From August 4th to 5th, 2026, the 2026 Frost & Sullivan Summit was held in Shanghai. Organized by Frost & Sullivan (hereafter referred to as "Frost & Sullivan"), the summit brought together representatives from industry, capital, and academia, aiming to create the leading platform for corporate investment and financing, supporting sustainable and high-quality development.
On August 5th, at the "Life Science New Investment Summit Forum - Biopharmaceutical Session," Frost & Sullivan officially released the "2026 Biopharmaceutical International Development Blue Book" (hereafter referred to as "Blue Book"), providing a comprehensive overview of the current status and future trends of China's biopharmaceutical internationalization.
This Blue Book focuses on the stage evolution, main paths, and industry trends of China's biopharmaceutical internationalization. It analyzes the opportunities and challenges of global expansion for enterprises in various sub-sectors, and outlines the overall context of the international development of Chinese biopharmaceutical companies. The Blue Book emphasizes analyzing key internationalization paths such as export of active pharmaceutical ingredients and intermediates, international registration of high-barrier generic drugs and biologics, independent global development of innovative drugs, foreign licensing, and cross-border cooperation. Combining with the practices of representative enterprises, it explores the global expansion models and development directions of enterprises at different stages and with different resource endowments, providing references for industry participants to understand global industrial changes and formulate international development strategies.
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Left: Li Qian, Executive Director of Frost & Sullivan China's Medical Health Division
Right: Zhang Chenyang, Consultant Director of Frost & Sullivan China's Medical Health Division
01
Background of China's Biopharmaceutical International Expansion
Due to intensified domestic competition, changing financing conditions, and global market growth opportunities, internationalization has become an important path for enterprises to expand market space, enhance asset value, and access global resources.
In recent years, with the approval of innovative drugs overseas, license-out, and the acceleration of NewCo and cross-border cooperation, Chinese biopharmaceutical enterprises have shifted from single-product exports to comprehensive global expansion including research and development, registration, manufacturing, and commercialization capabilities. By accessing multiple regional markets and engaging in international cooperation, they can realize innovation value. For more details, please refer to the full report.
02
Active Pharmaceutical Ingredients and Intermediates: It is the right time for structural optimization and upgrading, maintaining advantages in the reshaping of the global supply chain
Thanks to a complete industrial chain, cost advantages, and global supply capabilities, Chinese enterprises have long maintained an important position in the global pharmaceutical supply chain. In recent years, the industry's export scale has shifted from rapid growth to platform adjustment. Traditional bulk products are facing pressure, while high-value-added products such as peptide hormones have become new growth areas.
At the same time, the focus of enterprise international competition has shifted from cost advantages to quality systems, registration capabilities, process barriers, and deep customer engagement. By adopting special active pharmaceutical ingredients, key intermediates, CDMO, and integrated "intermediate - active pharmaceutical ingredient - formulation" strategies, enterprises can enhance their position in the global value chain. In the future, China's active pharmaceutical ingredients and intermediates industry is expected to maintain competitive advantages in the reshaping of the global supply chain through product structure optimization, business model upgrading, improved market access, and enhanced manufacturing capabilities. For more details, please refer to the full report.
03
Generic Drugs and Biologics: Using high barriers as a breakthrough point, transforming production capacity and development advantages into global commercial cooperation value
Global healthcare reforms, population aging, and the expiration of patents on major drugs continue to drive the development of generic drugs and biologics. Chinese generic drug enterprises are gradually shifting from traditional product competition to complex formulations, high-barrier dosage forms, and first-in-class products, expanding international markets by enhancing R&D, registration, and manufacturing capabilities. In mature markets such as the United States, complex generic drugs such as injections, inhalants, and sustained-release formulations have become important breakthroughs for Chinese enterprises in internationalization, and the ability to develop first-in-class drugs has also continued to improve.
Biologics internationalization relies more on similarity evaluation, CMC capabilities, quality systems, and global registration capabilities. Chinese enterprises are participating in the global market through license-out, regional licensing, and commercial cooperation, transforming local R&D and manufacturing advantages into international commercial value. As more high-value biologic patents expire, Chinese enterprises are expected to further enhance their international competitiveness in the biologics field due to cost advantages, manufacturing capabilities, and a continuously improved global registration system. For more details, please refer to the full report.
04
Innovative Drugs: Multiple models such as independent internationalization and foreign licensing coexist, forming diverse paths to integrate into the global industrial ecosystem
Internationalization development paths are becoming more diverse
Enterprises usually choose different internationalization methods based on product differentiation, overseas clinical needs, funding capabilities, desire to retain rights, and the difficulty of commercialization in target markets. Independent internationalization is more suitable for core assets with clear global competitiveness, prominent clinical value, and the ability to invest long-term; regional or global licensing is more suitable for projects that want to accelerate overseas development and reduce subsequent investment pressure; joint development and NewCo models fall between independent and licensed approaches, allowing retention of certain product rights and decision-making participation while introducing external funds and local development experience. For more details, please refer to the full report.
The independent internationalization path is steadily progressing
In recent years, Chinese enterprises have accelerated global clinical deployment, incorporating early international multi-center clinical trials and planning R&D paths according to the requirements of major regulatory markets, enhancing the global recognition of innovative assets. For already marketed products, enterprises further release commercial value by expanding overseas markets and indications. In the future, establishing a pre-customized global R&D system will be an important foundation for improving the success rate of innovative drug internationalization. For more details, please refer to the full report.
Foreign licensing transactions remain active, with each sub-sector having its own characteristics
The scale and number of Cross-Border E-commerce Trade transactions in China's biopharmaceutical BD sector continue to increase. From 2021 to 2025, the number of transactions increased from 159 to 328, and the transaction amount rose from $11.09 billion to $143.14 billion. Cross-Border BD is becoming an increasingly important component. In the first half of 2026, cross-border transactions exceeded domestic transactions for the first time. China's biopharmaceutical BD market is evolving from mainly relying on domestic resource integration to a pattern of domestic cooperation and cross-border value output coexisting. The foreign licensing cooperation model is also evolving, gradually upgrading from product licensing to long-term strategic cooperation based on platforms.
In terms of transaction structure, chemical drugs and monoclonal antibodies remain the most active sectors, with high transaction frequency; ADC and bispecific antibodies are the most core high-value sectors, with significantly higher average upfront payments per deal. Overseas buyers are more willing to pay premiums for complex mechanisms and differentiated platforms, and resources are clearly concentrated in the ADC and bispecific antibody-related areas. For more details, please refer to the full report.
Cross-Border M&A provides a new channel for value realization
Mergers and acquisitions bring financial support, resource integration, and global development opportunities to Chinese enterprises. Enterprises with high-barrier technology platforms and actively promoting clinical validation are more likely to be favored by overseas acquirers. For biotech companies, acquisition allows quick access to funding, connection to buyer resources, enhancement of company valuation and returns, and acceleration of global development of pipeline assets; for overseas buyers, they can quickly enter new targets and molecular assets with differentiated clinical data, directly obtaining verified process platforms, local clinical data, and commercialization infrastructure. Around 2024, there was a period of concentrated cross-border acquisitions. In the future, transactions will mainly continue around two directions: "platform-type assets" and "mid-to-late stage verification assets." For more details, please refer to the full report.
NewCo model becomes a new path connecting local innovation and global capital
By injecting overseas rights to drug pipelines into NewCo and introducing external funds, enterprises can relieve R&D funding pressures, transfer subsequent clinical and commercialization risks to new operating entities, and share future value gains from products through holding equity. Since 2024, there have been an obvious increase in NewCo events. By the first half of 2026, a total of 31 cases had occurred, and the participating enterprises have expanded from a few early explorers to various types of innovative drug enterprises. Existing cases have successfully verified the feasibility of the model, corresponding to different value realization paths such as IPOs, mergers and acquisitions, and continuous financing. Its future value still depends on factors such as clinical data, financing environment, regulatory pathways, and commercialization competition. For more details, please refer to the full report.
05
Internationalization situations of each sub-sector
Bispecific Antibody Sector: The internationalization process of Chinese bispecific antibody assets has significantly accelerated, and overseas cooperation has evolved from sporadic events to continuous transaction activities. At the same time, the overseas expansion of bispecific antibody assets shows an early-stage characteristic. Many projects have attracted attention from overseas pharmaceutical companies before sufficient human efficacy data was available, indicating that international buyers' judgment of Chinese bispecific antibody assets has advanced beyond clinical results to target combination, molecular structure design, and platform engineering capabilities. For more details, please refer to the full report.
ADC Sector: The ADC sector is one of the most mature paths for Chinese innovative drugs to go global. After rapid growth in transaction numbers in 2023, it has entered a relatively stable stage. In terms of licensing pace, Chinese ADC projects' foreign licensing occurs earlier than that of bispecific antibodies, with about 75% of transactions occurring before clinical phase I. The transaction value increases gradually as the R&D stage progresses. In terms of technical routes, the industry is highly concentrated on TOP1 inhibitor payloads and cleavable linkers, and the concentration of targets continues to decline. The industry is accelerating expansion to more new targets, with the main increment in the past two years coming from long-tail targets. Overall, China's ADC internationalization process has evolved from large-scale output of classic targets to in-depth exploration of multiple targets. For more details, please refer to the full report.
Bispecific ADC Sector: As of the first half of 2026, there were 9 foreign licensing cases of Chinese bispecific ADCs. The rise of bispecific ADCs directly addresses the three bottlenecks faced by single-target ADCs, showing three solutions: co-expression-dependent internalization, dual payloads collaborative delivery, and dual epitopes enhanced internalization. There is a high convergence in targets and payloads, with a relatively higher degree of homogenization, and thus a narrower differentiation space. For more details, please refer to the full report.
Peptide Sector: The trading routes of GLP-1 drugs show differentiation. Global/developed market-type transactions are basically focused on dual or multiple targets, emphasizing multiple targets and differentiated mechanisms; regional transactions are more centered around the single GLP-1R target and local market opportunities, taking advantage of local patent expiration, local registration, and marketing window opportunities. For more details, please refer to the full report.
Cell Therapy Sector: Chinese cell therapy foreign licensing started in 2017. By the first half of 2026, there were 16 cases, and the transaction amount showed an overall upward trend. The technical route is evolving towards diversification. In-vivo CAR-T, allogeneic CAR-T, and stem cell technologies are now experiencing overseas cooperation. Cooperation content is gradually shifting from single product rights output to output of special cell engineering technology, delivery technology, and platform capabilities. For more details, please refer to the full report.
06
Overall Challenges and Opportunities for China's Biopharmaceutical Internationalization
China's biopharmaceutical internationalization is in a stage of capability upgrading, while facing challenges such as stricter regulation, supply chain adjustments, differentiated asset values, and insufficient global operation capabilities. The global pharmaceutical supply chain is accelerating reconstruction, and enterprises need to continuously improve quality systems, registration capabilities, supply chain management, and overseas operation capabilities to enhance international competitiveness.
At the same time, internationalization development also brings important opportunities. The industrial structure is continuously upgrading towards high-value-added directions. Peptides, specialized CDMOs, high-barrier generic drugs, biologics, and differentiated innovative assets have become important growth areas. Enterprise internationalization paths are more diverse, with models such as independent global development, license-out, NewCo, and joint development being promoted simultaneously. Cross-border cooperation is gradually shifting from single-product licensing to platform and capability cooperation. In the future, Chinese biopharmaceutical enterprises will rely on high-end manufacturing, innovative R&D, and global coordinated layout to gradually upgrade from product output to R&D, technology platform, and comprehensive capability output, building a more stable international industrial ecosystem. For more details, please refer to the full report.
