Drugs / HB1801
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Her2-receptor negative breast cancer 1 milestone | |||||
| Filed | China (NMPA) | — | Her2-receptor negative breast cancer | 2026-08-04 | “NEW DRUG APPLICATION FOR ANBENITAMAB (KN026) AND DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) (HB1801) FOR NEOADJUVANT TREAT MENT ACCEPTED BY THE NMPA” irasia.com ↗ |
| Filed progesterone-receptor positive breast cancer 1 milestone | |||||
| Filed | China (NMPA) | — | progesterone-receptor positive breast cancer | 2026-08-18 | “NEW DRUG APPLICATION FOR ANBENITAMAB (KN026) AND DOCETAXEL FOR INJECTION (ALBUMIN-BOUND) (HB1801) FOR THE FIRST-LINE TRE ATMENT OF ADVANCED BREAST CANCER ACCEPTED BY THE NMPA” irasia.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 25 trials | ||||||
| Phase 2 | NCT07116824 | Sep 2025 → Jul 2026 overdue | HER2 positive breast carcinoma | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07083505 | Aug 2025 → Oct 2026 expected | breast cancer | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06525350 | Jul 2024 → Dec 2026 expected | non-small cell lung carcinoma | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05863325 | Jun 2023 → Mar 2024 | non-small cell lung carcinoma | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05582499 | Nov 2022 → Dec 2027 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT07805135 | Aug 2026 → Jun 2028 expected | Her2-receptor negative breast cancer | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| 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 1/2 | NCT06682611 Comparator | Nov 2024 → Nov 2026 expected | — | Shanghai Runshi Pharmaceutical Technology Co., Ltd | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 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 | Results 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 ↗
其联合白蛋白结合型多西他赛（HB1801）用于HER2阳性早期或局部晚期乳腺癌新辅助治疗的Ⅲ期临床研究，于2026年3月达到主要终点，结果具有显著的统计学和临床意义； |
| 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 ↗ |
| 2020-09-17 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - "DOCETAXEL FOR INJECTION (ALBUMIN-BOUND)" OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. irasia.com ↗ |
| 2020-05-19 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - "DOCETAXEL FOR INJECTION (ALBUMIN-BOUND)" OBTAINS CLINICAL TRIAL APPROVAL irasia.com ↗
has obtained appoval granted by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. |
All press releases naming this drug 18 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HB1801 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05838066 ↗ |
| Known as | Docetaxel | “HB1801 is Docetaxel for injection (Albumin-bound).” NCT07083505 ↗1“HB1801 (docetaxel, albumin-bound）” NCT06525350 ↗ |
| Route | Intravenous | “intravenous (IV) infusion” NCT05838066 ↗ |