Xiamen, China, March 12, 2021 – Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685) and Haihe Biopharma announced that they signed an agreement to use the MET mutation detection kit of AmoyDx as Companion Diagnostic (CDx) assay supporting the registration of Haihe's MET kinase inhibitor Glumetinib (SCC244) in the United States of America.
Under the terms of the agreement, AmoyDx will develop and register the AmoyDx® MET Mutation Detection Kit in the United States, to get the Premarket Approval (PMA) for an intended use as a c-MET exon14 skipping CDx for Haihe's Glumetinib (SCC244), a novel MET kinase inhibitor targeting c-MET exon14 skipping alterations, in subjects with Non-Small Cell Lung Cancer.
Before product launch in US market, AmoyDx would submit PMA to the FDA, which is the most stringent type of device marketing application required by the FDA among the three regulatory classes for medical devices.
AmoyDx had already signed CDx development agreement for AmoyDx® Pan Lung Cancer PCR Panel (PLC Panel) with Haihe Biopharma for the Chinese and Japanese market. National Cancer Center of Japan has evaluated PLC Panel and this assay was recognized by key clinical institutions with excellent performance, simple procedure and short turnaround time which are critical for clinicians. Moreover, PLC Panel was also selected as the oncology CDx assay by Eli Lilly, Amgen, Merck, Cosunter and so on. This product has completed registration clinical trials in Japan in 2020 and received the acceptance notification from Pharmaceuticals and Medical Devices Agency (PMDA), which is currently under administrative examination and approval.
About Haihe Biopharma
Haihe Biopharma is a leading innovation-driven biotechnology company in China. Focusing on the discovery, development, production and commercialization of innovative anti-tumor drugs. Haihe brings life-saving therapies to cancer patients worldwide. As a new drug R&D company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed to the path of independent innovation. It also has a research and management team with a global perspective, and it is proactively mapping out the international development of innovative drugs. Currently, seven of the 9 core products in the Haihe's R&D pipeline have entered the clinical development stage, and four have obtained IND approval from the US FDA. With support from top venture capitalists in life science and technology, Haihe is accelerating the clinical development and commercialization of innovative products, and strives to provide patients with safer and more effective drugs at the earliest possible time.
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.
For more information, please call us at +86-592-6892985 or email us at firstname.lastname@example.org.