On October 16, 2025, Hubei Yuanda Tianming Pharmaceutical, a wholly-owned subsidiary of Grand Pharmaceutical Group, had its marketing application for ivabradine hydrochloride oral solution, submitted as a Class 3 chemical drug, accepted. Less than three months later, on January 9, 2026, Hunan Kelun Pharmaceutical also submitted a marketing application for the same product, becoming the second company to enter the market.

This signifies the official start of the battle for the first generic version of ivabradine hydrochloride oral solution . Currently, only regular tablets of ivabradine hydrochloride are available on the Chinese market ; the oral solution formulation has not yet been approved.

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Peak revenue within the hospital exceeded 300 million yuan, and the original drug led the market with a 57.43% market share.

Ivabradine hydrochloride was originally developed by Servier in France . Its tablets were first approved for marketing in France in October 2005, in the United States in April 2015, and in China in May of the same year. This drug is used to improve the clinical symptoms and long-term prognosis of patients with chronic heart failure exhibiting sinus rhythm and a heart rate ≥75 beats/minute, accompanied by cardiac systolic dysfunction.
As the world's first selective and specific sinoatrial node F channel inhibitor, ivabradine reduces heart rate by selectively and specifically inhibiting cardiac pacing If current, without affecting myocardial contractility and atrioventricular conduction.
Currently, seven pharmaceutical companies in the domestic market have obtained approval for and passed the evaluation for ivabradine hydrochloride tablets . According to data from Moshang Pharmaceuticals, the peak sales of ivabradine hydrochloride tablets in the entire terminal hospital market exceeded 300 million yuan, with sales exceeding 200 million yuan in 2024 and sales exceeding 120 million yuan in the first three quarters of 2025.

Data from the first three quarters of 2025 shows that Servier , the original manufacturer, still dominates the market with a market share of 57.43%, followed by Beijing Bio-Pharmaceutical and Chongqing Decheng Yongdao Pharmaceutical with market shares of 12.80% and 12.11%, respectively. The competitive landscape of the tablet market has stabilized, and newcomers face high market barriers.

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The fierce competition between Kelun and Grand Pharmaceutical for the first generic drugs may reshape the market landscape.

Ivabradine has been included in the National Essential Medicines List as a cardiovascular drug—an anti-heart failure drug—and is also a Category B drug covered by the 2021 National Medical Insurance. The introduction of the oral solution formulation will provide more medication options for special patient groups and improve clinical treatment outcomes.
Currently, ivabradine hydrochloride is only available in regular tablet form in the domestic market ; oral solution formulations have not yet been approved. Regarding generic drug development, only Hunan Kelun Pharmaceutical and Hubei Yuanda Tianming Pharmaceutical, a wholly-owned subsidiary of Yuanda Pharmaceutical , have applied for ivabradine hydrochloride oral solution registration under Category 3 of chemical drug registration .

Kelun Pharmaceutical is a leading company in the field of first-to-market generic drugs. In 2023, it topped the list of first-to-market generic drug companies with 6 first-to-market generic drugs, and in 2024, it successfully won 4 more. In 2025, Kelun once again made a strong comeback to the top with 6 first-to-market generic drugs, further consolidating its leading position. (Related article: 2025 First-to-Market King! Kelun becomes the biggest winner, Qilu is catching up, and two dark horses have made a comeback to the list... )
Grand Pharma has been deeply involved in the treatment of cardiovascular and cerebrovascular diseases for many years, and the company has multiple products and pipeline products in the cardiovascular and cerebrovascular emergency care sector. ( See Grand Pharma's product portfolio for details .)
The fact that two companies are vying to apply for approval for ivabradine hydrochloride oral solution reflects their recognition of the market potential in the treatment of cardiovascular diseases. The number of cardiovascular disease patients in China has exceeded 330 million, of which approximately 8.9 million suffer from chronic heart failure. This number is projected to increase to 9.5 million by 2025, indicating a vast market potential.
Although Kelun entered the market a little late, the domestic market for related drugs is still small, leaving much room for development. It remains to be seen who will ultimately be the first to produce a generic version.
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