Since the start of this year, the globalization of domestically developed innovative drugs has continued to advance, with multiple overseas licensing deals being finalized. Meanwhile, the industry is being tested and is growing through iteration in global clinical and registration practices.

On one hand, domestic innovative drugs continue to open the door to international markets through the License-out model. Since the beginning of this year, the total value of outbound licensing deals for China's innovative drugs has exceeded US$120 billion. On the other hand, domestic innovative drugs continue to face challenges in overseas clinical development, drug registration, and other stages. On the evening of October 7, Shanghai Allist Pharmaceuticals Co., Ltd. announced that the global Phase III clinical trial of its product, furmonertinib mesylate tablets, failed to reach its primary endpoint (the most important observational indicator in clinical research). At the end of September, another pharmaceutical company, Hansoh Pharmaceutical Group Co., Ltd., announced that the marketing authorization for its core product, almonertinib mesylate tablets, was revoked just seven months after approval in the European Union. It is worth noting that both products had previously achieved overseas expansion through the License-out model.

While outbound licensing deals continue to surge, individual projects are encountering setbacks in clinical and registration stages one after another. This mixed picture of ups and downs is reshaping the market's understanding of innovative drug globalization. For a long time, the market was accustomed to treating BD (business development) signings as a sign of successful overseas expansion for innovative drugs. But in fact, a licensing agreement is merely the starting point of the journey: it only places the product onto the track of global competition, not the finish line. Currently, domestic innovative pharmaceutical companies still have shortcomings in grasping overseas review rules, executing global multi-center clinical trials, cross-border intellectual property disputes, post-market safety risk management, and remote commercial operations. Once clinical data falls short of expectations, overseas regulatory policies shift, or partner companies change strategy, projects face the risk of interruption, and domestic innovative pharmaceutical companies will bear the impact.

It can be seen that building full-chain capabilities for overseas expansion remains the core challenge for domestic innovative drugs going global. For companies, they must abandon impetuous attitudes and take a rational view of the gains and losses of overseas expansion. They should not only seize opportunities for overseas licensing cooperation, but also deepen original innovation, build a complete capability system covering early-stage R&D, global multi-center clinical trials, overseas registration applications, and commercial launch, and accept continuous testing against global standards. From an industry perspective, it is necessary to continuously promote the mutual alignment and compatibility of Chinese and foreign R&D standards, address the shortage of industry talent, and continuously cultivate a composite professional talent pipeline capable of global clinical protocol design, overseas regulatory submissions, and cross-border intellectual property management, thereby strengthening the foundation for the industry's long-term development. The path of globalization for domestic innovative drugs will never be smooth sailing. Short-term turbulence is an inevitable trial in the industry's growth. Only by settling down to hone full-chain hard skills and speaking through solid, reproducible global clinical data can more domestic innovative drugs truly benefit patients worldwide and secure a stable position in the global pharmaceutical innovation landscape.