Novartis' siRNA Cholesterol-Lowering Drug Leqvio Achieves 'Exhibit-to-Product' Milestone After Three Consecutive Appearances at CIIE

On November 6, 2023, at the 6th China International Import Expo (hereinafter referred to as "CIIE"), Novartis once again showcased its world-first small interfering RNA cholesterol-lowering drug Leqvio (Inclisiran Sodium Injection). Thanks to the spillover effects brought by CIIE, this "CIIE baby," which has been exhibited for three consecutive years, received approval from the National Medical Products Administration of China in August this year ahead of schedule, successfully achieving the transformation from "exhibit to product." Just before CIIE, Inclisiran Sodium Injection officially entered hospitals in many parts of China, successfully benefiting the first group of patients.
"The CIIE is a high-quality, open platform based in China and oriented towards the world. Over the past six years, Novartis has not only expanded its circle of partners by leveraging the opportunities provided by the CIIE but also accelerated the introduction and market entry of innovative drugs with the help of the spillover effects from the event. Inclisiran sodium injection was approved in China just nine months after the submission of its new drug application and achieved nationwide availability on the eve of this year’s CIIE, powerfully demonstrating 'China speed.'" said Zhang Ying, President of Novartis China, "We will accelerate the rollout of Inclisiran sodium injection in more medical institutions across China and further enhance its accessibility, providing a more convenient and adherence-friendly lipid management option for more cardiologists and patients with dyslipidemia. In the future, Novartis will continue to drive the continuous upgrading of treatment solutions in the cardiovascular field, expand and deepen cooperation with industry partners, and contribute to the early arrival of the turning point in cardiovascular disease incidence in China."
"CIIE Baby" Transformed into "Blockbuster Product"
Cardiovascular disease is the "number one killer" causing death among residents in China, and a high level of low-density lipoprotein cholesterol (LDL-C) is one of the significant risk factors for triggering atherosclerotic cardiovascular disease. Controlling LDL-C levels within an ideal range helps delay the formation of vascular atherosclerotic plaques and reduces the risk of severe cardiovascular events such as heart attacks and strokes.
As the world's first and currently only small interfering RNA (siRNA) drug for lowering LDL-C, inclisiran sodium injection has attracted widespread attention since its debut at the CIIE in 2021, thanks to its innovative mechanism of action and a disease management model of two injections per year*. Benefiting from China’s "pilot-first" policy for innovative drugs and the spillover effects of the CIIE, inclisiran sodium injection has been successively implemented in the Boao Lecheng Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area over the past two years. This has allowed more than 3,000 Chinese patients with dyslipidemia to benefit in advance, while also providing effective clinical data for real-world research. Since receiving early approval in August this year, inclisiran has been introduced in hospitals across more than 20 cities in China, offering more diverse clinical solutions for scientific and long-term lipid management.
This year marks the third consecutive year that Inclisiran Sodium Injection has been showcased at the CIIE, and it is also the first time it has appeared at the CIIE as an "officially approved drug" with a brand-new identity. In addition to showcasing the drug, Novartis has specially set up an Inclisiran interactive area at its booth, reviewing the journey of this innovative drug from being a "CIIE baby" to becoming a "blockbuster product." Through immersive interactive experiences, it also helps more visitors gain a deeper understanding of the "black technology" behind Inclisiran Sodium Injection in reducing levels of "bad cholesterol."

Immersive interactive experience helps audiences better understand how Inclisiran injection reduces "bad cholesterol" levels.

Health Popularization Makes "Lipid Management" Concept Deeply Rooted in People's Hearts
On the same day, Chen Zhenyue, Chief Physician of the Cardiology Department at Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, and Dr. Zhang Yi, Deputy Chief Physician of the Cardiovascular Department at the Tenth People's Hospital affiliated with Tongji University, were also invited to conduct more accessible science popularization activities such as "Talk Shows" and "TED Talks" at the Novartis booth, making the prevention and treatment of cardiovascular diseases more vivid, engaging, and easy for the public to understand.
"Ordinary people all know that the 'three highs' refer to high blood pressure, high blood sugar, and high blood lipids. High blood pressure and high blood sugar are very straightforward, while high blood lipids is just a common term. In clinical terms, a more precise description should be dyslipidemia, and the main factors related to disease are cholesterol and triglyceride levels. As we often say, 'To catch a thief, first catch the king,' when it comes to blood lipid indicators, we must pay attention to the level of low-density lipoprotein cholesterol (LDL-C). You can think of atherosclerosis as cooking millet porridge, with LDL-C being the handful of millet. If LDL-C remains at excessive levels, the porridge will become thicker and thicker, the plaque will grow larger and become unstable, accumulating on the blood vessel walls, causing vascular stenosis, or even plaque rupture, leading to heart attacks and strokes." In Chen Zhenyue's view, LDL-C in the human body is a long-term cumulative process, which means lipid-lowering treatment also needs to be maintained over the long term. Vascular health accompanies a person throughout their life, and only by managing it effectively in the long term can the incidence and mortality of cardiovascular diseases be reduced, as well as the risk of cardiovascular events.
"With the progress of clinical research and drug development, the concept of lipid management is also advancing. Whether in international guidelines or Chinese guidelines, LDL-C has been regarded as the target for lipid reduction, and the understanding of blood lipid levels may be shifting towards the idea of 'the lower, the better.'" Zhang Yi stated that while focusing on blood lipid levels, attention should also be paid to the concept of lipid burden. "Lipid burden is the product of increased lipid indicators and time, especially LDL-C burden. The duration and level of LDL-C exposure determine the occurrence of many cardiovascular and cerebrovascular events and diseases. Therefore, it is necessary to continuously control blood lipids to a lower level and maintain stability." Zhang Yi believes that the emergence of new lipid-lowering drugs, such as small interfering RNA, is expected to reduce blood lipid levels even further under the premise of ensuring safety, allowing patients to benefit even more.
It is estimated that the number of patients with cardiovascular diseases in China has reached 330 million, and the prevalence rate is still on the rise. At the same time, two out of every five deaths in China are caused by cardiovascular diseases. In contrast, the awareness rate, treatment rate, and control rate of dyslipidemia among Chinese residents remain at a relatively low level. It is crucial to emphasize the control of LDL-C levels, shift the focus of prevention and treatment forward through healthy lifestyle habits, and introduce a scientific, user-friendly, and convenient blood lipid management model to stabilize LDL-C levels within the target range as early as possible. This will help reduce the risk of cardiovascular events, alleviate the disease burden, and accelerate the arrival of a turning point in the prevention and control of cardiovascular diseases in China.