Novartis Launches Twice-Yearly Inclisiran in China at 9,988 Yuan per Dose, Sparking PCSK9 Price Competition

Recently, the first batch of prescriptions for Inclisran, an ultra-long-acting lipid-lowering drug developed by Novartis that is administered twice a year, have been issued in Beijing, with each injection priced at 9,988 yuan!

Inclisran is the world's first siRNA PCSK9 inhibitor, and its ultra-long duration of action gives it an advantage over PCSK9 monoclonal antibodies. The drug was approved in China this August, and also in the same month, IBI306 (Tolanesib), a PCSK9 monoclonal antibody from Innovent Biologics, was approved for marketing. Now that Novartis has set an unexpectedly high price, a price war for the PCSK9 target may be triggered.

New Star in Lipid-Lowering —— PCSK9 Inhibitors

Cardiovascular disease (CVD) is the leading cause of death globally, accounting for approximately 30% of total deaths worldwide. Among them, atherosclerotic cardiovascular disease (ASCVD) is the primary cause of mortality. The occurrence of ASCVD involves multiple risk factors, with dyslipidemia characterized by elevated low-density lipoprotein cholesterol (LDL-c) or cholesterol being a significant risk factor. Reducing LDL-c levels can significantly decrease the incidence and mortality risk of ASCVD.

Currently, statins are the first-line clinical drugs for lipid control. This class of drugs achieves a potent reduction in total cholesterol (TC) and low-density lipoprotein (LDL) by blocking cholesterol synthesis. Atorvastatin (Lipitor), the BIC of this class, has occupied the top-selling drug position for many years, with global cumulative sales reaching approximately 200 billion US dollars to date.

However, statin therapy is associated with adverse side effects, including statin-associated muscle symptoms, hepatotoxicity, the possibility of developing type 2 diabetes, and an increased risk of hemorrhagic stroke. Moreover, approximately 50% of individuals using statins are unable to reduce their LDL-C levels to the expected level.

Unlike statins that block cholesterol synthesis, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors regulate blood lipids by degrading LDL-C. PCSK9 inhibitors provide a new therapeutic approach for lowering LDL-C, offering new hope for the treatment of various refractory hypercholesterolemia patients and lipid management in extremely high-risk ASCVD patients.

Novartis and Innovent's PCSK9 New Drugs Approved at the Same Time,
Price War on the Brink of Eruption

In 2015, Evolocumab, developed by Amgen/Astellas, and Alirocumab, developed by Regeneron/Sanofi, were successively approved for the treatment of patients with hereditary hypercholesterolemia or high-risk ASCVD. Both of these monoclonal antibodies are administered via subcutaneous injection once every two weeks, which poses a challenge to the convenience of drug administration for chronic patients requiring long-term medication.

In 2020, Inclisiran (Leqvio), developed by Novartis/Alnylam, was the first to be approved for marketing in the EU. Inclisiran is an siRNA gene therapy targeting PCSK9 designed and developed by Alnylam based on its GalNAc delivery system, which enables long-acting dosing (after two injections within the first three months, one injection every six months), reduces the frequency of medication for patients, and greatly improves the convenience of patient medication.

With its excellent clinical advantages, Inclisiran achieved sales of $112 million in 2022. Novartis believes that the growth rate of Inclisiran is basically consistent with that of Sacubitril/Valsartan (Entresto), which reached $4.644 billion in sales for the full year of 2022 and is expected to become Novartis' next core growth point.

In China, evolocumab and alirocumab were successively approved for marketing in 2018 and 2019. This August, the National Medical Products Administration (NMPA) further approved Inclisiran Sodium Injection (inclisiran, brand name: Leqvio) by Novartis and Torliprosumab Injection by Innovent Biologics for marketing.

Innovent Biologics' Toripalimab was priced first: 1,388 yuan per injection, with an annual treatment cost of approximately 44,000 yuan. However, Novartis then priced Inclisiran sodium at 9,988 yuan per injection, with an annual treatment cost of less than 20,000 yuan, putting pressure on other PCSK9 inhibitors to lower their prices!

In addition, Junshi Biosciences' Onglericimab, Akeso Biopharma's Inucimab, and Hengrui Medicine's Recarcimab have also submitted marketing applications.

Multiple oral PCSK9 inhibitors have entered clinical stages globally, including Merck's MK-0616, Novo Nordisk's NN-6435, AstraZeneca's AZD-8233, and Civi Pharmaceuticals' CVI-LM001. It is foreseeable that the competition for PCSK9 lipid-lowering drugs will become increasingly intense.

Summary

The currently marketed PCSK9 inhibitors have demonstrated the advantages of this target in lipid-lowering, bringing therapeutic hope to refractory hyperlipidemia and familial hypercholesterolemia.

But there are many affordable options for lipid-lowering drugs, making it challenging for new mechanism lipid-lowering medications to gain a foothold in the Chinese market. Recently, Novartis priced its siRNA PCSK9 inhibitor surprisingly low, indicating that price competition for novel lipid-lowering drugs has already begun ahead of schedule. On the other hand, this competition also brings more cost-effective treatment options to patients.

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Editor: Bai Ji