Innovent Announces NMPA Acceptance of NDA for Picankibart (Anti-IL-23p19 Antibody) for Treating Moderate to Severe Plaque Psoriasis
Innovent Biologics announces the acceptance of a New Drug Application (NDA) by China's NMPA for picankibart, an anti-IL-23p19 antibody, for treating moderate to severe plaque psoriasis. Picankibart is the first IL-23p19 antibody to achieve over 80% PASI 90 after 16 weeks in a Phase 3 trial, offering the longest maintenance dosing interval (once every 12 weeks) in its class.
The NDA is based on positive results from the CLEAR-1 study, which met its primary and key secondary endpoints, showing significantly higher rates of skin lesion clearance and quality of life improvement compared to placebo. Picankibart demonstrated a favorable safety profile with no new safety signals.
As the first IL-23p19 antibody developed by a Chinese company to submit an NDA in China, picankibart shows best-in-class potential. Innovent aims to provide a safe and effective treatment option for Chinese psoriasis patients and continues to expand its portfolio in ophthalmology, autoimmune diseases, and cardiovascular and metabolic conditions.
Innovent Biologics annuncia l'accettazione di una Nuova Richiesta di Medicinali (NDA) da parte dell'NMPA cinese per picankibart, un anticorpo anti-IL-23p19, per il trattamento della psoriasi placche moderata a grave. Picankibart è il primo anticorpo IL-23p19 a raggiungere oltre l'80% di PASI 90 dopo 16 settimane in uno studio di Fase 3, offrendo il più lungo intervallo di dosaggio di mantenimento (una volta ogni 12 settimane) nella sua classe.
La NDA si basa su risultati positivi dello studio CLEAR-1, che ha raggiunto i suoi obiettivi primari e secondari chiave, mostrando tassi significativamente più elevati di eliminazione delle lesioni cutanee e di miglioramento della qualità della vita rispetto al placebo. Picankibart ha dimostrato un profilo di sicurezza favorevole senza nuovi segnali di sicurezza.
Essendo il primo anticorpo IL-23p19 sviluppato da un'azienda cinese a presentare una NDA in Cina, picankibart mostra un potenziale di eccellenza nella sua classe. Innovent si propone di fornire un'opzione di trattamento sicura ed efficace per i pazienti cinesi affetti da psoriasi e continua ad ampliare il proprio portafoglio in oftalmologia, malattie autoimmuni e condizioni cardiovascolari e metaboliche.
Innovent Biologics anuncia la aceptación de una Nueva Solicitud de Medicamento (NDA) por parte de la NMPA de China para picankibart, un anticuerpo anti-IL-23p19, para el tratamiento de la psoriasis en placa moderada a severa. Picankibart es el primer anticuerpo IL-23p19 en lograr más del 80% de PASI 90 después de 16 semanas en un ensayo de Fase 3, ofreciendo el intervalo de dosificación de mantenimiento más prolongado (una vez cada 12 semanas) en su clase.
La NDA se basa en resultados positivos del estudio CLEAR-1, que cumplió con sus objetivos primarios y secundarios clave, mostrando tasas significativamente más altas de eliminación de lesiones cutáneas y mejora de la calidad de vida en comparación con el placebo. Picankibart demostró un perfil de seguridad favorable sin nuevas señales de seguridad.
Como el primer anticuerpo IL-23p19 desarrollado por una empresa china en presentar una NDA en China, picankibart muestra un potencial de mejor clase. Innovent tiene como objetivo proporcionar una opción de tratamiento segura y efectiva para los pacientes chinos con psoriasis y continúa ampliando su cartera en oftalmología, enfermedades autoinmunes y condiciones cardiovasculares y metabólicas.
Innovent Biologics는 중국 NMPA가 중등도에서 중증의 판상 건선 치료를 위한 picankibart, 항-IL-23p19 항체에 대한 신규 의약품 신청(NDA)을 수락했다고 발표했습니다. Picankibart는 3상 시험에서 16주 후 80% 이상의 PASI 90을 달성한 첫 번째 IL-23p19 항체로, 동급에서 유지 투여 간격이 가장 긴(12주마다 한 번) 항체입니다.
NDA는 주요 및 2차 주요 목표를 달성한 CLEAR-1 연구의 긍정적인 결과를 기반으로 하며, 플라시보에 비해 피부 병변 제거율과 삶의 질 개선이 유의하게 높았습니다. Picankibart는 새로운 안전 신호 없이 우호적인 안전 프로필을 입증했습니다.
중국 기업이 중국에서 NDA를 제출한 첫 번째 IL-23p19 항체로서 picankibart는 차세대 선도 약제로서의 가능성을 보여줍니다. Innovent는 중국의 건선 환자에게 안전하고 효과적인 치료 옵션을 제공하고 안과, 자가면역 질환, 심혈관 및 대사 질환 분야의 포트폴리오를 지속적으로 확장할 계획입니다.
Innovent Biologics annonce l'acceptation d'une Nouvelle Demande de Médicament (NDA) par la NMPA de Chine pour picankibart, un anticorps anti-IL-23p19, destiné à traiter la psoriasis en plaque de modérée à sévère. Picankibart est le premier anticorps IL-23p19 à atteindre plus de 80 % de PASI 90 après 16 semaines dans un essai de Phase 3, offrant le plus long intervalle de dosage de maintien (une fois toutes les 12 semaines) dans sa catégorie.
La NDA est basée sur des résultats positifs de l'étude CLEAR-1, qui a atteint ses points de terminaison primaires et secondaires clés, montrant des taux de disparition des lésions cutanées et d'amélioration de la qualité de vie significativement plus élevés par rapport au placebo. Picankibart a démontré un profil de sécurité favorable sans nouveaux signaux de sécurité.
En tant que premier anticorps IL-23p19 développé par une entreprise chinoise à soumettre une NDA en Chine, picankibart montre un potentiel de meilleur de sa catégorie. Innovent vise à fournir une option de traitement sûre et efficace pour les patients chinois atteints de psoriasis et continue d'élargir son portefeuille en ophtalmologie, dans les maladies auto-immunes et les conditions cardiovasculaires et métaboliques.
Innovent Biologics gibt die Annahme eines neuen Medikamentenantrags (NDA) durch die NMPA Chinas für picankibart, einen Anti-IL-23p19-Antikörper zur Behandlung von mäßiger bis schwerer Plaque-Psoriasis, bekannt. Picankibart ist der erste IL-23p19-Antikörper, der nach 16 Wochen in einer Phase-3-Studie über 80 % PASI 90 erreicht hat und den längsten Erhaltungsdosisintervall (alle 12 Wochen) in seiner Klasse bietet.
Die NDA basiert auf positiven Ergebnissen der CLEAR-1-Studie, die ihre primären und wichtigsten sekundären Endpunkte erreicht hat und signifikant höhere Raten der Hautläsionen-Beseitigung und Verbesserung der Lebensqualität im Vergleich zu Placebo zeigt. Picankibart wies ein günstiges Sicherheitsprofil ohne neue Sicherheitsprobleme auf.
Als erster IL-23p19-Antikörper, der von einem chinesischen Unternehmen in China eine NDA eingereicht hat, zeigt picankibart ein Potenzial als bester seiner Klasse. Innovent hat sich zum Ziel gesetzt, eine sichere und effektive Behandlungsoption für chinesische Psoriasis-Patienten bereitzustellen und erweitert weiterhin sein Portfolio in der Ophthalmologie, bei Autoimmunerkrankungen sowie in der Herz-Kreislauf- und Stoffwechselmedizin.
- First IL-23p19 antibody to achieve over 80% PASI 90 after 16 weeks in Phase 3 trial
- Longest maintenance dosing interval (once every 12 weeks) among same class biologics
- Met primary and all key secondary endpoints in CLEAR-1 study
- Significantly higher rates of skin lesion clearance and quality of life improvement vs placebo
- Favorable safety profile with no new safety signals
- First IL-23p19 antibody developed by a Chinese company to submit NDA in China
- None.
SAN FRANCISCO and
This NDA acceptance is based on positive results from the Phase 3 registrational clinical study CLEAR-1 (NCT05645627) in Chinese patients with moderate to severe plaque psoriasis. The study successfully met its primary and all key secondary endpoints in May 2024, showing significantly higher rates of skin lesion clearance (PASI 90, PASI 75, PASI 100, sPGA 0/1, and sPGA 0) and quality of life improvement (DLQI 0/1) in the picankibart group compared to placebo. Picankibart showed a favorable safety profile, with no new safety signals. Detailed data from the CLEAR-1 study will be presented at future academic conferences and published in academic journals.
Professor Yulin Shi, the principal investigator of the clinical study, Shanghai Skin Disease Hospital, stated, "Psoriasis is a chronic, incurable disease that impacts both the physical and mental health, as well as the quality of life, of patients. Selecting effective treatment options is essential for managing the condition, reducing comorbidities, sustaining long-term therapeutic benefits, and improving overall quality of life. Evidence indicates that IL-23p19-targeted antibodies offer advantages in maintaining long-term efficacy and treatment convenience, which Picankibart has clearly demonstrated in clinical trials. Along with fellow investigators in the study, I'm proud of its NDA submission in
Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "We are honored to have received the regulatory acceptance of the NDA for picankibart, thanks to dedication of participants, investigators and regulatory authorities. This marks the first IL-23p19 antibody drug independently developed by a Chinese enterprise to submit an NDA in
About Psoriasis
Psoriasis is a chronic, recurrent, inflammatory and systemic disease included by genetic and environmental factors, affecting individuals of all ages and genders. It typically presents as scaly erythema or plaques, with non-infections, localized or widespread distribution. As a life-long noninfectious condition, psoriasis is notoriously difficult to treat. The disease can be categorized into psoriasis vulgaris (including guttate psoriasis and plaque psoriasis), pustular psoriasis, erythrodermic psoriasis and arthropathic psoriasis. Approximately
About Picankibart (IBI112)
Picankibart (IBI112) is a monoclonal antibody independently developed by Innovent with proprietary intellectual property rights. This product specifically targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors. Picankibart has the potential to offer a more effective treatment option for patients with psoriasis, ulcerative colitis or other autoimmune diseases.
Currently, multiple clinical studies of Picankibart are underway, including:
- Phase 3 study conducted in patients with moderate to severe plaque psoriasis (CLEAR-1), which has reached the study endpoints in May 2024;
- Phase 3 study conducted in patients with moderate to severe plaque psoriasis with randomized withdrawal and re-treatment;
- Phase 2 study in patients with moderate to severe plaque psoriasis who were previously treated with biologics;
- Phase 2 study in patients with moderate to severe active ulcerative colitis;
In September 2024, the NMPA accepted the first NDA for picankibart for the treatment of moderate to severe plaque psoriasis.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).
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