Drugs / CM310
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | atopic eczema | — | “司普奇拜单抗（CM310）用于成人中重度特应性皮炎治疗的药品上市许可申请（NDA）已获国家药品监督管理局受理” keymedbio.com ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07040072 | Oct 2025 → Jun 2027 expected | head and neck squamous cell carcinoma | Beijing Tongren Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06171048 | Apr 2024 → Apr 2025 | — | Keymed Biosciences Co.Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT05702450 | Mar → Jul 2023 | — | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06161090 | Sep 2019 → Jan 2020 | — | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06162507 | Dec 2023 → Jul 2024 | atopic eczema | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT04893941 | Jul 2020 → Jan 2021 | atopic eczema | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 216 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07617324 | Jun → Oct 2026 expected | seasonal allergic rhinitis | Chengdu Kangnuoxing Biopharma,Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06883552 | Oct 2025 → Oct 2026 expected | non-small cell lung carcinoma | Sichuan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06525597 | Sep 2024 → Oct 2025 overdue | allergic rhinitis | Keymed Biosciences Co.Ltd | Recruiting | No outcome recorded |
| Phase 2 | NCT06171074 | Mar 2024 → Mar 2025 | seasonal allergic rhinitis | Keymed Biosciences Co.Ltd | Unknown | No outcome recorded |
| Phase 2 | NCT06116565 | Mar 2024 → Mar 2026 | atopic eczema | Keymed Biosciences Co.Ltd | Unknown | No outcome recorded |
| Phase 2 | NCT06300203 | Mar 2024 → Jun 2026 overdue | seasonal allergic rhinitis | Beijing Tongren Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05908721 | Aug → Dec 2023 | allergic rhinitis | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 2 | NCT05715320 | Mar 2023 → Jul 2024 | atopic eczema | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 2 | NCT05579925 | Oct 2022 → Jul 2023 | atopic eczema | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 2 | NCT05452343 | Aug 2022 → Mar 2024 | — | Keymed Biosciences Co.Ltd | Unknown | No outcome recorded |
| Phase 2 | NCT05470647 | Aug → Sep 2022 | allergic rhinitis | Beijing Tongren Hospital | Completed | Missed primary |
| Phase 2 | NCT05186909 | Jan 2022 → Sep 2023 | asthma | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 2 | NCT05131464 | Nov 2021 → Jan 2024 | chronic rhinosinusitis | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 2 | NCT04893707 | Jun 2021 → Feb 2023 | atopic eczema | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 2 | NCT04805398 | Apr 2021 → Mar 2022 | chronic rhinosinusitis, nasal cavity polyp | Keymed Biosciences Co.Ltd | Completed | Met primary |
| Phase 2 | NCT04805411 | Feb → Nov 2021 | atopic eczema | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06547333 | Sep 2024 → Apr 2032 expected | chronic obstructive pulmonary disease | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05761028 | Apr 2023 → May 2032 expected | asthma | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 37 trials · 2 met primary | ||||||
| Phase 3 | NCT07678931 | Aug → Dec 2026 expected | seasonal allergic rhinitis | Chengdu Kangnuoxing Biopharma,Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07210554 | Nov 2025 → Mar 2028 expected | bullous pemphigoid | Chengdu Kangnuoxing Biopharma,Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06495229 | Aug 2024 → Aug 2026 overdue | atopic eczema | Keymed Biosciences Co.Ltd | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06424470 | Jun 2024 → Feb 2026 | prurigo nodularis | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 3 | NCT06277765 | Mar 2024 → Jan 2025 | atopic eczema | Keymed Biosciences Co.Ltd | Completed | Met primary |
| Phase 3 | NCT05908032 | Aug → Dec 2023 | seasonal allergic rhinitis | Keymed Biosciences Co.Ltd | Completed | Met primary |
| Phase 3 | NCT05265923 | Apr 2022 → Oct 2023 | atopic eczema | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06801353 | Feb → Dec 2025 overdue | chronic rhinosinusitis | Beijing Tongren Hospital | Not yet recruiting | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07616609 | Jun 2026 → Dec 2028 expected | chronic rhinosinusitis | Beijing Tongren Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07240376 | Nov 2025 → Dec 2026 expected | rhinitis | Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| — | NCT07143864 | Sep 2025 → Dec 2026 expected | primary cutaneous amyloidosis | First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | No outcome recorded |
| — | NCT05728684 | Feb 2023 → Feb 2024 | immunoglobulin G4-related sclerosing disease | Beijing Friendship Hospital | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT05436275 Comparator | Aug 2022 → Jun 2024 | chronic rhinosinusitis | Keymed Biosciences Co.Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Keymed Biosciences Co.Ltd | Results EADV 2026｜54周EASI-75应答率超九成！司普奇拜单抗青少年中重度AD长期数据重磅发布 keymedbio.com ↗
第18周已达到的疗效反应在第54周不仅得以维持，更获得进一步改善；长期暴露未发现新的安全性信号。 |
| 2026-09-30 | Keymed Biosciences Co.Ltd | Results EADV 2026｜应答导向，长效维持：司普奇拜单抗延长给药间隔52周数据为中重度AD长期管理提供新策略 keymedbio.com ↗ |
| 2026-09-30 | Keymed Biosciences Co.Ltd | Results 24周显著改善瘙痒与皮损！司普奇拜单抗治疗成人中重度结节性痒疹Ⅲ期临床数据亮相EADV 2026！ keymedbio.com ↗ |
| 2026-09-12 | Keymed Biosciences Co.Ltd | Regulatory 两载创新路，基药启新程｜康悦达®上市两周年特别回顾 keymedbio.com ↗ |
| 2026-06-18 | Keymed Biosciences Co.Ltd | Results EAACI 2026｜生物制剂破解难治性2型炎症性疾病和多病共存诊疗核心难题 keymedbio.com ↗
NPS改善在第2周首次评估时即已显现，鼻塞评分改善在第4周表现明显。 |
| 2025-12-10 | Keymed Biosciences Co.Ltd | Regulatory 国家医保局解读2025年医保药品目录，司普奇拜单抗作为新增药品代表获认可 keymedbio.com ↗
康悦达 ® （司普奇拜单抗）成功纳入新版国家基本医疗保险药品目录，将显著降低患者用药负担，让更多有需求的患者能够以可负担的价格获得创新治疗。 |
| 2025-10-09 | Keymed Biosciences Co.Ltd | Results 2025 APAAACI | 司普奇拜单抗四项III期研究事后分析报告发布，为鼻病精准治疗提供新临床依据 keymedbio.com ↗
该事后分析提示，司普奇拜单抗可为中重度SAR患者提供快速且具有临床意义的鼻塞缓解效果 1 。 |
| 2025-10-09 | Keymed Biosciences Co.Ltd | Results 2025 APAAACI | 慢性鼻窦炎伴鼻息肉“中国方案”助力临床治疗迈入更加精准、高效新阶段！ keymedbio.com ↗ |
| 2025-09-22 | Keymed Biosciences Co.Ltd | Results 18周EASI-75应答率达73.9%！司普奇拜单抗青少年特应性皮炎III期临床数据重磅亮相EADV 2025！ keymedbio.com ↗
18周时，司普奇拜单抗组高达73.9%的患者实现EASI-75应答，显著高于安慰剂组（43.3%，P<0.0001）。 |
| 2025-04-07 | Keymed Biosciences Co.Ltd | Results 特应性皮炎长期管理新方案：司普奇拜单抗延长给药间隔至Q4W、Q8W，依然可维持高水平应答！ keymedbio.com ↗
各组患者PP-NRS周平均值平均较基线改善73.2%，各组PP-NRS较基线改善≥4分的应答率均超70%（图4）。 |
| 2025-04-04 | Keymed Biosciences Co.Ltd | Results 全球首发！司普奇拜单抗治疗季节性过敏性鼻炎III期研究数据发表于国际顶刊《Nature Medicine》 keymedbio.com ↗ |
| 2024-10-28 | Keymed Biosciences Co.Ltd | Results 再度登顶：司普奇拜单抗III期研究52周数据发表于过敏与免疫学领域顶级期刊《Allergy》 keymedbio.com ↗ |
| 2024-06-07 | Keymed Biosciences Co.Ltd | Regulatory 司普奇拜单抗治疗慢性鼻窦炎伴鼻息肉的药品上市许可申请获国家药品监督管理局受理 keymedbio.com ↗
今日宣布，公司自主研发的1类新药司普奇拜单抗注射液（CM310）治疗慢性鼻窦炎伴鼻息肉的药品上市许可申请已获国家药品监督管理局受理，并被纳入优先审评审批程序。 |
| 2024-06-03 | Keymed Biosciences Co.Ltd | Results 强效持续临床获益：司普奇拜单抗治疗中重度特应性皮炎III期研究52周数据亮相EAACI年会 keymedbio.com ↗ |
| 2024-05-23 | Keymed Biosciences Co.Ltd | Regulatory 司普奇拜单抗注射液再被纳入优先审评审批程序，用于治疗慢性鼻窦炎伴鼻息肉 keymedbio.com ↗
这是继成人中重度特应性皮炎适应症后，司普奇拜单抗的第2项适应症被药审中心纳入优先审评审批程序。 |
| 2023-12-27 | Keymed Biosciences Co.Ltd | Results 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 keymedbio.com ↗
研究结果显示III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（P值均<0.0001），且安全性良好 。 |
| 2023-10-11 | Keymed Biosciences Co.Ltd | Results CM310 III期临床试验顶线数据入选2023年欧洲皮肤病与性病学会(EADV)年会壁报 keymedbio.com ↗
疗效结果显示，本试验在第16周达到了共同主要终点。 |
| 2022-06-15 | Keymed Biosciences Co.Ltd | Regulatory 康诺亚CM310获突破性治疗药物认定，拟治疗中重度特应性皮炎 keymedbio.com ↗
2022年6月15日，康诺亚（香港联交所股份代码：02162）宣布，公司自主研发的1类新药CM310重组人源化单克隆抗体注射液（以下简称“CM310”）获国家药品监督管理局药品审评中心（以下简称“药审中心”）突破性治疗药物认定，用于治疗中重度特应性皮炎。 |
All press releases naming this drug 18 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CM310 | “efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial.” PMID 38356731 ↗ Feb 202425“The goal of this clinical trial is to learn if Stapokibart (CM310) works to treat Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES) in adults.” NCT07240376 ↗ “Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis” NCT06300203 ↗ |
| Known as | Stapokibart | “BACKGROUND: Stapokibart/CM310, a humanized monoclonal antibody targeting the interleukin-4 receptor α chain, has shown promising treatment benefits in patients with...” PMID 39080181 ↗ Jul 202415“efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial.” PMID 38356731 ↗ Feb 2024 “Stapokibart is a novel anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD).” PMID 41284735 ↗ Mar 2026 “Stapokibart, a novel humanized monoclonal antibody that targets interleukin-4Rα, has been approved in China for the treatment of adults with moderate-to-severe AD.” PMID 41697953 ↗ May 2026 “An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer” NCT06883552 ↗ “Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis.” PMID 38833140 ↗ Jun 2024 |
| Known as | Stapokibart Injection | “Stapokibart Injection in Combination with Tislelizumab Injection in Patients with NSCLC” NCT06883552 ↗ |
| Action | Inhibit | “inhibits IL-4 and IL-13 signaling” PMID 37483544 ↗ Jul 2023 |
| Modality | Monoclonal antibody | “CM310, a humanised anti-interleukin (IL)-4 receptor alpha monoclonal antibody” PMID 37483544 ↗ Jul 2023 |
| Route | Subcutaneous | “receive subcutaneously either CM310 (300 mg) or placebo” PMID 37483544 ↗ Jul 2023 |
| Target | IL4R | “CM310, a humanised anti-interleukin (IL)-4 receptor alpha monoclonal antibody” PMID 37483544 ↗ Jul 2023 |