"Orphan medicine", the drug used to treat rare diseases.
the United States passed the Orphan Medicineacting Act in 1983 and released its latest revision in 2013, granting special benefits for the treatment of medicines for rare diseases with fewer than 200,000 patients in the United States.
this FDA-issued orphan drug qualification will help Tripley sing-up drug in the United States to enjoy certain policy support, including clinical trial fees tax credits, new drug application fee waiver and enjoy 7 years of market exclusive and not patent-affected, will reduce research and development investment to a certain extent, conducive to the promotion of clinical trials.
it is worth noting that the FDA in the approval document to Junshi biological seisi said: this grant of orphan drug certification of the indications is "mucosal melanoma", the scope of the vitamin organisms submitted a broader application for indications, "non-removable or metastatic mucosal melanoma" is included in this range.
this means that Trepri monotometreath is expected to play a role in a larger area of treatment.
mucosal melanoma is a rare melanoma subtype in white people, accounting for about 1.3% of all melanoma patients;
in addition to more invasive, prone to visceral metastasis, mucosal melanoma is currently not mature treatment guidelines, traditional chemotherapy and single-drug immunotherapy are not good.
preclinical studies have shown that combination immunotherapy can work together to inhibit tumor growth, pointing out new treatment directions for the treatment of mucosal melanoma.
Junshi biotriprim is the first domestic PD-1 drug successfully listed in China, and is currently approved as a local progression or metastatic melanoma after the failure of previous standard treatment.
So far, Junshi has conducted more than 30 clinical trials of Trepri's single drug treatment and combination therapy worldwide, including 14 key registered clinical trials, as well as a Phase Ib clinical trial in the United States for a wide range of solid tumors involving nasopharyngeal cancer, urinary skin cancer, lung cancer, stomach cancer, esophageal cancer, liver cancer, breast cancer, and more.