Recently, Salubris announced that the marketing application for its independently developed Class 1 biologic, Ticalicibart Injection (Project Code: SAL003), has been accepted by NMPA [1].
Cardiovascular diseases (CVD), with atherosclerotic cardiovascular disease (ASCVD) as the main type, are the leading cause of death among both urban and rural residents in China. Low-density lipoprotein cholesterol (LDL-C) is a causal risk factor for ASCVD and represents the primary target for lipid-lowering interventions [2].
The Chinese Guidelines for Lipid Management indicate that the combination of lipid-lowering drugs and the use of novel agents, such as PCSK9 inhibitor, can reduce LDL-C levels by 50% to 70% and further reduce the risk of major adverse cardiovascular events (MACE) on the basis of statin therapy [2].
Ticalicibart Injection (Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection) is a proprietary anti-PCSK9 monoclonal antibody developed by the company, intended for the treatment of hypercholesterolemia and mixed dyslipidemia. The dosing regimen involves a subcutaneous injection once every four weeks.
If approved, the product is anticipated to greatly improve patient convenience and adherence, thereby offer a new treatment option for the long-term management of dyslipidemia, while also strengthen the company's innovative portfolio in metabolic diseases.
About PCSK9 Inhibitor
As a new class of lipid-lowering drugs, PCSK9 inhibitors work by preventing PCSK9 from binding to the low-density lipoprotein receptor (LDLR), thereby reducing its degradation and significantly increasing the clearance rate of LDL-C.
References
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement on the Acceptance of the Marketing Application for Taixisimab Injection (SAL003).
[2] Chinese Guidelines for Lipid Management (2023).
[3] Ma, G., Liu, S., Wang, H., et al. Research Status of Novel Lipid-Lowering Drug PCSK9 Inhibitors in Atherosclerotic Cardiovascular Disease. Journal of Pharmaceutical Research, 2024.
Disclaimer:
1. This material is intended to provide knowledge in the field of disease, enhance disease awareness, and is not for promotional purposes.
2. The information contained herein is for reference only. Please follow the advice or guidance of physicians or other healthcare professionals.
| About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd., founded in 1998, is an innovation-driven pharmaceutical listed company (Stock Code: 002294) with integrated R&D, production, and marketing operations, rooted in China and serving
the global market. With the mission of "providing exceptional pharmaceutical products for human health," Salubris has deepened its expertise in chronic disease treatment with a focus on cardiovascular and cerebrovascular conditions. The company has successfully commercialized alisartan monotherapy, combination drugs, and co-crystal formulations to address diverse complex hypertension challenges, establishing a unique family of first-in-class antihypertensive therapies centered on alisartan.
Salubris has established five innovative drug R&D centers and three medical device R&D bases globally, creating innovation platforms focused on small molecule drugs, biological drugs, siRNA therapeutics, gene-editing therapies, and medical devices. The company is committed to developing innovative products that address unmet clinical needs, with the goal of enhancing people's quality of life and extending healthy lifespan.
