Investment Rating - The report maintains an "Outperform" rating for Ascentage Pharma with a target price of HKD 90.70, reflecting a potential upside from the current price of HKD 90.20 [2][24]. Core Insights - Ascentage Pharma reported strong product sales growth, with revenue from product sales reaching RMB 213 million, a 70.5% increase year-on-year, driven by a 93% increase in sales of Olverembatinib [3][15][17]. - The company achieved a gross profit of RMB 212 million with a gross margin of 90.7%, indicating improved operational efficiency [3][15]. - R&D expenses increased by 19% year-on-year to RMB 529 million, reflecting ongoing global clinical trials and the company's commitment to advancing its pipeline [3][18]. Financial Performance - For the first half of 2025, total revenue was RMB 234 million, down 71.6% year-on-year, primarily due to a one-off intellectual property income from Takeda in the previous year [3][15]. - The company recorded a net loss of RMB 591 million during the same period, with cash reserves totaling approximately RMB 3.15 billion [3][15][18]. - The report projects revenues for FY25, FY26, and FY27 to be RMB 730 million, RMB 3.16 billion, and RMB 3.02 billion, respectively, with corresponding net profits of RMB -1.09 billion, RMB 1.39 billion, and RMB 990 million [9][21]. R&D Progress - The approval of Lisaftoclax® for treating CLL/SLL patients was a significant milestone, and the initiation of the GLORA-4 Phase III trial for higher-risk MDS patients is expected to accelerate the drug's market entry [4][16][20]. - Efficacy data presented at the 2025 ASCO meeting showed promising results for Lisaftoclax® in MDS and CMML patients, with an overall response rate of 80% in newly diagnosed patients [20][21]. Market Dynamics - The report highlights the significant unmet medical need in the MDS treatment landscape, particularly for higher-risk patients, where current therapies have limited efficacy [19][20]. - The combination of National Reimbursement Drug List coverage and expanded hospital access has driven sales growth for Olverembatinib, with a 114% increase in sales volume [17][18].

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]

Major Events - Double End Co., Ltd. plans to globally offer 58.557 million H-shares from August 18 to August 21, with San Shui Venture Capital as a cornerstone investor [1] - Sunac China intends to issue mandatory convertible bonds and adopt a team stability plan [1] - Ascentage Pharma-B received FDA and EMA approval for the global registration of its Phase III clinical trial for the treatment of high-risk MDS patients [1] - 361 Degrees' subsidiary entered into a strategic cooperation agreement with Stand [1] - Eagle Precision indicates that additional tariffs may impact its business and operations [1] - Green Leaf Pharmaceutical's clinical trial for the treatment of generalized anxiety disorder has completed patient enrollment in China [1] - Tian Tu Investment and HashKey Capital signed a strategic cooperation memorandum to establish a virtual asset investment fund [1] - China Rare Earth Holdings expects annual gold production from MtBundy and Cygnet gold projects to exceed 200,000 ounces [1] Operating Performance - Xinhua Insurance reported a cumulative original insurance premium income of 137.806 billion yuan in the first seven months, a year-on-year increase of 23% [1] - China Biologic Products announced mid-term revenue of 17.57 billion yuan, up 10.7% year-on-year [1] - Meitu Inc. reported a mid-term profit attributable to shareholders of 397 million yuan, a year-on-year increase of 30.84%, with strong growth in MAU and paid subscribers [1] - Xtep International reported a mid-term profit attributable to shareholders of 914 million yuan, a year-on-year increase of 21.47% [1] - Leap Motor achieved a net profit of 33.03 million yuan in the first half of the year, marking its first positive half-year net profit [1] - Hansoh Pharmaceutical reported a mid-term profit attributable to shareholders of 3.135 billion yuan, a year-on-year increase of 15.02% [1] - Kangzheng Pharmaceutical announced a mid-term profit attributable to shareholders of approximately 941 million yuan, a year-on-year growth of 3.38% [1] - Kelun-Bio reported mid-term revenue of 950 million yuan with R&D expenses of 612 million yuan [1] - Sinopec Oilfield Services reported a net profit of approximately 492 million yuan in the first half, a year-on-year increase of 9% [1] - Wanwu Cloud reported a mid-term profit attributable to shareholders of 792 million yuan, a year-on-year increase of 3.88% [1] - Yunfeng Financial expects a significant year-on-year increase of approximately 139% in net profit attributable to equity shareholders, estimated at around 480 million HKD for the first half [1] - United Pharmaceutical anticipates a mid-term net profit of approximately 1.85 billion yuan, a year-on-year increase [1] - Sipai Health reported a mid-term overall gross margin increase of 4.7 percentage points to 14.4% [1] - Orange Sky Golden Harvest expects a net profit attributable to shareholders of no less than 125 million HKD for the first half, marking a turnaround from loss to profit [1] - Baifu Global reported a mid-term profit attributable to shareholders of 391 million HKD, proposing an interim dividend of 0.25 HKD per share [1] - WuXi AppTec reported a mid-term profit attributable to shareholders of 746 million yuan, a year-on-year increase of 52.74% [1] - Joy City Property reported a total contract sales amount of approximately 2.749 billion yuan in the first half, a year-on-year decrease of 81.4% [1]

Core Insights - The approval of the second global Phase III clinical trial for the drug Lisatoclax (brand name: Lishengtuo®) has led to a significant increase in the stock price of Ascentage Pharma-B (06855), reaching a new high of 95.35 HKD on August 18, with a year-to-date increase of 100.88% [1][2] Company Developments - Ascentage Pharma announced that the global Phase III clinical study (GLORA-4) for Lisatoclax in combination with Azacitidine (AZA) for newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients has received approval from the FDA and EMA [1][2] - The GLORA-4 study is a multi-center, randomized, double-blind trial aimed at evaluating the efficacy and safety of Lisatoclax combined with AZA compared to placebo plus AZA in adult HR-MDS patients [2][3] - The study has already commenced patient enrollment globally, with the first patients enrolled in China and Europe [2] Market Context - MDS is characterized by a significant age-related incidence, with a yearly incidence rate of 22 per 100,000 in individuals over 65 years old, and a median diagnosis age of 70 years [2] - The transformation rate to acute myeloid leukemia (AML) in high-risk MDS patients is alarmingly high, with a 5-year transformation rate of 40-60% [2][3] Product Efficacy - Lisatoclax is a novel oral Bcl-2 selective inhibitor that restores normal apoptosis in cancer cells, showing promising clinical benefits in previous studies [3][4] - In preliminary studies presented at major conferences, Lisatoclax combined with AZA achieved an overall response rate (ORR) of 75% in treatment-naive MDS patients, significantly higher than existing therapies [4][5] Future Prospects - The successful execution of the GLORA-4 study is expected to accelerate the clinical development and registration process for Lisatoclax in MDS indications [6] - The company aims to address unmet clinical needs globally, with hopes that Lisatoclax will become the first approved targeted therapy for first-line treatment of high-risk MDS patients [5][6]

Core Viewpoint - The recent approval of the second global Phase III clinical trial for the drug Lisatoclax (brand name: Lishengtuo®) has led to a significant increase in the stock price of Ascentage Pharma-B (06855), reaching a new high of 95.35 HKD, with a year-to-date increase of 100.88% [1][2]. Group 1: Clinical Development - The GLORA-4 study, which is a global Phase III clinical trial for Lisatoclax in combination with Azacitidine (AZA) for newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients, has received approval from the FDA and EMA [1][2]. - This study is notable as it is the only ongoing Phase III clinical trial for a Bcl-2 inhibitor in the high-risk MDS category, aiming to address a significant clinical gap in this area [2]. - The trial is designed as an international, multi-center, randomized, double-blind study to evaluate the efficacy and safety of Lisatoclax combined with AZA compared to placebo plus AZA in adult HR-MDS patients [2]. Group 2: Disease Context - Myelodysplastic syndromes (MDS) are characterized by a significant age-related incidence, with a rate of 22 per 100,000 in individuals over 65 years old, and a median diagnosis age of 70 years [3]. - The transformation rate to acute myeloid leukemia (AML) in high-risk MDS patients is alarmingly high, with a 5-year transformation rate of 40-60%, leading to poor prognosis [3]. - Current first-line treatments for high-risk MDS, such as demethylating agents, show limited efficacy, with overall response rates of only 30-40% and complete response rates of 10-17% [3]. Group 3: Drug Profile - Lisatoclax is a novel oral Bcl-2 selective inhibitor developed by Ascentage Pharma, designed to restore normal apoptosis in cancer cells [4]. - The drug has already been approved in China for use in adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone prior systemic therapy [4]. - Preliminary data from the 2024 American Society of Hematology (ASH) and 2025 American Society of Clinical Oncology (ASCO) meetings indicate that Lisatoclax combined with AZA achieves an overall response rate of 75% in treatment-naive MDS, significantly outperforming existing therapies [4]. Group 4: Market Potential - The approval of the GLORA-4 study is expected to accelerate the clinical development and registration process for Lisatoclax in MDS indications, addressing a substantial unmet clinical need in the market [5][6]. - The company aims to position Lisatoclax as the first targeted therapy approved for first-line treatment of high-risk MDS patients, potentially reshaping the treatment landscape in this area [5][6].

Core Insights - The company Ascentage Pharma-B (06855.HK) announced that its self-developed Bcl-2 selective inhibitor, Lisatoclax (brand name: Lifespan®; research code: APG-2575), has received approval from the FDA and EMA to initiate a global Phase III clinical trial (GLORA-4) for the treatment of newly diagnosed high-risk myelodysplastic syndromes (HR-MDS) patients [1] Group 1 - The GLORA-4 study is the second global Phase III trial for Lifespan® approved by regulatory agencies in Europe and the United States [1] - The trial will enroll patients simultaneously across multiple countries and centers, which is expected to accelerate the drug's market launch process [1] - As of the announcement date, Lifespan® is the only Bcl-2 inhibitor in the world advancing to a Phase III clinical trial for high-risk MDS [1] Group 2 - The GLORA-4 study is anticipated to address a long-standing clinical gap in the high-risk MDS field, marking another significant milestone in the global clinical development of Lifespan® [1] - Following the announcement, Ascentage Pharma's stock rose by 9.18%, reaching HKD 94 [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的全部內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 ASCENTAGE PHARMA GROUP INTERNATIONAL 亞盛醫藥集團 （於開曼群島註冊成立的有限公司） （股份代號：6855） 自願公告 亞盛醫藥利生妥®一線治療中高危MDS患者的全球註冊III期臨床研究 獲美國FDA和歐洲EMA批准 亞盛醫藥集團（「本公司」或「亞盛醫藥」）欣然宣佈，本公司自主研發的Bcl-2選 擇性抑制劑利沙托克拉（商品名：利生妥®；研發代碼：APG-2575）聯合阿扎胞 苷(AZA)一線治療新診斷的中高危骨髓增生異常綜合症(HR-MDS)患者的全球註 冊III期臨床研究(GLORA-4)獲美國食品藥品監督管理局(FDA)和歐洲藥品管理 局(EMA)同意開展。作為利生妥®在歐美監管機構獲批的第二個全球III期研究， GLORA-4 (NCT06641414)在多國家多中心同步入組，將加速新藥上市進程。截止 本公告日期，利生妥®也是國際上唯一正推進中高危MDS註冊I ...