Leading the nuclear medicine track, opening the road of RLT commitment to China

On April 22, the 2024 Radiopharmaceutical Innovation and Development Conference hosted by the China Isotope and Radiation Industry Association was held in Beijing. Representatives from research institutes, universities, medical institutions and enterprises in the field of domestic radiopharmaceuticals exchanged views on cutting-edge hot topics such as medical isotopes and the industrialization of radiopharmaceuticals, in order to promote the improvement of radiopharmaceutical research and development, commercialization capabilities and innovation levels, and promote high-quality development of the industry. During the conference, the Radiopharmaceutical Branch of the China Isotope and Radiation Industry Association was established, and the first meeting of the first council was held. In addition to the common domestic nuclear medicine companies, multinational pharmaceutical companies appeared in the newly established branches and conferences. As the vice president of the Radiopharmaceutical Branch and co-chair of the conference, Ms. Luo Ya, vice president of Novartis China and head of the Value Access Department, attended the conference. In addition, Ms. Wang Ziwen, head of Novartis China's new product planning, gave a special report entitled "Hard-core Innovation Commitment to China" at the conference. Novartis said it will make full use of its industry advantages, innovative research and development layout and leading production and supply capabilities in the field of radioligand therapy, and work with industry partners to jointly promote the development of China's radionuclide industry and the progress of clinical application of drugs.

Group photo of the vice-chairmen and secretary-general of the first council of the Radiopharmaceutical Branch of China Isotope and Radiation Industry Association (provided by China Isotope and Radiation Industry Association)

Radioligand therapy: expected to become a new pillar of cancer treatment

Since Becquerel first discovered radioactive substances in 1896, the application of radionuclides in the medical field has been explored for more than a century: In 1931, the advent of the world's first cyclotron promoted the clinical scientific research and application of radionuclides in medicine. Entering the 21st century, traditional nuclear drugs such as iodine-131 (sodium iodide) and radium-223 (radium chloride) have begun to be widely used in clinical treatment. In recent years, innovative radioligand therapy (RLT) represented by lutetium-177 has brought new hope to cancer patients, and its efficacy and safety have been confirmed in the treatment of gastroenteropancreatic neuroendocrine tumors and prostate cancer.
Radioligand therapy is actually a conjugated drug, which couples radionuclide chelates to molecules that can specifically bind to tumors, thereby accurately identifying and killing cancer cells. It is like a "tumor positioning missile" with the ability to accurately attack tumor cells, achieving precise attack and efficient removal of cancer cells. Currently, radioligand therapy has demonstrated significant clinical benefits worldwide, especially in the treatment of advanced metastatic prostate cancer, significantly improving patient survival rates. Different from traditional radioactive drugs such as iodine-131 (sodium iodide), radium-223 (radium chloride), etc., the highly targeted nature of radioligand therapy enables it to safely, accurately and efficiently attack tumor cells throughout the body. , without harming normal cells, is known as the "black technology" for tumor treatment. In addition, radioligand therapy and antibody drug conjugates (ADCs) are both conjugated drugs, but because they use radionuclides as payloads, peptides as carriers, and do not require hydrolysis, they have shown lower immunity in clinical applications. It has the characteristics of originality, better penetration and optimized body metabolism, and has stronger efficacy and higher safety. Experts and industry insiders participating in this Radiopharmaceutical Innovation and Development Conference all believe that radiopharmaceuticals represented by radioligand therapy are very promising to become a new pillar of tumor treatment and change the future of cancer treatment.

Group photo of representatives from the Radiopharmaceutical Branch of the China Isotope and Radiation Industry Association (provided by the China Isotope and Radiation Industry Association)

Novartis firmly believes in and continues to expand radioligand therapy

As early as 2017, when global pharmaceutical companies were competing for the PD-1, PD-L1 and ADC tracks, Novartis accurately grasped the strategic opportunity and took a unique approach to delve into radioligand therapy - first by acquiring Advanced Accelerator Applications for US$3.7 billion and acquiring its RLT and related technology platforms; in 2018, it acquired Endocyte for US$2.1 billion to further enrich the RLT pipeline; in March 2023, it reached a cooperation of more than US$1.7 billion with Bicycle Therapeut to develop radioactive conjugate drugs based on bicyclic peptides; in April 2023, Novartis reached a cooperation of more than US$400 million with 3B Pharmaceuticals GmbH to obtain the global development and commercialization privileges of peptide-targeted radioactive drugs. Novartis CEO Dr. Van Sihan, MD, clearly expressed his recognition of the value of radioligand therapy and long-term investment at this year's JPMorgan Healthcare Annual Meeting (JPM 2024), "Part of Novartis' key strategy is to find areas where we believe we can create long-term and sustainable leadership, and that is radioligand therapy." The continuous investment since 2017 has also brought two influential products in the field of radioligand therapy, which are used to treat patients with somatostatin receptor-positive gastrointestinal pancreatic neuroendocrine tumors and patients with castration-resistant prostate cancer who are still PSMA-positive after specific treatment, showing the market potential of "blockbuster". The excellent performance of these two products has not only led to the prosperity of the RLT track, but also triggered the enthusiastic attention and layout of major pharmaceutical companies around the world in the RLT field. In the face of the rapid advancement of RLT research and development and industrialization, Novartis not only continues to strengthen its existing "leader" advantages, but is also committed to continuously improving its research and development layout and production capabilities, and building efficient transportation and operation capabilities and all-round medical and patient service capabilities. In terms of R&D, in addition to the two drugs that have been launched, Novartis is also developing more than ten RLT drugs, covering a series of tumor diseases such as breast cancer, brain glioma, colon cancer, lung cancer, pancreatic cancer, etc.; in terms of production capacity, in addition to the existing three production bases, Novartis decided to expand its advanced Indiana RLT production base and add new plants in China and Japan to enhance the global production system; in terms of the supply system, due to the decay characteristics of radionuclides, radioactive drugs often have a very limited shelf life and need to reach patients within a few days after the drug is produced. Therefore, Novartis has set up a team responsible for logistics and is working hard to improve and enhance the supply logistics system of radioligand drugs. In order to provide better services to medical and health institutions, doctors and patients, Novartis has also launched a series of comprehensive customer service systems and products worldwide, including helping medical and health system construction, drug reservations, logistics tracking, RLT technical support, and medical education and training, and is committed to providing comprehensive services to doctors and patients. While Novartis is deploying RLT globally, it is also conducting continuous and extensive development and exploration in China, the most strategic market.

Novartis RLT has started the journey of commitment to China

Novartis means "promise to China". From the perspective of the advancement of Novartis' radioligand therapy project in China, Novartis RLT has already started the promised road of commitment to China. According to the official website of CDE, Novartis has launched several registered clinical studies involving RLT therapy in China, including RLT products for late-line metastatic prostate cancer indications that have been marketed in Europe and the United States, as well as front-line prostate cancer indications and other RLT pipeline products in the early stages of research and development that are being developed simultaneously around the world.
In addition to the introduction of innovative drugs, Novartis is also actively laying out a production base for radioligand therapy in China. On December 1, 2023, Novartis and the Haiyan government of Zhejiang Province announced the establishment of a new production base in Zhejiang Province, which is expected to be put into production by the end of 2026 to ensure the production capacity and supply of RLT drugs in China.
In addition, Novartis is also actively promoting the development of China's radiopharmaceutical industry and the implementation of policies. At the just-concluded 2024 China Development High-level Forum, Dr. Wan Sihan shared Novartis' insights and practices, submitted policy recommendations on "building a competitive innovation ecosystem to benefit Chinese patients", and actively advocated accelerating the development and application of radioligand therapy, an advanced therapy, in China. During the 6th China International Import Expo in 2023, Novartis joined hands with Chinese experts and scholars in the fields of urology and nuclear medicine, and partners in the Yangtze River Delta nuclear medical and health industry to jointly hold the "Prostate Cancer Targeted PSMA Diagnosis and Treatment Integrated Development Forum" and announced the establishment of the Yangtze River Delta Nuclear Medicine Technology Application Alliance.
Ms. Luo Ya said: "Novartis China has always adhered to the purpose of 'Commitment to China', committed to introducing innovative drugs with high clinical value to Chinese patients, and comprehensively deployed the Chinese market in terms of research and development, production and market expansion. Radioligand therapy is one of the five key global technology platforms for Novartis' R&D investment. We have accumulated highly professional R&D, production and clinical application, as well as interdisciplinary and cross-industry cooperation experience in the development of precision targeted drugs and therapies containing radioactive components. We look forward to bringing Novartis' experience in promoting the standardized development of the nuclear medicine industry to China through cooperation with industry associations, medical institutions and industry partners, to help China's nuclear medicine and nuclear medical industry develop with high quality, and to improve the accessibility of advanced therapies for integrated tumor diagnosis and treatment, so that patients can improve their lives and prolong their lives."