Welcome to our dedicated page for Ascentage Pharma Group International news (Ticker: AAPG), a resource for investors and traders seeking the latest updates and insights on Ascentage Pharma Group International stock.
Ascentage Pharma Group International reports recurring developments in cancer-focused drug commercialization and clinical development. The company is a global, commercial-stage integrated biopharmaceutical issuer with American depositary shares on Nasdaq and ordinary shares listed on HKEX. Its updates center on Olverembatinib, a third-generation BCR-ABL inhibitor approved in China, and Lisaftoclax, a China-developed Bcl-2 selective inhibitor, as well as oncology candidates such as Alrizomadlin, APG-2449, APG-5918 and APG-3288.
News from AAPG also covers clinical and preclinical data presented at oncology meetings, regulatory clearances for investigational studies, full-year financial results, commercial activity in China, pipeline progress in hematologic malignancies and solid tumors, and investor-conference communications.
Ascentage Pharma (NASDAQ: AAPG) outlined its 2026 global innovation strategy at the 44th J.P. Morgan Healthcare Conference on Jan 15, 2026, highlighting a dual‑engine growth model led by commercial hematology drugs Olverembatinib and Lisaftoclax. The company received U.S. FDA IND clearance for APG-3288, a next‑generation BTK PROTAC degrader, and said multiple global registrational Phase III studies (GLORA, GLORA-4, POLARIS-1, POLARIS-2) are advancing. Other pipeline notes: APG-2449 entered global Phase III in NSCLC; APG-5918, APG-115, and APG-1252 progress in various indications. Commercial goals for 2026 include broader sales, coverage across 1,500 hospitals, and NRDL inclusion for Lisaftoclax in China.
Ascentage Pharma (NASDAQ:AAPG) announced that the U.S. FDA has granted IND clearance for APG-3288, a next-generation BTK-targeted protein degrader, enabling a global, multicenter, open-label Phase I study in patients with relapsed/refractory B-cell malignancies.
APG-3288 is a PROTAC-designed degrader intended to remove wild-type and multiple mutant BTK proteins, with preclinical data claiming higher potency, selectivity, and favorable PK versus other BTK degraders; clinical evaluation will assess safety, tolerability, PK, and preliminary efficacy.
Ascentage Pharma (NASDAQ: AAPG) said its management will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco.
The presentation is scheduled for Wednesday, January 14, 2026 at 2:15 p.m. PT. Ascentage Pharma is described as a global, commercial-stage, integrated biopharmaceutical company focused on discovery, development and commercialization of novel cancer therapies.
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) 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) 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.