Why is sparsentan/sparsentan not available in China?

Sparsentan is an oral, dual endothelin-angiotensin receptor antagonist that combines endothelin type A (ETA) receptor blocking and angiotensin II type 1 (AT1) receptor antagonism in a single molecule. The drug, developed by Travere Therapeutics, has hemodynamic and anti-inflammatory properties and is primarily used to treat immunoglobulin A (IgA) nephropathy and focal segmental glomerulosclerosis (FSGS).

Sparsentan/Sparsentan received accelerated approval from the U.S. Food and Drug Administration (FDA) in February 2023 for the reduction of proteinuria in adults with primary IgA nephropathy who are at risk for rapid disease progression. The approval was based on clinical trials demonstrating significant efficacy in slowing the progression of the disease and reducing symptoms and complications in patients.

However, as to why sparsentan is not launched in China, this mainly involves many aspects such as the drug approval process, market demand, policies and regulations, and the market strategy of drug research and development companies. First of all, drugs need to go through a strict approval process before being launched in China, including clinical trials, safety assessment, efficacy verification and other links, which requires an investment of time and resources. Secondly, the market demand of the drug is also an important factor affecting the marketing decision. If the demand for sparsentan/sparsentan in the Chinese market is insufficient, or there are other more effective alternative drugs, the drug R&D company may choose to prioritize listing in other markets.

In addition, changes in policies and regulations may also affect the drug launch process. China's drug regulatory authorities will evaluate a drug's marketing application based on the actual domestic situation and the drug's safety, effectiveness and other factors, and may make additional requirements or suggestions. Therefore, even if Sparsentan is already on the market in other countries, it may not be immediately available in China.