AstraZeneca Returns Roxadustat Rights in U.S. and Other Regions to FibroGen, Retains China Rights

Feb 27, 2024 07:45 CST Updated 07:45

FibroGen

Developer of Oral Small Molecule Inhibitors

AstraZeneca

Biopharmaceutical Manufacturer

February 26,FibroGen (FibroGen）Announced that it has reached an agreement withAstraZenecaReached an agreement to terminate the contract signed on July 30, 2013, regardingRoxadustatCooperation Agreement.FibroGenWill regain access to roxadustatIn the United StatesAnd otherAll rights in the region (except for China and South Korea).

September 2004,AstellasReached an agreement with FibroGen to acquire the Japanese rights to roxadustat. In April 2006, Astellas expanded the agreement to include Europe, CIS countries, the Middle East, and South Africa. In July 2013, AstraZeneca acquired the development and commercialization rights to roxadustat in the United States, China, and regions not authorized by Astellas for a total deal worth $815 million.

However, the termination of this cooperation agreement did not affect the China region, and the cooperation agreement on Roxadustat in China between the two companies remains valid.

Roxadustat is a small-molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor developed by FibroGen. It promotes erythropoiesis by increasing endogenous erythropoietin production, improving iron absorption and mobilization, and downregulating hepcidin.

In December 2018, Roxadustat was approved for the first time in China to treat anemia caused by chronic kidney disease (CKD) in patients undergoing dialysis. In August 2019, the eligible population for Roxadustat was expanded to include non-dialysis CKD patients. In August 2023, RoxadustatNew capsule indication accepted by CDE again for the treatment of chemotherapy-induced anemia (CIA).According to AstraZeneca's financial reportIn 2023, the sales of Roxadustat were2.$71 billion (+38%）。

As of now, six HIF-PHI drugs for anemia in chronic kidney disease have been launched globally. However, the safety issues of HIF-PHI drugs (increasing the risks of thrombosis, severe infections, death, etc.) have been highly controversial, leading to FDA's successive rejections of Roxadustat,VadadustatThe listing application.GSKTheDaprodustatWith its significant efficacy in dialysis patients and no increased cardiovascular risk, it has gained FDA approval for marketing, becoming the first HIF-PHI class drug for treating anemia in chronic kidney disease to enter the U.S. market. However, the approval scope of this product is limited, as it is currently only permitted for treating patients undergoing dialysis and is not allowed for use in non-dialysis patients.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article.For reprint, please leave a message or send a message to the WeChat Official Account backend, and indicate the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Preview

Offline Salon

↑ Long PressScan the code, Register for the Salon ↑