AAPG Q2 2025: Olverembatinib China Sales Surge 93% as Dual-Engine Strategy Accelerates Hematology Expansion
AAPG’s China hematology franchise delivered a standout quarter, with Olverembatinib sales up sharply after expanded NRDL coverage and hospital access. Lisovatoclax’s approval adds a differentiated second commercial pillar, while global registration trials position the pipeline for multi-region impact. Management’s strong cash runway and focus on operational leverage signal sustained investment in both China and international markets.
Summary
- China Hematology Engine Accelerates: Olverembatinib’s rapid hospital penetration and NRDL-driven access fuel robust adoption.
- Pipeline-to-Commercial Transition: Lisovatoclax approval and global trials broaden addressable markets beyond China.
- Balance Sheet Strength: Recent capital raises provide cash runway through 2027, supporting global expansion and multi-indication trials.
Performance Analysis
Olverembatinib, third-generation BCR-ABL inhibitor, posted a 93% year-over-year sales jump in China, reaching $30.3 million for the first half of 2025. This growth was primarily driven by expanded NRDL (National Reimbursement Drug List, government insurance coverage) inclusion for all approved indications, which substantially improved affordability and broadened patient access. Hospital formulary penetration increased by 47% year-over-year, with management targeting coverage of over 500 major hospitals to capture 80% of the market potential.
Lisovatoclax, BCL2 inhibitor, was approved in July for CLL (chronic lymphocytic leukemia), launching as the first BCL2 inhibitor for CLL in China and only the second globally. The team executed first commercial sales within 15 days of approval and doubled the commercial team to drive rapid uptake. Gross margin remained robust at 90%, with sales and distribution expenses up 54% as the company invests in commercial infrastructure for both products. R&D expenses increased 19% as multiple global registration trials advanced, including FDA- and EMA-cleared studies in high-risk MDS (myelodysplastic syndromes) and other hematologic malignancies.
- China Commercial Leverage: Olverembatinib’s sales growth far outpaced commercial expense increases, demonstrating operational efficiency as scale builds.
- Pipeline Advancement: Four additional novel compounds are in development, with multi-region phase III trials underway for both Olverembatinib and Lisovatoclax.
- Capital Raises Drive Flexibility: Successful NASDAQ IPO and Hong Kong follow-on boosted pro forma cash to $424 million, supporting global ambitions and trial execution through 2027.
The company’s shift from single-product to dual-engine commercialization, coupled with robust clinical progress and financial strength, marks a strategic inflection toward global relevance in hematological oncology.
Executive Commentary
"Sales of oral martinib in China grow significantly at 93% year over year, driven by the NRDL coverage expansion, which is substantially improving affordability of the drug. And we have also made a lot of progress in improving patient access, with a 47% increase in the number of hospitals where Orenbutynib is on formulary."
Dr. Da Jun Yang, Chairman and CEO
"Product sales growth outpaced the increase in sales and distribution expenses, which grew 54% year-over-year as we expanded our commercialization team and prepared for the SAP Declasse launch. Ascentage is in a strong cash position as our current cash balance provides us with runway through 2027 without taking into account potential exercise of the Takeda option."
Dr. Veet Mishra, Chief Financial Officer
Strategic Positioning
1. Dual-Engine Commercial Model in China
Management is executing a dual-engine strategy, leveraging the established Olverembatinib infrastructure while rapidly scaling up for Lisovatoclax. This approach enables both operational efficiency and market reach, with the commercial team more than doubling in size to support two distinct, high-value hematology products.
2. NRDL and Hospital Access as Growth Catalysts
The expansion of NRDL coverage for Olverembatinib unlocked broad reimbursement, directly translating to affordability and patient uptake. Hospital access, now approaching 800 sites, is on track to saturate key centers, with management targeting 80% market penetration once 500 major hospitals are onboarded.
3. Global Clinical Ambitions and Pipeline Depth
With FDA and EMA clearances for pivotal trials, AAPG is positioning Lisovatoclax and Olverembatinib for approval in the US, Europe, and China using harmonized protocols. The pipeline includes four additional novel compounds, with multi-center trials in lung cancer and solid tumors, further diversifying long-term growth drivers.
4. Financial Firepower for Sustained R&D
The company’s pro forma cash of $424 million, following back-to-back capital raises, gives it operational runway through 2027. Management emphasizes disciplined R&D investment, balancing global trial expansion with cash preservation to support both near-term launches and longer-term pipeline bets.
5. Clinical Differentiation and Unmet Need Focus
Lisovatoclax’s daily dose ramp-up and favorable safety profile differentiate it from competitors, especially in indications where other BCL2 inhibitors have failed or are not approved (e.g., MDS, multiple myeloma). Management is targeting large, underserved patient populations with high unmet need, aiming for first- or best-in-class positioning.
Key Considerations
AAPG’s Q2 2025 results reflect a pivotal moment as the company transitions from a single-product China story to a multi-asset, global hematology contender. The interplay between commercial execution, trial momentum, and capital discipline will define its ability to scale and compete internationally.
Key Considerations:
- China Market Expansion: The pace of hospital onboarding and physician education will determine the depth of Olverembatinib’s penetration.
- Lisovatoclax Uptake Trajectory: Early commercial execution and differentiation in CLL and MDS offer a test case for broader market adoption.
- Regulatory Synchronization: Harmonized protocols across US, EU, and China for pivotal trials could accelerate multi-region approvals and commercial launches.
- Pipeline Productivity: The breadth of registrational trials and novel assets increases upside optionality, but also execution risk, especially outside China.
- Capital Allocation Discipline: Maintaining gross margin and controlling expense growth will be crucial as the company invests in global expansion and commercial scale-up.
Risks
Execution risk remains elevated as AAPG scales its commercial footprint and navigates global regulatory pathways. Competitive threats from entrenched therapies, especially in the US and Europe, could limit uptake if differentiation is not clearly established. Clinical trial setbacks or slower-than-expected hospital onboarding in China would pressure both revenue and investor confidence. Management’s ability to balance R&D spend with commercial returns is a watchpoint as cash burn accelerates with global ambitions.
Forward Outlook
For Q3 2025, AAPG guided to:
- Continued double-digit sequential growth in Olverembatinib sales as NRDL coverage and hospital access mature.
- Accelerated Lisovatoclax launch ramp, with expanded sales force driving early adoption in CLL.
For full-year 2025, management did not provide explicit revenue guidance but signaled:
- Ongoing commercial momentum for both products in China.
- Milestone progress from global registration trials, with potential for interim data in 2026.
Management highlighted several factors that will shape the outlook:
- Hospital access expansion and NRDL-driven affordability as key levers for China sales growth.
- Regulatory clarity and harmonized protocols as accelerators for multi-region approvals.
Takeaways
AAPG’s Q2 marks a strategic step-change, moving from single-product China execution to a global, multi-asset hematology growth story.
- China Commercialization Outperformance: Olverembatinib’s sales trajectory and hospital access expansion reinforce the strength of the NRDL-driven model and operational leverage.
- Pipeline Transition and Differentiation: Lisovatoclax’s launch and global trials provide a second commercial pillar and open new high-value indications, with a focus on unmet need and clinical differentiation.
- Global Scaling Watchpoints: Investors should monitor the pace of global trial enrollment, regulatory progress, and the ability to replicate China’s commercial success in new markets.
Conclusion
AAPG’s Q2 2025 results showcase the company’s evolution into a dual-engine hematology leader in China, with a clear pathway to global relevance. Execution on both commercial and clinical fronts, supported by a fortified balance sheet, positions the company for continued momentum and potential multi-region impact.
Industry Read-Through
AAPG’s rapid NRDL-driven growth and hospital access model highlight the critical role of reimbursement and formulary inclusion in China’s specialty pharma market. The company’s harmonized global trial approach sets a precedent for cross-region oncology development, especially in indications with high unmet need and limited competition. For sector peers, the focus on differentiated clinical profiles and operational leverage in China offers a blueprint for scaling novel therapies in emerging and mature markets alike. Expect increased competition and investment in hematology as companies seek to replicate AAPG’s dual-engine strategy and capitalize on large, underserved patient populations.