Adicon and Merck’s Companion Diagnostic AiHuiJie® (Lung Cancer PCR-11 Gene) for Tepotinib in METex14 Skipping Mutation NSCLC Receives NMPA Approval
Merck Group
Pharmaceutical R&D Developer
On September 5, 2024, Merck KGaA and Amoy Diagnostics Co. LTD jointly developed Todecom based on the VISION study.®(Tepotinib) METex14 Skipping Mutation Companion Diagnostic Kit AiHuiJie®(Lung Cancer PCR-11 Gene) Receives Approval from the China National Medical Products Administration for Market Launch.
Tepotinib, as the world's first approved highly selective MET inhibitor, was first launched in Japan in March 2020. In August 2021, the lung cancer PCR-11 gene panel was approved in Japan as a companion diagnostic for tepotinib. Clinical practice has confirmed,The combination of PCR-11 Gene Precision Diagnosis and Tepotinib Precision Treatment for Lung Cancer Effectively Improves Survival in Non-Small Cell Lung Cancer (NSCLC) Patients with METex14 Skipping Mutations.
Tepotinib was officially approved for marketing in mainland China in December 2023., for the treatment of adult patients with locally advanced or metastatic NSCLC carrying METex14 skipping mutations. To date, it has been fully approved in more than 30 countries and regions worldwide, with its efficacy and safety validated in real-world settings. Tepotinib has been unanimously recommended by authoritative guidelines both domestically and internationally, such as NCCN and CSCO.Including 2024 NCCN NSCLC and CNSC Guidelines, 2023 ASCO, 2023 ESMO, 2024 CSCO Guidelines (Level Ⅰ Recommendation)。
VISION Study is the largest (N=313), prospective clinical study conducted to date in NSCLC patients with METex14 skipping mutations, and it is the only study that has demonstrated treatment guidance can be provided through either liquid biopsy or tissue biopsy. The study results showed that in treatment-naïve tissue biopsy-positive patients (n=111), the objective response rate (ORR) for tepotinib was 58.6% (95% CI, 48.8-67.8), the median progression-free survival (mPFS) was 15.9 months (11.0, 49.7), and the median overall survival (mOS) was 29.7 months (18.8, ne). In previously treated tissue biopsy-positive patients (n=97), the ORR was 49.5% (95% CI, 39.2-59.8), the mPFS was 11.5 months (8.2, 14.7), and the mOS was 20.4 months (17.0, 25.5). For both treatment-naïve and previously treated patients, the median duration of response (mDOR) for tepotinib was 46.4 months (95% CI, 13.8-NE) and 12.6 months (95% CI, 9.5-18.5), respectively. Long-term follow-up safety results were consistent with previous reports, showing an overall manageable safety profile.
Amoy Diagnostics' Companion Diagnostic Reagent for Lung Cancer PCR-11 Gene covers a total of 11 essential and extended genes for NSCLC, enabling the co-detection of DNA and RNA. Among these, companion diagnostics have been approved for seven genes—EGFR, ALK, ROS1, BRAF, MET, KRAS, and RET—for guiding the clinical application of up to 16 targeted drugs. Currently, the Lung Cancer PCR-11 Gene has achieved regulatory approval and market launch in China, Japan, and Europe, benefiting numerous NSCLC patients worldwide.
Merck is a global leading technology company focusing on three major fields: healthcare, life sciences, and electronic technology. Approximately 63,000 employees worldwide work for Merck, bringing positive impacts to millions of lives by creating more enjoyable and sustainable lifestyles. From advanced gene-editing technologies and discovering unique methods to treat challenging diseases, to enabling smart devices—Merck is everywhere. In 2023, Merck achieved total sales of 21 billion euros across 65 countries/regions.
Scientific exploration and responsible entrepreneurship have always been the key to Merck's technological progress and the secret to Merck's vitality since 1668. The Merck family, as the founder of the company, still holds the majority of Merck's shares. We are known as "Merck" globally, except in the United States and Canada. Merck's three major fields: healthcare, life science, and electronic technology are respectively called "EMD Serono," "MilliporeSigma," and "EMD Electronics" in these two countries. Merck has a 90-year development history in China, with nearly 4,500 employees currently, and 21 registered companies in Beijing, Shanghai, Wuxi, Suzhou, Nantong, Hong Kong, and other places.
Amoy Diagnostics Co. LTD. focuses on the field of precision medicine diagnostics for oncology, committed to continuous medical innovation, providing patients with compliant and high-quality companion diagnostic products and services, enabling patients to truly benefit from precision medicine. The company holds qualifications such as the MIIT's "National Enterprise Technology Center," "Specialized,精细化, and New 'Little Giant' Enterprise," "Manufacturing Single-item Champion Enterprise," the Ministry of Human Resources and Social Security's "Postdoctoral Research Workstation," and the NDRC's "Gene Detection Technology Application Demonstration Center." The company owns ADx-ARMS.®、Super-ARMS®、ddCapture®, ADx-HANDLE® and other core technologies, and has been granted patents in China, the United States, the European Union, Japan, and other countries. The company has won the Second Prize of the National Science and Technology Progress Award and the Silver Award of the China Patent Award. Its products cover precise testing for various major cancers, and several products still have no competitors to date. Products have been approved for marketing in Japan, South Korea, and the European Union, with some entering the medical insurance systems in Japan and South Korea, setting a precedent for China's tumor companion diagnostics to gain overseas approvals. Currently, customers from dozens of countries and regions worldwide have chosen Amoy Diagnostics' products and services, benefiting hundreds of thousands of cancer patients annually. Additionally, the company targets the innovation source of the industry and has established strategic partnerships with many well-known pharmaceutical enterprises, becoming an internationally renowned Chinese brand.
Editor: Congying