据悉，HLX17是公司自主研发的帕博利珠单抗生物类似药，潜在适应症包括黑色素瘤、非小细胞肺 癌、食管癌、头颈部鳞状细胞癌、结直肠癌、肝细胞癌、胆道癌、三阴性乳腺癌、微卫星高度不稳定型 或错配修復基因缺陷型肿瘤、胃癌等原研药已获批的适应症。T细胞表达的PD-1受体与其配体PD-L1、 PD-L2结合，可以抑制T细胞增殖和细胞因子生成。部分肿瘤细胞的PD-1配体上调，通过这个通路信号 传导可抑制激活的T细胞对肿瘤的免疫监视。帕博利珠单抗是一种可与PD-1受体结合的单克隆抗体，可 阻断PD-1与PD-L1、 PD-L2的相互作用，解除PD-1通路介导的免疫抑制，包括抗肿瘤免疫应答，提高免 疫系统对肿瘤细胞的杀伤能力。2024年9月，HLX17的临床试验申请获国家药品监督管理局(NMPA)批 准。2025年9月，HLX17在多种已切除实体瘤患者中的1期临床试验申请(IND)获美国食品药品管理局 (FDA)批准。 智通财经APP讯，复宏汉霖(02696)公布，近日，公司自主研发的帕博利珠单抗生物类似药HLX17(重组 抗PD-1人源化克隆抗体注射液)(HLX17)在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中 ...

证券研究报告 2025年09月23日 作者： 分析师 杨松 SAC执业证书编号：S1110521020001 分析师 曹文清 SAC执业证书编号：S1110523120003 1 行业评级： 上次评级： 强于大市 强于大市 维持 （ 评级） 请务必阅读正文之后的信息披露和免责申明 摘要：中国创新药产业趋势已成，进军全球商业化 立足现在：进军全球商业化，大量优质项目将继续推高产业发展 行业报告 | 行业专题研究 医药生物 创新药产业趋势已成，进军全球商业化 政策端——全面支持"真创新"：从顶层设计到地方落地形成合力，全面支持创新。 人才端——梯队合理：战略层+执行层协同配置，成为药物研发各环节高效落地的关键保障，也代表中国本土Biotech正在构建自身可持续的研发引擎。 展望未来：提升创新度将进一步打开商业化价值空间，未来可期 产学研持续加深合作，为FIC分子产出蓄力。中国已成为全球靶点验证到IND路径中效率最高的国家之一。这种研发效率与成本优势，将推动产业迈向 更高创新度分子的开发，而更具创新度的分子也意味着更高的商业化价值。 建议关注： ①全球大单品：百济神州（H），科伦博泰生物(H)，信达生物（H），康方 ...

Core Viewpoint - Novo Nordisk announced a transformation plan that includes a layoff of approximately 9,000 employees, representing about 11% of its total workforce, while also lowering its 2025 operating profit forecast by 6 percentage points, marking the third downward revision this year [2][8]. Group 1: Transformation Plan - The transformation plan aims to simplify the organizational structure, enhance decision-making speed, and refocus resources on growth opportunities in diabetes and obesity [3]. - The company plans to cut around 9,000 positions from a total of 78,400 globally, with approximately 5,000 jobs being eliminated in Denmark [3]. - The layoffs will affect all departments, and the company expects to save an average of 8 billion Danish Kroner (approximately 8.93 billion Yuan) annually by 2026, with the savings reinvested in growth opportunities [3][4]. Group 2: Financial Performance and Market Position - Novo Nordisk's flagship drug, semaglutide, generated sales of $16.683 billion in the first half of the year, making it the best-selling drug globally [6]. - Despite strong sales, the company faces increasing competition in the diabetes and obesity markets, particularly from Eli Lilly's tirzepatide, which achieved sales of $14.734 billion in the same period [7]. - The company has lowered its 2025 operating profit growth forecast from 10%-16% to 4%-10%, marking the third adjustment this year due to competitive pressures and performance expectations [8][9].

Core Insights - The global top-selling drugs for the first half of 2025 have been released, with Novo Nordisk's semaglutide leading the sales at 166.83 billion USD, followed by Merck's pembrolizumab and Eli Lilly's tirzepatide [1][3][4] Group 1: Top-Selling Drugs - Semaglutide from Novo Nordisk achieved sales of 166.83 billion USD, maintaining its position as the "king of drugs" [1][3] - Pembrolizumab from Merck recorded sales of 151.61 billion USD, ranking second [3] - Tirzepatide from Eli Lilly reached sales of 147.34 billion USD, securing the third position [3] Group 2: Sales Growth and Market Dynamics - Semaglutide's sales growth is driven by its three products: Ozempic (95.46 billion USD), Rybelsus (16.79 billion USD), and Wegovy (54.58 billion USD), with Wegovy showing a remarkable growth of 78% [5][6] - Tirzepatide has rapidly gained market share, with Mounjaro's sales skyrocketing from 4.83 billion USD in 2022 to an expected 115.4 billion USD in 2024 [7] - The competition between semaglutide and tirzepatide is intensifying, with both drugs exceeding 140 billion USD in sales for the first half of 2025 [7] Group 3: Market Challenges - The entry of biosimilars has impacted the sales of established drugs, with Janssen's ustekinumab dropping out of the top 10 due to a significant decline in sales [8] - Ustekinumab's sales fell by 38.6% in the first half of 2025, reaching only 32.78 billion USD [8] - Despite challenges, Johnson & Johnson's daratumumab saw a 21.7% increase in sales, reaching 67.76 billion USD, indicating strong demand in the multiple myeloma market [9][10]

Core Insights - The global top-selling drugs for the first half of 2025 have been released, with Novo Nordisk's semaglutide leading the sales at 166.83 billion USD, followed by Merck's pembrolizumab and Eli Lilly's tirzepatide [1][3][4] Sales Performance - Semaglutide achieved sales of 166.83 billion USD, maintaining its position as the top-selling drug [1][3] - Pembrolizumab (K drug) recorded sales of 151.61 billion USD, while tirzepatide reached 147.34 billion USD [3] - Other notable drugs include apixaban at 111.71 billion USD and dupilumab at 80.15 billion USD [3] Market Dynamics - The competition for the title of "King of Drugs" is intensifying, with new entrants like tirzepatide rapidly gaining market share [1][5] - Semaglutide's sales are bolstered by its three product variants, with the weight loss version, Wegovy, showing a remarkable growth of 78% [5][6] - Tirzepatide has been recognized for its rapid market uptake, with sales skyrocketing from 4.83 billion USD in 2022 to an expected 115.4 billion USD in 2024 [7] Product Innovations - Wegovy has recently gained approval for treating metabolic-associated fatty liver disease, which is expected to further enhance its sales [6] - Tirzepatide is the first and only dual-target GLP-1 receptor agonist approved for type 2 diabetes, positioning it as a strong competitor to semaglutide [7] Market Challenges - The entry of biosimilars has impacted the sales of established drugs, with Johnson & Johnson's ustekinumab dropping out of the top 10 due to a significant sales decline [8] - Ustekinumab's sales fell by 38.6% in the first half of 2025, reflecting the challenges faced by original drugs as patents expire [8] Future Outlook - Daratumumab from Johnson & Johnson has shown a 21.7% increase in sales, indicating strong market potential in the multiple myeloma segment [9][10] - The overall trend suggests a shift in market leadership as newer drugs gain traction and established drugs face competitive pressures [1][5][8]

Core Insights - The article highlights the significant transformation occurring in China's biotech industry, driven by increased international investor interest and the competitive advantages of Chinese biotech companies [3][10]. Group 1: Investment Trends - Morgan Stanley has sponsored notable IPO projects in Hong Kong, including projects for companies like Hengrui Medicine and WuXi AppTec, raising substantial funds [2][3]. - The Hong Kong Stock Exchange has become the second-largest biotech financing center globally, with 12 healthcare companies raising a total of $2.5 billion in the first half of 2025 [5]. - New listings have shown strong market performance, with an average first-day increase of 23.1% for the 12 healthcare companies [5]. Group 2: Financing Activities - Morgan Stanley has assisted Chinese issuers in raising over $5 billion in financing by the end of July, with WuXi AppTec's $980 million being the largest new share issuance in the Hong Kong medical sector in four years [6]. - The financing activities reflect a strong market demand, as evidenced by the oversubscription of offerings like Innovent Biologics' $550 million issuance [6]. Group 3: Global Market Dynamics - Chinese biotech companies are increasingly recognized as significant players in the global market, driven by enhanced innovation capabilities, cost advantages, and supportive policies [10][14]. - The trend of "License-out" agreements is growing, allowing Chinese companies to leverage their innovations in international markets [10][11]. Group 4: Innovation and R&D - Chinese companies have made notable advancements in areas like antibody-drug conjugates (ADC), with total transaction values reaching approximately $44 billion since 2021 [11]. - The approval of innovative drugs like Zepzelca by BeiGene marks a significant milestone for Chinese companies in the international market [12]. Group 5: Challenges and Recommendations - Despite the progress, challenges remain, including complex international regulations and market entry barriers [15]. - Recommendations for Chinese biotech companies include building international talent teams, enhancing communication with regulatory bodies, and improving global brand influence [15].

Core Insights - The international investment community is increasingly focused on Chinese biotech companies, driven by innovation, cost advantages, and supportive policies [1][4] - Morgan Stanley has played a significant role in facilitating major IPOs and refinancing projects in the biotech sector, highlighting the growing interest and investment in this area [1][3] Group 1: IPO and Market Performance - Hong Kong has become the world's second-largest biotech financing center, with 12 healthcare companies successfully listed in the first half of 2025, raising a total of $2.5 billion [2] - Among these, 8 biotech companies raised a total of $890 million through the Hong Kong Stock Exchange's Chapter 18A, designed to attract innovative biotech firms [2] - The average first-day gain for these newly listed companies was 23.1%, indicating strong market performance and investor interest [2] Group 2: Refinancing Activities - Morgan Stanley has assisted Chinese issuers in raising over $5 billion by the end of July, with notable projects including WuXi AppTec's $980 million share placement, the largest in the Hong Kong medical sector in four years [3] - The refinancing activities reflect a robust demand for biotech stocks, with the issuance scale for Innovent Biologics being increased by 10% due to market demand [3] Group 3: Global Expansion of Chinese Biotech - Chinese biotech companies are increasingly pursuing international clinical registrations and market entries, with a notable rise in overseas clinical trial registrations [4][5] - The gap in innovation capabilities between Chinese and U.S. biotech firms has narrowed significantly, with research indicating a reduction from 10 years to 3.7 years [5] - The cost advantages in clinical trials, particularly in Phase III trials, allow Chinese companies to maintain high investment returns [5] Group 4: Strategic Collaborations and Licensing - Chinese biotech firms are forming strategic partnerships with international giants, exemplified by the $12.5 billion deal between Hengrui Medicine and GlaxoSmithKline [6] - The licensing-out model is becoming more prevalent, with significant transactions such as the $1.25 billion upfront payment for a PD-1/VEGF bispecific antibody deal [6] Group 5: Future Outlook and Challenges - The Chinese biotech sector is expected to continue its growth trajectory, with a focus on innovative technologies such as mRNA, ADC, and gene editing [7] - However, challenges remain, including complex international regulations, intellectual property issues, and cultural differences in global operations [8] - Recommendations for overcoming these challenges include building international talent teams, enhancing communication with regulatory bodies, and optimizing government support for innovation [8]

Core Insights - The article highlights the significant transformation occurring in China's biotechnology sector, driven by international investor interest and the competitive advantages of Chinese biotech companies [2][5]. Group 1: Investment Trends - Morgan Stanley has sponsored notable IPOs in the Hong Kong market, including projects from companies like Heng Rui Medicine and Ying En Biology, and has facilitated multiple refinancing projects totaling billions [1][3]. - The Hong Kong Stock Exchange has emerged as the world's second-largest biotechnology financing center, with 12 healthcare companies raising a total of $2.5 billion in the first half of 2025 [3]. - New listings have shown strong market performance, with an average first-day increase of 23.1% for the 12 healthcare companies [3]. Group 2: Financing Activities - Morgan Stanley has assisted Chinese issuers in raising over $5 billion in financing by the end of July, with notable projects including WuXi AppTec's $980 million share placement [4]. - The financing activities reflect a growing demand for biotech stocks, with significant oversubscription and reduced discount rates for recent offerings [4]. Group 3: Global Expansion of Chinese Biotech - Chinese biotech companies are increasingly pursuing international clinical registrations and market entries, with a notable rise in "License-out" agreements [5][6]. - The gap in innovation capabilities between Chinese and U.S. biotech firms has narrowed, with Chinese companies demonstrating significant advancements in drug development efficiency and cost [5][6]. - The total value of transactions related to antibody-drug conjugates (ADCs) has reached approximately $44 billion, indicating robust international collaboration [6]. Group 4: Strategic Collaborations - Chinese biotech firms are forming strategic partnerships with international giants, exemplified by Heng Rui Medicine's $12.5 billion deal with GlaxoSmithKline [6][7]. - The collaboration models are evolving from simple licensing to joint development and new company formations, showcasing increased confidence in Chinese biotech capabilities [6][7]. Group 5: Future Outlook and Challenges - The article emphasizes the need for Chinese biotech companies to overcome regulatory complexities and market entry barriers to enhance their global presence [8][9]. - Recommendations include building international talent teams, improving communication with regulatory bodies, and optimizing government support for innovation [9].

Group 1 - China's innovative drug assets are increasingly recognized globally, capturing a larger share of the global innovative drug licensing market, with 27% of global transaction volume and 32% of transaction value in 2023 [1] - Despite the growth, only 10 out of 307 new drugs approved by the FDA since 2019 are from China, representing less than 3% [1][11] - The market capitalization of Chinese pharmaceutical and biotech companies is significantly lower than their US counterparts, with only 14% of the total market cap of US listed companies [7] Group 2 - The Hong Kong stock market has seen multiple "10x stocks" in the pharmaceutical sector, with companies like Deqi Medicine and Hengrui Medicine experiencing significant price increases [4][5] - The recent IPOs of biopharmaceutical companies in Hong Kong have nearly matched the total for 2023, indicating a strong market interest [5] - A wave of high-profile IPOs is expected in the second half of 2025, driven by improved market conditions and increased liquidity [5][6] Group 3 - The capital market's enthusiasm has led to significant refinancing activities among listed companies, with major transactions from companies like Innovent Biologics and I-Mab [6] - Chinese companies now account for about one-third of the global pipeline of innovative drugs, with a total transaction scale of $48 billion in the first half of 2025 [6] - The trend of increasing licensing agreements with multinational pharmaceutical companies is expected to continue, as many innovative drugs are entering clinical stages [9][10] Group 4 - The focus of Chinese innovative drugs remains on oncology, with over 60% of licensing transactions in the past three years related to cancer treatments [12] - There is a rising interest in cardiovascular and metabolic disease drugs, particularly GLP-1 medications, which are becoming a focal point for multinational companies [12][13] - The global valuation of innovative drugs is undergoing a transformation, with a cautious approach towards high-priced acquisitions of late-stage drugs [10]

Group 1: Industry Overview - Major multinational pharmaceutical companies (MNCs) have reported their performance for the first half of 2025, with Johnson & Johnson leading with revenues of $45.636 billion, followed by Roche and Merck [1][2] - Nearly 200 drugs are expected to lose patent protection in the coming years, including at least 69 blockbuster drugs with annual sales exceeding $1 billion, leading to an estimated cumulative sales loss of over $300 billion for MNCs [2][3] - The competitive landscape among the top ten pharmaceutical companies remains intense, with close revenue figures among companies ranked fourth to eighth [2] Group 2: Company Performances - Johnson & Johnson reported a revenue of $45.636 billion for the first half of 2025, a year-on-year increase of 4.1%, driven by its innovative pharmaceuticals and medical technology segments [3] - Merck's total revenue was $31.335 billion, a decline of 2% year-on-year, with significant drops in its China revenue, which fell by 70% to $1.075 billion [4] - Eli Lilly achieved a remarkable revenue growth of 41%, reaching $28.286 billion, with its weight loss drug Mounjaro seeing an 85% increase in sales [5][6] - AstraZeneca reported a revenue of $28.045 billion, an 11% increase, with its China revenue growing by 5% to $3.515 billion, making it the top performer in the Chinese market [7] Group 3: Market Dynamics - The competition for the title of "King of Drugs" is intensifying, with Eli Lilly's two weight loss drugs nearing the sales figures of Novo Nordisk's semaglutide [6] - MNCs are increasingly focusing on the Chinese market, with a notable increase in collaborations with domestic innovative pharmaceutical companies, resulting in 52 outbound deals in the first half of 2025 [7][8] - The growth rates of MNCs in China are shifting, with some companies like Merck experiencing significant declines in sales, while others like AstraZeneca and Eli Lilly are capitalizing on the market opportunities [8]