Enhertu 联合疗法获 FDA 优先审评，有望 重塑 HER2 阳性乳腺癌一线治疗 [Table_Industry] 医药生物行业周报 [Table_ReportTime] 2025 年 9 月 26 日 证券研究报告 行业研究 医药生物 医药生物 投资评级 看好 上次评级 看好 [Table_A 唐爱金 uthor 医药首席分析师 ] 执业编号：S1500523080002 邮 箱：tangaijin@cindasc.com 贺鑫 医药联席首席分析师 执业编号：S1500524120003 邮 箱：hexin1@cindasc.com 曹佳琳 医药行业分析师 执业编号：S1500523080011 邮 箱：caojialin@cindasc.com 章钟涛 医药行业分析师 执业编号：S1500524030003 邮 箱：zhangzhongtao@cindasc.com 赵丹 医药行业分析师 执业编号：S1500524120002 邮 箱：zhaodan@cindasc.com 信达证券股份有限公司 CINDA SECURITIES CO.,LTD 北京市西城区宣武门西大街甲127号金隅大厦 B座 邮编 ...

Investment Highlights - The company is covered for the first time by CICC with an "outperform" rating and a target price of HKD 102.91, based on DCF valuation, positioning it as a leading innovative biopharmaceutical enterprise in China [1] - The company has adopted a dual strategy of innovation and internationalization, achieving domestic and international approvals for 6 and 4 products respectively by the end of 2024, establishing itself as a leader in domestic biopharmaceuticals [1] - Revenue has grown significantly from CNY 91 million in 2019 to CNY 5.724 billion, with a CAGR of 129%, while overseas revenue increased from CNY 2.62 million to CNY 678 million, expected to account for 11.9% of total revenue in 2024 [1] Innovation Pipeline - The company has developed a diverse innovation pipeline covering approximately 50 molecules, focusing on cutting-edge areas such as monoclonal antibodies, multi-antibodies, and ADCs [1] - HLX43 is the world's first PD-L1 ADC to enter clinical phase II, offering safety and competitive advantages, with low hematologic toxicity supporting its future use in first-line treatments and combination immunotherapy [1] - HLX22 has entered phase III international multicenter clinical trials for first-line treatment of advanced gastric cancer, with expectations to redefine standard therapies based on efficacy and safety data [1] Biosimilar Development - The company has a rich pipeline of biosimilars, leveraging first-mover advantages in the domestic market, with smooth commercialization progress anticipated [2] - It is expected that the domestic biosimilar procurement price reduction will be rational, allowing the company to achieve volume-based pricing [2] - The company has made strides in internationalization, with overseas revenue from Hanquyou reaching approximately CNY 120 million in 2024, a year-on-year increase of nearly 30%, and FDA approval achieved [2] Financial Forecast and Valuation - The company’s EPS is projected to be CNY 1.46 and CNY 1.55 for 2025 and 2026 respectively, with a CAGR of 1.2% [2] - Using a DCF valuation method with a WACC of 9.0% and a perpetual growth rate of 2.0%, the reasonable valuation for 2025 corresponds to a target price of HKD 102.91, implying an upside potential of 28.6% [2]

Core Viewpoint - The article discusses the extension of centralized procurement to biosimilars in China, highlighting the implications for market dynamics and pricing strategies in the pharmaceutical industry [4][6]. Group 1: Centralized Procurement of Biosimilars - The Anhui Provincial Medical Procurement Platform has initiated information reporting for eight monoclonal antibody products, marking the beginning of centralized procurement for biosimilars [4]. - Biosimilars are large molecule biological products that are similar in quality, safety, and efficacy to already approved reference drugs, and their development is typically more costly and time-consuming than small molecule drugs [4][8]. - The centralized procurement process for biosimilars is expected to take longer than previous chemical drug procurements due to the need for comprehensive data collection and rule formulation [6]. Group 2: Market Impact and Dynamics - The total sales of the eight involved biosimilar products are projected to approach 30 billion yuan in 2024, with specific products like Bevacizumab exceeding 10 billion yuan in sales [9]. - The article emphasizes that the centralized procurement of biosimilars will not drastically disrupt existing market structures but will lead to adjustments within the current competitive landscape [9][10]. - The involvement of multiple companies in the production of these biosimilars indicates a competitive environment, with several products having three or more approved manufacturers [8][9]. Group 3: Characteristics of Biosimilar Procurement - Compared to chemical drug procurement, biosimilar procurement is characterized by smaller price reductions, comprehensive reporting requirements, and a focus on high-quality products [13][14]. - The procurement process aims to clarify market demand and supply, allowing companies to better predict future business conditions and adjust their product pipelines accordingly [6][10]. - The article suggests that the pricing adjustments in biosimilar procurement will be more moderate than those seen in previous chemical drug procurements, reflecting the unique nature of biological products [14][15].

Core Viewpoint - The introduction of centralized procurement for biosimilars in China marks a significant shift in the pharmaceutical industry, aiming to enhance drug accessibility and affordability while maintaining quality standards [1][3][6]. Group 1: Centralized Procurement Overview - The centralized procurement initiative has officially extended to biosimilars, with the Anhui Provincial Medical Procurement Platform issuing a notification for companies to report pricing, sales volume, and production capacity for specific monoclonal antibody products [1][3]. - This marks the first instance of centralized procurement for biosimilars in mainland China, with expectations for a longer timeline for information organization and rule formulation compared to previous chemical drug procurements [1][2]. Group 2: Market Impact and Dynamics - The market for the eight involved biosimilar products is projected to reach nearly 30 billion yuan, with specific products like Bevacizumab exceeding 10 billion yuan in sales [4][6]. - The competitive landscape is expected to be influenced but not drastically altered, as the procurement process aims to provide a clearer understanding of market volumes and guide companies in their operational strategies [2][4]. Group 3: Characteristics of Biosimilar Procurement - Compared to chemical drug procurement, biosimilar procurement is characterized by smaller price reductions, comprehensive reporting requirements, and a focus on high-quality products [7][8]. - The procurement process emphasizes a data-driven approach, requiring companies to report detailed sales figures and product specifications to ensure a thorough understanding of the market [7][9]. Group 4: Future Expectations - The impact of the biosimilar procurement is anticipated to manifest in the performance of related companies and product sales starting from 2026, with ongoing adjustments to market dynamics expected [1][2]. - The overall goal of the procurement initiative is to optimize resource allocation in the pharmaceutical market while ensuring that patient interests remain a priority [5][9].

Core Viewpoint - The Anhui Provincial Medical Price and Centralized Procurement Center has initiated information collection for eight monoclonal antibody biological agents, indicating the commencement of a national centralized procurement alliance for biological drugs in China [1][5]. Group 1: Market Overview - The eight biological drugs targeted for information collection have a combined market sales exceeding 28 billion yuan [2]. - The original manufacturers of these drugs include AbbVie, Amgen, and Johnson & Johnson, with Roche holding the original drugs for several others [2]. - The competitive landscape is intense, particularly for Bevacizumab, which has 13 approved products in the domestic market, with sales reaching 10.576 billion yuan in 2023 [2]. Group 2: Sales Trends - Sales of Adalimumab in sample hospitals increased from 1.257 billion yuan in 2022 to 1.488 billion yuan in 2024, while sales in urban pharmacies rose from 743 million yuan to 931 million yuan [3]. - The market share of original drugs is declining due to the introduction of biosimilars, with the original Adalimumab being surpassed in market share by a biosimilar in 2023 [3]. Group 3: Impact of Centralized Procurement - Centralized procurement is expected to intensify market competition, leading to a redistribution of market shares, with original drugs facing greater pressure from price competition [3][7]. - The procurement process is anticipated to enhance drug accessibility for patients, potentially lowering prices and ensuring quality [4]. - Companies must improve production capacity and flexibility to meet the demands of centralized procurement [4]. Group 4: Regulatory Environment - The development of biosimilars in China has accelerated, with a record 104 registration applications for therapeutic biological products submitted in 2024 [5]. - The centralized procurement of biological drugs is not prohibited, and the National Healthcare Security Administration has indicated that it will consider various factors before implementing such measures [5][6]. Group 5: Future Industry Trends - The initiation of national centralized procurement for biological drugs may shorten the profit period for low-quality products, prompting companies to focus on enhancing product quality and R&D capabilities [7]. - Companies may also shift their R&D focus towards more valuable innovative fields and increase investments in overseas markets to mitigate the impact of localized procurement [7].

Core Viewpoint - The industry is making substantial progress towards centralized procurement of biopharmaceuticals, with a focus on monoclonal antibodies, expected to be implemented around 2026, potentially reshaping a market worth nearly 30 billion yuan [1][2][3]. Group 1: Industry Developments - The Anhui Provincial Medical Procurement Platform has initiated the collection of information for eight monoclonal antibody biopharmaceuticals, indicating a move towards centralized procurement [1]. - The global market for biosimilars is projected to grow from $18 billion in 2020 to $75 billion by 2030, with a compound annual growth rate of 17.2% [2]. - The centralized procurement of biopharmaceuticals is still in the preliminary research phase, with companies required to report key information such as pricing and production capacity [2][3]. Group 2: Market Dynamics - The eight monoclonal antibodies included in the procurement process cover major therapeutic areas, with a total market size approaching 30 billion yuan [3]. - Bevacizumab, trastuzumab, and pertuzumab are highlighted as key drugs in oncology, with domestic market sizes of approximately 10.4 billion yuan, 6 billion yuan, and 4 billion yuan, respectively [5]. - The competition for bevacizumab is particularly intense, with 12 companies approved to market it, leading to potential price wars that could impact profit margins [6]. Group 3: Company Responses - Companies like Baiyoutai and Fuhong Hanlin are preparing for the centralized procurement, with Baiyoutai expressing confidence in its ability to manage price impacts due to its self-developed products and sufficient production capacity [10]. - Fuhong Hanlin is actively addressing potential challenges from biosimilar procurement by promoting the commercialization of innovative drugs and optimizing production processes [11]. - The sales of biosimilars, such as Baiyoutai's product, have shown growth, with revenue attributed to the increasing sales of its adalimumab biosimilar [8].

Summary of Key Points from the Conference Call Company and Industry Overview - **Company**: 海正药业 (Haizheng Pharmaceutical) and 博瑞生物 (Borui Biopharmaceutical) - **Industry**: Pharmaceutical and Biotechnology Core Insights and Arguments Haizheng Pharmaceutical 1. **Transformation and Innovation**: Haizheng is actively transforming by enhancing its innovative drug pipeline through internal R&D and external collaborations, focusing on products like HS387 and Haibo Maibu tablets, which saw a 100% annual sales growth after entering the medical insurance system [2][3] 2. **Leadership Changes**: The new leadership under CEO Xiao has brought significant changes, improving operational efficiency and achieving record high net profits [8][9] 3. **Product Strategy**: The company is implementing a "big product" strategy, aiming for substantial sales from key products, including Haibo Maibu, projected to reach sales of 800 to 1,000 million [9] Borui Biopharmaceutical 1. **Growth Since Spin-off**: Since its spin-off in 2019, Borui has expanded its commercial product line from 1 to 7.5 products, with revenue increasing from 200 million to 1.63 billion, reflecting a compound annual growth rate of approximately 35% [2][5] 2. **Innovative Drug Development**: Borui has made significant strides in innovative drugs, including the launch of Anruixin (Zebetomab), the first Class 1 innovative drug in China, and is focusing on autoimmune and tumor immunity fields [6][7] 3. **ADC Platform**: Borui's unique approach in the ADC (Antibody-Drug Conjugate) platform, utilizing dual payload toxins and stable linker technology, enhances efficacy and reduces toxicity, positioning it competitively in the market [12][13] Additional Important Insights 1. **Market Expansion**: Borui is exploring the pet economy and has established a leading position in veterinary medicine, while also expanding into medical aesthetics and e-commerce channels [10][9] 2. **Future Revenue Goals**: Borui aims to achieve over 7.5 billion in revenue by 2029-2030, with expectations of significant contributions from various product lines [27][28] 3. **IPO Plans**: Borui is actively pursuing an IPO on the Sci-Tech Innovation Board, with a pre-IPO valuation of 13 billion as of late 2022, and is expected to meet listing conditions by June 2023 [29][22] This summary encapsulates the key developments and strategic directions of Haizheng Pharmaceutical and Borui Biopharmaceutical, highlighting their growth trajectories, innovative strategies, and market positioning within the pharmaceutical industry.

Investment Rating - The report does not explicitly state an investment rating for the industry or specific companies involved in the innovative drug sector. Core Insights - Enhertu combined with pertuzumab shows a median progression-free survival (mPFS) of 40.7 months for HER2-positive metastatic breast cancer, significantly outperforming the standard THP therapy which has an mPFS of 26.9 months [12][14] - The report highlights the increasing sales of Enhertu, projected to reach $3.754 billion in 2024, indicating strong market potential for HER2-targeted therapies [9] - The report emphasizes the importance of ADC (antibody-drug conjugate) technology in enhancing treatment efficacy for various cancers, particularly in combination with immune checkpoint inhibitors [17] Summary by Sections Section 1: Innovative Drug Focus - The report reviews the latest advancements in innovative drugs, particularly focusing on HER2-positive breast cancer treatments and the performance of Enhertu in clinical trials [4][5] Section 2: Clinical Trial Data - The DESTINY-Breast09 trial results indicate that Enhertu combined with pertuzumab significantly reduces the risk of disease progression or death by 44% compared to THP [14] - The overall response rate (ORR) for Enhertu plus pertuzumab is reported at 85.1%, compared to 78.6% for THP, showcasing the superior efficacy of the combination therapy [12][14] Section 3: Market Dynamics - The report outlines the competitive landscape for HER2 ADCs, listing various drugs in different stages of development and their respective companies [18] - It notes that the ADC market is expected to expand significantly, with potential market growth of 100-200% for certain indications due to the integration of ADCs with existing therapies [17] Section 4: Recent Announcements - Recent announcements from companies like 恒瑞医药 and 康宁杰瑞 highlight ongoing clinical trials and new drug applications, indicating a vibrant pipeline in the innovative drug sector [33][34]

Core Viewpoint - Breast cancer treatment is evolving towards more precise subtyping and mechanisms, with various innovative treatment options being introduced. However, to truly benefit patients, challenges related to education, accessibility, and standardized guidelines need to be addressed [1]. Group 1: Research and Development - AstraZeneca has showcased its commitment to breast cancer research at the ASCO conference, presenting significant studies such as SERENA-6 and DESTINY-Breast09, focusing on key molecular subtypes like HR-positive/HER2-negative and HER2-positive [3][4]. - The DESTINY-Breast09 trial demonstrated the benefits of trastuzumab deruxtecan combined with pertuzumab over traditional therapies for HER2-positive metastatic breast cancer, potentially offering new treatment options for patients [4]. - The SERENA-6 study highlighted the potential of Camizestrant in treating HR-positive, HER2-negative advanced breast cancer with ESR1 mutations, marking it as a significant finding at ASCO [5]. Group 2: Treatment Framework - AstraZeneca has developed a comprehensive treatment framework for the three major breast cancer subtypes: HER2-positive, HR-positive/HER2-negative, and triple-negative, covering all treatment stages from early to late [4]. - The company is actively exploring new mechanisms and treatment options for triple-negative breast cancer, aiming to introduce innovative ADC therapies to the Chinese market [5]. Group 3: Implementation and Accessibility - The BCCE project, led by the National Cancer Center with AstraZeneca's support, aims to bridge the gap between guidelines and clinical practice, enhancing breast cancer diagnosis and treatment across various healthcare levels [7][8]. - AstraZeneca is focused on improving drug accessibility by facilitating the registration and inclusion of innovative breast cancer drugs in China's national insurance directory, thereby reducing patient financial burdens [10]. - The company emphasizes the importance of patient education and multi-disciplinary collaboration to enhance the standardization of breast cancer treatment in China [8][10]. Group 4: Future Goals - AstraZeneca aims to contribute to the "Healthy China 2030" initiative by enhancing cancer survival rates through systematic approaches that promote standardized, precise, and sustainable breast cancer treatment [11].

Core Insights - Roche (RHHBY.US) announced statistically significant results from the final overall survival (OS) outcomes of the Phase III APHINITY study for patients with HER2-positive early breast cancer, showing a 17% reduction in death risk for those treated with Perjeta, Herceptin, and chemotherapy compared to those receiving Herceptin, chemotherapy, and placebo [1][2] Group 1 - The APHINITY study was a global, Phase III, randomized, double-blind, placebo-controlled trial involving 4,804 operable HER2-positive early breast cancer patients [1] - The primary endpoint of the study was invasive disease-free survival, with secondary endpoints including cardiac and overall safety, overall survival, and health-related quality of life [1] Group 2 - Ten-year survival rates showed that patients receiving the Perjeta regimen had a survival rate of 91.6%, compared to 89.8% for those receiving Herceptin, chemotherapy, and placebo (HR=0.83, 95% CI: 0.69-1.00, p=0.044) [2] - In the pre-specified subgroup of lymph node-positive patients, the death risk was reduced by 21% (HR=0.79, 95% CI: 0.64-0.97) [2] - The previously reported benefits in invasive disease-free survival were maintained (HR=0.79, 95% CI: 0.68-0.92), with no observed benefits in the lymph node-negative subgroup [2] - Safety profiles, including cardiac safety, were consistent with previous studies, with no new or unexpected safety signals identified [2]