Bifendate

As a classic drug for adjuvant treatment of liver diseases independently developed in China, bifendate is a synthetic analog of schisandrin C. Its mechanism of action is to induce the activity of hepatocyte cytochrome P450 enzyme, enhance the detoxification function of the liver, stabilize the liver cell membrane and reduce the release of alanine aminotransferase (ALT). It has a definite enzyme-lowering effect on patients with chemical liver injury, drug-induced liver injury and chronic persistent hepatitis with persistently elevated ALT. At present, it has been included in the common regimen for basic treatment of chronic liver diseases, and is especially suitable for patients who take hepatotoxic drugs such as anti-tuberculosis and anti-tumor drugs for a long time, as well as for symptomatic treatment of mild to moderate chronic hepatitis.

In the domestic liver disease drug market, bifendate maintains stable demand in primary medical institutions and chronic disease management scenarios by virtue of its advantages of high cost-effectiveness and few adverse reactions. In 2023, the overall market size of domestic adjuvant liver disease drugs exceeded 38 billion yuan, among which enzyme-lowering drugs accounted for about 11%. As a basic drug in this细分 field, the annual demand for bifendate remains at around 230 tons, and the compound annual growth rate of the market in the past three years has maintained a stable trend of 2.1%. The competitive landscape is dominated by domestic pharmaceutical enterprises. There is no original research monopoly at present, the product price system has been stable for a long time, it has not been included in the scope of national centralized volume-based procurement, and the supply chain has a high degree of marketization.

Bifendate is a variety independently developed in China, with no overseas original research enterprise. It was first developed in China by the Institute of Materia Medica, Chinese Academy of Medical Sciences, and the first generic drug launched was produced by Beijing Union Pharmaceutical Factory, with the trade name "Bifendate Pills". The core compound patent is held by domestic R&D institutions, and the patent protection period has expired. The main dosage forms currently on the market include dripping pills (1.5mg) and tablets (25mg), all of which have been included in the *National Essential Medicines List* and the *Pharmacopoeia of the People's Republic of China*. In terms of domestic API registration, as of now, 8 valid A-status registration numbers have been published on the CDE platform, and more than 20 enterprises have been approved for the corresponding oral preparations, which can fully meet the domestic preparation production demand. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for bifendate API, covering all path-related impurities such as synthetic process intermediates and degradation products. Most products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All reference standards meet the compliance requirements of multiple regulations such as the Pharmacopoeia of the People's Republic of China and FDA, and can directly support the work related to API quality research, impurity limit verification and preparation declaration.