Investment Rating - The report maintains a strong confidence in the pharmaceutical sector's potential for a reversal in 2025, particularly focusing on innovative drugs and the recovery of left-side sectors as the biggest investment opportunities for the year [5][14]. Core Insights - The innovative drug sector is expected to continue its upward trend, with BD (business development) activities anticipated to catalyze market movements. The upcoming ESMO conference (October 17-21) is highlighted as a key event for clinical data disclosures from domestic innovative drug companies [2][13]. - The report emphasizes the importance of recent Nobel Prize discoveries related to peripheral immune tolerance, which are relevant to the development of new therapies in oncology and autoimmune diseases. This underscores the significance of innovation in these fields [40][50]. - The report notes that the CXO industry in China is entering a recovery phase, with improvements expected in industry orders, capacity utilization, and performance metrics due to enhanced domestic investment and financing data [2][5]. Summary by Sections Innovative Drugs - The innovative drug sector has seen a recent pullback, but the long-term upward trend remains intact. The report suggests that the market is awaiting further BD catalysts and highlights the importance of upcoming clinical data from the ESMO conference [2][13]. - The report indicates that the overall sentiment in the innovative drug sector is still positive, with a focus on potential breakthroughs in cancer and autoimmune therapies following the recent Nobel Prize discoveries [40][50]. Biologics - Novo Nordisk announced an agreement to acquire Akero for $4.7 billion, with Akero's FGF21 analog EFX showing promise as a leading therapy for metabolic dysfunction-related fatty liver disease (MASH) [3][51]. - The report suggests that EFX is the only drug in Phase 2 trials demonstrating significant fibrosis regression in F4 patients, highlighting the need for continued attention to developments in this area [51][57]. Medical Devices - The commercialization of innovative products is accelerating, with domestic replacements making significant progress. For instance, MicroPort's Tumi laparoscopic surgical robot has surpassed 100 global orders and is leading the domestic market share [4][58]. - The report notes that the Tumi robot has received market access in over 60 countries and regions, with a strong presence in high-end markets such as Europe [60][62]. Traditional Chinese Medicine - There has been a continuous increase in new drug IND and NDA applications for traditional Chinese medicine, with 92 new IND applications and 42 NDA applications reported in the first nine months of 2025 [3][64]. - The report highlights ongoing policy support for traditional Chinese medicine, which is expected to drive further innovation and development in this sector [64][65].

Market Performance - The Hong Kong stock market continued its decline, with notable drops in several biotech companies [1] - Innovent Biologics (09969) fell by 11.19%, closing at 14.760, with a market capitalization of 26.021 billion and a year-to-date increase of 141.18% [2] - Rongchang Biologics (09995) decreased by 10.22%, with a latest price of 95.350 and a total market value of 53.74 billion, reflecting a year-to-date increase of 562.15% [2] - WuXi AppTec (02268) and WuXi Biologics (02269) experienced declines of 5.68% and 5.32%, respectively, with market caps of 89.818 billion and 1585.28 billion [2] - Other companies such as Fuhong Hanlin (02696) and Kelun-Biotech (06990) also saw declines of over 4% [1][2] Company Highlights - Innovent Biologics has shown a significant year-to-date performance increase of 141.18% despite the recent drop [2] - Rongchang Biologics has the highest year-to-date increase among the listed companies at 562.15% [2] - WuXi Biologics and WuXi AppTec have maintained strong year-to-date increases of 120.84% and 138.50%, respectively [2] - Fuhong Hanlin and Kelun-Biotech also reported substantial year-to-date increases of 205.49% and 199.33% [2]

Core Viewpoint - The Hong Kong biopharmaceutical stocks continued to decline, with significant drops in several key companies, indicating a bearish trend in the sector [1]. Group 1: Stock Performance - Innovent Biologics (09969) experienced a decline of 11.19%, with a latest price of 14.760 and a total market capitalization of 26.021 billion, despite a year-to-date increase of 141.18% [2]. - Rongchang Biologics (09995) fell by 10.22%, with a latest price of 95.350 and a market cap of 53.747 billion, showing a remarkable year-to-date increase of 562.15% [2]. - WuXi AppTec (02268) saw a decrease of 5.68%, with a latest price of 73.100 and a market cap of 89.818 billion, maintaining a year-to-date increase of 138.50% [2]. - WuXi Biologics (02269) dropped by 5.32%, with a latest price of 38.780 and a market cap of 158.528 billion, reflecting a year-to-date increase of 120.84% [2]. - Fuhong Hanlin (02696) declined by 4.42%, with a latest price of 72.400 and a market cap of 39.349 billion, showing a year-to-date increase of 205.49% [2]. - Kelun-Biotech (06990) decreased by 4.25%, with a latest price of 488.800 and a market cap of 113.981 billion, with a year-to-date increase of 199.33% [2]. - WuXi AppTec (02359) fell by 4.19%, with a latest price of 114.400 and a market cap of 339.275 billion, reflecting a year-to-date increase of 109.21% [2]. - Gendicine (09688) saw a decrease of 2.83%, with a latest price of 25.440 and a market cap of 28.432 billion, with a year-to-date increase of 21.72% [2]. - CanSino Biologics (09926) declined by 2.05%, with a latest price of 128.800 and a market cap of 118.643 billion, reflecting a year-to-date increase of 112.19% [2]. - Junshi Biosciences (01877) fell by 2.02%, with a latest price of 29.100 and a market cap of 29.877 billion, showing a year-to-date increase of 151.30% [2].

Core Viewpoint - The domestic innovative drug industry is transitioning from a follower to FIC/BIC innovation, supported by engineer dividends, abundant clinical resources, and favorable policies, indicating a qualitative improvement as it enters the 2.0 era [1][2] Group 1: Industry Development - The innovative drug sector is expected to benefit from policy reforms in payment systems, enhancing the profitability of innovative drug companies as they commercialize domestic products [2] - The upcoming ESMO conference in mid-October is anticipated to provide new investment opportunities through the release of relevant clinical data and business development (BD) activities [2] Group 2: Investment Climate - The investment landscape has improved since early this year, with a notable reversal in the financing trend for the innovative drug industry, particularly in the A/H market [3] - The recovery of IPO projects and financing activities in the secondary market is expected to positively impact investment data in Q3, benefiting domestic CROs and upstream research sectors [3] Group 3: Policy Support - Continuous advancement of commercial medical insurance policies since 2025 is likely to accelerate payment system reforms, easing supply-demand conflicts and supporting domestic innovation [4] - Fiscal policy enhancements are expected to increase market interest in domestic medical equipment stocks [4] Group 4: Target Companies - A-share targets include: BeiGene (688235.SH), Hengrui Medicine (600276.SH), Kelun Pharmaceutical (002422.SZ), WuXi AppTec (603259.SH), Tigermed (300347.SZ), New Industry (300832.SZ), BGI Genomics (688114.SH), Huatai Medical (688617.SH), and Dian Diagnostics (300244.SZ) [5] - H-share targets include: Kelun Biotech (06990), CSPC Pharmaceutical (01093), China Biologic Products (01177), CanSino Biologics (09926), WuXi Biologics (02269), Junshi Biosciences (01877), and Zai Lab (09688) [5]

Core Viewpoint - The Hong Kong biopharmaceutical sector experienced a significant decline, with major companies reporting substantial drops in stock prices, indicating a bearish trend in the market [1]. Group 1: Stock Performance - Innovent Biologics (099660) saw a decline of 11.54%, with a latest price of 16.640 and a market capitalization of 293.36 billion, despite a year-to-date increase of 171.90% [2]. - Rongchang Biologics (09995) dropped by 9.20%, priced at 108.600, with a total market value of 612.08 billion, and a remarkable year-to-date increase of 654.17% [2]. - Kelun-Biotech (06990) fell by 7.71%, with a latest price of 533.000 and a market cap of 1,242.88 billion, while still showing a year-to-date increase of 226.39% [2]. - Tigermed (03347) decreased by 6.86%, priced at 43.960, with a market capitalization of 378.51 billion and a year-to-date increase of 44.25% [2]. - WuXi AppTec (02268) experienced a decline of 6.22%, with a latest price of 77.650 and a market cap of 954.09 billion, maintaining a year-to-date increase of 153.34% [2]. - CanSino Biologics (09926) dropped by 5.15%, priced at 134.500, with a market capitalization of 1,238.94 billion, and a year-to-date increase of 121.58% [2]. - Other companies like Junshi Biosciences (01877) and BeiGene (06160) also reported declines, with respective decreases of 3.16% and 2.48% [2].

Core Insights - The Chinese immune checkpoint inhibitor industry is rapidly developing, with a projected market size of approximately 52.734 billion yuan in 2024, representing a year-on-year growth of 44.14% [1][4][8] - The primary driver of this growth is the innovative therapeutic mechanism of immune checkpoint inhibitors, which reactivate the immune system to identify and attack tumor cells, providing revolutionary treatment options for cancer patients with limited traditional therapies [1][4] Industry Overview - Immune checkpoint inhibitors enhance the immune system's ability to attack cancer cells by blocking immune checkpoint proteins, which are used by tumor cells to evade immune responses [2][5] - The industry has evolved through three stages: initiation, rapid development, and mature expansion, with significant policy support and market entry of domestic products since 2018 [3][4] Market Size - The immune checkpoint inhibitor market in China is expected to reach approximately 52.734 billion yuan in 2024, with a significant increase in clinical application driving market demand [1][8] Key Companies - Leading companies in the industry include Junshi Biosciences, Hengrui Medicine, Innovent Biologics, and BeiGene, which collectively hold over half of the market share [8] - Junshi Biosciences' core product, Toripalimab, has been approved for 12 indications and is the first domestic PD-1 inhibitor to receive FDA approval for kidney cancer treatment [9] - Akeso's dual antibody technology has led to significant advancements, with its PD-1/CTLA-4 dual antibody achieving notable efficacy in cervical cancer [11] Industry Development Trends 1. Continuous technological innovation is driving breakthroughs in precision treatment and combination therapies, with dual antibodies and ADCs becoming more prominent [12] 2. Market expansion and the shift of indications towards early-stage treatments are accelerating internationalization, with several domestic products gaining traction in overseas markets [13] 3. Policy and regulatory developments are promoting industry standardization, with support for new biological agents and reforms in medical insurance payment methods [13]

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: 康方生物科技（開曼）有限公司 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) | 09926 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | 本月底法定/註 ...

Core Insights - The report from CMB International highlights the release of the first batch of innovative pharmaceutical technology medical insurance payment incentive catalog by Zhejiang Province, which is expected to alleviate the challenges of innovative drugs entering hospitals [1] - Despite the Trump administration's announcement of a 100% tariff on imported innovative drugs, the overall impact on China's pharmaceutical industry chain is considered manageable, with a recommendation to monitor subsequent developments [1] - The upcoming ESMO conference in mid to late October is noted as a key event, with a focus on companies such as CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (688331.SH) that are expected to release significant data [1] Industry Summary - The Hong Kong pharmaceutical sector has shown relatively flat performance in September, but with increasing industry catalysts such as academic conferences and favorable policy implementations in October, a market rebound is anticipated [1] - The report recommends focusing on specific segments: 1) Innovative drugs: Companies like 3SBio (01530) and Eucure Biopharma-B (06996) have rich short-term catalysts and their valuations do not yet reflect the core value of major products; companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are considered significantly undervalued with clear long-term growth logic [1] 2) CXO: Leaders in this segment, such as WuXi AppTec (02268), are expected to benefit from high downstream demand and marginal recovery in financing [1]

康方生物科技(開曼)有限公司 Akeso, Inc. (於開曼群島註冊成立的有限公司) (Incorporated in the Cayman Islands with limited liability) Stock Code 股份代號 : 9926 2025 中期報告 INTERIM REPORT 康方生物科技(開曼)有限公司 Akeso, Inc. INTERIM REPORT 2025 中期報告 目 錄 | | 頁次 | | --- | --- | | 公司簡介 | 2 | | 釋義 | 3 | | 公司資料 | 6 | | 摘要 | 8 | | 管理層討論及分析 | 9 | | 補充資料 | 27 | | 獨立審閱報告 | 66 | | 中期簡明綜合損益及其他全面收益表 | 67 | | 中期簡明綜合財務狀況表 | 69 | | 中期簡明綜合權益變動表 | 71 | | 中期簡明綜合現金流量表 | 73 | | 中期簡明綜合財務資料附註 | 75 | 公司簡介 康方生物科技（開曼）有限公司是一家致力於研究、開發、生產及商業化讓全球病人可負擔的創新抗體藥的生物製藥 公司。自成立以來，本公司建立了端對端 ...

Core Viewpoint - The announcement of a 100% tariff on all branded/patented drugs by Trump starting in October is expected to have limited impact on China's innovative drug industry chain, with no excessive concerns warranted [1] Group 1: Impact on Innovative Drugs - Most Chinese innovative drugs that are currently being exported have either established production capacity in the U.S. or have outsourced production to local CMO companies [1] - The majority of domestic innovative drugs are exported using a business development (BD) model, which mitigates the impact of the tariff [1] Group 2: Impact on CXO Sector - The export products in the CXO sector primarily consist of raw materials and biological raw liquids, which are not affected by the new tariff; the proportion of finished dosage forms exported is low [1] - The investment timeline for multinational corporations (MNCs) to build factories in China will take time, leading to limited direct impact on CXO orders in the short term [1] - Long-term policy changes may influence the pace of factory construction by MNCs [1] Group 3: Upcoming Catalysts - The ESMO conference will take place in mid to late October, with a focus on companies like CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (09995) that are expected to release significant data [1] - The results of medical insurance negotiations and the first version of the commercial insurance innovative drug directory are expected to be announced in October-November [1] Group 4: Mid to Long-term Recommendations - Recommended stocks in the innovative drug sector include 3SBio (01530) and Eucure Biopharma-B (06996), which have rich short-term catalysts and their valuations do not yet reflect the core value of major products [2] - Companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are considered undervalued with clear long-term growth logic [2] - In the CXO sector, WuXi AppTec (02268) is highlighted as a leading player benefiting from high downstream demand and improving financing conditions [2]