（来源：经济参考报） 记者从国家药品监督管理局获悉，2025年我国创新药审评审批取得历史性突破，全年共批准上市创新药 76个，较2024年的48个大幅增长58.3%，创历史新高；同时，数据显示，中国创新药对外授权（BD）交 易总金额达1356.55亿美元，交易数量达157笔，双双刷新纪录。 2025年国家药监局批准上市的76个创新药包括47个化学药品、23个生物制品和6个中药。47个化学药品 中，38个为国产创新药，9个为进口创新药，国产创新药占比达80.85%；23个生物制品中，21个为国产 创新药，2个为进口创新药，国产创新药占比达91.30%。 "健康国策2050"创办人梁嘉琳表示，创新药审批创新高，体现了我国药品审评审批制度改革的成效，有 力支撑了创新药提升可及性的"最初一公里"。 值得一提的是，除了创新药审批大幅增长外，我国创新药对外授权再迎历史性突破。根据医药魔方 NextPharma数据库数据，截至2025年12月31日，中国创新药全年对外授权交易总额达1356.55亿美元， 首付款累计70亿美元，交易数量157笔，远超2024年全年的519亿美元和94笔。 奥优国际董事长张玥表示，2025年创 ...

Core Viewpoint - The article discusses the journey and insights of Lü Qiang, the founder of Jinfang Pharmaceutical, highlighting the challenges and strategies in the innovative drug development landscape in China, particularly focusing on the RAS target and the company's approach to commercialization and investor relations. Group 1: Company Overview - Jinfang Pharmaceutical was founded in August 2017 by Lü Qiang in Shanghai Zhangjiang, capitalizing on the favorable conditions for innovative drug development in China [1] - The company successfully listed on the Hong Kong Stock Exchange, with its stock price increasing over 100% on the first day, but faced a subsequent decline of over 30% due to market adjustments [6] - Jinfang's lead drug, Dabotinib, is set to be the first RAS-targeted drug approved in China by August 2024, marking a significant milestone in the company's pipeline [3] Group 2: R&D Focus and Innovation - Jinfang is heavily invested in the RAS target, which has historically been considered "undruggable," with no approved drugs for over 40 years until Amgen's Lumakras received FDA approval in May 2021 [2] - The company aims to cover 80% to 90% of pancreatic cancer patients with its four RAS drugs, addressing a significant unmet need in the oncology market [11] - Lü Qiang emphasizes the importance of innovation beyond just targeting new mechanisms, advocating for a comprehensive understanding of existing research to drive breakthroughs [7][8] Group 3: Commercialization Strategy - Lü Qiang believes that the era of "single product dominance" is over, and that a product matrix approach is necessary for successful commercialization in the competitive oncology market [12] - The company has opted to partner with larger pharmaceutical firms for commercialization rather than pursuing independent sales, reflecting a strategic decision to leverage collective strengths [10] - Jinfang's strategy focuses on creating a "small but beautiful" commercial portfolio, aligning with clinical market gaps and technological advancements [12] Group 4: Market Dynamics and Future Outlook - The article notes that the Chinese biotech sector is increasingly scrutinized by professional capital, which now values the progress and breadth of R&D pipelines more than before [6] - Lü Qiang acknowledges the challenges of balancing innovation with market demands, indicating that the pressures of entrepreneurship are often underestimated [4] - The article concludes with insights on the evolving landscape of biotech and biopharma, suggesting that both sectors have distinct roles and that the current trend of high financial expectations in business development may require recalibration [13][14]

Core Viewpoint - The article discusses the journey of Junfang Pharmaceutical, founded by scientist Lyu Qiang, focusing on its innovative drug development, particularly in targeting RAS proteins, and the challenges faced in the biotech industry in China [1][2][3]. Company Overview - Junfang Pharmaceutical was established in August 2017 in Zhangjiang, Shanghai, during a favorable period for innovative drug development in China [1]. - The company successfully listed on the Hong Kong Stock Exchange, with its stock price increasing over 110% on the first day, but later faced a decline of over 30% due to market adjustments [4]. Innovation and Drug Development - The company is heavily invested in RAS targets, which have historically been considered "undruggable," with no approved drugs for over 40 years until Amgen's Lumakras received FDA approval in May 2021 [2][3]. - Junfang's drug, Daberu (GFH925), became the first RAS-targeted drug approved in China and the third globally, highlighting the company's rapid development capabilities [3]. Market Strategy - Lyu Qiang emphasizes the importance of a product matrix approach rather than relying on a single blockbuster drug, aiming to cover a significant portion of pancreatic cancer patients with multiple RAS-targeted drugs [9][12]. - The company plans to establish a "small but beautiful" commercialization strategy, focusing on complementary drug projects rather than a broad market approach [12]. Competitive Landscape - Junfang's pipeline is compared to that of Revolution Medicines, a leading U.S. company in the RAS space, which has not yet launched products but has a market capitalization exceeding $13.5 billion [5]. - The article notes that many Chinese biotech firms are seen as following international innovations, but Lyu argues that Junfang's approach is based on clinical breakthroughs and a deep understanding of existing research [7][8]. Financial and Strategic Insights - Lyu highlights the need for a balanced approach to business development (BD) and emphasizes that Junfang is not BD-driven but data-driven, focusing on solving patient needs rather than merely financial returns [14][15]. - The article mentions that the financial expectations for BD in the industry may have become unrealistic, suggesting a potential market correction in the future [15].

Core Insights - The Chinese pharmaceutical innovation sector has seen a significant increase in transaction amounts, surpassing $100 billion in overseas deals, indicating a robust growth in the industry [1][2] - The National Medical Products Administration (NMPA) approved 43 new drugs in the first half of 2025, with domestic drugs accounting for 40, showcasing an acceleration in the pace of innovation [1] - Shanghai has emerged as a key hub for biopharmaceuticals, with 9 innovative drugs approved for overseas markets in 2023, reflecting a shift from single breakthroughs to batch outputs [2][3] Industry Trends - The total number of global pharmaceutical transactions reached 682, with a total value of $191 billion in the first three quarters of 2025, indicating a strong upward trend [1] - Chinese pharmaceutical companies are transitioning from being participants in the global market to becoming significant contributors to global health [3][4] - The focus on "source innovation" is critical for Chinese companies to differentiate themselves and avoid homogenization in drug development [2][4] Challenges and Opportunities - Despite the growth, the Chinese pharmaceutical industry faces challenges such as weak foundational research and a predominance of "follow-up" innovation, leading to issues with target homogenization [2][6] - There is a pressing need for differentiation in innovation to create value, as highlighted by industry leaders [2][5] - The industry must address the affordability of innovations for the Chinese population, necessitating a shift in cost strategies compared to Western markets [5][6] Strategic Directions - Companies are encouraged to adopt a rational approach to innovation, focusing on unmet clinical needs and leveraging emerging technologies to address these demands [7][8] - The ability to sell drugs globally is becoming a key competitive advantage, with companies needing to build strong commercial capabilities alongside their R&D efforts [9][10] - Collaborative approaches and localized strategies are essential for navigating international markets effectively [10][11] Future Outlook - The potential for "source innovation" to drive the next wave of growth in the Chinese pharmaceutical industry is recognized, contingent on overcoming existing barriers [11]

Core Insights - China's pharmaceutical innovation is experiencing a significant increase in transaction volume, with overseas transactions exceeding $100 billion, indicating a robust growth in the sector [1][5] - The National Medical Products Administration (NMPA) has approved 43 new drugs in the first half of 2025, with a notable acceleration in the pace of innovation drug approvals [1][4] - Despite the growth in quantity, the quality of innovation remains a concern, with a predominance of "follow-up" innovation and issues of target homogeneity [2][6] Industry Trends - The global pharmaceutical transaction volume reached $191 billion in the first three quarters of 2025, with China contributing $937 billion, showcasing its competitive position in the global market [1][5] - Shanghai has emerged as a key hub for biopharmaceuticals, with 9 innovative drugs approved for overseas markets in 2023, leading the nation in this regard [4][5] - The shift from "single product authorization" to a focus on systemic capabilities and deep collaboration reflects a changing strategy among Chinese pharmaceutical companies [13] Challenges and Opportunities - The industry faces challenges such as weak foundational research, a trust crisis in collaborations, and funding difficulties, which hinder the development of truly innovative products [8][9] - There is a pressing need for differentiation in innovation, with a focus on "source innovation" to avoid the pitfalls of homogeneous competition [2][6][12] - Companies are encouraged to adopt a cost-effective approach to innovation, particularly in the context of China's large population and healthcare affordability [7][10] Strategic Directions - Companies must recognize unmet clinical needs and maintain a rational approach to innovation, avoiding overcrowding in competitive areas [9][10] - The ability to sell innovative drugs globally is becoming a critical measure of a company's success, surpassing mere research capabilities [12][14] - Building strong global commercialization capabilities through partnerships and localized teams is essential for navigating international markets [13][14]

Core Viewpoint - The recent performance of the company shows a simultaneous decline in revenue and growth in profit, primarily due to cost optimization measures. However, the sustainability of this model raises concerns [2][4]. Financial Performance - The company has experienced a continuous decline in operating revenue for seven consecutive quarters from Q1 2024 to Q1 2025, with the largest drop of -7.24% in Q2 2024. The decline narrowed to -1.92% in Q1 2025 but did not reverse the downward trend [3]. - Despite a 1.92% drop in revenue, the net profit attributable to the parent company increased by 4.75%, attributed to significant cost optimization. In Q1 2025, the company reduced three types of expenses by 137 million yuan [4][5]. Cost Management - The company has a history of using cost-cutting measures to boost profits, having reduced sales expenses from 3.598 billion yuan in 2023 to 3.255 billion yuan in 2024, and management expenses from 654 million yuan to 613 million yuan [5]. - The reduction in asset impairment losses from 310 million yuan in 2023 to 182 million yuan in 2024, a decrease of 41.44%, also contributed to profit growth [6]. R&D Investment - The company's R&D expenses have been declining, with a drop from 1.335 billion yuan in 2023 to 1.033 billion yuan in 2024, representing a 22.58% decrease. In Q1 2025, R&D expenses were 216 million yuan, continuing the downward trend [7][8]. - The termination of several R&D projects, including the PD-1 project, reflects a strategic shift and raises concerns about the company's innovation capabilities [10][13]. Core Business Performance - Revenue from both chemical preparations and traditional Chinese medicine preparations has declined, with the overall revenue dropping by 4.97% in 2024. The chemical preparations segment saw a 6.87% decline, significantly impacted by national medical insurance negotiations and centralized procurement policies [14][15]. - The traditional Chinese medicine segment experienced a 19.27% revenue decline, primarily due to a drop in demand for antiviral granules following a high base effect from the previous year [15]. Market Challenges - The company faces multiple challenges in future growth due to policy adjustments and changes in market demand, particularly in the chemical and traditional Chinese medicine sectors [2][14].