Bisoprolol

As a highly selective β1-receptor blocker commonly used in clinical practice, bisoprolol specifically blocks cardiac β1-adrenergic receptors, reduces sympathetic nerve activity, slows heart rate, and inhibits myocardial contractility, thereby reducing myocardial oxygen consumption and improving myocardial ischemia. Its indications cover hypertension, coronary heart disease (angina pectoris), and moderate to severe chronic stable heart failure accompanied by left ventricular systolic dysfunction. Since it has minimal effect on β2 receptors and weak interference with blood glucose, blood lipids and airway function, it is particularly suitable for long-term use in patients with cardiovascular diseases complicated by diabetes mellitus and chronic obstructive pulmonary disease.

The global bisoprolol market size has maintained steady growth in recent years, with the overall market size reaching approximately USD 1.87 billion in 2023. The rising prevalence of cardiovascular diseases and the improvement of primary chronic disease management coverage are the core growth drivers. The domestic market size is approximately RMB 3.2 billion, with generic drugs accounting for more than 90%. At present, oral preparations from more than 20 enterprises have passed the consistency evaluation. The average price reduction of the selected products in the third batch of national centralized procurement reached 73% compared with that before the centralized procurement, and the accessibility at the primary level has been greatly improved. Meanwhile, the demand for APIs has shown a continuous upward trend along with the capacity expansion of enterprises selected in the centralized procurement.

The original research enterprise of bisoprolol is Merck, and the original brand name is "Concor". Its core compound patents expired in Europe and the United States in 2006 and 2007 respectively, and the compound patent in China expired in 2006. The main dosage form of the original research product is tablet, with specifications of 2.5mg and 5mg, which have been included in both the *Catalogue of Chemical Reference Preparations* of China and the FDA reference preparation catalogue. At present, more than 10 domestic bisoprolol APIs have obtained A-status registration numbers on the CDE platform, and both domestic and original research preparations have been approved for marketing for many years. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for bisoprolol APIs. Most products are available from stock. Spot orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for API R&D, quality research and consistency evaluation work.