Genetron Holdings Limited, a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, announced that it has signed a collaboration agreement with HUTCHMED Limited for the joint development of a companion diagnostic (CDx) test for ORPATHYS® (savolitinib) in China.
Under the agreement, the partners plan to jointly validate and register Genetron Health’s approved NGS-based 8-gene Lung Cancer Assay (Tissue) as CDx for ORPATHYS®. Developed based on Genetron Health’s proprietary One-step Seq method, the 8-gene Lung Cancer Assay (Tissue) was approved by China’s National Medical Products Administration (“NMPA”) as an IVD assay in 2020. This assay is the first approved NGS-based panel for non-small cell lung cancer (NSCLC) on the market that could detect RNA-based MET exon 14 skipping alterations for therapy selection and monitoring. The assay has been commercialized in China for use in hospitals and has also obtained CE Mark in 2021.
ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”) that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations) or gene amplification. Following a priority review, ORPATHYS® was granted drug registration conditional approval by the NMPA in China in June 2021.
More than a third of the world’s lung cancer patients are in China and, among those with NSCLC, approximately 2-3% have tumors with MET exon 14 skipping alterations, a targetable mutation in the MET gene.1-3 This mutation is more common (13-22%) among patients with pulmonary sarcomatoid carcinoma (PSC), a rare and aggressive subtype of NSCLC usually resistant to chemotherapy.4-5
Dr. Weiguo Su, Executive Director and Chief Scientific Officer of HUTCHMED, said, “We are delighted to work with Genetron Health, a leading precision oncology molecular diagnostic player in China. CDx test is becoming a valuable tool for the use of ORPATHYS® in the clinical setting for NSCLC patients harboring MET exon 14 skipping alterations. We look forward to developing this diagnostic solution with Genetron Health to allow more patients to benefit from this innovative therapy.”
“ORPATHYS® represents another important treatment option for NSCLC patients in China, and we are very excited to partner with HUTCHMED to further develop our Lung 8 assay as their first RNA-based NGS companion diagnostics product for this novel drug,” said Sizhen Wang, co-Founder and CEO of Genetron Health. “This partnership represents another major CDx partnership for us and upon approval, we expect this to further increase Lung 8’s penetration into China’s top hospitals. As precision medicine and targeted therapeutics continue to gain traction in China, we continue to expect CDx development to follow suit. CDx remains a big focus for Genetron, and we are committed to exploring more ways to develop innovative products to benefit more patients,” Wang said.
About Genetron Holdings Limited
Genetron Holdings Limited is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive oncology portfolio that covers the entire spectrum of cancer management, addressing needs and challenges from early screening, diagnosis and treatment recommendations, as well as continuous disease monitoring and care. Genetron Health also partners with global biopharmaceutical companies and offers customized services and products.
HUTCHMED is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,600 personnel across all its companies, at the center of which is a team of about 1,500 in oncology/immunology. Since inception it has advanced 12 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China.