Core Insights - The article highlights the journey of Ascentage Pharma, emphasizing its commitment to addressing unmet clinical needs through innovation and perseverance in the pharmaceutical industry [2][6]. Group 1: Company Overview - Ascentage Pharma, founded in 2009, has evolved from a small startup to a publicly listed company on both the Hong Kong Stock Exchange and NASDAQ, marking significant milestones in its growth [2][5]. - The company has successfully developed and commercialized two products: Nilotinib, which treats drug-resistant chronic myeloid leukemia, and a new Bcl-2 selective inhibitor, Lisenglitazone, which is the first domestically developed Bcl-2 inhibitor approved in China and the second globally [2][6]. Group 2: Financial and Investment Highlights - Ascentage Pharma has secured substantial funding over the years, including a $300 million investment from 3SBio in 2010, which was crucial for its survival during challenging times [4]. - The company raised nearly $100 million in Series A financing in 2015, which facilitated its establishment in Suzhou, benefiting from the region's vibrant biopharmaceutical ecosystem [4]. Group 3: Research and Development Focus - The company is dedicated to developing drugs that meet real clinical needs, with a pipeline that includes six products in clinical stages targeting various cancers, including non-small cell lung cancer and ovarian cancer [6][7]. - Ascentage Pharma aims to accelerate the internationalization of Nilotinib and further commercialize Lisenglitazone while expanding its pipeline to benefit more patients globally [6][8]. Group 4: Strategic Partnerships and Market Position - The company has engaged in significant business development (BD) transactions, including a notable $1 billion deal with Takeda Pharmaceutical for the global development and commercialization of Nilotinib, setting a record for domestic small molecule oncology drugs [7]. - Ascentage Pharma is transforming into a full-cycle enterprise encompassing drug research, production, and commercialization, enhancing its role in the biopharmaceutical industry ecosystem [7].

Core Insights - The Chinese sickle cell disease treatment industry is transitioning from symptomatic treatment to curative treatment, driven by breakthroughs in gene editing technology [1][11] - The market size for sickle cell disease treatment in China is projected to reach approximately 4.287 billion yuan in 2024, representing a year-on-year growth of 66.03% [1][11] Industry Overview - Sickle cell disease is an autosomal recessive genetic disorder caused by mutations in the beta-globin gene, leading to abnormal hemoglobin (HbS) that causes red blood cells to deform into a sickle shape, resulting in hemolysis, vascular occlusion, and multi-organ ischemic damage [2][6] - Current treatment methods include medication, blood transfusions, hematopoietic stem cell transplantation, and gene therapy, with the goal of alleviating symptoms, preventing complications, and improving quality of life [4][11] Industry Development History - The early exploration phase from the 1950s to the 1980s focused on symptom management through blood type screening and family history investigations in high-prevalence areas [6][7] - The standard treatment phase from the 1990s to the 2010s saw the introduction of hydroxyurea and regular blood transfusions, although long-term transfusions led to iron overload [7][11] - The breakthrough phase from the 2010s to present has seen advancements in gene therapy, with significant clinical trials and the approval of therapies like CASGEVY by the FDA [7][11] Industry Value Chain - The upstream of the sickle cell disease treatment industry includes raw materials such as cells, growth factors, and gene editing tools like CRISPR-Cas9 [9][10] - The midstream focuses on research and production of sickle cell disease treatments, while the downstream primarily serves patients suffering from the disease [9][10] Market Size - The sickle cell disease treatment market in China is experiencing significant growth, with a projected market size of approximately 4.287 billion yuan in 2024, reflecting a 66.03% increase from the previous year [1][11] Key Companies' Performance - The industry is characterized by a "technology-driven" competitive landscape, with companies like Zhengxu Bio leading in gene therapy innovations [12][13] - Traditional pharmaceutical companies such as Heng Rui Medicine and Shijiazhuang Pharmaceutical Group leverage their production capabilities and insurance coverage to maintain a strong presence in the basic treatment market [12][13] Industry Development Trends 1. Continuous technological innovation is driving a paradigm shift in treatment approaches, with gene editing tools enabling targeted repair of the beta-globin gene [14] 2. Policy and market developments are fostering industry expansion, with the government prioritizing gene editing in its biopharmaceutical strategy [15] 3. Deepening global collaborations are enhancing the industry ecosystem, with partnerships between multinational and local companies accelerating the localization of gene therapies [16][17]

Core Viewpoint - The report highlights the changes in the Hong Kong Stock Connect holdings, indicating which companies have seen the largest increases and decreases in ownership percentages over recent trading days [1][2][3]. Summary by Category Recent Changes in Holdings - GX Hengsheng High Dividend (03110) saw an increase of 0.22% in its Hong Kong Stock Connect holding percentage, bringing it to 2.09% [2] - The largest decrease was observed in Southern Hengsheng Technology (03033), which dropped by 0.31% to 59.93% [2] Five-Day Changes - The most significant increase in holdings over the last five trading days was for Dazhong Public Utilities (01635), which rose by 8.30% to 67.37% [3] - Conversely, Kingsoft Cloud (03896) experienced the largest decrease, falling by 2.65% to 25.92% [3] Twenty-Day Changes - Over the past twenty days, Dazhong Public Utilities (01635) also led with a substantial increase of 34.28%, reaching a holding percentage of 67.37% [4] - The largest decrease was recorded for Yisou Technology (02550), which fell by 13.04% to 33.85% [4]

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 ...

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].

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]

第 1 頁 共 10 頁 v 1.1.1 FF301 | 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 | | | 500,000,000 | USD | | 0.0001 USD | | 50,000 | 本月底法定/註冊股本總額： USD 50,000 FF301 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8月31日 | | | | 狀態: 新提交 | | --- | --- | --- | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | | | | 公司名稱: | 亞 ...

Investment Rating - The report assigns a "Buy-A" investment rating to the company, with a 6-month target price of 93.12 HKD [4][6]. Core Insights - The company reported a revenue of 234 million RMB and a net profit loss of 591 million RMB for the first half of 2025. The sales of Aorebatin continued to grow, with a 93% increase in revenue from 113 million RMB in the first half of 2024 to 217 million RMB in the first half of 2025 [2]. - The approval of Lisaftoclax in China is expected to provide a new revenue source, with multiple clinical trials progressing rapidly [3]. - The company anticipates revenues of 520 million RMB, 2.78 billion RMB, and 1.57 billion RMB for 2025, 2026, and 2027, respectively, with net profits projected at -1.04 billion RMB, 700 million RMB, and -520 million RMB for the same years [4]. Financial Performance Summary - Revenue for 2023 was 221.98 million RMB, projected to increase to 980.65 million RMB in 2024, and then to 519.81 million RMB in 2025, followed by 2.78 billion RMB in 2026 and 1.57 billion RMB in 2027 [9]. - The net profit for 2023 was -926.79 million RMB, expected to improve to -405.40 million RMB in 2024, and then to -1.04 billion RMB in 2025, with a forecasted profit of 696.27 million RMB in 2026 and a loss of 520.65 million RMB in 2027 [13]. - The company’s gross margin is expected to remain around 90% from 2025 to 2034, indicating strong profitability potential [10]. Clinical Development Pipeline - Aorebatin is undergoing multiple clinical trials, including the POLARIS-3, POLARIS-2, and POLARIS-1 studies, which are progressing smoothly [2]. - Lisaftoclax has received NMPA approval for treating adult CLL/SLL patients who have undergone prior treatment, with several global clinical trials also in progress [3].