Sintbilo (tafolecimab) / Innovent Biologics - LARVOL DELTA

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

TAFOLECIMAB IN CHINESE PATIENTS WITH DIABETES MELLITUS: A POOLED ANALYSIS OF EFFICACY AND SAFETY DATA FROM PHASE 3 RANDOMIZED, PLACEBO-CONTROLLED TRIALS - Hua Shen (ACC 2025) - "In Chinese patients with diabetes mellitus, tafolecimab 450 mg Q4W yields promising lipid-lowering efficacy and is generally well-tolerated."

P3 data • Retrospective data • Diabetes • Dyslipidemia • Metabolic Disorders • APOB

Cost-Effectiveness and Price Threshold Analysis of Tafolecimab in Chinese Patients with Elevated LDL Cholesterol Despite Statin Therapy. (PubMed, Am J Cardiovasc Drugs) - "From the perspective of the Chinese healthcare system, the cost-effective annual price threshold for tafolecimab for patients with hypercholesterolemia was CNY 7022, at a threshold of CNY 268,074 per QALY."

HEOR • Journal • Cardiovascular • Dyslipidemia • Metabolic Disorders • Myocardial Infarction

Tafolecimab, a Third Monoclonal Antibody for PCSK9 as the Novel Lipid-Lowering Drug Around the World: A Narrative Review. (PubMed, Drugs) - "The long-acting formulation of tafolecimab enables less frequent dosing, thereby promoting compliance. As cardiovascular diseases continue to escalate globally, tafolecimab holds promise not only for patients in China but also for broader international applications, representing a critical advancement in the evolving landscape of lipid-lowering therapies."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Metabolic Disorders • APOB

The clinical efficacy of PCSK9 inhibitors in neoadjuvant concurrent chemoradiotherapy combined with PD-1 inhibitors in the treatment of gastrointestinal malignancies: a prospective multicenter randomized controlled clinical trial (ChiCTR) - P1 | N=110 | Sponsor: The First Hospital of Lanzhou University; The First Hospital of Lanzhou University

New P1 trial • Cardiovascular • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology

PCSK9 Inhibitors for ASCVD Risk Reduction in Asian Populations — a meta-analysis of efficacy and safety profiles (AHA 2024) - "Inclisiran was used in 3 studies, evolocumab in 5, alirocumab in 2, and tafolecimab in 1, alongside statins or ezetimibe.PCSK9i reduced LDL by -74.21 mg/dL and increased the likelihood of >50% LDL reduction compared to placebo (RR: 37.41, 95% CI: 16.31-85.82, P < 0.00001; I^2: 0%). The considerable heterogeneity in LDL reduction may result from variations in dosing, different agents used, baseline LDL levels, and geographical diversity. Future research should explore effects across more ethnicities to enhance generalizability."

Retrospective data • Dyslipidemia • Metabolic Disorders

Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors and Lipid Reduction: A Network Meta-Analysis (AHA 2024) - "In patients with hypercholesterolemia and/or hyperlipidemia treated with medium-intensity statins, tafolecimab and evolocumab (either Q2W or Q4W) might be preferred choices for lowering LDL-C. Additionally, tafolecimab (either Q2W or Q4W) appears to be the most effective agent for reducing lipoprotein(a) levels."

Retrospective data • Dyslipidemia • Metabolic Disorders

Innovent Announces First-Time Inclusion of SINTBILO...in China's National Reimbursement Drug List (PRNewswire) - "In the updated NRDL, SINTBILO is newly listed for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial types) and mixed dyslipidemia. SINTBILO (tafolecimab injection) is Innovent's first entry into the cardiovascular field, offering multiple dosing options: 150mg Q2W, 450mg Q4W, and 600mg Q6W. These regimens significantly reduce low-density lipoprotein cholesterol (LDL-C) levels by nearly 70% and lower lipoprotein a [Lp(a)] by nearly 50%. As the first domestic PCSK9 inhibitor in the NRDL, SINTBILO provides an important new treatment option for cholesterol management in China, improving quality of life for a broad population of patients with hypercholesterolemia."

Reimbursement • Dyslipidemia • Heterozygous Familial Hypercholesterolemia

IMPROVE-AMI: Effectiveness of Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients (clinicaltrials.gov) - P4 | N=1160 | Not yet recruiting | Sponsor: The Affiliated Hospital of Xuzhou Medical University

New P4 trial • Cardiovascular • Myocardial Infarction

A Study of IBI306 in Participants With Hypercholesterolemia (clinicaltrials.gov) - P3 | N=306 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed

Trial completion • Dyslipidemia • Metabolic Disorders

The efficacy and safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors combined with statins in patients with hypercholesterolemia: a network meta-analysis. (PubMed, Front Cardiovasc Med) - "Notably, evolocumab exhibited the most pronounced effect with a treatment difference of -63.67% (-68.47% to -58.87%) compared with placebo...Furthermore, the safety profile of PCSK9 inhibitors was favorable with no increase in the incidence of AE, SAE, or AE leading to treatment discontinuation; however, alirocumab, inclisiran, and tafolecimab may potentially entail a potential risk associated with injection-site reactions...Furthermore, PCSK9 inhibitors and ezetimibe exhibit similar safety profiles. [PROSPERO], identifier [CRD42023490506]."

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

Antibodies to watch in 2024. (PubMed, MAbs) - "In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi))...These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa)...Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates..."

Journal • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases