Ascentage Pharma Presents Promising Clinical Data on Olverembatinib, Lisaftoclax, and Alrizomadlin at ASCO 2026 Annual Meeting 1

Ascentage Pharma Announces Promising Clinical Data at ASCO 2026 – Key Updates for Investors

Ascentage Pharma Group International (HKEX: 6855) has released significant clinical data from six of its ongoing trials, featured at the prestigious 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. This update covers their three lead drug candidates: olverembatinib (HQP1351), lisaftoclax (APG-2575), and alrizomadlin (APG-115). With three rapid oral presentations and three poster presentations, this news is highly relevant and potentially price-sensitive for shareholders.

Key Highlights for Investors

Six clinical abstracts selected by ASCO 2026, including three rapid oral presentations and three poster presentations.
Olverembatinib (HQP1351) continues to demonstrate strong efficacy and safety in multiple settings, including chronic myeloid leukemia (CML) and SDH-deficient tumors.
Lisaftoclax (APG-2575) progresses to a global phase 3 registration study for CLL/SLL, a potentially large patient population.
Alrizomadlin (APG-115) shows encouraging activity in pediatric solid tumors, an area with high unmet need.
Multiple global phase 3 registrational trials ongoing, including FDA and EMA-cleared studies.
Further expansion in international collaborations and patient recruitment, including the US, China, and 16 additional countries.

Detailed Clinical Results and Implications

1. Olverembatinib Combined with Blinatumomab in CML-LBP and Ph+ BCP-ALL

Phase Ib multicenter study in relapsed/refractory (R/R) patients shows four out of five patients with measurable residual disease achieved complete response (CR); two achieved MRD negativity.
The combination therapy shows a manageable safety profile, marking a potential breakthrough in combining targeted therapy and immunotherapy in these hard-to-treat populations.
This result could support expanded indications and potential label enhancements, boosting future revenue streams.

2. Updated Efficacy & Safety of Olverembatinib as Second-line Therapy for CP-CML

Chinese multicenter, single-arm study: Among 42 evaluable patients, the complete cytogenetic response (CCyR) rate at 24 cycles was 91.3%, major molecular response (MMR) rate 60.9%.
In a subgroup of 32 patients resistant to first-line second-generation TKIs, 81.3% achieved CCyR and 50% achieved MMR.
Favorable safety and tolerability profile supports market expansion as a second-line option, especially in patients without the T315I mutation.

3. Alrizomadlin (APG-115) Alone or with Lisaftoclax (APG-2575) in Pediatric RMS & Soft-Tissue Sarcomas

Multicenter Chinese trial in heavily pretreated pediatric patients with neuroblastoma, RMS, Ewing sarcoma, and other soft-tissue sarcomas.
No dose-limiting toxicities; manageable adverse event profile.
Monotherapy group: 1 refractory RMS patient achieved complete response.
Combination group: Objective response rate (ORR) of 30%, disease control rate (DCR) of 80%.
Represents a meaningful step forward in pediatric oncology, potentially opening new market opportunities and supporting orphan drug status in global markets.

4. Olverembatinib in SDH-deficient Tumors (Poster Presentation)

Study includes 26 SDH-deficient gastrointestinal stromal tumor (GIST) patients: 23.1% achieved partial response, median progression-free survival (PFS) 25.7 months.
Six SDH-deficient paraganglioma patients: 4 achieved clinical benefit (CBR 66.7%), median PFS 8.25 months.
Mechanistically, olverembatinib inhibits fatty acid-promoted tumor cell migration via the p38-CD36 pathway, indicating a differentiated mechanism of action and further supporting its use in rare tumors.

5. POLARIS-2: Global Phase III Trial of Olverembatinib for Chronic-phase CML

FDA and EMA-cleared, global phase III registrational study with two cohorts: Part A (olverembatinib vs bosutinib in patients with ≥2 prior TKI failures) and Part B (single-arm, T315I mutation patients).
Primary endpoint: MMR rate at or by 24 weeks.
Positive data from this study could significantly expand olverembatinib’s market and drive global sales.

6. GLORA: Global Phase III Study of Lisaftoclax in CLL/SLL

Global, multicenter phase 3 registration study evaluating lisaftoclax plus BTKi in CLL/SLL after 12 months of BTKi monotherapy without CR or PD.
Target enrollment: 440 patients across 126 centers in 18 countries.
Success in this trial would position lisaftoclax as a major player in the CLL/SLL market, with significant commercial potential.

Potential Share Price Sensitivities & Shareholder Considerations

Positive interim results and successful progression to global phase 3 trials indicate strong R&D execution and potential for regulatory approvals in major markets.
Expansion into pediatric oncology, rare tumors, and global markets (with FDA/EMA-cleared protocols) can unlock new revenue streams and enhance company valuation.
Strong efficacy and safety data, especially in refractory/relapsed populations, may improve competitive positioning, attract licensing/partnerships, and facilitate accelerated approvals.
Investors should note the cautionary statement: There is no guarantee of successful development or commercialization of alrizomadlin (APG-115), but the data is promising.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Clinical trial outcomes are subject to regulatory review and further validation. Investors should conduct their own due diligence and consult financial advisors before making investment decisions.

【廣東話版本】

亞盛醫藥於ASCO 2026發佈最新臨床數據——投資者須知重點

亞盛醫藥集團國際（HKEX: 6855）於2026年美國臨床腫瘤學會（ASCO）年會發佈六項臨床試驗最新數據，涵蓋其三款核心新藥：奧維替尼（Olverembatinib, HQP1351）、利司托克（Lisaftoclax, APG-2575）及阿瑞卓馬汀（Alrizomadlin, APG-115）。三項口頭快報及三項海報發佈對股東具重要參考性，具潛在股價敏感性。

投資者重點提要

六項臨床摘要獲ASCO 2026選中，三項快速口頭發表、三項海報發表。
奧維替尼於多種適應症（包括慢性髓性白血病CML及SDH缺陷腫瘤）持續展現良好療效及安全性。
利司托克進入CLL/SLL國際三期註冊臨床試驗，潛在病人基數龐大。
阿瑞卓馬汀於兒童實體腫瘤展現初步積極療效，填補市場空白。
多項全球三期註冊試驗正在進行，獲FDA及EMA批准。
國際合作及病人招募範圍擴大，覆蓋美國、中國及其他16國家。

詳細臨床數據及投資啟示

1. 奧維替尼聯合Blinatumomab於CML-LBP及Ph+ BCP-ALL

I期多中心研究，復發/難治病人中5例帶可測殘留病灶，4例達完全緩解（CR），2例達MRD陰性。
安全性可控，有望提升治療現有難治疾病的方案選擇，支持產品擴展適應症，增添未來營收來源。

2. 奧維替尼作為CP-CML二線治療更新療效與安全性

中國多中心單臂研究：42例患者24周期時CCyR達91.3%，MMR達60.9%。
32例一線二代TKI失敗患者中，81.3%達CCyR，50%達MMR。
安全性佳，有望成為二線治療新選擇，特別針對無T315I突變的患者。

3. 阿瑞卓馬汀單用或聯合利司托克治療兒童實體腫瘤

多中心中國研究，針對神經母細胞瘤、橫紋肌肉瘤、尤文氏肉瘤及其他實體腫瘤。
未見劑量限制毒性，安全性良好。
單藥組一例難治RMS患者達完全緩解，聯合組ORR達30%，DCR 80%。
有望進一步拓展兒童腫瘤市場，具潛在孤兒藥資格。

4. 奧維替尼於SDH缺陷腫瘤（海報發表）

26例SDH缺陷GIST患者中23.1%出現部分緩解，中位PFS 25.7個月。
6例SDH缺陷副神經節瘤患者中4例獲臨床獲益，中位PFS 8.25個月。
首次揭示奧維替尼可經p38-CD36通路抑制腫瘤遷移，具機制創新意義。

5. POLARIS-2：奧維替尼治療CML全球三期註冊試驗

獲FDA和EMA批准的全球三期註冊研究，分A/B兩部分，A部分比較奧維替尼與Bosutinib（二線或以上失敗患者），B為T315I單臂研究。
主要終點為24周內MMR率，若數據積極，將極大提升全球市場潛力。

6. GLORA：利司托克治療CLL/SLL全球三期註冊研究

全球多中心三期註冊研究，評估聯合BTKi於CLL/SLL患者，預計招募440名患者，遍及18國家126中心。
若研究成功，利司托克將晉身CLL/SLL市場主流治療方案，商業潛力巨大。

股價敏感因素及股東須知

正面中期數據及多項全球三期進展，顯示研發實力，有望推動主要市場的監管批准。
進軍兒童腫瘤、罕見腫瘤及全球市場，將開拓新收入來源，提升估值。
強勁療效及安全數據，有利競爭力提升、吸引合作及加快審批。
需留意風險提示：阿瑞卓馬汀（APG-115）能否最終成功商業化尚未確定，惟現有數據具吸引力。

免責聲明： 本文僅供參考，不構成投資建議。臨床試驗結果需經監管機構審查及進一步驗證，投資者須自作盡職調查並諮詢專業意見。