Radioactive drugs (nuclear medicine) are an indispensable part of medical diagnosis and treatment, and have become an important component of modern medicine. The field of the radioactive drug industry has become a hot spot for investment and financing in the pharmaceutical sector in recent years, with many multinational companies including Novartis and Eli Lilly making strategic investments. The industrial chain of Chinese nuclear medicine enterprises is becoming increasingly complete. Global research and development on innovative radioactive drugs cover both diagnostic and therapeutic areas, with indications covering a variety of disease categories. In addition to cancer, they also cover mental illnesses, autoimmune diseases, and other fields.
On December 28th, Frost & Sullivan (hereinafter referred to as 'Frost & Sullivan') officially released the 'Blue Book on the Current Situation and Future Development of China's Radioactive Drug Industry' (hereinafter referred to as the 'Blue Book'). The Blue Book tracks various aspects such as technological development, marketed products, clinical pipelines, favorable policies, market growth, capital enthusiasm, and industrial chain, demonstrating the development context of the industry. It analyzes the current situation of China's radioactive drug market industry and future development trends.
At 16:00 on December 28th, the seventeenth session of the 'Frost & Sullivan Greater China Region 25th Anniversary Series Symposium' will feature an online release and interpretation of the 'Blue Book on the Current Situation and Future Development of China's Radioactive Drug Industry'. You can click 'Reserve' on the Frost & Sullivan video account to secure your spot in advance for watching this symposium.
1
Overview of Nuclear Medicine and Radiopharmaceutical Industry
Nuclear medicine is an important part of modern basic and clinical medicine, as well as one of the significant symbols of medical modernization. It combines cutting-edge technology in the nuclear field with important research findings in the field of life sciences, making its application fields extremely broad.
Radiopharmaceuticals, according to the latest interpretation of the 'Administrative Measures for Radiopharmaceuticals' by the National Medical Products Administration of China, refer to radioactive nuclide preparations or their labeled drugs used for clinical diagnosis or treatment. Radiopharmaceuticals (nuclear medicine drugs) are an important cornerstone in the development of clinical nuclear medicine.
According to the clinical uses of radioactive drugs, they can be divided into diagnostic and therapeutic radioactive drugs. Diagnostic radioactive drugs utilize tracer technology to elucidate functional changes in diseased tissues, abnormal gene expression, biochemical metabolic changes, etc., at the molecular level. They have advantages such as speed, accuracy, sensitivity, and resolution. They can achieve early diagnosis of diseases and serve as a basis for formulating more effective preventive or treatment plans. They are also the only technology among almost all medical diagnostic techniques that can visualize the function of living metabolic processes in vivo. Therapeutic radioactive drugs can selectively and targetably treat diseased tissues using radionuclides.
Source: Frost & Sullivan research
With the development of the times and technology, especially the rise of Radionuclide Drug Conjugates (RDC), radiopharmaceuticals have been progressing towards integrated diagnosis and treatment in recent years. Diagnostic radionuclide molecular imaging can show lesions, while lesions can also target and uptake labeled therapeutic radionuclides. By using internal radiation therapy with radionuclides to treat identified lesions, personalized diagnosis and treatment are achieved. With the progress of basic research, clinical studies, and application transformation of new integrated diagnostic and therapeutic radiopharmaceuticals, the integration of nuclear medicine diagnosis and treatment will play a role in more fields.
The 'Blue Book' sorts out the definitions, classifications, characteristics, and development history of nuclear medicine and radiopharmaceuticals. For more detailed content, please refer to the full report.
2
Global marketing and research pipeline of radiopharmaceuticals
As of October 2023, 64 new radioactive drugs have been approved for marketing globally, including 50 that are only used for diagnosis, 13 for treatment, and 1 that is used for both diagnosis and treatment. A total of 339 new radioactive drugs are in clinical trials or applying for marketing. Most of these new radioactive drugs are in the early stages of clinical research and development, with 293 in Phase I, Phase I/II, and Phase II clinical trials. It is believed that with the progress in the research and development of new radioactive drugs, more drugs will enter Phase III clinical trials.
As of October 2023, 42 radioactive drugs in China have been approved for marketing by the National Medical Products Administration (NMPA). Among them, 22 drugs have been included in the Class B regular medical insurance catalog, while 20 drugs are non-medical insurance products. Unlike most of the marketed radioactive drugs, which are generic drugs, most of the under-development radioactive drugs are innovative products. Among the 32 radioactive drugs, only 8 are generic drugs, indicating the rapid development of original research radioactive drugs in China.
Source: CDE, Frost & Sullivan research
The 'Blue Book' sorts out information on the global and Chinese marketed and investigational radioactive drug pipelines, including indications, clinical stages, and more. For more detailed content, please refer to the full report.
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Analysis of RDC-listed drugs and research pipelines
Radioactive nuclides are a class of innovative drugs formed by the coupling of connecting groups. They utilize antibodies, antibody fragments, small molecules, or peptides to mediate specific targeting, delivering radioactive nuclides to target locations. This concentrates the radiation produced by radioactive isotopes on the tumor site, destroying either single-stranded or double-stranded cancer cell DNA, causing cells to stop growing and thus eliminating cancer cells. While achieving efficient and precise treatment, they also reduce damage to other tissues. Different nuclides can be used for diagnostic or therapeutic purposes. As of October 2023, there have been 11 new RDC drugs approved for marketing globally since 2016.
Source: Frost & Sullivan research
The 'Blue Book' sorts out information on the global and Chinese RDC drug pipelines that are already on market or in development, including indications, clinical stages, etc., as well as the therapeutic content of RDC drugs for diseases such as prostate cancer, neuroendocrine tumors, and leukemia. For more detailed content, please refer to the full report.
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China's market scale for radioactive drugs
In 2017, the market size of radioactive drugs for imaging diagnosis and treatment in China was 22 billion yuan. By 2021, the market size had increased to 30 billion yuan, with a compound annual growth rate of 9.0%. Although the overall market size of hospitals experienced a low compound annual growth rate due to the pandemic from 2020 to 2022, sales have tended to stabilize as the pandemic receded. With the departure of the pandemic and the promotion of policy planning in the field of radioactive drugs in China, the market size for radioactive drugs is expected to continue a stable growth trend in the future. It is estimated that from 2021 to 2025, the market size of radioactive drugs for imaging diagnosis and treatment in China will reach a compound annual growth rate of 32.4%, with the market size expected to reach 93 billion yuan by 2025; and from 2025 to 2030, the market size for radioactive drugs for imaging diagnosis and treatment in China will continue to expand at a stable and relatively high compound annual growth rate, with a compound annual growth rate of 22.7% during this period. It is expected that by 2030, the market size will further increase to 260 billion yuan.
Source: Frost & Sullivan research
The nuclear medicine equipment market related to radioactive drugs is also expected to see further growth during this process. The scale of the nuclear medicine equipment market in China (including radiotherapy equipment) is projected to maintain a compound annual growth rate of 15.3% from 2021 to 2025, and 10.3% from 2025 to 2030. The market size is also expected to reach 256 billion yuan by 2030.
The 'Blue Book' analyzes the market size of radioactive drugs in China, as well as fluorine18F] and its labeled compounds, technetium[99mTc] and its labeled compounds, iodine125I] Seal the seed source, strontium chloride89Sr], radium chloride223Ra], Yttrium90Y] resin microspheres, iodine131The market scale of sodium fluoride, as well as the development drivers of China's radioactive drug market. For more detailed content, please refer to the full report.
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China's Radioactive Drug Market Supervision
In 2006, China issued the 'Regulations on the Preparation and Use of Positron Radioactive Drugs by Medical Institutions', aiming to standardize the preparation and use of positron radioactive drugs by medical institutions. These regulations have been in use ever since; in December 2012, in response to the characteristics of radioactive drugs, Appendix VI of GMP (Revised in 2010) was issued: Radioactive Drugs, to better regulate the production of radioactive drugs by enterprises; in 2021, eight ministries and commissions jointly issued the 'Medium- and Long-Term Development Plan for Medical Isotopes (2021-2035)', which is China's first programmatic document targeting the application of nuclear technology in healthcare; in March 2022, the 'Administrative Measures for Radioactive Drugs' promulgated by the State Council in 1989 were amended for the third time according to Decree No. 752 of the State Council, delegating the approval authority for enterprise production and business licenses to provincial-level authorities, strengthening the supervision responsibilities of provincial institutions, further promoting the 'delegating power, improving regulation, and optimizing services' reform, and optimizing the business environment. After a series of major events and the issuance of relevant regulatory laws and policies, China's radioactive drug industry is entering a new historical stage.
Radioactive drugs used as raw materials for pharmaceutical preparations are radioactive, which makes their production, research and development, and operation particularly special. Therefore, there is more supervision during market approval to ensure the safety of drug use. In China, the research, development, production, and operation of radioactive drugs are jointly supervised by multiple departments; in the United States, personnel and institutions conducting research on radioactive drugs are regulated by the US FDA, and the use of radioactive drugs requires approval from the government's Radiation Safety Board or submission of an eIND/IND filing; in Europe, EU member states can introduce and use new radioactive drugs through two pathways: clinical trials and non-clinical trials. The clinical trials pathway is conducted according to the clinical trial management system, while the non-clinical trials pathway is based on EU clinical trial regulations and specific national regulations.
The field of radioactive drug industry has its particularities. Radioactive elements are extremely destructive to the environment and human health, and their use without strict supervision can cause great harm to society. Considering the accessibility of innovative radioactive drugs to patients, while calling for regulatory standardization, it is also necessary to optimize the approval process to help patients obtain critical diagnostic and therapeutic products, thereby improving and prolonging their lives.
Source: Frost & Sullivan research
The 'Blue Book' analyzes the changes in China's radioactive drug regulatory policies and key milestones, the regulatory practices for radioactive drugs in China, the United States, and Europe, as well as a comparison of the regulatory frameworks for radioactive drugs in China, the United States, and the European Union. For more detailed content, please refer to the full report.
6
Radioactive Drug Industry Chain and Investment, Financing, M&A
Looking at the entire process of radioactive drug research, development, production, and use, the industry chain of radioactive drugs can be divided into three segments: upstream - preparing nuclides through nuclear reactors, accelerator production, and separation and extraction of nuclear fuel waste liquids; midstream - radioactive drug products are produced by R&D, manufacturing, and distribution enterprises through technology research and development, clinical trials, production, etc.; downstream - providing diverse and efficient diagnostic and treatment methods for patients in conjunction with the diagnostic and treatment plans provided by medical institutions.
In 2023, the investment and financing amount in China's radioactive drug field continued to grow. Among them, Xiantong Medicine received over 1.1 billion yuan in financing, becoming the largest single financing deal in the domestic healthcare sector in 2023, attracting widespread attention. The uniqueness of radioactive drugs themselves and the high barriers in the industry have made them a hot spot for capital investment in recent years. On one hand, capital places great emphasis on the research and development of innovative radioactive drugs. On the other hand, capital also values the diversity of the radioactive drug industry, that is, developing various different radioactive drugs. While reducing risks, it can also promote industry innovation, encourage the development of new radionuclides and new indications, and bring good news to more patients with different needs. Among these, several companies deploying radioactive nuclear drugs have gained favor from the capital market. In addition to Xiantong Medicine, a number of new radioactive drug R&D enterprises are also developing rapidly. For example, Aiboz Medicine, spun off from RayzeBio, completed a $75 million financing at the end of 2021. Fuliang Technology has received multiple capital favors in recent years due to its strong pipeline of ongoing research, with a total financing amount reaching $47 million. RuiDiO, which developed China's first independently developed Class I innovative drug in the field of nuclear medicine, has also received strategic investment from Baiyang Medicine Group. At the same time, Tongrui Biopharmaceutical R&D and Production Base project, which has connected with multiple financial institutions for support, plans a total investment of 3 billion yuan to build an international first-class and domestically leading isotope drug industrialization base integrating R&D, transformation, and production.
Source: Frost & Sullivan research
The enthusiastic support from investors further proves that the prospects for China's radioactive drug market are very broad. A large number of overseas radioactive drugs have already entered clinical trials in China, showing a prosperous trend. Chinese enterprises are also conducting independent research and development, achieving certain success in radioactive drug research and development, and the gap with international markets is narrowing day by day. With the development of new targets, molecules, radionuclides, and indications, the Chinese radioactive drug market is expected to continue growing. The huge potential of radioactive drugs will make investors' interest in this field even more fervent.
The 'Blue Book' analyzes China's radioactive drug industry chain, entry barriers, and investment, financing, mergers, and acquisitions. It also addresses pain points in China's nuclear medicine industry chain: radionuclide raw material supply, radioactive drug circulation, hospital access, clinical application, as well as successful cases of companies in the radioactive drug industry chain. For more detailed content, please refer to the full report.
7
Introduction to Some Companies in the Field of Radioactive Drugs in China
China UnionPay
China Nuclide & Radiation Technology Group Co., Ltd., a holding subsidiary of China National Nuclear Corporation, was listed on the Hong Kong Stock Exchange (HK.01763) on July 6, 2018. China Nuclide & Radiation Technology Group can be traced back to the establishment of China Isotope Company in 1983. It has been deeply involved in the industry for 40 years and is a leading enterprise in nuclear technology application that integrates R&D, production, sales, and services in China. The company focuses on two major industrial directions: nuclear medicine health and radiation applications, and is committed to providing comprehensive solutions for nuclear medicine, radiotherapy, and the promotion and application of radiation technology. It is the main force for China National Nuclear Corporation's entry into the field of life and health technology and the main channel for the transformation of advanced nuclear scientific and technological achievements, bearing the dual responsibilities of building a 'nuclear industry powerhouse' and a 'Healthy China'.
Redio
Guangdong Radiomics Technology Co., Ltd. (hereinafter referred to as 'Radiomics') is centered around the team led by Professor Wang Fan, Director of the Peking University Medical Isotope Research Center. It focuses on the research and development of radionuclide drugs and nuclear medicine imaging equipment. In 2022, Radiomics jointly established the 'Peking University Medical - Radiomics Nuclear Medicine Molecular Imaging Joint Laboratory' with the Peking University Health Science Center. In the same year, Radiomics received strategic investment from the industrial investment group Baiyang Pharmaceutical Group, which is based on the concept of 'technological innovation optimizing medical scenarios', due to the innovative nature of its independently developed products and the uniqueness of integrating pharmaceuticals and medical devices. The two parties are working together to accelerate the research and development of nuclear medicine drugs and equipment. Radiomics is committed to providing comprehensive solutions for nuclear medicine molecular imaging diagnosis and treatment, focusing on developing internationally advanced radionuclide drugs with independent intellectual property rights. Characterized by 'integration of pharmaceuticals and medical devices', it drives equipment innovation through drug innovation, and develops highly sensitive SPECT/CT equipment. Currently, Radiomics' research pipeline covers multiple fields such as SPECT diagnostic drugs, PET diagnostic drugs, radiological targeted therapy drugs, and imaging equipment.
Fulian Technology
Felix Radcliffe Associates Technology (FRA) is an integrated international radiotherapy company with offices in Belgium, Germany, and China. FRA is committed to building a full-industry chain nuclear medicine company that encompasses radiotherapy drug research, development, production, and commercialization to benefit patients worldwide. It plans to address the core issues currently affecting radiotherapy drug research through innovative research on future treatment methods. FRA's team includes experienced entrepreneurs and scientists who are not only skilled in managing biopharmaceutical companies but also deeply knowledgeable about the research and clinical development methods of radioactive isotopes.
Tongrui Biology
Tongrui Biotech was established in 2021 and is an innovative biopharmaceutical company dedicated to the research, development, production, clinical application, and commercialization of radioactive drugs. We aim to develop new radioactive drugs with innovative advantages and high quality for tumor diagnosis and treatment in response to unmet clinical needs. The company has R&D centers and offices in Beijing and Shanghai. Utilizing its leading internal technology platform and advanced manufacturing facilities, it actively engages in strategic cooperation with external parties in innovative technology areas, rapidly promotes product development, realizes the industrial transformation of innovative radioactive drug technologies, compensates for the deficiencies of existing tumor therapies, and drives the development of the radioactive drug industry and technological progress in the biopharmaceutical field.
Aiboz Medicine
Eboz Medicine was established in 2021 and has offices in Shanghai, Beijing, and Chengdu. Its mission is to "provide innovative and accessible targeted radionuclide therapy drugs for Chinese patients." By continuously innovating, it aims to offer safe, effective, and patient-accessible targeted radionuclide therapy (TRT). Eboz Medicine was spun off from RayzeBio (NASDAQ:RYZB) in 2021, focusing on combining the cooperation with strategic partners at home and abroad with the construction of its own TRT pipeline capabilities. It aims to become a leader and preferred partner in China's emerging TRT market, opening a new chapter in targeted radionuclide therapy in China. Currently, the company has multiple candidate radionuclide therapy drugs, one of which targets the GPC3 receptor. This drug was further developed based on PeptiDream's PDPS technology platform and has shown excellent experimental data in preclinical studies. It can precisely locate liver tumor tissues to reduce normal tissue enrichment, improve treatment efficacy, and reduce side effects, with great clinical potential and is expected to fill the gap in the demand for liver cancer treatment in China. In addition, the company is also building a sustainable innovation platform for discovering its own TRT pipeline.
The 'Blue Book' introduces some companies in the gene drug field, including company profiles, development history, technology platforms, research pipelines, core strengths, etc. For more detailed content, please refer to the full report.
