Core Insights - The 2026 Drugs to Watch report by Clarivate identifies eleven therapies expected to significantly impact clinical practice and achieve strong commercial potential in the coming year [1][2][3] - The report emphasizes the importance of anticipating emerging drug trends and understanding market dynamics to navigate the complex pharmaceutical landscape [3] Metabolic Disease - Orforglipron and Retatrutide, both developed by Eli Lilly, are highlighted for managing obesity and type 2 diabetes mellitus (T2DM) with innovative delivery methods [4][5] - The report projects obesity drug sales to reach USD 150 billion by 2035, emphasizing the need for real-world effectiveness and differentiation in safety and clinical value [16] Rare Conditions - Development in rare diseases is expanding into neurological, psychiatric, and hematologic conditions, requiring targeted engagement and evidence-driven approaches [17] - Therapies like VOYXACT® for immunoglobulin A nephropathy and Relacorilant for ovarian cancer are noted for their potential in these areas [8][13] Oncology - The report features therapies such as Gedatolisib for breast cancer and Tolebrutinib for multiple sclerosis, showcasing advancements in precision oncology [10][9] - The increasing complexity of regulatory pathways in the U.S. and Europe is highlighted as a challenge for companies developing treatments for rare diseases [17] Delivery Innovations - The report underscores the growing importance of delivery innovations, including extended-release formulations and oral alternatives to injectable drugs, which can enhance patient adherence [18] - Mainland China is emerging as a significant market and source of innovation, influencing global strategies in oncology and metabolic disease [18] Methodology and Analysis - The report's findings are based on evaluations from over 160 analysts using integrated, AI-enhanced datasets covering the full R&D and commercialization lifecycle [20][21] - Therapies were selected based on their potential to achieve blockbuster status, defined as reaching USD 1 billion in annual sales within five years [20]

证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 银屑病口服 TYK2/IL23 双雄并立格局确立， 建议关注益方生物，诺诚健华，海思科等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 2025 年 12 月 23 日 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 行业走势 -9% -6% -3% 0% 3% 6% 9% 12% 15% 18% 21% 24% 2024/12/23 2025/4/22 2025/8/20 2025/12/18 医药生物 沪深300 相关研究 《全球最大单品 GLP1，口服临床数据 亮眼》 2025-12-14 《看好创新药出海，重点推荐恒瑞医 药、百济神州等》 2025-12-07 东吴证券研究所 1 / 30 请务必阅读正文之后的免责声明部分 ◼ 本周、年初至今 A 股医药指数涨幅分别为-0.14%、14.49%，相对沪深 300 的超额收益分别为 0.14%、-1.60%；本周、年初至今恒生医疗保健 指数涨跌幅分别为-1.77%、65.28%，相对于恒生科技指数跑赢 1.05%、 ...

Summary of Johnson & Johnson (NYSE: JNJ) 2025 Conference Call Company Overview - **Company**: Johnson & Johnson (J&J) - **Date of Conference**: November 17, 2025 - **Key Speakers**: Candace Long (Worldwide VP Immunology Global Commercial Strategy), David Lee (Global Immunology Therapeutic Area Head) Key Points Icotrokinra Development - **Product Description**: Icotrokinra is the first targeted oral peptide selective to the IL-23 receptor, seen as a transformative therapy for psoriasis [3][4] - **Clinical Data**: Phase three studies show it provides complete skin clearance and favorable safety, positioning it as a first-line systemic therapy for moderate to severe psoriasis [3][4] - **Market Opportunity**: Approximately 5 million Americans with moderate to severe psoriasis or inflammatory bowel disease (IBD) are not currently using biologic therapies, indicating a significant market opportunity [6] - **Approval Timeline**: Submission for regulatory approval was made in July 2025, with a confident expectation for a 2026 launch [4][5] Competitive Positioning - **Head-to-Head Studies**: Ongoing studies against Stelara, a leading biologic therapy, are expected to demonstrate superior efficacy [10][11] - **Manufacturing Capability**: J&J has invested heavily in manufacturing capabilities to meet global demand for Icotrokinra, ensuring readiness for large-scale launches [12] Market Expansion - **Impact on Biologics**: The introduction of Icotrokinra is expected to elevate discussions between clinicians and patients, potentially increasing the overall utilization of biologics [13][15] - **Patient Insights**: A study indicated that over 90% of patients currently on injectable therapies would prefer to switch to an oral option with similar efficacy and safety [18] Future Indications - **Expansion Beyond Psoriasis**: Pivotal studies for Crohn's disease and ulcerative colitis are underway, with positive initial data from the ulcerative colitis studies [5][22] - **Adolescent Studies**: Ongoing studies include adolescent populations to ensure comprehensive data at launch [22] Tremfya Performance - **Current Growth**: Tremfya is experiencing growth in psoriasis and psoriatic arthritis indications, with a focus on inhibiting structural damage in psoriatic arthritis [28][29] - **Market Share**: Over 50% of new patient starts in the IL-23 class for ulcerative colitis are attributed to Tremfya, indicating strong market penetration [30] Imavi Launch - **Unique Positioning**: Imavi is the first FcRn therapy with broad applicability across multiple patient segments, showing promise in myasthenia gravis [45][46] - **Market Potential**: Expected to be a $5 billion asset, with early signs of strong interest from neurologists for first-line use [47] Strategic Acquisitions - **Focus on Atopic Dermatitis and Respiratory Diseases**: J&J has secured multiple assets to address unmet needs in atopic dermatitis and respiratory diseases, which are large and underserved markets [51][52] - **Innovative Mechanisms**: The company is exploring various mechanisms, including IL-31 and TSLP, to enhance treatment efficacy in these complex diseases [54][56] Conclusion - **Overall Strategy**: J&J is focused on advancing its immunology portfolio through innovative therapies, strategic acquisitions, and a commitment to addressing significant unmet medical needs across various indications [58][59]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The report highlights the significant collaboration between Innovent Biologics and Takeda Pharmaceutical, which is seen as a positive trend for Chinese innovation going global. The deal includes an upfront payment of $1.2 billion and potential milestone payments, with a total deal value reaching up to $11.4 billion [2] - The report notes a surge in License-out transactions, with 103 deals and a total value of $92.03 billion in the first three quarters of 2025, marking a 77% increase compared to the total for 2024 [2] - The report emphasizes the recovery of the CDMO sector, with companies like Jiuzhou Pharmaceutical and Boteng achieving significant revenue growth in Q3 2025, indicating a positive trend in the industry [3] - The medical device market is showing a steady recovery, with a 29.8% year-on-year growth in the overall bidding market for medical devices in Q3 2025 [4] - The report discusses the increasing trend of oral immunomodulatory drugs, particularly in the treatment of psoriasis, with Johnson & Johnson's acquisition of Protagonist Therapeutics being a notable example [5] - The report also highlights the trends in respiratory infectious diseases, with an expected increase in cases in the coming months, which may impact medical testing and treatment medications [6] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry has underperformed compared to the CSI 300 index, with a recent weekly decline of 0.95% and a monthly decline of 3.28% [21][25] 2. Pharmaceutical Sector Performance and Valuation - The pharmaceutical sector's recent performance has been below the CSI 300 index, with a 1-month decline of 3.28% and a 3-month increase of only 1.75% [39][42] 3. Recent Research Achievements - The report lists various recent research outputs from the team, including deep dive reports on the growth of the blood products industry and the potential of GLP-1 drugs [47] 4. Recent Industry Policies and News - The report outlines significant recent policies, including the promotion of instant settlement reforms by the National Medical Insurance Administration and the regulation of clinical research for biomedical technologies [49] - Recent news highlights include major collaborations and drug approvals, such as the partnership between Innovent Biologics and Takeda, and the approval of new drugs by various companies [50][51]

Core Insights - Allka Research has over two decades of experience in investment, focusing on uncovering undervalued assets in various sectors including ETFs, commodities, technology, and pharmaceuticals [1] - The company adopts a conservative investment approach, aiming to deliver substantial returns and strategic insights to clients [1] - Allka Research is committed to simplifying investment strategies, making them accessible to both seasoned investors and newcomers [1] - The mission of Allka Research includes sharing knowledge and analyses through Seeking Alpha, fostering a community of informed investors [1] Company Overview - Allka Research is recognized for its dedication to guiding individuals in finding lucrative investment opportunities [1] - The firm emphasizes a passion for empowering others financially, contributing to the financial literacy of its audience [1] Community Engagement - Allka Research aims to demystify investing, inspiring confidence among readers and helping them navigate the markets intelligently [1] - The company seeks to create a community of informed investors through its contributions to Seeking Alpha [1]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The trend of Chinese innovative drugs going overseas is a long-term phenomenon, with external environmental changes having limited impact. In the first half of 2025, there were 72 License-out transactions, exceeding half of the total for 2024, with a total transaction amount 16% higher than in 2024. Notably, there were 16 transactions exceeding $1 billion each [2] - The small nucleic acid drug sector has seen significant breakthroughs, particularly in the treatment of chronic diseases such as hypertension and hyperlipidemia, with major collaborations and potential milestone payments indicating a robust commercial outlook [3] - The trend towards oral autoimmune drugs is gaining attention, with significant partnerships and clinical advancements in this area, highlighting the importance of oral formulations in autoimmune therapies [4] - Recent clinical data on long-acting insulin analogs shows promising weight loss results, with ongoing developments in combination therapies for metabolic diseases, indicating a growing market potential [5] - The CXO sector is gradually recovering, with an increase in License-out transactions serving as a vital funding source for biotech companies, leading to a resurgence in innovation and clinical development [6] - The 2025 national medical insurance negotiations and the commercial insurance innovative drug directory are crucial for companies involved, with a focus on orphan drugs and imported PD-1/L-1 products [7] Summary by Sections Industry Tracking - The pharmaceutical sector has underperformed compared to the CSI 300 index, with a recent weekly decline of 1.20% and a monthly decline of 3.38%, ranking 25th among 31 industry indices [22][26] Industry Trends and Valuation - The pharmaceutical industry index currently has a PE ratio of 39.05, above the five-year historical average of 31.36, indicating a higher valuation compared to historical trends [48][50] Recent Research Achievements - The research team has published several in-depth reports on various pharmaceutical topics, including the growth of the blood products industry and the potential of GLP-1 drugs in chronic disease management [53] Important Policies and News - Recent regulations have been introduced to standardize clinical research and ensure drug traceability, which will impact the pharmaceutical landscape significantly [55][56]

Core Insights - Icotrokinra, a first-in-class targeted oral peptide, has shown promising results in treating moderately to severely active ulcerative colitis, achieving a clinical response rate of 36.5% at the highest dose in the Phase 2b ANTHEM-UC study [1][2] - The study met its primary endpoint, demonstrating significant improvements across key secondary endpoints compared to placebo, indicating the potential of icotrokinra as a new treatment option [1][2] - Johnson & Johnson has initiated further clinical trials, including the ICONIC-UC Phase 3 protocol for ulcerative colitis and additional studies for Crohn's disease and psoriasis [3][4] Study Results - At Week 12, the clinical response rates for icotrokinra were 63.5% for the 400 mg dose, 58.1% for the 200 mg dose, and 54.7% for the 100 mg dose, compared to 27% for placebo [2] - Significant improvements in clinical remission, symptomatic remission, and endoscopic improvement were observed in the 400 mg group compared to placebo, with p-values indicating statistical significance [2] - All icotrokinra doses showed higher rates of symptomatic remission as early as Week 4 compared to placebo [2] Future Developments - Johnson & Johnson is advancing icotrokinra into Phase 3 trials for ulcerative colitis and Crohn's disease, reflecting the company's commitment to addressing inflammatory bowel diseases [3][4] - A New Drug Application (NDA) for icotrokinra has been submitted to the FDA for the treatment of moderate to severe plaque psoriasis, indicating the drug's potential across multiple indications [3][9] Background Information - Ulcerative colitis is a chronic inflammatory condition of the colon, characterized by symptoms such as abdominal pain, diarrhea, and rectal bleeding, which can significantly impact patients' quality of life [8] - Icotrokinra selectively blocks the IL-23 receptor, which is involved in the inflammatory response associated with ulcerative colitis and other related diseases [9]

Company Highlights - Cidara Therapeutics Inc. (CDTX) reached a 52-week high of $87.19 as it advances its development plan for CD388, a non-vaccine preventive treatment for seasonal influenza, with enrollment in a Phase 3 study expected to start by September 2025 targeting 6,000 participants [1] - Maze Therapeutics Inc. (MAZE) saw its stock rise to a 52-week high of $27.09 following positive Phase 1 clinical results for MZE782, an oral therapy for Phenylketonuria and chronic kidney disease, with plans to enter Phase 2 studies in 2026 [3][4] - Medpace Holdings Inc. (MEDP) is set to report Q3 2025 financial results on October 22, 2025, and has raised its full-year guidance twice, indicating strong operational momentum, with the stock hitting a 52-week high of $506.55 [5][6] - Monopar Therapeutics Inc. (MNPR) rebounded from potential Nasdaq delisting to a 52-week high of $73.75, planning to seek approval for ALXN1840 for Wilson disease in early 2026, supported by long-term clinical data [7][8] - Prenetics Global Limited (PRE) projects 2025 revenue between $85 million and $100 million, a significant increase from $30.6 million in 2024, with its new wellness brand IM8 Health on track for $100 million in annual recurring revenue [9][10] - Protagonist Therapeutics Inc. (PTGX) is nearing a major milestone with Icotrokinra for psoriasis, having submitted a regulatory application to the FDA and EMA in July 2025, with the stock reaching a 52-week high of $66.70 [11][12] - uniQure N.V. (QURE) announced positive results from its Phase I/II study of AMT-130 for Huntington's disease, planning to submit a Biologics License Application in Q1 2026, with the stock soaring over 200% to a 52-week high of $51.21 [13][14] - Rezolute Inc. (RZLT) surged to a 52-week high of $9.02 ahead of topline results from its pivotal Phase III trial for hypoglycemia treatment, expected in December [15][16] - United Therapeutics Corp. (UTHR) reached a 52-week high of $442.01 as anticipation builds for data from the TETON-2 study of nebulized Tyvaso in idiopathic pulmonary fibrosis, with positive results reported earlier [17][18]

Investment Rating - The report recommends a "Buy" rating for multiple companies in the pharmaceutical sector, including Junshi Biosciences, Hualan Biological Engineering-B, and others [3]. Core Insights - The pharmaceutical sector has shown a 1.90% increase this week, outperforming the CSI 300 index by 0.21 percentage points. Sub-sectors such as pharmaceutical outsourcing, vaccines, and medical consumables performed well, while innovative drugs lagged behind [6][42]. - The report emphasizes the potential of the 4-1BB target in cancer treatment, particularly the PD-L1/4-1BB bispecific antibodies, which may address the limitations of PD-1/PD-L1 monotherapy [5][16][17]. Summary by Sections Industry Viewpoints and Investment Recommendations - 4-1BB is recognized as a promising target for tumor therapy, enhancing T cell activation and survival, which is crucial for effective immune responses against cancer [16]. - Investment strategies focus on the innovative drug sector, driven by increased liquidity and risk appetite, with a recommendation to pay attention to companies with strong pipelines in bispecific antibodies and ADCs [6][38]. Pharmaceutical Industry Market Performance - The pharmaceutical sector's overall P/E ratio is reported at 30.67 times, with a premium of 40.37% compared to the overall A-share market excluding financials [42]. Company Dynamics - Notable company developments include: - LIZHU Group's successful Phase III trial for a monoclonal antibody for psoriasis [43]. - Baiyang Pharmaceutical's planned share reduction by its major shareholder [43]. - Mylab's new medical device approval, enhancing market competitiveness [44]. Industry Dynamics - The report highlights the increasing focus on innovative drug development and the potential for significant market opportunities in the context of upcoming patent expirations for key small molecule drugs [38].

Core Viewpoint - Protagonist Therapeutics has selected PN-477 as its primary development candidate for obesity treatment, which is a triple agonist peptide targeting GLP-1, GIP, and glucagon (GCG) receptors, offering both efficacy and convenience through oral or subcutaneous administration [2][4]. Group 1: Drug Development and Efficacy - PN-477 has completed extensive preclinical evaluations, demonstrating positive effects in various animal models of obesity and blood glucose control, including diet-induced obese mice, normal dogs, and crab-eating macaques [4]. - The drug exhibits strong activation of GLP-1, GIP, and GCG receptors in vitro, indicating its potential effectiveness [4]. - PN-477's pharmacodynamic properties and overall performance make it suitable for parallel development as both a daily oral medication (PN-477o) and a weekly injection (PN-477sc) [4]. Group 2: Clinical Trials and Future Plans - The Investigational New Drug (IND) application is currently underway, with the first phase of clinical trials expected to start in the second quarter of 2026 [4]. - Protagonist Therapeutics plans to submit a New Drug Application (NDA) for its other candidates in 2025, indicating a robust pipeline [6][7]. Group 3: Market Position and Competitive Advantage - Despite the dominance of GLP-1 receptor agonists in the market, there is room for improvement, and a triple agonist like PN-477 could provide a significant breakthrough in obesity treatment by offering an oral option alongside injectable therapies [6]. - PN-477 is anticipated to reduce fat mass while preserving lean body mass and improving tolerability and comorbidities, positioning it as a potential blockbuster product for the company [6]. Group 4: Company Overview - Protagonist Therapeutics is an integrated biopharmaceutical company focused on drug discovery and late-stage development, with two novel candidates in Phase III clinical trials and plans for NDA submissions in 2025 [6][7]. - The company is also advancing several preclinical peptide drug development projects, including PN-881 and oral hepcidin [7].