Orient Securities released a research report saying that due to the rising incidence of dyslipidemia and the tendency to be younger, the lipid-lowering drug market has broad prospects. At the same time, new targets and new technology routes are constantly being verified, and the approval of innovative drugs can also drive the rapid expansion of the market. Domestic innovative pharmaceutical companies have a layout in popular targets such as PCSK9, ANGPTL3, and Lp(a) inhibitors. In terms of PCSK9 targets, four domestic monoclonal antibodies from Innovent, Akeso, Junshi and Hengrui have all been approved for marketing, and a number of other products are in late-stage clinical trials. In addition, CSPC and Yuekang are actively deploying siRNA drugs targeting PCSK9. In terms of other targets, Hengrui and Junshi have deployed siRNA drugs targeting ANGPTL3, among which Hengrui's products have entered phase III clinical trials and are in the forefront.

The main views of Orient Securities are as follows:

The rising incidence of cardiovascular diseases across the globe is driving the steady growth of the lipid-lowering drugs market.

From a global perspective, the market size of lipid-lowering drugs in 2023 will be $33.12 billion, and it is expected to reach $46.58 billion in ten years, with a CAGR of 3.45% during the period. From the perspective of the domestic market, the mortality rate of dyslipidemia and cardiovascular disease has increased year by year, and tends to be younger, and the prevalence of dyslipidemia in people over 18 years old in China has increased to 40.4%. In 2023, the sales of lipid-lowering drugs in China's high-level hospitals and retail terminals will exceed 25 billion yuan, and they are expected to grow steadily in the future.

The import substitution of traditional lipid-lowering drugs is the general trend, and the combination of drugs has become a momentum.

Domestic drugs in traditional statins, cholesterol inhibitors, and fibrates are gradually occupying a major market position. Among statins, Qilu Pharmaceutical's market share of atorvastatin has increased rapidly in recent years, surpassing the original Pfizer. Similarly, among cholesterol inhibitors and fibrates, the share of domestic drugs is also increasing. In addition, in order to improve the rate of blood lipid compliance and reduce the incidence of adverse reactions, the combination of lipid-lowering drugs has become an important trend, and the single-tablet compound preparation provides a new option for lipid-lowering combined therapy.

The new drug of PCSK9 is menacing, and the domestic drug is coming later.

The global sales of PCSK9 inhibitors have a strong growth momentum, and the representative drugs on the market are: evolocumab and alixirumab, with global sales of US$1.64 billion (+26.2%) and US$1.09 billion (+26.4%) respectively in 23 years. Inclisiran, as the first long-acting siRNA drug, has global sales of $360 million in 23 years, with rapid growth (+217%). In terms of domestic drugs, the first PCSK9 inhibitor, Innovent Biologics' toleximab, was launched in August 23, and the same target drugs of Akeso, Junshi and Hengrui have recently been intensively approved for marketing, and the competition is fierce.

Innovative targets have emerged, and the global research and development of lipid-lowering drugs has been accelerated.

The four main targets are as follows:1) ANGPTL3: Hypertriglyceridemia and familial mixed hyperlipidemia, which are mainly ineffective to statins, are expected to be the dawn for patients with rare genetic diseases; 2) ApoC-III inhibitors: mainly RNA interference therapies, mainly for rare diseases such as hypertriglyceridemia and familial chylomicronsemia syndrome; 3) LP(a): Since the level of Lp(a) is mainly determined by genetic factors, the effect of traditional lipid-lowering drugs is limited, and many MNCs have actively deployed this target and have entered phase III. 4) CETP: This target has not been fully validated, Pfizer, Roche, Eli Lilly and Merck have all actively entered the market, but the research and development has been terminated due to safety issues or poor efficacy. Recently, NewAmsterdam Pharmaceuticals announced positive results from the Phase III BROADWAY trial, which could be a game-changer.

It is recommended to pay attention

Hengrui Pharmaceutical (600276.SH), Innovent Biologics (01801), Akeso Biologics (09926), Junshi Biosciences-U (688180.SH), Salubris (002294.SZ), CSPC Pharmaceutical Group (01093).

Risk Warning

The risk of regulatory changes, increased market competition, and the risk that R&D progress or clinical trial results may not be as expected.