Drugs / KN026
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Her2-receptor negative breast cancer 2 milestones | |||||
| Filed | China (NMPA) | 恩尼妥 | Her2-receptor negative breast cancer | 2026-08-05 | “2026年8月，安尼妥单抗联合HB1801用于HER2阳性早期或局部晚期乳腺癌新辅助治疗的NDA获NMPA受理，并纳入优先审评审批程序。” alphamabonc.com ↗ |
| Filed | China (NMPA) | — | Her2-receptor negative breast cancer | 2025-09-11 | “NEW DRUG APPLICATION FOR KN026 (ANBENITAMAB INJECTION) ACCEPTED BY THE NMPA” irasia.com ↗ “安尼妥单抗注射液（研发代号：KN026）的新药上市申请（NDA）已获国家药品监督管理局（NMPA）受理。” alphamabonc.com ↗ |
| Filed progesterone-receptor positive breast cancer 1 milestone | |||||
| Filed | China (NMPA) | 恩尼妥 | progesterone-receptor positive breast cancer | 2026-08-19 | “2026年8月，安尼妥单抗联合HB1801一线治疗不可切除或转移性HER2阳性乳腺癌的NDA获NMPA受理，并纳入优先审评审批。” alphamabonc.com ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04040699 | Sep 2019 → Sep 2022 | HER2 positive breast carcinoma | Peking University | Completed | No outcome recorded |
| Phase 1 | NCT03847168 | Jun 2019 → Dec 2022 | breast cancer, gastroesophageal cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT03619681 | Sep 2018 → Jun 2022 | breast cancer, gastric cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary | ||||||
| Phase 2 | NCT06998771 | Jun 2025 → Jun 2028 expected | carcinoma | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06023758 | Sep 2023 → Sep 2025 overdue | carcinoma | Peking University | Recruiting | No outcome recorded |
| Phase 2 | NCT05985707 | Aug 2023 → Dec 2026 expected | carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04881929 | Aug 2021 → Nov 2022 | breast cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Unknown | Met primary |
| Phase 2 | NCT04521179 | Dec 2020 → Jan 2022 | — | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT04165993 | Dec 2019 → May 2021 | breast cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Unknown | No outcome recorded |
| Phase 2 | NCT03925974 | Jun 2019 → May 2022 | gastroesophageal cancer | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07332533 | Dec 2025 → Jun 2032 expected | carcinoma | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT05427383 | Apr 2022 → Nov 2025 overdue | gastric cancer | Shanghai JMT-Bio Inc. | Recruiting | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07441460 | Mar 2026 → Aug 2034 expected | HER2 positive breast carcinoma | Shanghai JMT-Bio Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06747338 | Dec 2024 → Dec 2026 expected | HER2 positive breast carcinoma | Shanghai JMT-Bio Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT05838066 | Jul 2023 → Jul 2025 overdue | breast carcinoma by gene expression profile | Shanghai JMT-Bio Inc. | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07597629 Background | May 2026 → Nov 2027 expected | breast cancer | CSPC Megalith Biopharmaceutical Co.,Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 45
| Date | Issuer | Release |
|---|---|---|
| 2026-08-19 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 康宁杰瑞恩尼妥®（KN026）又一上市申请获受理，联合HB1801一线治疗乳腺癌 alphamabonc.com ↗ |
| 2026-08-18 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - NEW DRUG APPLICATION FOR ANBENITAMAB (KN026) AND DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) (HB1801) FOR THE FIRST-LINE TREATMENT OF ADVANCED BREAST CANCER ACCEPTED BY THE NMPA irasia.com ↗ |
| 2026-08-05 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 康宁杰瑞恩尼妥®（KN026）联合HB1801乳腺癌新辅助上市申请获受理，进入优先审评审批通道 alphamabonc.com ↗
用于早期或局部晚期HER2阳性乳腺癌新辅助治疗的新药上市申请（NDA）已获中国国家药品监督管理局（NMPA）受理，并纳入优先审评审批程序。 |
| 2026-08-04 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - NEW DRUG APPLICATION FOR ANBENITAMAB (KN026) AND DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) (HB1801) FOR NEOADJUVANT TREATMENT ACCEPTED BY THE NMPA irasia.com ↗ |
| 2026-07-15 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 康宁杰瑞恩尼妥®（KN026）再获突破性疗法认定，用于一线HER2阳性乳腺癌 alphamabonc.com ↗
此次突破性疗法认定，将加速恩尼妥 ® 晚期乳腺癌适应症的研发进程及审评审批进度。 |
| 2026-07-14 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) (HB1801) AND ANBENITAMAB (KN026) GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CHINA FOR THE FIRST-LINE TREATMENT OF ADVANCED HER2-POSITIVE BREAST CANCER irasia.com ↗
DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) (HB1801) AND ANBENITAMAB (KN026) GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CHINA FOR THE FIRST-LINE TREATMENT OF ADVANCED HER2-POSITIVE BREAST CANCER |
| 2026-06-11 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 康宁杰瑞安尼妥单抗（KN026）联合HB1801再添新彩 一线治疗乳腺癌Ⅲ期临床研究达到主要终点 alphamabonc.com ↗
本次一线治疗Ⅲ期临床研究达到主要终点，是该组合疗法继乳腺癌新辅助Ⅲ期临床（KN026-004）取得突破性阳性结果后再添新的循证证据。 |
| 2026-06-10 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - PHASE III CLINICAL STUDY OF ANBENITAMAB (KN026) IN COMBINATION WITH DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) (HB1801) FOR FIRST-LINE TREATMENT OF HER2-POSITIVE ADVANCED BREAST CANCER MEETS PRIMARY ENDPOINT irasia.com ↗ |
| 2026-06-01 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 2026 ASCO | LBA口头报告！康宁杰瑞安尼妥单抗（KN026）联合HB1801新辅助治疗乳腺癌Ⅲ期临床研究数据重磅公布 alphamabonc.com ↗
经BIRC评估，试验组tpCR率为62.4%（95% CI：56.2～68.2），显著高于对照组的tpCR率51.2%（95% CI：44.9～57.4），单侧 P=0.0036 ，差异具有统计学意义。 |
| 2026-06-01 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results PHASE III CLINICAL STUDY RESULTS OF ANBENITAMAB (KN026) IN COMBINATION WITH DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) (HB1801) FOR NEOADJUVANT TREATMENT OF HER2-POSITIVE BREAST CANCER SELECTED FOR LBA ORAL PRESENTATION AT THE 2026 ASCO ANNUAL MEETING irasia.com ↗
Assessed by BIRC, the tpCR rate in the experimental group was 62.4% (95% Confidence Interval (‘‘CI’’): 56.2 –68.2), which was significantly higher than the 51.2% (95% CI: 44.9 –57.4) in the control group (one-sided P=0.0036), showing a statistically significant difference. |
| 2026-05-29 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 中国首个胃癌二线HER2双抗！康宁杰瑞恩尼妥®（KN026）重磅上市，开启晚期胃癌治疗新时代 alphamabonc.com ↗
恩尼妥 ® （安尼妥单抗注射液，研发代号：KN026）已获得国家药品监督管理局（NMPA）批准上市（批准文号：国药准字S20260036） |
| 2026-04-22 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 2026 ASCO预告 | 康宁杰瑞安尼妥单抗（KN026）联合HB1801新辅助治疗乳腺癌Ⅲ期临床研究结果入选LBA口头报告 alphamabonc.com ↗
KN026联合疗法显著提升了患者的总体病理完全缓解率（tpCR） |
| 2026-04-01 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 康宁杰瑞安尼妥单抗（KN026）联合HB1801新辅助治疗乳腺癌Ⅲ期临床研究达到主要终点 alphamabonc.com ↗ |
| 2026-03-31 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - PHASE III CLINICAL STUDY OF ANBENITAMAB (KN026) IN COMBINATION WITH DOCETAXEL (ALBUMIN-BOUND) (HB1801) FOR NEOADJUVANT TREATMENT OF HER2+ BREAST CANCER MEETS PRIMARY ENDPOINT irasia.com ↗ |
| 2026-01-27 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 康宁杰瑞安尼妥单抗（KN026）研究成果荣登肿瘤学顶刊《Annals of Oncology》 alphamabonc.com ↗
安尼妥单抗组显著提升了中位PFS，安尼妥单抗组和SOC对照组的中位PFS分别为7.1个月和2.7个月（HR 0.25，p<0.0001），降低了75%的疾病进展/死亡风险。 |
| 2025-10-18 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 2025 ESMO │ LBA口头报告！安尼妥单抗（KN026）Ⅲ期临床研究最新成果重磅公布 alphamabonc.com ↗
安尼妥单抗组的中位无进展生存期（PFS）为7.1个月，对照组为2.7个月。 |
| 2025-09-12 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory KN026（安尼妥单抗注射液）新药上市申请获国家药品监督管理局受理 alphamabonc.com ↗
2025年9月12日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK）宣布，公司自主研发、与石药集团（股票代码：1093.HK）全资附属公司上海津曼特生物科技有限公司合作开发的安尼妥单抗注射液（研发代号：KN026）的新药上市申请（NDA）已获国家药品监督管理局（NMPA）受理。 |
| 2025-09-11 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - NEW DRUG APPLICATION FOR KN026 (ANBENITAMAB INJECTION) ACCEPTED BY THE NMPA irasia.com ↗
NEW DRUG APPLICATION FOR KN026 (ANBENITAMAB INJECTION) ACCEPTED BY THE NMPA |
| 2025-05-01 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results HER2双抗KN026关键性Ⅱ/Ⅲ期临床研究期中分析达到PFS主要终点 alphamabonc.com ↗
期中分析结果显示，与现有标准治疗相比，KN026联合化疗显著改善了患者的PFS，降低了疾病进展/死亡的风险，并具有OS获益趋势。 |
| 2025-04-30 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - PIVOTAL PHASE II/III CLINICAL STUDY OF KN026 MET PRIMARY ENDPOINT OF PROGRESSION-FREE SURVIVAL (PFS) AT INTERIM ANALYSIS irasia.com ↗ |
| 2024-10-17 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory HER2双抗KN026联合白蛋白结合型多西他赛新辅助治疗乳腺癌Ⅲ期临床获批 alphamabonc.com ↗
2024年10月17日，康宁杰瑞生物制药（股票代码：9966.HK）与石药集团（股票代码：1093.HK）共同宣布，HER2双特异性抗体KN026联合白蛋白结合型多西他赛HB1801的一项Ⅲ期临床研究（研究方案号：KN026-004）申请已获得国家药品监督管理局（NMPA）药品审评中心（CDE）批准，用于HER2阳性早期或局部晚期乳腺癌的新辅助治疗。 |
| 2023-12-07 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results KN026联合化疗一线治疗HER2阳性复发转移性乳腺癌研究结果长期随访数据更新发布 alphamabonc.com ↗
结果显示，55例可评价患者，客观缓解率（ORR）为76.4% (42/55，95% CI:62.98,86.77)。 |
| 2023-11-07 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory HER2双抗KN026获突破性疗法认定 alphamabonc.com ↗
KN026获授予突破性治疗认定，其研发和审评速度会进一步加快，有望成为首个针对HER2靶向治疗失败的2线胃癌抗HER2治疗的药物。 |
| 2023-11-06 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - KN026 WAS GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CHINA irasia.com ↗
KN026 WAS GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CHINA |
| 2023-10-24 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 康宁杰瑞于ESMO公布两项KN026联合多西他赛治疗HER2阳性乳腺癌研究的更新数据 alphamabonc.com ↗
2年随访数据显示，KN026联合多西他赛作为HER2阳性乳腺癌一线治疗方案疗效显著，mPFS 达到26.9个月，24个月的OS率高达84.2%。 |
| 2023-06-06 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 康宁杰瑞在ASCO 2023年会上更新KN026联合KN046治疗HER2阳性实体瘤的临床研究数据 alphamabonc.com ↗
其中15例结直肠癌患者ORR为53.3%(95% CI: 26.6, 78.7)，中位DOR为11.7个月(95% CI:3.2, NE)，中位PFS为12.2个月(95% CI: 2.7, NE)，12个月生存率为80.0%(95% CI: 50.0,93.1)。 |
| 2023-05-09 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory HER2双抗KN026联合化疗一线治疗乳腺癌三期临床获批 alphamabonc.com ↗
2023年5月9日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK）与石药集团共同宣布，HER2双特异性抗体注射液（研发代号：KN026）联合注射用多西他赛（白蛋白结合型）用于一线治疗HER2 阳性复发转移性乳腺癌的注册临床试验申请在中国获批。 |
| 2022-12-12 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results KN026联合化疗用于HER2阳性早期或局部晚期乳腺癌新辅助治疗的临床数据在SABCS 2022公布 alphamabonc.com ↗
截止2022年9月10日，20例患者完成手术和术后病理评估，tpCR率为50.0%，bpCR率为55.0%，ORR为100%。 |
| 2022-12-12 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results KN026联合化疗用于HER2阳性复发转移性乳腺癌一线治疗的临床数据在SABCS 2022公布 alphamabonc.com ↗
55例患者可进行疗效评估，经确认的客观缓解率（ORR）为76.4% （95% CI: 62.98，86.77），缓解持续时间（DoR）为24.0个月（95% CI: 18.070，NE），疾病控制率（DCR）为100%。 |
| 2022-11-23 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results KN026二线治疗HER2表达胃癌或胃食管结合部癌研究结果在国际知名期刊EJC发表 alphamabonc.com ↗
研究结果显示，KN026在HER2高表达胃癌/胃食管结合部癌患者中具有优异疗效和良好的安全性。 |
| 2022-09-14 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results KN026联合KN046用于一线HER2阳性胃/胃食管结合部癌治疗的最新数据公布 alphamabonc.com ↗
客观缓解率（ORR）高达77.8%（95% CI: 57.7, 91.4），疾病控制率（DCR）为92.6%（95% CI: 75.7, 99.1）。 |
| 2022-08-22 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 康宁杰瑞两项临床试验申请获CDE受理 alphamabonc.com ↗
2022年8月22日，中国国家药监局药品审评中心（CDE）信息公开中心显示，康宁杰瑞递交的两项临床试验申请获受理，分别为新型HER2双抗偶联药物（Antibody-drug conjugates, ADC）JSKN003的Ⅰ期临床研究（JSKN003-102）和HER2双抗KN026与PD-L1/CTLA-4 双抗KN046联合用药的Ⅲ期关键性临床研究（KN026-308）。 |
| 2022-06-06 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results KN026治疗HER2表达的晚期胃癌或胃食管结合部癌的Ⅱ期临床数据在ASCO 2022年会上公布 alphamabonc.com ↗
结果显示，KN026 单药在既往接受过治疗的 HER2高表达GC/GEJ患者中疗效优异，在HER2低表达患者中，疗效也与当前二线化疗具有可比性，且安全性良好。 |
| 2022-04-11 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results KN026联合KN046治疗HER2阳性实体瘤的最新数据亮相AACR 2022 alphamabonc.com ↗
客观缓解率（ORR）为55.0%（11/20, 95% CI: 31.5-76.9），疾病控制率（DCR）为85.0%（17/20, 95% CI: 62.1-96.8），6个月无进展生存率（PFS）为84.1%。 |
| 2022-02-24 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 康宁杰瑞KN026治疗HER2阳性乳腺癌的临床数据亮相《Clinical Cancer Research》 alphamabonc.com ↗
此次发表的更新数据，展示了KN026具有良好的耐受性和优效的抗肿瘤活性，后线治疗至少一线抗HER2治疗失败的HER2阳性转移性乳腺癌患者，达到良好的治疗效果。 |
| 2022-01-04 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory HER2双抗KN026联合化疗治疗胃癌的注册临床获批 alphamabonc.com ↗
2022年1月4日，康宁杰瑞生物制药（股票代码：9966.HK）与石药集团（股票代码：1093.HK）共同宣布，HER2双特异性抗体KN026联合化疗的一项注册临床试验（KN026-CSP-001）申请获得国家药品监督管理局药品审评中心（CDE）批准。 |
| 2021-12-09 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results HER2双抗KN026两项临床数据亮相圣安东尼奥乳腺癌大会 alphamabonc.com ↗
33例患者可进行总体有效率分析，客观缓解率（ORR）为48.5% (16/33，95%CI：30.8-66.5)，1例患者达到完全缓解(CR)；疾病控制率(DCR)为78.8% (26/33，95%CI 61.1-91.0)。 |
| 2021-10-21 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory HER2双抗KN026 Ⅲ期临床试验申请获CDE正式受理 alphamabonc.com ↗
2021年10月21日，康宁杰瑞生物制药（股票代码：9966.HK）与石药集团（股票代码：1093.HK）共同宣布，重组人源化抗HER2双特异性抗体KN026一项Ⅲ期临床试验申请（研究编号：KN026-306）获CDE正式受理，将开展联合化疗用于一线标准化疗后出现疾病进展的晚期胃癌/胃食管结合部腺癌的注册临床研究。 |
| 2020-12-28 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 抗HER2双特异性抗体KN026与爱博新® (哌柏西利)联合用药治疗方案获批临床 alphamabonc.com ↗
公司已于近期收到中国国家药品监督管理局颁发的药物临床试验批准通知书，批准开展KN026联合哌柏西利或KN026与哌柏西利和氟维司群联合，用于曲妥珠单抗和紫杉类药物治疗失败的HER2阳性局部晚期不可切除和/或转移性乳腺癌的治疗。 |
| 2020-12-23 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 双特异性抗体KN026与KN046联合疗法获美国FDA孤儿药资格认定，用于治疗胃癌及胃食管连接部癌 alphamabonc.com ↗
2020年12月23日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK）宣布，公司自主研发的双特异性抗体KN026（抗HER2双特异性抗体）与KN046（PD-L1/CTLA-4双特异性单域抗体）联合疗法获美国食品药品监督管理局（FDA）授予孤儿药资格（Orphan Drug Designation，ODD），用于治疗HER2-阳性或HER2-低表达胃癌及胃食管连接部癌（GC/GEJ）。 |
| 2020-11-10 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 康宁杰瑞KN026联合KN046临床Ⅰb期研究数据亮相癌症免疫治疗学会年会（SITC 2020） alphamabonc.com ↗
14例HER2阳性（HER2 IHC3+或者IHC2+且FISH+）受试者疗效可评价，客观缓解率（ORR）为64.3%，疾病控制率（DCR）为92.9%，中位无进展生存期（PFS）和中位总生存期（OS）尚未达到。 |
| 2020-05-18 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 江苏康宁杰瑞将在2020年 AACR年会上展示 KN026 研究进展 alphamabonc.com ↗
本次分析预测KN026 20 mg/kg Q2W和30 mg/kg Q3W这两种给药方式都能达到良好的临床疗效，KN026的负荷剂量有利于提高给药初期的肿瘤杀伤速率、提高患者获益。 |
| 2020-05-14 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 江苏康宁杰瑞肿瘤创新药 KN046 和 KN026 临床 I 期研究成果将在2020年ASCO大会展示 alphamabonc.com ↗
I期临床试验结果表明，KN026具有良好的耐受性和安全性，在多线抗HER2治疗后进展的HER2阳性乳腺癌患者中表现出了更优的抗肿瘤活性。 |
| 2020-05-12 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 江苏康宁杰瑞4项临床试验申请获国家药审中心正式批准 alphamabonc.com ↗
此次批准同意采用冻干制剂开展KN026用于HER2阳性或表达实体瘤的治疗，包括与多西他赛联用，用于一线治疗转移复发性HER2阳性或表达乳腺癌。 |
| 2018-10-16 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 江苏康宁杰瑞HER2 双特异性抗体KN026 临床试验申请获得美国FDA批准；临床一期试验在中国启动 alphamabonc.com ↗
2018年10月16日，江苏康宁杰瑞生物制药有限公司（以下简称：江苏康宁杰瑞）今日宣布，其自主研发的HER2双特异性抗体 (产品代码:KN026）的临床试验申请已获得美国FDA批准，预期不久将启动美国临床试验。 |
All press releases naming this drug 52 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | KN026 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03925974 ↗ |
| Known as | Anbenitamab | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594568 ↗ |
| Known as | Anti-her2 bsab kn026 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594568 ↗ |
| Action | Inhibit | “leading to a dual HER2 signal blockade” NCT04040699 ↗ |
| Modality | Monoclonal antibody | “KN026 is an anti-HER2 bispecific antibody” NCT04521179 ↗ |
| Route | Intravenous | “intravenously administrated” NCT03619681 ↗ |
| Target | ERBB2 | “targeting HER2” NCT07597629 ↗ |