Core Viewpoint - The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is a significant event in the oncology field, attracting global attention from both academia and investors, particularly regarding investment opportunities in innovative drugs like Lisaftoclax from Ascentage Pharma [1][3]. Group 1: Company Developments - Ascentage Pharma's stock price surged by 9.13% on May 23, reaching a peak of 53.20 HKD, marking the highest level since August 2021, following the announcement of data at the ASCO meeting [1]. - Lisaftoclax (APG-2575), a Bcl-2 inhibitor, is the second globally to submit a New Drug Application (NDA) and the first domestic Bcl-2 inhibitor in China to enter priority review, showcasing its potential in treating various hematological malignancies [3][12]. - The drug has been included in the 2025 CSCO Lymphoma Diagnosis and Treatment Guidelines, marking its first inclusion and recognition by a top academic institution in China [4]. Group 2: Clinical Research and Data - The latest clinical data presented at ASCO demonstrated that Lisaftoclax, in combination with Azacitidine, showed good tolerability and preliminary efficacy in treating newly diagnosed or previously treated acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients [5][7]. - In a study involving 103 patients, the overall response rate (ORR) for newly diagnosed AML patients was 83.3%, while the ORR for relapsed/refractory AML patients was 43.2% [6]. - Among 28 patients with relapsed/refractory AML who were previously treated with Venetoclax, the ORR was 31.8%, indicating Lisaftoclax's potential to overcome Venetoclax resistance [8][11]. Group 3: Market Potential - The global market for hematological malignancy treatments is projected to reach $40 billion by 2024, with a compound annual growth rate (CAGR) of 6% from 2024 to 2029, highlighting the significant unmet clinical needs in this area [10]. - Lisaftoclax is expected to achieve over $2 billion in sales potential, driven by its unique positioning and clinical data that suggest it could surpass the market performance of existing Bcl-2 inhibitors like Venetoclax [9][11].

Core Viewpoint - The recent policy announced by Trump to align U.S. drug prices with the lowest global prices could lead to a significant decrease in prescription drug prices in the U.S., potentially by 30% to 80%, raising concerns among pharmaceutical companies, especially those exporting to the U.S. [1][2] Group 1: Market Performance - As of May 13, 2025, the CSI Hong Kong Stock Connect Pharmaceutical and Healthcare Composite Index (930965) rose by 2.42%, with notable increases in stocks such as BeiGene (06160) up 4.15% and Innovent Biologics (01801) up 3.14% [1] - The Hong Kong Pharmaceutical ETF (159718) opened high and increased by 2.04%, with a latest price of 0.70 yuan, and a one-month cumulative increase of 3.32% [1] - The CSI Pharmaceutical and Medical Device Innovation Index (931484) increased by 0.87%, with stocks like East China Pharmaceutical (000963) rising by 2.23% [4] Group 2: Trading Volume and Liquidity - The Hong Kong Pharmaceutical ETF had a turnover of 1.72% during the trading session, with a transaction volume of 4.0999 million yuan, and an average daily transaction volume of 95.7602 million yuan over the past month [1] - The latest scale of the Medical Innovation ETF (516820) reached 1.588 billion yuan [4] Group 3: Index Composition - The top ten weighted stocks in the CSI Hong Kong Stock Connect Pharmaceutical and Healthcare Composite Index accounted for 60.54% of the index, including BeiGene (06160) and WuXi Biologics (02269) [5] - The top ten weighted stocks in the CSI Pharmaceutical and Medical Device Innovation Index represented 66.51% of the index, featuring companies like Hengrui Medicine (600276) and WuXi AppTec (603259) [8]

Group 1 - The Hong Kong innovative drug sector has rebounded rapidly due to a favorable external environment, with the China Securities Hong Kong Innovative Drug Index (931787) experiencing a significant recovery since its low on April 9, 2023 [1][3] - As of April 25, 2023, the index reached a peak of 979.92 points, showing a maximum cumulative increase of 37.43% from its previous low [1] - The overall increase in the Hong Kong innovative drug sector has outperformed the Hang Seng Technology Index, which has only seen a year-to-date increase of 12.48% compared to the innovative drug index's 31.03% [3] Group 2 - Recent data indicates a collective performance improvement among Hong Kong innovative drug companies, significantly exceeding market expectations [4] - In 2024, 10 out of 12 Hong Kong innovative drug companies with a market capitalization over 10 billion HKD reported positive revenue growth, with 8 companies also showing positive profit growth [4] - The company with the highest revenue growth is CloudTop New Drug-B (01952), with a revenue growth rate of 341.8%, while Innovent Biologics (01801) reported a net profit growth of 91.8% [4] Group 3 - The trend of "going global" has become a key topic, with Chinese pharmaceutical companies achieving significant growth in overseas licensing transactions [6][8] - The total transaction amount for licensing-out by Chinese pharmaceutical companies reached a historical high of 51.9 billion USD in 2024, indicating a strong global competitiveness in innovative drug development [6] - The NewCo model has emerged as a favorable strategy for domestic biotech companies, allowing for cash flow support and risk sharing in international collaborations [8] Group 4 - New industry trends in pharmaceuticals, such as weight-loss drugs, dual-antibody drugs, ADC drugs, and innovative medical devices, are expected to create new investment opportunities [9] - The Chinese government is increasing support for innovative drug exports, as evidenced by recent policies aimed at facilitating the import of research materials for biopharmaceutical companies [9] - Despite market fluctuations due to trade tensions, the pharmaceutical sector remains relatively insulated, presenting a favorable opportunity for large-scale investments [9] Group 5 - The Hong Kong innovative drug sector is poised for a valuation recovery, with significant inflows of capital from southbound investors since the beginning of the year [11] - As of April 24, 2023, net capital inflows from A-share investors into Hong Kong stocks reached 611.1 billion HKD, with healthcare becoming the second most net inflow sector [11] - The current price-to-earnings ratio (TTM) for the pharmaceutical and biotechnology sector is 27.1, indicating that the sector is undervalued compared to other growth sectors [12][13]

消息面上，相关机构近期表示，创新药仍处于产业加速向上的周期，今年也有强基本面的兑现支撑。在 既往ADC、PD1/VEGF等技术爆发之后，TCE、ProTac等新技术已经看到萌芽开花；同时，创新药从可 预期的BD潮走向盈利潮，以往大家对创新药的疑虑是研究壁垒高、企业没盈利，因此不敢投，但随着 未来企业的收入高增速带动利润的快速提升，就进入了投资者可理解的范畴内。 港股创新药板块高盈利持续消化估值。港股创新药指数2月21日市盈率为64倍，4月24日最新市盈率仅为 27倍，不足两个月前的一半，当前布局性价比突出。 4月24日，港股市场低开震荡，港股创新药板块全面爆发。港股创新药指数成分股中，凯莱英涨超 17%，荣昌生物、亚盛医药-B、康方生物涨超7%，信达生物、联邦制药涨超6%，康龙化成、三生制药 涨超4%。港股创新药ETF（159567）连续2个交易日成交额超9亿元，市场关注度较高。 西南证券表示，创新药板块的投资价值在于其背后的新质生产力和高质量发展的大背景。随着各地政府 不断出台支持创新药的政策，如北京、深圳等地发布的支持创新药政策，这些政策不仅加强了对创新药 械研发、生产、审批、使用的全链条支持，还促进了健 ...

同时在2025年《CSCO恶性血液病诊疗指南》中，奥雷巴替尼在CML治疗领域延续多项重要推荐，巩固 了其在CML治疗中的关键地位。在CML-慢性期(CP)治疗中，奥雷巴替尼是任何线T315I突变的I级推荐 治疗方案;也是尼洛替尼或达沙替尼一线治疗失败后的二线治疗，以及对≥2种TKI不耐受或╱且治疗失败 后的叁线治疗的I级推荐治疗方案。在CML-进展期治疗中，奥雷巴替尼也作为I级推荐治疗方案用于 CML-加速期(AP)伴T315I患者，以及从CP进展为AP、从CP或AP进展为BP患者。该指南还强调了在应 对多种BCR::ABL1突变(包括T315I、V299L、F317L/V/I/C、T315A、Y253H、E255K/V、F359C/V/I等) 以及任意其他突变(包括复合突变)时的治疗优势。 此外，在Ph+ALL领域，针对诱导缓解以及R/R患者的治疗中，奥雷巴替尼均延续I级推荐。 奥雷巴替尼是亚盛医药原创1类新药，获国家"重大新药创制"专项支持。作为中国首个获批上市的第叁 代BCR-ABL抑制剂，目前奥雷巴替尼已获批用于TKI耐药、并伴有T315I突变的CML–CP或CML-AP成 年患者的治疗;对一代和二代 ...

R&D Investment and Clinical Trials - Ascentage Pharma reported a significant increase in R&D investment, totaling approximately $50 million, representing a 25% increase year-over-year[2]. - The company is advancing multiple clinical trials, with APG-2575 showing promising results in Phase II trials for chronic lymphocytic leukemia (CLL)[1]. - Ascentage Pharma is focusing on the development of its novel small molecule drugs, with five candidates currently in various stages of clinical trials[1]. - The company has received breakthrough therapy designation (BTD) for APG-115, which is expected to expedite its development process[2]. - The company is conducting ten registration clinical studies, with two approved by the FDA, involving Olverembatin, Lisaftoclax (APG-2575), and APG-2449[25]. - The company is conducting multiple registration trials for CLL/SLL, AML, and MDS, with ongoing phase II trials for multiple myeloma (MM)[34]. - The company is actively recruiting patients for multiple clinical trials of Alrizomadlin (APG-115) in the U.S. and Australia[51]. - Lisaftoclax is undergoing multiple clinical trials in both China and the U.S. for various hematological malignancies[47]. - The company has initiated patient recruitment for the POLARIS-2 and POLARIS-3 registration clinical trials following FDA approval in February 2024[41]. - The company is focused on accelerating the development and launch of innovative therapies that can change patient lives, aiming to expand its global influence[26]. Financial Performance - Ascentage Pharma's revenue for the fiscal year reached $100 million, a 15% increase compared to the previous year[2]. - The company anticipates a revenue guidance of $120 million for the next fiscal year, reflecting a growth rate of 20%[2]. - The company reported a significant increase in user data, with a 25% growth in patient enrollment for clinical trials compared to the previous year[10]. - Total revenue for 2023 reached RMB 221,984 thousand, a 5.5% increase from RMB 209,711 thousand in 2022[22]. - The company projects a revenue target of RMB 980,650 thousand for 2024, representing a substantial growth of 341.5% compared to 2023[22]. - The company's revenue for the year ended December 31, 2024, was RMB 980.7 million, a significant increase of RMB 758.7 million or 342% compared to RMB 222.0 million for the year ended December 31, 2023[81]. - The total comprehensive loss for the year ended December 31, 2024, was RMB 398.7 million, down from RMB 899.5 million for the year ended December 31, 2023, representing a reduction of RMB 500.8 million or 55.6%[81]. - The company recorded a loss of RMB 405.7 million for the year ended December 31, 2024, a decrease of RMB 520.0 million or 56.2% from RMB 925.7 million for the previous year[93]. Market Expansion and Strategic Partnerships - Ascentage Pharma plans to expand its market presence in Europe and North America, targeting a 30% increase in market share by 2025[2]. - The company has initiated a strategic partnership with a leading pharmaceutical firm to co-develop new oncology therapies, aiming to accelerate product development timelines[2]. - A new partnership with a leading pharmaceutical company is expected to enhance distribution channels, potentially increasing sales by 40%[10]. - The company is exploring potential acquisitions to enhance its pipeline and strengthen its competitive position in the oncology market[2]. - The company has established strategic collaborations with leading biotech and pharmaceutical companies, including Incyte and AstraZeneca, enhancing its research and development capabilities[33]. Product Pipeline and Approvals - The core product HQP1351 is designed to overcome drug resistance caused by BCR-ABL kinase mutations, specifically targeting the T315I mutation[9]. - HQP1351 has been approved for all indications in China and included in the national medical insurance catalog since January 2025, enhancing affordability and accessibility for patients[35]. - The NDA for the new Bcl-2 selective inhibitor Lisaftoclax (APG-2575) was accepted by the CDE in November 2024 and is under priority review for treating relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)[24]. - Lisaftoclax has been granted orphan drug designation by the FDA for five indications, including chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML)[43]. - The company plans to launch Alrizomadlin (APG-115) for relapsed/refractory CLL/SLL in China by 2025, pending regulatory approval[51]. - The company has received FDA approval for clinical trials in the U.S. for multiple indications, including CML and GIST[37]. Intellectual Property and Technology - The company has a strong intellectual property portfolio with 541 authorized patents globally, of which 379 are licensed overseas[33]. - The company is leveraging advanced technologies in drug development to address unmet medical needs in cancer treatment[31]. - The company is developing targeted protein degraders to address resistance mechanisms in cancer therapies, with the first candidate aimed at the p53-MDM2 pathway[67]. Workforce and Management - The company plans to increase its workforce by 20% to support expanded operations and R&D efforts[11]. - As of December 31, 2024, the company has 567 full-time employees, with 71.8% (407 employees) in R&D, 16.4% (93 employees) in commercial roles, and 11.8% (67 employees) in administrative functions[114]. - The senior management team consists of 187 senior employees with an average of 15 to 20 years of experience in the biotechnology industry[114]. - The company actively recruits talent globally by providing a collaborative work environment, competitive compensation, and opportunities to engage in cutting-edge scientific projects[114]. Financial Risks and Challenges - The company reported a significant net loss during the reporting period, indicating challenges in achieving or maintaining profitability despite the commercialization of Nairik® (Orebatin) in China[174]. - The company requires additional financing to support operations, and failure to secure such financing may hinder the development and commercialization of candidate drugs, including Nairik® (Orebatin)[174]. - The company faces significant competition, which may lead to others discovering, developing, or commercializing competitive drugs ahead of it[178]. - The company has identified significant deficiencies in internal controls over financial reporting, which may impact the accuracy of financial performance reporting[188]. - The company relies on third parties for clinical trials and manufacturing, which poses risks if these parties fail to meet their obligations[1]. Corporate Governance and Social Responsibility - The company is committed to environmental responsibility and sustainable development, adhering to relevant laws and regulations[171]. - The company made charitable donations totaling RMB 4.3 million to various foundations[196]. - The company emphasizes the importance of maintaining good relationships with employees, customers, and suppliers to achieve business objectives[167].

Investment Rating - The report maintains an "Outperform" rating for Ascentage Pharma [2][21]. Core Insights - Ascentage Pharma achieved a revenue of RMB 980 million in 2024, representing a year-on-year growth of 343%, which includes a $100 million option payment from Takeda. The company reported a net loss of RMB 410 million, narrowing by 56.2% year-on-year [3][17]. - The domestic revenue performance of HQP1351 was strong, reaching RMB 240 million, with a significant increase in H2 revenue driven by improved penetration in pharmacies and hospitals [4][18]. - The company completed its U.S. IPO in 2025, raising RMB 967 million, which alleviated cash needs [3][20]. Financial Summary - Revenue projections for FY25-27 are RMB 5.7 billion, RMB 29.9 billion, and RMB 28.0 billion, respectively. Corresponding net profits are projected at RMB -8.4 billion, RMB 12.5 billion, and RMB 9.1 billion [8][21]. - The gross profit margin is expected to remain high, with estimates of 90.1% in FY25 and 98.1% in FY26 [8][14]. - The company’s cash and deposit balance was RMB 1.26 billion at the end of 2024, reflecting a 15.3% increase year-on-year [3][17]. R&D Progress - Ongoing Phase III trials include POLARIS-2 for pretreated CML-CP and POLARIS-3 for SDH-GIST, with plans to submit a Phase III application to the U.S. FDA for POLARIS-1 [5][23]. - The NDA for APG-2575 for R/R CLL/SLL has been accepted by the CDE, with multiple Phase III trials ongoing for various indications [5][23]. Valuation - The target price for Ascentage Pharma is set at HKD 53.1 per share, based on a risk-adjusted discounted cash flow (DCF) model with a WACC of 10.0% and a terminal growth rate of 3.0% [8][21].

Market Overview - The Hong Kong stock market showed positive movement in the morning, with the Hang Seng Index rising by 0.38% to close at 23,206.84 points, with a total turnover of 250.23 billion HKD [1] - Global uncertainties are increasing, leading to a cautious approach in the Hong Kong market, with upcoming data on consumption and real estate being key focus areas [1] Blue-Chip Stocks Performance - Xiaomi Group-W (01810) experienced a significant drop of 5.49%, closing at 46.5 HKD, impacting the Hang Seng Index negatively by 78.78 points [2] - Other blue-chip stocks showed mixed results, with CSPC Pharmaceutical Group (01093) rising by 10.93% and contributing 7.33 points to the index, while China Overseas Development (00688) fell by 4.46% [2] Sector Performance Pharmaceutical Sector - The pharmaceutical sector saw strong performance, with stocks like Yiming Pharmaceutical-B (01541) rising by 19.86% and Kangfang Biotech (09926) increasing by 12.86% [3] - The market anticipates policy optimizations in drug procurement, which is expected to benefit domestic pharmaceutical innovation [3] Oil Sector - Oil stocks generally rose, with CNOOC (00883) increasing by 2.7% and PetroChina (00857) up by 2.07% [4] - Concerns over geopolitical tensions have led to a rise in international oil prices, with projections for Brent crude oil prices to reach 70-75 USD per barrel by 2025 [4] Real Estate Sector - The real estate sector showed mixed results, with companies like Midea Real Estate (03990) rising by 12.04%, while China Overseas Development (00688) fell by 4.46% [6] - Data indicates a decline in sales for major real estate firms, with a 9.8% year-on-year drop in sales for the first quarter [6] Company Earnings Reports - Midea Real Estate reported a revenue of 3.73 billion HKD, a 33% increase, and a core net profit of 500 million HKD, up 25% [7] - China Overseas Development's revenue decreased by 8.58% to 185.15 billion HKD, with a profit drop of 38.95% [7] Notable Stock Movements - Lao Pu Gold (06181) reached a new high, closing up 19.07% at 868 HKD, with a significant increase in sales and net profit [8] - Haijia Medical (06078) rose by 9.97% after its founder increased shareholding, indicating confidence in the company's future [9] - XPeng Motors-W (09868) reported a 268% year-on-year increase in vehicle deliveries, reaching 33,205 units in March 2025 [10] - Pop Mart (09992) saw a 4.98% increase, with a reported revenue growth of 106.9% and a target to exceed 20 billion RMB in revenue this year [11]

Core Viewpoint - In 2024, the Hong Kong pharmaceutical sector experienced significant declines due to external factors, with the Hang Seng Healthcare Index down 18.93% and the Hong Kong Innovative Drug Index down 10.80%. However, Ascentage Pharma-B (06855) saw a remarkable stock price increase of 66.48%, outperforming the indices due to multiple unexpected positive developments in product internationalization, innovative research, and secondary market financing, validating the company's "investment certainty" [1]. Financial Performance - Ascentage Pharma reported a revenue of RMB 981 million in 2024, a substantial increase of 342% year-on-year. The sales revenue of the core product, Nairik (耐立克®), reached RMB 241 million, reflecting a growth of approximately 53%. The company's cash flow improved, with a monetary fund balance of RMB 1.261 billion as of December 31, 2024, up 15.3% year-on-year [2]. Product Development and Market Potential - Nairik has successfully passed the 2024 National Medical Insurance negotiation process and will be included in the new National Medical Insurance Drug List starting January 1, 2025. This inclusion indicates strong recognition of the drug's innovative capabilities by the domestic medical system, which typically leads to rapid sales growth for innovative drugs post-inclusion [2]. - Ascentage Pharma signed a $1.3 billion exclusive option agreement with Takeda Pharmaceutical for Nairik, setting a new record for domestic small molecule oncology drug business development transactions [3]. Clinical Advancements - Nairik is positioned to become the first TKI drug approved for first-line treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in China, with significant market potential. The drug has been included in the "Breakthrough Therapy Designation" list and is expected to generate considerable sales growth in the Ph+ ALL treatment market [4][5]. - In the solid tumor field, Nairik's Phase III clinical trial for treating SDH-deficient GIST patients has received approval, and the drug has shown excellent anti-tumor effects in various clinical presentations [4]. Research and Development - Ascentage Pharma's R&D investment reached RMB 947 million in 2024, supporting strong revenue growth and cash flow expectations. The company is conducting ten registration clinical trials, with two receiving FDA approval, laying a solid foundation for exploring the global differentiated innovative drug market [5]. - The company has two core products, Nairik and APG-2575, both with billion-dollar potential, alongside several other promising candidates in development. Ascentage holds 541 global patents, with 379 granted overseas, establishing a robust global intellectual property framework [5]. Market Position and Future Outlook - APG-2575, a Bcl-2 inhibitor, has been accepted for priority review by the NMPA for treating refractory or relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). It is expected to become the second Bcl-2 inhibitor approved globally, with projected sales exceeding $2 billion [6][7]. - Ascentage Pharma successfully listed on the US stock market in 2024, raising approximately $126 million, enhancing its international financing channels. The company is well-positioned as a high-value biopharmaceutical investment in the US market [7]. Conclusion - With strong cash flow and an integrated innovation loop, Ascentage Pharma is accelerating its transition to a leading global biopharma through systematic competition in global R&D, overseas registration, and international commercialization [8].

Core Insights - The core viewpoint of the articles highlights the strong performance and growth potential of Ascentage Pharma, particularly driven by its key products, including Nairik and APG-2575, which are positioned to capture significant market opportunities in the oncology sector [1][2]. Group 1: Financial Performance - Ascentage Pharma reported a total revenue of 981 million RMB for the year 2024, representing a 342% year-on-year increase, primarily driven by product sales and external collaboration licensing revenue [1]. - The sales revenue for Nairik reached 241 million RMB, showing a robust year-on-year growth of 52% [1]. Group 2: Product Development and Regulatory Approvals - Nairik is set to be included in the National Medical Insurance Drug List in November 2024, which is expected to provide broader growth opportunities for the company [1]. - Ascentage Pharma is advancing Nairik in three ongoing Phase III clinical trials for various indications, including Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL), with one trial approved by the FDA [1]. - The company has established a global rights collaboration with Takeda for Nairik, marking the largest external licensing deal in the domestic small molecule oncology drug sector to date [1]. - The NDA for APG-2575 was accepted by the CDE and is prioritized for review, targeting treatment for refractory/relapsed Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), positioning it as a potential second Bcl-2 inhibitor to market globally [2]. - APG-2575 is currently involved in four global Phase III clinical trials across multiple hematological cancer indications, with one trial also receiving FDA approval [2]. Group 3: Market Position and Future Outlook - The successful IPO on NASDAQ in January 2025 raised 967 million RMB, enhancing the company's financial position for future growth initiatives [3].