Core Insights - Ascentage Pharma announced that 13 studies of its key assets will be presented at the 2025 European Hematology Association Annual Congress in Milan, Italy, from June 12-15, 2025 [1][2] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [8][9] Key Assets and Studies - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for treating patients with chronic myeloid leukemia (CML) and is currently undergoing global registrational Phase III trials for CML and newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients [9][10] - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor for various hematologic malignancies, with an NDA accepted for priority review in China [10] - Studies to be presented include: - Oral presentation on integrating genomic and transcriptomic insights for predicting responses in patients with chronic myeloid leukemia (CML) [3] - Poster presentations on the combination of olverembatinib with other therapies for newly diagnosed Ph+ acute lymphoblastic leukemia [4][5] - Online publications covering various studies on olverembatinib's efficacy and safety in different patient populations [6] Event Significance - The EHA Annual Congress is the largest gathering of the hematology community in Europe, attracting over 10,000 attendees from more than 100 countries, showcasing cutting-edge research and clinical results [2]

Summary of the Conference Call for Ascentage Pharma Company Overview - **Company**: Ascentage Pharma - **Focus**: Development of innovative anti-cancer therapies, particularly BCL-2 selective inhibitors and MDM2-P53 pathway inhibitors Key Points Industry and Product Highlights - **APG2,575**: A selective BCL-2 inhibitor showing significant efficacy in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) - Overall Response Rate (ORR) in treatment-naive patients is 83% and 43% in relapsed/refractory patients - ORR of 31% in patients previously treated with Venetoclax, indicating potential for hard-to-treat cases [2][4] - Faster onset of action (Tmax of 3-8 hours vs. 25-30 hours for Venetoclax) and shorter half-life (3-5 hours vs. 25-30 hours) [2][6] - Lower incidence of tumor lysis syndrome compared to Venetoclax [6] - **APG115**: An MDM2-P53 pathway inhibitor with potential applications across various cancer types - Clinical data presented at ASCO showed promising results, particularly in neuroendocrine tumors (ACC) [2][7][11] - In a Phase II trial, 2 complete responses and significant disease stabilization were observed [11] Clinical Development Plans - Ascentage Pharma plans to continue advancing APG2,575 and APG115 through global clinical trials, including registration studies for high-risk MDS and treatment-naive AML patients [4][12] - Ongoing discussions with regulatory bodies regarding the next steps for APG115 registration studies [12] Competitive Landscape - Venetoclax has shown lower infection rates and better tolerability in nearly 100 AML and MDS patients, establishing it as a standard treatment [10] - Ascentage Pharma is positioned as the second company globally to enter BCL-2 inhibitor clinical trials, with IND approval obtained [16] Future Directions - The company aims to strengthen collaborations with leading research institutions and companies to accelerate the development of new anti-cancer therapies [9][25] - Focus on expanding clinical trials and exploring combination therapies to address unmet medical needs in oncology [25] Market Potential - The market for multiple myeloma is substantial, with sales exceeding $30 billion in 2024, and Ascentage's BCL-2 inhibitors are expected to play a significant role [23][24] - The company is exploring registration clinical plans for multiple myeloma based on promising safety and efficacy data [24] Additional Insights - The company is actively pursuing global registration studies and expanding patient enrollment in ongoing trials [15][21] - Emphasis on the importance of safety and tolerability in the development of BCL-2 inhibitors, especially in comparison to existing therapies [18][24] This summary encapsulates the key insights and strategic directions discussed during the conference call, highlighting Ascentage Pharma's commitment to advancing innovative cancer therapies and addressing significant market opportunities.

Group 1 - The core viewpoint of the article highlights the significant growth in revenue and net profit for Ascentage Pharma, with a total revenue of 981 million RMB, representing a year-on-year increase of 341.77%, and a net profit of -405 million RMB, showing a growth of 56.2% [1][2]. Group 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 drug discovery and clinical development [2]. - The company has established a proprietary drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway [2]. - Ascentage Pharma has a pipeline of nine clinical-stage first-in-class small molecule drugs, including inhibitors targeting key proteins in the apoptosis pathway, and is the only company globally with clinical development in this area [2]. - The core product, Olverembatinib (brand name: Nilotinib), has received priority review and breakthrough therapy designation from the Chinese National Medical Products Administration and is included in the National Basic Medical Insurance Drug List [2]. - The company has received multiple designations from the FDA, including orphan drug status and fast track designation for four investigational drugs, and has established collaborations with leading biotech and pharmaceutical companies [2].

Core Viewpoint - As of May 29, 2023, AAPG's stock price increased by 2.43%, reaching $25.02 per share, with a total market capitalization of $2.18 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][2]. Company Overview - AAPG is a biopharmaceutical company based in China, focusing on global markets, dedicated to developing innovative drugs for the treatment of cancer, hepatitis B, and age-related diseases [2]. - The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - AAPG has developed a proprietary drug design platform targeting protein-protein interactions, positioning itself at the forefront of new drug development in the apoptosis pathway [2]. Product Pipeline and Clinical Development - The company has established a pipeline of nine Class 1 small molecule new drugs that have entered clinical development, including inhibitors targeting key proteins in the apoptosis pathway such as Bcl-2, IAP, and MDM2-p53 [2]. - AAPG is the only innovative company globally with clinical development products in all key proteins of the apoptosis pathway [2]. - Currently, the company is conducting over 40 clinical trials across China, the United States, Australia, and Europe [2]. Key Product and Regulatory Approvals - The core product, Orebatinib (brand name: Nairike), used for treating chronic myeloid leukemia, has received priority review and breakthrough therapy designation from the China National Medical Products Administration (NMPA) and has been approved for sale in China [2]. - Nairike has also been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) [2]. - The product has received fast track designation, orphan drug designation from the FDA, and orphan drug designation from the EU [2]. Research and Development Capabilities - AAPG has undertaken multiple national science and technology major projects, including five related to "Major New Drug Creation" and one related to "Major Infectious Disease Prevention and Control" [2]. - The company has established a global intellectual property layout and formed partnerships with leading biotech and pharmaceutical companies and academic institutions, including UNITY, MD Anderson, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer [2]. - AAPG is building a high-standard commercialization and marketing team while continuously enhancing its R&D capabilities to accelerate the clinical development of its product pipeline [2].

Core Insights - Ascentage Pharma announced new clinical data for its drug candidates, lisaftoclax and alrizomadlin, which will be presented at the 2025 ASCO Annual Meeting, indicating their potential in treating various cancers [1][2] Group 1: Lisaftoclax - Lisaftoclax is a Bcl-2 inhibitor being evaluated in a Phase 1b/2 study in combination with azacitidine for treatment-naïve or prior venetoclax-exposed myeloid malignancies [2][5] - The study enrolled nearly 100 patients, showing that the combination was well tolerated with preliminary efficacy; the overall response rate (ORR) for treatment-naïve myelodysplastic syndromes (MDS) was 64% [6][8] - In patients with venetoclax-refractory acute myeloid leukemia (AML), the ORR was 17%, while for high-risk MDS, it was 50% [6][8] Group 2: Alrizomadlin - Alrizomadlin is an MDM2-p53 inhibitor showing initial clinical activity in advanced adenoid cystic carcinoma (ACC) and other solid tumors [9][10] - The monotherapy arm demonstrated an ORR of 22.2% in ACC patients, with a disease control rate (DCR) of 100% in MPNST patients [12] - In the combination arm with toripalimab, the ORR was 20% in biliary-tract cancer patients, and 16.7% in liposarcoma patients, with prolonged progression-free survival observed in some MPNST patients [13]

Core Viewpoint - As of May 17, 2023, AAPG's stock price increased by 3.26% to $23.29 per share, with a total market capitalization of $2.029 billion. The company reported a total revenue of 981 million RMB for the year ending December 31, 2024, representing a year-on-year growth of 341.77%, while the net profit attributable to shareholders was -405 million RMB, showing a growth of 56.2% year-on-year [1][2]. Company Overview - AAPG is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases. The company was listed on the Hong Kong Stock Exchange on October 28, 2019, under the stock code 6855.HK [2]. - The company has developed a proprietary drug design platform targeting protein-protein interactions and is at the forefront of new drug development in the apoptosis pathway. AAPG has established a pipeline of nine Class 1 small molecule new drugs in clinical development, including inhibitors targeting key proteins in the apoptosis pathway [2]. - AAPG is conducting over 40 clinical trials across China, the United States, Australia, and Europe. Its core product, Orebatinib (brand name: Nairike), has received priority review and breakthrough therapy designation from the China National Medical Products Administration (NMPA) and has been approved for sale in China [2]. Regulatory and Market Position - Orebatinib has been included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022) in China. The product has also received fast track designation, orphan drug designation from the FDA, and orphan drug designation from the EU [2]. - The company has four investigational new drugs that have received 16 FDA orphan drug designations, two FDA fast track designations, and two FDA rare pediatric disease designations [2]. Research and Development - AAPG has undertaken several national science and technology major projects, including five projects under the "Major New Drug Creation" initiative and one project for "Enterprise Innovative Drug Incubation Base" [2]. - The company has established global collaborations with leading biotechnology and pharmaceutical companies and academic institutions, including UNITY, MD Anderson, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer [2]. - AAPG is committed to enhancing its R&D capabilities and accelerating the clinical development of its product pipeline to meet unmet clinical needs globally [2].

Group 1 - The core viewpoint of the article highlights the significant financial growth of Ascentage Pharma (AAPG), with a notable increase in revenue and net profit for the year ending December 31, 2024 [1][2] - Ascentage Pharma's total revenue reached 981 million RMB, representing a year-on-year growth of 341.77% [1] - The company's net profit attributable to shareholders was -405 million RMB, showing a year-on-year increase of 56.2% [1] Group 2 - Ascentage Pharma is a biopharmaceutical company based in China, focusing on developing innovative drugs for cancer, hepatitis B, and age-related diseases [2] - The company has established a drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway [2] - Ascentage Pharma has a pipeline of nine clinical-stage Class 1 small molecule drugs, including inhibitors targeting key proteins in the apoptosis pathway [2] - The core product, Olverembatinib (brand name: Nilotinib), has received priority review and breakthrough therapy designation from China's National Medical Products Administration and is included in the National Basic Medical Insurance Drug List [2] - The company is conducting over 40 clinical trials across China, the US, Australia, and Europe [2] - Ascentage Pharma has received multiple designations from the FDA and the EU for its investigational drugs, including orphan drug status and fast track designation [2] - The company has established collaborations with leading biotech and pharmaceutical companies and academic institutions globally [2] - Ascentage Pharma aims to enhance its R&D capabilities and accelerate the clinical development of its product pipeline to meet unmet clinical needs [2]

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]

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].