出海新变量｜千亿美元规模交易热潮背后，中国创新药企出海还有多大空间

Core Insights - China's early-stage drug research and development (R&D) has become globally competitive, but there remains significant room for growth in later-stage R&D, including overseas clinical trials, regulatory submissions, and commercialization [1][3]. Group 1: Industry Growth and Achievements - On December 4, 2023, Chinese innovative pharmaceutical company Kelun-Biotech (6990.HK) entered into a licensing agreement with U.S. biopharmaceutical company Crescent Biopharma, which includes an upfront payment of $80 million and potential milestone payments of up to $1.25 billion [1]. - This agreement is part of a broader trend, with Chinese pharmaceutical companies completing 103 outbound licensing deals worth a total of $92.03 billion in the first three quarters of 2025, and the total for the year expected to exceed $100 billion, setting a new historical record [1]. - According to McKinsey, the share of innovative drugs licensed from China to the U.S. and Europe has increased from 2% in 2018 to 20% in 2023, and the share of new drugs approved by the FDA has risen from 1% in 2018 to 6% in 2025 [2]. Group 2: R&D Efficiency and Competitive Edge - Chinese pharmaceutical companies are estimated to convert molecular targets into candidate drugs and enter early clinical trials at a speed two to three times faster than the global average [2]. - The recruitment speed for clinical trial participants in China is approximately half of the global average, with costs per patient being about 50% lower than in the U.S. and Europe [3]. - The gap in early R&D capabilities between China and the U.S. has significantly narrowed, particularly in the field of innovative drugs, with Chinese companies holding 54% of assets in phase I and II clinical trials for antibody-drug conjugates (ADCs) and 48% for multi-specific antibodies [3]. Group 3: Future Prospects and Challenges - Despite the rapid growth in licensing agreements, no Chinese company has yet entered the top 20 global pharmaceutical companies by market capitalization, indicating that it will take many years for Chinese firms to reach the scale of giants like Johnson & Johnson or AstraZeneca [5]. - Industry executives believe that over time, Chinese companies will establish their global capabilities, enhancing their influence in the global pharmaceutical industry [4]. - The need for collaboration with multinational pharmaceutical companies is emphasized, as Chinese biotech firms require partnerships to accelerate their development and navigate international regulatory landscapes [5].