Drugs / Envafolimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed biliary tract cancer 1 milestone | |||||
| Filed | China (NMPA) | Envafolimab® | biliary tract cancer | 2026-01-16 | “an oncology biologic license application (“BLA”) of KN035 was submitted to China National Medicine Products Administration (NMPA) in December 2020.” ascletis.com ↗ “has been accepted for review by the China National Medical Products Administration (NMPA).” simcere.com ↗ “2026年1月，恩沃利单抗联合吉西他滨和奥沙利铂（GEMOX），用于一线治疗不可切除或转移性胆道癌的上市申请（NDA）获NMPA受理。” alphamabonc.com ↗ “恩沃利单抗联合吉西他滨和奥沙利铂（GEMOX），用于一线治疗不可切除或转移性胆道癌的上市申请（NDA）获NMPA受理。” alphamabonc.com ↗ “恩沃利单抗注射液（KN035）上市申请已获国家药品监督管理局（NMPA）正式受理并纳入优先审评。” alphamabonc.com ↗ “恩沃利单抗注射液（KN035）上市申请已获国家药品监督管理局（NMPA）正式受理” 3d-medicines.com ↗ “已向国家药品监督管理局（NMPA）提交上市申请并获得优先审评” alphamabonc.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | China (NMPA) | — | MSI-H/dMMR advanced solid tumors | 2020-11-16 | “KN035；通用名：恩沃利单抗注射液）的生物制品上市许可申请（BLA），已正式提交给国家药品监督管理局（NMPA）” alphamabonc.com ↗ “恩沃利单抗注射液（研发代号：KN035）的新药上市申请（NDA），已正式提交给国家药品监督管理局（NMPA）” 3d-medicines.com ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07260305 | Nov 2024 → Jan 2027 expected | — | Kangabio AUSTRALIA LTD PTY | Recruiting | No outcome recorded |
| Phase 1 | NCT03248843 | Sep 2017 → Mar 2020 | — | 3D Medicines (Sichuan) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03101488 | Mar 2017 → Sep 2019 | cancer | 3D Medicines (Sichuan) Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02827968 | Jan 2017 → Aug 2020 | cancer | 3D Medicines (Sichuan) Co., Ltd. | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT07636798 | Jun 2026 → Mar 2029 expected | biliary tract cancer | West China Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06663007 | Sep 2024 → May 2027 expected | prostate cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06226766 | Jan 2024 → Jul 2025 | neoplasm | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05448820 | Nov 2022 → Nov 2023 | soft tissue sarcoma | Tracon Pharmaceuticals Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05024214 | Nov 2021 → Dec 2026 expected | hepatocellular carcinoma, non-small cell lung carcinoma, renal cell carcinoma | 3D Medicines (Sichuan) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 274 trials | ||||||
| Phase 2 | NCT04910386 | Jun 2027 → Jun 2029 expected | biliary tract neoplasm | 3D Medicines (Sichuan) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07256223 | Dec 2026 → Nov 2027 expected | clear cell renal carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07818304 | Oct 2026 → Apr 2028 expected | non-small cell lung carcinoma | The First People's Hospital of Lianyungang | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07599995 | May 2026 → Mar 2028 expected | biliary tract cancer | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06059261 | Feb 2026 → Feb 2027 expected | nasopharyngeal carcinoma | Chongqing University Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07283198 | Dec 2025 → Aug 2027 expected | non-small cell lung carcinoma | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07159191 | Sep 2025 → Feb 2027 expected | renal cell carcinoma | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07142863 | Aug 2025 → Aug 2026 overdue | osteosarcoma | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06772233 | Jul 2025 → Jul 2027 expected | gastrointestinal stromal tumor | Peking University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07559864 | Jul 2025 → Jun 2027 expected | gastrointestinal stromal tumor | Jian Li | Recruiting | No outcome recorded |
| Phase 2 | NCT07003815 | Jun 2025 → Dec 2026 expected | biliary tract cancer | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06692491 | Jan 2025 → Dec 2027 expected | — | Peking University Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06618391 | Oct 2024 → Mar 2026 overdue | non-small cell lung carcinoma | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06656559 | Oct 2024 → Sep 2025 overdue | biliary tract cancer | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07243626 | Sep 2024 → Dec 2026 expected | soft tissue sarcoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT06498622 | Jul 2024 → May 2027 expected | hepatocellular carcinoma | Anhui Provincial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06734182 | Jun 2024 → Jun 2027 expected | non-small cell lung carcinoma | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06791083 | Jun 2024 → Dec 2025 overdue | gastric cancer | First Affiliated Hospital of Fujian Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06321081 | Mar 2024 → Feb 2026 overdue | RASopathy, colorectal cancer | Beijing Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06301828 | Feb 2024 → Jun 2025 | digestive system neoplasm | Nanjing First Hospital, Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT06218004 | Jan 2024 → Dec 2025 | — | Hairong Liu | Unknown | No outcome recorded |
| Phase 2 | NCT07266493 | Dec 2023 → Jun 2026 overdue | esophageal squamous cell carcinoma | Shanghai Zhongshan Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05959356 | Nov 2023 → Dec 2026 expected | colorectal cancer | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06060704 | Nov 2023 → Mar 2025 | colorectal cancer | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT06055816 | Oct 2023 → May 2026 overdue | nasopharyngeal carcinoma | Zhejiang Cancer Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06108726 | Oct 2023 → Jan 2025 | non-small cell lung carcinoma | Northern Jiangsu People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT07852091 | Oct 2023 → Dec 2026 expected | chronic hepatitis B virus infection | The Second Affiliated Hospital of Chongqing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06041724 | Sep 2023 → Sep 2025 | mucosal melanoma | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05969847 | Aug 2023 → Dec 2027 expected | rectal cancer | 池畔 | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05904015 | Aug 2023 → Dec 2026 expected | lung neoplasm | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05914389 | Aug 2023 → Aug 2025 overdue | colonic neoplasm | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT05910034 | Jul 2023 → Dec 2025 | non-small cell lung carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT06014372 | Jul 2023 → Jul 2024 | colon carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05828381 | Jun 2023 → Jun 2025 | — | Fujian Medical University Union Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05858567 | May 2023 → Dec 2024 | rectal cancer | Sir Run Run Shaw Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05799469 | May 2023 → May 2027 expected | cervical cancer | Chongqing University Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05685550 | Apr 2023 → Dec 2025 overdue | — | Tianjin Medical University Cancer Institute and Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05941325 | Apr 2023 → Dec 2026 | sarcoma | Shanghai 6th People's Hospital | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06239870 | Apr 2023 → Sep 2025 | — | Yunnan Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06013943 | Mar 2023 → May 2025 | gallbladder cancer | Eastern Hepatobiliary Surgery Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05722977 | Feb 2023 → Feb 2026 overdue | — | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05534113 | Dec 2022 → Jun 2025 | non-small cell lung carcinoma | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05582109 | Oct 2022 → Oct 2023 | — | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06030934 | Oct 2022 → Nov 2024 | gastroesophageal junction adenocarcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05552651 | Sep 2022 → Dec 2023 | esophageal squamous cell carcinoma | Tao Jiang | Unknown | No outcome recorded |
| Phase 2 | NCT05529355 | Sep 2022 → Sep 2023 | non-small cell lung carcinoma | Anhui Chest Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05551247 | Sep 2022 → Jun 2023 | colorectal neoplasm | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 2 | NCT05465733 | Aug 2022 → Jun 2025 | non-small cell lung carcinoma | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 2 | NCT05417230 | Aug 2022 → Aug 2024 | biliary tract cancer | Jiangsu Cancer Institute & Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05422183 | Jun → Dec 2022 | malignant epithelial tumor of ovary | Zhongda Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05129189 | Jun 2022 → Jul 2023 | HIV infectious disease | Shanghai Public Health Clinical Center | Unknown | No outcome recorded |
| Phase 2 | NCT05330143 | Jun 2022 → May 2024 | HIV infectious disease | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05397769 | Jun 2022 → Jun 2026 overdue | nasopharyngeal carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05414630 | Jun 2022 → Jun 2024 | non-small cell lung carcinoma | Anhui Provincial Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05387681 | May 2022 → Jul 2023 | gastroesophageal junction adenocarcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 2 | NCT05360979 | May 2022 → May 2023 | non-small cell lung carcinoma | Second Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| Phase 2 | NCT05385185 | May 2022 → May 2024 | neoplastic meningitis | Hebei Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05335460 | May 2022 → May 2023 | colon carcinoma | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05216653 | Apr 2022 → Mar 2023 | rectum adenocarcinoma | Sir Run Run Shaw Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05298020 | Apr → Dec 2022 | pancreatic neoplasm | The Affiliated Hospital of Xuzhou Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05213221 | Mar → Sep 2022 | hepatocellular carcinoma | Zhejiang University | Completed | No outcome recorded |
| Phase 2 | NCT05112991 | Mar 2022 → Dec 2026 expected | endometrial cancer | 3D Medicines (Sichuan) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05237349 | Mar 2022 → Dec 2024 | gastric adenocarcinoma | Liangjun Zhu M.M. | Unknown | No outcome recorded |
| Phase 2 | NCT05203276 | Mar 2022 → May 2024 | lung neoplasm | The First People's Hospital of Lianyungang | Unknown | No outcome recorded |
| Phase 2 | NCT05243355 | Dec 2021 → Dec 2023 | non-small cell squamous lung carcinoma | Qilu Hospital of Shandong University | Unknown | No outcome recorded |
| Phase 2 | NCT05068427 | Nov 2021 → Feb 2023 | non-small cell lung carcinoma | Chipscreen Biosciences, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05055167 | Aug 2021 → Dec 2024 | non-small cell lung carcinoma | The First Affiliated Hospital of Xiamen University | Unknown | No outcome recorded |
| Phase 2 | NCT04891198 | Aug 2021 → Aug 2027 expected | cancer | 3D Medicines (Sichuan) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT04480502 | Dec 2020 → Oct 2024 | myxofibrosarcoma, undifferentiated pleomorphic sarcoma | Tracon Pharmaceuticals Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT04770207 | Nov 2020 → Nov 2029 expected | hepatocellular carcinoma | Second Affiliated Hospital of Guangzhou Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT04465890 | Jul 2020 → Aug 2024 | chronic hepatitis B virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04034823 | Sep 2019 → Jan 2021 | HER2 positive breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04182789 | Mar 2019 → Feb 2021 | — | RenJi Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03667170 | Aug 2018 → Dec 2026 expected | cancer | 3D Medicines (Sichuan) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06959693 | Jun 2025 → Sep 2028 expected | colorectal cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06123754 | Nov 2023 → Dec 2027 expected | non-small cell lung carcinoma | 3D Medicines (Sichuan) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05752136 | Apr 2023 → Nov 2026 expected | rectal cancer | Sir Run Run Shaw Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT03478488 | Apr 2018 → Sep 2024 | biliary tract neoplasm | 3D Medicines (Sichuan) Co., Ltd. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07573943 | May 2024 → Dec 2026 expected | chronic hepatitis B virus infection | The Second Affiliated Hospital of Chongqing Medical University | Recruiting | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT06074497 Comparator | Dec 2023 → May 2026 overdue | — | Kangabio AUSTRALIA LTD PTY | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05849311 Comparator | May → Nov 2023 | — | 3D Medicines (Sichuan) Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT07327411 Background | Dec 2025 → Feb 2027 expected | refractory malignant neoplasm | Second Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06698965 Background | Oct 2024 → Oct 2029 expected | small cell lung carcinoma | Shanghai Chest Hospital | Recruiting | No outcome recorded |
| — | NCT06702566 Background | Jul 2024 → Jul 2026 overdue | acute leukemia, cancer | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 45
| Date | Issuer | Release |
|---|---|---|
| 2026-05-29 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Simcere Zaiming Presents 9 Studies at the 2026 ASCO Annual Meeting simcere.com ↗ |
| 2026-01-16 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Envafolimab Submits New Drug Application for Advanced Biliary Tract Cancer, Accepted for Review by NMPA simcere.com ↗ |
| 2025-12-25 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Envafolimab Granted FDA Orphan Drug Designation for Gastric and GEJ Cancer simcere.com ↗
This marks the third FDA orphan drug designation for Envafolimab, following previous designations for advanced bile duct cancer and soft tissue sarcoma. |
| 2025-12-23 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 恩沃利单抗再获美国FDA孤儿药资格认定，用于治疗胃癌和胃食管结合部癌 alphamabonc.com ↗
恩沃利单抗（英文通用名：Envafolimab，康宁杰瑞研发代号：KN035）获美国食品药品监督管理局（FDA）授予孤儿药资格认定（Orphan Drug Designation，ODD），用于治疗胃癌和胃食管结合部癌（GC/GEJ）。 |
| 2025-10-22 | 3D Medicines (Sichuan) Co., Ltd. | Results 2025 ESMO | 恩维达®多项研究成果闪耀亮相德国柏林 3d-medicines.com ↗
本研究首次证实恩沃利单抗联合同步放化疗在局部晚期宫颈癌患者中具有初步疗效和可耐受的安全性。 |
| 2023-12-04 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Envafolimab combination designated as breakthrough therapy by NMPA for Endometrial Cancer Treatment simcere.com ↗
December 4, 2023, according to the official website of National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE), the subcutaneous PD-L1 antibody injection Envafolimab (Enweida®) has been officially included in the "List of Breakthrough Therapies ". |
| 2023-11-13 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Poster Presentations at AASLD Annual Meeting 2023 Including a Late-Breaking Abstract of Interim Results from Phase IIb Expansion Cohort of ASC22 for Functional Cure of CHB ascletis.com ↗
ASC22 monotherapy with background NAs showed statistically significant HBsAg reduction and 21.1% (4/19) HBsAg loss after 24-week treatment. |
| 2023-10-30 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 康宁杰瑞宣布全球首个皮下注射PD-L1抗体恩维达®获美国FDA批准开展针对子宫内膜癌患者的Ⅲ期临床研究 alphamabonc.com ↗
共同宣布，全球首个皮下注射PD-L1抗体恩维达®联合仑伐替尼对比卡铂-紫杉醇化疗用于一线治疗错配修复完整（pMMR）晚期或复发性子宫内膜癌患者的Ⅲ期临床研究（KN035-US-004）获得美国食品药品监督管理局（FDA）的新药临床试验（IND）同意。 |
| 2023-09-29 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Positive Interim Data from the Phase IIb Expansion Cohort of ASC22 (Envafolimab) for Chronic Hepatitis B Functional Cure ascletis.com ↗
Topline results indicated that in ASC22 cohort, 4 patients (4/19, 21.1%) achieved HBsAg loss at the end of 24-week treatment. |
| 2023-08-27 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 恩维达®用于非小细胞肺癌新辅助/辅助治疗的Ⅲ期临床研究获得国家药品监督管理局临床试验许可 alphamabonc.com ↗
全球首款皮下注射PD-L1抑制剂恩维达 ® （恩沃利单抗注射液，研发代号：KN035）一项Ⅲ期临床试验申请（研究编号：KN035-CN-017），获得国家药品监督管理局批准。 |
| 2023-08-25 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory 思路迪医药宣布恩维达®针对非小细胞肺癌患者的新辅助/辅助治疗的III期临床研究已获得国家药品监督管理局的临床试验许可 3d-medicines.com ↗
恩维达 ® 联合含铂双药化疗对比安慰剂联合含铂双药化疗用于可切除III期非小细胞肺癌患者新辅助/辅助治疗的随机、对照、双盲、多中心III期临床研究 （KN035-CN-017)已获国家药品监督管理局（NMPA）的临床试验许可。 |
| 2023-07-25 | Ascletis Pharmaceuticals Co., Ltd. | Results Shanghai Public Health Clinical Center Presented Clinical Results of ASC22 (Envafolimab) in Combination with Chidamide for Functional Cure of HIV Infection at the 12th IAS Conference on HIV Science ascletis.com ↗
This Phase II study showed that combination treatment with ASC22 and Chidamide is well tolerated and effectively activated latent HIV reservoirs. |
| 2022-12-15 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 康宁杰瑞恩沃利单抗美国关键性Ⅱ期注册临床试验ENVASARC期中分析取得阳性结果 alphamabonc.com ↗
经盲态独立中心评估，两个队列的有效性分析均达到了预设的无效性检验统计标准，取得了两位数的客观应答率（ORR）。 |
| 2022-11-18 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 恩维达®（恩沃利单抗）治疗MSI-H/dMMR晚期实体瘤患者随访更新数据在CSCO会上报告 alphamabonc.com ↗
经确认的客观缓解率（ORR）为47.6%， 24个月缓解持续时间（DoR）率为82.2%， 中位无进展生存期为16.6个月， 24个月总生存率为66.5%。 |
| 2022-09-16 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory U.S. FDA Fast Track Designation Granted for Envafolimab in Soft Tissue Sarcoma Subtypes simcere.com ↗
On September 14，Envafolimab, the world's first subcutaneously PD-L1 inhibitor has received Fast Track designation granted by the U.S. FDA to be used in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS). |
| 2022-09-15 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 康宁杰瑞恩沃利单抗治疗软组织肉瘤获美国FDA快速审批资格 alphamabonc.com ↗
恩沃利单抗注射液（Envafolimab，研发代号：KN035）获美国食品药品监督管理局（FDA）授予快速审批通道（FTD）资格，用于治疗一线/二线化疗后疾病进展的局部晚期、不可切除或转移性多形性肉瘤（UPS）/纤维组织细胞肉瘤（MFS）。 |
| 2022-09-15 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory 思路迪医药宣布，恩维达®治疗软组织肉瘤适应症获美国FDA快速通道资格 3d-medicines.com ↗
恩维达 ® （Envafolimab）治疗先前接受过化疗后进展的局部晚期、不可切除或转移性未分化多形性肉瘤（UPS）和粘液纤维肉瘤（MFS）患者已获得美国食品和药物管理局（FDA）快速通道认定（Fast Track Designation）。 |
| 2022-08-19 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 恩维达®获批两周给药方案，大幅提高患者用药便捷性 alphamabonc.com ↗
2022年8月19日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK）宣布，全球首款皮下注射PD-L1抑制剂恩维达®（恩沃利单抗注射液，研发代号：KN035），新增“300mg每两周给药一次”的用法用量方案，获国家药品监督管理局（NMPA）批准。 |
| 2021-11-26 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Envafolimab, The World’s First Subcutaneously Injected PD-L1 Antibody Approved by NMPA! Simcere Partners with Alphamab Oncology and 3DMed to Innovate Immunotherapy simcere.com ↗ |
| 2021-11-10 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Ascletis Announces Approval of Phase II Clinical Trial of ASC22 (Envafolimab) by China NMPA for Immune Restoration/Functional Cure of HIV-1 Infected Patients ascletis.com ↗ |
| 2021-11-09 | Ascletis Pharmaceuticals Co., Ltd. | Results Sustained Hepatitis B Surface Antigen Loss in Chronic Hepatitis B Patients with Subcutaneous PD-L1 Antibody ASC22 Treatment: Interim Results of Phase IIb Study ascletis.com ↗
16 out of 33 patients treated with ASC22 had baseline HBsAg ≤ 500 IU/mL, 19% (3/16) of patients obtained HBsAg loss and no rebound after the last dosing of ASC22, indicating HBV functional cure. |
| 2021-09-15 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 恩沃利单抗（KN035）联合仑伐替尼治疗子宫内膜癌获批临床 alphamabonc.com ↗
2021年9月15日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK）宣布，恩沃利单抗注射液（研发代号：KN035）联合甲磺酸仑伐替尼临床试验申请，获得国家药品监督管理局批准，用于治疗既往至少一线含铂化疗失败或不耐受的不适合根治性治疗的局部晚期、转移性或复发性非微卫星高度不稳定（非MSI-H）/非DNA错配修复缺陷（非dMMR）的子宫内膜癌。 |
| 2021-09-15 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory 恩沃利单抗联合仑伐替尼治疗子宫内膜癌获临床试验批准通知书 3d-medicines.com ↗
这是继二者联用治疗晚期恶性实体瘤的多中心、开放标签、Ib/II期临床研究后获批的又一项II期临床试验。 |
| 2021-09-15 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Envafolimab in Combination with Lenvatinib for the Treatment of Endometrial Cancer Granted Implied License for Clinical Trials simcere.com ↗
On September, 14 , Simcere Pharmaceutical Group Limited (2096.HK) announced that the clinical trials application for Envafolimab in combination with Lenvatinib Mesylate in the treatment of endometrial cancer has been granted approval by NMPA（ National Medical Products Administration ） via an implied license. |
| 2021-07-21 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Phase Ⅱ Clinical Data of Envafolimab in MSI-H/dMMR Solid Tumors Published in the Journal of Hematology & Oncolog simcere.com ↗
From this study, most of the treatment-emergent adverse events related to Envafolimab were grade 1~2. |
| 2021-06-30 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 皮下注射PD-L1抗体恩沃利单抗（KN035）再获美国FDA孤儿药认定 alphamabonc.com ↗
2021年6月30日，中国苏州，康宁杰瑞生物制药（股票代码：9966.HK）宣布，公司自主研发的重组人源化PD-L1单域抗体恩沃利单抗注射液（研发代号：KN035）获美国食品药品监督管理局（FDA）授予孤儿药资格（Orphan Drug Designation，ODD），用于治疗软组织肉瘤。 |
| 2021-06-30 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Envafolimab Obtained Its 2nd Orphan Drug Designation from the U.S. Food and Drug Administration simcere.com ↗
On 29 June 2021, Simcere announced that the innovative subcutaneously injected PD-L1 single domain antibody Envafolimab has received the Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with soft tissue sarcoma. |
| 2021-06-25 | 3D Medicines (Sichuan) Co., Ltd. | Results 全球首个皮下注射PD-L1抗体恩沃利单抗关键性Ⅱ期临床研究结果获国际知名期刊《Journal of Hematology & Oncology》在线发表 3d-medicines.com ↗
研究结果表明，恩沃利单抗单药治疗既往至少一线治疗失败的 MSI-H/dMMR 晚期实体瘤疗效显著且持久，且安全性良好。 |
| 2021-06-17 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory IND Application of Envafolimab in Combination with Lenvatinib in the Treatment of Advanced Solid Tumors has been Approved simcere.com ↗
On June 17, Simcere Pharmaceutical Group Limited (2096.HK) announced that the clinical trial application for Envafolimab in combination with Lenvatinib Mesylate in treating advanced malignant solid tumors, has been approved by the National Medical Products Administration (NMPA). |
| 2021-05-28 | 3D Medicines (Sichuan) Co., Ltd. | Results 恩沃利单抗美国I期临床数据荣登《The Oncologist》杂志 3d-medicines.com ↗
其中共3例受试者获得经确认的部分缓解，低至0.3mg/kg QW即可观察到疗效应答。 |
| 2021-01-19 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 恩沃利单抗注射液（KN035）上市申请获国家药品监督管理局纳入优先审评 alphamabonc.com ↗
2021年1月19日，康宁杰瑞生物制药（以下简称“康宁杰瑞”，股票代码：9966.HK）宣布，重组人源化PD-L1单域抗体恩沃利单抗注射液（研发代号：KN035）上市申请获中国国家药品监督管理局（NMPA）药品审评中心（CDE）纳入优先审评，首个申请的适应症为既往标准治疗失败的微卫星不稳定(MSI-H)晚期结直肠癌、胃癌/错配修复功能缺陷(dMMR)的其他晚期实体瘤。 |
| 2021-01-19 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory 恩沃利单抗注射液（KN035）上市申请获国家药品监督管理局纳入优先审评 3d-medicines.com ↗
恩沃利单抗注射液（研发代号：KN035）上市申请获中国国家药品监督管理局（NMPA）药品审评中心（CDE）纳入优先审评 |
| 2020-12-22 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 喜讯！国家药品监督管理局正式受理KN035（恩沃利单抗注射液）生物制品上市许可申请 alphamabonc.com ↗
恩沃利单抗注射液的新药上市申请获得国家药品监督管理局正式受理，是思路迪医药在临床开发及商业化进程中取得的重大阶段性成果。 |
| 2020-12-22 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory 恩沃利单抗注射液（KN035）新药上市申请获国家药监局正式受理 3d-medicines.com ↗ |
| 2020-12-04 | Ascletis Pharmaceuticals Co., Ltd. | Results Subcutaneously Administered PD-L1 Antibody ASC22 (Envafolimab) is Safe and Well Tolerated in Phase IIa HBV Study ascletis.com ↗
The data from Phase IIa study indicated that ASC22 (Envafolimab) is safe and well tolerated in the CHB patients receiving nucleos(t)ides as the background therapy. |
| 2020-11-16 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory 全球首个皮下注射PD-L1抗体KN035（恩沃利单抗注射液）提交生物制品上市许可申请 alphamabonc.com ↗
重组人源化PD-L1单域抗体（研发代号：KN035；通用名：恩沃利单抗注射液）的生物制品上市许可申请（BLA），已正式提交给国家药品监督管理局（NMPA），申请的适应症为用于治疗标准治疗失败的微卫星不稳定(MSI-H)/ 错配修复功能缺陷(dMMR) 晚期结直肠癌、胃癌及其他晚期实体瘤。 |
| 2020-11-16 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory 皮下注射PD-L1抗体恩沃利单抗注射液（KN035）提交中国新药上市申请 3d-medicines.com ↗
恩沃利单抗注射液（研发代号：KN035）的新药上市申请（NDA），已正式提交给国家药品监督管理局（NMPA） |
| 2020-09-20 | 3D Medicines (Sichuan) Co., Ltd. | Results 思路迪医药联合开发的皮下注射PD-L1抗体KN035“单药治疗MSI-H/ dMMR晚期实体瘤的Ⅱ期研究结果”获CSCO展示 3d-medicines.com ↗
BIRC评估经确认的 ORR 在晚期CRC、晚期GC、其他实体瘤和所有人群中分别为43.1%、44.4%、40.0%和42.7%； |
| 2020-05-29 | 3D Medicines (Sichuan) Co., Ltd. | Results 2020 ASCO发布皮下注射PD-L1抗体Envafolimab（KN035）的最新研究结果 3d-medicines.com ↗
PEPi人群中经确认的客观缓解率为30％（95％CI：17.9％，44.6％），80%的缓解在数据截止时仍在持续。 |
| 2020-05-15 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 江苏康宁杰瑞皮下注射PD-L1抗体KN035的临床数据将在ASCO大会发布 alphamabonc.com ↗
总体人群经确认的客观缓解率为34.0％（95％CI：24.9％，44.0％），85.7%的缓解在数据截止时仍在持续。 |
| 2020-05-15 | 3D Medicines (Sichuan) Co., Ltd. | Results 思路迪医药皮下注射PD-L1抗体KN035的临床试验数据将在ASCO大会发布 3d-medicines.com ↗
PEPi人群中经确认的客观缓解率为30％（95％CI：17.9％，44.6％），80%的缓解在数据截止时仍在持续。 |
| 2020-01-19 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Regulatory PD-L1抗体KN035被美国FDA授予孤儿药资格 alphamabonc.com ↗
美国食品和药物管理局（FDA）已授予KN035（envafolimab）孤儿药资格（Orphan Drug Designation，ODD），用于治疗胆道癌。 |
| 2020-01-18 | 3D Medicines (Sichuan) Co., Ltd. | Regulatory KN035（Envafolimab）被FDA授予孤儿药资格 3d-medicines.com ↗
2020年1月18日，思路迪医药（以下简称“3D Medicines”或“思路迪”）与康宁杰瑞生物制药（股票代码：9966.HK）（以下简称“康宁杰瑞”或“公司”）联合宣布，美国食品和药物管理局（FDA）已授予KN035（envafolimab）孤儿药资格（Orphan Drug Designation，ODD），用于治疗胆道癌。 |
| 2019-09-19 | 3D Medicines (Sichuan) Co., Ltd. | Results 思路迪医药皮下注射PD-L1抗体KN035的临床试验数据在2019年CSCO学术年会发布 3d-medicines.com ↗
各剂量组均未观察到剂量限制性毒性，且未达到最大耐受剂量。 |
| 2018-10-20 | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Results 全球领先的皮下注射PD-L1抗体KN035已启动临床后期开发；KN035美国I期临床数据在欧洲肿瘤内科协会2018年大会上公布 alphamabonc.com ↗
在美国部分的临床I期试验中，至2018 年7月5日数据截点为止，共计18名受试者入组；在第一轮完成的对17名受试者的疗效评价中，根据RECIST1.1评价标准, 有2名受试者被确认为部分缓解（PR），5名受试者为疾病稳定(SD)；本次试验未出现剂量限制性毒性（DLT）；KN035的暴露量与剂量呈现相关性，体内药物半衰期约为200小时。 |
All press releases naming this drug 54 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 94 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | envafolimab | “Based on phase I clinical trial data of Envafolimab, a dose reduction design was conducted to minimize the incidence of adverse events while ensuring therapeutic efficacy.” NCT05914389 ↗83“Phase I study of envafolimab (KN035), a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors.” PMID 35932387 ↗ Aug 2022 “The subjects receive Envafolimab/placebo treatment with a dosage of 600 mg/3 ml subcutaneously injected every 3 weeks.” NCT06123754 ↗ “JSKN033 is a fixed-dose combination consisting of JSKN003 (a HER2-targeted ADC) and envafolimab (a PD-L1 inhibitor)” NCT07283198 ↗ “JSKN033 is a combination drug product comprised of JSKN003 and envafolimab for subcutaneous injection.” NCT06226766 ↗ “intraoperative arterial envafolimab and lenvatinib as first-line therapy for unresectable BTC” NCT07636798 ↗ “Envafolimab, a humanized single-domain anti-PD-L1 antibody fused to an Fc fragment” PMID 34154614 ↗ Jun 2021 “Envafolimab: 150mg, subcutaneous injection, administered on days 1, 8, and 15” NCT07266493 ↗ “PD-L1 inhibitor includes durvalumab,Atezolizumab,Adebrelimab,Envafolimab.” NCT06702566 ↗ “Envafolimab: 400 mg on Day 1, repeated every 3 weeks (Q3W).” NCT07599995 ↗ “PD-L1 inhibitor，Envafolimab 400mg，d1，q3w, until PD” NCT07327411 ↗ |
| Known as | ASC22 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07573943 ↗ |
| Known as | Envolimab | “Envafolimab indication: Envolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.” NCT05203276 ↗ |
| Known as | KN035 | “Phase I study of envafolimab (KN035), a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors.” PMID 35932387 ↗ Aug 2022 |
| Known as | KN053 | “Drug: Envafolimab This product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW). Other Name: KN053” NCT05752136 ↗ |
| Action | Inhibit | “Phase 1 Study of Anti-PD-L1 Monoclonal Antibody KN035 to Treat Locally Advanced or Metastatic Solid Tumors” NCT02827968 ↗ |
| Modality | Monoclonal antibody | “KN035 is a monoclonal antibody drug” NCT02827968 ↗ |
| Route | Subcutaneous | “formulated for subcutaneous injection” NCT02827968 ↗ |
| Target | CD274 | “a PD-L1 inhibitor” NCT07283198 ↗ |