Surufatinib has not yet been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2020)", but hospitals can reasonably equip corresponding drugs based on clinical needs.
In November 2019, the FDA granted surufatinib orphan drug designation for the treatment of pancreatic neuroendocrine tumors. In the same month, the State Food and Drug Administration accepted the marketing application (NDA) for surufatinib for the treatment of non-pancreatic neuroendocrine tumors. In December 2019, the application was included in priority review. Now that we are catching up with the epidemic, it will take the second half to the end of the year to get approval in China at the earliest.
Based on their origin, neuroendocrine tumors are usually divided into pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors. Approved targeted therapies include sunitinib malate and everolimus for the treatment of pancreatic neuroendocrine tumors or highly differentiated non-functional gastrointestinal or pulmonary neuroendocrine tumors.
Sunitinib (Pfizer Sutent) and everolimus (Novartis Oncology Afinitor) have been on the market for many years respectively, and have also entered the medical insurance, and the two companies have also vigorously promoted them. Surufatinib has dual anti-angiogenesis and immunomodulatory activities, and is theoretically more effective than the two existing targeted drugs. The results of phase III clinical trials are also good. Sovan should be Hutchison Whampoa's second product ready to be launched. The first is fruquintinib, which Eli Lilly is doing clinical promotion and sales. If you want to cut your salary from a foreign company to make this product, you still have to think carefully.
Surufatinib capsule is an innovative drug independently developed by my country and has independent intellectual property rights. This product is a single drug suitable for locally advanced or metastatic, progressive non-functional and well-differentiated patients that cannot be surgically removed ( G1, G2) non-pancreatic neuroendocrine tumors.
It is easy to understand that neuroendocrine tumors are slow-growing tumors that can occur in many tissues and organs throughout the body. Neuroendocrine tumors of the gastrointestinal and pancreatic tract are the most common. Depending on the primary site, It can be divided into pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors. In the past few decades, neuroendocrine tumors have been considered a rare "intractable disease" that progresses slowly in the early stages, has no specific symptoms, and is difficult to detect. It is often diagnosed after metastasis occurs.
Sulfatinib has announced two studies on pancreatic neuroendocrine tumors and non-pancreatic neuroendocrine tumors, and applied for marketing to the State Food and Drug Administration in November last year and September 17 this year respectively. In December 2019, the marketing application for the treatment of non-pancreatic neuroendocrine tumors was included in priority review.
On September 21 this year, Chi-Med’s Vice President of Marketing and Sales Ma Xuchun stated at the 2020ESMO latest research data conference of surufatinib that after surufatinib is launched, it will actively apply to enter the country. The medical insurance catalog allows more patients to use it and put it to good use.