Drugs / Pucotenlimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed melanomatosis 1 milestone | |||||
| Filed | China (NMPA) | — | melanomatosis | 2021-07-05 | “7月5日，药监局受理了乐普生物旗下PD-1普特利单抗的上市申请” lepubiopharma.com ↗ |
| Filed mismatch repair cancer syndrome 3 1 milestone | |||||
| Filed | China (NMPA) | — | mismatch repair cancer syndrome 3 | 2021-10-26 | “普特利单抗（HX008）用于治疗MSI-H/dMMR实体瘤的上市申请获得NMPA受理” lepubiopharma.com ↗ |
Trials 69 · started per year
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07356466 | May 2025 → Apr 2027 expected | gastric cancer | Fujian Medical University | Enrolling by invitation | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT07054307 | Feb → Jul 2026 overdue | penile cancer | Jiyan Liu | Recruiting | No outcome recorded |
| Phase 1 | NCT05070221 | Oct 2021 → Oct 2023 | melanoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 1 | NCT05068453 | Oct 2021 → Oct 2023 | metastatic melanoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 1 | NCT04756934 | Aug 2020 → Aug 2021 | melanoma | Taizhou HoudeAoke Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04825392 | Sep 2019 → May 2021 | neoplasm | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT07479485 | Apr 2026 → Apr 2028 expected | hepatocellular carcinoma | Lepu Biopharma Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07312422 | Sep 2025 → Apr 2026 overdue | malignant pancreatic neoplasm | Zhejiang Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06456892 | Jun 2024 → Jun 2026 overdue | childhood malignant neoplasm, rhabdomyosarcoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05338957 | Aug 2022 → Jun 2024 | cancer | Shanghai Miracogen Inc. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05688605 | Jun 2022 → Aug 2027 expected | cancer | Lepu Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04616443 | Dec 2020 → Nov 2025 overdue | melanoma | Binhui Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04750382 | Jul 2019 → Dec 2020 | triple-negative breast carcinoma | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT03866525 | Apr 2019 → Aug 2025 overdue | digestive system cancer | Binhui Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 246 trials | ||||||
| Phase 2 | NCT07844551 | Oct 2026 → Oct 2028 expected | oral cavity squamous cell carcinoma, oropharynx squamous cell carcinoma | Huashan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07800000 | Sep 2026 → Sep 2028 expected | anal canal squamous cell carcinoma | Wang Xin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07497919 | Sep 2026 → May 2029 expected | penile cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07707167 | Aug 2026 → Jan 2028 expected | head and neck squamous cell carcinoma | Jiangsu Cancer Institute & Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07712029 | Aug 2026 → Aug 2028 expected | refractory malignant neoplasm | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07518979 | Jul 2026 → May 2028 expected | penile cancer | Jiyan Liu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07692334 | Jul 2026 → Sep 2027 expected | gastric cancer, gastroesophageal junction adenocarcinoma | West China Second University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07627321 | Jul 2026 → Jul 2028 expected | non-small cell lung carcinoma | Anhui Provincial Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07665190 | Jul 2026 → Oct 2027 expected | hypopharynx squamous cell carcinoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07649980 | Jul 2026 → Jul 2029 expected | biliary tract cancer | HuiKai Li | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07632339 | Jun 2026 → Jun 2028 expected | head and neck cancer | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Recruiting | No outcome recorded |
| Phase 2 | NCT07651007 | May 2026 → Dec 2027 expected | rectal cancer | Wang Xin | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07628855 | May 2026 → Aug 2028 expected | hereditary nonpolyposis colon cancer | Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07501104 | May 2026 → Sep 2029 expected | melanoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07589049 | May 2026 → Nov 2027 expected | head and neck squamous cell carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07814287 | Apr → Dec 2026 expected | head and neck squamous cell carcinoma | Xuekui Liu | Recruiting | No outcome recorded |
| Phase 2 | NCT07545083 | Apr 2026 → Mar 2027 expected | head and neck squamous cell carcinoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06889610 | Mar 2026 → Dec 2027 expected | colorectal cancer, melanoma, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07464366 | Mar 2026 → May 2028 expected | salivary gland carcinoma | Ji Dongmei | Recruiting | No outcome recorded |
| Phase 2 | NCT07514533 | Mar 2026 → Dec 2027 expected | cholangiocarcinoma | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07353827 | Feb 2026 → Aug 2027 expected | intrahepatic cholangiocarcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07381699 | Feb 2026 → Feb 2028 expected | nasopharyngeal carcinoma | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07393477 | Feb 2026 → Jul 2028 expected | head and neck squamous cell carcinoma | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07394244 | Jan 2026 → Dec 2028 expected | skin squamous cell carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07354984 | Jan 2026 → Dec 2029 expected | head and neck squamous cell carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07353073 | Jan 2026 → Dec 2027 expected | mucosal melanoma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06959108 | Oct 2025 → Jun 2029 expected | head and neck squamous cell carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | Recruiting | No outcome recorded |
| Phase 2 | NCT07386158 | Jul 2025 → Dec 2026 expected | clear cell renal carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06969534 | May 2025 → Dec 2027 expected | carcinoma, lymphoepithelial-like carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06895369 | May 2025 → Dec 2028 expected | head and neck squamous cell carcinoma | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07235566 | Apr 2025 → Apr 2029 expected | thyroid cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06872606 | Apr 2025 → Apr 2026 overdue | rectum adenocarcinoma | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06869174 | Mar 2025 → Mar 2027 expected | cancer of unknown primary site | Zhiguo Luo, MD, PhD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06770270 | Aug 2024 → Dec 2027 expected | rectal cancer | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT06530914 | Aug 2024 → Dec 2026 expected | head and neck squamous cell carcinoma | Lei Liu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06524466 | Jul 2024 → Dec 2026 expected | hepatocellular carcinoma | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06192797 | Jun 2024 → Dec 2026 expected | intrahepatic cholangiocarcinoma | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06192784 | Dec 2023 → Jan 2025 | intrahepatic cholangiocarcinoma | Tongji Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06129955 | Nov 2023 → Dec 2025 | renal cell carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04868162 | Apr 2021 → Jul 2024 | head and neck squamous cell carcinoma | Lepu Biopharma Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04741165 | Jan 2021 → Apr 2022 | hepatocellular carcinoma | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04574817 | Dec 2020 → May 2022 | thyroid gland undifferentiated (anaplastic) carcinoma | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04738630 | Sep 2020 → Dec 2022 | urinary bladder cancer | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04508803 | Sep 2020 → Aug 2022 | — | Fudan University | Completed | No outcome recorded |
| Phase 2 | NCT04749485 | Nov 2018 → Aug 2020 | melanoma | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT03704246 | Sep 2018 → Dec 2019 | neoplasm | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04750083 | Sep 2020 → Sep 2022 | non-small cell lung carcinoma | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07524413 | Apr 2026 → Apr 2030 expected | nasopharyngeal carcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07524452 | Feb 2026 → Feb 2031 expected | head and neck squamous cell carcinoma | Ming-Yuan Chen | Recruiting | No outcome recorded |
| Phase 3 | NCT06976190 | May 2025 → May 2029 expected | nasopharyngeal carcinoma | Lepu Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05652894 | Feb 2023 → Jun 2026 overdue | colorectal cancer | Taizhou Hanzhong Biomedical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05647954 | Dec 2022 → Dec 2024 | neuroendocrine neoplasm | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04486651 | Sep 2020 → Aug 2023 | gastric cancer | Taizhou Hanzhong Biomedical Co., Ltd. | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07092449 | Aug 2025 → Dec 2027 expected | gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | Tang-Du Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07188311 | Apr 2025 → Apr 2027 expected | childhood malignant neoplasm, hepatoblastoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT07586124 Background | Jul 2026 → Dec 2027 expected | head and neck squamous cell carcinoma | Lepu Biopharma Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07448142 Background | Mar 2026 → Sep 2027 expected | colorectal cancer | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07598318 Background | May 2026 → Dec 2027 expected | cholangiocarcinoma | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07528209 Comparator | Apr 2026 → Apr 2032 expected | rectal cancer | Sun Yat-sen University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2026-03-23 | Lepu Biopharma Co., Ltd. | Regulatory 乐普生物MRG003联合普特利单抗头颈鳞癌围手术期IND获批，全球首创实现治疗线数全面前移 lepubiopharma.com ↗
用于局部晚期可切除头颈部鳞状细胞癌围手术期治疗的临床试验申请，已获国家药品监督管理局临床试验默示许可。 |
| 2024-12-08 | Lepu Biopharma Co., Ltd. | Results 【4134】ESMO ASIA 2024丨徐瑞华教授团队：MRG003与普特利单抗联用，解围R/M-NPC困境 lepubiopharma.com ↗
本次ESMO ASIA会议上报道的II期研究中R/M-NPC队列的初步结果，进一步佐证了PD-1联合MRG003治疗R/M-NPC患者的疗效，为免疫治疗失败的患者提供了一种新的治疗选择[6]。 |
| 2024-05-24 | Lepu Biopharma Co., Ltd. | Results 三项临床研究成果在2024年ASCO年会上公布 lepubiopharma.com ↗
在27名可评价患者中，17名患者达到PR，7名患者达到SD，因此ORR和DCR分别为63.0%（95%置信区间为42.4至80.6）及88.9%（95%置信区间为70.8至97.7）。 |
| 2022-09-30 | Lepu Biopharma Co., Ltd. | Regulatory 再斩新绩，闪耀上市｜黑色素瘤免疫新药隆重获批，普特利单抗成就治疗新选择 lepubiopharma.com ↗
普特利单抗于2022年9月20日获中国国家药品监督管理局（NMPA）批准上市，成为我国新获批黑色素瘤适应症的PD-1单抗。 |
| 2022-07-25 | Lepu Biopharma Co., Ltd. | Regulatory 黄镜教授专访丨普特利单抗重磅获批，MSI-H/dMMR晚期实体瘤迎来新选择！ lepubiopharma.com ↗
2022年7月22日，NMPA正式批准普特利单抗用于既往经治的MSI-H/dMMR实体瘤适应证。 |
| 2021-10-26 | Lepu Biopharma Co., Ltd. | Regulatory 乐普生物PD-1申报第2项适应症：MSI-H实体瘤 lepubiopharma.com ↗
2021年10月26日，乐普生物PD-1单抗普特利单抗（HX008）用于治疗MSI-H/dMMR实体瘤的上市申请获得NMPA受理，这是该产品申报的第二个适应症。 |
| 2021-07-05 | Lepu Biopharma Co., Ltd. | Regulatory 首个产品NDA受理，乐普生物商业化箭在弦上 lepubiopharma.com ↗
近日，乐普生物向国家药品监督管理局提交了PD-1单抗普特利单抗（HX008）用于二线治疗黑色素瘤的上市申请，并于2021年7月5日获得CDE正式承办受理。 |
| 2021-06-07 | Lepu Biopharma Co., Ltd. | Results 乐普生物差异化PD-1单抗，临床优势初显 lepubiopharma.com ↗
普特利单抗（HX008）二线及以上治疗晚期黑色素瘤的总响应率ORR为18.49%，疾病控制率DCR为44.54%，中位无进展生存期mPFS为3.25个月，中位总生存期mOS为17.91个月。 |
All press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-23 | Lepu Biopharma Co., Ltd. | 乐普生物MRG003联合普特利单抗头颈鳞癌围手术期IND获批，全球首创实现治疗线数全面前移 lepubiopharma.com ↗ |
| 2024-12-08 | Lepu Biopharma Co., Ltd. | 【4134】ESMO ASIA 2024丨徐瑞华教授团队：MRG003与普特利单抗联用，解围R/M-NPC困境 lepubiopharma.com ↗ |
| 2024-05-24 | Lepu Biopharma Co., Ltd. | 三项临床研究成果在2024年ASCO年会上公布 lepubiopharma.com ↗ |
| 2022-09-30 | Lepu Biopharma Co., Ltd. | 再斩新绩，闪耀上市｜黑色素瘤免疫新药隆重获批，普特利单抗成就治疗新选择 lepubiopharma.com ↗ |
| 2022-07-25 | Lepu Biopharma Co., Ltd. | 黄镜教授专访丨普特利单抗重磅获批，MSI-H/dMMR晚期实体瘤迎来新选择！ lepubiopharma.com ↗ |
| 2021-10-26 | Lepu Biopharma Co., Ltd. | 乐普生物PD-1申报第2项适应症：MSI-H实体瘤 lepubiopharma.com ↗ |
| 2021-07-05 | Lepu Biopharma Co., Ltd. | 首个产品NDA受理，乐普生物商业化箭在弦上 lepubiopharma.com ↗ |
| 2021-06-07 | Lepu Biopharma Co., Ltd. | 乐普生物差异化PD-1单抗，临床优势初显 lepubiopharma.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 75 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pucotenlimab | “CONCLUSIONS: Pucotenlimab as a ≥ 2nd line therapy showed promising efficacy and tolerable toxicity for patients with locally advanced or metastatic melanoma.
TRIAL...” PMID 36747118 ↗ Feb 202354“We report a multicenter, phase 2 study evaluating the efficacy of pucotenlimab, an anti-PD-1 antibody, in patients with mismatch repair-deficient (dMMR) or microsatellite...” PMID 38016482 ↗ Nov 2023 “Neoadjuvant immunotherapy with pucotenlimab (200mg, Day 1, Q3W, 2 cycles); Adjuvant immunotherapy duiring and after radiotherapy with pucotenlimab (200mg, Day 1, Q3W, for a...” NCT07524452 ↗ “Patients will first receive 2 cycles of induction therapy consisting of Becotatug Vedotin combined with Pucotenlimab and Capecitabine.” NCT07800000 ↗ “Multimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1” NCT06889610 ↗ “short-course radiotherapy (SCRT) followed by NALIRIFOX chemotherapy plus Pucotenlimab immunotherapy” NCT07651007 ↗ “Pucotenlimab combined with chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin)” NCT07092449 ↗ “[Docetaxel 75mg/m2 + Nimotuzumab 400mg + Pucotenlimab 200mg]” NCT07354984 ↗ “2. pucotenlimab： 200mg, intravenous, every 3 weeks, on day 1” NCT07514533 ↗ “MRG006A+Pucotenlimab + Bevacizumab” NCT07479485 ↗ “Drug: HX008(Pucotenlimab)” NCT05652894 ↗ |
| Known as | HX008 | “Patients histologically confirmed mucosal melanoma will get OH2 （once every two weeks）and HX-008 (once every three weeks)and Axitinib (once every day).” NCT05070221 ↗22“Pucotenlimab (HX008): Administered from Cycle 1 to Cycle 4 at a dose of 3 mg/kg (maximum 200 mg), once every 3 weeks on Day 1 (D1).” NCT07627321 ↗ “Pucotenlimab (HX008) is a PD-1 inhibitor with an extended half-life (T1/2 = 21.76 days).” NCT07589049 ↗ “HX-008：200mg/time，Q3W，i.v.；” NCT05068453 ↗ “Pucotenlimab(HX008)” NCT07665190 ↗ |
| Known as | Puco | “After enrollment, patients will immediately begin treatment with Lenvatinib (Len) and Pucotenlimab (Puco).” NCT06524466 ↗ |
| Action | Inhibit | “PD-1 blockade monotherapy” NCT03704246 ↗ |
| Modality | Monoclonal antibody | “Anti-PD-1 Monoclonal Antibody” NCT04486651 ↗ |
| Route | Intravenous | “200 mg administered as IV infusion” NCT04486651 ↗ |
| Target | PDCD1 | “pucotenlimab, an anti-PD-1 antibody” PMID 38016482 ↗ Nov 2023 |