Drugs / Recaticimab
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Recaticimab

also known as SHR-1209

Monoclonal antibody targets PCSK9

Developed for
hyperlipidemia · hyperlipoproteinemia · intracranial arteriosclerosis · ischemic stroke · non-small cell lung carcinoma · atherosclerosis · biliary tract cancer · cerebral artery stenosis
+6 more · cerebral atherosclerosis · cognitive disorder · familial hypercholesterolemia · hyperlipidemia, combined, 2 · psoriasis · ST-elevation myocardial infarction
Investigated by
Jiangsu HengRui Medicine Co., Ltd. · Peking Union Medical College Hospital · Baotou Central Hospital · Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine · Chinese PLA General Hospital · Chongqing General Hospital
+28 more · First Affiliated Hospital of Harbin Medical University · Hebei General Hospital · Huashan Hospital · Jining First People's Hospital · Liaocheng People's Hospital · Nanjing First Hospital, Nanjing Medical University · Taihe Hospital · Tangshan Worker's Hospital · The Affiliated Hospital of Qingdao University · The First Affiliated Hospital of Zhengzhou University · Weifang People's Hospital · Zhongnan Hospital · Beijing Chest Hospital, Capital Medical University · First Affiliated Hospital of Gannan Medical University · First People's Hospital of FuZhou · Hunan Cancer Hospital · Jiangsu Hengrui Pharmaceutical Co., Ltd. · Jiujiang No.1 People's Hospital · Loudi Central Hospital · Second Affiliated Hospital of Nanchang University · Shanghai East Hospital · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sun Yat-sen University · The First People's Hospital of Changde City · Xiangtan Central Hospital · Xiangya Hospital of Central South University · Yueyang Central Hospital · ZhuZhou Central Hospital

Trials 18 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT06837077 Mar → Jun 2025 overdue hyperlipidemia Jiangsu HengRui Medicine Co., Ltd. Active not recruiting No outcome recorded
Phase 1 NCT05370950 May → Dec 2022 hyperlipidemia Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1 NCT03634436 Aug 2018 → May 2019 hyperlipidemia Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT03944109 Jun 2019 → Dec 2020 hyperlipidemia Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 23 trials
Phase 2 NCT07062328 Jul 2025 → Dec 2026 expected biliary tract cancer Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT06467617 Aug 2024 → Aug 2026 overdue non-small cell lung carcinoma Beijing Chest Hospital, Capital Medical University Recruiting No outcome recorded
Phase 2 NCT04455581 Sep 2020 → Jun 2021 familial hypercholesterolemia Jiangsu HengRui Medicine Co., Ltd. Unknown No outcome recorded
Phase 35 trials
Phase 3 NCT07119918 Sep 2025 → Dec 2029 expected intracranial arteriosclerosis Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Not yet recruiting No outcome recorded
Phase 3 NCT07002476 Jun 2025 → Jun 2028 expected ischemic stroke Shanghai East Hospital Recruiting No outcome recorded
Phase 3 NCT04885218 Jul 2021 → May 2023 hyperlipidemia, combined, 2, hyperlipoproteinemia Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 3 NCT04849000 Apr 2021 → Jun 2022 hyperlipidemia, hyperlipoproteinemia Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 3 NCT04844125 Apr 2021 → Aug 2022 hyperlipoproteinemia Jiangsu HengRui Medicine Co., Ltd. Completed No outcome recorded
Phase 46 trials
Phase 4 NCT07466251 Sep 2026 → Dec 2028 expected atherosclerosis, intracranial arteriosclerosis, ischemic stroke Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase 4 NCT07674368 Jul 2026 → Jul 2028 expected non-small cell lung carcinoma Hunan Cancer Hospital Not yet recruiting No outcome recorded
Phase 4 NCT07605130 May 2026 → Sep 2028 expected cognitive disorder, intracranial arteriosclerosis Peking Union Medical College Hospital Not yet recruiting No outcome recorded
Phase 4 NCT07373847 Jan 2026 → Jun 2027 expected psoriasis Xiangya Hospital of Central South University Not yet recruiting No outcome recorded
Phase 4 NCT07290699 Jan 2026 → Aug 2027 expected ST-elevation myocardial infarction Second Affiliated Hospital of Nanchang University Not yet recruiting No outcome recorded
Phase 4 NCT06902740 Nov 2025 → Dec 2027 expected cerebral artery stenosis, cerebral atherosclerosis Peking Union Medical College Hospital Recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT07567326 Background Jul 2026 → Dec 2028 expected non-small cell lung carcinoma Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 19 sources stand behind the page.

FieldValueCited text
Known as recaticimab “This study aimed to assess the efficacy and safety of recaticimab, a new humanized anti-PCSK9 antibody capable of reducing LDL-C levels in patients with poorly controlled HeFH.” PMID 40911402 Oct 2025
13

Recaticimab (SHR-1209) is a humanized monoclonal antibody that binds to the proprotein convertase subtilisin/kexin type 9 (PCSK9) with high affinity.” PMID 40252193 Apr 2025

Recaticimab (SHR-1209, a humanized monoclonal antibody against PCSK9) showed robust LDL-C reduction in healthy volunteers.” PMID 35039035 Jan 2022

NCT07290699

NCT07119918

NCT07674368

NCT07567326

NCT06467617

NCT06902740

NCT07466251

NCT07373847

NCT07605130

NCT07002476

NCT07062328

Known as SHR-1209 “Recaticimab (SHR-1209) is a humanized monoclonal antibody that binds to the proprotein convertase subtilisin/kexin type 9 (PCSK9) with high affinity.” PMID 40252193 Apr 2025
7

“Recaticimab (SHR-1209, a humanized monoclonal antibody against PCSK9) showed robust LDL-C reduction in healthy volunteers.” PMID 35039035 Jan 2022

“Recaticimab (SHR-1209) injection, a fully human monoclonal antibody targeting PCSK9.” NCT07674368

NCT06837077

NCT04849000

NCT04885218

NCT03634436

NCT04455581

Action Inhibit “PCSK9 inhibitor recaticimab for hypercholesterolemia on stable statin dose: a randomized, double-blind, placebo-controlled phase 1b/2 study.” PMID 35039035 Jan 2022
Modality Monoclonal antibody “a humanized monoclonal antibody against PCSK9” PMID 35039035 Jan 2022
Route Subcutaneous “Route of administration: subcutaneousNCT03634436
Target PCSK9 “a humanized monoclonal antibody against PCSK9PMID 35039035 Jan 2022