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AmoyDx and BeiGene Announce Strategic Cooperation on HER2 Companion Diagnostics

Xiamen, China – October 11, 2022 – Amoy Diagnostics (300685.SZ) and BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) announced a strategic partnership in the field of companion diagnostics. Pursuant to the collaboration agreement, AmoyDx will leverage its self-developed HER2 gene IHC and FISH detection kit as companion diagnostics to support BeiGene’s ongoing project registration in China in ways that drive the development of precision diagnosis and treatment of cancer.

Companion diagnostics is of more significance considering the rising cost and difficulties to develop new medicine. It is proved that its introduction in the R&D session can help identify patients in a more efficient way and lift the success rate of clinical trials. AmoyDx, a pioneer in companion diagnostics product development and commercialization, has rich experiences in developing and registering companion diagnostics products for multiple technology platforms including PCR, NGS, FISH and IHC. Take IHC for example, AmoyDx has NMPA-approved AmoyDx® PD-L1 Expression Detection Kit and many of its IHC products have been accredited as Class I product. As for FISH, the HER-2 Gene Amplification Analysis Kit AmoyDx developed, is the sole product in China that can be used for both breast and gastric cancer detection. The partnership with BeiGene allows AmoyDx solutions for IHC and FISH to catalyze the new drug development and expand its scope of adaptive disease.

“AmoyDx has been focusing on molecular diagnostics for oncology precision medicine since its establishment in 2008,” said Li-Mou Zheng, Ph.D., Founder and Chairman of AmoyDx. “We are honored to form this strategic partnership with BeiGene. I believe that, together we will continuously promote the development of oncology precision medicines in China and boost its diagnosis and treatment to a higher level.”

“We are excited to collaborate with AmoyDx to promote the integration of precision diagnosis and treatment and drive the development of new medicine to benefit more patients with cancer,” said Wang Lai, Ph.D., Senior Vice President and Global Head of R&D, BeiGene. “As a global science-based biotechnology company, BeiGene is willing to work with partners sharing the similar vision to advance the development of “best in class” or “first in class” clinical drug candidates, with an aim to accelerate the development of diverse, innovative drug pipelines and expand patients’ excess to medicines, hence to improve their treatment outcomes.”


About BeiGene
BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 9,000 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland.


About AmoyDx
Amoy Diagnostics Co., Ltd. is a pioneer and globally leading company in the field of molecular diagnostics for precision oncology, focusing on companion diagnostics product development and commercialization. A rich product portfolio has been established with more than twenty products approved by China NMPA, EU authority, Japan MHLW, South Korea MFDS, etc. Patients in more than 60 countries are benefiting from AmoyDx products. With multiple technological platforms and full capability for companion diagnostics product development and commercialization, AmoyDx has become an important diagnostics partner of many pharmaceutical companies over the globe. For more information, please visit

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