 RET 融合阳性 NSCLC，并正在美国、英国、欧盟和阿联酋开展临床试验。信立泰：泰卡西单抗第 5 款国产 PCSK9 单抗 9 月 19 日，信立泰的泰卡西单抗注射液上市申请获得受理，适应症为用于高胆固醇血症和混合型血脂异常。这是第 5 款报产的国产 PCSK9 单抗。截图来源：CDE 官网目前国内已有 7 款 PCSK9 靶向疗法获批，其中只有诺华的英克司兰钠是 siRNA，其它 6 款都是 PCSK9 单抗，分别来自安进、赛诺菲、信达、康方、君实、恒瑞。值得一提的是，由于全球原料供应短缺以及优化心血管市场的策略和管线等原因，赛诺菲将停止波立达 (阿利西尤单抗) 在中国市场的推广，并将逐步退出中国市场。信立泰公告指出，国内已上市的 PCSK9 单抗，若每 4 周一次皮下注射，需要同时注射 2-3 针或无菌配药。而泰卡西单抗虽然也是每 4 周一次皮下注射，但一次只需一针，有望大幅提升患者用药便利性和治疗依从性。智翔金泰：泰利奇拜单抗第 3 款国产 IL-4Rα 单抗 9 月 11 日，智翔金泰泰利奇拜单抗（GR1802）注射液上市申请获得受理，适应症为中、重度特应性皮炎。这是第 3 款报产的国产 IL-4Rα 单抗。截图来源：CDE 官网 GR1802 用于中、重度特应性皮炎适应症的 III 期临床试验已达到了主要疗效终点。除了特应性皮炎，GR1802 还正在开展针对慢性鼻窦炎伴鼻息肉、慢性自发性荨麻疹、成人季节性过敏性鼻炎、青少年季节性过敏性鼻炎适应症的 Ⅲ 期临床。根据 Insight 数据库，目前全球共有两款 IL-4Rα 单抗获批上市，分别为赛诺菲/再生元的度普利尤单抗、康诺亚/津曼特生物的司普奇拜单抗。其中，度普利尤单抗是全球首个获批的 IL-4Rα 单抗，2024 年全球销售额为 140.89 亿美元，2025 上半年销售额为 73.12 亿欧元（约 80 亿美元）。在国内，除了已获批的度普利尤单抗和司普奇拜单抗，康乃德/先声药业的乐德奇拜单抗、智翔金泰的泰利奇拜单抗已申报上市。此外，还有 7 款在研产品正在开展 Ⅲ 期临床，来自正大天晴/博奥信、恒瑞、康方、荃信生物、三生国健、麦济生物、齐鲁，竞争非常激烈。复星医药：布瑞基奥仑赛第二款 CAR-T 报上市 9 月 24 日，复星医药旗下复星凯瑞（曾用名复星凯特）的布瑞基奥仑赛注射液上市申请获受理，适应症为复发或难治性前体 B 细胞急性淋巴细胞白血病（ALL）成人患者。来源：CDE 官网布瑞基奥仑赛（Brexucabtagene autoleucel、KTE-X19）是吉利德科学旗下 Kite Pharma 开发的一种靶向 CD19 的 CAR-T 细胞疗法。此前，该药已在美国、欧盟、加拿大等国家和地区获批上市，用于治疗套细胞淋巴瘤、B 细胞急性淋巴细胞白血病（B-ALL）。复星凯瑞拥有布瑞基奥仑赛在中国内地、香港、澳门地区的权益，目前正在中国内地开展布瑞基奥仑赛治疗套细胞淋巴瘤、B-ALL 的单臂 Ⅱ 期临床。今年 6 月，复星凯瑞公布了 KTE-X19 在中国 R/R B-ALL 患者中的桥接注册临床研究的最新结果，该试验主要终点为中心评估的 CR/CR 伴不完全血液学恢复（CRi）率。截至 2024 年 10 月 28 日，共纳入 28 例患者接受 KTE-X19 回输（1×10⁶ CAR-T 细胞/kg）。疗效性数据显示：中位随访 8.1 个月时，CR/CRi 率为 78.6%；中位 DOR、中位 RFS 和中位 OS 均未达到，所有应答者的 MRD 检测结果均为阴性（100%）。安全性数据显示，在中国人群中未观察到新的安全性信号。此前，复星凯瑞从 Kite Pharma 引进的 CD 19 CAR-T 阿基仑赛已在国内获批，用于治疗弥漫性大 B 细胞淋巴瘤、原发纵隔大 B 细胞淋巴瘤。除了上述产品，还有多款新药也在本月向 CDE 递交了首次上市申请，限于篇幅本文不再一一介绍。如欲了解更多国内新药注册情况，可前往 Insight 数据库查看。 Insight 数据库整理了 2025 年全球新药申报上市清单，扫描下方二维码 👇，回复关键词新药报上市即可免费获取（每月初更新一次，目前更新至 8 月）。封面来源：站酷海洛免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

临床3期申请上市上市批准

2025-09-29

·casipharma.com.cn

CASI任命James Huang为董事会成员

行业资深专家，拥有逾35年生物医药领域创业与投资经验丰富运营经验将助力CID-103（抗CD38单抗）研发进程 2025年9月26日，CASI今日宣布，任命James Huang先生为公司董事会独立董事。该任命自2025年10月1日起正式生效。 Huang先生在全球生物医药领域拥有超过35年的创业与投资经验。作为Panacea Venture创始人及管理合伙人，并曾担任KPCB中国与Vivo Ventures的管理合伙人，他成功推动了多家跨境企业在关键发展阶段的成长、融资及全球拓展。职业生涯早期，他曾在Tularik（后被安进收购）、葛兰素史克、百时美施贵宝及ALZA（后被强生收购）担任业务拓展、市场营销及研发等高级管理职务。目前，他还担任康圣环球、康乃德、李氏大药厂、Atara Biotherapeutics及多家非上市公司的董事职务。他拥有加州大学伯克利分校化学工程学士学位及斯坦福大学商学院工商管理硕士学位。 Huang先生表示：“CASI正处于关键发展阶段，公司正进一步聚焦美国市场，并致力于加速推进CID-103在自身免疫性疾病及器官移植抗体介导的排斥反应的临床开发。在此之际加入董事会，我深感荣幸。我期待与管理团队紧密合作，为公司注入战略视野、强化合规治理、实现与股东的长期价值契合，助力CASI成长为美国本土临床阶段的自身免疫及移植领域领导者。” CASI首席执行官David Cory表示：“随着CID-103项目在临床研究中的不断推进，并在不同患者群体和适应症中积累更多数据，我们相信，James的全球视野及他在企业规模化发展方面的成功经验将为我们带来重要价值。我们热烈欢迎James加入董事会，期待与他携手推动CASI迈向新发展阶段。” Panacea Venture为CASI现有股东，随着Huang先生出任董事，该机构计划通过注册交易从CASI收购最多150万股新发行的普通股。

并购高管变更

100 项与苏州康乃德生物医药有限公司相关的药物交易

登录后查看更多信息

100 项与苏州康乃德生物医药有限公司相关的转化医学

登录后查看更多信息

组织架构

使用我们的机构树数据加速您的研究。

或

查看完整样例数据

管线布局

2025年10月16日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

临床申请批准

临床3期

其他

登录后查看更多信息

当前项目

药物(靶点)	适应症	全球最高研发状态

乐德奇拜单抗 ( IL-4Rα )	慢性鼻窦炎伴鼻息肉更多	终止
CBP-246 ( IL1RAP )	炎症更多	终止
CBP-403	炎症更多	终止
Icanbelimod ( S1PR1 )	溃疡性结肠炎更多	无进展
CBP-312 ( GPCR )	自身免疫性疾病更多	无进展