Novartis' siRNA Cholesterol-Lowering Drug Inclisiran (Leqvio®) Launches in China's Boao Lecheng with First-Ever Injection

On the morning of July 2, a launch conference was held in Haikou to announce the debut of Novartis’s blockbuster small interfering RNA (siRNA) lipid-lowering drug LEQVIQ® (Inclisiran) in China’s Boao Lecheng Pilot Zone. It was announced that the first dose of Novartis’s innovative cholesterol-lowering drug Inclisiran in China was administered yesterday at Boao Super Hospital in the Hainan Boao Lecheng Pilot Zone. The first batch of authorized administration hospitals also includes the Lecheng Campus of Hainan General Hospital.

As the first-in-class small interfering RNA (siRNA) therapy designed to lower low-density lipoprotein cholesterol (LDL-C), inclisiran was approved in Europe in December 2020 for the treatment of hypercholesterolemia and mixed dyslipidemia in adults. Its innovative siRNA mechanism of action enables patients to achieve lipid-lowering efficacy with only two subcutaneous injections per year.

Globally, cardiovascular disease (CVD) is the "number one killer" threatening human health, ranking first among causes of death worldwide. With socioeconomic development, the prevalence of cardiovascular disease in China has shown a continuous upward trend. Data indicate that the number of CVD patients in China has reached 330 million, with an average of approximately 3.5 million deaths from CVD annually. Hyperlipidemia is one of the major risk factors for atherosclerotic cardiovascular disease (ASCVD); however, approximately 80% of high-risk cardiovascular patients with dyslipidemia in China still fail to achieve the guideline-recommended target levels for low-density lipoprotein cholesterol (LDL-C). Finding a safe, effective lipid-lowering drug with high patient adherence has long remained a persistent challenge for this patient population.

Although existing statin therapies are highly effective in lowering LDL-C, the Chinese population is at a higher risk of statin-induced myopathy and elevated liver enzymes with high-dose statin use compared to other ethnic groups. Consequently, most Chinese patients can only tolerate moderate-dose statin therapy. Coupled with poor treatment adherence, this further results in a low goal attainment rate. Additionally, high-dose statin therapy upregulates PCSK9 protein expression, which partially limits its LDL-C-lowering efficacy. Inhibiting PCSK9 biosynthesis enables a more effective reduction of circulating LDL-C levels.

“For PCSK9 inhibitors currently marketed in China, patients require a subcutaneous injection every two weeks or once a month, amounting to at least 12 injections annually. This not only poses a challenge to patient adherence but also increases their financial burden,” explained Professor Huo Yong from Peking University First Hospital. “Inclisiran provides sustained inhibition of hepatic PCSK9 synthesis and lowers LDL-C levels, with a duration of action lasting up to six months. In other words, patients only need two injections per year to effectively control their blood lipid levels.”

The ORION clinical trials demonstrated that in patients who fail to achieve LDL-C targets despite treatment with maximally tolerated statin doses, inclisiran achieved a 52% reduction in LDL-C compared with the placebo group.

The Hainan Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the "Lecheng Pilot Zone") is the only national-level international medical tourism industrial park approved and established by the State Council in 2013. It enjoys preferential policies, including expedited registration and approval for imported medical devices and pharmaceuticals, as well as regulatory access for medical technologies intended for clinical application and research. Leveraging the "Nine Special Policies" for concessional healthcare in the Lecheng Pilot Zone, Boao Lecheng has become China's gateway to global innovative pharmaceutical technologies.

Academician of the Chinese Academy of Sciences Ge Junbo stated, "Inclisiran is the first RNA therapeutic targeting cardiovascular disease. Its launch in Boao marks that cardiovascular disease treatment in China has accelerated into the RNA therapeutic era. Moreover, due to its low dosing frequency, many cardiovascular experts refer to it as a 'vaccine' for cardiovascular disease. I believe that with the continued introduction of Inclisiran in China, it will help accelerate the early arrival of a turning point in cardiovascular events."

Zhang Ying, President of Novartis Pharmaceuticals (China), emphasized, "We are delighted that Inclisiran, Novartis's blockbuster cardiovascular product, has been introduced in Boao, bringing this novel therapy to the treatment of hyperlipidemia in China. Novartis boasts a comprehensive product portfolio and a robust R&D pipeline in cardiovascular diseases, and is committed to improving the treatment and management of cardiovascular patients. Going forward, we will continue to facilitate the introduction of more breakthrough innovative drugs, enabling patients in China to benefit earlier from the world's most advanced therapies."

Executive Editor: Liuli

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