On August 17, 2026, Lunsafe^® — the Methylation Detection Kit for Human HOXB4 and SRCIN1 Genes (Real-Time PCR), independently developed by Creative Biosciences (Guangzhou) Co., Ltd. — was officially granted registration approval by Brazil’s National Health Surveillance Agency (ANVISA, Agência Nacional de Vigilância Sanitária). This marks Lunsafe^®’s successful entry into South America’s largest healthcare market, representing a pivotal step in its expansion into the international market.

ANVISA is Brazil’s national regulatory authority responsible for the registration and oversight of pharmaceuticals, medical devices, in vitro diagnostic reagents, and other health-related products. Renowned for its rigorous review standards and high entry barriers, ANVISA holds significant influence in the international regulatory landscape. This successful approval signifies that Lunsafe^® has earned recognition from an internationally authoritative regulatory body for its quality management system, clinical performance, and compliance — officially opening a new chapter in its Latin American market strategy.

Lung cancer is one of the malignant tumors with the highest incidence and mortality rates worldwide. Early detection and timely intervention are critical to reducing mortality. Lunsafe^®’s entry into the Brazilian market means that local populations will have access to China’s non-invasive sputum-based early lung cancer screening technology, contributing to early diagnosis and treatment of the disease.

Lunsafe^® is the first domestically developed sputum-based lung cancer methylation detection kit in China, independently developed by Creative Biosciences. By detecting aberrant DNA methylation changes (methylation of the human HOXB4 and SRCIN1 genes) in exfoliated tumor cells from sputum samples, Lunsafe^® can assist in the early detection of lung cancer and help identify early-stage pulmonary lesions — potentially intercepting lung cancer at an early stage to enable proactive prevention and treatment. Compared with conventional imaging and invasive biopsy, sputum sampling is non-invasive, convenient, and highly acceptable to patients, providing a novel technological approach for early screening of high-risk lung cancer populations.

Lunsafe^®’s overseas expansion echoes the internationalization journey of Colosafe^®. Colosafe^® has previously obtained EU CE certification, Thailand import licenses, Brazil market access, and other international qualifications, covering over 40 countries and regions across four continents — Asia, Europe, South America, and Africa. With both colorectal cancer and lung cancer early screening product lines now expanding internationally in tandem, Creative Biosciences’ globalization strategy is advancing steadily.

Rooted in China, reaching the world. Creative Biosciences will continue to uphold the noble vision of “Human Health, Our Mission,” staying true to its commitment to quality. By delivering high-standard products to serve the people and continuously expanding its global market footprint, the company aims to bring Chinese innovations to the broader international stage and contribute to global cancer prevention and control efforts.