经观健康 2025年1-8月，中国创新药BD（狭义：药物对外授权）交易首付款超300亿元，已超同期一级市场融资 额，在二级市场，BD推动了创新药行业进入第二个市值高峰。 BD，无疑是今年创新药行业乃至中国股市的关键词之一。 近期，美国相关行政命令草案、个别出海药物临床数据争议，又让市场对BD热潮陷入迷茫和犹疑。 经济观察报【分子圆桌派第一期：重估BD】由经济观察报大健康新闻部主任张英主持，中国生物制药 执行董事、资深副总裁谢炘、中信证券医疗健康产业首席分析师陈竹就2025年中国创新药行业的BD热 潮展开了探讨，以下为此次主题沙龙的相关实录。 张英：大家好，欢迎来到经济观察报《分子圆桌派》，我是今天的主持人张英。今年以来，创新药BD 交易吹动了股市热，也推动了多家创新药企进入第二个市值高峰。不过我们也关注到近期多家创新药企 的股价有一定的回调，那么近期美国的相关行政命令草案以及个别出海药物的临床数据争议，也让部分 市场人士对当前的创新药 BD 热潮陷入了这个迷茫和犹疑。在此背景之下，分子圆桌派第一期我们将聚 焦今年的创新药 BD 热潮，重估它的价值和前景。 张英：以及中信证券医疗健康产业首席分析师陈竹，陈老师。 ...

Group 1 - The company is covered for the first time by Guojin Securities, which gives a "buy" rating and forecasts revenue of 33.41 billion, 37.17 billion, and 41.70 billion yuan for 2025, 2026, and 2027 respectively, with year-on-year growth of +15.75%, +11.24%, and +12.21% [1] - The net profit attributable to the parent company is projected to be 4.63 billion, 4.75 billion, and 5.28 billion yuan for the same years, with year-on-year growth of +32.17%, +2.75%, and +11.17% [1] - The company has a solid position as a leading pharmaceutical player, with a steady increase in revenue and operating profit, and a significant rise in R&D investment, which accounted for 18.1% of revenue in H1 2025, up from 11.1% in 2020 [1] Group 2 - The company acquired Lixin Pharmaceutical for approximately 500 million USD, enhancing its oncology product pipeline [2] - The drug Anlotinib has been approved for 9 indications, and its combination with PD-1 has shown superior results in head-to-head trials against other treatments [2] - The company aims to license out innovative products as a key strategic goal, with promising candidates in oncology and respiratory fields, potentially generating recurring revenue from business development transactions starting in 2025 [3]

Core Viewpoint - Company is positioned as a leading player in the biopharmaceutical industry, with a strong focus on innovation and growth in revenue and profit margins [1][2][3] Group 1: Financial Projections - Company is expected to achieve revenues of 334.12 billion, 371.66 billion, and 417.04 billion CNY in 2025, 2026, and 2027 respectively, representing year-on-year growth of +15.75%, +11.24%, and +12.21% [1] - Projected net profit attributable to shareholders is 46.26 billion, 47.53 billion, and 52.84 billion CNY for the same years, with year-on-year growth of +32.17%, +2.75%, and +11.17% [1] - Earnings per share (EPS) are forecasted to be 0.25, 0.25, and 0.28 CNY for 2025, 2026, and 2027 [1] Group 2: Strategic Developments - Company has acquired Lixin Pharmaceutical for approximately 500 million USD, enhancing its oncology product pipeline [2] - The acquisition includes key products such as LM-299 and LM-305, which have been licensed to major pharmaceutical companies [2] - Anlotinib has been approved for 9 indications, showing promising results in head-to-head trials against competitors [2] Group 3: Innovation and R&D Focus - Company has significantly increased R&D investment, with 18.1% of revenue allocated to R&D in the first half of 2025, up from 11.1% in 2020 [1] - The number of approved innovative products has reached 19, with innovative product revenue accounting for 44.4% of total revenue in the first half of 2025 [1] - Company aims to leverage its innovative products, such as CDK2/4/6 inhibitors and HER2 bispecific antibodies, to establish a competitive edge in the international market [3]

Group 1 - The core viewpoint of the article emphasizes the ongoing developments related to the essential drug catalog, indicating that while the release has been delayed, it is expected to occur soon, with a focus on unique essential drugs that are anticipated to grow faster than non-essential drugs [11][20][21] - The article highlights the performance of the pharmaceutical sector, noting that the CITIC pharmaceutical index fell by 1.98%, underperforming the CSI 300 index by 1.54 percentage points, ranking 22nd among 30 primary industries [8][9] - The article discusses the investment opportunities in the pharmaceutical sector, particularly in traditional Chinese medicine, state-owned enterprise reforms, and the impact of the new medical insurance catalog on OTC companies [11][14][29] Group 2 - The article provides a detailed overview of the essential drug catalog selection process, which includes expert evaluations and consultations to ensure that the selected drugs meet clinical and economic criteria [34] - It presents data on the historical changes in the essential drug catalog, showing a gradual increase in the number of traditional Chinese medicine products included, with a notable shift towards unique products since the 2009 version [17][18] - The article outlines the sales performance of newly included unique essential drugs, indicating significant growth rates for certain products, particularly in the pediatric and respiratory categories [30][32]

Investment Rating - The report maintains an optimistic outlook on the pharmaceutical industry, suggesting a potential for diverse investment opportunities by 2025 [10]. Core Insights - The pharmaceutical sector is currently undervalued, with public funds showing low allocation to this sector. Positive macroeconomic factors, such as the recovery of U.S. Treasury rates, are expected to drive growth in the industry [10]. - The report emphasizes a shift from quantity to quality in the domestic innovative drug sector, highlighting the importance of products that can generate profits. Companies such as BeiGene, Innovent Biologics, and others are recommended for investment [10]. - In the medical device sector, there is a notable recovery in bidding for imaging equipment, and home medical devices are expected to benefit from subsidy policies. Companies like Mindray and Yuwell are highlighted as key players [10]. - The report discusses the potential for growth in the CXO and life sciences services sectors, with expectations of a rebound in domestic investment and a return to high growth rates by 2025 [10]. - The traditional Chinese medicine sector is expected to see significant growth due to the upcoming updates to the essential drug list, with companies like Kunming Pharmaceutical and Kangyuan Pharmaceutical recommended for attention [12][31]. Summary by Sections Market Review - The report notes a 1.98% decline in the CITIC Pharmaceutical Index, underperforming the CSI 300 Index by 1.54 percentage points, ranking 22nd among 30 sectors [7]. - The top-performing stocks include Yino Science, Furuida, and Chengda Pharmaceutical, while the worst performers include Anglikang and Nuo Cheng Jianhua [7]. Industry and Stock Events - The report highlights the ongoing work related to the essential drug list, with expectations for updates that will favor innovative and traditional Chinese medicines [13][15]. - The essential drug list has not been updated since 2018, and the report anticipates a dynamic management approach to future updates [13]. Overall Perspective and Investment Themes - The report suggests that the pharmaceutical industry is entering a new growth cycle, particularly in the specialty raw materials sector, which is currently at a near-decade low in valuation [10]. - The report emphasizes the importance of the essential drug list in promoting reasonable drug use and its integration into hospital performance assessments [19]. - The report identifies several categories of products likely to be included in the essential drug list, including unique proprietary drugs and innovative traditional Chinese medicines [31][33].

Core Insights - The 28th Annual Academic Conference of the Chinese Society of Clinical Oncology (CSCO) showcased significant research findings on innovative cancer treatments, particularly focusing on the efficacy and safety of Anlotinib in various cancer types [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. Non-Small Cell Lung Cancer (NSCLC) - Anlotinib combined with immune checkpoint inhibitors (ICIs) shows potential as an adjuvant therapy for non-pathological complete response (non-pCR) NSCLC patients post-neoadjuvant immunotherapy, with manageable safety profiles and promising disease-free survival [1]. - A prospective study indicates that the combination of Tislelizumab, Anlotinib, and chemotherapy is effective for resectable NSCLC, achieving a major pathological response (MPR) rate of 81.3% [2]. - Anlotinib combined with Pembrolizumab demonstrates efficacy in elderly patients with advanced PD-L1 positive NSCLC, with a median progression-free survival (PFS) of 8.2 months [3][4]. - The combination of Anlotinib, Pembrolizumab, and chemotherapy shows promising results in treating pulmonary sarcomatoid carcinoma, with an overall response rate (ORR) of 80% [5]. - Real-world data suggests that Anlotinib combined with PD-1/PD-L1 inhibitors is effective for advanced NSCLC, with a median PFS of 7.8 months and an overall survival (OS) of 17.0 months [6]. - A retrospective analysis indicates that Anlotinib combined with ICIs is a viable option for advanced NSCLC patients who have progressed after prior immunotherapy, showing an ORR of 28.6% [8]. Small Cell Lung Cancer (SCLC) - A study on the combination of liposomal Irinotecan, platinum-based chemotherapy, and Anlotinib for extensive-stage SCLC shows promising results, with a focus on maintaining treatment efficacy post-induction therapy [9]. - The combination of Surufatinib, albumin-bound Paclitaxel, and Anlotinib in second-line treatment for extensive-stage SCLC demonstrates a high ORR of 73.33% [10]. - Anlotinib combined with ICIs shows improved efficacy compared to Anlotinib alone in treating extensive-stage SCLC, with a median PFS of 6.5 months [11]. Gastrointestinal Tumors - Anlotinib combined with TAS-102 shows potential as a third-line treatment for metastatic colorectal cancer, with a DCR of 95% and a median PFS of 5.6 months [12]. - The combination of Anlotinib and chemoradiotherapy demonstrates significant efficacy in treating postoperative lymph node recurrence of esophageal squamous cell carcinoma, with a median PFS of 20.2 months [13]. Soft Tissue Sarcoma - Anlotinib combined with Cadonilimab shows promising results in advanced soft tissue sarcoma patients who have failed first-line treatment, with a median PFS of 6.9 months [14]. - The combination of Atezolizumab and Anlotinib in treating advanced liposarcoma and leiomyosarcoma shows a DCR of 89.5% [15]. Thyroid Cancer - Anlotinib combined with Sintilimab shows efficacy in treating BRAF wild-type anaplastic thyroid cancer, with an ORR of 47.6% and a median PFS of 9.63 months [17][18]. Other Cancers - The combination of Sintilimab and Anlotinib shows efficacy in treating advanced SMARCA4-deficient thoracic tumors, with an ORR of 51% [19]. - A real-world study indicates that prior treatment with Bevacizumab does not affect the efficacy of Anlotinib in treating solid tumors, with significant benefits observed in combination therapies [20]. Neutropenia Prevention - The Guard-04 study demonstrates that Aibegersit can effectively prevent chemotherapy-induced neutropenia in colorectal and pancreatic cancer patients, with manageable safety profiles [22].

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 - China National Pharmaceutical Group's subsidiary, Chengdu Tianqing Pharmaceutical, has successfully completed the first shipment of innovative anti-cancer drugs to the Hong Kong-based Greater China Cancer Foundation, marking a significant step in their collaboration [1][2] - The shipment includes innovative anti-cancer drugs Anlotinib and Bemarituzumab, providing new treatment options for cancer patients in Hong Kong with urgent medical needs [1][2] - The Named Patient Program (NPP) allows doctors to provide unregistered drugs to patients in need, aligning with the Hong Kong government's 2023 policy report aimed at improving drug accessibility [1][2] Company Collaboration - The partnership agreement between Chengdu Tianqing and the Greater China Cancer Foundation was signed in March, focusing on providing innovative cancer treatment solutions to patients with significant unmet medical needs in Hong Kong [2] - The efficient completion of compliance reviews and cross-border logistics demonstrates the effectiveness of the NPP model in enhancing drug accessibility [2] - The president of Chengdu Tianqing emphasized the commitment to advancing China's pharmaceutical development and ensuring that innovative products reach Hong Kong patients [2] Social Responsibility - China National Pharmaceutical Group integrates corporate social responsibility into its development strategy, actively participating in charitable initiatives [3] - The successful shipment enhances treatment options for cancer patients in Hong Kong and reflects the deepening and innovative collaboration between mainland China and Hong Kong in the healthcare sector [3]

Market Overview - The CITIC Pharmaceutical Index rose by 1.17%, underperforming the CSI 300 Index by 3.01 percentage points, ranking 29th among 30 primary industries [3] - The retail scale of China's physical pharmacies in Q2 2025 was 1,485 billion yuan, a year-on-year decline of 1.6%, with a cumulative scale of 2,961 billion yuan in the first half of 2025, down 2.2% year-on-year [18][25] Drug Retail Market Analysis - The retail scale of drug sales in Q2 2025 was 1,212 billion yuan, with a slight year-on-year increase of 0.2% [25] - Monthly retail scale for April, May, and June 2025 was 409 billion yuan, 409 billion yuan, and 394 billion yuan respectively, with May showing a year-on-year decline of 0.3% [25] - The drug category maintained a market share of 81.5% by the end of June, with a year-on-year increase of 1.1 percentage points [15] Traditional Chinese Medicine (TCM) Market Analysis - The cumulative scale of TCM retail in Q2 2025 was 111 billion yuan, down 5.9% year-on-year [26] - Monthly retail scale for TCM in April, May, and June 2025 was 30 billion yuan, 36 billion yuan, and 38 billion yuan respectively, indicating a short-term recovery in June [26] Medical Device Market Analysis - The cumulative scale of medical device retail in Q2 2025 was 69 billion yuan, down 4.2% year-on-year [32] - Monthly retail scale for medical devices in April, May, and June 2025 was 22 billion yuan, 24 billion yuan, and 23 billion yuan respectively, with May showing a year-on-year decline of 7.7% [32] Health Products Market Analysis - The cumulative scale of health products in Q2 2025 was 56 billion yuan, down 18.8% year-on-year [34] - Monthly retail scale for health products in April, May, and June 2025 was 18 billion yuan, 19 billion yuan, and 19 billion yuan respectively, with April showing a significant year-on-year decline of 21.7% [34] Chemical Drug Market Analysis - The top 20 chemical drug categories accounted for 78.3% of the sales scale in June 2025, with a year-on-year growth of 7.1% [36] - Notable growth was observed in hemostatic drugs, lipid-regulating agents, and immune stimulants, while cough and cold medications experienced a decline of 12.2% [36] Investment Outlook - The pharmaceutical sector is expected to see a recovery driven by macroeconomic factors and the increasing demand for innovative drugs [10] - The medical device market is anticipated to benefit from the recovery of bidding activities and government subsidies for home medical devices [45]

Investment Rating - The report maintains an optimistic outlook on the pharmaceutical industry for 2025, suggesting a potential for diverse investment opportunities as the sector is currently undervalued [11]. Core Insights - The pharmaceutical sector is experiencing a transition from quantity-driven growth to quality-driven growth, particularly in the innovative drug segment, with a focus on differentiated products and international expansion [11]. - The medical device market is showing signs of recovery, particularly in imaging equipment and home medical devices, with significant growth potential in domestic and international markets [11]. - The report highlights the importance of the innovation chain (CXO + life sciences services) as a key growth driver, with expectations for a rebound in domestic financing and a shift towards high-profit models [11]. - The traditional Chinese medicine market is expected to benefit from policy changes and an aging population, with specific companies recommended for investment [13]. - The retail pharmacy sector is projected to improve due to prescription outflow and market optimization, with several leading pharmacy chains identified as potential investment targets [13]. Summary by Sections Market Overview - The report indicates that the retail market for pharmaceuticals is under pressure due to policy constraints and competition, with a cumulative scale of 2,961 billion yuan in H1 2025, reflecting a year-on-year decline of 2.2% [16]. - Monthly retail sales data shows fluctuations, with April 2025 recording a retail scale of 497 billion yuan, a decrease of 4.6% month-on-month [16]. Product Category Analysis - All product categories in the retail pharmacy sector experienced negative growth in Q2 2025, although the rate of decline has narrowed [17]. - The pharmaceutical segment showed a slight year-on-year increase of 0.2% in Q2 2025, with a cumulative scale of 1,212 billion yuan [20]. - The traditional Chinese medicine segment saw a cumulative scale of 111 billion yuan in Q2 2025, down 5.9% year-on-year [23]. - The medical device market recorded a cumulative scale of 69 billion yuan in Q2 2025, down 4.2% year-on-year [26]. - The health supplement market faced a significant decline of 18.8% year-on-year, with a cumulative scale of 56 billion yuan in Q2 2025 [30]. Chemical Drug Analysis - The top 20 chemical drug categories accounted for 78.9% of the market share in April 2025, with notable growth in immune stimulants and hemostatic drugs [33]. - The report highlights a trend of increasing market share for certain categories, with a focus on the performance of specific drugs [36]. Traditional Chinese Medicine Analysis - The top 20 categories of traditional Chinese medicine accounted for 83.8% of the market share in April 2025, with a decline in several categories [37]. - Seasonal demand fluctuations are noted, impacting the performance of specific drug categories [39]. Investment Recommendations - The report suggests focusing on companies with strong innovation pipelines and market positioning, particularly in the fields of innovative drugs and medical devices [41][42][43].