National Day Special 5: From Overseas Validation to Global Implementation, Chinese ADC Drugs Enter a Stage of Original Innovation Breakthrough

Recently, ten departments including the Ministry of Industry and Information Technology jointly released the "15th Five-Year Plan for Pharmaceutical Industry Development" (referred to as the "Plan"). The "15th Five-Year Plan Outline for National Economic and Social Development of the People's Republic of China" issued in March this year listed biomedicine as a national emerging pillar industry. The release of this specialized plan represents further refinement and implementation of the outline's provisions. The Plan explicitly identifies next-generation conjugate drugs as a key innovation direction in the biopharmaceutical field, proposing to focus on developing dual/multispecific antibody conjugates (ADC), highly targeted ADCs based on new payloads, antibody/protein radionuclide conjugates (RDC), and antibody oligonucleotide conjugates (AOC) among other cutting-edge categories. The Plan provides a detailed classification and systematic deployment of next-generation conjugate drugs, marking the transition of China's ADC industry from scale expansion to an era of original innovation exploration."15th Five-Year" period, Chinese ADC will exhibit three core characteristics: the development focus will shift from product licensing to global commercialization; the technology route will evolve from single-targets to dual antibodies, dual payloads, and multi-modal approaches; the industrial value will move from following innovation to standard leadership.

As of early 2026, in the ADC drug field, the top 10 multinational pharmaceutical companies worldwide have reached approximately 20 transactions with Chinese innovative pharmaceutical companies, covering nearly 30 pipelines. Chinese ADC has become an indispensable part of the global tumor pipeline layout. Looking at the transaction structure,The cooperation focus is shifting from single product licensing to multiple pipelines and multi-stage bundling. Some leading pharmaceutical companies have intervened even in the early discovery stage, indicating that recognition of China's ADC's original innovation capabilities has evolved from follow-up verification to proactive planning.

Entering the "15th Five-Year" period, the ADC industry is transitioning from the transaction verification stage to the global commercialization stage. Previous licensed cooperation is entering a critical window for registration clinical trials and marketing applications. The start rate of global multi-center Phase III studies has significantly increased, and the number of approved products has steadily grown.

First, technological route iteration.The Plan clearly identifies dual/multispecific ADCs, ADCs based on new payloads (including dual payloads), and highly targeted ADCs with tumor microenvironment-specific release connectors as key development directions. It also includes RDC and AOC as new conjugate drugs in the innovation landscape. This means the technical competition in ADC has moved from monoclonal conjugate to dual antibody conjugate, dual payloads, and multi-modal new stages.

The acceleration of technological iteration is already clearly reflected in clinical settings. Dual-specificity ADCs improve endocytosis efficiency and expand antigen coverage through target combination and affinity design, moving from concept verification to a critical clinical realization stage. More forward-looking is the integration of dual antibodies and dual payloads. The core value of the dual payload strategy lies in synergy and resistance delay. By delivering two different mechanism-acting cytotoxic drugs simultaneously, it provides a more comprehensive coverage of tumor heterogeneity. Connector technology is also evolving, upgrading from early maleimide connectors to a newer generation design that is more hydrophilic and has higher plasma stability. Substantial progress has been made in AI-assisted connector stability prediction and cutting efficiency optimization. The diversification of technical routes is reshaping the competitive landscape of ADC.

Second, industrial chain autonomy has become a hard constraint.The Plan emphasizes improving the safety risk assessment and response mechanisms for the pharmaceutical industry supply chain, and breaking through key technologies in high-end pharmaceutical equipment and consumables, raw materials, etc. In the ADC field, this means that the localization of upstream processes such as connector design, new payload synthesis, and site-specific conjugation will accelerate.

The core contradiction of industrial chain security is: while the conjugation service capacity in the midstream is rapidly improving, the key upstream raw materials still rely heavily on imports. Local enterprises have made breakthroughs in some areas, but high-end functional carriers and special chemical modification services still depend on imports. In the key process of site-specific conjugation, which determines the uniformity and batch consistency of ADC, domestic enterprises in the enzyme conjugation branch have initially formed a competitive advantage. Both the number of clinical drugs and the proportion of transactions where enterprises act as transferors are high, but the overall technical layout still lags behind developed countries in Europe, America, and Japan. The key to industrial chain autonomy is to move from follow-up innovation to differentiated innovation. Only by forming independent intellectual property rights in underlying capabilities such as connector chemistry, site-specific conjugation platform, and new payload synthesis can China's ADC industry occupy an irreplaceable position in the global division of labor.

Third, internationalization shifts from licensing to joint commercialization.The Plan supports enterprises to actively participate in the global pharmaceutical innovation division cooperation through joint research and development, joint commercialization, etc., enhancing the entire chain of pharmaceutical research, development, and production capabilities. The global path of ADC enterprises is shifting from "selling molecules" to deeply participating in global clinical development and commercialization operations.

The change in transaction structure is the most direct signal. The traditional License-out model focuses on upfront payments and milestone payments, and enterprises' participation in global clinical development and commercialization operations is limited. The Co-Co model requires both parties to jointly develop, share costs, and share profits globally. The global role of Chinese ADC enterprises is shifting from asset providers to development partners. The rise of the Co-Co model indicates that the evaluation criteria of multinational pharmaceutical companies for Chinese ADC enterprises have expanded from "whether the molecule is good" to "whether the team can conduct clinical trials, registrations, and commercialization globally." Once this capability verification is completed, the status of China's ADC industry in the global pharmaceutical innovation division will undergo substantial changes.

Fourth, AI empowerment permeates the entire ADC research and development process.The Plan proposes to create high-value application scenarios for AI in pharmaceuticals, accelerating the transformation of the AI-driven pharmaceutical research and development paradigm. In the ADC field, AI has already been applied in target screening, connector optimization, payload design, and other aspects, expected to significantly shorten the research and development cycle and improve the accuracy of drug efficacy prediction.

AI's penetration in ADC research and development is evolving from a single tool to a full-chain platform. In the target discovery stage, AI can integrate multi-omics data such as genomics, transcriptomics, and proteomics to identify antigens with high tumor selectivity and surface accessibility, and support patient stratification strategies. In the antibody engineering stage, deep learning models can predict antibody structure, affinity, stability, and developability, and generative algorithms accelerate affinity maturation and specificity optimization. In the connector and conjugation design stage, computational models can predict connector plasma stability, payload release efficiency, and drug-antibody ratio, thereby optimizing ADC uniformity and safety. In the clinical development stage, hybrid physiological pharmacokinetics-AI models and digital twin simulations can virtually evaluate tumor penetration, system exposure, and safety, providing a basis for dose optimization.

First, multispecific ADCs.Currently, antibody carriers are driving ADC evolution along two paths: First, the target spectrum expands from classic tumor antigens to immune checkpoints and low-expression antigens, overcoming the limitation of ADCs targeting only highly expressed antigens through the bystander effect, allowing HER2-low expression tumor patients to benefit. Second, antibody structures continue to be innovated, with strategies such as silencing Fc function and miniaturization designs continuously optimizing pharmacokinetics and tumor penetration, and the rise of dual- and even multispecific ADCs further broadens the treatment window through multi-pathway synergistic regulation.

The Plan places dual/multispecific antibody conjugates at the forefront of next-generation conjugate drugs, responding to this technological trend. Multispecific ADCs have moved from concept verification to a critical clinical realization stage. Chinese enterprises' pipeline density and clinical advancement speed in the field of multispecific ADCs are at the world's leading level, and multispecific ADCs are expected to be a key pillar for maintaining China's global competitiveness during the "15th Five-Year" period.

Second, "antibody+X" new conjugate antibodies.Currently, effective payloads are evolving from traditional cytotoxins to diversified and functional directions, promoting ADCs to expand from a single killing mechanism to a multi-dimensional treatment paradigm. Among them, antibody radionuclide conjugates are advancing fastest due to their integrated diagnosis and treatment advantages, becoming an important supplement to ADC drugs. At the same time, the dual payload strategy, which conjugates two different mechanisms of toxins on the same antibody, achieves synergy and resistance delay, representing another important direction for ADC payload design.

The Plan explicitly includes antibody oligonucleotide conjugates (AOC) and other new conjugate drugs in key innovation areas, providing a top-level design guide for the technical research and industrialization of "antibody+X" general conjugates. During the "15th Five-Year" period, with the continuous maturity of new payload mechanisms such as immune activation, targeted degradation, and gene silencing, "antibody+X" new conjugate drugs are expected to become an important growth driver in the tumor treatment field after traditional ADCs.

"15th Five-Year" is a crucial period for China's ADC industry to fully shift from following to running alongside, and even leading. The Plan systematically includes next-generation conjugate drugs as key innovation directions, providing a top-level design guide for the technical iteration and commercialization of the ADC industry. From overseas experience to global realization, from single-targets to multi-target synergy evolution, China's ADC industry is entering an era of original innovation breakthroughs. In this process, multispecific ADCs, by integrating the multi-pathway synergistic regulation ability of dual antibodies and the efficient cytotoxic effect of ADCs, demonstrate stronger targeting and anti-tumor efficacy, becoming the core direction of next-generation ADC innovation; "antibody+X" new conjugate drugs break through the single paradigm of traditional cytotoxin killing, expanding the range of intervenable targets through diverse mechanisms such as immune activation, target protein degradation, and gene silencing, opening up new paths for ADCs to extend from tumor treatment to broader disease areas. Together, they form the dual drivers of China's ADC original innovation and are also the key pillars for maintaining global competitiveness during the "15th Five-Year" period.

Facing the future, China's ADC will build core competitiveness through original innovation, validate drug value through global clinical verification, and strengthen safety foundations through industrial chain autonomy, injecting Chinese strength into the global tumor treatment landscape.