Ribociclib manufacturer information and whether there is a domestic version

The original developer of Riboxil is Switzerland's Novartis Pharmaceuticals (Novartis), and its trade name is Kisqali® (Kisqali). The drug was approved for marketing in China in January 2023. It is used to treat HR+/HER2- advanced or metastatic breast cancer. It covers perimenopausal and postmenopausal groups and has wide applicability. Currently, the tablets are produced by Novartis in factories in Singapore and Switzerland and then imported to domestic pharmacies. The domestic version has not yet been released. It has not been included in medical insurance since it was launched, and the price is about 13,360yuan/box (63 tablets/box).

Although there is currently no domestic version of finished drugs, domestic suppliers have intervened in the field of raw materials (API). For example, manufacturers in Hangzhou, Beijing and Shandong can produce Riboxil succinate intermediates or raw materials, mainly for bulk raw material use. In addition, domestic pharmaceutical companies have applied for patents on API crystallization, preparation and other technical paths, and some scientific research institutions and pharmaceutical factories are also continuing to promote local production processes. However, from API to qualified preparations, it still needs to go through GMP certification, clinical trials and drug regulatory registration review.

Currently, Chinese pharmaceutical companies have not yet launched domestically produced Riboxil, but the industry has clear R&D signals. Data shows that leading companies in the field of CDK4/6 such as Hengrui Pharmaceuticals, Qilu, and Lunan have expectations for this drug. In addition, Since 2022, many institutions have successively carried out improvements in solid preparation methods based on China's patent layout and submitted new indication registration information to CDE. Therefore, it is foreseeable that if the domestic version successfully passes registration, the market supply will be diversified and price competition will be better.

Taken together, at present, only Novartis’ original brand Kaililon® is imported and marketed in China, and it is still a drug for external use under medical insurance. However, from the perspective of raw material supply and generic drug research and development, the market has a good foundation, and domestic versions are expected to break the monopoly in the future. Once domestically produced and marketed, it will not only help reduce drug prices and improve accessibility, but also provide more choices for patients undergoing treatment. If you are concerned about medication costs and supply channels, it is recommended to continue to pay attention to the announcement of generic drug approval documents on the official website of the State Food and Drug Administration, as well as the clinical application progress information of relevant pharmaceutical companies.

Reference materials:https://us.kisqali.com/