XtalPi × Yaosu Technology: Advancing FDA ISTAND and Launching Korean DILI Model

I. Key Events
• Yaosu Technology is set to participate in Bio Korea 2026 (2026 Korea International Bio Industry Conference);
• At the conference, Yaosu Technology will deliver a keynote speech;
• Simultaneously, Yaosu Technology and its long-term Korean partner Woojung Bio will officially launch the Korean version of the DILI model (a localized drug-induced liver injury organ-on-a-chip model for Korea).

II. Core Highlights
• This is another significant market entry move for Yaosu's EPIC™ organ-on-a-chip platform in the Korean market, focusing on DILI (drug-induced liver toxicity), a frequent pain point in new drug development;
• Through the localized model, Yaosu can provide Korean pharmaceutical companies with liver toxicity prediction services that better align with local regulations and practical needs;
• The event combines a keynote speech with a model launch, representing a format that integrates technical demonstration with commercial promotion.

III. FDA ISTAND
• The speech title clearly states: "Validation and Regulatory Qualification of an MPS-based DILI Model through FDA ISTAND," which is fully consistent with the FDA's formal acceptance of Yaosu's ISTAND Letter of Intent (entering the review pathway) in January 2026;
• This indicates that Yaosu has not remained at the "entered the pathway in January" stage but is proactively showcasing progress at international conferences, promoting and endorsing the subsequent formal submission of supplementary materials and the pursuit of qualification, representing a typical public action of "data validation + ISTAND qualification advancement."

Thoughts: Following the previous private DILI Demo Day held in Korea, the strategy has now been upgraded directly to delivering a speech and officially launching a localized model at a major industry conference like Bio Korea, accelerating the pace. Leveraging the strength of Woojung Bio, Yaosu is rapidly pushing the EPIC™ platform into the Korean market, aiming to attract more Korean pharmaceutical companies to pay for services through the localized DILI model, thereby further expanding overseas revenue.

$XTALPI(02228.HK)