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]

Core Viewpoint - The report from China Galaxy recommends the pharmaceutical industry, highlighting the significant growth potential in the hematological oncology market driven by innovative therapies and the increasing number of long-term patients [1] Group 1: Market Dynamics - The hematological oncology market is expanding due to advancements in precision diagnostics, prognostic stratification, immunotherapy, and targeted therapies, leading to improved survival rates and quality of life for patients [1] - According to WHO, the number of long-term patients with hematological malignancies reached approximately 4 million in 2022, which is three times the number of new patients, indicating a growing market for treatments [1] - The market is expected to see blockbuster products, with global sales of Daratumumab exceeding $10 billion in 2024, and both Ibrutinib and Lenalidomide surpassing $5 billion in sales [1] Group 2: Treatment Trends - Future treatment directions for hematological malignancies focus on improving efficacy, reducing relapse rates, and optimizing administration methods, particularly in acute leukemias and chronic leukemias [2] - In chronic myeloid leukemia (CML), the use of BCR-ABL TKI therapy is being explored to overcome resistance through technological iterations and new targets [2] - CAR-T therapy is providing more treatment options for patients with high relapse rates, particularly in aggressive lymphoma and multiple myeloma [2] Group 3: Competitive Landscape - The targeted drug market for hematological malignancies is entering a new competitive phase, with innovations in BTK inhibitors and BCL-2 inhibitors leading the way [3] - Zebutinib has outperformed Ibrutinib, establishing itself as a leading product in the BTK space, while the market for post-resistance treatments is becoming increasingly competitive [3] - In the BCL-2 space, advancements in dosing and differentiated designs are giving products like Lisocabtagene Maraleucel a competitive edge [3] Group 4: Investment Opportunities - The complexity of hematological malignancies presents numerous investment opportunities, particularly as treatment approaches evolve towards chronic disease management [4] - Companies to watch include BeiGene, which is covering the CLL/SLL indications with a comprehensive product matrix, and Innovent Biologics, which is building a diversified product portfolio centered around Orelabrutinib [4] - Ascentage Pharma is focusing on third-generation BCR-ABL inhibitors and BCL-2 inhibitors to create differentiated competitive advantages [4]

Investment Rating - The report maintains a "Buy" rating for the blood cancer drug industry [3][6]. Core Insights - The blood cancer market is expanding due to innovative therapies, with significant advancements in precision diagnosis, prognosis stratification, and targeted therapies such as CAR-T and TCE, leading to improved patient survival and quality of life [5][8]. - The number of patients with blood cancer who have survived for five years or more is approximately 4 million globally, which is three times the number of new patients, indicating a growing market for long-term treatments [5][13]. - The high cost of blood cancer drugs and the emergence of blockbuster products are driving market growth, with several drugs expected to exceed $10 billion in sales by 2024 [5][17]. Summary by Sections 1. Blood Cancer Market Expansion - The proportion of new blood cancer patients is less than 10% of all new cancer cases, with a steady increase in incidence rates [8]. - Blood cancer patients have a long survival period, resulting in a large population of existing patients [13]. - The high cost of blood cancer treatments contributes to the frequent emergence of blockbuster drugs [17]. 2. Clinical Diagnosis and Treatment of Blood Cancer - Blood cancers are classified based on cell origin, differentiation, and affected sites, including leukemia, lymphoma, and multiple myeloma [19][20]. - Treatment for acute leukemia primarily involves chemotherapy or targeted combination therapies to improve survival rates [24]. - Lymphoma treatment varies by subtype, with Rituximab being a cornerstone therapy [23]. - Multiple myeloma treatment focuses on CD38 monoclonal antibodies, with ongoing exploration of solutions for relapsed and refractory cases [23]. 3. Analysis of Popular Targets and Therapies - The BTK field is seeing intense competition, with new products emerging to address resistance issues [5]. - The BCL-2 area is advancing with differentiated designs and optimized dosing strategies [5]. - The BCR-ABL TKI domain is witnessing the introduction of third-generation inhibitors that show superior efficacy [5]. 4. Company Profiles - BeiGene is focusing on a comprehensive product matrix to cover CLL/SLL indications [5]. - Innovent Biologics is building a diversified product portfolio centered around Oubreti [5]. - Ascentage Pharma is developing third-generation BCR-ABL inhibitors and BCL-2 inhibitors to create competitive advantages [5]. - Diligent Pharma is innovating with a globally first high-selectivity JAK1 inhibitor and a dual-target LYN/BTK inhibitor [5]. 5. Investment Recommendations - The blood cancer sector presents numerous investment opportunities due to its complexity and the variety of treatment subfields [5]. - The long survival cycle of blood cancer patients and the high costs of drug treatments indicate a significant market potential [5].

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.

Group 1 - As of recent announcements, the company has completed a fundraising of approximately HKD 14.93 billion (around CNY 1.368 billion), bringing total fundraising to over CNY 2.2 billion within six months [1][3] - The core purpose of the fundraising is to commercialize the newly approved core product, APG-2575, a selective Bcl-2 inhibitor, which is the first domestically developed Bcl-2 inhibitor approved for market [1][4] - The company plans to establish its own commercialization team for APG-2575, with expectations to achieve breakeven by 2027 [1][6] Group 2 - The recent fundraising was completed through the sale of 22 million shares at HKD 68.60 each, with all preconditions for the placement being met [2][3] - The net proceeds from the recent fundraising are expected to be allocated as follows: 40% for expanding coverage and improving patient access (approximately CNY 5.47 billion), 35% for global clinical development of core pipeline products (approximately CNY 4.76 billion), and 25% for infrastructure and operational funding (approximately CNY 3.42 billion) [3] - The company has signed cooperation agreements with major pharmaceutical distributors to advance the commercialization of APG-2575 [6] Group 3 - The company reported a revenue of CNY 981 million in 2024, with a loss of CNY 405 million, marking the lowest loss level in recent years [6] - The company is currently conducting four global Phase III clinical trials for APG-2575, targeting multiple indications including acute myeloid leukemia and multiple myeloma [7] - The global sales of the first Bcl-2 inhibitor, Venclexta, are projected to exceed USD 3 billion in 2024, indicating a strong market potential for Bcl-2 inhibitors [7]

Core Insights - The successful launch of the drug Lisatoclax (also known as Lishengtuo) by Ascentage Pharma marks a significant milestone in the development of Bcl-2 inhibitors, breaking a nine-year monopoly held by AbbVie in this field [3][10] - The research on the Bcl-2 target has spanned over three decades, highlighting the challenges and complexities involved in drug development [3][5] - Ascentage Pharma aims to differentiate its products from existing therapies, focusing on innovative solutions to address unmet clinical needs [4][6] Company Overview - Ascentage Pharma's Lisatoclax is the first domestically developed Bcl-2 inhibitor in China and the second globally, showcasing the company's commitment to innovation [3][10] - The company has also developed another product, Olverembatinib (brand name: Nairike), which took 13 years to develop, further emphasizing its long-term investment in research [3] - The CEO of Ascentage Pharma, Yang Dajun, emphasizes the importance of targeting difficult drug targets and conducting rigorous clinical designs to achieve superior drug efficacy [4][6] Clinical Development - The Bcl-2 target is likened to PD-1 in blood cancer treatment, with the potential to treat various B-cell tumors effectively [5][6] - Lisatoclax has a unique dosing regimen that allows for a rapid escalation to the target dose, which is crucial for minimizing severe side effects like Tumor Lysis Syndrome (TLS) [6][7] - Clinical data suggest that Lisatoclax has a lower incidence of TLS compared to its competitors, enhancing its safety profile and making it a more convenient treatment option [6][7] Market Position and Strategy - Ascentage Pharma's stock has seen significant growth, with a year-to-date increase of over 70% in Hong Kong and more than 120% in the US market, indicating strong investor confidence [12] - The company aims to navigate the competitive landscape of innovative drugs by focusing on unique therapeutic targets rather than following trends in the market [12][13] - Yang Dajun believes that the current wave of innovation in the pharmaceutical industry is a result of accumulated experience, technological breakthroughs, and supportive policies [10][11] Future Outlook - Ascentage Pharma is optimistic about achieving profitability by 2027, reflecting its strategic focus on developing proprietary products that can generate revenue [13] - The company is positioned to capitalize on the evolving landscape of the biopharmaceutical industry, where the distinction between biotech and large pharmaceutical companies is increasingly defined by the ability to generate profits from self-developed products [13]

Core Insights - A Chinese original drug, APG-2575 (brand name: Lisatoclax), has broken the nearly decade-long monopoly of multinational pharmaceutical companies in the global anti-cancer drug market, marking a significant shift in the competitive landscape [2][9] - The drug has received conditional approval from the National Medical Products Administration (NMPA) in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have undergone at least one systemic treatment including a BTK inhibitor [2][5] Drug Development Challenges - The Bcl-2 target, discovered in 1985, has only two approved drugs: AbbVie's venetoclax and APG-2575, due to the high difficulty of drug development associated with protein-protein interactions and the need for drugs to penetrate cell membranes and mitochondrial membranes [3][4] - Major pharmaceutical companies have attempted to develop Bcl-2 inhibitors over the past 20 years without success, highlighting the complexity of this target [4] Market Potential - The global targeted apoptosis therapy market is projected to grow at a compound annual growth rate (CAGR) of 24% from 2023 to 2030, reaching a market size of $22 billion by 2030 [6] - The approval of Lisatoclax is expected to change treatment paradigms and expand the market for Bcl-2 inhibitors, especially in combination therapies [6] Commercialization Strategy - The company plans to independently drive the commercialization of Lisatoclax in China, aiming to explore additional indications beyond CLL/SLL [7][8] - The CEO emphasizes the importance of generating profits from product sales to support ongoing research and development, aiming for the company to achieve overall profitability by 2027 [8] Industry Trends - Following the success of APG-2575, other Chinese companies like BeiGene and Innovent Biologics are also developing Bcl-2 inhibitors, indicating a shift towards a new ecosystem of anti-cancer drugs led by Chinese enterprises [9]

Company Update - The company announced that its self-developed Bcl-2 selective inhibitor, APG-2575 (also known as Lisangtuo), received conditional approval from the National Medical Products Administration of China for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor [1] - Lisangtuo is the first Bcl-2 inhibitor approved in China for the treatment of CLL/SLL and the second globally, following AbbVie's venetoclax [1] Clinical Value and Research - The approval of Lisangtuo is based on a pivotal Phase II clinical study (APG2575CC201) that demonstrated an overall response rate (ORR) meeting the predefined endpoint for patients who failed BTK inhibitors and/or immunochemotherapy, with a favorable safety profile [2] - The drug has been included in the "CSCO Lymphoma Diagnosis and Treatment Guidelines 2025" as of April 2025 [2] - The company is conducting four global Phase III clinical studies to further explore Lisangtuo's indications, including studies for treated CLL/SLL patients and newly diagnosed acute myeloid leukemia (AML) patients [2] Profit Forecast and Valuation - The company maintains its net profit forecast for 2025 and 2026 at a loss of 1.09 billion yuan and 320 million yuan, respectively [2] - Given the approval of Lisangtuo and the potential for global indication expansion, the company maintains an outperform rating and raises the target price by 27.5% to 88 HKD, indicating a 15.3% upside from the current stock price [2]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has received conditional approval from the National Medical Products Administration (NMPA) for its self-developed Bcl-2 selective inhibitor APG-2575, marking it as the first domestically produced Bcl-2 inhibitor to be launched in China [7] - APG-2575 is positioned as a new treatment option for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy, including BTK inhibitors [7] - The company expects rapid revenue growth driven by the sales of its drug Aolebatin and potential payments from Takeda, with projected revenues of 5.19 billion, 32.15 billion, and 20.95 billion yuan for 2025, 2026, and 2027 respectively [1][7] Financial Projections - Total revenue is projected to reach 980.65 million yuan in 2024, followed by 519 million yuan in 2025, and then a significant increase to 3,215 million yuan in 2026, before declining to 2,095 million yuan in 2027 [1][8] - The net profit attributable to the parent company is expected to be (405.43) million yuan in 2024, (726.53) million yuan in 2025, 1,097.79 million yuan in 2026, and (841.66) million yuan in 2027 [1][8] - The earnings per share (EPS) are forecasted to be (1.16) yuan in 2024, (2.08) yuan in 2025, 3.15 yuan in 2026, and (2.42) yuan in 2027 [1][8]

Core Insights - The clinical data for Aosheng Pharmaceutical's core product, Orebatinib, presented at the EHA annual meeting indicates its potential to improve long-term outcomes for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) through various combination therapies [1] - Aosheng Pharmaceutical's APG-2575 showed promising results in treating myeloid malignancies, enhancing its commercial prospects against competitors like Venetoclax [2] - The company is expected to experience rapid revenue growth due to the sales ramp-up of Orebatinib and potential payments from Takeda, with revenue forecasts for 2025-2027 indicating significant increases [3] Group 1: Orebatinib Clinical Data - Orebatinib combined with Belinostat in a single-arm clinical trial for Ph+ or Ph-like ALL showed a median follow-up of 17 months, with a complete response (CR) rate of 100% after one treatment cycle and an overall survival (OS) rate of 100% at 18 months [1] - In the Orebatinib combined with VP regimen for adult Ph+ ALL, the overall response rate (ORR) was 100%, with a CR rate of 97.3% and a 2-year OS rate of 96.3% [1] Group 2: APG-2575 Clinical Data - The ASCO annual meeting revealed that APG-2575 combined with Azacitidine in a clinical study for previously treated or untreated myeloid malignancies had an ORR of 31.8%, with 4.6% of patients achieving a partial response (PR) [2] - The data suggests that APG-2575 may have a competitive edge over Venetoclax, particularly in differentiated indications, and the company is also exploring potential markets in MDS and MM [2] Group 3: Revenue Forecast and Investment Outlook - The company anticipates rapid revenue growth, maintaining revenue forecasts of 519 million yuan and 3.215 billion yuan for 2025 and 2026, respectively, with an additional forecast of 2.095 billion yuan for 2027 [3] - The strong growth outlook is supported by the overseas market potential and the expected sales increase of Orebatinib, leading to a "buy" rating for the stock [3]