Ascentage Pharma Group International Stock Price, News & Analysis

Ascentage Pharma (NASDAQ: AAPG) presented four-year follow-up data from a randomized registrational Phase II trial of olverembatinib in TKI-resistant/intolerant chronic-phase CML (CML-CP) at ASH 2025. The olverembatinib arm showed median event-free survival (EFS) 21.2 months versus 2.9 months for investigator’s choice BAT (P < 0.0001). In patients without T315I, EFS was 11.9 vs. 3.1 months (P = 0.0159). Response rates favored olverembatinib (CHR 85% vs 35%; CCyR 38% vs 19%; MMR 30% vs 8%). Safety was described as favorable with 7% vascular occlusion and grade ≥3 hematologic toxicities reported. Olverembatinib is approved in China and covered by NRDL; global rights are subject to a Takeda option.

Ascentage Pharma (NASDAQ: AAPG) presented updated ASH 2025 data showing Olverembatinib (HQP1351) produced high response rates as second-line therapy in chronic-phase chronic myeloid leukemia (CP-CML).

Key metrics: CCyR 71.8% and MMR 43.6% in 39 efficacy-evaluable patients; among 30 patients who failed first-line second-generation TKIs, CCyR 76.7% and MMR 43.3%. Responses deepened over time, with MMR 60.0% at cycle 21. Safety profile was consistent with prior reports; no new safety signals and no on-study deaths.

Ascentage Pharma (NASDAQ:AAPG) presented first dataset from the global registrational Phase III POLARIS-1 study of olverembatinib plus low-intensity chemotherapy in newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) at ASH 2025.

Key results (as of July 18, 2025): among 53 efficacy-evaluable patients, 50 (94.3%) achieved CR/CRi; best MRD negativity 66.0% and MRD-negative CR 64.2% by end of three induction cycles. IKZF1plus subgroup showed 90% molecular response (9/10). Common grade ≥3 TEAEs included neutropenia 63.6%, thrombocytopenia 56.4%, and pneumonia 30.9%. POLARIS-1 was cleared by FDA and EMA; an option agreement with Takeda is in place for ex-China rights.

Ascentage Pharma (NASDAQ: AAPG) reported Phase Ib/II data for lisaftoclax (APG-2575) plus azacitidine presented at ASH 2025 on Dec 6, 2025. In a 103-patient study the combination showed a 31.8% ORR in venetoclax–exposed relapsed/refractory AML/MPAL (7/22) and an 80.0% ORR in newly diagnosed high‑risk MDS/CMML (12/15). No dose‑limiting toxicities were observed across dose‑escalation and expansion. Median overall survival was reported as 7.6 months for R/R AML/MPAL and 11.3 months for R/R HR MDS/CMML; median OS was not reached in ND HR MDS/CMML. Common grade ≥3 TEAEs included neutropenia (41.7%) and febrile neutropenia (35.0%).

Ascentage Pharma (NASDAQ: AAPG) presented registrational Phase II China data for lisaftoclax (APG-2575) at ASH 2025 showing durable efficacy in BTKi‑refractory relapsed/refractory CLL/SLL.

Among 77 enrolled patients (high‑risk enrichment: 42.9% complex karyotype, 39% del(17p)/TP53), lisaftoclax achieved an IRC‑confirmed ORR 62.5% and median PFS of 23.89 months (median follow‑up 22.01 months). MRD negativity was 21.8% in peripheral blood and 54.5% in bone marrow (n=11). Safety showed manageable profile with frequent grade ≥3 hematologic toxicities; no tumor lysis syndrome or treatment‑related deaths were reported. The data supported China NMPA approval in July 2025.

Ascentage Pharma (NASDAQ: AAPG) announced that the US FDA and the EMA cleared a global registrational Phase III study (POLARIS-1; NCT06051409) of olverembatinib plus chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

The POLARIS-1 trial is a randomized, open-label, global study already initiated in China after CDE clearance in 2023 and is simultaneously enrolling across multiple countries to accelerate registration in the US and Europe. An ASH 2025 abstract reported ~65% MRD-negativity and molecular MRD-negative CR rates after three cycles and described a favorable safety profile. Olverembatinib is China-approved for drug-resistant CML, covered by the China NRDL, and is subject to an exclusive option agreement with Takeda (June 14, 2024). The drug is not yet FDA-approved in the US.

Ascentage Pharma (NASDAQ:AAPG) will host two investor webcasts to highlight key presentations from the 67th American Society of Hematology (ASH) Annual Meeting. The English webcast with Q&A will be held on December 11, 2025 at 8:30 AM EST / 9:30 PM HKT; a Mandarin webcast with Q&A will be held on December 11, 2025 at 9:00 PM EST / December 12, 2025 at 10:00 AM HKT. Chairman & CEO Dr. Dajun Yang and members of management will review the company’s portfolio and pipeline and discuss key ASH data. Registration is required to access each webcast; English replay will be posted on the company’s News & Events page.

Ascentage Pharma (NASDAQ:AAPG) published Phase Ib data for olverembatinib in Signal Transduction and Targeted Therapy reporting activity in SDH-deficient GIST. In 26 evaluable SDH-deficient patients the study showed an ORR 23.1%, CBR 84.6% (95% CI 65.1–95.6), and median PFS 25.7 months (95% CI 12.9–not reached) with median follow-up 14.5 months. Translational analyses identified lipid‑metabolism dysregulation and CD36 overexpression in SDH-deficient tumors and showed olverembatinib reduced CD36 and lipid uptake while inhibiting HIF, FGFR, and VEGFR pathways. Olverembatinib holds Breakthrough Therapy Designation from China CDE and a global Phase III trial (POLARIS-3, NCT06640361) is recruiting.

Ascentage Pharma (NASDAQ: AAPG) said its management will participate in three investor conferences in December 2025. Piper Sandler fireside chat is set for 9:00 AM ET on Dec 2, 2025. Evercore ISI HealthCONx fireside chat is set for 3:50 PM ET on Dec 3, 2025. The company will hold one-on-one meetings at the Citi 2025 Global Healthcare Conference on Dec 4, 2025. Investors can expect management commentary on company strategy and recent developments during these events.