Quanxin Bio-B (02509): QX030N obtained approval from the Human Research Ethics Committee for phase I clinical trial in Australia and received milestone payment

According to the Zhitong Finance App, Quanxin Bio-B (02509) announced that on December 8, 2025, the company received a milestone payment of 5 million US dollars from partner Caldera Therapeutics, Inc. (Caldera). The payment was triggered by QX030N/CLD-423* obtaining an ethics license from the Human Research Ethics Committee (HREC) Phase I clinical trial ethics committee (HREC).

Recently, the dual antibody QX030N/CLD-423 independently developed by the company passed HREC approval in Australia, and clinical trials are scheduled to begin in early 2026. The trial is a randomized, double-blind, placebo-controlled, dose-escalating phase I clinical trial whose main purpose was to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) characteristics of QX030N/CLD-423 for single and multiple intravenous (IV) /subcutaneous (SC) administration in healthy adults.

This license marks the official entry of the company's dual-antibody matrix layout into the clinical phase overseas, and will further strengthen the company's leading position in the field of self-prevention and allergic diseases. The company and Caldera will also speed up project development and achieve more clinical progress as soon as possible.

According to reports, the company and Caldera signed an external licensing agreement on April 23, 2025, and Caldera obtained exclusive global development and commercialization rights for QX030N/CLD-423. As of December 8, 2025, the company has received prepayments and milestone payments totaling US$15 million, as well as a percentage of Caldera's shares. In the future, on the premise of reaching specific clinical development, regulatory and commercial milestones, the company can also receive additional payments of up to $540 million and collect tiered royalties based on net sales of QX030N/CLD-423.