Menarini Asia Pacific and Astellas Enter into Exclusive Licensing Agreement for Commercialization of SMYRAF® in Taiwan and Select Southeast Asian Markets

ShanghaiSeptember 13, 2023PR Newswire -- Menarini Asia-Pacific and Astellas Pharma, Inc. (referred to as "Astellas") have reached a long-term exclusive licensing cooperation partnership to develop, manufacture, and commercialize oral Janus kinase (JAK) inhibitors in Taiwan.Shi Xunfu^®50 mg and 100 mg tablets (generic name: peficitinib hydrobromide), for the treatment of rheumatoid arthritis.Shi Xunfu^®Approved in Taiwan, with patent protection for its composition extending until 2032.

According to the terms of the agreement, Astellas will receive total payments of up to 5.5 million euros, including upfront and milestone payments. In addition, Menarini will also pay Astellas aShi Xunfu^®High single-digit percentage of net sales as royalties. Menarini also has the option to expand the rights to certain Southeast Asian markets.

Shi Xunfu^®Developed by Astellas and currently sold in Japan, it is used to treat rheumatoid arthritis (including the prevention of structural joint damage) that responds poorly to conventional therapies.

Rheumatoid Arthritis (RA) is a chronic autoimmune disease that primarily affects the joints, leading to inflammation, pain, and potential joint damage. In Taiwan, the incidence rate of rheumatoid arthritis is estimated at 287.0 cases per 100,000 people.^[1], which is a recognized major health issue. Against the backdrop of an aging population in Taiwan, the region is striving to enhance the diagnosis, treatment, and management of the disease.

Maurizio Luongo, CEO of Menarini Asia-Pacific, stated: "Menarini has long been the preferred partner for many biopharmaceutical companies in the Asia-Pacific region, and we are delighted that Astellas has entrusted Menarini to promoteShi Xunfu^®And commercialize it. Rheumatoid arthritis patients who do not reach the treatment goal often need to choose a different therapy.Shi Xunfu^®"With the advantages of clear efficacy and flexible dosage, it will play an important role in this aspect."

^[1]{Global Burden of Disease Collaborative Network}. 2020. Global Burden of Disease Study 2019 (GBD 2019) Results. Seattle. USA. {Institute for Health Metrics and Evaluation (IHME)}. https://vizhub.healthdata.org/gbd-results/