Global Release | Access to the full text is included with the Blue Book on the Current Situation and Development Trends of the Conjugated Drug Industry (Chinese-English bilingual edition)

The concept of ADC (Antibody-Drug Conjugate) drugs has been around for a hundred years, and its research and development technology is continuously evolving and maturing. ADC drugs are conjugates of biological macromolecules and chemical small molecules, with unique mechanisms of action and metabolic kinetic characteristics. After three generations of technological innovation, they have achieved significant improvements in tumor targeting, circulation stability, and anti-cancer activity, ushering in a new era of precision cancer treatment. In recent years, there has been a surge in global enthusiasm for the research and development of ADC drugs, with a sharp increase in the number of clinical pipelines. Currently, countries such as China, the United States, and Japan are making rapid progress in research and development.

Data source: Literature search, Frost & Sullivan analysis

Based on sales by drug trade name, the top five ADC drugs by global sales in 2023 are Enhertu.^®, Kadcyla^®Adcetris^®, Padcev^®Trodelvy^®Its global sales in 2023 all exceeded $1 billion. The market scale of ADC drugs continues to expand.

According to data analysis from Frost & Sullivan, the global ADC drug market size has maintained a high growth rate, increasing from $2 billion in 2018 to $10.4 billion in 2023, with a compound annual growth rate of 39.1%. From 2023 to 2030, the market is expected to continue growing at a compound annual rate of 30.3%, with the global ADC drug market size projected to reach $662 billion by 2030.The Blue Book sorts out the global ADC drug sales statistics for 2023, as well as the global ADC drug market size and forecasts. For more detailed content, please refer to the full report..

Data source: Analysis by Frost & Sullivan

With the development of ADC drugs, the development of more conjugated drugs has accelerated, bringing diverse options and new hope to patients. In the future, conjugated drugs will have great development prospects.The 'Blue Book' sorts out the concept and main advantages of novel conjugated drugs. For more detailed content, please refer to the full report.

The country attaches great importance to the development of ADC drug industries, creating top-level designs at the national level to support enterprises in integrating technological resources and building new industrial technological advantages. The development of ADC drugs has enabled healthcare to make leapfrog progress, with an increasing acceptance of ADC drugs by doctors and patients. The growing medical demand continues to drive the growth of the ADC drug market. Transactions and investments in the field of ADC drugs remain hot. In addition, the complex production and preparation processes of ADC drugs have given rise to outsourcing needs for enterprises' production and research and development. The rapid growth of the ADC CDMO market has driven ADC CDMO companies to actively expand their ADC production capacity, further driving the growth of the ADC drug market.The 'Blue Book' sorts out the internal driving factors behind the rise of the conjugated drug industry from dimensions such as policy support, medical demand, capital markets and active pipeline transactions, as well as the emergence of ADC CMDOs. For more detailed content, please refer to the full report..

In the ADC drug field, innovation is accelerating. In the past three years, products have been approved intensively, with a frequent emergence of blockbuster drugs. The marketed ADC drugs have diverse combinations such as targets, antibodies, payloads, and conjugates, achieving significant clinical effects in cancer treatment.The 'Blue Book' sorts out the targets, antibodies, conjugates, payloads, and coupling methods of marketed ADC drugs, and analyzes and discusses the drug design, key clinical data, marketing history, marketing strategies, and significance of some representative marketed ADC drugs. For more detailed content, please refer to the full report..

ADC drugs have revolutionized the paradigm of cancer treatment, bringing about tremendous market opportunities. While attracting a large number of innovative pharmaceutical companies and capital, they also test the R&D innovation, clinical design, strategic execution, and commercialization capabilities of major pharmaceutical companies.The Blue Book comprehensively analyzes the main commonalities of listed ADC drugs.This includes: 1) Innovation is the driving force behind breakthroughs in ADC drugs; 2) The ultimate manifestation of the value of ADC drug innovation is in clinical results; 3) Commercial production is a key point for transforming innovative ADC drug achievements into reality.For more detailed content, please refer to the full report..

In recent years, there has been an explosive growth in the number of clinical research projects for ADC drugs globally and in China, with a significant increase in the number of ADC drugs in the market application stage.The Blue Book systematically sorts out the information on ADC drug research pipelines globally and in China, including indications, target distribution, clinical stages, etc. It also presents information on ADC drugs in the global and Chinese market application stages. The top 10 companies conducting ADC drug research pipelines globally can be found in the full report. For more detailed content, please refer to the complete report..

In addition, the 'Blue Book' presents key pipeline projects and products that are expected to bring therapeutic breakthroughs. It analyzes relevant clinical data disclosed at international top-tier academic conferences and journals. For more detailed content, please refer to the full report..

The 'Blue Book' analyzes and discusses the development trends of ADC drug industries.This includes: 1) New targets and mechanisms for ADC drugs; 2) Advances in ADC drug design and conjugation technology; 3) Strategies for combination therapy to enhance efficacy; 4) Expanding indications and treatment lines.The Blue Book incorporates some representative achievement examples and systematically elaborates on them in conjunction with the segmentation trend. For more detailed content, please refer to the full report..

Radionuclide Drug Conjugates (RDC) are composed of a targeting carrier (such as monoclonal antibodies, peptides, small molecules, etc.) coupled with a radionuclide through a linker, guiding the radionuclide to precisely target tumors. They play an important role in the diagnosis and treatment of tumors. Depending on their use, RDC drugs can be divided into diagnostic and therapeutic types. RDC drugs provide new treatment options for advanced tumor patients with multiple metastases, effectively reducing the risk of death and prolonging patient survival.The 'Blue Book' analyzes the commonly used radionuclides of RDC drugs and their main characteristics, and lists the new RDC drugs launched globally after 2016. For more detailed content, please refer to the full report..

The Blue Book provides a comprehensive analysis of key listed drugs in the RDC sector.Including 1) drug structure, 2) main clinical data, 3) commercial performance, etc.For more detailed content, please refer to the full report..

In recent years, the RDC field has developed vigorously, with the variety of nuclides continuously expanding.The 'Blue Book' systematically sorts out the information on R&D pipelines of RDC drugs globally and in China, including types of radionuclides, indications, target distribution, clinical stages, etc. It presents key ongoing pipelines and products that are expected to bring therapeutic breakthroughs. It also analyzes relevant clinical data disclosed at international top-level academic conferences and journals. For more detailed content, please refer to the full report..

The application potential of RDC drugs is being continuously explored, with the hope of meeting more unmet clinical needs. At the same time, exploring the regulatory construction of RDC drugs, promoting drug market launch, and improving drug accessibility are also key areas for industry development.The 'Blue Book' analyzes and discusses the development trends of the RDC drug industryThis includes: 1) development of new radionuclides, new targets, and new RDC drugs; 2) exploration of new indications; 3) exploration of integrated diagnosis and treatment and the convergence of drugs and medical devices; 4) promoting the construction of RDC drug regulatory frameworks and improving product accessibility.The Blue Book includes representative achievement examples, systematically elaborates in conjunction with the segmentation trend, and makes comparisons of radioactive drug regulation in China, the United States, and the European Union. For more detailed content, please refer to the full report..

Peptide Drug Conjugates (PDC) are novel conjugated drugs that use peptides as targeting carriers. PDCs offer higher payload, stronger tissue penetration, more flexible multifunctional modifications, and lower preparation costs.The Blue Book sorts out the structure, mechanism of action, advantages, and future research and development directions of PDC drugs. For more detailed content, please refer to the full report..

The 'Blue Book' systematically sorts out information on the global and Chinese PDC drug research pipelines, including indications, target distribution, clinical stages, etc., and presents key research pipelines and products that are expected to bring therapeutic breakthroughs. It also analyzes relevant clinical data disclosed at international top academic conferences and journals. For more detailed content, please refer to the full report.

By optimizing the structure of PDC drugs, the targeting and specificity of peptides can be further improved. More potent and safe PDC drugs can be developed to achieve more precise treatment.The Blue Book provides a comprehensive analysis of methods for optimizing the drug structure of PDCs. For more detailed content, please refer to the full report.PDC drugs not only provide new possibilities for targeted therapy of tumors, but with the continuous deepening understanding of peptide structures and mechanisms of action in recent years, their application scope has gradually expanded. They are used in many fields such as immunomodulation, neuroscience, and metabolic diseases.The Blue Book sorts out the disease areas where PDC drugs can be applied. For more detailed content, please refer to the full report..

SMDC (Small Molecule-Drug Conjugates) are emerging conjugated drugs that use small molecular groups as targeting ligands, and they possess pharmacokinetic characteristics different from ADC drugs.The 'Blue Book' analyzes the concept and characteristics of SMDC drugs, sorts out information on the research pipelines of SMDC drugs globally and in China, including indications, target distribution, clinical stages, etc., and presents key research pipelines. It also parses key clinical data. For more detailed content, please refer to the full report..

Other novel conjugated drugs include various types represented by Immune-stimulating Antibody Conjugates (ISAC), Antibody-Photosensitizer Conjugates (APC), Antibody-Cell Conjugation (ACC), and Antibody-oligonucleotide Conjugates (AOC).The 'Blue Book' analyzes the concepts and characteristics of other drugs, sorts out information on ongoing research pipelines for other conjugated drugs globally and in China, including indications, target distribution, clinical stages, etc., and presents key ongoing research pipelines. It also analyzes key clinical data. For more detailed content, please refer to the full report..

The research and development of SMDC drugs and other novel conjugated drugs are still in the early exploration stage, requiring overcoming various existing challenges, but they have broad market potential in the future.The 'Blue Book' analyzes the future development trends of SMDC and other novel conjugated drugs. For more detailed content, please refer to the full report..

In recent years, the ADC drug field has seen strong development momentum, with exceptionally active trading and investment activities.The 'Blue Book' sorts out the financing situation in the primary market of ADC drugs in recent years, as well as the global M&A activities in the ADC drug field for some Chinese ADC drug-listed companies. For more detailed content, please refer to the full report..

Data source: Analysis by Frost & Sullivan

The export of ADC drugs is a significant event in the field of biomedicine technology in China. Along with the export of Chinese ADC drugs, it has further set off a wave of biomedicine exports from China.The Blue Book sorts out the licensing and overseas development of ADC drugs in China, analyzes the key products and companies in the overseas development layout of ADC drugs in China, and more detailed content can be found in the full report..

RDC drugs are entering a golden period of rapid development, with a total global transaction amount of $951 million in the RDC drug sector in 2023. It is worth noting that the RDC drug sector in China has seen a surge in transactions in recent years. Since 2023, several Chinese companies in the RDC drug sector have received financing exceeding one hundred million yuan.The Blue Book presents the financing situation of RDC drug markets globally and in China. For more detailed content, please refer to the full report.In recent years, multinational pharmaceutical companies have been competing to deploy in the RDC drug space through acquisitions, especially since the end of 2023 when there have been frequent large-scale mergers and acquisitions.The Blue Book presents the global R&D contract acquisition and merger activities of RDC drugs, as well as the transaction details of major acquisition cases. For more detailed content, please refer to the full report..

PDC can effectively make up for the shortcomings of traditional small molecule chemical drugs in treating tumors. Through a precise drug delivery system, it achieves better therapeutic effects with lower dosages, attracting the research and development interests and capital investment of many domestic and foreign enterprises, and has become one of the current hot fields in biomedicine.The Blue Book presents the financing situation of the global PDC drug primary market and that of some companies involved in the PDC sector. For more detailed content, please refer to the full report..

SMDC combines the precision of targeted therapy with the powerful lethality of small molecule drugs, attracting the attention and investment of numerous investors, pharmaceutical companies, and government-funded institutions in the SMDC market.The Blue Book presents the financing situation of some companies involved in SMDC-related fields. For more detailed content, please refer to the full report..

Dongyao Pharmaceutical is located in Suzhou Industrial Park, focusing on biopharmaceuticals, especially in the fields of Antibody/Proteins/ADC/Bioconjugate. It provides one-stop CDMO solutions from biopharmaceutical development to production. Dongyao Pharmaceutical has been deeply involved in this field for over a decade and possesses core technical platforms for antibody and conjugated drug technology, process development/magnification, as well as independent analysis capabilities for key quality attributes, ensuring high-quality product development, production, and delivery. In addition, the company's quality system complies with Chinese/American/European GMP standards. It owns multiple OEB-5-level ADC/ conjugated drug commercial production lines integrating bulk antibody, ADC, and conjugated drug preparations (including non-toxic conjugates), leading domestic production capacity. The antibody production capacity has reached over ten thousand units per upgrade, and there are commercially produced products online. Currently, it has accumulated more than a hundred years of project execution experience in international standards, covering services from early research and process development of antibodies/ADC and conjugated drugs, clinical stages, marketing filings to commercial GMP production.

Zhongshan Lebo Biopharmaceutical Co., Ltd. is an innovative drug R&D platform company focusing on the treatment of refractory orthopedic diseases. Oriented towards the unmet clinical medication needs in China and globally, it develops original orthopedic drugs with 'First-in-Class' potential. Since its establishment, Lebo has built a complete technical platform including PDC conjugation and high-throughput screening. The first product for the treatment of osteonecrosis, RAB001, has currently completed Phase I clinical trials in the United States and obtained a clinical approval from the Center for Drug Evaluation (CDE) in China, completing Phase I bridging clinical trials and is currently conducting Phase II clinical trials. Additionally, several other products are in preclinical development stages for the treatment of bone and joint-related diseases.

RadiodiO is committed to providing comprehensive solutions for nuclear medicine molecular imaging diagnosis and treatment, focusing on developing internationally advanced radiopharmaceuticals with independent intellectual property rights. Characterized by 'integration of medicine and equipment', it drives equipment innovation through drug innovation, developing highly sensitive SPECT/CT devices. Currently, RadiodiO's research pipeline covers multiple fields such as SPECT diagnostic drugs, PET diagnostic drugs, radiopharmaceuticals for targeted therapy, and imaging equipment.

Shanghai Shijian Biotechnology Co., Ltd. was registered and established in March 2017 in Zhangjiang High-tech Park, Pudong New Area, Shanghai, focusing on the research and development of differentiated innovative antibody-drug conjugates (ADCs). Shijian Biotechnology's independently developed ADC technology platform EZWi-Fit®> uses highly efficient and low-toxicity camptothecin payloads, which have significant advantages in terms of safety, efficacy, resistance to drug resistance, and pharmacokinetic characteristics, supporting the rapid expansion of ADC product lines targeting new and validated targets. Currently, Shijian Biotechnology has several product pipelines entering clinical trials, mainly treating malignant tumors.

Tongrui Biotech was established in 2021, initiated and funded by Tonghe Yucheng, a well-known biopharmaceutical venture capital institution in the industry, and Jiu Rui Health, an industry partner. The company raised approximately $82 million through Series A+ financing in 2024, exceeding $100 million. Tongrui Biotech is committed to building a vertically integrated platform enterprise for radioactive drug research and development, production, and clinical application that is based in China, global-oriented, and driven by innovation. In 2021, the company invested in and constructed the "Tongrui Biotech Chengdu Wenjiang R&D and Production Base Project" within the Chengdu Medical City in China. It has built a world-class radioactive drug research and development center and a cGMP production base that meets the regulatory requirements of the US FDA, EU EMA, and Chinese NMPA, and has obtained a Class A "Radiation Safety License".

Duality Biologics is a clinical-stage innovative biopharmaceutical company focused on developing new generation ADC therapeutic drugs for cancer and autoimmune diseases. Duality Biologics has successfully built multiple new generation ADC technology platforms with global intellectual property rights. Based on in-depth research and exploration of disease biological mechanisms, Duality Biologics has seven clinical-stage ADCs and has conducted seven global multi-center clinical trials in more than 17 countries, enrolling over 1,000 patients. In addition, Duality Biologics is continuing to develop its novel protein engineering and ADC technologies to develop the next generation 'super ADC' molecules, including bispecific ADCs, novel mechanism payload ADCs, and autoimmune ADCs.