Paper presented by:

Dr. Vas Narasimhan, Chief Executive Officer of Novartis

Executive Summary

Radiopharmaceuticals are unique medicines that use particles or rays emitted by radioisotopes for both diagnosis and treatment. Radiopharmaceuticals are fundamental elements of nuclear medicine. They serve as the foundation of molecular imaging and precision medicine and contribute to novel approaches in the early diagnosis and precision treatment of diseases. Innovative radiopharmaceuticals are bio-targeted therapies that are composed of a targeting molecule (ligand) attached to a therapeutic radioisotope.  The ligand delivers radioisotopes that directly target lesions.  Then radioisotopes emit ionizing radiation to kill diseased cells, with minimal impact to healthy tissues. Innovative radiopharmaceuticals have shown the potential to change patients’ outlook on diagnosis and treatment of cancer, cardiovascular diseases, and neurodegenerative disorders.

Over the past several decades, China has made significant progress in the research, development, and clinical application of radiopharmaceuticals. This said, there remains significant growth potential for China’s radiopharmaceutical industry.

This report outlines some important benefits of radiopharmaceutical therapy and identifies opportunities to address the challenges to the development of the radiopharmaceuticals industry in China. With the implementation of the Healthy China 2030 Initiative, and the Chinese radiopharmaceutical industry under development, the coming years represent a critical period and opportunity for China to overcome these challenges. To help patients obtain and benefit from radiopharmaceutical treatment, it will be important for all stakeholders to partner in the development of a sustainable ecosystem to better support the radiopharmaceutical industry in China.

As a government-supported strategic emerging industry, nuclear medicine is becoming an important industry that will contribute to the high-quality development of medical and healthcare in China. Issued in 2021, The Medium and Long-Term Development Plan (2021-2035) for Medical Isotopes establishes an overall framework from within China may develop the radiopharmaceutical industry. To help ensure that this advanced treatment can better reach Chinese patients, Novartis encourages the Chinese government to consider the following key areas:

• Optimize regulatory frameworks and policies. Propose strengthening the cross-departmental regulatory coordination system for radiopharmaceuticals and to conduct scientific supervision while balancing its unique property of being both a medicine and having radioactivity. Establish a relevant technical evaluation system that meets the characteristics of radiopharmaceuticals and ensures practical and relevant radiation and environmental protection policies, thereby appropriately and scientifically relaxing restrictions on new therapeutic nuclides.

• Support the construction and development of nuclear medicine departments. Optimize the licensing application procedure for the clinical use of radiopharmaceuticals in hospitals and increase the quotas for medical isotopes in medical institutions; offer necessary assistance and guidance for hospitals and healthcare personnel (including hardware facilities and trainings, etc.); establish relevant standards for the clinical use of radiopharmaceuticals and enhance radiation safety management.

• Further improve patient access to medicines. Establish a national or regional comprehensive pricing model and charging basis that is more standardized and in line with the actual diagnosis, treatment technology and labor costs. Promote the increased inclusion of innovative radiopharmaceuticals for inclusion in the NRDL and explore the establishment of a classification system for therapeutic radiopharmaceuticals based upon the existing NRDL diagnostic radiopharmaceutical classification system.

Novartis is committed to supporting the Chinese government’s efforts to address current and new healthcare challenges and to meet the people’s health needs via continuous medical innovation.

Download the full report：Improving access to innovative radiopharmaceuticals in China