Is Seladelpar an imported prescription drug?

Seladelpar (Seladelpar) is a drug used to treat primary biliary cholangitis (PBC) and is not yet on the market in China. According to the current situation, once Siladepa is approved domestically, it is very likely that it will enter the market as an imported drug.

Siladepa was developed by an American company to targetPBC, a chronic liver disease. It is an oral drug, provided in capsule form, and is usually taken once a day. Primary biliary cholangitis is an autoimmune disease characterized by chronic damage to the bile ducts of the liver. Patients usually present with symptoms such as jaundice, fatigue, and abdominal pain. Long-term failure to receive effective treatment may lead to liver failure. Therefore, it is crucial to develop effective therapeutic drugs. The approval of Siladepa in the United States and Europe marks that its therapeutic effect has gradually been recognized by the global medical community.

Currently, Siladepa has been approved and used to treat PBC in many countries and regions, including the United States and Europe.PBC. The main mechanism of this drug is to regulate bile acid metabolism and reduce the symptoms and liver damage of PBC by activating peroxisome proliferator-activated receptor (PPAR) δ. Due to the relatively long drug approval process in China, Siladepa still needs to verify its efficacy and safety through clinical trials before entering the Chinese market.

Once Siladepa is approved by China, it will most likely be marketed as an imported drug. China has relatively strict regulations on imported drugs. Drugs can only gain market access after sufficient clinical trials and evaluations. In addition, as domestic treatment options for PBC patients are relatively limited, Siladepa, as a new drug, will become one of the important options for the treatment of this disease once it is launched on the market.

In short, although Siladepa is currently not on the market in China, if it is approved in the future, it will enter the Chinese market as an imported prescription drug, providing patients with a new treatment option.

Reference materials:https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217899s000lbl.pdf