Core Insights - The company achieved a revenue of 234 million RMB in the first half of 2025, with sales of its core product, Nairike® (Orebatinib), reaching 217 million RMB, a year-on-year increase of 93% due to its inclusion in the national medical insurance catalog [1][3] - The company has a strong cash position with over 3 billion RMB in total cash, indicating improved cash flow [1][10] - The approval of the core product, Lishengtuo® (APG-2575), by the National Medical Products Administration (NMPA) in July 2025 marks a significant milestone, entering a dual-engine growth phase for the company [1][5] Product Development and Clinical Trials - Lishengtuo® has received global registration for a Phase III clinical trial for treating high-risk MDS patients, approved by both the FDA and EMA, which is a significant step in accelerating its market entry [2][8] - Nairike® has been recognized in updated clinical guidelines, enhancing its clinical value and potential, particularly in treating pediatric patients with Ph+ ALL [4][7] - The company is advancing multiple Phase III clinical trials globally, with nine ongoing studies, three of which have received FDA approval [7][10] Commercialization Strategy - The commercialization of Nairike® has accelerated, with a 90% quarter-on-quarter growth in sales, reflecting strong clinical demand and increased accessibility due to insurance coverage [3][10] - The company has established partnerships with major pharmaceutical distributors to enhance the commercialization of Lishengtuo®, achieving rapid prescription issuance across multiple cities and hospitals [5][10] - The successful launch of Lishengtuo® positions the company to maximize product synergies and strengthen its commercialization framework [5][10] Market Potential - Lishengtuo® is positioned to fill a significant market gap as the only Bcl-2 inhibitor advancing in the high-risk MDS space, with the potential to become the first approved treatment in this category globally [8][9] - The failure of a competitor's Bcl-2 inhibitor in clinical trials enhances Lishengtuo®'s market prospects, potentially leading to a dominant position in a multi-billion dollar market [9][10] - The company is exploring Lishengtuo®'s potential in various hematological malignancies, with ongoing global Phase III trials in multiple indications [10]

Core Insights - The company achieved significant milestones in product commercialization, clinical development, and international expansion under its "Global Innovation" strategy, reporting a revenue of 234 million RMB for the first half of 2025, with sales of Nairike® reaching 217 million RMB, a 93% year-on-year increase due to its inclusion in the medical insurance coverage for all approved indications [1][2] Financial Performance - The company reported a total revenue of 234 million RMB for the reporting period, with Nairike® sales contributing 217 million RMB, reflecting a 93% increase year-on-year [1] - The company has over 3 billion RMB in cash and cash equivalents, indicating improved cash flow [2] Product Development - Nairike® is currently involved in three global Phase III clinical trials, with one trial approved by the FDA, targeting Chronic Myeloid Leukemia (CML), Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL), and SDH-deficient Gastrointestinal Stromal Tumors (GIST) [2] - The company is advancing its other key product, Lisengtuo®, which received NMPA approval in July 2025, marking it as China's first domestically approved Bcl-2 inhibitor [3] Strategic Initiatives - The launch of Lisengtuo® signifies the company's entry into a dual-engine growth phase, with plans to enhance its commercialization system to maximize product synergy [3] - The company is exploring Lisengtuo®'s potential in treating CLL/SLL, AML, MDS, and multiple myeloma (MM), with four global Phase III clinical trials currently underway, two of which have received FDA approval [3]

Core Viewpoint - Asiasoft Pharmaceuticals (NASDAQ: AAPG; HKEX: 6855) reported strong financial performance for the first half of 2025, driven by significant sales growth of its innovative drugs, particularly the launch of its new product, Lisengto® [1][2]. Financial Performance - The company generated revenue of 234 million RMB in the reporting period, with sales of Nairike® (Orebatin) reaching 217 million RMB, representing a 93% year-on-year increase due to its inclusion in the medical insurance coverage [1]. - The company's cash flow has improved, with total cash exceeding 3 billion RMB as of the current date [1]. Product Development and Approval - Lisengto® (Lisatrakra) received approval from the National Medical Products Administration (NMPA) on July 10, 2025, for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one systemic therapy, marking it as the first domestically approved original Bcl-2 inhibitor [1][2]. - The company is actively exploring the therapeutic potential of Lisengto® in CLL/SLL, acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and multiple myeloma (MM), with four global Phase III clinical trials currently underway, two of which have received FDA approval [3]. Commercialization Strategy - Following the approval of Lisengto®, the company has signed cooperation agreements with major pharmaceutical distribution companies to accelerate its commercialization efforts, achieving rapid prescription issuance in over 30 cities and 40 hospitals within 15 days [2]. - The launch of Lisengto® signifies the company's transition into a dual-engine growth phase, enhancing its commercial framework to maximize product synergy [2]. International Development - Asiasoft Pharmaceuticals became the first biopharmaceutical company to list on both the Hong Kong and NASDAQ stock exchanges, which supports its international development and provides financial backing for the commercialization strategies of Lisengto® and Nairike® [3].

Core Insights - Ascentage Pharma reported strong business momentum in the first half of 2025, with a 93% year-over-year growth in Olverembatinib sales to $30.3 million, driven by expanded NRDL coverage in China [2][6][7] - The approval of Lisaftoclax in July 2025 marks a significant milestone as the first Bcl-2 inhibitor approved for CLL/SLL treatment in China, with commercial sales commencing shortly after [2][13] - The company has a robust pipeline with nine registrational clinical trials ongoing, including three cleared by the FDA, demonstrating its commitment to innovative cancer therapies [2][3] Financial Performance - Total revenue for the six months ended June 30, 2025, was $32.6 million, a decrease of 71.6% compared to $113.4 million in the same period of 2024, primarily due to the absence of intellectual property revenue recorded in 2024 [12] - Product sales of Olverembatinib increased by 92.5% on a constant currency basis, contributing significantly to the overall revenue [12] - The company reported a loss of $82.5 million for the first half of 2025, compared to a profit of $22.4 million in the same period of 2024, with a loss per share of $0.24 [19] Commercial and Clinical Developments - Olverembatinib is the first third-generation BCR-ABL1 TKI approved in China for CML treatment, with ongoing evaluations for additional indications [3][28] - Lisaftoclax is being evaluated in multiple registrational Phase III trials for various hematologic malignancies, including CLL/SLL and AML [9][29] - The company completed a financing round in July 2025, raising $190.1 million in net proceeds, enhancing its financial position to support commercialization and development efforts [2][21] Operational Metrics - The number of pharmacies and hospitals where Olverembatinib is available increased by 17% to 782, with a notable 47% increase in hospitals to 295 as of June 30, 2025 [7] - Selling and distribution expenses rose by 53.7% to $19.2 million, reflecting increased commercialization efforts for Olverembatinib and preparations for Lisaftoclax [14] - Research and development expenses increased by 19.0% to $73.8 million, driven by ongoing global clinical trials [15]

Core Viewpoint - As of August 18, 2023, AAPG's stock price increased by 5.35%, reaching $47.4 per share, with a total market capitalization of $4.406 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 year-on-year increase of 56.2% [1]. Financial Performance - AAPG's total revenue for the fiscal year ending December 31, 2024, is projected to be 981 million RMB, reflecting a significant year-on-year growth of 341.77% [1]. - The net profit attributable to shareholders is expected to be -405 million RMB, which indicates a year-on-year increase of 56.2% [1]. Upcoming Events - AAPG is scheduled to disclose its mid-year report for the fiscal year 2025 on August 20, 2023, after the market closes (Eastern Time) [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 [3]. - AAPG has established a proprietary drug design platform targeting protein-protein interactions and is at the forefront of developing new drugs in the apoptosis pathway. The company has a pipeline of nine clinical-stage Class 1 small molecule drugs, including inhibitors targeting key proteins in the apoptosis pathway [3]. - The core product, Olarebatin (brand name: Nairike), has been approved in China and is included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2022). It has also received various designations from the FDA and the EU [3]. - AAPG has engaged in over 40 clinical trials across China, the U.S., Australia, and Europe, and has established collaborations with leading biotech and pharmaceutical companies and academic institutions globally [3].

Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial for lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing novel therapies for cancer, with a strong pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [11][12] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is the second registrational Phase III trial for lisaftoclax to receive clearance from both the FDA and EMA, with simultaneous patient enrollment across multiple countries [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment for higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the urgent need for innovative therapies [5][9] Clinical Data - Earlier studies of lisaftoclax in combination with azacitidine showed an ORR of 75%, significantly higher than HMAs alone, with a favorable safety profile and low incidence of severe hematologic toxicities [8][9] - The combination therapy demonstrated a low requirement for dose adjustments and no treatment-related mortalities within 60 days, indicating its potential as a superior treatment option [8][9] Expert Commentary - Experts emphasize the challenges in treating higher-risk MDS due to the limited efficacy of current therapies and the absence of breakthrough treatments in the last two decades, underscoring the importance of the GLORA-4 study [9][10]

Core Viewpoint - Ascentage Pharma has received FDA and EMA clearance for the GLORA-4 study, a Phase III trial of lisaftoclax in combination with azacitidine for treating higher-risk myelodysplastic syndrome (HR-MDS), marking a significant step towards addressing unmet medical needs in this area [1][2][3] Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on developing novel therapies for cancer [1][11] - The company has a robust pipeline that includes innovative drug candidates targeting key proteins in the apoptotic pathway [12][14] Study Details - The GLORA-4 study is a global, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax combined with azacitidine compared to placebo plus azacitidine in newly diagnosed adult patients with HR-MDS [3][4] - This study is notable as it is the second registrational Phase III study of lisaftoclax to receive clearance from both the FDA and EMA [2][3] Clinical Need - There is a significant unmet clinical need for targeted therapies in first-line treatment of higher-risk MDS, as current options like hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) have limitations [3][5][9] - The overall response rate (ORR) for HMAs is only 30-40%, with a complete response (CR) rate of 10-17%, highlighting the need for more effective treatments [5][9] Lisaftoclax Profile - Lisaftoclax is a proprietary, orally administered Bcl-2 selective inhibitor that has shown promising clinical benefits and tolerability in earlier studies [6][8] - The drug is already approved in China for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have received prior systemic therapy [7][14] Clinical Data - Clinical data presented at major conferences indicated an ORR of 75% for the combination of lisaftoclax and azacitidine in treatment-naïve MDS, significantly higher than HMAs alone [8] - The combination therapy demonstrated a favorable safety profile with low incidence of severe hematologic toxicities [8][9] Global Collaboration - The GLORA-4 trial is being co-led by prominent researchers from leading institutions, including The University of Texas MD Anderson Cancer Center and Peking University [3][4]

本文源自：金融界 财务数据显示，截至2024年12月31日，亚盛医药收入总额9.81亿人民币，同比增长341.77%；归母净利 润-4.05亿人民币，同比增长56.2%。 资料显示，亚盛医药集团是一家立足中国、面向全球的生物医药企业,致力于在肿瘤、乙肝及与衰老相 关的疾病等治疗领域开发创新药物。2019年10月28日,亚盛医药在香港联交所主板挂牌上市,股票代 码:6855.HK。亚盛医药拥有自主构建的蛋白-蛋白相互作用靶向药物设计平台,处于细胞凋亡通路新药研 发的全球前沿。公司已建立拥有9个已进入临床开发阶段的1类小分子新药产品管线,包括抑制Bcl-2、 IAP或MDM2-p53等细胞凋亡通路关键蛋白的抑制剂;新一代针对癌症治疗中出现的激酶突变体的抑制剂 等,为全球唯一在细胞凋亡通路关键蛋白领域均有临床开发品种的创新公司。目前公司正在中国、美 国、澳大利亚及欧洲开展40多项临床试验。用于治疗慢性髓细胞白血病的核心品种奥雷巴替尼(商品名: 耐立克)曾获中国国家药品监督管理局新药审评中心(CDE)纳入优先审评和突破性治疗品种,并已在中国 获批,是公司的首个上市品种。目前,耐立克已被成功纳入《国家基本医疗保险、工伤 ...

ROCKVILLE, Md. and SUZHOU, China, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) ("Ascentage Pharma" or the "Company"), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced today that it will release its six months 2025 unaudited interim results and provide business updates at 7:00 pm Eastern Daylight Time (EDT) on August 20, 2025 / 7:00 am Hong Kong Time (HKT) on August 21, 2025. Analysts and investors are in ...

Summary of Ascentage Pharma's Conference Call Company Overview - **Company**: Ascentage Pharma - **Key Products**: Lisatoclax (2,575) and Olverembatinib (Aurebatinib) Industry Insights - **Market Focus**: Hematological malignancies, specifically targeting CLL (Chronic Lymphocytic Leukemia), MDS (Myelodysplastic Syndromes), and MM (Multiple Myeloma) [2][6] - **Competitive Landscape**: The market for BCL-2 inhibitors is competitive, with Lisatoclax being the second BCL-2 inhibitor globally approved, following Venetoclax [19] Core Points and Arguments - **Lisatoclax Development**: - Submitted for CLL indication in China and plans to expand into MDS and MM, which have less competition [2][6] - Expected to leverage safety advantages to capture market share [2] - Clinical trial data presented at ASCO 2025 showed an ORR of 83.3% in AML patients and 43% in difficult-to-treat AML patients [23] - **Olverembatinib Performance**: - Achieved sales of 241 million RMB in 2024, with expectations to double in 2025 [3] - Positioned as a third-generation TKI targeting T315I resistant patients, showing significant safety advantages over competitors [11][15] - **Collaboration with Takeda**: - A $1.3 billion licensing agreement was reached, with Takeda expected to exercise options post-2026 [5] - This partnership indicates recognition of Chinese-developed drugs by international firms [5] - **Research and Development Focus**: - Future R&D investments will prioritize overseas registration and domestic indication expansions for Lisatoclax [4] - Cash flow is projected to support these initiatives [4] Additional Important Insights - **Market Potential**: - Lisatoclax's peak sales potential is estimated between $3 billion to $4 billion globally [19] - Olverembatinib's peak sales in overseas markets could reach $2 billion to $3 billion, with domestic sales expected to approach 2 billion RMB [18] - **Competitive Advantages**: - Lisatoclax offers better safety and faster dose escalation compared to Venetoclax, enhancing patient compliance [19] - The strategic approach of entering the market with a cautious clinical trial design allows for quicker market capture [22] - **Management and Shareholder Structure**: - Led by Dr. Yang Dajun, with a strong management team experienced in drug development [7] - Takeda is a significant shareholder, reflecting confidence in Ascentage's capabilities [8] - **Future Outlook**: - Plans to expand into ALL (Acute Lymphoblastic Leukemia) with Philadelphia chromosome-positive patients, which could significantly boost sales [14] - The company is also exploring new product pipelines targeting solid tumors and hematological malignancies [9] This summary encapsulates the key insights from Ascentage Pharma's conference call, highlighting the company's strategic direction, product performance, and market opportunities.