Group 1 - The core viewpoint of the article highlights the significant growth in revenue and net profit for Ascentage Pharma (AAPG), with a revenue increase of 341.77% year-on-year and a net profit increase of 56.2% [1][2] - Ascentage Pharma is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases, with a strong emphasis on apoptosis pathway drug development [2] - The company has established a pipeline of nine clinical-stage first-class small molecule drugs, including inhibitors targeting key proteins in the apoptosis pathway, and is conducting over 40 clinical trials globally [2] Group 2 - Ascentage Pharma's core product, Olverembatinib (brand name: Nilotinib), has received priority review and breakthrough therapy designation from the Chinese National Medical Products Administration and has been included in the National Basic Medical Insurance Drug List [2] - The company has achieved multiple designations from the FDA, including orphan drug status and fast track designation for four investigational new drugs, demonstrating its strong regulatory engagement [2] - Ascentage Pharma has formed global collaborations with leading biotech and pharmaceutical companies and academic institutions, enhancing its research capabilities and market presence [2]

Core Insights - Ascentage Pharma presented results from five preclinical studies at the 2025 AACR Annual Meeting, showcasing its innovative drug pipeline targeting hematological malignancies [1][3][19] Group 1: Drug Candidates and Their Mechanisms - The five drug candidates presented include olverembatinib (HQP1351), lisaftoclax (APG-2575), APG-2449, APG-5918, and AS03157, each targeting different pathways in cancer treatment [2][19] - Olverembatinib combined with lisaftoclax showed strong synergistic effects in overcoming venetoclax resistance in acute myeloid leukemia (AML) models, indicating potential for new therapeutic strategies [4][7] - APG-5918, an EED inhibitor, demonstrated potent antitumor activity and synergized with enzalutamide in preclinical prostate cancer models, suggesting a promising combination therapy [10][16] - APG-2449, a FAK inhibitor, enhanced the antitumor activity of chemotherapy in small-cell lung cancer (SCLC) models, supporting its further clinical development [13][17] - AS03157, an IAP antagonist, showed high affinity for cIAP1 and XIAP, with potent antiproliferative activities in cancer cell lines, indicating its potential as a therapeutic candidate [25] Group 2: Clinical Development and Regulatory Status - Olverembatinib is already approved in China and included in the National Reimbursement Drug List, while a New Drug Application for lisaftoclax has been accepted for Priority Review by the China CDE [21][22] - Ascentage Pharma has received 16 Orphan Drug Designations from the US FDA and 1 from the EMA for its investigational drug candidates, highlighting its commitment to addressing unmet medical needs [22][19] Group 3: Company Overview and Strategic Goals - Ascentage Pharma is focused on discovering and developing therapies for hematological malignancies, with a robust pipeline of innovative drug candidates [19][20] - The company aims to strengthen its R&D capabilities and accelerate clinical development programs to meet global clinical needs [23]

Core Insights - Ascentage Pharma announced the selection of results from two clinical studies of its drug candidates, lisaftoclax (APG-2575) and alrizomadlin (APG-115), for presentation at the 2025 ASCO Annual Meeting [1][3] - The ASCO Annual Meeting is a significant event in the oncology field, attracting over 40,000 professionals globally [2] - The company aims to advance its clinical development and provide more treatment options for patients with hematological malignancies [3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on therapies for unmet medical needs, particularly in hematological malignancies [1][7] - The company has been listed on the Hong Kong Stock Exchange since October 2019 and on the Nasdaq since January 2025 [8] - Ascentage Pharma has a diverse pipeline of innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation TKIs [9] Clinical Studies - A Phase 1b/2 study of lisaftoclax combined with azacitidine in patients with treatment-naïve or prior venetoclax-exposed myeloid malignancies will be presented [4] - A Phase 2 study of alrizomadlin with or without toripalimab in patients with advanced adenoid cystic carcinoma or other solid tumors will also be presented [5] Regulatory Status - Lisaftoclax and alrizomadlin are investigational drugs and are not yet approved in the U.S. [6] - Olverembatinib, another key asset, is approved in China and included in the National Reimbursement Drug List [10] - The company has received multiple Orphan Drug Designations from the US FDA and the European Medicines Agency for its investigational drug candidates [11] Partnerships and Collaborations - Ascentage Pharma has established partnerships with leading biotechnology and pharmaceutical companies, including Takeda, Merck, and Pfizer, as well as research institutions like Mayo Clinic and Dana-Farber Cancer Institute [11]

ROCKVILLE, Md. and SUZHOU, China, April 21, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily for hematological malignancies, today announced that two of its proprietary novel drugs have been included in the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines. Lisaftoclax (APG-2575), the company's investigational novel oral Bcl-2 sel ...

Financial Performance - For the year ended December 31, 2024, the company generated revenue of RMB980.7 million (US$134.3 million), representing an increase of RMB758.7 million, or 341.8%, compared to RMB221.0 million for the year ended December 31, 2023[1012]. - The net loss for the year ended December 31, 2024, was RMB405.7 million (US$55.6 million), compared to a net loss of RMB925.7 million for the year ended December 31, 2023[984]. - The loss for the reporting period decreased by RMB520.0 million, or 56.2%, to RMB405.7 million (US$55.6 million) for the year ended December 31, 2024, down from RMB925.7 million in 2023[1022]. - Other income and gains for the year ended December 31, 2024 decreased by RMB2.0 million, or 3.3%, to RMB57.4 million (US$7.9 million) compared to RMB59.3 million for 2023, primarily due to a decrease in government grants[1014]. Research and Development - Research and development expenses for the year ended December 31, 2024, were RMB947.2 million (US$129.8 million), representing 67.5% of total operating expenses[993]. - Research and development expenses increased by RMB240.3 million, or 34.0%, to RMB947.2 million (US$129.8 million) for the year ended December 31, 2024, up from RMB707.0 million in 2023, driven by increased clinical research expenses[1016]. - The company has ten ongoing U.S. and/or international registrational trials for its six key clinical-stage assets, including two that are FDA-regulated[983]. - The company is the only one in the world with active clinical programs targeting all three known classes of key apoptosis regulators[983]. Expenses and Costs - The cost of sales for the year ended December 31, 2024, was RMB29.1 million (US$4.0 million), a decrease of RMB1.5 million, or 4.8%, compared to RMB30.5 million for the year ended December 31, 2023[1013]. - Selling and distribution expenses for the year ended December 31, 2024, were RMB196.0 million (US$26.9 million), compared to RMB195.4 million for the year ended December 31, 2023[1011]. - Selling and distribution expenses increased by RMB0.6 million, or 0.3%, to RMB196.0 million (US$26.9 million) for the year ended December 31, 2024, attributed to commercialization efforts[1015]. - Finance costs decreased by RMB31.6 million, or 32.9%, to RMB64.5 million (US$8.8 million) for the year ended December 31, 2024, due to lower interest rates on bank borrowings[1018]. Cash Flow and Financing - Net cash used in operating activities for the year ended December 31, 2024 was RMB111.4 million (US$15.3 million), primarily due to a loss before tax of RMB395.3 million (US$54.2 million)[1029]. - Net cash provided by financing activities for the year ended December 31, 2024 was RMB314.8 million (US$43.1 million), primarily from net proceeds of RMB533.9 million (US$73.1 million) from the issuance of shares[1033]. - The company entered into an exclusive option agreement with Takeda Pharmaceuticals in June 2024, receiving US$100.0 million related to intellectual property income and option payment, with potential total payments up to approximately US$1.2 billion[1027]. - The company believes that net proceeds from public and private financings, along with existing cash and cash equivalents, will fund operating expenses and capital expenditures for at least the next 12 months[1293]. Borrowings and Liabilities - As of December 31, 2024, total current borrowings amounted to RMB 779.1 million (US$ 106.7 million), an increase from RMB 616.4 million in 2023[1039]. - The total non-current borrowings decreased to RMB 889.4 million (US$ 121.9 million) in 2024 from RMB 1,179.2 million in 2023[1039]. - The total interest-bearing borrowings as of December 31, 2024, were RMB 1,668.5 million (US$ 228.6 million), down from RMB 1,795.6 million in 2023, reflecting a reduction of approximately 7.1%[1039]. - The total current portion of long-term bank loans was RMB 213.2 million (US$ 29.2 million) in 2024, down from RMB 322.5 million in 2023[1039]. Risk Factors - The company’s liquidity risk arises primarily from mismatches in the maturities of financial assets and liabilities[1291]. - The company does not currently have significant direct foreign exchange risk, but the value of investments in ADSs will be affected by the exchange rate between the U.S. dollar and RMB[1296]. - The RMB has fluctuated against the U.S. dollar significantly and unpredictably in recent years, making future predictions difficult[1297]. - Appreciation of RMB against the U.S. dollar would reduce the RMB amount received from conversions for operational needs[1298]. - Conversely, appreciation of the U.S. dollar against the RMB would reduce the U.S. dollar amounts available for dividends or debt servicing[1298].

Summary of Conference Call Notes Company and Industry - The conference call discusses the performance and future outlook of a biopharmaceutical company, specifically in the field of hematology and oncology, with a focus on their products and clinical trials. Key Points and Arguments 1. **Significant Achievements in 2024**: The company achieved substantial results in its Nasdaq listing, which is expected to bring significant excess returns to investors in 2024, with high expectations for 2025 as well [1] 2. **Transformation Year**: 2014 is highlighted as a milestone year for the company, marking a transformation phase with risk mitigation and global capital expansion, establishing its position as a leading player in hematology [2] 3. **FDA Approvals**: The company received FDA approval for its global Phase III clinical trial for Olaparib (Polaris 2) and a second NDA application for Olympus 2575, solidifying its global presence in hematology [2] 4. **Collaboration with Takeda**: The partnership with Takeda is noted as crucial for addressing financial challenges and providing necessary commercialization resources, enhancing growth potential [3] 5. **Sales Growth**: The company reported a 52% increase in sales for its product, demonstrating strong market interest and performance [4] 6. **Insurance Coverage**: The company successfully obtained insurance coverage for its products, significantly reducing patient costs from over 10,000 to 1,000-2,000, making treatments more accessible [5] 7. **Clinical Research Recognition**: The company has received recognition in major international conferences and journals, indicating strong peer acknowledgment of its research outcomes [6] 8. **Market Potential**: The potential market for its products is substantial, with estimates of 300 billion USD for the AUK market alone, highlighting the demand for effective treatments [7] 9. **Clinical Trial Progress**: The company is advancing multiple clinical trials, including a global registration trial for Polaris 2, with a focus on first-line treatments for acute patients [8] 10. **Patient Outcomes**: Clinical data shows promising results, with over 30% efficacy in patients who have failed previous treatments, indicating the potential for significant therapeutic impact [10] 11. **Pipeline Development**: The company is actively developing its pipeline, with several products in late-stage clinical trials, aiming for first-in-class status upon approval [20] 12. **Regulatory Challenges**: The company faces high regulatory standards for its NDA applications, particularly for patients who have failed previous therapies, indicating a competitive landscape [13] 13. **Future Milestones**: The company is focused on achieving key milestones in its clinical trials, particularly for its Glora products, which are positioned for first-line treatment in hematological malignancies [19] 14. **Global Positioning**: The company aims to leverage its global presence to attract investment and partnerships, enhancing its market reach and investor returns [23] Other Important but Overlooked Content - The company emphasizes the importance of safety and efficacy in its clinical trials, particularly in high-risk patient populations, which is critical for gaining regulatory approval and market acceptance [18] - The discussion includes insights into the challenges faced in the development of certain drug candidates, particularly in the context of rare diseases and complex regulatory environments [21][22]

Core Insights - Ascentage Pharma's drug olverembatinib has received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration for treating newly-diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with low-intensity chemotherapy [1][2][3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on discovering, developing, and commercializing therapies for unmet medical needs, particularly in hematological malignancies [10][11] - The company is listed on both the Hong Kong Stock Exchange and Nasdaq, indicating its global presence and investment appeal [10] Drug Development and Approval - Olverembatinib is the first third-generation BCR-ABL inhibitor approved in China, with prior approvals for chronic-phase chronic myeloid leukemia (CML-CP) and gastrointestinal stromal tumors [5][12] - The drug has been included in the China National Reimbursement Drug List, enhancing its accessibility to patients [5][12] - A global Phase III study has been cleared for olverembatinib in combination with chemotherapy, positioning it to potentially be the first TKI approved for first-line treatment of Ph+ ALL in China [6] Clinical Significance - The incidence rate of ALL in China is approximately 0.69 per 100,000, with Ph+ ALL representing 20%-30% of adult cases, highlighting a significant unmet medical need [4] - Prior to TKIs, the five-year overall survival rate for Ph+ ALL patients treated with chemotherapy was below 20%, underscoring the importance of new treatment options [4] Regulatory and Market Impact - BTDs are granted to innovative drugs that address serious conditions with no existing treatment, allowing for prioritized development and review processes [3] - The recognition of olverembatinib's clinical value by regulatory authorities is expected to accelerate its development and availability to patients [7]