Global Release | '2026 China Biopharmaceutical Internationalization Development Blue Book' (Chinese and English Version), including access methods

With the accelerated adjustment of the global pharmaceutical supply chain and the continuous enhancement of domestic innovation capabilities, the internationalization of Chinese biopharmaceutical enterprises is evolving from単-segment product exports to a global layout covering research and development, registration, production, and commercialization. Against the backdrop of intensified domestic competition and changing financing environments, internationalization has become an important strategic direction for enterprises to expand market space and enhance asset value. A multi-level development system has now been established, including export of active pharmaceutical ingredients and intermediates, international registration of high-barrier generic drugs and biosimilar drugs, global development of innovative drugs and cross-border licensing.

Active pharmaceutical ingredients and intermediates are a traditional advantage for Chinese enterprises in participating in the global supply chain. As competition over bulk products intensifies, the industrial focus is shifting toward specialty active pharmaceutical ingredients, higher-value-added intermediates, and peptide products. The competitive advantages are also moving from cost and capacity to process technology, quality management, and international registration capabilities. Enterprises are enhancing their value within the global supply chain by developing CDMO services and promoting the integration of active pharmaceutical ingredients and formulations, thereby continuously increasing their value.

Generic drugs and biosimilar drugs are also upgrading towards higher barriers and higher value. Global price control, population aging, and the expiration of patents on blockbuster drugs generate ongoing demand. Generic drug enterprises are accelerating their layout in complex injectable products; biosimilar drug enterprises, relying on similarity assessment, CMC development, and quality management capabilities, enter the global market through regional licensing and commercialization cooperation. Thus, China’s biopharmaceutical industry is moving from large-scale product exports to the export of higher-value-added products and comprehensive capabilities.

While the industry as a whole is upgrading, innovative drugs have become the most active area for internationalization. With the continuous improvement in original research and development, clinical development efficiency, and technical platform strength, the overseas expansion of Chinese innovative drugs has evolved from a mere transaction of product rights to global clinical collaboration and long-term strategic cooperation. Enterprises can flexibly choose between independent overseas expansion, license-out, and joint development, depending on the degree of product differentiation and their overseas commercialization capabilities.

In terms of independent overseas expansion, an increasing number of enterprises place global demand and international regulatory requirements at the early stages of research and development, gradually building global development capabilities through international multi-center clinical studies, FDA and EMA submissions, and overseas indication expansion. Foreign licensing, meanwhile, utilizes overseas partner financial, clinical, and commercialization resources to reduce the pressure on R&D investment while accelerating the realization of asset value. Consequently, cross-border BD transactions remain actively engaged—the number of transactions in the first half of 2026 exceeded those in the same period domestically for the first time. Structurally, chemical drugs and monoclonal antibodies maintain an active base, while ADCs and bispecific antibodies have become important directions for high-value transactions; cooperation has also shifted from single-product licensing to platform technology and long-term cooperation.

Cross-border mergers and acquisitions and the NewCo model further enrich the overseas expansion pathways. Cross-border mergers and acquisitions provide value realization channels for enterprises with differentiated platforms or clinical validation outcomes. NewCo, by introducing overseas capital, development teams, and commercialization resources, reconfigures overseas rights and development risks. Since 2024, NewCo transactions have significantly increased, becoming an important bridge connecting domestic innovation and global capital.

From the perspective of market segment distribution, the overseas expansion of Chinese innovative drugs is accelerating into cutting-edge technology. As an important overseas expansion sector, ADCs have seen the transaction targets shift from mature targets to new targets and differentiated conjugate technologies. Bispecific antibodies, leveraging new target combinations and molecular engineering capabilities, continue to attract overseas pharmaceutical companies; the cooperation format has also evolved from single-molecule licensing to overall platform-based cooperation. New types of molecules such as bispecific ADCs combine two types of technological advantages, indicating that the overseas expansion of Chinese innovative drugs is moving from single-product innovation to complex molecular design and platform technological innovation. Cooperation on GLP-1 drugs follows a layered pattern: multi-target and differentiated mechanism products are more favored by global partners, while mature mechanism products expand overseas markets via regional market access and patent expiration windows. Cooperation in cell therapy is shifting from traditional CAR-T to in vivo CAR-T, allogeneic CAR-T, and stem cells—the cooperation content has expanded from the output of single pipeline rights to underlying platform capabilities such as cell engineering and delivery technology.

As internationalization deepens, the competitive barriers are also rising. Global regulation, intellectual property, supply chain adjustments, and overseas commercialization operations all impose higher demands on enterprises. An enterprise’s international competitiveness no longer depends solely on the cost or clinical advantages of a single product but should be reflected in its global R&D planning, international registration, differentiated platform, large-scale production, and cross-regional commercialization—its comprehensive capabilities.

Looking ahead, the internationalization of China’s biopharmaceutical industry will develop in the directions of high-endization, diversification, platformization, and global synergy. Active pharmaceutical ingredients and intermediates will continue to upgrade to higher value-added segments, while cutting-edge technology will drive differentiated assets to the global stage; diverse cooperation models will deepen global industrial synergy. China’s biopharmaceutical industry is expected to transition from product exports to the output of innovation research and development, technical platforms, and comprehensive industrial capabilities, playing a more significant role in the global value chain.

The Blue Book combinesAiboitek, Orange Sail Medicine, Huilan Co., Ltd., Gene Qiming, Shibekangand other representative enterprises from different fields’ internationalization practices, providing an introduction to their business layouts, core product pipelines, global cooperation models, and competitive advantages, and showcasing the internationalization paths and differentiated competitive capabilities of Chinese biopharmaceutical enterprises in various sectors, offering a reference for industry participants to seize international market opportunities and optimize their global expansion strategies.For more detailed information, please refer to the full report.