Ascentage Pharma Group International

In the first half of 2026, total revenue was $44.5 million versus $32.6 million in the first half of 2025, an increase of $11.9 million or 29.3% on a constant exchange-rate basis. Product sales were $41.6 million and were the main driver of revenue. R&D expense was $102.8 million versus $73.8 million a year ago; selling and distribution expense was $33.4 million versus $19.2 million; and administration expense was $17.5 million versus $13.9 million. Cash and cash equivalents were $279.4 million at June 30, 2026, and management reaffirmed cash runway through the end of 2027. Forward-looking, management said GLORA-4 and POLARIS-1/2 enrollment could complete by late 2026 or early 2027, with potential NDA filings in the second half of 2027. For POLARIS-2, management referenced a 24-week MMR endpoint for the trial and said the NDA filing would follow 6-month MMR data after last patient in; for POLARIS-1, the filing would follow a 3-month MRD-negative CR endpoint after last patient in. For GLORA-4, management said the NDA would use CRi as the primary endpoint and OS would continue to mature sometime next year.

Dr. Yang framed the company as transitioning into a “leading global, fully integrated hematology-oncology company,” with two approved products and a broad late-stage pipeline. He repeatedly emphasized differentiation: lisaftoclax’s daily dosing ramp, safety, and lower DDI risk; and olverembatinib’s long-term data, potency against T315I and compound mutations, and advantage in heavily pretreated CML. His tone was confident and assertive, with repeated references to being “on track” for major milestones and becoming a different company over the next year.

Dr. Misra said first-half results reflected continued commercial growth and investment behind global development programs, while maintaining a disciplined approach to expenses. He cited $44.5 million in revenue, $102.8 million of R&D spend, $33.4 million in selling and distribution, and $17.5 million in administration expense, and noted the company is funding 9 registrational programs while beginning U.S. commercial buildout. He also said OpEx is now near peak as enrollment reaches late stages, and reiterated that the cash position of $279.4 million supports the runway through end-2027.

Analysts focused on NRDL listing for lisaftoclax in China, enrollment timing and NDA path for GLORA and POLARIS, the Takeda option on olverembatinib, the commercial buildout in China, and whether APG-3288 could produce data at ASH. Management said lisaftoclax has passed initial review and is on the final product list for NRDL expert review, with a meeting possible later this month or in early September. For the major registrational studies, management said GLORA-4 and POLARIS-1/2 enrollment could finish late this year or early next year, supporting potential NDA filings in the second half of next year; they also said APG-3288 is still in dose escalation and likely would not have Phase I data ready for ASH this year.