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Drugs / Benmelstobart
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Benmelstobart

also known as TQB-2450 · Benmelstobart Injection · Anicol · APL-502 · CBT-502 · Piamprilizumab · TQB2450 injection · TQB2450 solution

Monoclonal antibody targets CD274

Developed for
non-small cell lung carcinoma · small cell lung carcinoma · hepatocellular carcinoma · endometrial cancer · esophageal squamous cell carcinoma · gastric cancer · head and neck squamous cell carcinoma · triple-negative breast carcinoma
+35 more · biliary tract cancer · cancer · gastroesophageal adenocarcinoma · gastroesophageal junction adenocarcinoma · hormone receptor-positive breast cancer · malignant pancreatic neoplasm · neoplasm · adenocarcinoma · alveolar soft part sarcoma · biliary tract neoplasm · breast cancer · cholangiocarcinoma · chronic hepatitis B virus infection · clear cell renal carcinoma · digestive system neoplasm · fallopian tube cancer · female breast carcinoma · female reproductive organ cancer · gastroesophageal cancer · kidney cancer · lung cancer · mature T-cell and NK-cell non-Hodgkin lymphoma · melanoma · nasopharyngeal carcinoma · neoplasm of esophagus · non-small cell squamous lung carcinoma · oral cavity cancer · ovarian cancer · pheochromocytoma · primary mediastinal large B-cell lymphoma · primary peritoneal carcinoma · pulmonary large cell neuroendocrine carcinoma · renal cell carcinoma · thyroid cancer · uterine corpus sarcoma
Investigated by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Fudan University · Henan Cancer Hospital · Shanghai Pulmonary Hospital, Shanghai, China · Sun Yat-sen University · The First Affiliated Hospital of Zhengzhou University
+31 more · Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Peking University · RenJi Hospital · Shanghai Zhongshan Hospital · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Tang-Du Hospital · Tianjin Medical University Cancer Institute and Hospital · Yayi He · Chinese Academy of Medical Sciences · Chinese PLA General Hospital · First Affiliated Hospital of Zhejiang University · Huadong Hospital · Jiangsu Cancer Institute & Hospital · Jiangsu Provincial Stomatological Hospital · Jiangxi Provincial Cancer Hospital · Jinming Yu · Nanfang Hospital, Southern Medical University · Peking Union Medical College Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · The First Affiliated Hospital of Guangzhou Medical University · The First Affiliated Hospital with Nanjing Medical University · The Second Affiliated Hospital of Shandong First Medical University · The Third Xiangya Hospital of Central South University · Tongji Hospital · Xianhai Mao · Xijing Hospital · Xinqiao Hospital of Chongqing · Yongxu Jia · Zhejiang Cancer Hospital

Trials 87 · started per year

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20182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT05942508 May 2023 → Feb 2026 small cell lung carcinoma Jinming Yu Unknown No outcome recorded
Phase 1 NCT06116240 Sep 2022 → Dec 2023 cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03897283 Jun 2019 → Jun 2020 cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03910127 Jun 2019 → Dec 2020 non-small cell lung carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03855358 May 2019 → Jun 2020 triple-negative breast carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03460457 Mar 2018 → Mar 2019 neoplasm Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT05608785 Jan → Dec 2023 gastric cancer, gastroesophageal cancer Henan Cancer Hospital Unknown No outcome recorded
Phase 1/2 NCT05645315 Apr 2022 → Dec 2023 neoplasm Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT05139082 Nov 2021 → Oct 2023 digestive system neoplasm Peking University Unknown No outcome recorded
Phase 1/2 NCT04888546 Apr 2021 → Jul 2024 hepatocellular carcinoma Chinese Academy of Medical Sciences Unknown No outcome recorded
Phase 1/2 NCT04236362 Feb 2020 → Dec 2021 female reproductive organ cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT03996408 Jun 2019 → Dec 2020 cholangiocarcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT03991975 Jun 2019 → Mar 2020 melanoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT03983928 Jun 2019 → Oct 2020 lung cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT03825705 Apr 2019 → Jan 2021 adenocarcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 252 trials
Phase 2 NCT07602101 May 2026 → Dec 2027 expected clear cell renal carcinoma RenJi Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07627464 May 2026 → Dec 2028 expected renal cell carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07643350 May 2026 → May 2029 expected non-small cell lung carcinoma The Third Xiangya Hospital of Central South University Not yet recruiting No outcome recorded
Phase 2 NCT07510594 May → Dec 2026 expected pulmonary large cell neuroendocrine carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07538258 Apr 2026 → Sep 2027 expected small cell lung carcinoma Yayi He Not yet recruiting No outcome recorded
Phase 2 NCT07537777 Apr 2026 → Jan 2028 expected hepatocellular carcinoma Nanfang Hospital, Southern Medical University Not yet recruiting No outcome recorded
Phase 2 NCT07538271 Apr 2026 → Sep 2027 expected small cell lung carcinoma Yayi He Not yet recruiting No outcome recorded
Phase 2 NCT07548177 Apr 2026 → Nov 2027 expected alveolar soft part sarcoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT07193186 Apr 2026 → Dec 2029 expected thyroid cancer Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07489300 Mar 2026 → Jan 2027 expected fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07535567 May 2026 → Dec 2028 expected head and neck squamous cell carcinoma Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Not yet recruiting No outcome recorded
Phase 315 trials · 3 met primary
Phase 3 NCT07446335 Apr 2026 → Dec 2028 expected esophageal squamous cell carcinoma The First Affiliated Hospital of Zhengzhou University Not yet recruiting No outcome recorded
Phase 3 NCT06955325 May 2025 → Dec 2030 expected non-small cell lung carcinoma The First Affiliated Hospital of Guangzhou Medical University Not yet recruiting No outcome recorded
Phase 3 NCT06469879 Sep 2024 → Sep 2026 overdue small cell lung carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT06475599 Jul 2024 → Dec 2027 expected endometrial cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT05922345 Jun 2023 → Aug 2025 non-small cell lung carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 3 NCT05718167 Feb 2023 → Oct 2024 non-small cell squamous lung carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 3 NCT05346952 Jan 2022 → Dec 2023 non-small cell lung carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 3 NCT05145218 Sep 2021 → Oct 2024 — Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 3 NCT04964479 Aug 2021 → Dec 2022 non-small cell lung carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown Met primary
Phase 3 NCT04809142 Feb 2021 → Mar 2022 biliary tract cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 41 trial
Phase 4 NCT06931145 Apr 2025 → Apr 2027 expected small cell lung carcinoma Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase not applicable3 trials
— NCT07849712 Oct 2026 → Dec 2028 expected non-small cell lung carcinoma Zhejiang Cancer Hospital Not yet recruiting No outcome recorded
— NCT06603974 Oct 2024 → Jul 2026 overdue gastric cancer Xijing Hospital Not yet recruiting No outcome recorded
— NCT04891900 May 2021 → Dec 2024 gastric cancer, gastroesophageal junction adenocarcinoma Henan Cancer Hospital Unknown No outcome recorded
Comparator or background therapy7 trials
Phase 1/2 NCT07371663 Background Dec 2025 → Sep 2028 expected endometrial cancer, gastric cancer, melanoma, non-small cell lung carcinoma Beijing Tide Pharmaceutical Co., Ltd Recruiting No outcome recorded
Phase 1/2 NCT05859373 Background Jun 2023 → Sep 2024 non-small cell lung carcinoma Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT04611711 Background Nov → Dec 2020 digestive system cancer Peking University Unknown No outcome recorded
Phase 2 NCT07172412 Background Nov 2025 → Dec 2027 expected small cell lung carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06141226 Background Apr 2023 → Dec 2027 expected non-small cell lung carcinoma Tianjin Medical University Cancer Institute and Hospital Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 13

DateIssuerRelease
2026-02-14 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Regulatory 贝莫苏拜单抗第4个适应症获批上市，用于Ⅲ期非小细胞肺癌巩固治疗 cttq.com ↗
2月14日，中国生物制药（1177.HK）核心企业正大天晴1类新药贝莫苏拜单抗注射液（安得卫®）获得国家药品监督管理局（NMPA）批准，用于在接受铂类药物为基础的同步或序贯放化疗后未出现疾病进展的未携带已知表皮生长因子受体（EGFR）敏感突变或间变性淋巴瘤激酶（ALK）重排的不可切除Ⅲ期非小细胞肺癌（NSCLC）患者的治疗。
2025-07-03 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results Molecular Cancer（IF33.5）：得福组合去化疗方案为食管鳞癌患者提供治疗新思路 cttq.com ↗
研究结果显示，经确认客观缓解率（ORR）为56.5%，疾病控制率（DCR）达到91.3%，中位无进展生存期（PFS）达到15.74个月，中位总生存期（OS）为20.57个月，展现了良好的生存获益。
2025-06-05 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results 去化疗新选择！“得福组合”一线治疗三阴性乳腺癌展现临床获益趋势 cttq.com ↗
中位总生存期（OS）：联合组35.81个月vs.对照组21.03个月（HR=0.78；95%CI：0.49-1.24；P=0.2625），较对照组提升近15个月;
2025-06-03 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results ASCO LBA重磅发布：全球首个靶免巩固治疗Ⅲ期非小细胞肺癌研究，中位PFS突破15个月刷新记录 cttq.com ↗
试验组1：中位PFS 为15.1个月，对照组4.2个月（HR=0.49, 95%CI 0.36-0.66， P<0.001），疾病进展或死亡风险降低51%。
2025-06-02 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results ASCO 重磅！ “得福组合”头对头战胜K药，一线治疗PD-L1阳性非小细胞肺癌取得重大突破 cttq.com ↗
在全人群中，“得福组合”中位PFS达到11.0个月，较帕博利珠单抗治疗提升3.9个月，疾病进展或死亡风险降低30%（HR=0.70）。
2025-05-24 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results “国药之光”领衔12大ORAL刷屏ASCO，中国生物制药引领中国创新药企冲刺全球新 cttq.com ↗
数据提示贝莫苏拜单抗联合安罗替尼的去化疗方案较化疗对一线TNBC患者有更长的生存获益趋势，有望为不能耐受化疗的一线TNBC患者提供新的治疗选择。
2025-05-23 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results 首个战胜PD-1联合化疗研究数据公开！正大天晴 “得福组合”一线治疗肺鳞癌获显著阳性结果 cttq.com ↗
2025-04-24 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Regulatory 双适应症申报获受理！贝莫苏拜方案“头对头”优于替雷联合化疗、覆盖Ⅲ期肺癌巩固治疗 cttq.com ↗
4月23日，正大天晴1类创新药贝莫苏拜单抗注射液联合盐酸安罗替尼胶囊两项新适应症获得国家药品监督管理局药品审评中心（CDE）受理：针对晚期鳞状非小细胞肺癌（sq-NSCLC）患者的一线治疗、Ⅲ期非小细胞肺癌（NSCLC）患者的巩固治疗。
2024-12-27 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results 贝莫苏拜单抗联合安罗替尼再传喜讯！本月已有三个适应症计划申报上市 cttq.com ↗
近日，贝莫苏拜单抗联合化疗后序贯联合盐酸安罗替尼胶囊一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）的Ⅲ期临床研究（TQB2450-Ⅲ-12）取得阳性结果。
2024-12-23 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results 2024新药成绩单，正大天晴领跑肿瘤1类创新药赛道 cttq.com ↗
2024-12-19 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results 贝莫苏拜单抗Ⅲ期临床研究取得阳性结果，Ⅲ期非小细胞肺癌治疗迎新曙光 cttq.com ↗
本研究的期中分析结果显示，相比对照组，实验组可显著降低患者的疾病进展或死亡风险，延长患者无进展生存期（PFS）。
2024-10-10 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results 聚焦放疗前沿，正大天晴2款创新药最新数据亮相2024 ASTRO cttq.com ↗
中位随访时间为12.03个月，15例患者中13例病情控制良好，一年无进展生存（PFS）率为86.7%，一年总生存（OS）率为100.0%。

All press releases naming this drug 13 releases

DateIssuerRelease

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 99 sources stand behind the page.

FieldValueCited text
Known as benmelstobart “The ETER701 study showed that Benmelstobart (TQB2450, an anti-PD-L1 antibody) combined with Anlotinib and chemotherapy achieved the longest progression-free survival (PFS) and...” PMID 40114144 ↗ Mar 2025
41

“Patients randomly received benmelstobart and anlotinib plus etoposide/carboplatin (EC; n = 246), placebo and anlotinib plus EC (n = 245) or double placebo plus EC ('EC alone'; n = 247)” PMID 38992123 ↗ Jul 2024

“TQB2450 (benmelstobart) is a novel humanized immunoglobulin G1 monoclonal antibody against programmed death-ligand 1 (PD-L1).” PMID 39507039 ↗ Oct 2024

“Benmelstobart (TQB2450) is a humanized monoclonal antibody” NCT06914297 ↗

NCT07806292 ↗

NCT06637163 ↗

NCT07489300 ↗

NCT06767800 ↗

NCT07627464 ↗

NCT06978153 ↗

NCT07371663 ↗

Show 31 more sources
Known as Anicol “Piamprilizumab (Anicol) is a new PD-1 monoclonal antibody developed by Zhengda Tianqing Pharmaceutical Group Co., LTD.” NCT06429397 ↗
Known as APL-502 ChEMBL registry synonym — accepted as the source's own label CHEMBL5315042 ↗
Known as Benmelstobart Injection “The purpose of this study is to evaluate the efficacy and safety of Benmelstobart Injection combined with Anlotinib Hydrochloride and chemotherapy as first-line treatment for...” NCT07510594 ↗
1

“benmelstobart injection, intravenous infusion” NCT06897579 ↗
Known as CBT-502 ChEMBL registry synonym — accepted as the source's own label CHEMBL5315042 ↗
Known as Piamprilizumab “Piamprilizumab (Anicol) is a new PD-1 monoclonal antibody developed by Zhengda Tianqing Pharmaceutical Group Co., LTD.” NCT06429397 ↗
Known as TQB-2450 “TQB-2450 is a humanized mAb of PD-L1 that prevents PD-L1 from binding to PD-1 and B7.1 receptors on the T cell surface, enabling T cells to restore immune activity and thus...” NCT05111366 ↗
58

“Surgery or Radiotherapy After PD-L1 Inhibitor (TQB-2450) and Chemotherapy Induction Therapy in Patients With Limited-stage Small-cell Lung Cancer” NCT04539977 ↗

“21 days as a treatment cycle, Anlotinib 12 mg/day, Orally (D1-D14); TQB 2450 1200 mg, iv (D1).” NCT05252078 ↗

NCT04809142 ↗

NCT04306926 ↗

NCT04523272 ↗

NCT05812430 ↗

NCT05922345 ↗

NCT03855384 ↗

NCT03855358 ↗

NCT05481645 ↗

Show 48 more sources
Known as TQB2450 injection “TQB2450 injection (1200mg ivgtt, q3W)” NCT04888546 ↗
Known as TQB2450 solution “TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).” NCT04665609 ↗
Action Inhibit “prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface” NCT03825705 ↗
Modality Monoclonal antibody “TQB2450, a novel monoclonal antibody targeting programmed cell death ligand 1, has shown safety and efficacy in preclinical studies.” PMID 38188467 ↗ Jan 2024
Route Intravenous “eligible patients with advanced malignant tumors received intravenous TQB2450 once every 3 weeks.” PMID 38188467 ↗ Jan 2024
Target CD274 “TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).” NCT04665609 ↗