Amoy, Beigene Partner to Improve HER2 companion diagnostics

Amoy (300685.SZ) and Beigene (NASDAQ: BGNE, HKEX: 06160, SSE: 688235) have recently entered into a strategic collaboration on companion diagnostics. According to the agreement, the HER2 gene IHC and FISH test kits developed by Amoy will be used as companion diagnostics to support the registration and submission of Beigene's research projects in China, which will help the development of precision cancer diagnosis and treatment.

With the increasing difficulty and cost of new drug development, the value of companion diagnostics has become more and more prominent, which can screen out drug-sensitive patients to improve the success rate of clinical trials and accelerate the process of new drug launch. In recent years, Chinese regulations announced that it emphasizes the important clinical value of oncology drug concomitant diagnostics, from clinical trials of new drugs to post-marketing clinical applications, the support of concomitant diagnostic reagents is indispensable. Amoy is a leading company in the development and commercialisation of oncology companion diagnostic products, with successful development and registration of companion diagnostic products on multiple technology platforms such as PCR, NGS, FISH and IHC. On the IHC platform, Amoy has the first domestic PD-L1 concomitant diagnostic certificate, and several IHC products have been registered as Class I products. On the FISH platform, the HER2 amplification kit (fluorescence in situ hybridization) is the only product in China that can be used for both breast cancer and gastric cancer detection.

This strategic collaboration will enable the development of new drugs through the development of companion diagnostic solutions on both the IHC and FISH platforms, and further expand the scope of companion diagnostic indications for Aide Bio.