Innovent's PECONDLE® Becomes China's First Approved IL-23p19 Monoclonal Antibody

Introduction

China's National Medical Products Administration (NMPA) has granted approval for Innovent's PECONDLE® (picankibart injection), marking a significant advancement in the treatment of moderate-to-severe plaque psoriasis. This approval represents a breakthrough not only for Innovent Biologics but for countless patients suffering from this chronic dermatological condition.

Overview of PECONDLE®

PECONDLE® is the first monoclonal antibody targeting the IL-23p19 subunit, an essential cytokine involved in the inflammatory pathways of psoriasis. In clinical trials, PECONDLE® demonstrated remarkable efficacy, with over 80% of participants showing a 90% improvement in psoriasis severity, measured by the Psoriasis Area and Severity Index (PASI 90) within the first 16 weeks of treatment. It is noteworthy that PECONDLE® requires administration only once every 12 weeks during the maintenance phase, an interval that enhances adherence and patient convenience compared to existing biologic therapies.

The Challenge of Psoriasis

Psoriasis is a chronic autoimmune disorder affecting more than 7 million individuals in China alone. It is characterized by red, scaly patches that can be itchy, painful, and distressing, severely impairing patients' quality of life. The disease frequently leads to associated comorbidities, including cardiovascular risks and mental health issues such as anxiety and depression. Given the significant psychological and economic impact of this disease on both patients and society, effective and convenient treatments are critical.

Transition to Precision Medicine

The past few years have seen a shift towards precision therapy in treating psoriasis, moving away from traditional systemic therapies to targeted biologics. The treatment strategy has evolved to focus on achieving even higher PASI scores, with a goal of PASI 90 or 100, to ensure a profound and enduring remission of symptoms.

Clinical Trials and Efficacy

The key to PECONDLE®'s approval was the CLEAR-1 Phase 3 clinical trial, which enrolled Chinese participants with moderate-to-severe plaque psoriasis. The trial demonstrated that at week 16, 80.3% of participants achieved PASI 90, a stark contrast to the placebo group's mere 2.0%. Furthermore, at week 52, the efficacy was sustained, indicating the drug’s long-term benefits. Both PASI 75 and PASI 100 rates were also significantly higher compared to controls, highlighting its capacity to deliver comprehensive skin clearance.

Safety Profile

Safety data from the trial illustrated that PECONDLE® has a favorable safety profile. The most common adverse event reported was upper respiratory infections, aligning with what has been observed with other IL-23p19 inhibitors. Importantly, no new safety concerns were identified during the study, underscoring the potential of PECONDLE® as a reliable treatment option.

Comments from Experts

Professor Shi Yuling, a leading investigator from Shanghai Skin Disease Hospital, remarked on the profound impact of psoriasis on patients, noting the importance of individualized and effective treatment options to improve quality of life. As the first domestically developed IL-23p19 monoclonal antibody, PECONDLE® exemplifies a crucial step forward in chronic disease management in China. Dr. Lei Qian, Innovent's Chief RD Officer, emphasized the significant clinical benefits and the long-anticipated market authorization of this therapy, which aims to enhance the lifestyle of psoriasis patients.

Conclusion

In summary, PECONDLE®'s approval marks a pivotal moment in the treatment landscape of moderate-to-severe psoriasis in China. It not only offers enhanced treatment options for patients but also flags a new era of precision medicine that prioritizes both efficacy and safety. As Innovent looks to expand its portfolio further into autoimmune therapies and other major disease areas, PECONDLE® stands out as a promising treatment that seeks to redefine the management of psoriasis, ensuring better health outcomes and improved quality of life for many individuals across the country.