Luye Pharma Becomes the Marketing Authorization Holder for Seroquel and Seroquel XR in Saudi Arabia

Press Release

JEDDAH, Saudi Arabia, Sept. 17, 2021 /PRNewswire/ — Luye Pharma Group has recently been granted official approval by the Saudi Food and Drug Authority to become the Marketing Authorization Holder (MAH) for Seroquel and Seroquel XR in Saudi Arabia. Meanwhile, the new localized packaging for Seroquel products in Saudi Arabia, bearing the logo of Luye Pharma, is now in use to serve patients across the nation.

Seroquel and Seroquel XR are two of Luye Pharma’s key Central Nervous System (CNS) products marketed in more than 50 countries and regions around the world; marketing authorization for the Seroquel series in Saudi Arabia was previously held by AstraZeneca. The MAH transfer represents an important milestone for Luye Pharma, which now takes full ownership and responsibility for all business operations related to the series in Saudi Arabia, including market supervision, marketing, distribution and supply chain management, among others. The move will help the company to integrate resources more effectively, expand future business development locally, and further increase Seroquel products’ market penetration.

Saudi Arabia is the first Gulf Cooperation Council (GCC) member state to approve the Seroquel series MAH transfer for Luye Pharma, paving the way for the company’s business development in the region. Luye Pharma considers the GCC region an emerging international market with high growth potential, and has established a local team of distributors to market the two products. The successful MAH transfer in Saudi Arabia also provides the company with valuable experience, supporting its efforts for future Seroquel series MAH transfers in other GCC states and helping to drive the acceleration of commercial operations there. MAH transfer for the Seroquel series in other GCC states is expected to be completed in 2022.

“We are striving to become a well-recognized CNS specialty pharmaceutical company in GCC member state markets over the next five years. The Seroquel series is our first product in the region, and also represents the first step in our blueprint for local business development. We will continue to expand and deepen our presence in GCC member states with the Seroquel series, laying a solid commercial foundation for a range of our subsequent CNS products.” said Dr. Slim Ben Rhayem, MEA Commercial Manager at Luye Pharma Group.

Luye Pharma is planning to establish a regional office in Dubai, with the aim of introducing its pipeline products to the GCC region. The Group is also actively seeking external partnerships to combine resources and strengths with local business partners to better serve patients in the region.

About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Along with a number of new drugs and new formulations in the central nervous system and oncology therapeutic areas under study in the U.S. Europe and Japan, Luye Pharma has reached high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems, as well as actively making strategic developments in the fields of biological antibodies, cell therapies and gene therapies, among others.

Luye Pharma is developing a global supply chain of 8 manufacturing sites with over 30 production lines in total, establishing GMP quality management and international standard control systems. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets – China, the U.S., Europe and Japan, as well as in fast growing emerging markets.