On December 20, CSPC Xuanning, a patented hypertension drug, was reviewed and approved by the US Food and Drug Administration and became the first innovative drug in China to be fully approved by the United States. As the first L-Amlodipine approved by the U.S. Food and Drug Administration, China's new blood pressure-lowering drug has become an international standard, representing a new height for Chinese pharmaceuticals going abroad. The US Food and Drug Administration's approval to market in the United States means that the product is licensed to be marketed globally.
In fact, as early as 2006, CSPC had "touched the net" in the international high-end market. The patent use right of a class of its new drug butylphthalide was transferred to well-known companies in Europe, America and South Korea, which realized the "export" of Chinese drug patents for the first time, which is of landmark significance.
Going out on behalf of Chinese pharmaceutical companies to become participants in international new drug R & D competitions and to become international standard makers is the key to going abroad. Currently, CSPC has 8 innovative drugs for clinical research overseas, and 5 products have obtained the US Orphan Drug / Child Rare Disease Qualification. Xuanning's listing in the United States this time will also be eligible to become an international standard that must be referenced for the re-marketing of similar drugs.
In the great occasion of the state's encouragement to "go global", CSPC has achieved soft landing in various ways, including product mergers and acquisitions, and technology transfer. In the future, CSPC's internationalization path will gradually transform from product export to capital export. Through international expansion, it will introduce overseas advanced technologies and resources into the country, combine with the application of the local market, and finally seek to expand the overseas market.
Cai Dongchen, chairman of CSPC, said that L-Amlodipine maleate was a successful attempt by the company to expand China's domestic innovative drugs to the United States and the world. We will focus on innovation and create a "hard core" for Chinese pharmaceutical companies in the international market, and we are committed to providing the best medicines for global patients.