[Edaily Reporter KIM SAE-MI ] It has been confirmed that a product developed based on Genomictree Inc.(228760)’s early-stage colorectal cancer diagnostic technology has received marketing authorization from China’s National Medical Products Administration (NMPA). This comes approximately five years after Genomictree Inc. transferred its early-stage colorectal cancer diagnostic technology to China in 2021.

On the 18th, E-Daily reviewed the Chinese NMPA medical device database and confirmed that Shandong Lukang Haoliyou Biotechnology Development Co., Ltd.’s “Human SDC2 Gene Methylation Detection Kit (Fluorescent PCR Method)” was officially registered on the 14th.

This product qualitatively detects the methylation status of the SDC2 gene in vitro using intestinal epithelial cell DNA isolated from human feces. It incorporates the core technology of “EarlyTec-C,” a colorectal cancer early-diagnosis product for which Genomictree Inc. transferred the technology to China, and has been approved as a Class III medical device under China’s medical device classification system. The approval is valid until September 13, 2031.

The registrant, Shandong Lukang Haoliyou, is a joint venture established by ORION Holdings(001800)and the Chinese state-owned pharmaceutical company Shandong Lukang Pharmaceutical. Genomictree Inc. signed a technology transfer agreement with this company in 2021 for the early diagnosis of colorectal cancer, totaling 6 billion won. Royalties from product sales are paid separately.

Genomictree Inc. received an upfront payment of 2 billion won at the time of the agreement. Subsequently, the local joint venture established production facilities and conducted clinical trials; after completing clinical trials in China and applying for approval from the NMPA, Genomictree Inc. received an additional milestone payment of 1 billion won last year.

According to previously disclosed contract terms, Genomictree Inc. is set to receive an additional 1 billion won milestone payment upon obtaining the final manufacturing license in China. The structure provides for up to 2 billion won in additional milestone payments, based on local sales performance, as well as separate sales royalties.

However, this NMPA approval is a product license for sales within China and is separate from the final manufacturing license, which is the contractual condition for the payment of additional milestones. This means that the conditions for the payment of the additional 1 billion won milestone are not met by this product license alone. It is expected that GenomicTree will receive this milestone once the final manufacturing license is obtained in the future. Plans for the local launch and sales in China have not yet been disclosed.

With this approval, Genomictree Inc.’s China business has cleared a major regulatory hurdle for local commercialization, moving beyond the technology transfer, clinical trials, and regulatory approval stages. In China, rather than Genomictree Inc. selling the product directly, a joint venture that received the technology transfer will handle production and sales. Once actual sales begin in China, Genomictree Inc. can expect not only milestone payments based on sales performance but also separate royalty revenue.

An ORION Holdings official stated, “This approval means the product has been officially registered for sale in China following a review of its performance and quality,” adding, “We are currently discussing future plans with our Chinese partner, Lukang Pharmaceutical.”

Meanwhile, Genomictree Inc. is currently marketing Earlytec-C, a product for the early diagnosis of colorectal cancer, in South Korea. Earlytec-C detects whether the SDC2 gene—which is associated with the development of colorectal cancer—is methylated in fecal DNA; it is characterized by greater convenience compared to colonoscopy.