BioDyne Enters Revenue Phase in Roche Deal[K-Bio Pulse]

[Kim Jiwan, Edaily Reporter] The Korean biotech market on the 11th was driven by a trio of positive catalysts across technology licensing, regulatory momentum, and clinical progress. Companies benefiting from these themes led the day’s trading.

Roche’s Ventana SP400 Cervical Cancer Diagnostic Device Built on BioDyne’s Blowing Technology

BioDyne advanced on expectations surrounding the commercialization of its Roche partnered diagnostic platform while the government’s new healthcare AI data policy boosted Geninus. Meanwhile Aptabio surged as its kidney disease program continued to show steady clinical progress.

BioDyne Rises on Revenue Momentum

BioDyne shares climbed after news that its exclusive global agreement with Roche has entered a revenue-generating phase. The stock closed at 16,310 won, up 8.73 percent. A PharmiDaily report highlighting BioDyne’s shift toward profitability also supported sentiment.

The company received a final milestone payment of 250,000 dollars, marking the commercial start of Roche’s Ventana SP400 diagnostic device. Total milestone payments under the deal are 6.75 million dollars. SP400 is currently sold only in Japan, with rollout to more than 40 countries planned for next year. Royalties from Japan should begin in the first quarter.

A company official said the launch marks a real inflection point for the 2019 Roche partnership. After years of losses linked to pandemic delays BioDyne’s earnings outlook is improving. Demand for cervical cancer screening is rising globally and sales of PathExplorer and related reagents are expected to grow 20 to 30 percent this year.

The company is also preparing the launch of EarlyPop Brush a self collection cervical sampling device with no major competitors. A 520 patient Korean study is complete and CE related publication is underway.

Senior executives recently bought shares calling the stock undervalued. Analysts expect annual revenue from SP400 royalties and consumables to surpass 40 billion won from 2028.

Geninus Up on Gov’t AI Data Support

Geninus rose on the government’s announcement of expanded support for medical AI. The stock closed at 2,810 won, up 13.54 percent.

The Ministry of Health and Welfare stated that it plans to strengthen public healthcare data infrastructure and broaden access for AI startups and SMEs.

A Geninus spokesperson said expanded data access would support the company’s genomic and spatial transcriptomics AI services.

CEO Park Woong-yang noted that collaborations with major pharmaceutical companies in Japan and other regions are accelerating, with several contracts already in progress.

Aptabio Up on Smooth Trial Progress

Aptabio also gained sharply as its diabetic kidney disease candidate APX-115 continued its successful clinical trajectory. The stock closed at 10,420 won, up 12.28 percent.

The company said approximately 30 percent of the target 186 patients in the global phase 2b trial have already been dosed. Interim results are planned for late next year with final dosing targeted by year-end.

In a previous European phase 2a study involving 140 patients, APX-115 showed clear benefit in moderate to severe patients, reducing urine albumin creatinine ratio by about 50 percent versus placebo.

The American Society of Nephrology (ASN) 2025, held in Houston, USA from November 5–9 (Photo: Aptabio)

The product had been featured as a key clinical highlight at the American Society of Nephrology’s Kidney Week in 2022. APX-115 works by regulating excessive reactive oxygen species in the kidney through inhibition of NADPH oxidase.

CEO Lee Soo-jin said enrollment and dosing are progressing smoothly and added that the company aims to validate efficacy in the ongoing study while advancing global licensing and commercialization plans.

김지완 (2pac@edaily.co.kr)