Pfizer's Breakthrough Dermatology Drug CIBINQO® Approved in China, Accelerating Access for Moderate-to-Severe Atopic Dermatitis Patients

Shanghai, April 12, 2022 /PR Newswire/ -- Pfizer Inc. announced today the innovative dermatological drug Cibinqo^®（CIBINQO^®, Generic Name: Abrocitinib Tablets) has been approved by the China National Medical Products Administration for the treatment of moderate to severe atopic dermatitis (Atopic dermatitis, abbreviated as "AD") in adults. As a breakthrough therapy for AD treatment, Cibinqo^®It is a highly selective JAK1 (Janus kinase 1) inhibitor, requiring only once-daily oral administration, and will provide a new treatment option for patients in China.

Peng Zhenke, President of Pfizer Biopharmaceuticals Group, ChinaRepresentation:"Pico Innovation Drug Cibecan^®It is a重磅 product of Pfizer's global synchronized R&D and registration. This accelerated approval in China marks an important milestone for Pfizer in the field of inflammation and immunology. We thank the Chinese government for encouraging innovation and the implementation of policies to expedite the review and approval of new drugs, allowing Chinese patients with atopic dermatitis to access this breakthrough treatment simultaneously with the rest of the world. We also extend our gratitude to those who actively participated in Cibinqo.^®Chinese researchers and patients in international clinical studies have contributed 'China's strength' to global research. In the future, Pfizer will continue to uphold its commitment to 'bring breakthrough innovations that change patients' lives,' leveraging its strong global R&D capabilities to provide Chinese patients with high-quality innovative products and treatment solutions, supporting the realization of the grand goal of 'Healthy China 2030.'

High SelectivityJAK1 Inhibitor Cibinqo^®Bring a milestone breakthrough in AD treatment

As the first pharmaceutical company in the world to develop the JAK pathway for inflammatory and immune diseases, Pfizer began focusing on the development of JAK inhibitors in the early 1990s. It has created nearly a thousand compounds and continues to explore the clinical application value of JAK inhibitors in immune-related skin diseases such as atopic dermatitis, psoriasis, and alopecia areata.

AD is a common chronic skin disease characterized by skin inflammation and skin barrier defects, with the prevalence of AD continuously increasing globally over the past 30 years. The disease is marked by intense itching and recurrent skin lesions, and can also be accompanied by chronic conditions such as asthma, allergic rhinitis, and insomnia symptoms, significantly reducing the quality of life for patients.¹。

Cibinqo^®Professor Li Hang, the principal investigator in China for the global clinical research project and the director of the Department of Dermatology at Peking University First Hospital, stated"The severe itching caused by atopic dermatitis significantly affects patients' quality of life, but delays and recurrence are often due to insufficient disease awareness, increasing the disease burden. For patients with moderate to severe atopic dermatitis, the primary need is rapid relief of itching symptoms. The newly approved highly selective JAK1 inhibitor Cibinqo for AD treatment..."^®Will bring breakthrough innovations in this aspect, looking forward to Cibinqo.^®Land in China as soon as possible to benefit a large number of patients with atopic dermatitis."

Cibinqo^®Professor Zhirong Yao, the principal investigator in China for the global clinical research project and the director of the Department of Dermatology at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, stated"Atopic dermatitis is a refractory inflammatory immune disease. Intense itching and rashes affect many patients’ work, studies, and physical and mental development. If it appears on areas such as the face or hands, the impact is even greater. Therefore, symptoms of moderate to severe atopic dermatitis need to be controlled as soon as possible. This time, Cibinqo..."^®The approval fills the gap in the insufficient clinical use of commonly prescribed drugs for patients with moderate to severe atopic dermatitis, bringing new benefits to the systemic treatment of these patients.

In 2018, the U.S. Food and Drug Administration (FDA) granted Cibinqo^®Breakthrough Therapy Designation for the Treatment of Moderate to Severe AD. In 2020, Cibinqo^®Awarded the "Promising Innovative Medicine (PIM)" designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA). Since September 2021, Cibinqo^®Has obtained marketing approval in multiple regions around the world, including the UK, Japan, the EU, and the US. In April 2021, Cibinqo^®Received the designation of priority review and approval qualification from the National Medical Products Administration of China, achieved global synchronized R&D and registration, and successfully participated in multiple Cibinet projects in China.^®International Multicenter Clinical Study.

Abrocitinib Tablets (100mg) Exhibited at the 4th China International Import Expo

Abrocitinib Tablets (200mg) Exhibited at the 4th China International Import Expo