Novartis 

Executive Summary

Radioligand Therapy (RLT) has emerged as one of the most dynamic segments in China's booming biotech industry, evidenced by accelerated investment and a robust pipeline of drug candidates. At the same time, RLT involves distinctive safety and environmental considerations, requiring careful alignment between rapid innovation and robust safety governance as the sector develops. 

To achieve this balance, two foundational systems should be strengthened in parallel with industry growth:

● A clear and predictable regulatory framework that robustly safeguards safety and efficacy while providing reliable, innovation-friendly guidance to bring highquality RLT candidates to market.

● An optimized hospital access and clinical implementation pathway that enables innovative RLT therapies to be delivered safely, efficiently, and in a timely manner, translating scientific progress into real-world patient benefit.

Recommendations 

Recommendation 1: Further refine and align the regulatory governance framework for radiopharmaceuticals to reflect the full lifecycle of RLT products, supporting safe innovation, orderly competition, and localization.

Key actions include:

● Update Regulations: Revise the Administrative Regulation on Radioactive Pharmaceutical Products to clarify the definitions, regulatory attributes, registration pathways, and technical requirements for radiopharmaceuticals and their components.

● Standardize Management of Locally Manufactured Therapies: Establish nationally consistent, risk-based quality and safety control systems, approved by provincial or national medical products regulatory authorities, taking into account safety, regulatory complexity, and intellectual property considerations.

● Strengthen Technical Review Standards for Me-too and Generics: Establish reasonable technical review criteria for “me-too” radiopharmaceuticals and reinforce consistent application of Regulatory Data Protection (RDP) principles, ensuring that proprietary originator data are not relied upon in stand-alone regulatory assessments without authorization. Further clarify technical and bioequivalence requirements for generic radiopharmaceuticals to enhance product quality, safety assurance, and regulatory predictability.

● Optimize Localization Rights: Allow originator products to continue using their original brand names after localization, so as to protect originator rights and ensure policy continuity across the full product lifecycle.

Recommendation 2: Further optimize the hospital access and clinical implementation framework for radiopharmaceutical therapies, enabling safe, timely, and scalable clinical use of RLT while improving patient affordability.

Key actions include:

● Establish Green Channels for Qualified Institutions: Encourage priority clinical use of innovative therapeutic radiopharmaceuticals in medical institutions with appropriate qualifications and capabilities, and ensure that hospitals participating in clinical research are able to provide RLT therapies on an asneeded basis.

● Implement Differentiated Hospital Access Mechanisms: For short half-life, high-clinical-benefit radiopharmaceuticals, explore tailored evaluation approaches such as pre-assessment plus dynamic filing to streamline formulary entry and temporary procurement processes.

● Optimize Hospital Performance Assessment Policies: Exclude eligible highvalue radiopharmaceutical therapies from drug expenditure ratio evaluations and refine DRG management models to better reflect the clinical and operational characteristics of RLT.

● Strengthen Nuclear Medicine Capacity and MDT Integration: Support more hospitals in obtaining RLT treatment qualifications, expand multidisciplinary team participation, and enhance the training pipeline for specialized nuclear medicine professionals.

● Advance Coordinated Access and Payment Pathways: Incorporate eligible radiopharmaceuticals into standardized disease treatment pathways and explore alignment with city-level inclusive insurance and commercial insurance programs to form an integrated access, payment, and clinical management framework.

Conclusion

Experience across emerging technologies shows that only well-coordinated and orderly development delivers lasting impact. Continued policy refinement and system alignment will be key to translating RLT innovation into sustainable clinical and industrial value. Novartis stands ready to work with all stakeholders to support the safe and sustainable development of radioligand therapy in China

Download the full report：Steady Progress, Long-Term Success: Advancing the High-Quality and Sustainable Development of the Radioligand Therapy Industry