Sanofi announced that its targeted alpha nuclide therapy AlphaMedix achieved all primary efficacy endpoints in the Phase II clinical trial ALPHAMEDIX-02, demonstrating significant clinically meaningful efficacy in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

This achievement not only further confirms the potential of targeted α therapy to provide precise treatment for GEP-NETs, but also marks Sanofi's challenge to Novartis, the "No. 1 nuclear medicine company."

01 New Force Alpha Nuclide

AlphaMedix is a targeted alpha therapy based on lead-212. It consists of a peptide complex that binds to somatostatin receptors and is coupled to a radionuclide. It serves as an in vivo generator of alpha particles. Due to their high energy and short range, alpha particles can precisely kill cancer cells while minimizing damage to surrounding healthy tissue, presenting potential therapeutic advantages.

AlphaMedix wasn't developed independently by Sanofi, but rather a key move in rapidly expanding its nuclear medicine portfolio through imports. In September 2024, Sanofi reached a licensing agreement with radiopharmaceutical companies RadioMedix and Orano Med, securing global commercialization rights for the drug for an upfront payment of €100 million and potential milestone payments of up to €220 million.

It is worth noting that AlphaMedix is the first targeted alpha therapy to receive Breakthrough Therapy Designation from the U.S. FDA for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor (SSTR)-positive GEP-NET who have not received peptide receptor radionuclide therapy (PRRT).

ALPHAMEDIX-02 is a Phase II, open-label, multicenter study designed to evaluate the efficacy and safety of AlphaMedix in patients with GEP-NETs. The study included two cohorts: PRRT-naive patients (n=35) and PRRT-experienced patients (n=26). AlphaMedix was administered every eight weeks at a dose of 67.6 μCi/kg for up to four cycles. Primary endpoints included objective response rate (ORR) according to RECIST 1.1 and safety.

Results showed that the drug demonstrated clinically meaningful ORR and durable clinical benefit in patients with unresectable or metastatic SSTR-positive GEP-NETs, regardless of whether the patients had previously received PRRT. Benefits were also observed in key secondary endpoints, including progression-free survival (PFS) and overall survival (OS). AlphaMedix's safety profile was manageable and similar in both cohorts. Full data are expected to be presented at the 2025 ESMO Congress.

Novartis' Lutathera was once the only peptide receptor radionuclide therapy (PRRT) option for GEP-NETs. Lutathera, a lutetium-177-based beta particle radiotherapy, was acquired by Novartis through its 2017 acquisition of Advanced Accelerator Applications. Lutathera's sales were projected to reach $724 million in 2024.

Although Sanofi is a newcomer to the nuclear medicine field, the alpha therapy represented by AlphaMedix theoretically offers greater precision and efficacy. Once approved, AlphaMedix will directly compete with Novartis's already marketed Lutathera. However, AlphaMedix's success remains to be seen. The drug is currently in clinical development, and its future development will be determined by factors such as real-world clinical efficacy and patient accessibility.

02 Fierce battle between giants

In the past, the development of nuclear medicine was slow due to technical bottlenecks and insufficient commercial potential. However, with advances in targeted radioligand therapy (RLT) technology and the clinical and commercial breakthroughs of several therapeutic nuclear medicines, this field is entering a period of rapid development.

Bayer's radium chloride [223Ra] received US FDA approval in 2013 for the treatment of castration-resistant prostate cancer patients with symptomatic bone metastases and no known visceral metastases, marking the beginning of the development of therapeutic nuclear medicines. Novartis launched Lutathera in 2018 and Pluvicto in 2022. Their remarkable efficacy and rapid market growth have ignited global pharmaceutical companies' enthusiasm for the nuclear medicine market.

According to Precedence Research, the global nuclear medicine market reached US$10.7 billion in 2023 and is projected to reach US$22.8 billion by 2030, achieving a compound annual growth rate of 11.5%. In the Chinese market, Frost & Sullivan predicts that the nuclear medicine market is expected to grow from 5 billion yuan in 2023 to 26 billion yuan by 2030, a compound annual growth rate of 22.7%, demonstrating strong growth momentum.

Novartis is undoubtedly the current leader in nuclear medicine. Its product, Pluvicto, is the first "blockbuster nuclear medicine" to exceed $1 billion in annual sales, reaching $1.392 billion in revenue in 2024, a 42% year-on-year increase; continued high growth in the first half of 2025, reaching $825 million. Furthermore, Novartis is actively expanding Pluvicto's indications, having received approval in March 2025 for the treatment of earlier-stage prostate cancer. Novartis anticipates peak sales of Pluvicto to exceed $5 billion. Meanwhile, Lutathera also performed steadily, with sales reaching $724 million in 2024, a 20% year-on-year increase.

From a technical perspective, both Lutathera and Pluvicto are radioactive drug conjugates (RDCs). They precisely deliver radionuclides to tumors through targeted molecules, killing them through internal irradiation and the "bystander effect." These drugs offer advantages such as precision, efficacy, and a unique mechanism of action. Novartis leverages its comprehensive industry chain capabilities, from R&D to production and distribution, to establish significant competitive advantages.

As Novartis successfully commercialized Pluvicto, multinational pharmaceutical companies have accelerated their layout in nuclear medicines, with nuclear medicine transactions worth more than US$1 billion appearing frequently, and the nuclear medicine track is beginning to take shape.

It is worth noting that in the field of nuclear medicine, most current therapeutic nuclear medicines are still concentrated on "β-nuclides + PSMA/SSTR targets", and homogeneous competition is gradually emerging.

Compared to beta radiation, alpha particles have a larger mass, shorter range, and greater lethality. They can precisely kill cancer cells while minimizing radiation damage to surrounding normal tissues, making them particularly suitable for advanced or metastatic solid tumors. The therapeutic advantages of alpha radionuclides over beta radionuclides are becoming increasingly apparent, leading more MNCs to shift their nuclear medicine development towards alpha radionuclides.

In October 2023, Eli Lilly acquired Point Biopharma for $1.4 billion, acquiring its PSMA-targeted therapy PNT2002. Subsequently, in July 2024, Eli Lilly reached an acquisition option agreement with Radionetics Oncology, and in February 2025, it collaborated with AdvanCell to develop a targeted α therapy based on Pb-212.

Bristol-Myers Squibb acquired RayzeBio for $4.1 billion in December 2023, rapidly entering the field of radioligand drugs. RayzeBio, founded in 2020, has a core pipeline drug, RYZ101, which delivers the potent alpha-particle radioisotope actinium-225 to tumors with SSTRs.

AstraZeneca acquired Fusion for an upfront payment of US$2.4 billion in March 2024, acquiring the FOLH1-targeted α therapy FPI-2265 and establishing R&D, manufacturing and supply chain capabilities for actinium [AC-225]-based radioconjugates.

These multi-billion dollar deals reflect the recognition and strategic investment commitment of major pharmaceutical companies in the promising prospects of alpha-nuclides, and further demonstrate the changing competitive landscape in the nuclear medicine market. While Novartis remains the leading nuclear medicine company, is its first-mover advantage in beta-nuclides being gradually diluted by competitors transitioning to alpha-nuclides?

03 Domestic companies actively deploy

In China, the nuclear medicine market is also booming. Companies such as Dongcheng Pharmaceutical, Yuanda Pharmaceutical, and China Tongfang Pharmaceutical are steadily advancing product commercialization. Meanwhile, a number of emerging companies, such as Tongrui Biotechnology, Lannacheng, and Hexin Pharmaceutical, are also rapidly entering the market, jointly driving the maturity of the local nuclear medicine ecosystem.

Yuanda Pharmaceutical is one of the most systematic companies in China's nuclear medicine field. Its core product, yttrium [90Y] microsphere injection (Yigantai), was approved in China in 2022 for the treatment of colorectal cancer liver metastases and received further FDA approval in the US for hepatocellular carcinoma (HCC) in July 2025. This product saw rapid growth after its launch, with sales revenue reaching nearly HK$500 million in 2024, a growth rate exceeding 140%. The company is also actively developing multiple RDC drugs. For example, the prostate cancer diagnostic drug TLX591-CDx is currently in Phase III clinical trials in China, and the PSMA-targeting TLX591 has entered a multi-center international Phase III clinical trial.

Dongcheng Pharmaceutical's current marketed products are primarily diagnostic nuclear medicines. Its nuclear medicine business revenue reached 1.017 billion yuan in 2023, an 11.20% year-on-year increase. In the first half of 2025, its core product, 18F-FDG, generated 212 million yuan in revenue, maintaining steady growth.

China Nuclear Power Technology is simultaneously advancing the research and development and commercialization of both diagnostic and therapeutic nuclear medicines. According to its 2025 semi-annual report, its R&D pipeline includes several nuclear medicine products, primarily targeting areas of nuclear medicine expertise such as oncology and neurodegenerative diseases. For example, Fluoro[18F]betazine Injection (an Aβ-PET imaging agent) has entered Phase III clinical trials; 6-[18F]fluoro-L-dopa Injection is currently undergoing Phase III clinical trials. Upon its launch, this drug will fill the gap in domestic PET Parkinson's disease treatments.

In addition, traditional pharmaceutical companies such as Hengrui Medicine, Kelun Pharmaceutical, and Yunnan Baiyao have also made progress in the nuclear medicine field. Hengrui currently has five nuclear medicine products in clinical trials, including three therapeutic nuclear medicines: HRS-4357, Lutetium [177Lu] Oxyoctreotide Injection, and HRS-6768, and two diagnostic nuclear medicines: HRS-9815 and Gallium [68Ga] Ixotreotide Injection. Both HRS-9815 (diagnostic) and HRS-4357 (therapeutic) target the PSMA, demonstrating the company's commitment to integrated nuclear medicine diagnosis and treatment for prostate cancer. Kelun Biotech's RDC drug SKB107 has also received approval for clinical trials in the treatment of bone metastases from advanced solid tumors. Yunnan Baiyao's innovative nuclear medicine INR102 has also received approval for clinical trials in prostate cancer.

04 Conclusion

The initial success of Sanofi's AlphaMedix, along with significant investment in alpha nuclides by companies like Bristol-Myers Squibb and AstraZeneca, suggests that the next phase of nuclear medicine competition will revolve around the principles of greater precision, enhanced efficacy, and greater safety. It is foreseeable that with the accumulation of more clinical data and the expansion of indications, nuclear medicine will become an indispensable component of the oncology treatment system and play an increasingly important role in the era of precision medicine.

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