中经记者 苏浩 卢志坤 北京报道 | 治疗领域 | 药品 | 作用靶点 | 适应症 | 开发 区域 | 临床前 研究 | IND申报 | 临床 期 | 临床川期 | 临床川期 | NDA | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 気思扎鲁胶软胶膏 | AR (ჟ制剂) | 阿比特龙/化疗后的转移性去势抵抗性 | 中国 | | | | | | 颈批上市 | | | (HC-1119) | | 前列腺癌(mCRPC) | | | | | | | | | 癌症 | HP518 (PROTAC) | AR | 标准治疗失败的转移性去势抵抗性 前列腺癌(mCRPC) | 澳大利亚 | | | | | | | | | | | | 美国 | | | | | | | | | | | | 中国 | | | | | | | | | | | AR+三阴乳胺癌(TNBC) | 中国 | | | | | | | | | | | | 英国 | | | | | | | | | H6568 | ER | ER+乳腺癌 | 中国 | | ...

中经记者苏浩卢志坤北京报道 2018年11月，海创药业自主研发的高尿酸血症和痛风1类新药HP501缓释片获得国家药监局颁发的《临 床试验通知书》。公司满怀希望地宣布，这款具有自主知识产权的URAT1抑制剂将为中国1.3亿高尿酸 血症患者带来新希望。 然而，近七年后，2025年8月13日，海创药业在发布年中财报的同时宣布了一则消息：拟暂停HP501项 目的研发推进。此时，该项目已投入募集资金8111.25万元。 决定背后的原因是残酷的市场竞争：国内已有药企针对URAT1靶点的产品获批上市，并有多项围绕该 靶点的Ⅲ期临床研究正在进行。 8月22日，海创药业方面在接受《中国经营报》记者采访时表示，募投项目子项目调整是基于公司实际 情况并结合当前市场竞争格局、行业发展趋势等多重因素决定的。上述调整将更好地维护公司和广大投 资者的利益，符合公司的长远发展及规划。不会对公司当期经营业绩产生重大影响，不存在损害股东利 益的情形。 从临床到落寞 据了解，HP501是海创药业自主研发的小分子化学创新药，为尿酸盐阴离子转运体1（URAT1）抑制 剂。临床前研究结果显示，其生物活性优于同类药物，展现了优良的药代动力学和毒理学性质。 ...

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [1] Core Insights - The trend of innovation going overseas remains unchanged, with significant business development (BD) opportunities expected to continue driving valuation increases [2] - The market for gout and hyperuricemia treatment presents substantial potential, with a growing patient population in China and globally [4] - The dual antibody and antibody-drug conjugate (ADC) sectors in tumor immunotherapy are anticipated to yield groundbreaking products [6] Summary by Sections 1. Industry Trends - The value reassessment of innovative drugs is significantly driven by overseas business development, particularly for PD-1/VEGF dual antibodies, with transaction values rapidly increasing [2] - In Q1 2025, the number of pharmaceutical transactions in China rose by 34% year-on-year, while total transaction value surged by 222% [2] 2. Market Opportunities - The American Diabetes Association (ADA) conference highlighted the focus on GLP-1 drugs, with several domestic companies showcasing their research [3] - The potential market for gout treatment is vast, with an estimated 1.7 billion patients globally by 2030, and current treatments showing poor adherence and efficacy [4] 3. Clinical Developments - Significant clinical data from the ADA conference is expected to influence the weight loss drug market, with partnerships and new drug developments being announced [3] - The report notes that several innovative drugs targeting gout are entering critical clinical phases, with promising results from recent studies [4] 4. Stock Recommendations - The report recommends stocks in various sectors, including: - **Weight Loss and GLP-1 Drugs**: Recommended companies include Zhongsheng Pharmaceutical and others [7] - **Gout Treatment**: Recommended companies include Changchun High-tech and Yipin Pharmaceutical [9] - **Tumor Immunotherapy**: Companies like Fuhong Hanlin and Innovent Biologics are highlighted for their advancements in PD-1 dual antibodies and ADCs [9] 5. Company Performance Forecast - The report provides earnings per share (EPS) forecasts and price-to-earnings (PE) ratios for several companies, indicating a positive outlook for firms like Yuyue Medical and others [10]

Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical industry [1] Core Insights - The recent surge in significant transactions, particularly in the innovative drug sector, is driving a revaluation of drug values, especially for PD-1/VEGF dual antibodies [2] - The Chinese pharmaceutical market is witnessing a notable increase in transaction volume and value, with a 34% year-on-year increase in the number of transactions and a 222% increase in total transaction value in Q1 2025 [2] - The upcoming ADA conference is expected to showcase key clinical data and collaborations in the weight loss and muscle gain sectors, indicating a strong focus on GLP-1 drugs [3] - The gout treatment market presents substantial growth potential, with a projected increase in the number of patients in China from 170 million in 2020 to 240 million by 2030 [4] - The PD-1/VEGF dual antibody is positioned to challenge existing global drugs, with significant transactions indicating strong market interest [5] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 1.66% over the past week and ranked 5th in terms of weekly gains [18] - Over the past month, the pharmaceutical industry outperformed the CSI 300 index by 9.26%, ranking 1st among 31 primary industry indices [21][23] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical industry index has a current PE (TTM) of 34.88, slightly above the 5-year historical average of 33.02 [40] 3. Recent Research Achievements - The report highlights various recent research outputs from the pharmaceutical team, including insights into the growth of blood products and the impact of policy support on inhalation formulations [46] 4. Recent Industry Policies and News - The report outlines significant recent policies aimed at improving governance in the pharmaceutical sector, including measures to combat corruption and enhance regulatory oversight [48] - Notable industry news includes the approval of multiple innovative drugs and collaborations among major pharmaceutical companies, indicating a vibrant market environment [49][50]

Industry Overview - Gout is a chronic disease caused by purine metabolism disorders, characterized by hyperuricemia and the deposition of urate crystals in joints and tissues, leading to various clinical symptoms [1][2] - The gout medication market in China has grown significantly, with the market size increasing from 700 million yuan in 2015 to 2.2 billion yuan in 2024 [1][10] - The prevalence of hyperuricemia in China is approximately 14%, with a patient population of around 197 million, while gout prevalence ranges from 1% to 3%, affecting approximately 15.5 to 42.29 million people [6][8] Market Dynamics - The gout medication market is primarily driven by the increasing incidence of gout and hyperuricemia due to lifestyle changes and dietary habits [10] - The market is currently experiencing a contraction due to the entry of mainstream gout medications like febuxostat into centralized procurement, but future growth is expected as patient numbers rise [10] - By 2030, the gout medication market in China is projected to exceed 10 billion yuan [10] Product Classification - Gout medications are categorized into acute anti-inflammatory analgesics and long-term urate-lowering drugs, with urate-lowering drugs accounting for about 40% of the global market [2][4] - In the domestic market, traditional drugs like febuxostat and benzbromarone hold a market share of approximately 60% [2] Competitive Landscape - The industry is characterized by intense competition, with generic drugs dominating the market while innovative drugs are rapidly being developed [14] - Major players include Kangyuan Pharmaceutical, Huahai Pharmaceutical, Yipinhong, and Hengrui Medicine, which are focusing on developing new urate-lowering agents to address the limitations of existing medications [14][15] - The introduction of centralized procurement policies has pressured generic drug prices, prompting companies to shift towards high-value innovative drugs [14] Key Companies - Hengrui Medicine is developing a new urate-lowering drug, SHR4640, which has shown significant efficacy and low toxicity, with a market application expected in 2025 [15][18] - Yipinhong is working on AR882, a new urate excretion promoter, which has received FDA support for global clinical trials [15] - Tonghua Dongbao has expanded its product pipeline in the gout treatment area, with two new drugs in clinical trials [16] Development Trends - The industry is shifting from generic to innovative drug development, with URAT1 inhibitors becoming a research focus [20] - Biologics and long-acting therapies are emerging as new growth points, with products like SEL-212 expected to enhance patient compliance and market potential [21] - Personalized treatment and combination therapies are becoming key research directions, aiming to meet unmet clinical needs [22]

Investment Rating - The report maintains an optimistic outlook on the pharmaceutical industry, particularly focusing on the potential growth in the gout medication market and ongoing drug development [11][18]. Core Insights - The pharmaceutical sector is currently undervalued, with public funds showing low allocation to this sector. The report anticipates a recovery driven by macroeconomic factors and significant product launches in the industry by 2025 [11]. - The report emphasizes the importance of innovative drugs, particularly in the gout treatment space, highlighting the shift from quantity to quality in drug development [11][20]. - The report identifies several key companies and products to watch, including innovative drug developers and medical device manufacturers, suggesting a diversified investment approach [11][12][18]. Summary by Sections Market Overview - The report notes that the CITIC pharmaceutical index rose by 1.22%, outperforming the CSI 300 index by 0.34 percentage points, ranking 16th among 30 sectors [8]. - The top-performing stocks in the pharmaceutical sector include Yiming Pharmaceutical and Wanbangde, while the worst performers include Longjin Retreat and Huasen Pharmaceutical [8]. Gout Treatment Market - The report highlights the significant market potential for gout medications, with a projected market size of approximately 1.821 billion yuan in 2024. The report notes that the market for febuxostat is expected to decline due to its inclusion in national procurement [20]. - The report outlines the two main therapeutic approaches for gout: inhibiting uric acid production and promoting uric acid excretion, with key drugs identified for each approach [20][21]. Innovative Drug Development - The report provides an overview of ongoing clinical trials for gout medications, particularly focusing on URAT1 inhibitors, which are currently the most promising targets in drug development [22][35]. - It highlights the progress of SHR4640, a URAT1 inhibitor developed by Hengrui Medicine, which has shown promising results in clinical trials and is expected to be the first domestic URAT1 inhibitor to be approved [26]. Medical Devices and Equipment - The report discusses the recovery of the medical device market, particularly imaging equipment, which is expected to see significant growth due to ongoing procurement processes and government subsidies [42]. - It emphasizes the importance of domestic manufacturers in the medical device sector, particularly in the context of increasing competition and the need for innovation [42][43]. Investment Recommendations - The report suggests focusing on companies with strong pipelines and innovative products, including those in the pharmaceutical and medical device sectors, to capitalize on the anticipated growth in the industry [11][12][41].

Investment Rating - The report maintains an optimistic outlook on the pharmaceutical industry, particularly focusing on the potential growth in the gout medication market and ongoing drug development [11]. Core Insights - The pharmaceutical sector is currently undervalued, with public funds showing low allocation to this sector. The report anticipates a recovery driven by macroeconomic factors and significant product launches in the industry by 2025 [11]. - The report emphasizes the importance of innovative drugs, particularly those that can transition from quantity to quality, highlighting the need to focus on differentiated products and international pipelines [11]. - The gout medication market is identified as a "blue ocean" with significant growth potential, driven by the high prevalence of hyperuricemia and gout in China [18][20]. Market Overview - The report notes that the overall prevalence of hyperuricemia in China is approximately 13.3%, affecting around 177 million people, while gout affects about 14.66 million individuals [17]. - The market for gout medications is projected to reach approximately 1.821 billion yuan in 2024, with significant contributions from drugs like febuxostat and probenecid [20]. Drug Development Landscape - The report outlines the current landscape of gout treatments, categorizing them into two main mechanisms: uric acid synthesis inhibitors and uric acid excretion promoters [20]. - Several innovative drugs are in various stages of clinical development, with a focus on URAT1 inhibitors, which are currently the most promising targets in gout treatment [21][22]. - The report highlights the progress of SHR4640, a URAT1 inhibitor developed by Heng Rui Medicine, which has shown promising results in clinical trials and is expected to be the first domestic URAT1 inhibitor to be approved [26]. Investment Opportunities - The report suggests focusing on companies with strong pipelines in innovative drug development, particularly those targeting gout and related conditions, such as BeiGene, Innovent, and others [11]. - It also recommends monitoring the progress of medical device companies that are benefiting from policy support and market recovery, particularly in imaging and home healthcare devices [42][43]. Conclusion - The report concludes that the pharmaceutical and medical device sectors present significant investment opportunities, driven by innovation, market recovery, and favorable demographic trends [11][42].

Investment Rating - The investment rating for the pharmaceutical industry is "Recommended" (maintained) [1] Core Insights - Significant transactions are driving the revaluation of innovation value in the pharmaceutical sector, with notable deals such as a $60 billion transaction by 3SBio and a $50 billion forecasted deal by CSPC Pharmaceutical Group [3] - The 2025 ASCO conference highlighted ADC, bispecific antibodies, and tri-specific antibodies as key areas of focus, with promising clinical results reported by Chinese companies [4] - Chinese innovative pharmaceutical companies are leading breakthroughs in CAR-T technology, with significant advancements expected in 2025 [6] - The gout treatment market presents substantial potential, with a projected increase in patients in China from 170 million in 2020 to 240 million by 2030 [8] - The oral weight loss drug market is seeing increased activity from leading companies, with notable collaborations and clinical advancements [10] - The approval of the world's first flu RNA polymerase PB2 protein inhibitor offers new treatment options for flu resistance [12] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 2.21% over the past week, with a weekly increase of 3.30% [28] - Over the past month, the industry also outperformed the CSI 300 index by 4.57%, with a monthly increase of 6.42% [31] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's current PE (TTM) is 34.03, slightly above the five-year historical average of 32.54 [45] 3. Recent Research Achievements - Recent reports highlight the steady growth of blood products and the acceleration of the import substitution process in inhalation preparations [48] 4. Recent Industry Policies and News - The State Council announced a reduction in tariffs on imports from the U.S., which may impact the pharmaceutical sector [51] - Several innovative drugs have received approval for clinical trials and market entry, indicating a robust pipeline for the industry [52][53] 5. Recommended Companies and Earnings Forecast - Companies recommended for investment include Changchun High & New Technology, Yifan Biotech, and Zhongsheng Pharmaceutical, among others, with a focus on areas such as gout treatment and CAR-T technology [14]

Investment Rating - The industry investment rating is "Recommended" (Maintained) [1] Core Viewpoints - The trend of "going abroad" remains a major focus, with short-term impacts from tariffs diminishing. In Q1 2025, China's pharmaceutical exports reached $26.632 billion, a year-on-year increase of 4.39%, with exports to the U.S. at $4.639 billion, up 9.6% [3] - The market for gout and uric acid reduction presents significant potential, with the number of patients expected to rise from 1.7 billion in 2020 to 2.4 billion by 2030 in China. Current treatments show poor adherence and efficacy, indicating a need for safer and more effective drugs [4] - The oral weight loss drug sector is seeing major players like Novo Nordisk intensifying their efforts, with significant collaborations and clinical advancements. Chinese companies are also making rapid progress in this area [6] - Breakthroughs in universal CAR-T and autoimmune applications are emerging, with promising clinical data from companies like Kintor Pharmaceutical and Bangyao Biotech [8] Summary by Sections 1. Pharmaceutical Export Trends - Pharmaceutical exports are on the rise, with a notable increase in trade volume and value. The U.S. remains the largest single market for Chinese pharmaceutical exports [3] 2. Gout Treatment Market Potential - Gout is a global health issue, particularly in China, where the prevalence is increasing. The market for gout treatments is expected to grow significantly due to the high number of patients and the need for better treatment options [4] 3. Weight Loss Drug Developments - Major pharmaceutical companies are investing heavily in oral weight loss drugs, with significant collaborations and clinical trials underway. Chinese firms are also positioned to capitalize on this growing market [6] 4. Advances in CAR-T Therapy - New developments in universal CAR-T therapies are showing promise, with initial clinical results indicating high efficacy and safety. This could lead to broader applications in various diseases [8] 5. Stock Recommendations - The report recommends several companies based on their potential in various segments, including those focusing on international collaborations, innovative drug development, and market expansion [10]

Investment Rating - Industry investment rating: Recommended (Maintained) [1] Core Views - The trend of going abroad remains the main focus, with short-term impacts from tariffs diminishing. In Q1 2025, pharmaceutical exports reached $26.632 billion, a year-on-year increase of 4.39%, with exports to the U.S. at $4.639 billion, up 9.6% [3] - The market for gout and uric acid reduction presents significant potential, with the number of patients expected to rise from 1.7 billion in 2020 to 2.4 billion by 2030 in China. Current treatments show poor adherence and efficacy, indicating a need for safer and more effective drugs [4] - The oral weight loss drug sector is seeing major players like Novo Nordisk increasing their investments, with opportunities for Chinese companies in this rapidly evolving market [6] - Breakthroughs in universal CAR-T and autoimmune applications are emerging, with promising clinical data supporting their efficacy and safety [8] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 0.16 percentage points in the past week, with a weekly increase of 1.27% [23] - Over the past month, the industry also outperformed the CSI 300 index by 0.68 percentage points, with a monthly increase of 3.76% [26] 2. Pharmaceutical Sector Trends and Valuation - The pharmaceutical sector's current PE (TTM) is 32.65, slightly below the five-year historical average of 32.73 [40] 3. Recent Research Achievements - The research team has published several in-depth reports on various aspects of the pharmaceutical industry, highlighting trends in supply and demand, and the growth of specific sectors such as blood products and inhalation therapies [44] 4. Recent Industry Policies and News - Recent policy changes include a reduction in tariffs on U.S. imports, which may positively impact the pharmaceutical sector [46] - Notable industry news includes the approval of several innovative drugs and collaborations among major pharmaceutical companies, indicating a dynamic and competitive landscape [47]