Keymed Biosciences secures NMPA approval for Stapokibart in chronic rhinosinusitis treatment

Keymed Biosciences Inc. (HKEX: 02162) has received a significant regulatory endorsement as the National Medical Products Administration (NMPA) of China approved its supplemental New Drug Application (sNDA) for Stapokibart, commercially known as Kangyueda (康悦达). The breakthrough anti-IL-4Rα monoclonal antibody is now authorised for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP), a debilitating condition that severely impacts patients’ quality of life.

This approval positions Stapokibart as a transformative therapeutic option, leveraging its innovative mechanism to target a condition that remains challenging to manage with conventional treatments.

What Is Stapokibart, and How Does It Work?

Stapokibart, developed by Keymed Biosciences, is a high-efficiency, humanised antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα). By blocking the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13)—cytokines central to type II inflammation—it directly addresses the inflammatory pathways that drive conditions such as CRSwNP.

The drug’s targeted approach allows for precise management of inflammation, reducing nasal polyps and alleviating symptoms such as congestion and sinus discomfort. Its approval marks it as the first domestically manufactured IL-4Rα antibody to be granted marketing approval by the NMPA, underscoring its significance within China’s pharmaceutical landscape.

Clinical Trial Insights: Evidence Supporting Approval

The NMPA’s decision follows the successful outcomes of a phase III clinical trial, a multi-centre, randomised, double-blind, placebo-controlled study evaluating Stapokibart’s efficacy and safety. Over 24 weeks, patients treated with Stapokibart experienced substantial improvements in key clinical metrics compared to those receiving a placebo.

Nasal polyps were significantly reduced, with the Nasal Polyps Score (NPS) improving by 2.3 points from baseline. Nasal congestion also eased notably, with a Nasal Congestion Score (NCS) improvement of 0.7 points. Both outcomes were statistically significant, with P-values less than 0.0001, highlighting the drug’s robust clinical performance.

Beyond these primary endpoints, patients reported additional benefits, including improved olfactory function, relief from sinus inflammation, and enhanced overall quality of life. The study also confirmed Stapokibart’s favourable safety profile, with no unexpected adverse effects reported.

Addressing a Persistent Unmet Need in CRSwNP

Chronic rhinosinusitis with nasal polyposis is a condition marked by persistent inflammation of the nasal passages, leading to symptoms such as obstruction, loss of smell, and sinus pressure. The condition often proves resistant to standard therapies, creating a pressing need for more advanced treatment options.

Stapokibart’s approval fills this gap, offering a targeted therapeutic pathway for patients who struggle to achieve relief through traditional approaches. This milestone also reinforces the growing role of biologic treatments in managing inflammatory diseases.

Broader Applications of Stapokibart

The recent approval builds on Keymed Biosciences’ earlier success with Stapokibart, which was granted market authorisation for the treatment of moderate-to-severe atopic dermatitis in adults in September 2024. Additionally, the NMPA has accepted the company’s application to expand Stapokibart’s indications to include seasonal allergic rhinitis, further showcasing its versatility in addressing inflammatory conditions.

These developments highlight Keymed Biosciences’ dedication to advancing biopharmaceutical solutions that meet critical healthcare needs. The company’s commitment to leveraging cutting-edge science positions it as a leader in the field of immunology and inflammation treatment.

Implications for the Future of Biologic Therapies

Stapokibart’s approval for CRSwNP underscores a broader trend in modern medicine, where biologics are increasingly being embraced for their precision and efficacy. By targeting specific pathways within the immune system, these therapies not only provide symptom relief but also address the underlying causes of complex conditions.

Keymed Biosciences’ success reflects a growing emphasis on innovative treatment options tailored to previously underserved patient populations. With its expanding portfolio and ongoing research, the company continues to play a pivotal role in redefining therapeutic possibilities for inflammatory and immune-mediated diseases.