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CStone se asocia con SteinCares para comercializar sugemalimab en la región
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CStone Pharmaceuticals, una innovadora compañía biofarmacéutica enfocada en la investigación y el desarrollo de terapias contra el cáncer anunció hoy una alianza estratégica de comercialización con SteinCares, compañía líder en medicamentos de alta complejidad con más de 40 años de experiencia y una fuerte presencia en Latinoamérica. En virtud de este acuerdo, SteinCares obtendrá los derechos de comercialización de sugemalimab en 10 países de América Latina, incluidos Brasil, Argentina, México, Chile, Colombia, Costa Rica, Panamá, Perú, Guatemala y Ecuador.
Como parte de esta colaboración, SteinCares será responsable de los asuntos regulatorios y las actividades de comercialización de sugemalimab en estos países. CStone suministrará sugemalimab y recibirá pagos por adelantado, por hitos regulatorios y comerciales, así como ingresos por el suministro del producto.
El Dr. Jason Yang, CEO, presidente de I+D y director ejecutivo de CStone, declaró: “tras el éxito de nuestro ingreso en los mercados de Europa Central y Oriental, Suiza, Oriente Medio y África, nos complace anunciar otro hito importante en la expansión global de sugemalimab. Como el primer anticuerpo monoclonal anti-PD-L1 -aprobado tanto en la Unión Europea como en el Reino Unido para el tratamiento de primera línea del cáncer de pulmón no microcítico (NSCLC) en estadio IV, en todos los pacientes-, sugemalimab está bien posicionado para alcanzar el éxito en Latinoamérica. La amplia red de distribución de SteinCares y su profunda experiencia en marketing, aumentarán significativamente el alcance del medicamento”.
“Asimismo, estamos en conversaciones activas con socios internacionales en Europa Occidental, Sudeste Asiático y Canadá, mientras avanzamos en las solicitudes regulatorias para indicaciones adicionales de sugemalimab. Confiamos en que estos esfuerzos fortalecerán aún más el potencial terapéutico y comercial de sugemalimab, beneficiando a los pacientes en todo el mundo”.
Mitchell Waserstein, CEO de SteinCares, agregó: “este acuerdo con CStone representa un avance significativo en nuestra misión de crear oportunidades en salud para los pacientes en Latinoamérica. En SteinCares, estamos comprometidos a brindar a más latinoamericanos un mayor acceso a terapias seguras, innovadoras y asequibles. Con nuestra amplia experiencia y sólida red de distribución en toda la región, confiamos en nuestra capacidad para comercializar con éxito sugemalimab en Latinoamérica y generar un impacto significativo en la salud y el bienestar de los pacientes”.
Sugemalimab: mecanismo de acción
El anticuerpo monoclonal anti-PD-L1 sugemalimab fue desarrollado por CStone. Se trata de un anticuerpo monoclonal anti-PD-L1 de inmunoglobulina G4 (IgG4) totalmente humano, que puede reducir el riesgo de inmunogenicidad y toxicidad para los pacientes, una ventaja única con respecto a medicamentos similares.
El diseño molecular único de sugemalimab permite un mecanismo de acción dual que no sólo bloquea la interacción PD-1/PD-L1, sino que también induce la fagocitosis celular dependiente de anticuerpos (ADCP), mediante la reticulación de células tumorales que expresan PD-L1 con macrófagos asociados a tumores (TAM), sin dañar las células T efectoras. Esta diferenciación ha demostrado en una eficacia y seguridad superiores en varios tipos de tumores.
La Administración Nacional de Productos Médicos (NMPA) de China ha aprobado sugemalimab para cinco indicaciones:
- En combinación con quimioterapia como tratamiento de primera línea para pacientes con cáncer de pulmón no microcítico (NSCLC) metastásico escamoso y no escamoso.
- Para el tratamiento de pacientes con NSCLC en estadio III, cuya enfermedad no ha progresado después de quimiorradioterapia concurrente o secuencial basada en platino.
- Para el tratamiento de pacientes con linfoma extraganglionar de células NK/T en recaída o refractario;
- En combinación con fluorouracilo y quimioterapia basada en platino como tratamiento de primera línea para pacientes con carcinoma de células escamosas esofágico (ESCC), localmente avanzado, recurrente o metastásico irresecable, y
- En combinación con quimioterapia que contenga fluoropirimidina y platino como tratamiento de primera línea para adenocarcinoma gástrico o de la unión gastroesofágica (G/GEJ), localmente avanzado o metastásico irresecable con una expresión de PD-L1 (puntuación positiva combinada [CPS] ≥5).
La Comisión Europea (CE) ha aprobado sugemalimab (nombre comercial: Cejemly®) en combinación con quimioterapia basada en platino para el tratamiento de primera línea de pacientes con NSCLC metastásico sin mutaciones sensibilizantes de EGFR, o aberraciones tumorales genómicas ALK, ROS1 o RET.
La Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA) del Reino Unido ha aprobado la solicitud de autorización de comercialización para sugemalimab en combinación con quimioterapia basada en platino para el tratamiento de primera línea del NSCLC metastásico sin mutaciones sensibilizantes de EGFR, o aberraciones tumorales genómicas ALK, ROS1 o RET.
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