Xiamen, China, August 27, 2020– Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685) announced that it signed an agreement with Haihe Pharmaceutical to develop a Companion Diagnostic (CDx) test supporting the novel MET inhibitor Glumetinib (SCC244). The CDx test is based on AmoyDx's industry-leading PCR platform.
Under the terms of the agreement, AmoyDx will develop and register the AmoyDx® Pan Lung Cancer PCR Panel (9-in-1 Plus) in Japan, to get the PMDA approval for an intended use as a c-MET exon14 skipping companion diagnostic for Haihe's Glumetinib (SCC244), a novel MET kinase inhibitor targeting c-MET exon14 skipping, in subjects with Non-Small Cell Lung Cancer.
“Haihe is a clinical stage biotech to use biomarkers to discover and develop safer and more effective, innovative medicines for cancer patients with unmet medical needs. AmoyDx is a leading company in the field of precision oncology focusing on companion diagnostics. Haihe is so glad to partner with AmoyDx to develop the best diagnostic solutions for the success of the targeted medicine Glumetinib in Japan”, said Ruiping Dong, Ph.D., CEO of Haihe Pharmaceutical.
“We announce with great excitement this co-development collaboration for the Japan market” said Li-Mou Zheng, Ph.D., Founder and CEO of AmoyDx. “AmoyDx has a strong pipeline of diagnostic products for precision medicines, as well as successful CDx development experience in Japan. Exploiting our test to help guide treatment decisions will address a high unmet medical need from patients. AmoyDx is a trusted partner with the expertise in R&D, Regulatory Affairs and Commercialization for co-development of companion diagnostic.”
About Haihe Pharmaceutical
Haihe pharmaceutical focuses on discovery, development and commercialization of innovative anti-tumor drugs. Guided by our mission, “Inclusive and open to diversity, innovation oriented to win together and benefit the mankind”, Haihe pharmaceutical pursues for global development of Chinese original innovative drugs. There are 7 compounds in clinical and 3 compounds in preclinical studies.
About Amoy Diagnostics Co., Ltd.
Amoy Diagnostics Co., Ltd. (SZSE: 300685) is a leading biotech company which pioneered the development and commercialization of cancer diagnostics in China. It is the largest provider of molecular diagnostics products for personalized healthcare in China, as well as a service center for oncology biomarker analysis. AmoyDx has a market-leading portfolio of molecular tests and is the therapy diagnostics partner for several major multinational pharmaceutical companies offering precision therapies for cancer.