Sintbilo (tafolecimab) / Innovent Biologics - LARVOL DELTA

TRIUNITE-08: Tafolecimab Combined With Chemoimmunotherapy as Neoadjuvant Treatment for pMMR/MSS Locally Advanced Colon Cancer (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

New P2 trial • pMMR • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Tafolecimab mitigates ox-LDL-induced macrophage foam cell formation and inflammation by modulating SR-A/ABCG1 expression and inhibiting the NF-κB/MAPK pathways. (PubMed, Biomed Rep) - "Foam-cell models were established by exposing RAW264.7 cells to 100 µg/ml ox-LDL for 24 h. The study groups included a blank control group, a model group, low-, medium- and high-dose tafolecimab groups (5, 10 and 20 µmol/l, respectively), and a positive control group treated with evolocumab. Furthermore, it effectively inhibited the phosphorylation of NF-κB p65 and MAPK p38, which was accompanied by reduced secretion of TNF-α and IL-6 (P<0.001). The present results indicate that tafolecimab inhibits ox-LDL-induced macrophage foam-cell formation and inflammatory responses, likely by modulating the balance between SR-A-mediated cholesterol influx and ABCG1-mediated cholesterol efflux in favor of cholesterol efflux, and by inhibiting NF-κB and MAPK pathway activation."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Inflammation • Oncology • ABCG1 • IL6 • TNFA

IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia (clinicaltrials.gov) - P3 | N=198 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia • APOB

Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial (clinicaltrials.gov) - P3 | N=148 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital

New P3 trial • pMMR • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

SYSTEM: Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

IO biomarker • New P2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: Mei Gao

New trial • Dyslipidemia

STAR-SCLC: Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Bezafibrate-associated rhabdomyolysis in a patient with diabetic kidney disease: A case report and successful transition to tafolecimab. (PubMed, Medicine (Baltimore)) - "Bezafibrate may result in severe rhabdomyolysis in diabetic CKD, particularly when combined with nifedipine (a CYP3A4 inhibitor) and reduced renal clearance. Tafolecimab's nonrenal metabolism and low myotoxicity make it a safe and efficient substitute."

Journal • Cardiovascular • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Dyslipidemia • Fatigue • Hypertension • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Pain • Renal Disease

Tafolecimab Combined With Sintilimab and SOX in the Treatment of pMMR/MSS Gastric Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: First Affiliated Hospital of Zhejiang University

New P2 trial • pMMR • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

NGGT006, an AAV-mediated LDLR gene transfer therapy achieves efficient and sustained reduction in LDL-C in subjects with homozygous familial hypercholesterolemia (ASGCT 2026) - "One subject dosed at 4.6x1013 vg/kg maintained a stable LDL-C level below 1.8 mmol/L till Week 40, then below 2.5 mmol/L with combined treatment of Tafolecimab from Week 44...Conclusion This study demonstrated that a single dose of NGGT006 was well-tolerated and effective in a stable normalization of blood LDL-C and other lipoprotein parameters in HoFH patients. AAV gene therapy represents an encouraging approach for treating HoFH."

Clinical • First-in-human • Atherosclerosis • Dyslipidemia • Familial Hypercholesterolemia • Gene Therapies • Genetic Disorders • Homozygous Familial Hypercholesterolemia • Metabolic Disorders • LDLR

IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia (clinicaltrials.gov) - P3 | N=198 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia • APOB

IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia (clinicaltrials.gov) - P3 | N=198 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Monotherapy • New P3 trial • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Mixed Hyperlipidemia • APOB

Therapeutic Effects of PCSK9 Inhibitors on Lp(a)-Associated Atherosclerosis: Evidence and Perspectives. (PubMed, J Cardiovasc Pharmacol) - "We systematically searched PubMed and Embase for clinical trials and mechanistic studies (2010-2025), utilizing the PRISMA and AMSTAR-2 frameworks to ensure methodological rigor and demonstrated that PCSK9 inhibitors (e.g., alirocumab, evolocumab, and tafolecimab) not only reduced low-density lipoprotein(LDL-C),by 55-60% but also lowered Lp(a) by 20-30%. This evidence supports the 2023 ESC guidelines, which issued a Class IIa recommendation for PCSK9 inhibitor use in patients with ASCVD and elevated Lp(a) levels. Given the evolving landscape, further research is warranted to confirm the role of these therapies in precision medicine paradigms for managing Lp(a)-associated risks."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia

The Efficacy and Safety of Four Novel PCSK9 Monoclonal Antibodies in Patients With Hypercholesterolemia: A Systematic Review With Network Meta-Analysis and Trial Sequential Analysis. (PubMed, Cardiovasc Ther) - "These findings positioned ongericimab 150 mg Q2W as a clinically optimal PCSK9 inhibitor with robust lipid-lowering capacity. The results highlight the potential of next-generation PCSK9 monoclonal antibodies, particularly in East Asian populations, while underscoring the need for large-scale multinational trials to validate ethnic-specific responses."

Biomarker • Clinical • Journal • Retrospective data • Review • Dyslipidemia • Metabolic Disorders • APOB

INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2) (clinicaltrials.gov) - P=N/A | N=242 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

New trial • Atherosclerosis • Cardiovascular • Ischemic stroke • APOB

Cost-utility analysis of PCSK9 inhibitors for hypercholesterolemia: a Chinese healthcare perspective. (PubMed, Front Pharmacol) - "In the base-case analysis, evolocumab 140 mg every 2 weeks (Q2W) was the most cost-effective option, dominating all other active regimens...All other regimens were dominated, and inclisiran showed the least favorable cost-utility profile (ICUR $113,800.14 per QALY)...Alirocumab 75 mg Q2W and tafolecimab 150 mg Q2W also represent cost-effective alternatives. These findings provide important evidence to support clinical decision-making and optimize resource allocation in China."

HEOR • Journal • Cardiovascular • Dyslipidemia • Metabolic Disorders

Comparative Efficacy of Ongericimab Versus Six PCSK9 Inhibitors in Treating Hypercholesterolemia or Mixed Dyslipidemia: A Network Meta-Analysis (ISPOR-EU 2025) - "This study aimed to assess the relative lipid-lowering efficacy of ongericimab compared with other PCSK9 inhibitors through a network meta-analysis (NMA). We conducted a systematic literature review (SLR) to identify phase 3 randomized controlled trials (RCTs) of ongericimab and six other PCSK9 inhibitors (evolocumab, alirocumab, tafolecimab, recaticimab, ebronucimab, and inclisiran) assessing efficacy in adult patients with hypercholesterolemia or mixed dyslipidemia, compared with background lipid-lowering therapies. Ongericimab demonstrated superior efficacy in reducing LDL-C and Lp(a) levels compared with most existing PCSK9 inhibitors. These findings may inform clinical decisions and support formulary positioning in lipid-lowering treatment strategies."

Retrospective data • Dyslipidemia • Metabolic Disorders • Mixed Hyperlipidemia

A Phase II Clinical Study of Tafolecimab Combined With Sintilimab in the Treatment of Advanced NSCLC Who Failed the Previous Immunotherapy (IASLC-WCLC 2025) - P1/2 | "Sintilimab treatment is capped at 24 months.The primary endpoints are objective response rate (ORR) per RECIST 1.1 and safety profile. Secondary endpoints include progression-free survival (PFS), overall survival (OS), 1-year PFS rate, disease control rate (DCR), and duration of response (DOR)."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Efficacy and safety of tafolecimab in Chinese patients with familial hypercholesterolemia: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Ann Med Surg (Lond)) - "Although adverse events were more frequent, their severity did not significantly differ from placebo. The generalizability of these findings is limited to Chinese populations, highlighting the need for further research in diverse cohorts."

Journal • Retrospective data • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Immunology • Metabolic Disorders

The efficacy of tafolecimab in lipoprotein(a) reductions in hypercholesterolaemic patients: a pooled analysis of three phase 3 trials (ESC-WCC 2025) - "Tafolecimab 450 mg Q4W offers greater reductions in Lp(a) levels in hypercholesterolaemic patients with higher initial Lp(a) levels, which provides a novel therapeutic option for improving Lp(a) and preventing cardiovascular risks for this patient population."

P3 data • Retrospective data • Atherosclerosis • Cardiovascular • Dyslipidemia

PCSK9 targeting therapies for familial hypercholesterolaemia: a meta-analysis of efficacy on lipid biomarkers and safety in adults and children across 23 RCTs. (PubMed, Open Heart) - "PCSK9i and Inclisiran demonstrate significant and sustained reductions in LDL-C, ApoB, Lp(a) and TGL in FH patients, especially in heterozygous FH patients. These agents are generally well-tolerated and represent effective treatment options for FH patients inadequately controlled by standard lipid-lowering therapies."

Biomarker • Clinical • Journal • Retrospective data • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Familial Hypercholesterolemia • Genetic Disorders • Heterozygous Familial Hypercholesterolemia • Pediatrics • APOB

STAR-SCLC: Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and safety of Tafolecimab in Chinese patients with type 2 diabetes and hypercholesterolemia: a post-hoc analysis of pooled data from three phase 3 trials. (PubMed, Cardiovasc Diabetol) - "Tafolecimab 450 mg Q4W demonstrated a superior lipid-lowering efficacy and favorable safety profile compared to placebo. This suggests it could be a promising new treatment option for Chinese patients with T2D and hypercholesterolemia."

Journal • P3 data • Retrospective data • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus • APOB

PD-1 Combined With Bevacizumab and PCSK-9 Inhibitor in Patients With Advanced NSCLC Who Have Progressed After Anti- PD- 1/L1 Therapy (clinicaltrials.gov) - P2 | N=52 | Not yet recruiting | Sponsor: Anhui Provincial Cancer Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and safety of tafolecimab a new PCSK9 inhibitor in patients with hyperlipidemia: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Egypt Heart J) - "Tafolecimab is a valuable treatment option for hyperlipidemia, which showed improvement in several lipid indices (LDL, LDL-C, LDL CFB, non-HDL-C CFB, and apolipoprotein B CFB). However, it increased the rates of injection site reactions."

Journal • Retrospective data • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Metabolic Disorders • Myocardial Infarction • APOB