股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年9月30日 | 狀態: | 新提交 | | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | 公司名稱: | 亞盛醫藥集團 | | | | 呈交日期: | 2025年10月8日 | | | | I. 法定/註冊股本變動 | | | | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06855 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 500,000,000 USD | | 0.0001 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 500,0 ...

Core Viewpoint - Ascentage Pharma Group International is actively participating in several investor conferences in October 2025, highlighting its ongoing commitment to engage with investors and stakeholders in the biopharmaceutical sector [1][7]. Company Overview - Ascentage Pharma is a global, commercial stage, integrated biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for unmet medical needs in cancer [2][5]. - The company has developed a robust pipeline of innovative drug products, including inhibitors targeting key apoptotic pathway proteins and next-generation kinase inhibitors [2]. Product Portfolio - The first approved product, Olverembatinib, is a third-generation BCR-ABL1 inhibitor for chronic myelogenous leukemia (CML) patients with specific mutations and is included in the China National Reimbursement Drug List [3]. - The second approved product, Lisaftoclax, is a Bcl-2 inhibitor for various hematologic malignancies, with multiple global registrational Phase III trials currently underway [4]. Research and Development - Ascentage Pharma has established a strong R&D capability and has built a portfolio of global intellectual property rights [5]. - The company has formed partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer, as well as collaborations with prominent research institutions [5].

Core Viewpoint - The establishment of the Suzhou Innovation Drug Research Institute marks a significant step in promoting the biopharmaceutical industry in Suzhou, focusing on innovation and collaboration among government, academia, and enterprises [1][2]. Group 1: Establishment and Purpose - The Suzhou Innovation Drug Research Institute was inaugurated on September 29, with key figures from the government and academia in attendance [1]. - The institute aims to serve as a "catalyst" for technological breakthroughs, a "nurturer" for top talent, and a "connector" for the transformation of research outcomes, thereby becoming a source of innovation for Suzhou's biopharmaceutical industry [1]. Group 2: Collaborative Framework - The institute is a collaborative effort between the Suzhou municipal government, Suzhou Industrial Park, and Suzhou University, adhering to the principle of "enterprises pose questions, jointly solve problems, and the government assists" [2]. - It will focus on cutting-edge fields such as molecular targeted drugs, biopharmaceuticals, gene and cell therapy, and AI drug development, aiming to create an organized research and transformation framework [2]. Group 3: Integration and Development - The research institute seeks to establish a three-in-one innovation loop involving laboratories, enterprises, and hospitals, promoting deep integration of government, industry, academia, research, and medical sectors [2]. - During the inauguration, the institute also unveiled joint innovation centers with Ascentage Pharma and Innovent Biologics, and held its first council meeting [2].

Core Viewpoint - Nasdaq is proposing new regulations that significantly increase the listing requirements for companies, particularly affecting Chinese firms planning to go public in the U.S. [2][3] Group 1: Proposed Listing Standards - The new regulations will raise the minimum public float market value for IPOs to at least $8 million for the global market and $5 million for the capital market, with a unified increase to $15 million for companies listing based on net profit [2][3] - Chinese companies will be required to raise at least $25 million through public offerings during their IPOs [2][4] - The proposed rules will also tighten the delisting procedures for companies that do not meet ongoing listing standards, particularly for Chinese firms [2][4] Group 2: Impact on Chinese Companies - The new regulations are expected to have a significant impact on the enthusiasm of Chinese companies to list in the U.S., especially small and medium-sized enterprises [3][4] - In the current year, 59 companies have gone public on Nasdaq, raising a total of $1.02 billion, with an average fundraising of $17.3 million, indicating that only three companies exceeded the new $25 million threshold [4][5] - The proposed changes are seen as a move to maintain market integrity and protect investors, particularly against potential stock price manipulation [3][5] Group 3: Delisting Pressures - The new rules will introduce immediate delisting conditions for companies that fail to meet ongoing listing requirements, such as maintaining a market value of at least $5 million for ten consecutive trading days [5][6] - Previously, companies were given a grace period to comply with listing standards, but the new regulations may eliminate this buffer, increasing the risk of delisting [5][6] Group 4: Recommendations for Companies - Companies planning to list in the U.S. should prepare in advance by assessing their current stage and potentially accelerating their listing processes [6][7] - For those already listed, it is advised to focus on core business operations, optimize asset structures through mergers and acquisitions, and maintain regular communication with investors [7]

Investment Rating - The report assigns a rating of "Buy" for the company [5][9]. Core Insights - The company's hematology business continues to strengthen its leadership position with the advancement of products like Obinutuzumab and ICP-248, while the autoimmune pipeline is entering Phase III trials across multiple indications [2][9]. - The company achieved a revenue of 731 million RMB in the first half of 2025, representing a year-on-year growth of 74.26%, with a narrowed net loss of 30 million RMB, down 88.51% year-on-year [9]. - The report forecasts revenues for 2025-2027 to be 14.43 billion RMB, 18.59 billion RMB, and 26.91 billion RMB, respectively, with growth rates of 43%, 29%, and 45% [9]. Financial Summary - Total revenue is projected to grow from 739 million RMB in 2023 to 1,443 million RMB in 2025, reflecting an 18% increase in 2023, followed by a 37% increase in 2024, and a 43% increase in 2025 [4]. - Gross profit is expected to rise from 610 million RMB in 2023 to 1,306 million RMB in 2025, with a gross margin improvement from 82.5% to 90.5% [4]. - The net profit is projected to improve from a loss of 631 million RMB in 2023 to a loss of 308 million RMB in 2025, with a significant turnaround expected by 2027, achieving a profit of 195 million RMB [4]. Market Data - The current stock price is 16.44 HKD, with a market capitalization of 29,011 million HKD and a 52-week price range of 5.18 to 20.00 HKD [6][9]. - The report sets a target price of 24.53 RMB or 26.70 HKD for the company, based on a 30x PS ratio for 2025 [9][12].

Financial Performance - Ascentage Pharma reported a significant increase in revenue, reaching HKD 500 million for the first half of 2025, representing a 25% year-over-year growth[2]. - The company reported a net loss of HKD 100 million for the first half of 2025, a 10% improvement compared to the same period in 2024, indicating progress towards profitability[2]. - The company reported a total comprehensive loss of RMB 591.8 million for the six months ended June 30, 2025, compared to a total comprehensive income of RMB 165.1 million for the same period in 2024[89]. - For the six months ended June 30, 2025, the company's revenue was RMB 233.7 million, a decrease of RMB 590 million or 71.6% compared to RMB 823.7 million for the same period in 2024[90]. - The company reported a net income of $30 million, a 15% increase compared to the same quarter last year[10]. Research and Development - The company has allocated HKD 200 million for R&D in 2025, focusing on the development of new products like APG-5918 and APG-1252[2]. - The company is focused on research and development (R&D) in the field of oncology, particularly targeting diseases like small cell lung cancer (SCLC) and T315I mutations[13]. - R&D expenses rose by RMB 84.5 million (USD 12.7 million) or 19.0% to RMB 528.6 million (USD 73.8 million) for the six months ended June 30, 2025, mainly due to increased external R&D expenses related to ongoing global clinical trials[20]. - The company has a robust internal R&D capability, positioning itself as the only global company with clinical development programs targeting all three known key apoptosis regulators[30]. - The company is developing next-generation cell signaling inhibitors and epigenetic modifiers, including PROTACs targeting traditionally "undruggable" proteins[30]. Product Development and Launches - Ascentage Pharma has advanced its clinical trials for APG-2449, with a projected completion date in Q4 2025, aiming to address unmet medical needs in oncology[1]. - The company has successfully launched its new product, Lisaftoclax, which is expected to contribute approximately HKD 150 million in revenue in the next fiscal year[2]. - New product launches included the introduction of two innovative therapies, which are projected to generate $50 million in revenue within the first year[10]. - The company’s second product, Lisengto® (Lisatrakra), received conditional approval from the NMPA on July 10, 2025, for the treatment of adult CLL/SLL patients who have received prior systemic therapy including BTK inhibitors, marking it as the first Bcl-2 inhibitor approved for this indication in China[27]. - The company is advancing APG-5918 in I phase clinical studies for advanced solid tumors and hematologic malignancies in both China and the U.S.[63]. Market Expansion - Ascentage Pharma is expanding its market presence in Europe, with plans to establish partnerships with at least three major pharmaceutical companies by the end of 2025[1]. - The company is expanding its market presence in Europe, with plans to enter three new countries by mid-2024[11]. - The company is conducting multiple global Phase III clinical trials for lisatoclax in combination with AZA for newly diagnosed high-risk MDS and AML patients, with ongoing patient recruitment[50]. - The company plans to accelerate the market penetration of Lishengtuo® (Lisatrag) as the first Bcl-2 inhibitor conditionally approved for CLL/SLL treatment in China[72]. - The company is expanding its market presence with ongoing clinical trials in multiple countries, including the U.S. and China[45]. Strategic Partnerships and Collaborations - The company is exploring potential mergers and acquisitions to enhance its product pipeline, with a budget of HKD 300 million earmarked for this purpose in 2025[1]. - The company has established collaborations with leading biotech and pharmaceutical companies, including clinical partnerships with AstraZeneca, Merck, and Pfizer[31]. - The company has established a partnership with a leading pharmaceutical firm to co-develop a new drug, which is anticipated to enter clinical trials in Q1 2024[12]. - The company has entered into an exclusive option agreement with Takeda Pharmaceuticals for global development and commercialization rights outside of certain regions[26]. - The company plans to actively seek strategic partnerships with global biotech and pharmaceutical companies to capitalize on commercialization opportunities in the global drug market[129]. Financial Guidance and Projections - Future guidance suggests a revenue target of HKD 1 billion for the full year 2025, reflecting a 40% increase from 2024[2]. - The company provided guidance for Q4 2023, expecting revenue to be between $160 million and $170 million, indicating a potential growth of 20% to 30%[12]. - The company plans to use approximately 40% of the net proceeds from the 2025 placement for commercialization efforts, 35% for global clinical development, and 25% for infrastructure and operational funding[85]. Shareholder Information - The company has agreed to issue and allocate 24,307,322 shares to Takeda Pharmaceuticals under the securities purchase agreement[14]. - The share purchase price is set at HKD 24.09850, equivalent to approximately USD 3.08549 per share[14]. - Major shareholders collectively hold 17.38% of the company's shares, with Li Ju-Yun and Gao Sharon Xia each holding 60,665,461 shares[137]. - The company has a total of 6,787,587 unlisted warrants that can be exercised for new shares[14]. - The total number of issued shares is 348,999,320[136]. Clinical Trials and Efficacy - The company is conducting a Phase III clinical trial (POLARIS-2) for Nairike® (Aoralbatin) in CML patients, and has entered into an exclusive option agreement with Takeda Pharmaceuticals for global development and commercialization rights outside of certain regions[26]. - The ongoing clinical trials for Oreba include single-agent therapy for TKI-resistant CML-CP patients, with breakthrough therapy designation expected in 2025[35]. - Nairike® demonstrated high complete response (CR) rates and complete molecular response (CMR) rates in studies presented at the EHA 2025, indicating strong clinical efficacy for Ph+ ALL treatment[41]. - The overall response rate (ORR) for patients with R/R AML/MDS who are resistant to venetoclax and treated with lisatoclax is 31.8%, indicating significant anti-tumor activity[48]. - APG-2449, a novel oral FAK inhibitor, has shown preliminary clinical benefits and good safety in patients with NSCLC who are resistant to second-generation ALK TKIs[51]. Operational and Administrative Updates - The company employed 605 full-time employees as of June 30, 2025, with 421 (69.6%) in R&D roles[122]. - The employee retention rate over the past two years exceeded 82%, supporting the continuous development of the company's knowledge base[123]. - The company has established a global R&D center and industrialization base in Suzhou, which became operational in late 2021 and Q4 2022, respectively[77]. - The company has leased a facility of approximately 50,000 square feet in Taizhou, Jiangsu Province, for R&D and production to support clinical trials[79]. - The company has not engaged in any significant acquisitions or disposals during the reporting period[111].

Summary of Ascentage Pharma Conference Call Company Overview - **Company**: Ascentage Pharma - **Core Products**: Olverembatinib (APG-115), Fayankirin, APG-2,575 - **Industry**: Pharmaceutical/Biotechnology Key Points and Arguments Product Performance 1. **Olverembatinib (APG-115)**: - Sales doubled in the first half of 2024 after being included in the medical insurance coverage, with expectations to maintain the same growth rate in the second half [2][4][7] - Targeting chronic myeloid leukemia (CML) with significant market potential for future growth [2][4] 2. **Fayankirin**: - Currently undergoing POS D1 trials in China and Phase III registration trials in the U.S. [2][4] - Key data on 3-6 month MMR and 3 month CMR rates expected soon [2][4] 3. **APG-2,575**: - Launched in July 2024, it is the second BCL-2 inhibitor globally and the first for CLL in China [2][5] - Expected peak sales could exceed $4 billion, providing substantial growth potential [3][16] Financial Position 4. **Funding and Cash Reserves**: - Completed two rounds of financing through NASDAQ IPO and Hong Kong placement, currently holding approximately 3 billion RMB, sufficient to meet funding needs until 2027 [2][5] 5. **Collaboration with Takeda**: - A $100 million option payment and $75 million equity investment from Takeda, with potential future payments and royalties of 12%-19% [6] Market Dynamics 6. **Sales Performance in Hematology**: - Sales in the hematology sector have exceeded expectations due to the chronic disease management characteristics of the drugs, leading to sustained use by existing patients and an increase in new patients [9] - The company leverages the DOT (Duration of Therapy) effect to enhance sales [9] Clinical Development and Future Catalysts 7. **Clinical Trials and Pipeline**: - APG-2,575's daily dose escalation improves patient compliance and safety, with a faster onset of action compared to competitors [3][12] - The company is also advancing FAK inhibitor 2,449 into Phase III trials, with potential for commercial value through combination therapies [3][17] 8. **Comparative Advantage**: - APG-2,575 shows better safety and efficacy profiles compared to existing treatments like Venetoclax, with a lower rate of dose reduction and treatment interruption [13][16] Future Plans 9. **Upcoming Milestones**: - Plans to initiate the next U.S. registration clinical study and complete multiple Phase III clinical enrollments for APG-115 and APG-2,575 by 2026 [19] 10. **Expansion into New Areas**: - The company is exploring additional therapeutic areas, including apoptosis pathway inhibitors and anemia treatments, indicating a broadening of its research pipeline [17][18] Additional Important Insights - **Market Trends**: - BCL-2 inhibitors are gaining traction in hematological malignancies, with a focus on selective targeting to improve safety and efficacy [14][15] - **Strategic Positioning**: - The company’s strong cash position and ongoing clinical trials position it well for future growth and market expansion [5][19]

Core Viewpoint - The company is experiencing significant growth in sales of Orelabrutinib, with a projected revenue increase of 93% year-on-year to 217 million yuan in the first half of 2025, driven by effective hospital access and chronic disease management strategies [1] Group 1: Orelabrutinib Sales and Market Position - Orelabrutinib's sales are expected to continue growing due to its inclusion in the medical insurance directory, expanding the patient population eligible for reimbursement [1] - The number of hospitals administering Orelabrutinib increased by 47% year-on-year in the first half of 2025, with extended treatment duration for patients [1] - The long-term follow-up data from the 2022 ASH conference indicates a progression-free survival (PFS) rate of 88.6% at 48 months for Orelabrutinib in treating CML-CP, suggesting its potential for long-term management [1] Group 2: APG-2575 Development and Market Potential - APG-2575 is expected to be approved for domestic market launch in mid-2025, further solidifying the company's position in the hematological oncology sector [1] - APG-2575 is positioned as a potential second BCL-2 inhibitor globally, with a unique daily dose escalation design that allows for rapid achievement of therapeutic doses [1] - Early clinical data suggests that APG-2575 combined with azacitidine shows comparable efficacy to venetoclax while significantly improving safety profiles [1] Group 3: Future Pipeline and Clinical Trials - The company has a robust pipeline with multiple promising candidates, including APG-2449, which is undergoing Phase III trials for ALK-positive NSCLC [2] - APG-5918, an EED inhibitor for anemia-related indications, is in Phase I trials, with a unique mechanism that may provide a competitive edge in the market [4] - Upcoming milestones include the completion of several Phase III clinical trials for key products, which could lead to significant market expansions [5] Group 4: Financial Projections - Revenue projections for the company are estimated at 589 million yuan, 1.509 billion yuan, and 1.449 billion yuan for 2025-2027, reflecting a growth trajectory despite a projected decline in 2025 [6] - The company is transitioning from a biotech to a biopharma entity, with a focus on Orelabrutinib and the high-potential APG-2575 as core products [6]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative performance increase of over 15% compared to the benchmark index within the next 6 to 12 months [23]. Core Insights - The company is transitioning from a biotech to a biopharma entity, with a focus on its first commercialized product, Aorebatinib, and the promising APG-2575, which is expected to partially replace and surpass Venetoclax in the large MDS and MM markets [4][21]. - APG-2575 is positioned as a potential "Best-in-Class" BCL-2 inhibitor, with unique clinical data supporting its convenient dosing regimen and improved safety profile compared to existing treatments [14][18]. - The company has a robust pipeline with multiple promising candidates, including APG-2449 and various apoptosis pathway inhibitors, which are expected to enhance its market position and growth potential [15][18]. Summary by Sections Financial Forecasts and Valuation - The company is projected to achieve revenues of 589 million, 1.509 billion, and 1.449 billion yuan for the years 2025 to 2027, with growth rates of -40%, 156%, and -4% respectively [4][21]. - The net profit attributable to the parent company is expected to be -681 million, 196 million, and 156 million yuan for the same period, indicating a significant turnaround [4][21]. - Earnings per share (EPS) are forecasted to improve from -1.83 yuan in 2025 to 0.42 yuan in 2027 [4][21]. Product and Market Insights - Aorebatinib's sales are expected to continue growing, with a 93% year-on-year increase to 217 million yuan in the first half of 2025, driven by effective hospital access and chronic disease management strategies [7][11]. - APG-2575 is anticipated to receive regulatory approval in mid-2025, further solidifying the company's leadership in the domestic hematological oncology market [11][12]. - The report highlights the potential of APG-2575 to achieve rapid relief and improved safety in treating high-risk myelodysplastic syndromes (HR MDS) compared to existing therapies [14][18]. Pipeline and Future Developments - The company has several promising candidates in its pipeline, including APG-2449, which is undergoing Phase III trials for ALK-positive NSCLC, and various apoptosis inhibitors that are expected to provide competitive advantages in the oncology market [15][18]. - Upcoming milestones include the completion of several Phase III clinical trials for key products, which are expected to enhance the company's market presence and revenue potential [20].

Core Insights - The Suzhou biopharmaceutical industry is experiencing a surge in innovation, with significant regulatory approvals and investments, positioning itself as a leader in the sector [1][2][4] Industry Developments - The approval of the world's first dual-target weight loss drug by Innovent Biologics and the simultaneous regulatory green light for Ascentage Pharma's innovative drug in the US and Europe highlight the rapid advancements in Suzhou's biopharmaceutical sector [1] - The establishment of the China (Jiangsu) Free Trade Zone Biopharmaceutical Industry Chain Open Innovation Development Plan is expected to further enhance the growth of the biopharmaceutical industry in Suzhou [1] Investment and Growth - As of July 2023, there are 261 foreign-funded biopharmaceutical enterprises in Suzhou, with a total output value exceeding 880 billion yuan, reflecting a year-on-year growth of 3.4% [2] - Roche Diagnostics has made a significant investment of approximately 480 million USD in Suzhou, marking its largest single investment in China, which underscores the importance of the Suzhou base for its global operations [2] Local Innovation - Suzhou has seen the addition of four new biopharmaceutical companies listed this year, bringing the total to 38, which is expected to exceed 40 by year-end [3] - A total of 64 companies are participating in the application for the seventh batch of national "specialized, refined, distinctive, and innovative" small giant enterprises, with expectations to surpass 100 by year-end [3] Product Innovation - From January to July 2023, Suzhou introduced six new Class I innovative drugs, accounting for 14% of the national total, and five new innovative medical devices, representing 10.6% of the national total [4] - The launch of Innovent Biologics' injection, a dual receptor agonist for weight loss, breaks the long-standing monopoly of multinational pharmaceutical companies in the GLP-1 weight loss market [5] Global Collaboration - Suzhou's biopharmaceutical companies are increasingly engaging in high-value overseas licensing agreements, with notable collaborations exceeding 10 billion USD [6] - The global registration of a Bcl-2 selective inhibitor by Ascentage Pharma, approved by both the FDA and EMA, signifies the international recognition of Suzhou's clinical trial standards [6] Technological Advancements - The successful use of a medical device developed by Suzhou's Peijia Medical in a complex surgery in Ethiopia exemplifies the global impact of Suzhou's innovative medical solutions [7] - The Suzhou government is actively drafting development plans for the biomanufacturing industry, aiming to enhance project attraction and support [8]