Pfizer's Breakthrough Alopecia Areata Drug Litfulo® (Ritlecitinib) Approved in China for Adolescents and Adults

October 19, China — Pfizer, Inc. announced that the innovative alopecia areata drug Lefunuo® (LITFULO®, generic name: Ritlecitinib Tosylate Capsules) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of severe alopecia areata in adolescents aged 12 years and older and adults. As the world’s first and only approved innovative drug for treating severe alopecia areata in patients aged 12 years and older, Lefunuo® is a dual-channel inhibitor of the JAK3/TEC kinase family, requiring only once-daily oral administration. It is expected to bring a new treatment option for patients with severe alopecia areata in China, ushering in a new era of systemic treatment covering both adolescents and adults in the field of alopecia areata.

Jean-Christophe Pointeau, President of Pfizer China, Chairman of the RDPAC Executive Committee, and Vice President of the China Association of Enterprises with Foreign Investment, stated: "As the only treatment for alopecia areata in China to receive the 'Breakthrough Therapy' designation from the National Medical Products Administration (NMPA), Lefluno® is a key product developed and registered globally by Pfizer. Its recent approval in China marks another significant milestone in Pfizer's expansion into the inflammation and immunology field and strengthens its JAK portfolio. We thank the NMPA and relevant authorities for their efforts in accelerating the review and approval of innovative medicines. The swift approval and market launch of Lefluno® in China, achieved at 'China speed,' addresses gaps in systemic treatment options for alopecia areata in China, providing more innovative therapeutic solutions for Chinese adolescents and adults with severe alopecia areata. As the first biopharmaceutical company to research the JAK pathway for inflammatory and immune diseases, Pfizer remains committed to its mission of 'bringing breakthrough innovations that change patients' lives.' We will continue to accelerate the development and introduction of groundbreaking innovative products and therapies to meet the health needs of Chinese patients, thereby supporting the realization of the grand goal of 'Healthy China 2030.'"

Alopecia Areata is an autoimmune disease where the immune system attacks the body's hair follicles, leading to hair loss. It typically occurs on the scalp but can also affect facial hair such as eyebrows, eyelashes, and beards, as well as body hair in other areas. According to statistics, a survey of six provinces in China shows that the prevalence of Alopecia Areata is 0.27%. Alopecia Areata is the second most common type of hair loss disease after androgenetic alopecia. Previously, adolescent patients with severe Alopecia Areata lacked available treatment options, and adult patients with moderate to severe Alopecia Areata had limited treatment choices.

Refulan® is a kinase inhibitor that irreversibly inhibits JAK3 and TEC kinase families by blocking the ATP binding site. At the cellular level, Refulan® inhibits cytokine-induced STAT phosphorylation mediated by JAK3-dependent receptors. Additionally, Refulan® can inhibit immune receptor signaling dependent on members of the TEC kinase family.

Professor Zhang Jianzhong, head of the Hair Group of the Chinese Medical Association, pointed out, "Currently, there are approximately 4 million alopecia areata patients in China, and in recent years, the prevalence of alopecia areata has been increasing annually. Previous treatment solutions still have certain limitations and cannot meet the treatment needs of the majority of severe patients, especially adolescents and children. With the development of new global technologies, products, and methods, particularly landmark advances in translational medicine, the launch of new drugs has brought a new systemic JAK treatment solution to Chinese alopecia areata patients beyond traditional treatments. The recent approval of Lefluno® in China has broken this void. As the world's first and only innovative systemic treatment oral medication for severe alopecia areata patients aged 12 years and above, it will provide a brand-new treatment option for clinical practice in China and is also expected to bring benefits to more alopecia areata patients."

About Lefunon® (Ritlecitinib Tosylate Capsules)

As the first and only approved innovative therapy for the treatment of severe alopecia areata in adolescents aged 12 years and above as well as adults, Leflunon® has received marketing authorization in multiple regions worldwide, including the United States, the European Union, and Japan, since June 2023. In December 2020, Leflunon® was granted "Breakthrough Therapy Designation" by the China National Medical Products Administration (NMPA) for the treatment of alopecia areata. In November 2022, Leflunon® received priority review and approval qualification from the China NMPA, achieving synchronized global research and registration.

Editor: Mu Mian

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