AmoyDx Debuts on A-Share Market, Focusing on Proprietary Platforms for Molecular Diagnostics in Targeted Cancer Therapy

On August 2, AmoyDx officially listed on the ChiNext board of the Shenzhen Stock Exchange, with an initial public offering of 20 million shares at an issue price of RMB 13.86 per share, becoming a landmark publicly traded company in the field of companion diagnostics for precision oncology.

AmoyDx is China's first specialized R&D and manufacturing enterprise for molecular diagnostic reagents in precision oncology, founded by Professor Zheng Limou in 2008.

The company focuses on the field of companion diagnostics for precision oncology, possessing fully independent intellectual property rights for its patented ADx-ARMS and Super-ARMS technologies. Its developed gene detection kits for EGFR, RAS, ALK, PIK3CA, ROS1, and other genes were among the first to receive certification from the China Food and Drug Administration (CFDA) and the European CE mark, offering a more comprehensive product portfolio than domestic and international competitors.

Meanwhile, AmoyDx integrates the research and development, manufacturing, sales, and services of diagnostic products for precision oncology. It operates the Xiamen Amoy Diagnostics Laboratory, which specializes in third-party molecular testing services.

In the external quality assessment (EQA) programs conducted by the globally renowned European Molecular Genetics Quality Network (EMQN) and the Pathology Quality Control Center (PQCC) of China’s National Health and Family Planning Commission, AmoyDx’s products have consistently demonstrated excellent accuracy and high utilization rates for many consecutive years. Currently, hundreds of large and medium-sized hospitals in more than 50 countries and regions worldwide have chosen AmoyDx’s products, benefiting hundreds of thousands of cancer patients annually. The technology and product quality of AmoyDx are widely recognized by customers both domestically and internationally.

Amoy Diagnostics has established strategic collaborations with multiple multinational corporations, including AstraZeneca, Boehringer Ingelheim, Pfizer, Merck, and Illumina, in the fields of tissue- and blood-based testing for genes such as EGFR, ALK, ROS1, and RAS, as well as in the development of new products.

AmoyDx also provides companion diagnostic support for large-scale international clinical trials of targeted oncology drugs to pharmaceutical R&D and manufacturing companies both in China and abroad. Notably, its ROS1 detection product has been approved by Japan’s PMDA, becoming the first globally approved companion diagnostic kit for crizotinib.

According to Zhu Guanshan, Vice President of AmoyDx, the company is currently developing two major product lines of companion diagnostic reagents: one based on PCR technology and the other on next-generation sequencing (NGS) technology.

In the field of PCR, the company’s proprietary ADx-ARMS platform has increased the sensitivity of existing detection technologies by more than 10-fold. The Super-ARMS technology platform has further enhanced sensitivity by an order of magnitude, and products developed based on this platform have entered the National Innovative Medical Device Expedited Review Pathway.

In the field of next-generation sequencing (NGS), AmoyDx established a strategic partnership with Illumina in 2015. Patent applications for new technologies and product development have been proceeding in an orderly manner, with certain products having entered the National Innovative Medical Device Priority Review Pathway.

However, Dr. Zhu Guanshan believes that, considering factors such as technological maturity, complexity, stability, testing costs, and regulatory requirements, it may take another 3–5 years for next-generation sequencing (NGS) to be widely adopted in companion diagnostics. As a leader in this field, AmoyDx needs to make strategic preparations in advance.

According to AmoyDx’s prospectus, the funds raised in this offering will be primarily allocated to four areas: the industrialization of molecular diagnostic reagents and next-generation sequencing instruments, the construction of a research and development center, the expansion of the sales network, and the supplementation of working capital.

It is understood that upon completion of the industrialization project for molecular diagnostic reagents and next-generation sequencing (NGS) instruments, the company will expand its product portfolio from the current PCR technology platform to include multiple technology platforms such as PCR, FISH, and cytology. Additionally, it will establish a production platform based on next-generation sequencing technology and launch combined gene detection reagent products. The construction period of the project is 12 months. The capacity utilization rate is planned to be 30% in the first year of production, 60% in the second year, and reach full capacity in the third year. After reaching full capacity, the annual sales revenue is expected to reach RMB 335 million, with a net profit of RMB 72 million.

AmoyDx currently holds a dominant market share in China and is rapidly expanding its presence in the international market. According to its prospectus, AmoyDx’s products are now being sold in more than 200 hospitals.

Meanwhile, the company has established partnerships with internationally renowned pharmaceutical companies such as AstraZeneca, Pfizer, and Merck in the field of molecular diagnostics for oncology. Notably, its ROS1 detection product has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and been included in Japan’s national health insurance reimbursement scheme, becoming the first globally approved companion diagnostic test for crizotinib.

“AmoyDx will continue to focus on the field of precision oncology. At this stage, AmoyDx primarily serves patients with advanced-stage cancer; in the future, the company plans to expand its business around comprehensive disease management across the entire cancer care continuum, developing new technologies and products to benefit more cancer patients,” stated Zhu Guanshan.

According to Aier Medical's prospectus, Qianzhan Investment is the company's largest shareholder, while Zheng Limou, the Chairman of the Board, is the controlling shareholder and actual controller. He holds a 31.45% stake in Qianzhan Investment. Other shareholders of the company include Xiamen Yixiang, Xiamen Ruidingsheng, Xiamen Keying, Qiming Chuangzhi, QM18, and Orbimed.

Qiming Venture Partners was one of the key institutional investors in Amoy Diagnostics prior to its IPO. According to the prospectus, Qiming Venture Partners invested a total of RMB 66.66 million in Amoy Diagnostics in December 2014 through Suzhou Qiming Chuangzhi and QM18, holding a combined stake of 9.02% before the listing.

Hu Xubo, Managing Partner at Qiming Venture Partners, stated, “Globally, precision diagnosis and treatment of tumors are in an exciting phase of development, with companion diagnostics being a critical component. We hope to leverage continuous technological advancements to deepen our understanding of tumor diagnosis and treatment and achieve better therapeutic solutions. Amoy Diagnostics has already played a significant role in this field. We are confident that, by maintaining its focus on healthcare and technology, Amoy Diagnostics will continue to launch more high-quality products, thereby benefiting a larger number of patients.”

It is reported that, following its listing, Airui Biology will focus on building a platform of proprietary intellectual property technologies over the next three years. The company will prioritize the development of molecular diagnostic reagents for precision oncology, leverage its advantageous resources, and utilize major diagnostic technology platforms covering precision oncology to optimize and upgrade existing products and scale up production capacity. Meanwhile, it will also strengthen the construction of its R&D system as well as its marketing and sales networks.