Group 1 - The report highlights the focus on innovative drugs and the opportunities within the pharmaceutical industry chain, indicating a positive outlook for the Hong Kong pharmaceutical sector by 2026 [1][3] - Multiple policies are supporting the development of the innovative drug industry, with record highs in both transaction amounts and numbers for domestic innovative drugs going overseas [3][6] - The report notes a rebound in valuations for the sector, with leading companies achieving profitability through increased commercialization and licensing revenues [3][6] Group 2 - Key companies such as BeiGene and Innovent Biologics are experiencing significant sales growth, with BeiGene's global sales exceeding $1 billion in Q3 2025, marking a 51% year-on-year increase [3][4] - Innovent Biologics is expanding its pipeline and is expected to achieve positive non-IFRS net profit and EBITDA in 2024, with continued growth projected for 2025 [3][4] - The report emphasizes the strong performance of the CXO sector, driven by a recovery in investment and demand for early-stage research, particularly in emerging fields like peptides and ADCs [3][6] Group 3 - The report provides a detailed earnings forecast and valuation for key companies, indicating significant revenue growth for companies like BeiGene and Innovent Biologics, with projected revenues of $5.1 billion and $2.7 billion respectively for 2025 [4][6] - The pharmaceutical sector is noted for its robust performance, with companies like Sihuan Pharmaceutical and Hengrui Medicine showing strong revenue contributions from innovative products [4][6] - The report also highlights the increasing competitiveness of domestic innovative drugs on a global scale, with successful international collaborations and licensing agreements [3][6] Group 4 - The report indicates that the Hong Kong pharmaceutical market has shown impressive performance year-to-date, with the Hang Seng Healthcare Index significantly outperforming other markets, achieving an approximate 82% increase [15][16] - Valuations for Hong Kong pharmaceuticals are noted to be lower than those in A-shares and overseas markets, with a median PE of 17x for 2025 [15][16] - The report mentions a notable increase in the number of IPOs in the Hong Kong pharmaceutical sector, with over 20 new companies listed in 2025, raising substantial capital [40][41]

Core Viewpoint - The introduction of the commercial insurance innovative drug directory is expected to address the accessibility and affordability issues of high-priced innovative drugs by guiding market forces [1][3]. Group 1: Policy Changes - The National Medical Insurance Administration organized a 5-day negotiation for the medical insurance drug directory and commercial insurance innovative drug directory, with 120 domestic and foreign companies participating [2]. - The new directory is set to be released in early December and will officially take effect on January 1 of the following year [2]. Group 2: Market Opportunities - The commercial insurance innovative drug directory aims to open market space for high-cost or rare disease medications, particularly for rare disease treatments and high-value innovative drugs [3]. - Notably, five CAR-T drugs have been submitted for approval, which could significantly benefit patients due to their high annual treatment costs [3]. Group 3: Drug Submission Strategies - The introduction of the "dual directory" submission allows companies to choose between submitting for both the basic medical insurance directory and the innovative drug directory, providing more strategic options [4]. - For example, BMS's O drug (Nivolumab) opted for dual submission after previous failures, while competitors like Merck's K drug (Pembrolizumab) have not submitted any applications [4]. Group 4: Competitive Landscape - Domestic innovative drugs are becoming major competitors to imported drugs, with examples like the TROP2 ADC drug Gosituzumab (Gilead) and its domestic counterpart [5]. - The increasing support for innovative drugs from the government and the diversification of the medical insurance payment system are expected to create new market demand for innovative drugs [5]. Group 5: Investment Recommendations - The medical insurance bureau is encouraging the high-quality development of innovative drugs, indicating a warming trend in payment policies [6]. - Relevant investment targets include companies such as Heng Rui Medicine, Kelun Pharmaceutical, and others that are actively transitioning towards innovation [6].

Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [5] Core Insights - The report highlights the significant performance of domestic new drugs showcased at the ESMO 2025 conference, with several companies presenting excellent clinical data [3][21] - The report emphasizes the importance of academic conferences as key catalysts for the innovative drug sector, particularly mentioning ESMO, ASCO, and WCLC as critical events for Chinese pharmaceutical companies [20] Weekly New Drug Market Review - From October 20 to October 26, 2025, the top five gainers in the new drug sector were: - 欧康维视 (+8.87%) - 君圣泰 (+8.21%) - 诺思兰德 (+7.07%) - 友芝友 (+4.42%) - 海创药业 (+3.73%) - The top five losers were: - 康宁杰瑞 (-17.72%) - 北海康成 (-14.42%) - 创胜集团 (-14.29%) - 宜明昂科 (-13.40%) - 来凯医药 (-12.40%) [16][17] Recommended Focus Stocks - The report suggests focusing on several stocks with potential catalysts, including: 1. Products with high overseas volume certainty after MNC certification: - PD-1 upgraded product: 三生制药 - GLP-1 asset: 联邦制药 - ADC assets: 科伦博泰, 百利天恒 2. Potential heavyweights for overseas MNC authorization: - PD-1 upgraded products: 康方生物, 信达生物 - Breakthroughs in autoimmune fields: 益方生物, 中国抗体 - Innovative target ADC: 复宏汉霖, 石药集团 3. Stocks likely to benefit from medical insurance negotiations and commercial insurance innovative drug directories: - Beneficiaries of medical insurance directory: 恒瑞医药, 康诺亚, 迈威生物, 智翔金泰, 海创药业 - Beneficiaries of commercial insurance innovative drug directory: 药明巨诺, 科济药业 [2][20] New Drug Approval and Acceptance - This week, four new drug or new indication applications were approved, and five new drug or new indication applications were accepted in the domestic market [9] - A total of 46 new drug clinical applications were approved, and 31 new drug clinical applications were accepted [10] Key Domestic Market Events - 信达生物 announced a global strategic partnership with Takeda to accelerate the development of new generation tumor immunotherapy and antibody-drug conjugate therapies [11] - 康宁杰瑞 and 石药集团 announced that their HER2 bispecific antibody-drug conjugate JSKN003 received breakthrough therapy designation from the CDE [11] - 和黄医药 presented clinical data for HMPL-A251 at the AACR-NCI-EORTC conference [11] Key Overseas Market Events - 罗氏 received FDA approval for Gazyva/Gazyvaro for the treatment of active lupus nephritis in adult patients [12] - Electra Therapeutics announced that its therapy ELA026 received breakthrough therapy designation from the FDA and PRIME qualification from the EMA [12] - 安斯泰来 announced that the FDA accepted its supplemental biologics license application for the antibody-drug conjugate Padcev in combination with Keytruda [12]

Core Insights - Goldman Sachs highlights the promising preliminary Phase 1 data for CS2009, a tri-specific antibody targeting PD-1, VEGF, and CTLA-4, presented at the ESMO 2025 conference, indicating good safety and early tumor response signals across various cancer types [1][2] Group 1: Safety and Tolerability - CS2009 demonstrated good tolerability during the Phase 1 dose escalation study involving 72 patients across six dosage levels (1/3/10/20/30/45 mg/kg) [2] - In comparison, the HARMONi-2 trial showed that ivonescimab (PD-1/VEGF dual antibody) had a 29% incidence of grade 3 or higher treatment-related adverse events (TRAE) and 7% for immune-related adverse events (irAE) [2] - Higher dose groups of CS2009 reported fewer adverse reactions, potentially due to shorter observation periods, with the median observation time being 1.9 months [2] Group 2: Competitive Potential in NSCLC - Among 49 patients who underwent at least one tumor assessment, partial responses were observed in seven patients across five cancer types, suggesting CS2009's broad potential [3] - Notably, in 12 IO-treated NSCLC patients without prior anti-angiogenic therapy, CS2009 exhibited a 25% objective response rate (ORR) and an 83% disease control rate (DCR) [3] - The initial ORR signals are viewed positively, although further data is needed to assess CS2009's potential differentiated efficacy due to the small sample size and short follow-up [3] Group 3: Future Development Plans - The management plans to select the recommended Phase 3 dose from 20 mg/kg and 30 mg/kg based on Phase 1 data, aiming to initiate a global Phase 3 trial by the end of 2026 [4] - The ongoing Phase 2 trials in Australia and China have commenced with over 30 clinical centers, and patient enrollment is expected to begin soon [4] - Goldman Sachs has upgraded its earnings forecasts for the company, reflecting an increased view on CS2009's success probability from 30% to 49%, and revised the 12-month target price to HKD 7.05 [4]

Core Viewpoint - The stock of Yaoke Ankang experienced a dramatic rise and fall within a short period, reflecting the volatile nature of the market and investor sentiment towards innovative drug companies in Hong Kong [3][4]. Company Overview - Yaoke Ankang, a company focused on the drug Tinengotinib, saw its stock price surge by 10 times after its IPO three months ago, reaching a market capitalization close to 270 billion HKD [3][6]. - The company was included in the national index for innovative drugs, which attracted significant passive investment, leading to a rapid increase in stock price [3][8]. Market Dynamics - The stock price increased by 447% from September 8 to September 15, 2023, driven by positive clinical trial news and inclusion in major indices, but then plummeted by 53.73% on September 16 [3][8]. - The limited free float of shares (approximately 549,000 shares, or 1.38% of total shares) contributed to the stock's volatility, as it made the price more susceptible to market sentiment [3][6]. Investor Behavior - Investors in the secondary market tend to focus on short-term gains, often leading to speculative trading behaviors such as "chasing highs" and "panic selling" [3][7]. - The influx of mainland capital through the Hong Kong Stock Connect has intensified speculative trading in the innovative drug sector, which may undermine long-term investment confidence [9]. Future Outlook - The market's current enthusiasm for innovative drugs presents a unique opportunity for companies to secure funding for research and development, but it also raises concerns about the sustainability of such valuations [9][11]. - Yaoke Ankang's reliance on a single core asset and the timing of its IPO may hinder its ability to maintain a stable market valuation without significant clinical milestones [11][13].

Core Viewpoint - Company maintains a "buy" rating for Kangfang Biopharma, projecting revenue growth from 34.19 billion to 85.77 billion CNY from 2025 to 2027, supported by strong commercialization and clear overseas clinical data [1] Group 1: Financial Performance - In H1 2025, Kangfang Biopharma achieved revenue of 14.12 billion CNY, a year-on-year increase of 37.75%, with product sales revenue reaching 14.01 billion CNY, up 49.20% [2] - R&D expenses were 7.31 billion CNY, increasing by 23.06%, while sales and management expenses rose by 29.84% and 34.00%, respectively [1] Group 2: Product Development and Clinical Trials - The commercialization of core dual antibodies, Kadunil and Ivosidenib, is driving revenue growth, with expectations for further performance increases as new products and indications are approved [2] - Ivosidenib's OS data presented at the WCLC 2025 showed significant improvement, with an OSHR of 0.70 in the North American population, indicating a strong survival benefit [2][3] - Ongoing clinical trials for Ivosidenib include various cancer types, with a focus on expanding indications, which could enhance its market potential [3]

Core Viewpoint - The report maintains a "buy" rating for Kangfang Biopharma (09926), projecting significant revenue growth from 2025 to 2027, driven by strong commercialization and a promising innovation pipeline [1][2]. Group 1: Financial Performance - Kangfang Biopharma reported a revenue of 14.12 billion yuan for H1 2025, representing a year-on-year increase of 37.75% [1][2]. - The sales revenue from product sales reached 14.01 billion yuan, reflecting a 49.20% year-on-year growth [2]. - R&D expenses were 7.31 billion yuan, up 23.06% year-on-year, while sales and management expenses increased by 29.84% and 34.00%, respectively [1]. Group 2: Product Development and Clinical Trials - The commercialization of core dual antibodies, Kadunil and Ivosidenib, is driving revenue growth, with expectations for further performance improvements as new products and indications are approved [2]. - The WCLC 2025 conference showcased updated overall survival (OS) data for Ivosidenib, indicating a significant improvement in survival benefits, particularly in the North American population [2][3]. - Ongoing clinical trials for Ivosidenib include various cancer types, with a focus on expanding its indications, which could enhance its market potential [3].

Investment Rating - The investment rating for the company is "Buy" (maintained) due to smooth commercialization progress and further updates on HARMONi data [5]. Core Views - The company reported a revenue of 1.412 billion RMB in H1 2025, representing a year-on-year increase of 37.75%, with a net profit attributable to shareholders of -570 million RMB [7]. - The commercialization of key products, namely Cadonilimab and Ivosidenib, has driven revenue growth, with product sales revenue increasing by 49.20% year-on-year [7]. - The HARMONi study presented at the WCLC 2025 conference showed improved overall survival (OS) data, with an OS hazard ratio (HR) of 0.78, indicating significant survival benefits [7]. - The company is expected to achieve revenues of 34.19 billion RMB, 55.98 billion RMB, and 85.77 billion RMB for the years 2025 to 2027, respectively [7]. Financial Summary - Revenue projections for 2023, 2024, 2025E, 2026E, and 2027E are 4,526 million RMB, 2,124 million RMB, 3,419 million RMB, 5,598 million RMB, and 8,577 million RMB, respectively, with corresponding growth rates of 440.3%, -53.1%, 61.0%, 63.7%, and 53.2% [6]. - The net profit attributable to shareholders is projected to be 2,028.30 million RMB in 2023, -514.52 million RMB in 2024, -29.64 million RMB in 2025E, 586.11 million RMB in 2026E, and 1,485.85 million RMB in 2027E, with growth rates of 273.6%, -125.4%, 94.2%, 2077.2%, and 153.5% respectively [6]. - The company's reasonable equity value is estimated at 187.5 billion HKD, assuming a perpetual growth rate of 3% and a WACC of 7.06% [7].

Core Viewpoint - The innovative drug sector in China is experiencing a recovery, with over half of the companies having commercialized innovative drugs, despite many still not being profitable [1][2][12]. Group 1: Market Overview - As of the first half of 2025, 70 innovative drug companies have been listed on the Hong Kong Stock Exchange and the STAR Market, with 15 companies achieving profitability, including notable firms like BeiGene and Innovent Biologics [2][19]. - Among the 70 companies, 55 are still operating at a loss, representing approximately 79% of the total [6][19]. - Of the 55 unprofitable companies, 28 have commercialized innovative drug products, indicating that profitability may be achievable for some in the near future [4][12]. Group 2: Profitability Analysis - Only 3 companies are generating profits primarily from innovative drug sales, namely BeiGene, Innovent Biologics, and Elysium [23][22]. - The majority of profitable companies rely on other revenue streams, such as biosimilars or licensing agreements, rather than solely on innovative drug sales [23][25]. - For instance, Elysium achieved significant revenue from its lung cancer drug, while companies like WuXi Biologics and Hengrui Medicine have seen profitability through biosimilars and licensing deals [24][25]. Group 3: Company Performance - BeiGene reported a total revenue of 175.18 billion yuan in the first half of 2025, with a net profit of 4.5 billion yuan, largely driven by its innovative drugs [28]. - Innovent Biologics achieved revenue of 59.53 billion yuan, with 88.76% coming from product sales, reflecting strong performance in the oncology sector [29]. - Elysium's revenue for the first half of 2025 was 23.73 billion yuan, with over 99% derived from innovative drug sales, showcasing its successful product launch [23][20].

Core Viewpoint - The Chinese innovative drug sector is experiencing a stock market recovery in 2025, with 15 companies achieving profitability, although only 3 are profitable through innovative drug sales [2][3][4]. Group 1: Profitability and Performance - In the first half of 2025, 15 companies reported profitability, with 6 achieving their first profit [2][4]. - Among the 70 innovative drug companies listed, 55 remain unprofitable, accounting for approximately 79% [3][4]. - Of the 55 unprofitable companies, 28 have commercialized innovative drug products, indicating potential for future profitability [7][8]. Group 2: Revenue Sources - Only 3 companies, including Baijie Shenzhou and Xinda Biopharmaceuticals, achieved profitability primarily through innovative drug sales [12][15]. - Other profitable companies rely on alternative revenue sources, such as biosimilars or business development (BD) transactions [12][14]. - For instance, Ailisi's revenue in the first half of 2025 was largely driven by its self-developed lung cancer drug, achieving significant sales [12][13]. Group 3: Market Dynamics - Baijie Shenzhou's total revenue reached 17.518 billion yuan, with a significant portion derived from overseas markets [16]. - Xinda Biopharmaceuticals reported revenue of 5.953 billion yuan, primarily from its oncology products, benefiting from strong market demand [17]. - The innovative drug market is characterized by long R&D cycles and high risks, making profitability a critical milestone for listed companies [4][8].