Core Viewpoint - The National Healthcare Security Administration (NHSA) emphasizes the continuous improvement of medical insurance coverage since its establishment in 2018, with a total of 3,159 drugs included in the medical insurance catalog, significantly enhancing the coverage for major diseases like cancer [1] Group 1: Misconceptions about Medical Insurance - Misconception 1: Only 2% of drugs are reimbursed by insurance. The NHSA clarifies that this claim misrepresents data by comparing different statistical methods without proper conversion, leading to an incorrect conclusion about the proportion of drugs in the catalog [1] - Misconception 2: Imported drugs are not reimbursed. The NHSA states that reimbursement does not differentiate between manufacturers, as long as the drug is included in the insurance catalog [3] - Misconception 3: Only cheap, old drugs are reimbursed. The NHSA refutes this by highlighting that many new and effective drugs, including cancer treatments, are regularly added to the reimbursement list, often within a year of approval [4] Group 2: Drug Statistics and Approval - The NHSA explains that the total number of drugs in the insurance catalog is based on active ingredients, which counts drugs with the same active ingredient as one, leading to 3,159 drugs in the catalog [1] - An alternative method counts the number of drug approval numbers, resulting in over 150,000 approved drugs in China, with more than 110,000 having sales records. The NHSA indicates that if the approval numbers for the 3,159 drugs in the catalog are calculated, it would exceed 70,000, representing about 63% of the market [2]

Core Viewpoint - The Chinese pharmaceutical industry is experiencing a significant transformation driven by technological breakthroughs and demographic changes, leading to a shift from a reliance on license-in to license-out strategies, positioning Chinese companies as key players in the global market [2][4][11]. Group 1: Industry Trends - The Hong Kong pharmaceutical sector is witnessing a surge, with ETFs tracking the Hang Seng Biotechnology Index showing strong performance, indicating a structural change in the industry [1][3]. - Innovation drugs are becoming a major investment theme for 2025, with significant year-to-date gains in related indices, highlighting the leading role of companies like WuXi Biologics and BeiGene [4][5]. - The Chinese pharmaceutical industry now ranks second globally, with approximately 30% of innovative drugs under development worldwide, and a notable increase in the approval rate of new drugs [8][9]. Group 2: Technological Advancements - The advent of CRISPR gene editing and AI technologies is revolutionizing drug development, significantly reducing research and development cycles and enhancing the capabilities of Chinese pharmaceutical companies [2][7]. - The emergence of platform technologies such as ADCs, bispecific antibodies, and cell therapies is opening new avenues for drug development, contributing to the increased competitiveness of domestic biotech products [7]. Group 3: Market Dynamics - The market is currently experiencing a revaluation of innovative drug companies, with many leading firms turning profitable and their valuations being reassessed positively [7][11]. - The increase in license-out transactions indicates a shift in the global innovation chain, with Chinese companies now accounting for over 51% of the total transaction value in the BD market [11]. Group 4: Policy and Financial Environment - Supportive policies, including stable medical insurance negotiations and expedited drug approval processes, are fostering an environment conducive to innovation [8]. - The easing of monetary policy, including interest rate cuts by the Federal Reserve, is providing a favorable financing environment for biotech companies, further enhancing their growth prospects [8]. Group 5: Investment Opportunities - The Hang Seng Medical ETF and the Hong Kong Stock Connect Medical ETF are emerging as attractive investment vehicles, providing exposure to core assets in the Hong Kong pharmaceutical sector [3][15]. - The recent restructuring of the Hang Seng Biotechnology Index has improved its focus on leading companies in the biotech field, enhancing its investment appeal [14][15].

证券研究报告 2025年09月23日 作者： 分析师 杨松 SAC执业证书编号：S1110521020001 分析师 曹文清 SAC执业证书编号：S1110523120003 1 行业评级： 上次评级： 强于大市 强于大市 维持 （ 评级） 请务必阅读正文之后的信息披露和免责申明 摘要：中国创新药产业趋势已成，进军全球商业化 立足现在：进军全球商业化，大量优质项目将继续推高产业发展 行业报告 | 行业专题研究 医药生物 创新药产业趋势已成，进军全球商业化 政策端——全面支持"真创新"：从顶层设计到地方落地形成合力，全面支持创新。 人才端——梯队合理：战略层+执行层协同配置，成为药物研发各环节高效落地的关键保障，也代表中国本土Biotech正在构建自身可持续的研发引擎。 展望未来：提升创新度将进一步打开商业化价值空间，未来可期 产学研持续加深合作，为FIC分子产出蓄力。中国已成为全球靶点验证到IND路径中效率最高的国家之一。这种研发效率与成本优势，将推动产业迈向 更高创新度分子的开发，而更具创新度的分子也意味着更高的商业化价值。 建议关注： ①全球大单品：百济神州（H），科伦博泰生物(H)，信达生物（H），康方 ...

Core Insights - The report indicates a 2.07% week-on-week decline in the Shenwan Pharmaceutical Index, underperforming both the CSI 300 Index and the ChiNext Index during the week of September 15-19, 2025 [1][12] - The focus for the upcoming 1-2 quarters includes significant global conferences related to innovative drugs and the business development (BD) spending rhythm of multinational corporations (MNCs) [1][18] Recent Market Review - The market experienced fluctuations, with a notable rise in coal, electricity, electronics, and real estate sectors, while the pharmaceutical index showed similar volatility, particularly with a larger adjustment on Thursday and Friday [2][13] - The innovative drug sector is currently in a state of adjustment, reflecting a digestion of trading structures and a lack of short-term catalysts [3][14] Future Outlook - The report emphasizes a positive outlook for the pharmaceutical sector in 2025, driven by innovative drugs, with a focus on overseas major pharmaceuticals, small and medium-sized technology revolutions, and the revaluation of generic pharmaceuticals [4][15] - The report suggests that the innovative drug sector is entering a second wave of growth over the next 5-10 years, with the keyword being "disruption" [3][14] Investment Strategy - The report outlines specific investment strategies in the innovative drug sector, highlighting key companies such as Innovent Biologics, BeiGene, and others in various therapeutic areas including oncology and chronic diseases [7][16] - It also identifies emerging technologies such as brain-computer interfaces and AI in medicine as potential investment opportunities [8][16] Upcoming Conferences - Key upcoming global conferences include the ESMO Congress and SABCS, which are expected to influence BD activities and provide insights into the latest advancements in oncology [18][19] Performance Metrics - The report notes that the CSI Innovative Drug Index has increased by 38.55% since the beginning of 2025, outperforming both the Shenwan Pharmaceutical Index and the CSI 300 Index [23][26]

Investment Rating - The industry investment rating is "Positive" [1][23] Core Viewpoints - External risks are controllable, and innovative drugs remain an important investment theme. The report suggests that the commercial value of innovative drugs is being realized smoothly, with biotech and biopharma operational efficiency continuously improving. The long-term outlook indicates that Chinese companies are significantly enhancing their position in the global innovative drug supply chain, with increasing source innovation capabilities [5][16]. Summary by Sections 1. Source Innovation Capability and External Risks - In the first half of 2025, the transaction amount related to the pharmaceutical sector in China reached 60.8 billion USD, a year-on-year increase of 129%, with 144 transactions, up 67% year-on-year. China's share in global pharmaceutical transactions was 46.63% in amount and 31.58% in number [6][8]. - The report emphasizes that U.S. government restrictive policies will have limited impact on the overseas market expansion of Chinese innovative drugs due to the collaborative interests of multinational corporations (MNCs) and biotech firms [5][8]. 2. Commercialization Value of Innovative Drugs - The report analyzed 19 representative large pharmaceutical companies, which collectively generated revenue of 139.5 billion CNY in the first half of 2025, with a net profit of 25.4 billion CNY, showing stability. Notably, innovative drug revenues are growing rapidly, with companies like Hengrui Medicine and Hansoh Pharmaceutical showing significant increases in their innovative drug sales [10][12]. 3. Investment Recommendations - The report suggests selecting stocks based on validated R&D and commercialization capabilities, including industry leaders like Hengrui Medicine and 3SBio. Companies that are entering a performance release phase, such as Eddingpharm and Kangzhe Pharmaceutical, are also recommended. Additionally, it highlights event-driven or valuation-sensitive stocks like Innovent Biologics and Genscript Biotech [16].

Core Viewpoint - Kangfang Biopharma/Summit presented updated data from the HARMONi study at the 2025 WCLC, showing improved overall survival (OS) with a hazard ratio (HR) of 0.78 (P=0.0332), indicating a significant trend of survival benefit compared to previous analyses [1][2] Group 1: Study Overview - The HARMONi study is a global, multicenter, randomized, double-blind, placebo-controlled Phase III trial assessing the efficacy and safety of Ivonescimab in patients with disease progression after third-generation EGFR-TKI treatment [2] - A total of 438 patients were randomized (219 per group), with a median follow-up of 22.3 months, showing a significant improvement in progression-free survival (PFS) for the Ivonescimab group (HR=0.52, P<0.001) [3] Group 2: Efficacy Results - The median OS for the Ivonescimab group was 16.8 months compared to 14.0 months for the placebo group (HR 0.79, P=0.0570) [3] - Objective response rates were 44.7% for the Ivonescimab group versus 34.2% for the placebo group, with intracranial PFS also showing improvement [3] Group 3: Safety Profile - The Ivonescimab group demonstrated good safety and tolerability, with treatment-related adverse events (TRAEs) of grade ≥3 occurring in 50.0% of patients compared to 42.2% in the placebo group [4] - The most common TRAEs were laboratory abnormalities, with no new safety signals identified [4] Group 4: Follow-Up and Trends - Extended follow-up showed further improvement in OS, particularly in North American patients, with a median OS of 17 months compared to 14 months for the control group (HR=0.84) [5] - The study indicated that patients with brain metastases had better PFS outcomes compared to those without [5] Group 5: Comparative Analysis - The HARMONi study results align with the HARMONi-A study, demonstrating consistent efficacy trends across different regions, highlighting the global market potential of Ivonescimab [6] - Both studies achieved significant clinical endpoints, confirming the drug's rapid efficacy and favorable safety profile [6] Group 6: Future Outlook - Future focus will be on the results of ongoing Phase III trials, particularly HARMONi-3 and HARMONi-7, which will be critical for the drug's commercialization prospects [7] - The company has initiated multiple Phase III studies across various cancer types, indicating a robust pipeline and potential for sustained growth [7] Group 7: Financial Projections - The company projects revenues of 34.42 billion, 51.49 billion, and 76.28 billion for 2025, 2026, and 2027, respectively, with corresponding growth rates of 62.04%, 49.62%, and 48.14% [8] - The company is expected to achieve profitability by 2026, supported by a rich pipeline of products nearing approval [8]

Core Insights - The Hong Kong stock market saw a net inflow of 73.31 billion HKD from northbound trading on September 12, with the Shanghai Stock Connect recording a net outflow of 14.87 billion HKD and the Shenzhen Stock Connect a net inflow of 88.18 billion HKD [1] Group 1: Stock Performance - Alibaba (09988) had a net inflow of 54.25 billion HKD, with total trading volume of 87.74 billion HKD, resulting in a net inflow of 20.76 billion HKD [2] - Tencent (00700) recorded a net inflow of 16.78 billion HKD, with a total trading volume of 31.72 billion HKD, leading to a net inflow of 1.85 billion HKD [2] - Pop Mart (09992) saw a net inflow of 8.70 billion HKD, with a total trading volume of 15.81 billion HKD, resulting in a net inflow of 1.60 billion HKD [2] Group 2: Notable Stocks - Alibaba (09988) received a net inflow of 43.8 billion HKD this week, totaling approximately 220 billion HKD in net inflows, driven by news of its internal chip development for AI models [4] - Tencent (00700) gained a net inflow of 9.29 billion HKD, with market analysts noting that its gaming and advertising businesses are entering a mature phase, making future growth challenging [5] - Pop Mart (09992) attracted a net inflow of 6.42 billion HKD, with positive outlooks from analysts regarding upcoming product launches and seasonal sales [5] Group 3: Other Stocks - Semiconductor stocks like Hua Hong Semiconductor (01347) and SMIC (00981) received net inflows of 4.01 billion HKD and 830.3 million HKD respectively, amid reports of domestic chip development [6] - Kangfang Biologics (09926) had a net inflow of 2.25 billion HKD, supported by positive clinical data announcements [7] - Yaojie Ankang-B (02617) saw a net inflow of 1.8 billion HKD after being added to the Hong Kong Stock Connect list [7]

Market Overview - The A-share market experienced fluctuations, with the Shanghai Composite Index down 0.12%, Shenzhen Component down 0.43%, and ChiNext down 1.09% at the close [2] - The film and semiconductor sectors showed strong performance, while insurance, liquor, and banking sectors faced declines [2] Film Industry - The film sector saw a late surge, with China Film hitting the daily limit and achieving three consecutive gains over six days, while other companies like Golden Shield Film and Happiness Blue Sea also saw significant increases [3] - According to the National Film Administration, the total box office for the 2025 summer season in mainland China reached 11.966 billion yuan, with total attendance at 321 million, marking year-on-year growth of 2.76% and 12.75% respectively [5] - Analysts expect continued growth in the film box office for the year, driven by the release of several major films [5] Semiconductor Industry - The semiconductor sector was notably strong, with Chipone Technology hitting the daily limit and companies like Sai Microelectronics and Beijing Junzheng rising over 10% [5] - TSMC reported a revenue of 335.77 billion New Taiwan dollars for August 2025, reflecting a year-on-year increase of 33.8% and a quarter-on-quarter increase of 3.9% [7] - The global semiconductor industry remains robust, with China's sector performing particularly well, and the industry is expected to continue its "AI-driven + self-controllable" dual development strategy in the second half of the year [7] Pharmaceutical Sector - In the Hong Kong market, the stock of Drug Innovation Technology surged nearly 120% following the announcement of clinical trial approval for its core product Tinengotinib for breast cancer treatment [9] - Kangfang Biologics saw a rise of over 6% after updates on its AK112 clinical trial, which successfully met its primary endpoint for progression-free survival [9] Other Notable Stocks - Alibaba's stock increased by over 5% after the release of its next-generation model architecture Qwen3-Next, which includes significant improvements over its previous model [9]

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].