Guangzhou, China – May 30, 2025 – Creative Biosciences (Guangzhou) CO., Ltd. today announced that its independently developed methylation test kit for the early detection of lung cancer, Lunsafe, has received official approval from China’s National Medical Products Administration (NMPA) for market entry. This milestone marks a decade-long commitment by Creative Biosciences to advancing innovative non-invasive cancer diagnostics for patients worldwide.

A new standard for cancer screening
Lunsafe is the first sputum-based methylation test kit for early lung cancer detection approved in China, and a pioneering breakthrough on the global stage. The product offers a transformative solution for early lung cancer screening and diagnosis, representing another major achievement for Creative Biosciences in the field of precision oncology testing.

Screenshot of the public announcement on the NMPA official website

Addressing a pressing health challenge
According to the National Cancer Center, lung cancer remains the most common and deadliest cancer in China, with 1.06 million new cases and 730,000 deaths in 2022 alone, posing a serious threat to public health. The majority of patients are diagnosed at mid-to-late stages, missing optimal treatment opportunities and contributing to a low five-year survival rate. The urgent need for accurate, accessible, and early detection methods has driven decades of research and innovation.

Over the past few decades, lung cancer screening methods have evolved from sputum cytology and chest X-ray to low-dose spiral CT (LDCT). Chest X-ray, due to its low resolution and inability to detect early-stage lung cancer lesions, has gradually been phased out. Sputum cytology can detect tumor cells in sputum, but it has relatively low sensitivity and is cumbersome to perform, making it unsuitable for large-scale population screening. Currently, LDCT is the preferred method for lung cancer screening. It offers high resolution and low radiation exposure but still faces issues such as high false-positive rates and overdiagnosis, which limit its widespread application.

Lunsafe advantages
Leveraging its deep expertise in precision oncology, Creative Biosciences developed Lunsafe to detect methylation abnormalities of HOXB4 and SRCIN1 genes in exfoliated tumor cells from sputum samples. Multi-stie clinical trials demonstrated outstanding performance:

· Sensitivity: 82.82%

· Specificity: 91.79%

· Kappa value: 0.74

· Strong detection capability across all stages and pathological types of lung cancer

· Excellent differentiation between benign and malignant pulmonary nodules

Compared with existing screening methods, Lunsafe offers:

· Non-invasiveness & convenience – Simple, painless sputum collection, easily accepted by the public.

· High accuracy – Genetic methylation profiling provides a precise reflection of tumor biology.

· Wide applicability – Suitable for adults over 50, smokers, individuals exposed to second-hand smoking or cooking fumes, those with occupational carcinogen exposure, personal or family history of lung cancer, or chronic lung disease.

Looking ahead
The NMPA approval of Lunsafe is not only a breakthrough for Creative Biosciences but also a landmark for the industry. It provides high-risk individuals with a more accurate and convenient option for early detection and gives healthcare providers a reliable diagnostic tool. With the launch of Lunsafe, Creative Biosciences reaffirms its commitment to driving innovation in precision oncology. The company will continue to expand its portfolio of advanced diagnostic solutions, contributing to the global fight against cancer and improving outcomes for patients worldwide.