▎WuXi AppTec Content Team Report

On July 3, Amgen announced that it had reached an agreement with CSL Vifor,Obtain the commercialization rights of Avacopan (trade name: Tavneos) in Asia and Latin America, including the Chinese mainland market.. Avacopan is aTreatmentAnti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (ANCA）The innovative drug has been approved for marketing in many countries around the world and has already been submitted for marketing approval in China.

Avacopan isAn Orally Administered Selective Complement 5a (C5a) Receptor InhibitorIt can precisely block the C5a receptor located on inflammatory cells such as neutrophils, preventing these cells from being activated by C5a and reducing inflammatory damage.

Public information shows that Avacopan was initially discovered and developed by ChemoCentryx, which holds the commercial rights in the United States. In August 2022, Amgen announced a planned investment of approximately $3.7 billion.AcquisitionChemoCentryx. Previously, the commercial rights for Avacopan outside the United States were owned by CSL Vifor. Following this collaboration, Amgen will also hold the commercial rights for Avacopan in Asia and Latin America, including the Chinese mainland market.

In October 2021, Avacopan was approved by the U.S. FDA.ApprovalMarketed as an adjunctive treatment for adult patients with active severe ANCA-associated vasculitis (particularly Granulomatosis with Polyangiitis [GPA] and Microscopic Polyangiitis [MPA]), in combination with other therapies, includingStandard treatment regimens including glucocorticoids (Avacopan does not eliminate the use of glucocorticoids).ChemoCentryxThe press release at the time pointed out,This is also the first oral complement C5a receptor inhibitor approved by the FDA.。

Currently,AvacopanHas received marketing approval in eight countries: the United States, Canada, Australia, the United Kingdom, Germany, the United Arab Emirates, Japan, and South Korea.Information disclosed on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China shows,As early as December 2022, Avacopan hard capsules had also been submitted for marketing in China.。

Screenshot source: CDE official website

Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis is a group of rare vascular inflammatory diseases that may lead to organ dysfunction. The annual incidence of ANCA-associated vasculitis is approximately 10–20 per million, with a prevalence rate of 0.25‰ among hospitalized patients in China.[3]If left untreated, 80% of patients will die within two years of diagnosis.[4]。

Ms. Xu Ailing, Vice President of Amgen and General Manager of Amgen China, stated that Avacopan is an important growth product for Amgen, and the company looks forward to its swift approval and market launch in China, where it can serve more patients suffering from autoimmune diseases.

[2] AMGEN TO ACQUIRE CHEMOCENTRYX FOR $4 BILLION IN CASH. Retrieved 2022-08-04, from https://www.prnewswire.com/news-releases/amgen-to-acquire-chemocentryx-for-4-billion-in-cash-301599672.html

[3] Li J, Cui Z, Long JY, et al. The frequency of ANCA-associated vasculitis in a national database of hospitalized patients in China. Arthritis Res Ther. 2018;20(1):226. Published 2018 Oct 4. doi:10.1186/s13075-018-1708-7

[4] Mukhtyar C, Flossmann O, Hellmich B, et al. Outcomes from studies of antineutrophil cytoplasm antibody associated vasculitis: a systematic review by the European League Against Rheumatism systemic vasculitis task force. Ann Rheum Dis. 2008;67(7):1004-1010. doi:10.1136/ard.2007.071936