Chengdu December 25, 2024 /PR Newswire/ -- On December 25, 2024, the first domestic biologic for the treatment of chronic sinusitis with nasal polyps, Kangyueda (Suplicadab injection), was prescribed by Director Zhang Luo at the Beijing Tongren Hospital affiliated with Capital Medical University, marking the first prescription in the country. As the first of its kind in China and one of only two approved IL-4Rα antibody drugs globally, Kangyueda (Suplicadab injection) offers a new treatment option for patients suffering from chronic sinusitis with nasal polyps.

Director Zhang Luo, the principal investigator of the Phase III clinical study for the indication of Suplicadab in chronic sinusitis with nasal polyps at Beijing Tongren Hospital, stated: "Suplicadab is a milestone drug for the treatment of chronic sinusitis with nasal polyps. As the principal investigator of the clinical trials, I am pleased to witness its application in clinical settings, helping patients to achieve symptoms relief such as reduction of nasal polyps, alleviation of nasal congestion, and restoration of sense of smell, thus improving disease management and enhancing patients' quality of life. With the issuance of the first prescription, chronic sinusitis with nasal polyps has entered a new stage of precise treatment, and we look forward to Suplicadab accelerating its clinical application to benefit more patients suffering from chronic sinusitis with nasal polyps."

The refractory and recurrent nature of chronic sinusitis with nasal polyps poses serious challenges to patients' quality of life.

Chronic sinusitis with nasal polyps is a chronic inflammatory disease occurring in the nasal mucosa, characterized primarily by type 2 inflammation, with clinical symptoms such as nasal congestion, reduced sense of smell, rhinorrhea, and facial swelling that severely affect patients' quality of life. Currently, the conventional treatment for chronic sinusitis with nasal polyps is a combination of pharmaceutical and surgical approaches, but these treatment methods have certain limitations. Some patients may not achieve satisfactory outcomes, resulting in persistent symptoms or recurrence of polyps after treatment. A 3-year follow-up survey targeting Chinese patients showed that the recurrence rate of nasal polyps was as high as 99%[1]. The pathogenesis of chronic sinusitis with nasal polyps is complex, where IL-4 and IL-13 play a key role in type 2 inflammatory responses through the shared receptor IL-4Rα. Therefore, a targeted treatment approach focusing on the core driving Indicators of type 2 inflammation is urgently needed for the innovative precision treatment of this disease.

Biological agent Kangyueda (Dupilumab) brings new breakthroughs in treatment models.

Kangnuoya's independently developed class 1 innovative drug Kangyueda (Dupilumab) combines with IL-4Rα to block the IL-4 and IL-13 signaling pathways that affect the occurrence of chronic sinusitis with nasal polyps, thereby reducing serum IgE levels, inhibiting Th2 cell differentiation, and alleviating inflammation to maintain health.

As the first biological agent in China to complete clinical research on chronic sinusitis with nasal polyps, Kangyueda (Dupilumab) demonstrated multiple benefits in phase III clinical studies [2], [3]:

• At two weeks after the first administration of Kangyueda (Dupilumab), nasal polyps significantly reduced; after four weeks of treatment, olfactory function significantly recovered, and nasal symptoms improved markedly.
• At 24 weeks of treatment, over 80% of patients achieved a reduction of at least 50% in nasal polyps (NPS score improved by ≥2 points compared to baseline), and nearly half of the patients achieved "pharmacological removal of polyps" (NPS score = 0 or 1); 70% of patients achieved nasal ventilation (NCS score improved by ≥1 point compared to baseline), effectively alleviating nasal congestion; over 70% of patients showed significant improvement in quality of life.
• At 52 weeks of treatment, the benefits for patients continued, with 90% achieving a reduction of at least 50% in nasal polyps (NPS score improved by ≥2 points compared to baseline), and over 60% achieving "pharmacological removal of polyps" (NPS score = 0 or 1); more than 80% achieved nasal ventilation (NCS score improved by ≥1 point compared to baseline) and significantly improved quality of life.
• Kangyueda (Supuqibaidankang) has good safety, with the incidence of adverse events (TEAE) during treatment comparable to that of the placebo group, with the vast majority of TEAEs being mild or moderate, and long-term safety is good.

Simultaneously implemented in multiple provinces and cities to assist patients and further enhance the accessibility of Innovative Drugs.

Kangyueda (Supuqi Baidankang) was approved for marketing by the National Medical Products Administration on December 17, 2024, for the treatment of chronic sinusitis with nasal polyps. With the prescription from the first party, this indication will gradually be implemented across all provinces and cities, promoting the widespread availability of Innovative Drugs to patients in various regions.

With the approval and commercial launch of Kangyueda (Supuqi Baidankang) for adult moderate to severe atopic dermatitis and chronic sinusitis with nasal polyps, Kangnuo Ya has partnered with charitable foundations to carry out the Kangyueda Patient Assistance Program, providing partial pharmaceutical aid to patients, helping to alleviate their financial burden, supporting patients in maintaining standardized treatment, and further enhancing the accessibility and affordability of Innovative Drugs.

About Kangyueda (Supuqi Baidankang):

Kangyueda (Supuqi Baidankang) is a highly efficient, humanized monoclonal antibody targeting the interleukin-4 receptor α subunit (IL-4Rα), and it is the first IL-4Rα antibody drug developed independently in China and approved for marketing. By targeting IL-4Rα, Supuqi Baidankang can dual-block interleukin-4 (IL-4) and interleukin-13 (IL-13), two key cytokines that trigger type 2 inflammation, effectively curbing disease progression. Supuqi Baidankang has been approved for the treatment of adult moderate to severe atopic dermatitis and chronic sinusitis with nasal polyps, and the marketing license application for its use in treating seasonal allergic rhinitis has been accepted.

About Connoa:

Connoa (Hong Kong Stock Exchange code: 02162) is a comprehensive biopharmaceutical company focused on the independent research and development and production of Innovative Drugs, dedicated to providing patients with more competitively priced, high-quality, and affordable innovative therapies. At the core is the inventor of the PD-1 antibody drug that was first invented and approved for market launch in both Global and China, with the main leadership team comprised of renowned experts in the biopharmaceutical Industry, having world-class achievements in technology transfer and exceptional domestic and international industrialization experience.

The company adheres to independent innovation and possesses an efficiently integrated internal research and development capability, relying on proprietary platforms such as the novel T cell redirecting (nTCE) bispecific platform, antibody-drug conjugate platform, and small nucleic acid drug platform to build an industry-leading drug discovery engine. The company focuses on its own immune diseases, tumors, and neurodegenerative disease treatment fields, creating a differentiated product pipeline, developing multiple potential world-first or best-in-class candidate drugs, with several advancements leading domestically or globally. Connoa is deeply engaged in the entire Industry Chain of biopharmaceuticals, covering the entire cycle from molecular discovery to commercial production, with its established international production bases designed to meet the cGMP requirements of the National Medical Products Administration, the USA FDA, and the European Union EMA.

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