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AmoyDx Collaborates with Merck KGaA, Darmstadt, Germany to Develop Companion Diagnostics for China Market

Xiamen, China, December 23, 2020 (12:30 pm) – Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685) announced that it signed an agreement with Merck KGaA, Darmstadt, Germany, to develop a Companion Diagnostic (CDx) test supporting the novel MET inhibitor tepotinib for China market. The CDx test is based on AmoyDx's industry-leading PCR platform.

Under the terms of the agreement, AmoyDx will develop and register AmoyDx® Lung Cancer PCR Panel (11-in-1 Panel) in China, to get the NMPA approval for an intended use as a MET exon14 skipping companion diagnostic for tepotinib, a novel highly selective small molecule targeted medicine designed to specifically inhibit MET, in subjects with Non-Small Cell Lung Cancer and MET alterations.
"We announce with great excitement this co-development collaboration with Merck KGaA, Darmstadt, Germany", 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 China. 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 Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of € 16.2 billion in 66 countries.
The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.
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.

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