TG103、HER2 双抗、白紫II 等新品重磅有望26 年获批上市，贡献收入增量。 EGFR ADC：海内外临床稳步推进，看好重磅出海潜力我们看好EGFR ADC 年内国内+海外积极开启三 期：1）国内临床：积极拓展EGFR 突变二线III 期、联合奥希替尼突变一线Ib 随访中，有望年内III期， 及联合PD-1 野生型一线II 期，头颈鳞癌/食管鳞癌在策划一线三期：2）海外临床进展：NSCLC 经典突 变三线及野生型2L+为重点。我们认为EGFRADC 依旧是海内外从数据质量、入组人数及临床进展均具 备竞争力的ADC管线，看好年底到1H26 出海潜力。 机构：华泰证券 研究员：代雯/沈卢庆/孙茗馨 公司公告，实现1-3Q25 收入198.9 亿元（-12.3%yoy，3Q 收入+3.4%yoy，+5.7%qoq），归母净利润35.1 亿元（-7.1%yoy，3Q 利润+27%yoy）；其中3Q25 利润为9.6 亿元（我们估测近6 亿内生利润）。公司 3Q25 收入重回增长，主因：1）成药业务剔除授权收入降幅缩窄，多美素集采影响逐步消散；2）期内 确认与阿斯利康AI 平台及部分Lp（a）小分子BD 合作的 ...

Investment Rating - The report maintains an investment rating of "Buy" for the company with a target price of HKD 12.75 [7]. Core Views - The company achieved a revenue of RMB 19.89 billion for the first three quarters of 2025, representing a year-over-year decline of 12.3%, but a growth of 3.4% year-over-year in Q3 [1]. - The net profit attributable to the parent company for the first three quarters was RMB 3.51 billion, down 7.1% year-over-year, with Q3 profit showing a significant increase of 27% year-over-year [1]. - The revenue growth in Q3 is attributed to the narrowing decline in the prescription drug business and the gradual dissipation of the impact from centralized procurement [1][2]. - The company is optimistic about the continued market expansion of new products such as Omaguzumab and Mingfule under the backdrop of ongoing market development [1][2]. Summary by Sections Revenue and Profitability - The company reported a revenue of RMB 19.89 billion for 1-3Q25, with Q3 revenue showing a 3.4% year-over-year increase and a 5.7% quarter-over-quarter increase [1]. - The net profit for 1-3Q25 was RMB 3.51 billion, with Q3 profit at RMB 960 million, indicating a strong recovery in profitability [1]. Product Pipeline and Business Development - The report highlights the potential of the EGFR ADC pipeline, with ongoing clinical trials both domestically and internationally, indicating strong competitive advantages [3]. - The company confirmed BD revenue of RMB 1.54 billion in 1-3Q25, with expectations for continued BD opportunities in 2026 [4]. Future Outlook - The company anticipates a return to positive growth in prescription drug revenue by 2026, driven by new product launches and the absence of major products in the latest round of centralized procurement [2]. - The projected net profits for 2025-2027 are RMB 4.55 billion, RMB 4.63 billion, and RMB 5.03 billion respectively, with corresponding EPS estimates of RMB 0.40, RMB 0.40, and RMB 0.44 [5][10].

Group 1 - The Hang Seng Index opened down 0.07%, while the Hang Seng Tech Index fell by 0.65% [1] - China Metallurgical Group (601618) and China CNR Corporation (601766) both dropped over 3%, while Lepu Biopharma-B surged over 7% following the domestic approval of the world's first FIC drug EGFR ADC [1] - The fourth quarter is expected to see a fluctuating upward trend in Hong Kong stocks, with the "barbell strategy" being the optimal choice to respond to market changes [1] Group 2 - The barbell strategy consists of a technology sector that benefits from the AI revolution and new productivity, focusing on high-growth opportunities, while the high-dividend sectors provide stable cash flow to mitigate market risks [1] - This investment configuration aligns with the current market environment characterized by "policy support + technological breakthroughs" and matches the preferences of foreign institutions for growth leaders and high-dividend stocks [1] - For investors, positioning in Hong Kong tech stocks represents capturing the most imaginative growth opportunities in a fluctuating market, achieving a balance between offense and defense [1] Group 3 - Relevant ETFs for Hong Kong tech include the Hong Kong Stock Connect Technology ETF (159101), which covers the entire technology industry chain, and the Hang Seng Internet ETF (513330), which focuses on internet leaders [2]

Core Viewpoint - The article reviews the ten-year development of China's innovative drug industry, highlighting significant breakthroughs in quantity, quality, and technology, supported by a complete industrial chain, the growth of CXO, and increased investment in research and development [2][3]. Summary by Sections Development of Innovative Drugs - China's self-developed innovative drugs have ranked first globally, with over 50% of popular target pipelines now accounted for by China, expected to exceed 60% by June 2025 [6]. - The proportion of FIC (First-in-Class) molecules developed by Chinese companies has risen from 9 in 2015 to 120 by 2024, indicating a significant release of potential in original drug research [9]. Technological Breakthroughs - The gap in drug approval times between China and the U.S. has narrowed significantly, from about 8 years before 2015 to less than 2 years post-2015, with some FIC drugs being approved first in China [15][16]. Industrial Chain Advantages - China has a complete industrial chain from raw materials to services, with significant production capabilities in nucleotides and a robust logistics network enhancing the innovative drug sector [18]. - The CXO model has strengthened the industrial foundation for innovative drugs, making China an indispensable part of the global biopharmaceutical industry [19]. - China boasts a large, cost-effective, and younger pool of pharmaceutical engineers, with the number of science and engineering PhD graduates expected to be double that of the U.S. by 2025 [20][21]. Research and Development Growth - The output of biomedical research papers in China has grown rapidly, with a compound annual growth rate (CAGR) of 14.3% from 2015 to 2020, making it the second-largest producer of such papers after the U.S. [22]. - R&D expenditures in the biopharmaceutical sector have increased from 19.2 billion yuan in 2016 to 119.04 billion yuan in 2024, reflecting a CAGR of 29.8% [22]. Market Dynamics - The average time from application to approval for innovative drugs in China has decreased by 57 days, with priority-reviewed drugs seeing an even greater reduction of 189 days [30]. - The market share of domestically developed innovative drugs has increased from 18.7% in 2015 to 27.8% in 2024, indicating a significant breakthrough against foreign competitors [34].

Summary of CSPC Pharmaceutical Group Conference Call Company Overview - **Company**: CSPC Pharmaceutical Group (1093.HK) - **Industry**: China Healthcare - **Current Stock Price**: HK$10.51 (as of August 22, 2025) - **Market Capitalization**: HK$125,653 million - **Price Target**: HK$9.60, indicating a downside of 9% from the current price [6][8] Key Financial Highlights - **2Q Revenue**: Decreased by 14% YoY, with finished drug sales down 27% YoY and 8% QoQ, which was 15% below estimates [8] - **Gross Profit Margin (GPM)**: Declined by 6.7 percentage points [8] - **Operating Expenses Ratio**: Increased by 8.7 percentage points YoY [8] - **Underlying Profit**: Fell by 39% YoY and 36% QoQ in 2Q; without business development (BD) income, the decline would have been 59% YoY and 24% QoQ [8] - **Fiscal Year Ending**: Expected EPS for 2025 is Rmb0.45, with revenue projected at Rmb29,036 million [6] Growth and Strategic Initiatives - **Revised Guidance**: CSPC recalibrated its target to achieve 5% half-on-half growth in 2H25, anticipating growth acceleration from 2026 [8] - **Sales Target for Mingfule**: On track to reach Rmb1 billion in sales in 2025 [2] - **Business Development (BD) Strategy**: Aims to complete two more BD deals, each exceeding US$5 billion by year-end 2025 [8] - **Focus on Retail Channels**: Plans to strengthen out-of-pocket retail channels to sustain Rmb2 billion in sales post-patent expiry [2] Clinical and Product Development - **EGFR ADC Updates**: Global Phase 3 trials for 3L+ EGFRm NSCLC and 2L+ EGFRwt NSCLC are set to begin in 2H25, with conditional approval based on Overall Response Rate (ORR) [3] - **Competitive Positioning**: Early data in China shows competitive Progression-Free Survival (PFS) and Overall Survival (OS) trends in 2L EGFRwt NSCLC compared to TROP2 ADCs [3] Technology and Pipeline - **Diverse Technology Platforms**: CSPC is nurturing eight technology platforms to support BD candidates across various therapeutic areas [4] - **Metabolic Portfolio**: Includes monthly-dosing semaglutide (Phase 1), GLP-1/GIP, and other innovative therapies [9] Risks and Challenges - **Market Risks**: Stricter reimbursement controls and Value-Based Pricing (VBP) headwinds are impacting legacy drug sales [8] - **Potential Downside Risks**: Include pipeline failures, rising operating costs, and further government price cuts [14] Analyst Ratings and Market Sentiment - **Stock Rating**: Overweight, indicating a positive outlook compared to the industry average [6] - **Industry View**: Attractive, suggesting favorable conditions for growth in the China healthcare sector [6] Conclusion CSPC Pharmaceutical Group is navigating a challenging market environment with a focus on strategic growth through business development and innovative product pipelines. The company is positioned for potential recovery and growth in the coming years, despite current financial setbacks and market pressures.

Summary of the Conference Call for Lepu Biopharma Company Overview - **Company**: Lepu Biopharma - **Industry**: Biopharmaceuticals, specifically focusing on Antibody-Drug Conjugates (ADCs) Key Points and Arguments 1. **Patent Dispute with CSPC**: Lepu Biopharma is involved in a patent dispute with CSPC following CSPC's acquisition of Jinmant. CSPC is currently seeking to invalidate Lepu's antibody patent, which could impact the commercialization of the EGFR ADC [2][3][4] 2. **Clinical Development**: Lepu's GP104 ADC is in Phase I trials and shows promise in treating second-line liver cancer, with plans to present detailed data at the SGO conference in 2026 [2][5] 3. **Revenue Growth**: Lepu Biopharma reported a revenue of 368 million RMB in 2024, a 63% increase year-on-year. The company anticipates its core product MRG003 will be launched by late 2025 or early 2026, with an expected profit of over 20 million RMB in 2025 [2][6] 4. **NDA Submission**: The EGFR ADC (MRG003) for nasopharyngeal carcinoma has submitted a New Drug Application (NDA) and received priority review status, expected to be approved in early 2026 [2][6] 5. **Platform Upgrade**: The ADC platform has been upgraded from second-generation to third-generation, enhancing its potential for international collaboration, as evidenced by licensing agreements with AstraZeneca and Arrivant totaling 1.2 billion USD [2][7] 6. **Pipeline and Market Potential**: Lepu's pipeline focuses on unmet clinical needs in major diseases such as pancreatic cancer, liver cancer, and colorectal cancer, indicating a strategic direction towards high-demand therapeutic areas [2][5][10] 7. **Clinical Data**: Recent data from the SGO conference showed that Lepu's ADC outperformed chemotherapy in terms of Objective Response Rate (ORR) and Progression-Free Survival (PFS), with a notable safety profile [3][11] 8. **Market Size**: The combined peak sales potential for nasopharyngeal and head and neck squamous cell carcinoma is estimated at 2.7 billion RMB, with head and neck cancer representing a larger market opportunity [12] 9. **Future Catalysts**: Key upcoming events include the presentation of clinical data at the ESMO conference in October 2025 and the potential for breakthrough therapy designation for the 004 drug, which would enhance its market entry prospects [9][10] 10. **Valuation**: Lepu Biopharma's valuation is based on pipeline progress and projected sales multiples, estimated at approximately 22.4 billion HKD, indicating room for growth in the current market [19] Other Important but Overlooked Content - **Acquisition Strategy**: Lepu has grown through mergers and acquisitions, integrating various small companies and collaborating on multiple projects, which strengthens its market position [10] - **Emerging Technologies**: The company is also exploring the use of oncolytic viruses, with plans for a BLA submission in the U.S. by the end of 2025, which could further diversify its product offerings [8][10] - **Competitive Landscape**: The ADC market is competitive, with several companies, including Innovent and AstraZeneca, developing similar products, highlighting the need for Lepu to maintain a strong clinical and commercial strategy [16][17] This summary encapsulates the critical insights from the conference call, focusing on Lepu Biopharma's current status, future prospects, and the competitive landscape within the biopharmaceutical industry.

Core Viewpoint - Dongwu Securities report indicates that Xinowei achieved a net profit attributable to shareholders of -0.03 billion yuan (-102%) in the first half of the year, with a slight increase in revenue but a significant decline in profit [1] Group 1: Financial Performance - The company reported a net profit of -0.03 billion yuan, reflecting a 102% decline [1] - Revenue showed a slight growth despite the substantial drop in profit [1] Group 2: Research and Development Progress - The company continues to increase investment in R&D, with the EGFR ADC expected to initiate its first overseas registration clinical trial in the second half of the year [1] - Overseas clinical trials are accelerating, with over 100 patients enrolled to date, and the potential for a significant business development (BD) blockbuster [1] - SYSA1501 (HER2-MMAE) completed the last patient enrollment for the 2L+HER2+ breast cancer Phase 3 clinical trial in China in April [1] - The mRNA vaccine platform is progressing smoothly, with RSV, VZV, and HPV vaccines currently in Phase I clinical trials [1] - The PD1 monoclonal antibody completed the first patient enrollment for the domestic SCLC post-chemotherapy consolidation treatment Phase 2/3 clinical trial in June [1] - Omabuzumab for the treatment of moderate to severe allergic asthma was approved in February [1] - The pertuzumab analog completed Phase 3 clinical trials in June and achieved topline results, with expectations for production reporting in the second half of the year [1] Group 3: Business Stability - The company's biopharmaceutical R&D is progressing smoothly, while the functional food and raw material drug businesses are gradually stabilizing [1] - The company maintains a "buy" rating [1]

Group 1 - The core viewpoint of the report is that Dongwu Securities has given a "buy" rating for XinNuoWei (300765.SZ) based on its performance and potential in the biopharmaceutical sector [2] - The company experienced a slight revenue growth in H1, but a significant decline in profits [2] - The EGFR ADC data presented at the AACR conference is seen as a potential "blockbuster" drug, indicating strong future prospects [2] - The company is actively increasing its investment in research and development, focusing on ADC, mRNA, and monoclonal antibody drugs [2]

Core Viewpoint - The investment landscape for innovative drugs in 2025 is expected to be clear and profitable, particularly for those with overseas market potential, but selecting stocks will be challenging due to market sentiment and rapid shifts in hot sectors [2]. Group 1: Market Performance - Over 50 stocks have increased by more than 30% this year, with around 30 of these related to innovative drugs, indicating a strong correlation between stock performance and the innovative drug sector [3]. - Innovative drug assets, with clear labeling, have an average increase of 50%, with a median increase of 35% [4]. Group 2: High-Elasticity Stocks and Their Logic - Stocks like Shuyatong and Yipanghong have seen significant price increases due to their innovative drug targets and clinical progress, with Shuyatong's stock rising fourfold in two months [5][6]. - Sanofi's PD-1/VEGF dual antibody has doubled its market value due to a lucrative deal, showcasing the impact of strategic partnerships on stock performance [6]. - Yifang Bio's stock surged by 150% following positive clinical data, highlighting the importance of clinical trial results in driving stock prices [7]. - Stocks like Hot Scene Bio and Rongchang Bio have experienced substantial increases due to market sentiment and clinical data releases, with increases of 300% and 130% respectively [7][8]. Group 3: Characteristics of Innovative Drug Market - Stocks that have significantly outperformed typically have either strong clinical data or are widely recognized drugs, such as Yipanghong's gout medication and Taienkang's vitiligo treatment [10]. - The current market phase is characterized by a focus on pipeline exploration, with investors looking for promising clinical-stage products [13]. Group 4: Future Market Trends - Key events to watch for in the innovative drug sector include business development (BD) transactions, important data releases from clinical trials, and the potential for overvaluation leading to market corrections [15].

Core Viewpoint - The company is facing significant pressure from centralized procurement and medical insurance cost control in Q1 2025, but is expected to see gradual improvement starting from Q2 2025, with projections of achieving three major BD licensing deals exceeding $5 billion each in 2025 [1][2] Group 1: Q1 2025 Performance - In Q1 2025, the company's revenue decreased by 30% year-on-year, excluding BD income, with the prescription drug segment declining by 37% [1] - Key therapeutic areas experienced declines: CNS down 30% due to medical insurance cost control and a 13% price reduction from negotiations; oncology core products saw a 66% drop in sales due to centralized procurement and channel price adjustments [1] - The company recorded 720 million RMB in licensing fee income, primarily from collaborations with AstraZeneca and BeiGene [1] - Revenue from raw materials increased by 15% year-on-year, driven by demand in the VC market and rising product prices, while functional foods and other business revenues fell by 9% due to declining demand and prices for caffeine [1] - The net profit margin improved by 3.1 percentage points to 21.1% due to high-margin licensing income and cost control efforts [1] Group 2: Future Outlook and BD Transactions - The company anticipates gradual improvement in performance starting Q2 2025, driven by increased promotion of Enbip, stabilization from procurement and inventory adjustments, rapid market entry of new products, and additional BD income recognition [2] - Management expects to achieve three large overseas licensing deals in 2025, each exceeding $5 billion, including a comprehensive technology platform licensing deal [2] - The company is advancing a Phase III study for EGFR ADC in second-line EGFR+ NSCLC in China and has initiated studies for third-line EGFR classic mutation NSCLC overseas, with further discussions with the FDA planned for June [2] - Based on optimistic BD income and operating expense forecasts, the company has raised its revenue projections for 2025-2027 by 1.5-7.5% and net profit forecasts by 8-13% [2] - The DCF target price has been adjusted to 7.2 HKD, corresponding to a 14.7x P/E ratio and 1.1x PEG for 2025, indicating that the current stock price reflects the anticipated pressure on 2025 performance and future BD transactions, with limited upside potential [2]