玛巴洛沙韦

As a globally prevalent seasonal respiratory infectious disease, influenza causes millions of severe cases every year. Traditional anti-influenza drugs of the neuraminidase inhibitor class need to be administered within 48 hours of onset and taken for multiple days, so there are unmet clinical needs. Baloxavir marboxil is a CAP-dependent endonuclease inhibitor, the first oral anti-influenza drug with a completely new mechanism of action in the world in the past 20 years. It exerts its effect by blocking the key early link of influenza virus replication, and the full course of treatment can be completed with only a single oral dose. It is suitable for the treatment of influenza A and influenza B in people aged 12 years and above, and can also be used for post-exposure prophylaxis, which greatly improves patients' medication compliance.

Since the launch of baloxavir marboxil, its global market scale has risen rapidly. In 2023, its global sales have exceeded 1.5 billion US dollars, and its market scale in China is nearly 1.8 billion yuan, with a compound annual growth rate of more than 70% in the past three years. After the release of the patent cliff effect, domestic generic drug enterprises have high enthusiasm for layout. At present, baloxavir marboxil tablets from 6 domestic enterprises have been approved for marketing, and the winning bid price in centralized procurement has dropped by more than 80% compared with the price of the original research drug, which has driven a substantial increase in drug accessibility, and the demand for upstream API has also entered a period of rapid growth.

The original research enterprise of baloxavir marboxil is Shionogi Pharma Co., Ltd. of Japan, with the original research trade name "Xofluza", and its compound patent in China expired in 2031. The dosage form approved for the original research product is tablet, with two specifications of 20mg and 40mg. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. Up to now, there are more than 10 registration numbers of baloxavir marboxil API in China, among which 8 have obtained A status through the associated review with preparations, and all the domestic preparations approved for marketing have realized local supply of API. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for baloxavir marboxil API, covering all categories such as production process impurities and degradation impurities. Most of the products are in stock, and spot orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the needs of various scenarios such as API research and development, quality research and registration declaration.