Lunan Pharmaceutical's Injectable Nicorandil Approved: A Dual-Mechanism Breakthrough in Angina Treatment

From June 9 to June 15, a total of 57 varieties passed/were considered to have passed the consistency evaluation. During the same period, 106 varieties applied for the consistency evaluation.

Lunan Pharmaceutical: Nicorandil for Injection

Recently, the official website of the National Medical Products Administration announced that the injectable Nicorandil (brand name: Xinpingning®) from Shandong New Era Pharmaceutical, a subsidiary of Lunan Pharmaceutical, has been officially approved for marketing in China. It comes in two specifications, 12mg and 48mg, and is deemed to have passed the generic drug consistency evaluation.

Data Source: NMPA Official Website

Unstable angina is known as the "precursor to myocardial infarction" — the rupture of coronary artery plaques in patients triggers thrombosis, which can progress to myocardial infarction or sudden death at any time. The incidence of adverse cardiovascular events within one year is as high as 10%-20%. Traditional nitrate drugs, while being the first-line choice, have long faced two major challenges: high drug tolerance (requiring intermittent dosing to prevent ineffectiveness) and limited improvement in microvascular function (ineffective against coronary microcirculatory disorders).

The unique value of Nicorandil lies precisely in this:

Dual Mechanism Breakthrough: Simultaneous activation of potassium ion channels (dilating microvessels) and release of nitric oxide (dilating large coronary arteries), achieving full-pathway blood supply improvement from the epicardium to myocardial cells;

Avoiding Drug Resistance Pain Points: No cross-resistance with nitrates, continuously effective for 24 hours, becoming an alternative solution for patients with drug resistance;

Improving Long-term Prognosis: The IONA study confirmed that it can reduce the risk of cardiovascular events in patients with stable angina by 17% and decrease all-cause mortality risk by 35%.

Although Nicorandil tablets have been on the market in China for over a decade, there has always been a lack of rapid intervention options for acute episodes of unstable angina. When patients experience worsening chest pain, oral administration is slow to take effect with only 75% bioavailability, whereas intravenous injection can reach peak plasma concentration within 5 minutes.

Lunan's Xinpingning® is targeting precisely this gap. Previously, only a few companies in China, such as Laimei Pharmaceuticals, had received approval for injectable nicorandil, and those were primarily concentrated in small specifications of 2mg and 12mg. Lunan’s newly added 48mg large specification is better suited to meet the loading dose requirements of critically ill patients.

This layout is backed by a rapidly growing market: according to data from Yazhi, domestic sales of Nicorandil in China approached 2 billion yuan in 2023, with sales increasing year by year in recent years.

Source of the image: Yaoke Data —— Full Terminal Analysis System for Pharmaceutical Market

The market entry of Nicorandil Injection is far from simply adding another generic drug to the list. With the increasing prevalence of coronary heart disease among younger populations (over 10% are under 40 years old) and the high incidence of diabetic microvascular complications, it may potentially reshape the medication logic for anti-angina treatment. For Lunan Pharmaceutical, this drug, which carries the "dual-channel mechanism," is also becoming a new beacon guiding its path through the storm of centralized procurement and towards the deeper waters of clinical value.

Status of Consistency Evaluation Approval

From June 9 to June 15, a total of 57 varieties passed/were considered to have passed the consistency evaluation. The specific situation is as follows:

Table 1: Varieties that have passed the consistency evaluation

Table 2: Varieties Deemed to Have Passed the Consistency Evaluation

Acceptance Status of Consistency Evaluation

From June 9 to June 15, a total of 106 varieties applied for consistency evaluation, with specific details as follows:

Table 3: Consistency Evaluation Submission Status

Data Source: Yaoke Data Enterprise Edition - Generic Drug Consistency Evaluation Analysis System

Editor: Muyan

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