Dupixent® Listed in China's National Reimbursement Drug List Just Five Months After Launch, Showcasing Accelerated Access for Innovative Medicines

Shanghai, December 28, 2020 /PRNewswire/ -- Today, the National Healthcare Security Administration officially announced the results of the 2020 national medical insurance negotiations, Dupixent^®(Dupilumab Injection) was officially included in the "National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalog (2020)" for the treatment of moderate-to-severe atopic dermatitis that is ineffective, contraindicated, or intolerant to traditional therapies. Benefiting from the dynamic adjustment mechanism established by the national medical insurance catalog to encourage innovation, Dupixent^®Following its approval two years ahead of schedule and a record-breaking 25-day timeline for drug supply, the medication was included in the national medical insurance coverage within five months of its market launch. This once again demonstrates the “China Speed” in accelerating the accessibility of innovative drugs, which will significantly improve patient access to medication and deliver long-term benefits by enhancing patients’ quality of life.

Dupixent^®It is currently the first and only targeted biologic agent approved by the U.S. Food and Drug Administration (FDA) and the European Union for the treatment of moderate-to-severe atopic dermatitis. In May 2019, it was included in the second batch of the list of urgently needed overseas new drugs by the Center for Drug Evaluation (CDE) under the National Medical Products Administration. It was recommended in the "Chinese Guidelines for the Treatment of Atopic Dermatitis (2020)" before being marketed in China.

This year, a key focus of the dynamic adjustment mechanism for the National Reimbursement Drug List (NRDL) established by the National Healthcare Security Administration (NHSA) is to include more innovative drugs in the reimbursement scope. Dr. He En Ting, President of Sanofi China, stated, “Benefiting from the accelerated approval and review process for new drugs in China and the new NHSA reimbursement access policy this year, Dupixent”^®"Every step of the approval, market launch, and inclusion in the national reimbursement drug list for this breakthrough innovative drug with high clinical and economic value has set a new record for 'China Speed.' We extend our gratitude to the healthcare security authorities and experts from all sectors for their efforts to benefit patients. Sanofi will continue to prioritize patients, accelerating the introduction of globally leading revolutionary therapies for those in need, supporting national initiatives to enhance access to innovative medicines and chronic disease treatments, thereby making a positive impact on patients' lives."

Moderate-to-Severe Atopic Dermatitis (AD) is not merely a skin disease, but a systemic immune-mediated disorder primarily driven by type 2 inflammation. Patients suffer from a substantial disease burden characterized by chronic, intense pruritus, severe skin lesions, and sleep disruption, which significantly impairs their quality of life, making AD the skin condition with the highest disease burden among non-fatal diseases. In patients with severe atopic dermatitis, the disease exacerbates for more than half of the year.^[1]Atopic dermatitis is the initial disease in the “skin–gastrointestinal tract–respiratory tract” allergic march. Early onset of atopic dermatitis often indicates a higher risk of developing other type 2 inflammatory diseases, such as allergic rhinitis and asthma, in the future.

Professor Zhang Jianzhong, Director of the Department of Dermatology at Peking University People’s Hospital, stated: “Unlike traditional systemic therapies with oral glucocorticoids or immunosuppressants, the targeted biologic agent Dupixent^®It can specifically block the key pathogenic factors of atopic dermatitis, treat type 2 inflammation-related diseases from a mechanistic perspective, and rapidly, significantly, and continuously eliminate and improve rash and pruritus symptoms. In addition, Dupixent^®“It does not require the pre-treatment screenings typically necessary for conventional biologics. Its efficacy and safety have been corroborated by multiple clinical trials and real-world studies, establishing it as a safe, effective systemic therapy suitable for long-term use. Inclusion in the national medical insurance scheme will significantly alleviate patients’ financial burden, providing robust support for standardized long-term treatment.”

Dupixent^®Prescriptions are now available at nearly 200 hospitals and 81 DTP pharmacies across 55 cities, including Beijing, Shanghai, Guangzhou, Chengdu, Wuhan, and Shenyang.

^[1] Clark C. Clinical Pharmacist 2010;54:285–289. 2. Torrelo A. Eur J Dermatol 2012;22:97–105. 3. Zuberbier T et al. J Allergy Clin Immunol 2006;118:226–232.