- 2025,09,02
In the evening of September 1, sincerity Pharmaceutical (603811.sh) announced that its eicosapentaenoic acid ethyl ester soft capsule (hereinafter referred to as "EPA soft capsule") had recently been approved by the food and drug administration to issue a drug registration certificate, and the company's layout in the field of high-purity EPA preparations was successfully implemented.
It is worth mentioning that the company recently disclosed the 2025 semi annual report. Driven by the continuous improvement of the sales of joint drugs, the net profit attributable to the parent company and net profit deducted from non-profit in the first half of the year increased by 47.03% and 54.21% respectively year-on-year, reaching 112million yuan and 111million yuan. With the successful approval of fish oil products, the company is expected to create a new heavy-duty single product by relying on the integration advantage of API preparations in the field of high-purity EPA.
According to the announcement, the EPA soft capsules of Chengyi Pharmaceutical Co., Ltd. were approved by the category 4 Registration of chemical drugs to reduce the triglyceride (TG) level of adult patients with severe hypertriglyceridemia (≥ 500mg/sub). Combined with statins, the drug can be used to diagnose cardiovascular disease or diabetes with ≥ 2 other cardiovascular disease risk factors, and adult patients with hypertriglyceridemia (≥ 150mg/dl), so as to reduce the risk of cardiovascular events.
It is noteworthy that EPA soft capsules focus on the broad market of lipid modulators. In recent years, with the acceleration of population aging and the change of lifestyle in China, the incidence of chronic diseases such as cardiovascular and cerebrovascular diseases, metabolic syndrome and elderly constipation has increased year by year. Among them, according to Zhiyan consulting, the overall prevalence of hyperlipidemia among residents aged 18 and over in China has increased from 18.6% in 2002 to 35.6% in 2020, which has brought a heavy burden on social health. Data show that the global market scale of lipid-lowering drugs has reached US $33.12 billion in 2023, and it is expected to climb to about US $46.58 billion by 2033. The total sales of lipid-lowering drugs in China's three major terminals and six major markets in 2023 have exceeded 22billion yuan.
At one end, there is a strong demand for lipid-lowering drugs, while at the other end, the mainstream lipid-lowering drugs, mainly statins and Bates, are difficult to meet the urgent needs of patients for long-term medication safety due to more toxic and side effects. The high-purity EPA drugs approved by sincerity pharmaceutical this time are filling the gap in this market. Huaxi Securities research pointed out that EPA with 97% purity is the first EPA drug approved by FDA with priority review qualification to reduce cardiovascular risk and triglyceride and cholesterol. It has also been recommended as primary and secondary preventive drugs for cardiovascular high risk by many guidelines in Europe and the United States and other medical developed countries. The global sales of EPA drugs will reach $1.838 billion in 2023. However, until 2023, when China won the first imitation of EPA soft capsules for pharmaceuticals, this variety is still blank in China.
The successful approval of sincere pharmaceutical EPA soft capsule is expected to further improve the drug selection of domestic lipid modulators, compete for the 20 billion market of lipid-lowering drugs, and is expected to become another performance pillar of the company after joint drugs. It is worth mentioning that in the field of fish oil, sincerity pharmaceutical has not only been approved EPA soft capsule preparations, but also has a batch of fish oil health products, and is building a thousand ton capacity of EPA API, which is expected to form a unique competitiveness in the field of fish oil.
Source: Securities Times