Core Insights - The surge in demand for new drug R&D by Chinese companies has led to a near doubling of the market value of biotech stocks listed in Hong Kong this year [1] - Several biotech firms have raised billions of dollars in Hong Kong under special listing rules, indicating strong investor interest [1] - China's biopharmaceutical industry is transitioning from being a low-cost generic drug supplier to a manufacturer of cutting-edge products, aided by advancements in artificial intelligence [1] Industry Developments - China controls approximately 80% of the global supply chain for active pharmaceutical ingredients (APIs) but is now also home to 23% of next-generation therapeutic candidates [3] - The rise of China's biopharmaceutical sector is attributed to comprehensive reforms in drug approval regulations since 2015 and the inclusion of biotechnology in the "Made in China 2025" strategic plan [3] - As of June this year, China ranks second globally in bioscience research, with six of the top 20 global research institutions located in Chinese universities [3] Cost Competitiveness - From 2017 to 2023, the average patient cost for clinical research of innovative drugs in China is only 30% to 50% of that of multinational companies, enhancing the global competitiveness of Chinese innovative drugs [3] - For instance, the drug Orelabrutinib, developed by Ascentage Pharma for chronic myeloid leukemia, is expected to be priced at one-third to one-fourth of the U.S. developed Iclusig [3] Geopolitical Context - The U.S. has recognized the rise of Chinese pharmaceuticals and has attempted to impose a 100% tariff on imported brand-name drugs unless companies establish manufacturing in the U.S. [5] - This creates a paradox for the U.S., as it seeks to reduce reliance on China while also aiming to lower drug prices, which tariffs cannot achieve simultaneously [5] - Despite tariff barriers, the global demand for high-cost performance innovative drugs remains strong, prompting Chinese biotech firms to accelerate their internationalization efforts [5]

Summary of the Conference Call for Ascentage Pharma Industry and Company Overview - The conference call focuses on Ascentage Pharma, a biopharmaceutical company specializing in innovative cancer therapies, particularly in the field of apoptosis and targeted therapies [2][3]. Key Points and Arguments 1. **Orebatein Expansion**: Orebatein, a third-generation TKI, expanded its indications in October 2023 to cover more CML patients, with expectations to be included in the national health insurance by the end of 2024, significantly enhancing market potential. The domestic sales reached 217 million yuan, with a forecasted doubling for the year [2][4]. 2. **BCL-2 Inhibitor Launch**: Ascentage Pharma launched its first domestic BCL-2 inhibitor, targeting relapsed CLL/SLL, which has a superior administration method compared to venetoclax, faster cellular uptake, and higher safety. Multiple phase III registration trials are ongoing, indicating a broad market outlook [2][4]. 3. **Collaboration with Takeda**: The company entered a licensing agreement with Takeda for the drug Nilotinib, with a total transaction value of 1.3 billion USD, including an upfront payment of 100 million USD. The remaining amount consists of milestone payments and sales sharing, with three phase III registration trials currently in progress [2][5]. 4. **Sales and R&D Expenses**: In the first half of 2024, sales expenses were 138 million yuan, with an annual estimate of 250 to 300 million yuan. R&D expenses reached 529 million yuan, with expectations to exceed 1 billion yuan for the year, indicating a continued increase in R&D investment [2][5]. 5. **Clinical Trials**: Orebatein is undergoing three phase III registration trials, while the BCL-2 inhibitor is also in multiple phase III trials covering AML, CLL/SLL, MDS, and multiple myeloma [2][6]. 6. **CML Market Size**: The global TKI market for CML is approximately 6 billion USD, with the domestic market around 4 billion yuan. The rapid growth of third-generation TKIs is noted, with Nilotinib being the only domestic third-generation TKI, providing a competitive edge [2][7][8]. Additional Important Information 1. **Market Competition**: The global CML TKI market is characterized by the expiration of patents for first and second-generation TKIs, with significant market players like Novartis and Takeda. Orebatein is positioned to complete its overseas phase III trials and apply for market approval by 2026 [7][9]. 2. **Advantages of BCL-2 Inhibitor**: Compared to venetoclax, Ascentage's BCL-2 inhibitor offers advantages in administration, faster cellular uptake, and lower side effects due to a shorter half-life. Ongoing trials include combinations with other therapies for various indications [2][11]. 3. **Future Directions**: Ascentage Pharma aims to continue its focus on apoptosis pathways and advance new L-type inhibitors for solid tumors, while also pursuing international expansion and product innovation to meet market expectations [3][12].

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].

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].

Core Viewpoint - The company is experiencing significant growth in its core product, Orebacitinib, despite a decline in overall revenue due to previous collaborations and licensing income. The commercial team is effectively expanding patient access and driving sales growth [1][2]. Group 1: Financial Performance - In H1 2025, the company's main operating revenue was 234 million yuan, a year-on-year decrease of 71.6%, primarily due to 678 million yuan in licensing income recorded in the same period of 2024 [1]. - The gross margin for H1 2025 was approximately 91% [1]. - Sales revenue from Orebacitinib increased significantly by 92.4% year-on-year to 217 million yuan [1]. - Sales expenses rose by 53.7% to 138 million yuan, while R&D expenses increased by 19% to 529 million yuan [1]. Group 2: Product Development and Commercialization - Orebacitinib's sales growth is expected to double by the end of the year, with a 93% increase in H1 2025 aligning with expectations [1]. - The company has expanded its commercial team, with a 47% increase in patient admissions in H1 2025, and all approved indications are now covered by insurance [1]. - The company is advancing multiple global clinical trials for Orebacitinib, including treatments for CML and Ph+ALL [1]. - On July 10, 2025, the company received conditional approval for Lisatoclax for CLL/SLL patients, with the first prescription already issued [2]. - The company has built its domestic commercialization team, which has grown to over 140 people as of July 31, 2025, and is expected to exceed 200 by the end of the year [2]. Group 3: Leadership and Cash Reserves - The company appointed Dr. Veet Misra as CFO and Mr. Huang Zhi as Senior Vice President of Global Corporate Development & Finance, enhancing leadership in global development [3]. - Cash reserves reached 1.661 billion yuan in H1 2025, and after a 1.5 billion yuan placement in Hong Kong, total cash reserves exceeded 3 billion yuan, sufficient to support ongoing core pipeline development [3]. Group 4: Revenue Forecast - The company anticipates rapid revenue growth driven by Orebacitinib and Lisatoclax sales, revising revenue forecasts for 2025-2027 to 586 million, 3.266 billion, and 2.121 billion yuan respectively [3].

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].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company's drug commercialization is in line with expectations, and the potential for clinical advancement has significantly increased [1] - The core product, Orebate, has shown impressive sales growth, with a year-on-year increase of 92.4% to 217 million yuan in the first half of 2025, and is expected to double by the end of the year [7] - The company has successfully launched another product, Lisatoclax, which received conditional approval for marketing, indicating strong commercialization progress [7] - The company has a robust cash reserve of over 3 billion yuan, sufficient to support ongoing pipeline development [7] - Revenue forecasts for 2025-2027 have been revised upwards due to the anticipated sales growth of Orebate and Lisatoclax [7] Financial Summary - Total revenue for 2023 is projected at 225.09 million yuan, with significant growth expected in subsequent years, reaching 3,265.89 million yuan by 2026 [1] - The net profit for 2023 is expected to be a loss of 925.64 million yuan, with a forecasted recovery to a profit of 1,058.67 million yuan by 2026 [1] - The earnings per share (EPS) is projected to improve from a loss of 2.49 yuan in 2023 to a profit of 2.85 yuan in 2026 [1] - The company’s cash and cash equivalents are expected to reach 1,105.83 million yuan by 2025, supporting its operational needs [8]

Group 1 - The complexity of hematological tumors presents numerous investment opportunities in various subtypes of treatment [1] - The market for hematological tumors is expanding due to innovative therapies, with significant product launches expected [1] - The number of long-term patients is increasing, with approximately 4 million patients globally having survived five years or more as of 2022, which is three times the number of new patients [1] Group 2 - Future development directions for hematological tumor treatment include improving efficacy, reducing recurrence, and optimizing administration [2] - Acute leukemias like AML and ALL primarily use chemotherapy or targeted combination therapies to enhance survival rates [2] - CAR-T therapy shows high remission rates for aggressive lymphomas and multiple myeloma, providing more treatment options for patients [2] Group 3 - The competition in the targeted drug market for hematological tumors has entered a new phase, with a focus on technological iterations and exploration of new targets [3] - In the BTK field, new products are emerging to compete in the post-resistance market, with Zebutinib outperforming Ibrutinib [3] - The BCL-2 domain is seeing advancements with differentiated designs and optimized dosing strategies to gain competitive advantages [3]

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.