2025年落下帷幕，医药行业这一年可谓波澜壮阔。仿制药领域更是风起云涌。既有集采价格战的激烈厮杀，又有监管"风暴"的强力洗礼，而首仿药的争夺 战，更是成为这场行业大戏中的核心看点。 这足以证明，即便在严苛环境下，首仿药市场依然释放着强大吸引力。 这不仅仅是数量的竞争，更是研发速度、立项眼光和注册策略的综合比拼。首仿药，已成为衡量药企仿制药研发实力的核心指标之一。 二、科伦再首仿王座，齐鲁制药紧随其后 2025年的首仿排行榜，呈现"一超多强，新老交替"的格局。 在国内首仿药领域，齐鲁、科伦、恒瑞医药、石药集团为头部企业。科伦药业展现出持续的领跑优势。2022年与恒瑞均以7款首仿并列榜首，2023年以6款首 仿位居榜首。尽管2024年首仿获批数量有所回调，但仍成功斩获4款首仿药。2025年，科伦再度以6款首仿强势回归榜首，进一步巩固其龙头地位。 一、集采深水区，首仿药成"避风港" 第十一批国家药品集采围绕"稳临床、保质量、反内卷、防围标"系统优化规则，堪称行业分水岭。此次集采品种多，且首次纳入胰岛素专项、生物类似药及 中成药大品种，降价压力从化学药延伸至更多治疗领域。 在常规仿制药进入"微利时代"的背景下，首仿药 ...

Core Viewpoint - The Chinese innovative drug market is experiencing a "structural turning point," which is expected to reverse the downward trend in the pharmaceutical industry [3][11]. Industry Overview - The domestic pharmaceutical terminal sales have shown negative growth since 2024, with over 30% of regulated pharmaceutical companies reporting losses in the first half of this year [3][7]. - The low concentration in several sub-sectors, particularly in the generic drug industry, has led to "price internalization," which is a key constraint on the development of the Chinese pharmaceutical industry [3][7]. Innovative Drug Market Potential - Despite the challenges, there has been a significant emergence of innovative drug achievements in China this year, with innovative drugs rapidly increasing their market share and frequent external licensing deals [3][5]. - The market share of innovative drugs in China is currently only 8.6%, compared to over 70% in the US and European countries, indicating substantial growth potential [5][17]. Financial Performance - The overall revenue of pharmaceutical companies in China decreased by 5.5% year-on-year, but innovative transformation companies and some emerging innovative drug firms have maintained good growth and profitability [3][7]. - In the first half of 2025, 34.3% of the surveyed companies reported losses, highlighting the financial strain within the industry [7][10]. Market Dynamics - The average price level of generic drugs has been further reduced due to policies on price governance and drug price control, leading to intensified competition and downward pressure on prices [8][9]. - The Chinese pharmaceutical industry is still primarily driven by domestic circulation, with exports contributing only 10% to 15% of industrial revenue over the past four years [7][10]. Future Outlook - The commercialization of innovative drugs is expected to become the core driving force for industry growth during the downturn [11][12]. - The market for innovative drugs (including biosimilars) reached 120 billion yuan in 2023, with a growth rate of 27%, indicating a robust pipeline of new products [12][17]. Export Performance - From January to October 2025, China's pharmaceutical product exports reached 91.17 billion USD, a year-on-year increase of 3.5%, with a significant growth in formulation exports [15][16]. - The proportion of formulation exports in total pharmaceutical exports reached a historical high of 16.1%, indicating a shift in the export landscape [16]. Challenges and Opportunities - The domestic innovative drug market is still not large enough, and the pricing support system needs improvement to sustain growth [17][21]. - The industry faces challenges from funding shortages and low accessibility of innovative drugs, with about 88% of respondents in a survey indicating insufficient funding for innovative drug development [17][21]. Strategic Recommendations - To enhance the commercialization efficiency of innovative drugs, the industry should focus on reducing competition among numerous players and fostering a healthier market structure [23][24]. - Building an international innovation platform is crucial for Chinese pharmaceutical companies to capture a larger share of the global innovation dividend [24].

Group 1: Market Overview - In the US and five European countries, innovative drugs account for 70%-80% of the local market, while in China, the market share of innovative drugs is only 8.6% [1][10] - The Chinese innovative drug market is experiencing a "structural turning point," which is expected to reverse the downward trend in the pharmaceutical industry [1] - The domestic pharmaceutical terminal sales are projected to show negative growth starting in 2024, with over 30% of regulated pharmaceutical companies reporting losses in the first half of this year [1][3] Group 2: Industry Challenges - The pharmaceutical industry is facing a survival crisis due to external growth factors diminishing, and the capital market's enthusiasm for business development (BD) transactions cooling down [3] - The low concentration in several sub-sectors, particularly in the generic drug industry, has led to price competition, which is a key constraint on the development of the Chinese pharmaceutical industry [3][4] - The average price level of generic drugs has been further reduced due to policies on price governance and drug price comparison [4] Group 3: Innovative Drug Growth - Despite the overall revenue decline in the pharmaceutical industry, innovative drug companies have maintained good growth and profitability, with some achieving record high revenues [1][7] - The market size of innovative drugs (including biosimilars) reached 120 billion yuan in 2023, with a growth rate of 27% [7] - The revenue growth rate for biological products was 2.2%, with profit growth at 10.6%, indicating a strong performance in the innovative drug sector [8][7] Group 4: Regulatory and Policy Developments - The National Healthcare Security Administration has announced reforms to improve the immediate settlement of medical insurance funds, which is expected to alleviate the financial pressure on hospitals and improve drug payment timelines [5][6] - The implementation of policies to expand the scope of drug procurement and price control is expected to further impact the market dynamics [4][10] Group 5: Future Opportunities - The commercial potential of innovative drugs is anticipated to become the core driver of industry growth during the downturn [7] - The increasing number of innovative drug approvals and the shift in hospital medication structure are expected to enhance the market share of innovative products [7] - The industry is encouraged to build international innovation platforms to capture a larger share of the global market [2][18]

Investment Rating - The report recommends a "Buy" rating for multiple companies in the pharmaceutical sector, including Junshi Biosciences, Hualing Pharmaceutical-B, Aorite, and others [1]. Core Views - The pharmaceutical sector experienced a 3.29% increase this week, outperforming the CSI 300 index by 4.37 percentage points. Sub-sectors such as pharmaceutical commerce, pharmacies, and innovative drugs performed well, while medical devices and consumables lagged [2][12]. - The report emphasizes the importance of market pricing power and the impact of liquidity and risk appetite on investment strategies, particularly in innovative drugs and related supply chains [2][12]. - The report highlights the upcoming patent expirations for small molecule drugs, which are expected to create significant demand for raw materials, with a projected sales impact of $390 billion from 2025 to 2030 [3][13]. Summary by Sections Industry Performance - The pharmaceutical sector's performance this week was characterized by a 3.29% increase, with notable performances in pharmaceutical commerce (+7.31%), pharmacies (+6.83%), and innovative drugs (+5.01%). In contrast, medical devices (0.16%) and new medical infrastructure (1.18%) showed weaker performance [17][29]. - The overall price-to-earnings (P/E) ratio for the pharmaceutical industry is reported at 30.84 times, with a premium of 25.08% compared to the overall A-share market excluding the financial sector [33]. Company Dynamics - Notable company announcements include: - Prologis Pharmaceuticals received a European certificate for its product, enhancing its international market prospects [18]. - Jianyou Co. announced FDA approval for its production site, expanding its manufacturing capabilities [19]. - Fuyuan Pharmaceuticals received a drug registration certificate from the National Medical Products Administration, allowing for the marketing of its product [20]. - The report suggests focusing on companies benefiting from domestic innovative drug support policies, such as Yangguang Nuohuo and Nuosige, as well as those with strong overseas business prospects [15][7]. Raw Materials - The report indicates that the raw materials sector is expected to see a significant increase in demand due to patent expirations, with a projected sales impact of $390 billion from 2025 to 2030. The production of raw materials in H1 2025 reached 1.935 million tons, reflecting an 8.2% year-on-year increase [3][13]. - Companies recommended for attention in the raw materials sector include Aorite, Prologis Pharmaceuticals, and Aoxiang Pharmaceuticals, focusing on innovation and strong performance [3][16].

Core Insights - The Chengdu-Chongqing economic circle is experiencing unprecedented development vitality, with the economic total increasing from 6.3 trillion to 8.7 trillion yuan over five years, showcasing its significant support for high-quality development in the western region and nationwide [1] Industry and Company Developments Biopharmaceutical Sector - Companies like Olin Bio are focusing on innovative vaccine development, achieving significant sales in their tetanus vaccine and leading global research in recombinant Staphylococcus aureus vaccines, demonstrating that high R&D investment is crucial for core competitiveness [2] - Yuandong Bio is transforming through a combination of imitation and innovation, progressing from high-end generics to innovative drug development, providing a model for small and medium-sized pharmaceutical companies [2] Traditional Industry Transformation - Chongqing Pharmaceutical Holdings exemplifies traditional enterprise transformation through identity, business, and digital changes, enhancing growth and efficiency [3] - Huaxi Securities is strategically integrating into the Chengdu-Chongqing economic circle, focusing on unique business offerings to leverage local policy benefits and industry characteristics [3] Advanced Technology Sector - Zhongzi Technology has evolved over 20 years, turning laboratory innovations into market-ready products, and has established a business matrix encompassing catalysts, new energy, and new materials [3] - Reascent Technology is developing core technologies in ultra-fine fiber materials, expanding applications in air purification and insulation [4] - Silica Treasure Technology has become a leader in organic silicon sealing materials, achieving a comprehensive product system and multi-field layout [4] Niche Market Leaders - Shanwaishan has achieved international advanced levels in blood purification equipment, expanding its market presence both domestically and internationally [5] - Zhongguang Lightning Protection has built a unique technological moat through a full-chain approach to lightning protection, supported by a legacy of technical expertise [6] Conclusion - Companies across various sectors in the Chengdu-Chongqing region are leveraging innovation and resilience to contribute significantly to the economic landscape, marking a vibrant chapter in the development of the dual-city economic circle [6]

Summary of Conference Call Notes Company and Industry Overview - **Company**: 广生堂 (Guangshengtang) - **Industry**: Innovative Pharmaceuticals, Traditional Chinese Medicine, Medical Devices, CRO (Contract Research Organization) Key Points and Arguments 1. **Market Opportunities in Innovative Pharmaceuticals**: The innovative drug sector is expected to see a new wave of opportunities following irrational market perceptions and rapid digestion of shares, supported by new catalysts and expectations [2][6] 2. **Collaboration with Global Pharma**: Pfizer's CEO expressed willingness to collaborate with Chinese pharmaceutical companies, indicating a strong industry trend that could benefit local firms [2][6] 3. **Potential of Guangshengtang's Products**: Guangshengtang's products 131 and 141 show promise for achieving clinical cure for hepatitis B, with their efficacy recognized both domestically and internationally [2][7][8] 4. **Market Statistics**: In 2022, hepatitis B caused 1.1 million deaths in China, with chronic HPV infections affecting 86 million people, but diagnosis and treatment rates remain low at 22% and 15%, respectively [2][7][8] 5. **Focus on Q4 Opportunities**: Anticipation of catalysts in Q4 includes the digestion of BD expectations, increased spending by multinational corporations before Christmas, and positive data from major conferences [2][6] 6. **Performance of Traditional Chinese Medicine**: The traditional Chinese medicine sector outperformed the Shenwan Pharmaceutical Index last week but has underperformed year-to-date. Key companies to watch include Guizhou BaiLing and Wanbangde [2][11] 7. **CRO Sector Outlook**: The CRO sector is expected to benefit from supportive domestic policies and a gradual recovery in investment, with positive changes in CDMO (Contract Development and Manufacturing Organization) business anticipated [4][17] 8. **Medical Device Sector Performance**: Recent data from companies like Lepu Biotech shows significant clinical effectiveness, with overall survival (OS) of 13.8 months and progression-free survival (PFS) of 5.9 months in treatments [4][12] 9. **Regulatory and Policy Impacts**: The focus on policy-friendly enterprises in the traditional Chinese medicine sector and the impact of outpatient policy advancements on pharmacy performance are critical [2][11] 10. **Investment Strategy**: The investment strategy emphasizes identifying companies with strong Q3 performance, focusing on innovative drugs, and returning to a leadership-driven selection process [2][9][10] Additional Important Insights - **Emerging Trends in Medical Devices**: The medical device sector is experiencing a downturn, but long-term trends include a focus on domestic substitution and internationalization [4][18] - **CRO and Medical Services Performance**: The CRO sector has seen a decline recently but remains ahead year-to-date, while the medical services sector is under pressure but may recover as consumer spending increases [4][17] - **Future of PD-L1S**: PD-L1S shows consistent performance in first and second-line therapies, indicating potential market expansion opportunities [4][13] - **Recent Transactions in Generic Drugs**: The generic drug sector saw a slight decline, but significant transactions, such as Hansoh Pharma's licensing deal with Roche, highlight ongoing activity in the market [4][15] This summary encapsulates the key insights and trends discussed in the conference call, providing a comprehensive overview of the current state and future outlook of the pharmaceutical and medical device industries.

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]

Policy & Regulation - The Trump administration has been discussing strict restrictions on drugs from China, potentially disrupting the US pharmaceutical industry's supply of drugs ranging from generics to advanced treatments [1] - Prominent investors and business executives with close ties to the White House are advocating for decisive action against what they see as a Chinese existential threat to US biotechnology [1] Industry Impact - Major pharmaceutical companies have been acquiring rights to drugs developed in China for diseases such as cancer, obesity, heart disease, and Crohn's disease [1]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [7] Core Insights - The report highlights that the pharmaceutical sector is experiencing a rebound, particularly in innovative drugs and their supply chains, with a strong emphasis on the potential for a second wave of innovation over the next 5-10 years [3][4][12] - The report indicates that the recent market adjustments have not altered the fundamental industry logic, and the core theme for innovative drugs is "disruption" [3][4][14] Summary by Sections 1. Industry Performance - The pharmaceutical index increased by 1.40% during the week of September 1-5, underperforming the ChiNext index but outperforming the CSI 300 index [12] - The market has shown a tendency for larger stocks to perform better than smaller ones, with innovative drugs and their supply chains being the main focus [2][3] 2. Recent Review - The report notes a significant rebound in the market after a period of adjustment, with innovative drugs remaining the strongest sector [3][4] - The report emphasizes that the recent adjustments in innovative drug stocks are primarily market-driven and do not reflect changes in industry fundamentals [3][4][14] 3. Future Outlook - The report suggests a continued focus on innovative drugs, particularly overseas large pharmaceuticals and small to mid-cap technology revolutions, with an optimistic outlook for 2025 [4][15] - Key investment themes include innovative drugs, new technologies like brain-computer interfaces and AI in medicine, and internationalization of research instruments and equipment [4][15][16] 4. Strategic Allocation - The report outlines specific companies to focus on within the innovative drug sector, including major players like Innovent Biologics and BeiGene, as well as smaller firms involved in gene therapy and weight loss drugs [16][17] - It also highlights opportunities in new technologies and internationalization, suggesting a diversified approach to investment within the pharmaceutical sector [16][18]

Group 1 - The U.S. has signed an executive order to implement a trade agreement with Japan, which includes a reduction of tariffs on Japanese automobiles from 27.5% to 15%, effective as early as next week [1] - The executive order states that nearly all Japanese products entering the U.S. will be subject to a 15% baseline tariff, with specific industries like automotive, aerospace, and pharmaceuticals receiving targeted treatment [1] - Japan is expected to provide market access opportunities for U.S. manufacturers in key sectors, including a plan to increase U.S. rice imports by 75% under a minimum import quota framework [1] Group 2 - Japan has agreed to invest $550 billion in the U.S., with the investment content to be chosen by the U.S. government [2] - The perceived reduction of the "reciprocal tariff" from 25% to 15% is viewed as a psychological effect rather than a substantial concession, as the actual tariff on Japanese automobiles has increased significantly from 2.5% to 15% [2] - The investment memorandum signed by Japan does not fully reflect Japan's interests, indicating that further negotiations will be necessary for the Japanese government [2]