On April 22, the 2024 Radiopharmaceutical Innovation and Development Conference hosted by the China Isotope and Radiation Industry Association was held in Beijing, where representatives from domestic research institutes, universities, medical institutions and enterprises in the field of radiopharmaceuticals exchanged and communicated on cutting-edge hot topics such as medical isotopes and radiopharmaceutical industrialization, in order to promote the improvement of radiopharmaceutical research and development, commercialization capabilities and innovation levels, and promote the high-quality development of the industry.
During the meeting, 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 drug companies, multinational pharmaceutical companies have appeared in the newly established branches and conferences. As the vice president of the Radiopharmaceuticals Branch and the co-chair of the conference, Ms. Luo Ya, Vice President and Head of Value Access Department of Novartis China, attended the meeting. In addition, Ms. Wang Ziwen, Head of New Product Planning of Novartis China, gave a special report entitled "Hard-core Innovation, Commitment to China" at the conference. Novartis said that it will make full use of its industry advantages, innovative R&D layout and leading production and supply capabilities in the field of radioligand therapy to 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 chairman and secretary-general of the first council of the Radiopharmaceutical Branch of the China Isotope and Radiation Industry Association
Radioligand therapy:
It is expected to become a new pillar of cancer treatment
Since Becquerel's first discovery of radioactive substances in 1896, the application of radionuclides in the medical field has gone through more than a century: in 1931, the world's first cyclotron was introduced, which promoted the clinical research and application of radionuclides. In 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 a new dawn to cancer patients, and its efficacy and safety have been confirmed in the treatment of gastroenteropancreatic neuroendocrine tumors and prostate cancer.
Radioligand therapy, which is actually a drug conjugate, is a type of radionuclide chelation conjugated to a molecule that binds specifically to tumors, thereby precisely identifying and killing cancer cells. It is like a "tumor positioning missile" with the ability to accurately hit tumor cells, realizing precise attack and efficient removal of cancer cells. At present, radioligand therapy has shown significant clinical benefits worldwide, especially in the treatment of advanced metastatic prostate cancer, which has significantly improved the survival rate of patients.
Different from traditional radiopharmaceuticals such as iodine-131 (sodium iodide) and radium-223 (radium chloride), the high targeting of radioligand therapy allows it to safely, accurately and efficiently attack tumor cells throughout the body without harming normal cells, which is known as the "black technology" of tumor treatment. In addition, radioligand therapy and antibody drug conjugate (ADC) are both drug conjugates, but due to their use of radionuclides as the payload, peptides as the carrier, and no hydrolysis of the linkage, it has shown lower immunogenicity, better penetration, and optimized in vivo metabolism in clinical applications, with stronger efficacy and higher safety.
Experts and industry insiders at this year's Conference on Radiomedicine Innovation and Development believe that radiopharmaceuticals represented by radioligand therapy are very promising to become a new pillar of cancer treatment and change the future of cancer treatment.
Group photo of representatives of the Radiopharmaceutical Branch of the China Isotope and Radiation Industry Association
Novartis is firmly optimistic and continues to expand
Radioligand therapy
As early as 2017, when global pharmaceutical companies were competing for PD-1, PD-L1 and ADC, Novartis seized the strategic opportunity to explore radioligand therapies in a unique way, starting with the $3.7 billion acquisition of Advanced Accelerator Applications and its RLT and related technology platforms, in 2018 it acquired Endocyte for $2.1 billion to further enrich its RLT pipeline, in March 2023, it entered into a more than $1.7 billion collaboration with Bicycle Therapeut to develop bicycline-based radioconjugates, and in April 2023, Novartis entered into a partnership with 3B Pharmaceuticals GmbH enters into a partnership of over US$400 million to obtain global development and commercialization privileges for peptide-targeted radiopharmaceuticals.
Novartis CEO Joseph Van M.D. made clear at this year's J.P. Morgan Healthcare Conference (JPM 2024) that he recognized the value of radioligand therapies and made his long-term commitment to it, "Part of Novartis' focused strategy is to look for 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 gastrointestinal pancreatic neuroendocrine tumors who are positive for somatostatin receptors and castration-resistant prostate cancer patients who are still PSMA-positive after specific treatments, showing the market potential of "blockbusters". The excellent performance of these two products not only led the prosperity of the RLT track, but also aroused the enthusiastic attention and competition of major pharmaceutical companies around the world for the RLT field.
In the face of the rapid advancement of RLT R&D and industrialization, Novartis not only continues to strengthen its existing "leader" advantages, but is also committed to continuously improving its R&D layout and production capacity, and building efficient transportation operation capabilities and all-round doctor-patient service capabilities.
In terms of R&D, in addition to the two drugs that have been marketed, Novartis is also developing more than 10 RLT drugs, covering breast cancer, glioma, colon cancer, lung cancer, Pancreatic cancer and a series of oncological diseases; 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 factories in China and Japan to enhance the global production system; in terms of supply system, due to the decay characteristics of radionuclides, radiopharmaceuticals often only have a very limited expiration date, and need to reach patients within a few days after the drug is produced, so Novartis has set up a team in charge of logistics, and is focusing on improving and improving 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 all-round customer service systems and products around the world, including helping with medical and health system construction, drug ordering, logistics tracking, RLT technical support, medical education and training, and is committed to providing a full range of services for doctors and patients.
While Novartis is deploying RLT globally, it is also carrying out continuous and extensive development and exploration in China, the most strategic market.
The Novartis RLT has been turned on
Commitment to the Chinese road
Novartis means "Commitment to China". From the perspective of the promotion of Novartis' radioligand therapy project in China, Novartis RLT has started the promised road of commitment to China.
According to the information on the official website of CDE, Novartis has initiated a number of registrational clinical studies involving RLT therapies 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 a number of other RLT pipeline products in the early stage of research and development.
In addition to the introduction of innovative drugs, Novartis is also actively deploying the production base of radioligand therapy in China. On December 1, 2023, Novartis and the Zhejiang Haiyan government announced the establishment of a new production base in Zhejiang Province, which is expected to be put into operation 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 Forum, Dr. Wan Sihan shared Novartis' insights and practices, submitted policy recommendations on "Building a Competitive Innovation Ecosystem for the Benefit of Chinese Patients", and actively advocated for accelerating the development and application of radioligand therapy as an advanced therapy in China. During the 6th China International Import Expo in 2023, Novartis, together with experts and scholars in the field of urology and nuclear medicine in China, and partners in the nuclear medical and health industry in the Yangtze River Delta, jointly held the "Integrated Development Forum on Targeted PSMA Diagnosis and Treatment of Prostate Cancer" 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 tenet of 'Commitment to China', and is committed to introducing innovative drugs with high clinical value to Chinese patients, and has a comprehensive layout in the Chinese market in terms of R&D, production and market expansion. Radioligand therapy is one of the five key technology platforms invested by Novartis in the world, and we have accumulated highly specialized R&D, manufacturing and clinical applications, as well as interdisciplinary and cross-industry collaboration in the development of precision targeted drugs and therapeutics containing radioactive components. We look forward to working with industry associations, medical institutions and industry partners to bring Novartis' experience in promoting the standardization of the nuclear medicine industry to China, contribute to the high-quality development of China's nuclear medicine and nuclear medicine industry, and improve the accessibility of advanced therapies for the integration of cancer diagnosis and treatment, so that patients can improve their lives and prolong their lives. ”
Text: Wang Zhen
Photo: Courtesy of China Isotope and Radiation Industry Association
Editor: Jiang Tianyi
Review: Sun Meng