Core Viewpoint - The innovative drug sector has rebounded significantly within six months, indicating a completed valuation repair and a shift towards event-driven phases in business development and clinical trials [3][4]. Group 1: Market Dynamics - The price-to-sales ratio (PS) for innovative drugs is currently at 14 times, close to the five-year average, suggesting a recovery in valuations [3]. - The Hong Kong market has become a primary venue for innovative drugs and new consumer products, with 28 new listings raising HKD 77.36 billion in the first five months of the year, a 707% increase year-on-year [7]. - Southbound capital has been a major force in driving up the stock prices of innovative drugs and new consumer sectors, with net inflows of HKD 55.14 billion and HKD 18.32 billion respectively throughout the year [9]. Group 2: Investment Sentiment - The innovative drug sector is experiencing a bubble, characterized by unrealistic expectations for companies lacking overseas expansion plans or self-research capabilities [3][4]. - Despite the risks associated with bubbles, they can stimulate investment in the sector, as the original innovation capabilities are strengthening, with China leading in the number of research pipelines [4][5]. - The trading congestion in the innovative drug sector has reached a high point, with trading volume nearing 4.8%, indicating a potentially overheated market [11]. Group 3: Future Outlook - The Chinese market is expected to see a surge in innovative drug supply, driven by regulatory changes that expedite clinical trial reviews, with timelines reduced from 60 days to 30 days for certain drugs [16]. - The potential for large business development (BD) opportunities in the second half of the year is significant, with a focus on companies that have demonstrated strong BD capabilities in the past [28]. - The innovative drug sector is projected to continue its growth trajectory, with major academic conferences scheduled for the latter half of the year, which will likely showcase new clinical data and further stimulate interest [28].

Core Viewpoint - The company’s core product, Lisaftoclax, demonstrated excellent efficacy in patients who were resistant to venetoclax, with an overall response rate (ORR) of 31.8% in 22 evaluable patients and 80% in 15 CMML patients, indicating strong potential for future clinical and international development [1][2]. Event - On June 3, 2025, the company announced the presentation of oral data on Lisaftoclax for patients who failed venetoclax treatment at the ASCO conference [1]. Efficacy Summary - In a study of 28 patients previously treated with venetoclax, 22 evaluable patients showed an ORR of 31.8%, with 22.8% achieving complete response (CR) or complete response with incomplete blood count recovery (Cri). Additionally, in 15 evaluable CMML patients, the ORR was 80%, with 40% achieving CR [1]. - Among 22 evaluable R/R MDS/CMML patients, the ORR was 50%, with 27.3% achieving CR and 18.2% achieving marrow CR [1]. Future Outlook - The company anticipates accelerated global commercialization, with core products expected to enter the U.S. market between 2026 and 2027. The commercial launch of Venetoclax is expected to further increase in 2025 as its indications expand [2]. - The POLARIS-2 clinical trial for Venetoclax is expected to be completed in 2026, with an NDA submission planned for the same year, potentially leading to U.S. market entry [2]. - The GLORA clinical trial for APG-2575 is expected to complete in 2027, with subsequent NDA submission and potential U.S. market launch [2]. Revenue Forecast and Investment Suggestion - The company has established multiple product pipelines in hematological malignancies and solid tumors, with significant revenue growth expected from international product launches and upfront payments. Revenue projections for 2025-2027 are 588 million, 883 million, and 1.324 billion respectively, with year-on-year growth rates of -40%, 50%, and 50% [2].

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]

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The report highlights that multiple clinical data presentations at ASCO and EHA conferences support the commercialization of the pipeline, particularly focusing on the promising results of core products like Olverembatinib and APG-2575 [7] - The report anticipates rapid revenue growth driven by the sales ramp-up of Olverembatinib and potential payments from Takeda, projecting revenues of RMB 5.19 billion and RMB 3.215 billion for 2025 and 2026 respectively, with an additional forecast of RMB 2.095 billion for 2027 [7] Financial Projections - Total revenue projections for the company are as follows: - 2023A: RMB 225.09 million - 2024A: RMB 980.65 million - 2025E: RMB 519.00 million - 2026E: RMB 3,215.00 million - 2027E: RMB 2,095.00 million - Year-on-year growth rates for total revenue are projected at: - 2024A: 335.68% - 2025E: -47.08% - 2026E: 519.46% - 2027E: -34.84% [1][8] - The net profit projections are as follows: - 2023A: -RMB 925.64 million - 2024A: -RMB 405.43 million - 2025E: -RMB 1,035.92 million - 2026E: RMB 1,092.41 million - 2027E: -RMB 842.34 million - Year-on-year growth rates for net profit are projected at: - 2024A: 56.20% - 2025E: -155.51% - 2026E: 205.45% - 2027E: -177.11% [1][8] Clinical Data Highlights - Olverembatinib's clinical data for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) showed a complete response (CR) rate of 100% after one treatment cycle, with an overall survival (OS) rate of 100% at 18 months [7] - APG-2575's clinical trial results indicated an overall response rate (ORR) of 31.8% in patients with relapsed/refractory acute myeloid leukemia (AML) who were previously treated with venetoclax [7]

Investment Rating - The report maintains a "Buy" rating for multiple companies in the pharmaceutical and biotech industry, indicating a positive outlook on their growth potential and market performance [6]. Core Insights - The ASCO conference showcased significant advancements in domestic innovative drugs, highlighting the competitive edge of Chinese pharmaceutical companies in the global market [4][12]. - The report emphasizes the clinical value and market potential of several key drugs presented at ASCO, including promising results from various companies [4][12]. Summary by Relevant Sections Domestic Key Research Overview - BaiLi Tianheng's BL-B01D1 demonstrated a 35.3% confirmed overall response rate (cORR) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [18]. - DiZhe Pharmaceutical's DZD6008 achieved over 80% overall response rate (ORR) in heavily treated chronic lymphocytic leukemia (CLL) patients, indicating its potential as a new treatment option [4][12]. - FuHong HanLin's PD-L1 ADC showed excellent performance in immune-resistant squamous NSCLC patients, while HLX22 is expected to redefine first-line treatment for advanced gastric cancer [4][12]. - KeLun BoTai's sac-TMT data confirmed long-term survival benefits in third-line EGFR-mutant NSCLC and first-line triple-negative breast cancer (TNBC) [4][12]. - KangNing JieRui's HER2 bispecific ADC demonstrated comparable efficacy and better safety than existing treatments [4][12]. - MaiWei Biotech's 9MW2821 combined with toripalimab is anticipated to be a strong contender in first-line urothelial carcinoma treatment [4][12]. - SanSheng Pharmaceutical updated data on SSGJ-707 for first-line treatment of wild-type NSCLC, with a significant partnership with Pfizer [4][12]. - XinDa Biotech's IBI363 showed potential in activating "cold" tumors, aiming to become a cornerstone drug in immunotherapy [4][12]. - YaSheng Pharmaceutical's Lisaftoclax achieved positive results in patients resistant to venetoclax, filling a treatment gap in myeloid malignancies [4][12]. - ZhengDa TianQing's "DeFu combination" was selected for LBA, potentially offering a new first-line treatment for PD-L1 positive NSCLC [4][12]. - ZeJing Pharmaceutical and ZaiDing Pharmaceutical presented excellent data on ZG006 and ZL-1310 for late-line SCLC treatment, showcasing the global competitiveness of domestic drugs [4][12].

Company Updates - The company presented data on Bcl-2 inhibitor APG-2575 (lisaftoclax) in combination with azacitidine for myeloid malignancies at the 2025 ASCO annual meeting, along with updates on MDM2-p53 inhibitor APG-115 (alrizomadlin) for advanced adenoid cystic carcinoma (ACC) and other solid tumors [1][2] Clinical Data Highlights - APG-2575 demonstrated promising results in a global multicenter Ib/II study for relapsed/refractory acute myeloid leukemia (R/R AML) with an overall response rate (ORR) of 43.2% among 44 evaluable patients, including a complete response (CR) or complete response with incomplete blood count recovery (CRi) rate of 31.8% [1] - In a subgroup of 22 patients previously treated with venetoclax, the ORR was 31.8%, with 22.8% achieving CR/CRi [1] - For newly diagnosed myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), APG-2575 showed an ORR of 80% in 15 evaluable patients, with 40% achieving CR [2] - Among 22 evaluable R/R MDS/CMML patients, the ORR was 50%, with 27.3% achieving CR [2] - APG-115 showed anti-tumor activity with an ORR of 16.7% in advanced ACC patients and 100% disease control rate (DCR) in a cohort of cholangiocarcinoma patients [2] Financial Forecast and Valuation - The company maintains its net loss forecast for 2025 and 2026 at 1.095 billion and 319 million respectively [3] - Due to the promising data from APG-2575, the company sees potential for unlocking more commercial value in AML/MDS indications and has raised its target price by 25.5% to HKD 69, indicating a 16.2% upside from the current stock price [3]

Core Viewpoint - Ascentage Pharma's stock surged over 7%, reaching a historic high of 59.55 HKD, following the presentation of promising clinical trial data for its Bcl-2 inhibitor, APG-2575 (lisaftoclax), at the 61st American Society of Clinical Oncology (ASCO) annual meeting [1] Group 1: Clinical Research and Development - The latest data from the Ib/II clinical study of APG-2575 combined with azacitidine for treating newly diagnosed or previously treated myeloid malignancies demonstrated both excellent efficacy and safety [1] - The study reported for the first time that lisaftoclax showed good therapeutic responses in patients who previously failed treatment with venetoclax, highlighting its differentiated efficacy and potential advantages over similar products [1] Group 2: Regulatory Progress - Lisaftoclax, a novel Bcl-2 selective inhibitor developed by Ascentage Pharma, has had its New Drug Application (NDA) accepted for priority review by the National Medical Products Administration (NMPA) in November 2024 for treating relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - It is the second Bcl-2 inhibitor globally to submit an NDA and the first domestically developed Bcl-2 inhibitor in China to enter priority review [2] - Currently, there are four global registration III clinical trials underway for Lisaftoclax, covering indications such as CLL/SLL, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS), with one trial being FDA-approved for global registration [2]

Group 1 - As of June 3, a total of 105 stocks reached their 52-week highs, with Huayin International Holdings (00989), Dingyifeng Holdings (00612), and Youquhui Holdings (02177) leading the high rate at 57.26%, 37.93%, and 23.02% respectively [1] - The closing prices and highest prices for the top three stocks are as follows: Huayin International Holdings at 1.370 and 1.950, Dingyifeng Holdings at 0.770 and 0.800, and Youquhui Holdings at 3.550 and 3.580 [1] - Other notable stocks that reached their 52-week highs include China Antibody-B (03681) with a high rate of 21.62% and Fengcheng Holdings (02295) at 19.52% [1] Group 2 - The report also lists stocks that reached their 52-week lows, with Des Holdings (08437) showing the largest decline at -38.79%, followed by Dimi Life Holdings (01667) at -20.50% [3] - The closing prices and lowest prices for the top three stocks that reached their lows are: Des Holdings at 0.177 and 0.071, Dimi Life Holdings at 0.140 and 0.128, and Lujizhi Technology (01745) at 0.197 and 0.194 [3] - Other stocks with significant declines include GBA Group (00261) at -11.48% and Baide International (02668) at -10.88% [3]

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

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