Ascentage Pharma Advances Olverembatinib With New Liver Function Study, Offering Gradual Upside for Investors

Ascentage Pharma Group International (HK:6855) announced an update on their ongoing clinical study.

Study Overview

The trial, officially titled “An Open-Label, Phase 1 Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of Olverembatinib,” aims to understand how liver problems affect the way the cancer drug olverembatinib moves through the body. The goal is to see whether dosing needs to change in patients with mild, moderate, or severe liver impairment, which is key for safer and broader use of the drug and supports Ascentage Pharma’s long-term commercial strategy.

Intervention/Treatment

The study tests a single oral dose of olverembatinib 20 mg, taken after a meal. Olverembatinib is a targeted cancer pill that Ascentage Pharma is developing to treat certain blood cancers. This study does not compare different drugs; it compares how the same dose behaves in people with different levels of liver function.

Study Design

This is an interventional Phase 1 study with a non-randomized, open-label, parallel-group design. All participants know they are receiving olverembatinib, and there is no placebo. Participants are divided into six groups: mild, moderate, and severe liver impairment, each matched with a group of people with normal liver function. The main purpose is treatment-focused: to guide safe dosing in real-world cancer patients with liver issues.

Study Timeline

The study is listed as recruiting, meaning enrollment is active and data are still being collected. The protocol was first submitted on 19 November 2025, marking the formal start of the regulatory process. The most recent update was filed on 21 December 2025, signaling that the sponsor is actively maintaining the record and that the study plan or status has been recently reviewed. Primary and final completion dates have not yet been posted, reflecting the early stage of the trial.

Market Implications

For investors, this update reinforces Ascentage Pharma’s push to de-risk olverembatinib for broader use, including in patients with liver impairment who are common in late-stage cancer. Positive pharmacokinetic results could support label expansions, wider patient eligibility, and stronger pricing power over time, which would be supportive for HK:6855 valuation. In a crowded tyrosine kinase inhibitor space that includes major players like Novartis and other global oncology firms, strong safety and dosing data in special populations can be a differentiator and help Ascentage win share in niche but high-value segments. In the near term, the news is incremental rather than transformational, but continued clinical progress may improve sentiment among long-term holders and specialized biotech investors who are tracking the depth and quality of the company’s clinical package.

The study is ongoing and recently updated, with further details available on the ClinicalTrials portal.

To learn more about HK:6855’s potential, visit the Ascentage Pharma Group International drug pipeline page.