drugset
Drugs / TQB2868
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TQB2868

Protein / enzyme biologic targets PDCD1 via inhibition

Developed for
triple-negative breast carcinoma · cancer · cervical cancer · female breast carcinoma · hepatocellular carcinoma · hormone receptor-positive breast cancer · intrahepatic cholangiocarcinoma · pancreatic ductal adenocarcinoma
+1 more · pancreatic neoplasm
Investigated by
Fudan University · Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Trials 8

today NCT07846267 · Ph 2 NCT07165951 · Ph 3 NCT06441019 · Ph 2 NCT06767813 · Ph 2 NCT05998941 · Ph 2 NCT05749588 · Ph 2 NCT05582499 · Ph 2 NCT05198505 · Ph 1
2023202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05198505 Apr 2022 → Jun 2023 cancer Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 26 trials
Phase 2 NCT07846267 Oct 2026 → Oct 2029 expected intrahepatic cholangiocarcinoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT06441019 Jul 2024 → May 2025 hepatocellular carcinoma Fudan University Unknown No outcome recorded
Phase 2 NCT06767813 Mar 2024 → Nov 2026 expected pancreatic neoplasm Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT05998941 Aug 2023 → Feb 2025 cervical cancer Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Withdrawn No outcome recorded
Phase 2 NCT05749588 Mar 2023 → Dec 2027 expected triple-negative breast carcinoma Fudan University Recruiting 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 31 trial
Phase 3 NCT07165951 Dec 2025 → May 2028 expected pancreatic ductal adenocarcinoma Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2025-06-11 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Regulatory 突破“癌王”治疗困境！正大天晴TQB2868联合方案获批Ⅲ期临床，剑指胰腺癌一线免疫治疗空白 cttq.com ↗
6月11日，正大天晴宣布自主研发的1类创新药TQB2868注射液联合盐酸安罗替尼胶囊及化疗，用于转移性胰腺导管腺癌（mPDAC）一线治疗方案，已获得国家药品监督管理局药品审评中心（CDE）批准开展Ⅲ期注册临床试验。
2025-05-28 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Results 破解胰腺癌免疫逃逸！正大天晴PD-1/TGF-β双功能融合蛋白联合疗法Ⅱ期数据亮相ASCO cttq.com ↗
安全耐受性良好，3级及以上不良反应发生率为52.5%（AG化疗方案为68.1%-77%）。
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 ↗
研究数据显示，接受四药方案治疗患者的ORR为63.9%，是接受系统性化疗（AG）方案治疗的患者历史数据的2到3倍（23-36%）。

All press releases naming this drug 3 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as TQB2868 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05998941 ↗
7

NCT05582499 ↗

NCT05198505 ↗

NCT07165951 ↗

NCT05749588 ↗

NCT06767813 ↗

NCT07846267 ↗

NCT06441019 ↗
Action Inhibit “The bifunctional fusion protein targets and neutralizes TGF-β in the tumor microenvironment.” NCT05198505 ↗
Modality Protein / enzyme biologic “TQB2868 protein is a bi-functional fusion protein targeting PD-1 and TGF-β” NCT05198505 ↗
Route Intravenous “administered by IV” NCT07846267 ↗
Target PDCD1 “TQB2868: an anti-PD-1/TGF-β bispecific antibody in all-comer TNBC” NCT05749588 ↗