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 (NASDAQ: AAPG; HKEX: 6855) generates frequent news flow as a global, commercial‑stage biopharmaceutical company focused on oncology. News coverage for AAPG centers on clinical trial data, regulatory milestones, commercialization updates in China, and strategic collaborations related to its portfolio of apoptotic pathway inhibitors and next‑generation kinase inhibitors.
Investors following AAPG news can expect regular updates on olverembatinib, the first novel third‑generation BCR‑ABL1 inhibitor approved in China for multiple drug‑resistant CML indications and covered by the China National Reimbursement Drug List. Recent announcements have highlighted four‑year follow‑up data in TKI‑resistant/intolerant CML‑CP, updated results in second‑line CML‑CP, and the first dataset from the global registrational Phase III POLARIS‑1 study in newly diagnosed Ph+ ALL, as well as regulatory clearances from the U.S. FDA and EMA for global Phase III trials.
News items also focus on Lisaftoclax, Ascentage Pharma’s Bcl‑2 selective inhibitor. Disclosures include pivotal China registrational Phase II data in BTK‑refractory relapsed/refractory CLL/SLL supporting NMPA approval, Phase Ib/II results in myeloid malignancies including venetoclax‑exposed patients, and global Phase III plans in CLL/SLL, AML, and HR MDS. Additional coverage addresses early‑stage programs such as the BTK degrader APG‑3288, which has received IND clearance from the U.S. FDA for a global Phase I study.
Beyond clinical data, AAPG news includes participation in major scientific and investor conferences, such as the American Society of Hematology (ASH) Annual Meeting and the J.P. Morgan Healthcare Conference, as well as investor webcasts and interim business updates furnished via Form 6‑K filings. This news page helps readers track how Ascentage Pharma advances its oncology pipeline, secures regulatory clearances, and expands commercialization of its hematology products.
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.
Ascentage Pharma (NASDAQ: AAPG) announced that new clinical data for its orally available Bcl-2 inhibitor lisaftoclax (APG-2575) were selected for presentations at the 67th ASH Annual Meeting (Dec 6-9, 2025) including an oral report of a registrational Phase II in relapsed/refractory CLL/SLL and a poster of lisaftoclax plus azacitidine in myeloid malignancies.
Key disclosed results: in 72 evaluable R/R CLL/SLL patients ORR was 62.5%, median PFS 23.89 months, and peripheral blood MRD-negativity 21.8%. The drug is commercialized in China after NMPA approval for CLL/SLL.
Ascentage Pharma (NASDAQ: AAPG) will present multiple clinical and preclinical datasets at the 67th ASH Annual Meeting (Dec 6-9, 2025, Orlando and online). Key releases include the first dataset from POLARIS-1 (global Phase III; poster #1574) evaluating olverembatinib plus low-intensity chemotherapy in newly diagnosed Ph+ ALL and a reported MRD‑negative CR rate of 64.2% at end of induction (53 efficacy-evaluable patients).
Additional highlights: updated 4-year follow-up from a registrational randomized Phase II CML-CP study showing median EFS 21.22 vs 2.86 months (olverembatinib vs BAT; P < 0.001), second-line CP-CML updates, and multiple lisaftoclax and APG-5918 presentations.