Drugs / Tafolecimab
last change Jun 2026 re-read 2 minutes ago

Tafolecimab

also known as IBI306

Monoclonal antibody targets PCSK9 via inhibition

Developed for
aortic valve stenosis · homozygous familial hypercholesterolemia · hyperlipidemia · hyperlipoproteinemia · acute coronary syndrome · acute myocardial infarction · familial hypercholesterolemia · gastric adenocarcinoma
+6 more · gastroesophageal junction adenocarcinoma · ischemic stroke · lung cancer · non-small cell lung carcinoma · rectal cancer · small cell lung carcinoma
Investigated by
Innovent Biologics (Suzhou) Co. Ltd. · Beijing Anzhen Hospital · Beijing Friendship Hospital · Innovent Biologics, Inc. · Peking University Cancer Hospital & Institute · Shenzhen People's Hospital
+34 more · Affiliated Hospital of Qinghai University · Anhui Provincial Cancer Hospital · Beijing Hospital · Beijing Jishuitan Hospital · Beijing Luhe Hospital · Beijing Municipal Health Commission · Beijing Tiantan Hospital · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Changhai Hospital · China National Center for Cardiovascular Diseases · Chinese Academy of Medical Sciences, Fuwai Hospital · First Affiliated Hospital of Zhejiang University · Fudan University · Guangdong Provincial People's Hospital · Innovent Biopharmaceutical Co., Ltd. · Jinghui Wang · Meizhou People's Hospital · Nanchang University Second Affiliated Hospital · Nanchong Central Hospital · Peking Union Medical College Hospital · Peking University First Hospital · Ruijin Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Sixth Affiliated Hospital, Sun Yat-sen University · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sun Yat-sen University Cancer Center · The Affiliated Hospital of Xuzhou Medical University · The First Affiliated Hospital of Xiamen University · The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine · The First Hospital of Jilin University · Third Affiliated Hospital, Sun Yat-Sen University · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Yiwu Central Hospital · Zhangzhou Hospital, Fujian Province

Trials 19 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 26 trials
Phase 2 NCT07621562 Jun 2026 → Sep 2027 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma First Affiliated Hospital of Zhejiang University Not yet recruiting No outcome recorded
Phase 2 NCT07061535 Jul 2025 → Aug 2027 expected small cell lung carcinoma Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
Phase 2 NCT07014215 Jun 2025 → May 2027 expected non-small cell lung carcinoma Anhui Provincial Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06421298 May 2024 → May 2027 expected lung cancer Jinghui Wang Recruiting No outcome recorded
Phase 2 NCT06304987 Apr 2024 → Apr 2026 Beijing Friendship Hospital Unknown No outcome recorded
Phase 2 NCT03815812 Mar → Dec 2019 hyperlipidemia Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT04948008 Nov 2019 → Jul 2020 homozygous familial hypercholesterolemia Shenzhen People's Hospital Unknown No outcome recorded
Phase 2/3 NCT04031742 Sep 2019 → Dec 2021 homozygous familial hypercholesterolemia Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 38 trials
Phase 3 NCT07686796 Jan 2027 → Jan 2030 expected rectal cancer Guangdong Provincial People's Hospital Not yet recruiting No outcome recorded
Phase 3 NCT07473960 Apr → Sep 2026 expected hyperlipoproteinemia Innovent Biologics (Suzhou) Co. Ltd. Recruiting No outcome recorded
Phase 3 NCT07256197 Apr 2026 → Dec 2028 expected aortic valve stenosis Beijing Anzhen Hospital Not yet recruiting No outcome recorded
Phase 3 NCT04968509 Mar 2024 → Dec 2027 expected aortic valve stenosis Beijing Anzhen Hospital Recruiting No outcome recorded
Phase 3 NCT04709536 Feb → Nov 2021 hyperlipoproteinemia Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 3 NCT04759534 Sep 2020 → Oct 2021 hypercholesterolemia, autosomal dominant, 3 Shenzhen People's Hospital Unknown No outcome recorded
Phase 3 NCT04289285 Apr 2020 → Feb 2022 hyperlipidemia Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 3 NCT04179669 Dec 2019 → Jun 2021 familial hypercholesterolemia Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase 41 trial
Phase 4 NCT06683131 Nov 2025 → Nov 2027 expected acute myocardial infarction The Affiliated Hospital of Xuzhou Medical University Not yet recruiting No outcome recorded
Phase not applicable2 trials
NCT07341958 Feb → Dec 2026 expected ischemic stroke Beijing Tiantan Hospital Not yet recruiting No outcome recorded
NCT06096909 Nov 2023 → Nov 2025 overdue acute coronary syndrome China National Center for Cardiovascular Diseases Not yet recruiting No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT03366688 Comparator Nov 2017 → Nov 2018 hyperlipidemia Innovent Biologics (Suzhou) Co. Ltd. Completed No outcome recorded
Phase not applicable1 trial
NCT05457582 Comparator Mar 2023 → Sep 2026 expected acute coronary syndrome, hyperlipidemia Nanjing First Hospital, Nanjing Medical University Recruiting No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

FieldValueCited text
Known as tafolecimab “Sixty patients with hypercholesterolemia (phase 1b) were randomized to receive 75 or 140 mg tafolecimab every 2 weeks, 300 or 420 mg every 4 weeks, or 450 or 600 mg every 6...” PMID 36341216 Nov 2021
13

“Patients in experimental group are treated with PCSK9 inhibitors (150mg Tafolecimab subcutaneously every two weeks) and guideline-directed management in cardiovascular primary...” NCT07256197

“Patients in experimental group are treated with PCSK9 inhibitors (140mg with Evolocumab or 75mg with Alirocumab or 150mg with Tafolecimab subcutaneously every two weeks)” NCT04968509

Tafolecimab is a novel fully human proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody, developed for the treatment of hypercholesterolemia.” PMID 37614541 Jul 2023

“Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.” NCT05457582

“PD-1 inhibitor (Sintilimab) and PCSK9 inhibitor (Tafolecimab)” NCT06304987

NCT06421298

NCT07014215

NCT07341958

NCT06683131

NCT06096909

NCT07686796

NCT07061535

NCT07621562

Known as IBI306 IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9)” NCT03366688
8

IBI306 is a kind of protein convertase subtilisin/kexin type 9 inhibitor.” NCT04759534

NCT04289285

NCT04179669

NCT03815812

NCT04031742

NCT07473960

NCT04948008

NCT04709536

Action Inhibit “preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R)” NCT03366688
Modality Monoclonal antibody “fully human monoclonal antibodyNCT03366688
Route Intravenous “Subcutaneous or intravenous injection of a single dose of IBI306” NCT03366688
Route Subcutaneous Subcutaneous or intravenous injection of a single dose of IBI306” NCT03366688
Target PCSK9 “binds proprotein convertase substilisin/kexin type 9 (PCSK9)” NCT03366688