On September 12th, Konya announced that the company's independently developed Class 1 new drug, Kangyueda ® (Sipuximab Injection) has been officially approved for marketing by the National Medical Products Administration for the treatment of moderate to severe atopic dermatitis in adults. As the first domestic and second globally approved IL-4R alpha antibody drug, Kangyueda ® The launch of Sipuqibai monoclonal antibody not only fills the gap in the field of domestic atopic dermatitis biologics, but also brings new hope for patients with moderate to severe atopic dermatitis to achieve higher treatment goals.

Kangyueda ® (Sprucubizumab)

Kangyueda ® The Phase III clinical trial of (Sipuximab) is the largest randomized controlled trial of dermatological subjects completed in China to date. The research results show that,

The first dose takes effect quickly: Kangyueda ® The first dose of single agent treatment with (Sipuximab) can quickly relieve itching symptoms within one day; After 2 weeks of treatment, it has a strong improvement effect on skin lesions in all parts of the body.

Treatment goal "Double 9 achievable": monotherapy for 52 weeks, Kangyueda ® The treatment goal of continuous improvement of skin lesions can be achieved with the "Double 9" treatment target of (Sipuximab) - that is, over 90% of patients achieve a 75% or more improvement in eczema area and severity index (EASI-75), and nearly 80% of patients achieve a 90% or more improvement in eczema area and severity index (EASI-90).

Continuous relief of itching: Kangyueda ® After 52 weeks of monotherapy with Sipuximab, the PP-NRS decreased by ≥ 4 compared to baseline, with a response rate as high as 67.3%. At the same time, monotherapy continued to improve the DLQI and POEM scores compared to baseline, significantly improving the quality of life of patients.

Long 9 Health Guardian: Kangyueda ® (Sipuximab) can effectively reduce the risk of recurrence, demonstrating good safety and tolerability. The recurrence rate after 52 weeks of treatment is only 0.9%, and after 8 weeks of discontinuation, the recurrence rate is only 0.9%. The incidence of conjunctivitis is only 5.3%, providing long-term protection for patient health.

About Konya

Konya (Hong Kong Stock Exchange code: 02162) is a comprehensive biopharmaceutical company that focuses on independent research and production of innovative drugs, committed to providing patients with more competitive, high-quality, and affordable innovative therapies worldwide. The core is the inventor of the PD-1 antibody drug, which was first developed and approved for market globally and in China.

The company focuses on the treatment of autoimmune diseases, tumors, and neurodegenerative diseases, builds a differentiated product pipeline, and develops multiple potential world first or best in class candidate drugs, with multiple advances leading globally or domestically. Kangnuo has a deep layout of the entire biopharmaceutical industry chain, covering the entire cycle from molecular discovery to commercial production. The international production base that has been built is designed to meet the cGMP requirements of the National Medical Products Administration, the US FDA, and the EU EMA.