Top 10 Radiopharmaceutical Events of 2024: Breakthroughs, Partnerships, and Commercial Milestones

Mar 16, 2025 20:35 CST Updated 20:35

Novartis China

Innovative Drug Developer

Source: Liu Xiaoyu, Ding Tingting, et al. HJHK

Text / Hejun Consulting Pharmaceutical and Healthcare DivisionLiu Xiaoyu、Ding Tingting、Confidence、Chen Jianguo

1. Fulllink Technology Secures First Overseas Authorization for Radiopharmaceuticals

On July 17, 2024, Fluorine Link Technology Co., Ltd. announced that it had signed an out-licensing agreement with South Korea's global biotech company SK Biopharmaceuticals. The agreement grants SK Biopharmaceuticals exclusive global rights to clinically research, develop, manufacture, and commercialize the radiopharmaceutical FL-091 for cancers positive for neurotensin receptor 1 (NTSR1), with a total transaction value of $571.5 million.

2、China National Nuclear CorporationLayout of Two Major Medical Isotope Production Bases

On December 26, 2024, China's first commercial reactor-based online irradiation facility for isotope production was officially commissioned at the Qinshan Nuclear Power Base of the China National Nuclear Corporation (CNNC). The first batch of medical isotopes, Lutetium-177, produced at this facility also came out of the reactor simultaneously. This marks that China has successfully mastered the key technology for large-scale online irradiation production of short half-life isotopes, breaking the long-term reliance on imports for critical medical isotopes. On December 30, 2024, China's largest medical isotope production base was officially launched. Eight production lines for medical isotopes, including Lutetium-177, Yttrium-90, Radium-223, Iodine-125, Phosphorus-32, Rhenium-188, Holmium-166, and Carbon-14, completed all construction work. After production begins, the Nuclear Power Institute of CNNC will have the capacity for large-scale production of medical isotope products, with output that can basically meet domestic demand for related medical isotopes in China, playing a significant role in establishing an independent medical isotope security system in China. On the same day, the world’s most powerful solution-type medical isotope test reactor, designed and built by the Nuclear Power Institute, successfully topped off. In its initial phase after completion, the reactor will address part of the urgent domestic demand for certain isotopes and drugs; in the medium term, it will largely satisfy domestic needs and achieve localization of several new types of medical isotopes; in the long term, it will reach international leadership, completely solving the problems of shortages of medical isotopes and the development of nuclear medicine in China.

3. The First Major Foreign Investment Project in China's Nuclear Medicine Field Breaks Ground in Haiyan

On July 2, 2024, Novartis China's radiopharmaceutical production project was inaugurated in Haiyan, marking the construction of China's first production base for radioligand therapy. This follows the global pharmaceutical giant's announcement on December 1 of last year.Novartis GroupAnother important milestone and progress after signing with the Haiyan County Government. The project is expected to be completed and put into operation by the end of 2026. The Novartis China radiopharmaceutical production project covers an area of 18.86 mu, with a total investment of 600 million yuan. It will utilize the isotope Lutetium-177 of the element Lutetium and plans to produce the world's first innovative drug for treating prostate cancer using radioligand therapy.

4. Pluvicto Becomes the World's First Nuclear Medicine to Break $1 Billion in Sales

Novartis, the multinational pharmaceutical leader, saw two of its RDC radiopharmaceutical products far exceed sales expectations: Lutathera for neuroendocrine tumors and Pluvicto for prostate cancer. Pluvicto, primarily used to treat prostate cancer, was launched in 2022 and generated $270 million in sales that year. In 2023, its full-year sales reached $980 million, just shy of the "billion-dollar molecule" milestone. In 2024, Pluvicto's sales surged to $1.392 billion, a 42% year-over-year increase, making it the world’s first radiopharmaceutical product to surpass $1 billion in sales. Another radiopharmaceutical, Lutathera, achieved sales of $724 million, a 20% year-over-year increase. The total revenue from the two radiopharmaceuticals amounted to $2.116 billion. Wall Street predicts that Pluvicto's peak sales will reach $6 billion.

5. Another Major Acquisition – AstraZeneca Acquires Fusion Pharmaceuticals for $2 Billion

On March 19, 2024, AstraZeneca announced the acquisition of Fusion Pharmaceuticals for $2 billion, making it a wholly-owned subsidiary of AstraZeneca. If Fusion achieves specific regulatory milestones in the future, AstraZeneca may pay an additional $400 million to Fusion’s shareholders. Fusion's most advanced R&D program currently is FPI-2265, a prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical therapy being developed as a treatment for metastatic castration-resistant prostate cancer (mCRPC). It is currently undergoing Phase 2 clinical trials and is expected to enter Phase 3 registration trials by 2025. On February 16, 2024, Fusion Pharmaceuticals, in collaboration with Heidelberg University andEuratomA Global Exclusive License Agreement for Actinium-based PSMA-Targeted Radiotherapy Has Been Reached, Granting Fusion the Exclusive Right to Use, Develop, Manufacture, and Commercialize the Compounds Covered by the Patent on a Global Scale, Including 225AC-PSMA (FPI-2265) for the Treatment of Prostate-Specific Membrane Antigen (PSMA)-Expressing Cancers.

6, $1.75 Billion! Novartis Strikes Again, Acquires Radiopharmaceuticals

On May 2, 2024, Novartis acquired Mariana Oncology for an upfront payment of $1 billion and potential milestone payments of up to $750 million. This acquisition combines Mariana Oncology's innovative radiopharmaceutical pipeline and platform with Novartis' established clinical development and commercialization expertise. Mariana Oncology is a fully integrated radiopharmaceutical company pioneering new approaches in cancer treatment—targeted peptide-based Radioligand Therapy (RLT), designed to maximize tumor penetration while minimizing toxicity. Mariana’s lead program, MC-339, is an actinium-based radioligand therapy under investigation for the treatment of small cell lung cancer.

7. BPA becomes the first (second globally) BNCT boron drug in China to enter registered clinical trials

On January 4, 2024, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its official website that the clinical trial application for "Boron [10B] Phenylalanine Injection" (referred to as "BPA"), a Category 2 new drug independently developed by Zhongpeng (Xiamen) Biomedical Co., Ltd., had been approved (acceptance number: CXHL2301125). This makes it the first BNCT boron drug in China (and the second globally) to enter registered clinical trials.

8. The First Introduction and Implementation of Radionuclide Terbium-161 in China

On August 27, 2024, byChina IsotopesThe newly introduced therapeutic radionuclide terbium-161 (Tb-161) has successfully landed at the China Institute for Radiation Protection and experimental work has commenced. This marks the first time that Tb-161, a medical therapeutic radionuclide with broad application prospects, has been imported from overseas into China. As the supplier, China Isotopes & Radiation Corporation was fully involved in the labeling synthesis and quality control process of this Tb-161 drug, contributing to the successful completion of the first-ever Tb-161 drug labeling in China.

9. The First Bone Metastasis Detection Product for Cancer in China Officially Approved

In September 2024, Fluorine [18F] Sodium Injection, a new product for detecting bone metastases in cancer patients developed by Atom High-Tech Co., Ltd., a subsidiary of China Isotope & Radiation Corporation under the China National Nuclear Corporation (CNNC), received official approval from the National Medical Products Administration (NMPA). Independently developed by Atom High-Tech, Fluorine [18F] Sodium Injection is the first PET imaging agent approved in China for this field. It fills the market gap for PET diagnostic imaging agents in bone scanning in China, greatly promoting early, precise, and non-invasive diagnosis of bone metastases. With its convenient, sensitive, safe, and efficient features, it will benefit a wide range of patients. This not only demonstrates CNNC's innovative strength in radiopharmaceutical research and development but also signifies that China has reached a new level in the independent research, development, and production capabilities of such high-end diagnostic reagents.

10. China Successfully Develops "Human Hubble Telescope"

At the China International Medical Device Expo held from May 15 to 18, 2024, the "strongest ever" product was jointly created by Shanghai United Imaging Healthcare and the U.S.-based top molecular imaging research team, the "Explorer" consortium.PET-CT"——The world's first total-body PET-CT scanner, uExplorer, makes its global debut. This medical device is internationally leading in terms of whole-body scan imaging time and sensitivity. It also achieves high-definition dynamic imaging of multiple organs and tissues for the first time, enabling 4D panoramic imaging, providing vast potential for research in personalized precision diagnosis and treatment, new drug development, and other fields. These technological breakthroughs position the uExplorer as the 'Hubble Telescope' for exploring the mysteries of the human body, with broad and forward-looking application prospects.

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