创新药出海已成“必选项” 行业大咖展望未来新范式

Core Insights - The Chinese biopharmaceutical industry experienced a historic leap in 2025, with 76 innovative drugs approved for market, a 58% increase from 2024, and total licensing transactions exceeding $130 billion, marking record highs in both transaction volume and value [1] - The "China strategy" has become a central topic at the JPM 2026 conference, highlighting the importance of global collaboration in the biopharmaceutical sector [2] Industry Developments - Chinese biopharmaceutical companies face significant challenges when entering markets like the US and Europe, including stringent regulatory requirements and high competition, with a success rate of only 0.4% for Chinese biopharmaceuticals from clinical phase I to market in the US [3] - The complexity of healthcare systems in Europe and the strict approval processes by the EMA further complicate market entry for Chinese firms [3] Transaction Trends - There has been a notable decline in cross-border License-in transactions from 2022 to 2025, while License-out transactions have surged, with the total value in 2025 being approximately 2.5 times that of 2024 [4] - New transaction structures such as the NewCo model and Royalty Monetization are emerging as preferred options for Chinese pharmaceutical companies, indicating a shift towards a more integrated global partnership approach [4][5] Future Outlook - The next 3-5 years are expected to be significant for business development (BD) in China's biopharmaceutical sector, with a strong recovery in financing and an optimistic outlook for international collaboration [7][8] - The industry is positioned to leverage its comprehensive R&D capabilities and cost advantages, with innovative drugs priced at about one-tenth of their US counterparts, suggesting a continued role as a source of global innovation [8]