QYUNS-B (02509): QX030N Receives HREC Approval for Phase I Clinical Trial in Australia and Milestone Payment

Stock News12-09

QYUNS-B (02509) announced that on December 8, 2025, the company received a $5 million milestone payment from its partner Caldera Therapeutics, Inc. (Caldera). This payment was triggered by the approval of QX030N/CLD-423* for Phase I clinical trials by the Human Research Ethics Committee (HREC) in Australia.

Recently, the company's self-developed bispecific antibody QX030N/CLD-423 received HREC approval in Australia, with clinical trials scheduled to commence in early 2026. The trial is a randomized, double-blind, placebo-controlled, dose-escalation Phase I study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple intravenous (IV) and subcutaneous (SC) doses of QX030N/CLD-423 in healthy adults.

This approval marks the official entry of the company's bispecific antibody portfolio into the clinical stage overseas, further strengthening its leading position in autoimmune and allergic diseases. Both QYUNS-B and Caldera will accelerate project development to achieve more clinical progress.

Under the licensing agreement signed on April 23, 2025, Caldera secured exclusive global development and commercialization rights for QX030N/CLD-423. As of December 8, 2025, QYUNS-B has received a total of $15 million in upfront and milestone payments, along with a certain equity stake in Caldera.

Upon achieving specific clinical, regulatory, and commercial milestones, the company may receive up to an additional $540 million, as well as tiered royalties based on net sales of QX030N/CLD-423.

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