Drugs / Enlonstobart
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | Enshuxing | recurrent or metastatic cervical cancer | 2023-03-10 | “NMPA ACCEPTANCE OF APPLICATION FOR MARKETING APPROVAL OF ENLONSTOBART FOR INJECTION” irasia.com ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03852823 | May 2019 → Sep 2022 | cervical cancer, lymphoma, malignant mesothelioma, non-small cell lung carcinoma | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT07622225 | May 2026 → Dec 2028 expected | neoplasm | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07282509 | Dec 2025 → Jun 2028 expected | hepatocellular carcinoma | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07288814 | Dec 2025 → Dec 2026 expected | peripheral T-cell lymphoma, not otherwise specified | Sun Yat-sen University Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06132217 | Jan 2024 → Jan 2027 expected | neoplasm | Shanghai Runshi Pharmaceutical Technology Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06136988 | Dec 2023 → Apr 2027 expected | esophageal squamous cell carcinoma | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05508659 | Sep 2022 → Sep 2024 | cancer | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 213 trials | ||||||
| Phase 2 | NCT07810114 | Aug 2026 → Dec 2027 expected | rectal cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07714668 | Aug 2026 → Apr 2028 expected | ovarian cancer | CSPC Megalith Biopharmaceutical Co.,Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07448077 | Mar 2026 overdue | — | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07281157 | Nov 2025 → Apr 2027 expected | rectal cancer | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06989671 | Aug 2025 → Dec 2027 expected | head and neck squamous cell carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06998771 | Jun 2025 → Jun 2028 expected | carcinoma | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06981858 | May 2025 → Feb 2029 expected | cervical carcinoma | Chongqing University Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07183865 | Mar 2025 → Mar 2030 expected | rectal cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06089330 | Jan → Jul 2024 | colorectal cancer | Shanghai JMT-Bio Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT05068141 | Oct 2021 → Oct 2022 | triple-negative breast carcinoma | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05009953 | Sep 2021 → Jan 2023 | gallbladder carcinoma, intrahepatic cholangiocarcinoma | CSPC Ouyi Pharmaceutical Co., Ltd. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04983550 | Sep 2021 → Jan 2023 | fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04886700 | Jul 2021 → Dec 2022 | cervical cancer | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT07662811 | Jun 2026 → Dec 2027 expected | non-small cell lung carcinoma | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07585279 | May 2026 → Feb 2031 expected | colorectal cancer | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07251062 | Dec 2025 → Dec 2029 expected | esophageal squamous cell carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT07332533 | Dec 2025 → Jun 2032 expected | carcinoma | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07672223 | Jun 2026 → Sep 2029 expected | non-small cell lung carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07633873 | Jun 2026 → Sep 2027 expected | non-small cell lung carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05715840 | Jan 2023 → Jul 2024 | — | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Unknown | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT06682611 Comparator | Nov 2024 → Nov 2026 expected | — | Shanghai Runshi Pharmaceutical Technology Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07254585 Background | Dec 2025 → Jun 2026 overdue | head and neck squamous cell carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Results VOLUNTARY ANNOUNCEMENT - PHASE I/II CLINICAL TRIAL DATA OF SYS6010 IN COMBINATION WITH ENLONSTOBART FOR THE TREATMENT OF SYSTEMIC TREATMENT-NAIVE, ACTIONABLE GENOMIC ALTERATION-NEGATIVE ADVANCED NSCLC ORALLY PRESENTED AT THE 2026 WORLD CONFERENCE ON LUNG CANCER (WCLC) irasia.com ↗ |
| 2024-06-28 | Hangzhou Sumgen Biotech Co., Ltd. | Regulatory 重大里程碑！恩朗苏拜单抗注射液（恩舒幸®）国内获批上市！ sumgenbio.com ↗
国家药品监督管理局（ NMPA ）官网最新公示 ， 恩朗苏拜单抗注射液 （ 商品名：恩舒幸 ® ） 正式获得上市许可批准 ，用于治疗至少一线含铂方案化疗失败的 PD-L1 表达阳性的复发或转移性宫颈癌患者。 |
| 2024-06-28 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ENLONSTOBART INJECTION OBTAINS CONDITIONAL MARKETING APPROVAL GRANTED BY NMPA irasia.com ↗
ENLONSTOBART INJECTION OBTAINS CONDITIONAL MARKETING APPROVAL GRANTED BY NMPA |
| 2023-03-10 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTANCE OF APPLICATION FOR MARKETING APPROVAL OF ENLONSTOBART FOR INJECTION irasia.com ↗
The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the application for marketing approval of enlonstobart for injection (brand name: Enshuxing) of CSPC Megalith Biopharmaceutical Co., Ltd* (石藥集團巨石生物製藥有限公司), a subsidiary of the Company, has been accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China with eligibility for the conditional approval pathway. |
| 2018-11-08 | Hangzhou Sumgen Biotech Co., Ltd. | Regulatory 尚健生物首个Ⅰ类新药获临床试验批件 sumgenbio.com ↗
杭州尚健生物技术有限公司（以下简称“尚健生物”）近日宣布，公司自主研发的国家Ⅰ类新药—重组抗PD-l全人源单克隆抗体注射液（SG001），获得国家药品监督管理局颁发的药物临床试验批件。 |
All press releases naming this drug 7 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enlonstobart | “Enlonstobart (SG001) is a fully humanized and high-affinity anti-PD-1 immunoglobulin G4 monoclonal antibody.” PMID 39447517 ↗ Oct 202415“Enlonstobart Enlonstobart 200mg IV every 3 weeks” NCT07448077 ↗ “Enlonstobart: 240mg, ivgtt, d1” NCT07281157 ↗ |
| Known as | SG001 | “Enlonstobart (SG001) is a fully humanized and high-affinity anti-PD-1 immunoglobulin G4 monoclonal antibody.” PMID 39447517 ↗ Oct 2024 |
| Known as | SG001: Enlonstobart | “SG001: Enlonstobart” NCT07251062 ↗ |
| Action | Inhibit | “novel PD-1 inhibitor” PMID 39447517 ↗ Oct 2024 |
| Modality | Monoclonal antibody | “SG001 is a humanized, IgG4 monoclonal antibody against human PD-1.” PMID 41321671 ↗ Nov 2025 |
| Route | Intravenous | “Subjects will receive intravenous infusion of SG001” NCT03852823 ↗ |
| Target | PDCD1 | “SG001 is a humanized, IgG4 monoclonal antibody against human PD-1.” PMID 41321671 ↗ Nov 2025 |