证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-103 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过 特异性结合 PD-L1 分子从而阻断导致肿瘤免疫耐受的 PD-1/PD-L1 通路，重新激 活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。公司阿得贝利单抗注射液 （商品名：艾瑞利）已于 2023 年 3 月获批上市，获批的适应症为与卡铂和依托 泊 苷 联 合 用 于 广 泛 期 小 细 胞 肺 癌 患 者 的 一 线 治 疗 。 国 外 有 同 类 产 品 Atezolizumab （ 商 品 名 ： Tecentriq ） 、 Avelumab( 商 品 名 ： Bavencio) 和 Durvalumab(商品名：Imfinzi)于美国获批上市销售，其中 Atezolizumab 和 Durvalumab 已在中国获批上市。国内有康宁杰瑞/思路迪药业的恩沃利单抗 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) has received approval from the National Medical Products Administration for clinical trial notifications for four drugs, indicating progress in its drug development pipeline [1] Drug Development Summary - SHR-8068 Injection: A fully human anti-CTLA-4 monoclonal antibody with a development investment of approximately 214 million yuan [1] - Abediterol Injection: A self-developed humanized anti-PD-L1 monoclonal antibody with a development investment of approximately 887 million yuan [1] - Bevacizumab Injection: A humanized anti-VEGF monoclonal antibody with a development investment of approximately 345 million yuan [1] - Apatinib Mesylate Tablets: An innovative small molecule targeted drug with a development investment of approximately 587 million yuan [1] Regulatory Process Summary - Following the approval of the clinical trial notifications, the drugs must undergo clinical trials and receive further review and approval from the National Medical Products Administration before they can be manufactured and marketed [1]

Core Viewpoint - The rise of innovative drug themes is driven by a combination of policy, technology, and capital, marking a significant transition in China's pharmaceutical industry from generics to innovation [1] Historical Context of Innovative Drugs - Before 2015, China's pharmaceutical industry was dominated by generics, with long drug approval cycles (averaging 3-5 years) and low R&D investment (less than 5% of revenue) [2] - Key players like Hengrui Medicine and BeiGene began to focus on innovative drug development, with Hengrui launching the first domestic PD-1 inhibitor in 2014 [3] Current Landscape and Policy Support - By 2025, the National Medical Products Administration (NMPA) aims to significantly reduce clinical trial review times from 60 days to 30 days, with pilot projects averaging only 23.8 working days [5] - In the first half of 2025, 43 innovative drugs were approved, with over 90% being domestic products, particularly in oncology [5] - New policies in Beijing allow for direct hospital admission of innovative drugs without the need for a drug committee meeting, enhancing access [5] Technological Advancements and Internationalization - Chinese pharmaceutical companies are increasingly competitive globally, with significant advancements in areas like ADC and bispecific antibodies [5] - In the first half of 2025, over 70 overseas licensing transactions were recorded, with total transaction amounts reaching $48 billion, including a record $1.25 billion upfront payment for a PD-1/VEGF bispecific collaboration [6] Market Dynamics and Investment Trends - The innovative drug sector is expected to enter a three-year upward cycle driven by frequent major business development (BD) transactions and improving profitability for leading companies [7] - The innovative drug index in Hong Kong has seen a year-to-date increase of over 34%, reflecting strong market recognition of long-term value [9] Key Players and Financial Performance - Hengrui Medicine, with a market cap of approximately 379.78 billion yuan, leads in R&D investment and has a robust pipeline, including a PD-1 inhibitor with cumulative sales exceeding 20 billion yuan [10] - BeiGene, with a market cap of around 369.47 billion yuan, has achieved significant international sales, with its drug Zanubrutinib generating over 8 billion yuan in global sales in the first half of 2024 [11] Emerging Trends and Future Outlook - The integration of AI in drug development is expected to enhance efficiency, with projections indicating the AI pharmaceutical market could exceed $3 billion by 2030 [16] - The innovative drug market in China is anticipated to reach approximately 2.3 trillion yuan by 2030, with a compound annual growth rate of 24.1% [16]

Core Insights - A new obesity treatment, HRS9531, developed by Chinese drugmaker Hengrui Pharma and Kailera Therapeutics, has shown positive results in late-stage trials, positioning it as a potential competitor to existing treatments from Eli Lilly and Novo Nordisk [2][6]. Group 1: Drug Performance - HRS9531 helped patients lose nearly 18% of their body weight on average after 48 weeks, which is over 16% greater weight loss compared to placebo [4]. - Approximately 90% of patients receiving HRS9531 lost at least 5% of their body weight, and 44.4% achieved at least 20% weight loss [4]. - There was no plateau in weight loss observed at the 48-week mark [4]. Group 2: Market Context - Kailera and Hengrui are among several companies, including Merck and Regeneron, exploring the Chinese market for weight loss drugs [3]. - In May 2024, Kailera licensed rights to multiple experimental drugs from Hengrui for over $100 million in upfront payments, a 20% equity stake, and nearly $6 billion in future milestones [3]. Group 3: Future Developments - Hengrui plans to file for approval of HRS9531 in China, while Kailera will initiate global studies with higher doses and longer treatment durations [6]. - It may take several years for HRS9531 to enter markets outside of China, particularly the U.S. [6]. Group 4: Comparison with Competitors - HRS9531 works by activating GLP-1 and GIP hormones, similar to Eli Lilly's Zepbound, which helped patients lose up to 21% of their body weight over 72 weeks in trials [7][8]. - Novo Nordisk's Wegovy targets only GLP-1, differentiating it from HRS9531 and Zepbound [9].

Summary of Conference Call Notes Industry or Company Involved - The discussion primarily revolves around the pharmaceutical industry, particularly focusing on the implications of U.S. drug pricing policies and U.S.-China trade negotiations on Chinese pharmaceutical companies and their market opportunities. Core Points and Arguments 1. **Positive Impact of U.S.-China Negotiations on Pharmaceuticals** The recent U.S.-China negotiations are viewed as a significant positive for the pharmaceutical sector, alleviating previous concerns regarding trade impacts on drug pricing and exports of innovative drugs and raw materials [1] 2. **U.S. Drug Pricing Policy Changes** Trump's announcement of an executive order to reduce prescription drug prices by 30% to 80% is highlighted. The U.S. drug pricing system, characterized by high list prices, is under scrutiny, with the potential for significant price reductions impacting the market [2][3] 3. **Global Drug Pricing Context** U.S. drug prices are noted to be among the highest globally, particularly for innovative drugs, which are approximately 300% higher than prices in countries like Japan and Germany. This pricing structure encourages innovation but also raises concerns about affordability [3] 4. **Encouragement of Competition** The U.S. policy aims to accelerate competition among high-priced drugs, encouraging the entry of biosimilars and generic drugs, which could benefit Chinese pharmaceutical companies that can offer lower-cost alternatives [4][6] 5. **Opportunities for Chinese Pharmaceutical Companies** The reduction in U.S. drug prices is expected to create opportunities for Chinese companies, particularly in the fast-follow and biosimilar segments, as they can provide high-quality, cost-effective alternatives [6][8] 6. **Long-term Trends Favoring Chinese Innovation** The inefficiencies in innovation among multinational pharmaceutical companies may lead to increased reliance on Chinese innovation and manufacturing capabilities, especially if U.S. companies face cost pressures [7][8] 7. **Market Dynamics and Export Opportunities** The easing of trade tensions is anticipated to enhance the macroeconomic environment in China, leading to improved domestic demand and potential export opportunities for medical devices and raw materials [10][9] 8. **Impact of Drug Price Reductions on Market Dynamics** The anticipated drug price reductions in the U.S. are not expected to significantly diminish the addressable market for Chinese companies, as their market share in the U.S. remains relatively small [11][12] 9. **Long-term Supply Chain Considerations** U.S. concerns regarding supply chain security may lead to a push for domestic manufacturing, which could have long-term implications for Chinese companies seeking to penetrate the U.S. market [14][15] 10. **Investment Recommendations** The call suggests focusing on three categories of companies: innovative leaders, those with strong business development (BD) expectations, and upstream suppliers with global advantages, as the market enters a new growth cycle [16][18] Other Important but Possibly Overlooked Content 1. **Sector-Specific Insights** The discussion includes insights into specific companies and their competitive advantages, such as the potential for certain drugs to achieve significant market penetration despite pricing pressures [31][33] 2. **Emerging Trends in Medical Devices** The call also touches on the medical device sector, emphasizing the importance of high-end equipment and the potential for growth in home healthcare products, which may offer higher profit margins compared to domestic markets [25][26] 3. **Long-term Growth Projections** There is an optimistic outlook for the pharmaceutical sector, with expectations of a gradual recovery in demand and performance improvements in the coming years, driven by policy support and market dynamics [29][40] 4. **Focus on Innovation and R&D** The emphasis on innovation and the need for companies to adapt to changing market conditions is reiterated, highlighting the importance of R&D in maintaining competitive advantages [19][20] 5. **Market Sentiment and Future Outlook** The overall sentiment is cautiously optimistic, with a belief that the current market conditions present opportunities for growth and investment in the pharmaceutical and medical device sectors [46][47]

Core Viewpoint - The injectable GLP-1/GIP dual agonist HRS9531 developed by Heng Rui Pharmaceutical has shown promising results in a 48-week Phase III clinical trial, achieving an average weight loss of nearly 18%, with plans to apply for market approval in China as soon as possible [2][6]. Group 1: Clinical Trial Results - The Phase III clinical study conducted in China evaluated doses of HRS9531 at 2 mg, 4 mg, and 6 mg weekly, involving 531 overweight or obese adults without diabetes, showing a maximum weight loss of 17.7%, with a placebo-adjusted weight loss of 16.3% [2]. - In a predefined supplementary analysis, the 6 mg dose group achieved a weight loss of 19.2% [2]. - Among participants receiving HRS9531, 88% achieved at least a 5% weight loss, and 44.4% achieved a weight loss of 20% or more, meeting the primary endpoint [3]. Group 2: Safety and Side Effects - Most adverse events reported were mild to moderate, primarily gastrointestinal reactions [3]. - The company emphasized the good safety and tolerability of HRS9531, suggesting its potential to help more obese patients achieve personalized weight loss goals [7]. Group 3: Competitive Landscape and Future Plans - HRS9531 is expected to compete with Eli Lilly's GLP-1/GIP dual agonist Tirzepatide (Zepbound), which previously demonstrated a 20.9% weight loss in a 36-week study [2]. - Kailera Therapeutics, Heng Rui's partner in the U.S., announced plans to explore higher doses and longer treatment durations in global clinical trials to expand the drug's potential [5][6]. - If approved, HRS9531 will be the second domestically approved weight loss drug following Innovent Biologics' dual agonist Mazdutide [6].

Core Viewpoint - The article discusses the resurgence of the Hong Kong stock market as a global hub for IPOs, highlighting its transformation from a "financial wasteland" to a leading destination for capital investment in China within a year [4][21]. IPO Boom - In 2024, 70% of new IPOs in Hong Kong experienced first-day price drops, but by the following year, retail investors were eagerly participating in IPOs, indicating a significant shift in market sentiment [5]. - In the first half of the year, 240 companies entered the Hong Kong market, with 220 more in the pipeline as of June 30 [5][17]. - Hong Kong's IPOs raised a total of HKD 1,067.1 billion, surpassing Nasdaq's HKD 713 billion, reclaiming the top position globally [6][15]. Historical Context - The article reflects on Hong Kong's historical role as a financial center, noting its decline during the pandemic and subsequent recovery driven by mainland Chinese enterprises [6][22]. - The influx of Chinese companies into Hong Kong is seen as a strategic move to access international capital markets, with the city serving as a critical link for these firms [6][24]. Market Dynamics - The article emphasizes the role of Hong Kong as a "super connector" and "super value creator" in the financial landscape, with increasing ties between mainland China and Hong Kong [7]. - The article notes that the current IPO wave is reminiscent of past trends, such as the return of Chinese companies to the Hong Kong market starting in 2020 [9][10]. Future Outlook - Deloitte predicts that Hong Kong could see 80 new IPOs in 2023, raising HKD 200 billion, further solidifying its position as a global financial leader [20]. - The article suggests that the Hong Kong market is poised for continued growth, driven by reforms and the increasing presence of mainland Chinese enterprises [48][49]. Competitive Landscape - The article highlights the dominance of Chinese financial institutions in the IPO space, with major players like China International Capital Corporation leading the way [27][28]. - The shift in capital dynamics is evident, with mainland Chinese funds increasingly participating in Hong Kong's market, accounting for 43.9% of trading volume [34].

Hengrui and its US partner said their obesity drug candidate succeeded in a late-stage China study https://t.co/VDCShdXlw3 ...

Core Viewpoint - The article discusses the resurgence of the Hong Kong stock market as a global hub for IPOs, highlighting a significant increase in new listings and capital raised, positioning Hong Kong as a critical player in international finance and investment, particularly for Chinese enterprises [3][4][30]. IPO Boom - In the first half of the year, Hong Kong saw 240 companies enter the market, with 220 more in the pipeline as of June 30 [4][11]. - A total of 43 new stocks were listed, a 43.3% increase compared to the same period in 2024, raising HKD 1,067.1 billion, surpassing Nasdaq [4][10]. - The IPO of Ningde Times raised approximately HKD 357 billion, marking the largest global IPO of the year [8]. Historical Context - The article reflects on the historical evolution of Hong Kong's IPO landscape, from the early days of state-owned enterprises to the current influx of tech and consumer companies [6][14]. - The return of Chinese companies to Hong Kong, particularly in the wake of the pandemic and geopolitical tensions, has revitalized the market [4][30]. Market Dynamics - The article notes that the Hong Kong stock market has become a vital link for Chinese companies seeking international capital, with a significant portion of new listings being from mainland enterprises [4][30]. - The dominance of Chinese financial institutions in underwriting new listings is highlighted, with major players like CICC and CITIC leading the way [16][18]. Investment Trends - The influx of capital from mainland investors has increased, with southbound funds contributing HKD 730 billion, raising their market share to 43.9% [21][22]. - New consumer brands and innovative companies are capturing investor interest, with examples like Moutai and Bubble Mart showcasing unique business models that resonate with global investors [9][20]. Future Outlook - Predictions suggest that Hong Kong could see up to 80 new IPOs in 2024, raising HKD 200 billion, reinforcing its status as a leading global financial center [13][30]. - The article emphasizes the ongoing reforms in Hong Kong's financial market, including the introduction of SPACs and support for tech companies, which are expected to attract more listings and investments [30].

Economic Overview - China's GDP grew by 5.3% year-on-year in the first half of the year, an increase of 0.3 percentage points compared to the same period last year [2] - The unemployment rate remained stable, fluctuating between 5.0% and 5.4% throughout the year [2] - Consumer spending contributed 52% to economic growth, while capital formation contributed 16.8% and net exports contributed 31.2% [2] - The government is optimistic about consumer trends in the second half of the year, with policies aimed at boosting consumption being rolled out [2] Real Estate Market - The real estate market showed signs of stabilization, with improved transaction volumes and a narrowing decline in sales [3] - Despite ongoing declines in sales area and sales amount, the market is expected to undergo a bottoming process [3] - The government is focused on pushing for a recovery in the real estate market [3] Corporate Developments - Geely Automobile and Zeekr Technology have signed a merger agreement, with Geely acquiring all shares of Zeekr not already owned [4] - JD Health has opened its first self-operated medical beauty clinic in Beijing, with plans for a second location by September or October [5] - Pop Mart anticipates a revenue increase of no less than 200% and a profit increase of no less than 350% for the first half of the year [5] Strategic Partnerships - Roborock has partnered with Uber to deploy thousands of autonomous vehicles globally, starting in Asia and the Middle East [6] - Heng Rui Medicine plans to submit a new drug application for a dual-target weight loss drug following positive clinical trial results [7] Market Regulations - The State Administration for Market Regulation is intensifying efforts to regulate the live-streaming e-commerce industry to protect consumer rights [21] - New national standards for power banks are being developed to enhance safety and performance [17] Stock Market Insights - The Shanghai Composite Index has broken through a key resistance level, indicating a positive feedback loop of capital inflow and market growth [22] - The World Gold Council reported a 26% increase in gold prices in USD terms for the first half of 2025, driven by strong investment demand [23]