Caliway Biopharmaceuticals stock gains China trial clearance milestone
Published on 11/10/2026 at 17:01 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWSChina trial adds development milestone
- China's Center for Drug Evaluation authorized Caliway's CBL-0102 study for CBL-514 to proceed.
- Enrollment is expected to begin in December 2026, with clinical data anticipated in the second quarter of 2027.
- The randomized study will assess pharmacokinetics, safety and tolerability in approximately 30 healthy subjects.
Caliway Biopharmaceuticals said on November 6 that China's Center for Drug Evaluation authorized its CBL-0102 clinical study for CBL-514 to proceed. AD HOC NEWS reported that the authorization came ahead of schedule.
China study moves toward enrollment
Enrollment in the study is expected to begin in December 2026. Caliway expects clinical data in the second quarter of 2027, shortly after the planned completion of the study.
CBL-0102 is designed as a randomized, open-label, single-dose, parallel-group study involving approximately 30 healthy subjects at two sites in China. The trial will assess ethnicity sensitivity, pharmacokinetics, safety and tolerability across different dose levels.
Regional path remains in development
The study could support later clinical development and regulatory submissions in China and other Asian markets. It forms part of Caliway's broader program for CBL-514, an investigational injectable candidate intended for localized subcutaneous fat reduction.
The company said more than 544 subjects have participated in related clinical trials and that ten completed trials with finalized statistical reports met their primary and key secondary efficacy endpoints. These company-reported results do not establish regulatory approval or commercial availability.
Caliway Biopharmaceuticals
- Company: Caliway Biopharmaceuticals Co., Ltd.
- ISIN: TW0006919004
- Ticker: 6919 on TWSE
- Clinical milestone: CBL-0102 authorized to proceed in China on November 6, 2026
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