Ascentage Pharma Runs Nine Phase III Trials Amid 29% H1 Growth

Nine concurrent registrational Phase III trials, four of them FDA and EMA-cleared, are now the operational baseline for Ascentage Pharma, a scale that places immediate pressure on clinical supply chains, comparator sourcing, and site-level GMP compliance across multiple jurisdictions simultaneously.

The company reported unaudited H1 2026 revenue of US$44.5 million, a 29% year-over-year increase driven primarily by product sales of its two China-approved assets: Olverembatinib, a third-generation BCR-ABL1 TKI approved for CML with T315I mutations, and Lisaftoclax, an oral Bcl-2 inhibitor. Formulary penetration for Olverembatinib reached 394 hospitals as of June 30, 2026, a 34% increase over the same period in 2025, signalling that domestic commercial infrastructure is maturing even as global registrational programs accelerate.

For contract manufacturers and supply planners supporting oncology biotechs at this stage, the Ascentage portfolio presents a familiar but demanding profile: two approved small molecules generating commercial revenue in China while simultaneously serving as investigational products in multinational trials subject to 21 CFR Part 211 and equivalent EMA GMP expectations. Managing dual-track supply, commercial release batches alongside clinical trial material with distinct labelling, serialisation, and chain-of-custody requirements, is where execution risk concentrates.

The POLARIS program spans three Olverembatinib trials: POLARIS-1 targets newly diagnosed Philadelphia chromosome-positive ALL in combination with chemotherapy; POLARIS-2 addresses previously treated CML-CP patients with and without T315I mutation; POLARIS-3 evaluates SDH-deficient gastrointestinal stromal tumour. Each trial carries its own comparator arm, which introduces sourcing complexity that QA and supply teams must resolve well ahead of interim analysis timelines. Lisaftoclax adds a fourth FDA and EMA-cleared registrational trial to the active portfolio.

Ascentage also appointed Dr. Faiçal Miyara as Chief Business Officer and Mr. James Ziegler as Chief Commercial Officer during the period, reinforcing the commercial infrastructure needed to support ex-China launches if registrational readouts support regulatory submissions in the US and EU.

Enrollment progress across all nine trials will be the measurable checkpoint that determines whether Ascentage's manufacturing and supply commitments can sustain the pace its clinical timelines now demand.

Source: Ascentage Pharma via GlobeNewswire, August 19, 2026. Chinese-language investor webcast held 9:00 am HKT August 20, 2026; English-language webcast held 8:00 am EDT August 20, 2026.