重压之下的生物制药：如何从“单点创新”转向“系统能力共建”？

Core Insights - The pharmaceutical manufacturing industry in China is projected to maintain stable revenue in 2024, with total revenue reaching 25,298.5 billion yuan, while total profit is expected to decline by 1.1% to 3,420.7 billion yuan [1] - The global biopharmaceutical sector is facing increasing pressure, with nearly half of executives reporting failure to meet revenue and profit targets, and 60% indicating unmet market share expansion goals [1][2] - Despite significant advancements in innovative fields such as cell and gene therapy, the market performance has not kept pace with scientific breakthroughs, leading to concerns over market share loss [1][2] Industry Performance - In 2024, two-thirds of the top 20 global biopharmaceutical companies experienced a decline in market value, while only three companies achieved over 10% growth [2] - The Chinese market has seen a surge in innovative drug approvals, with 22 new biopharmaceutical products and 48 innovative drugs approved in 2024, reflecting China's position as a leading source of drug development [2][3] Investment Trends - The first three quarters of 2025 have shown a significant potential for domestic innovative drugs, with total licensing-out amounts reaching 92.03 billion USD, surpassing 100 billion USD with additional transactions [3] - The innovation drug sector has rebounded strongly, with the China Innovation Drug Index rising over 13% in the first half of the year, significantly outperforming the broader market [3] Market Environment - The industry is currently in a phase of "innovation explosion" coupled with "commercialization challenges," with China contributing nearly 30% of the global innovative pipeline [4] - The shift from "single-point innovation" to "system capability co-construction" is evident, as Chinese pharmaceutical companies engage in a record number of global collaborations [4] Future Trends - The biopharmaceutical industry is expected to focus on chronic diseases, neurodegenerative diseases, and rare genetic diseases, with AI and digital technologies becoming integral to the drug development process [5] - Chinese companies are transitioning from "technology introduction" to "technology output," with a need to enhance global clinical development and compliance capabilities [5][6] Challenges and Recommendations - The industry faces challenges such as a lack of high-quality collaborative institutions, talent shortages in new therapies, regulatory inconsistencies, and supply chain vulnerabilities due to geopolitical factors [6][7] - To overcome these challenges, companies should enhance collaboration across disciplines, improve regulatory interactions, and focus on talent development [7][8] - Specific recommendations include establishing global standards for CMC capabilities, creating comprehensive CMC data packages, and collaborating with compliant global suppliers to mitigate risks [8][9]