中国创新药BD交易进入“后签约时代” 争议解决或成行业必修课

Core Insights - The Chinese innovative drug industry is entering a new decade of development in 2025, with a significant increase in business development (BD) transactions, reaching a total value of $135.655 billion and 157 transactions, both setting historical records, indicating the growing global appeal of Chinese innovative drugs [1] - Milestone payments from previously established collaborations are beginning to materialize, providing cash flow relief for companies and marking substantial progress in global development [1] - However, potential risks associated with BD collaborations are emerging, including the premature termination of agreements and disputes leading to arbitration or litigation, signaling a need for caution in the industry [1] Industry Trends - The surge in BD transactions in 2025 is driven by the long-accumulated innovative potential of China's biopharmaceutical sector, with expectations for continued growth in cross-border transactions between China and the US/Europe [2] - The BD trend began in 2022, but many companies have not yet experienced the full lifecycle of BD transactions, leading to potential undisclosed issues in long-term performance [2] - The period from 2026 to 2028 may see an increase in BD disputes, as the industry transitions from rapid growth to a more regulated and mature phase [2] Financial Highlights - In May 2025, a record-breaking upfront payment of $12.5 billion was secured by a collaboration between Sangamo Therapeutics and Pfizer, with potential total payments reaching $48 billion [3] - In July 2025, China National Pharmaceutical Group announced a $300 million milestone payment from Merck for a collaboration on a PD-1/VEGF dual antibody [3] - In October 2025, a $250 million milestone payment was triggered for a collaboration between SystImmune and Bristol-Myers Squibb, marking the largest single milestone payment for an ADC asset disclosed in China [3] Payment Structures - The "upfront payment + milestone + sales royalty" model remains the dominant approach for Chinese companies in BD transactions, but only 22% of biopharmaceutical companies achieved milestone events by mid-2025, a decrease from previous years [4] - Among 128 transactions with at least one milestone node, 45% did not generate any revenue, highlighting the uncertainty of milestone payment realizations [4] - Increasing the proportion of upfront payments to secure immediate cash flow has become a consensus among companies to mitigate risks [4] Contractual Strategies - Companies are advised to enhance negotiation strategies by creating competitive environments and optimizing milestone payment terms to reduce ambiguity and disputes [5][6] - Specific, quantifiable conditions for milestone payments should be established to minimize subjective interpretations and risks of disputes [5] - The interrelation of contractual terms should be considered to avoid imbalances in rights and obligations, which could lead to significant disagreements during project execution [6] Legal Considerations - The potential for a wave of litigation in the BD sector is rising, driven by long-term contracts and various uncertainties affecting performance [7] - Companies often prioritize commercial negotiations to resolve disputes, but if unsuccessful, they must rely on the agreed dispute resolution mechanisms, emphasizing the importance of precise contract language [7][8] - Early identification of dispute trajectories and effective crisis management can significantly influence the outcome of legal proceedings [8] Future Outlook - As of January 2026, 17 BD transactions have occurred, totaling $133.61 billion, with significant projects continuing to emerge [9] - The ADC sector, small nucleic acid drugs, and in vivo CAR-T therapies are expected to be key areas for BD transactions in the next 1-2 years, with a shift in focus towards clinical data validation [10] - The industry is moving towards a more mature and regulated phase, with an emphasis on risk awareness and compliance as essential elements for successful cross-border BD initiatives [10]