Expanding Radiopharmaceutical Market Sees Breakthroughs from AstraZeneca and Dongcheng Pharmaceutical

　　【Pharmaceutical Network Market Analysis】Radiopharmaceuticals, also known as "nuclear medicine," refer to a special type of drug containing radioactive isotopes used for medical diagnosis and treatment. Industry insiders point out that radiopharmaceuticals can be divided into diagnostic and therapeutic drugs, and are currently considered an effective clinical method for cancer treatment.
 

In recent years, with the continuous emergence of new directions and therapies, the market space for radiopharmaceuticals has also been expanding. Data shows that the global radiopharmaceuticals market size was $5.9 billion in 2020, and it is expected to reach $30 billion by 2030. Facing the vast market, pharmaceutical companies are also accelerating their layout and continuously achieving breakthroughs.
 

It was reported that on May 7, the Clinicaltrials website showed that FPI-2265 (225Ac-PSMA-I&T), a radiopharmaceutical developed by Fusion Pharmaceuticals, a subsidiary of AstraZeneca, had initiated Phase II/III clinical trials. This drug is the first radiopharmaceutical in AstraZeneca's pipeline to enter the later stages of development.
 

This study is a randomized, multi-center, open-label clinical trial designed to evaluate the safety, tolerability, and anti-tumor activity of FPI-2265 in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients who have previously received treatment with 177Lu-PSMA-617 or other 177Lu-PSMA radiopharmaceutical therapies.
 

Data show that FPI-2265 delivers the radioactive isotope actinium-225 (225Ac), an α-radiopharmaceutical that releases more energy compared to β-radiopharmaceuticals (such as Novartis' Pluvicto). This drug is expected to become the first 225Ac-PSMA targeted radiopharmaceutical therapy approved for mCRPC patients post-Pluvicto treatment.
 

It is reported that there are four radiopharmaceuticals in AstraZeneca's pipeline, including FPI-2265, FPI-1434, FPI-2068, and FPI-2059. Except for FPI-2265, the other three are still in the early stages. In fact, all four radiopharmaceuticals come from Fusion Pharmaceuticals.
 

According to reports, on March 19, 2024, AstraZeneca announced the acquisition of Fusion Pharmaceuticals for $2 billion, which will become a wholly-owned subsidiary of AstraZeneca. Industry insiders stated that this is another major acquisition case in the field of nuclear medicine following Novartis' $3.9 billion acquisition of Advanced Accelerator Applications, Eli Lilly's $1.4 billion acquisition of Point Biopharma Global, and Bristol-Myers Squibb's $4.1 billion acquisition of RayzeBio.
 

According to recent reports, in addition to AstraZeneca's new breakthrough in the field of nuclear medicine, DC PHARMA recently announced that on May 2nd, its subsidiary LNC PHARMAPTE.LTD. received the clinical trial approval notice for the 18F-LNC1007 injection from the U.S. Food and Drug Administration. The Phase I clinical trial will be conducted in Australia soon.
 

According to the announcement, the company's research product 18F-LNC1007 Injection is a novel dual-target radiopharmaceutical diagnostic agent that simultaneously targets fibroblast activation protein (FAP) and integrin αvβ3 (αvβ3), intended for diagnosing FAP and αvβ3 positive solid tumors in adults.
 

Dual-targeting FAP and αvβ3 can further enhance the efficiency of tumor diagnosis. In preclinical and translational clinical studies, 18F-LNC1007 injection significantly prolongs tumor uptake time, improves tumor targeting efficiency, and offers high-quality tumor imaging. It holds promise to become a non-invasive tracer for the clinical diagnosis of patients with positive expression of FAP and/or αvβ3 in the future.
 

Industry insiders say that in recent years, radioligand therapy has become a promising approach in cancer treatment. This type of drug conjugates radioactive isotopes with antibodies, peptides, or small-molecule drugs, enabling precise targeting and delivery of the radioactive isotope to cancer cells. Compared with traditional radiotherapy, this method offers many potential advantages, including minimizing damage to healthy cells and reaching deep-seated tumors that are inaccessible to external beam radiation.
 

In recent years, pharmaceutical companies in China have been increasingly focusing on the radiopharmaceuticals sector. Data shows that there are over 50 radiopharmaceutical research and development enterprises in China, such as China Isotope & Radiation Corporation, Grand Pharmaceutical, Jiangsu Institute of Nuclear Medicine, Guangdong Raydiant Technology, Suzhou Smart Nuclear Biotechnology, covering radioactive isotopes like 18F, 177Lu, 99mTc, 68Ga, 89Zr, and 131I. In addition, several traditional pharmaceutical companies, including Hengrui Medicine, Wuxi Borui, Yunnan Baiyao, and Xiantong Pharmaceutical, are also accelerating their presence in this field.
 

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