Sorafenib

In response to the treatment needs of solid tumors such as advanced hepatocellular carcinoma and renal cell carcinoma, multi-target tyrosine kinase inhibitors are currently one of the core drugs for systemic therapy. As a representative variety of this class of drugs, sorafenib can simultaneously inhibit the RAF/MEK/ERK signaling pathway to directly suppress tumor cell proliferation, and can also inhibit tumor neovascularization by blocking targets such as VEGFR and PDGFR. It is the world's first targeted drug approved for advanced hepatocellular carcinoma, and is currently routinely used in clinical practice for the treatment of patients with hepatocellular carcinoma that is inoperable or has distant metastasis, advanced renal cell carcinoma, as well as locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer, significantly prolonging the median survival time of patients with related solid tumors.

Sorafenib is a mature product in the field of global targeted therapy for solid tumors. In 2023, its global market size was approximately USD 470 million, and its market size in China was approximately RMB 1.28 billion. With the expansion of the patient base for indicated diseases and the increasing clinical application of combined immunotherapy regimens, the annual compound growth rate of the Chinese market is expected to remain at around 5% in the next three years. In terms of the competitive landscape, the original research product still accounts for approximately 35% of the market share. More than 10 domestic enterprises have had their generic versions of sorafenib approved for marketing, and the drug has been included in multiple rounds of national centralized procurement. The winning bid price has dropped by more than 90% compared with the initial launch price of the original research product, and the accessibility for patients has been greatly improved.

The original research enterprise of sorafenib is Bayer from Germany, and the trade name of the original research product is Nexavar. The core compound patents of sorafenib expired in both the United States and China in 2020. The main dosage form of the original research product approved globally is tablet, with a specification of 0.2 g per tablet. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also a reference preparation announced by the FDA. As of now, there are more than 20 sorafenib API registration numbers on the China API Registration Platform, most of which are in the status of "A" (can be used in marketed preparations). Multiple preparation varieties, including the original research product and generic drugs, have been approved for marketing in China. (Data is as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for sorafenib API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of the whole process including API R&D, quality research and consistency evaluation.