Delving into the Latest Updates on SHR-1918 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

SHR 1918, SHR1918

Target

ANGPTL3

Action

inhibitors

Mechanism

ANGPTL3 inhibitors(Angiopoietin like 3 inhibitors)

Therapeutic Areas

Congenital DisordersEndocrinology and Metabolic DiseaseOther Diseases

Active Indication

Homozygous familial hypercholesterolemiaHypertriglyceridemiaHyperlipidemia, Familial Combined+ [1]

Inactive Indication-

Originator Organization

Beijing Suncadia Pharmaceuticals Co., Ltd

Active Organization

Beijing Suncadia Pharmaceuticals Co., Ltd

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationPriority Review (China), Breakthrough Therapy (China)

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Several pharmacologic approaches have demonstrated robust lipid-lowering efficacy through ANGPTL3 inhibition. Monoclonal antibodies (evinacumab, SHR-1918) and RNA-based therapies (vupanorsen, zodasiran, solbinsiran) effectively reduce triglycerides, apoprotein B (apoB)-containing lipoproteins, and nonhigh-density lipoprotein cholesterol. The newest and most promising innovation is CRISPR-mediated disruption of ANGPTL3 (CTX310).

Summary:

ANGPTL3 inhibition represents one of the most powerful current strategies for lowering triglyceride-rich lipoproteins and residual cardiovascular risk. While monoclonal antibodies and RNA-based drugs offer effective, repeat-dose therapies, in vivo CRISPR editing could enable a one-time, lifelong correction of hypertriglyceridemia and mixed dyslipidemia. The main challenge ahead lies in ensuring safety, scalability, and equitable access if long-term efficacy and tolerability are confirmed in phase 3 trials.

01 Feb 2026·JAMA Cardiology

Anti-ANGPTL3 Antibody SHR-1918 for Homozygous Familial Hypercholesterolemia

Article

Author: Chen, Xiaoshu ; Pi, Lin ; Wu, Yanqing ; Wang, Lvya ; Qi, Sheng ; Wang, Nan ; Cheng, Gang ; Feng, Sheng ; Chen, Jiyan ; Peng, Daoquan ; Xu, Yawei ; Lv, Chao ; Zhu, Min ; Zhu, Ying

Importance:

Homozygous familial hypercholesterolemia (HoFH) is a rare, life-threatening genetic disorder. Patients with HoFH have markedly elevated low-density lipoprotein cholesterol (LDL-C) levels from birth, and their activity of LDL receptor (LDLR) is typically absent or severely impaired. However, efficacy of traditional lipid-regulating agents relies on residual LDLR function. Angiopoietinlike 3 (ANGPTL3)–directed therapies could reduce lipid levels through an LDLR-independent pathway.

Objective:

To evaluate SHR-1918, a fully human monoclonal antibody targeting ANGPTL3, in adults with HoFH taking stable lipid-lowering therapy.

Design, Setting, and Participants:

This was a multicenter, single-arm, phase 2 nonrandomized clinical trial conducted at 8 sites in China between December 19, 2023, and April 2, 2024. Included were participants with HoFH taking stable lipid-lowering therapy.

Interventions:

Patients were given subcutaneous SHR-1918 at 600 mg every 4 weeks for 12 weeks, followed by an 8-week follow-up.

Main Outcomes and Measures:

The primary end point was the percent change in serum LDL-C level from baseline to week 12.

Results:

A total of 26 patients (mean [SD] age, 36.1 [12.2] years; 16 female [61.5%]) were included in this analysis. The mean (SD) baseline LDL-C level was 433.59 (173.74) mg/dL. At week 12, the mean percent change in LDL-C level was −59.09% (SD, 11.71%; 95% CI, −63.81% to −54.36%). The reduction was observed throughout the entire 8-week follow-up period. SHR-1918 suggested similar LDL-C reduction across HoFH genotypes, with a percent change from baseline to week 12 of −61.32% for homozygous, −56.40% for compound heterozygous, and −72.21% for double heterozygous. Overall, 16 patients (61.5%) had at least 1 treatment-emergent adverse event, with the most common being proteinuria (4 [15.4%]). Injection site reaction occurred in only 1 patient (3.8%) and included pain and rash or erythema (both grade 1).

Conclusions and Relevance:

Results show that SHR-1918 was associated with a substantial reduction in LDL-C level and favorable safety profile among patients with HoFH taking stable lipid-lowering therapy.

Trial Registration:

ClinicalTrials.gov Identifier: NCT06009393

01 Aug 2025·CLINICAL PHARMACOKINETICS

SHR-1918, A Monoclonal Antibody Against Angiopoietin-Like 3, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Study

Article

Author: Lian Duan ; Zhihong Xie ; Wenkai He ; Min Zhu ; Mingyan Li ; Rong Jin ; Shihui Wang ; Deen Li ; Xiao Mei ; Ruzhai Qin ; Chao Lv ; Lika Ye

BACKGROUND AND OBJECTIVE:

Angiopoietin-like 3 (ANGPTL3) increases serum low-density lipoprotein cholesterol and triglyceride by reducing their clearance. SHR-1918 is a monoclonal antibody against ANGPTL3. This study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SHR-1918 in healthy subjects.

METHODS:

Six dose cohorts (100, 300, 450, 750, 900, and 1200 mg) were planned, each containing 12 healthy subjects randomized (9:3) to receive a single dose of subcutaneous SHR-1918 or placebo. Subjects were followed up to day 148 for the 100-mg cohort and day 190 for the other cohorts.

RESULTS:

A total of 72 subjects were enrolled (SHR-1918, n = 54; placebo, n = 18). SHR-1918 was well tolerated at 100-1200 mg. Treatment-emergent adverse events were comparable between the SHR-1918 (90.7%) and placebo (94.4%) groups. All treatment-emergent adverse events were mild or moderate in severity, with no serious adverse events or treatment-emergent adverse events leading to death. Maximum serum concentration was reached 7.98-10.0 days after injection, and mean half-life was 29.4-53.5 days across the dose range. Serum low-density lipoprotein cholesterol and triglyceride markedly and rapidly decreased upon SHR-1918 administration, whereas those in the placebo group were above baseline at most follow-up visits. The largest median percentage decline in serum low-density lipoprotein cholesterol and triglyceride ranged from - 28.7 to - 49.1% and from - 46.6 to - 82.8%, respectively. For dose levels 300 mg or higher, the low-density lipoprotein cholesterol reduction remained over 30% for 64 days and triglyceride reduction remained over 50% for 85 days.

CONCLUSIONS:

SHR-1918 was well tolerated and showed promising efficacy in lipid reduction among healthy subjects.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT05432544 (24 June, 2022).

1

News (Medical) associated with SHR-1918

11 Dec 2024

·www.echemi.com

Heng Rui Pharma Launches Phase III Trial for ANGPTL3 Monoclonal Antibody

According to information from the U.S. clinical trial registry Clinicaltrials on December 10, Chinese company Heng Rui Pharma has launched its first Phase III clinical trial (SHR-1918-301) for the ANGPTL3 monoclonal antibody SHR-1918. This drug marks the first domestic ANGPTL3 monoclonal antibody to enter the Phase III clinical trial stage. SHR-1918 is an ANGPTL3 monoclonal antibody developed by Heng Rui Pharma, which works by inhibiting ANGPTL3 activity to lower triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C) levels in serum. LDL-C and TG are significant risk factors for the development of atherosclerotic cardiovascular diseases. ANGPTL3 plays a key role in lipid metabolism regulation by inhibiting lipoprotein lipase and endothelial lipase, thereby reducing the clearance of TG and LDL-C. In September this year, Heng Rui Pharma announced the results of its first Phase I study (SHR-1918-101) at the European Society of Cardiology (ESC) annual meeting. The study showed that SHR-1918 (100-1200mg, subcutaneously) demonstrated good tolerance and pharmacokinetic characteristics in healthy subjects, with a peak time of 8.0-10.0 days and a half-life of 29.4-53.5 days. Additionally, SHR-1918 effectively and durably reduced LDL-C and TG levels: patients receiving doses of SHR-1918 of 300mg or higher had LDL-C levels reduced by over 30% (up to 49.1%), lasting more than 64 days; TG levels were reduced by over 50% (up to 82.8%), lasting more than 85 days. Given the potential of SHR-1918 for treating rare dyslipidemia disorders, the drug received breakthrough therapy designation for homozygous familial hypercholesterolemia (HoFH) from the Chinese National Medical Products Administration (NMPA) in September. The launched Phase III study is a multicenter, randomized, double-blind, placebo-controlled clinical trial (n=45), aimed at evaluating the efficacy and safety of SHR-1918 in treating homozygous familial hypercholesterolemia (HoFH). The primary endpoint is the percentage change in LDL-C levels from baseline at week 12. Homozygous familial hypercholesterolemia (HoFH) is a rare and severe genetic disorder where patients accumulate LDL-C in the blood due to defects or deficiencies in low-density lipoprotein receptors (LDLR), increasing the risk of heart disease and stroke. Currently, available treatment options for these patients include statins (simvastatin, atorvastatin, and rosuvastatin), ezetimibe, lomitapide, mipomersen, PCSK9 monoclonal antibodies (evolocumab and alirocumab), and evinacumab. Among these, evinacumab (Regeneron/Ultragenyx) is the only marketed ANGPTL3 monoclonal antibody, with global sales of $80.9 million in 2023.

Phase 3Clinical ResultPhase 1Breakthrough TherapyPhase 2

100 Deals associated with SHR-1918

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Homozygous familial hypercholesterolemia	NDA/BLA	China	Beijing Suncadia Pharmaceuticals Co., Ltd	12 Dec 2025
Hypertriglyceridemia	Phase 3	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	04 Mar 2026
Hypertriglyceridemia	Phase 3	China	Beijing Suncadia Pharmaceuticals Co., Ltd	04 Mar 2026
Hyperlipidemia, Familial Combined	Phase 3	China	Beijing Suncadia Pharmaceuticals Co., Ltd	02 Dec 2025
Hyperlipidemia, Familial Combined	Phase 3	China	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	02 Dec 2025
Hypercholesterolemia	Phase 1	China	-	08 Dec 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06009393 (Pubmed \| JAMA Cardiol \| NEWS) Manual	Phase 2	Homozygous familial hypercholesterolemia	26	SHR-1918 600 mg	zcucpsvutn(arikbbziph) = iqxgcozxsl hhayihqqpp (vlvxifbbiu, −63.81 - −54.36) View more	Positive	07 Jan 2026
				SHR-1918 600 mgSHR-1918 600 mg (homozygous)	zcucpsvutn(arikbbziph) = sggbprwvwt hhayihqqpp (vlvxifbbiu )
NCT05432544 (SHR-1918, Pubmed \| Clin Pharmacokinet)	Phase 1	serum low-density lipoprotein cholesterol \| triglyceride	72	SHR-1918 100 mg	umvwksnpme(hzavhzoiwl) = Treatment-emergent adverse events were comparable between the SHR-1918 (90.7%) and placebo (94.4%) groups. All treatment-emergent adverse events were mild or moderate in severity, with no serious adverse events or treatment-emergent adverse events leading to death dvazeaivcf (tqrurhjqbo )	Positive	01 Aug 2025
				SHR-1918 300 mg
NCT05432544 (NEWS) Manual	Phase 1	Hyperlipidemias	-	SHR-1918	kiogpkzwne(wumlacqaul) = 300mg及以上剂量水平的LDL-C降低超过30%，持续64天以上，最高达49.1%。 vwwpcblcth (sinrbenzbk ) View more	Positive	06 Sep 2024
CTR20221447 (ESC2024)	Phase 1	-	-	SHR-1918	lpewvlbxjq(jeimlfjbjq) = Treatment-emergent adverse events (TEAEs) were reported in 49 (90.7%) subjects in the SHR-1918 group and 17 (94.4%) subjects in the placebo group. The most common TEAEs were upper respiratory tract infection (25.9% with SHR-1918 vs. 27.8% with placebo), protein urine present (22.2% vs. 22.2%), and blood uric acid increased (16.7% vs. 16.7%). All TEAEs were mild or moderate in severity. There were no serious adverse events or TEAEs leading to death. iyfjkafowg (mdrjkjyagd ) View more	-	01 Sep 2024
				Placebo

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