Novartis Announces New Radiopharmaceutical Manufacturing Facility in China to Accelerate Access to Innovative Radioligand Therapies

Promote Local Collaboration, Accelerate the Introduction of Innovative Therapies, and Deepen Trust Continuously

ShanghaiDecember 1, 2023PR Newswire -- Novartis announced today that it will invest in the establishment of a new radiopharmaceutical production base in China to accelerate the introduction of innovative radioligand therapies into China, benefiting domestic cancer patients with clinical needs.

This production base will be located in the Nuclear Technology Application (Isotopes) Industrial Park in Haiyan County, Zhejiang Province, with a total investment expected to exceed 600 million RMB. The construction of the base will adhere to the highest quality standards for safe and efficient operations. Provided that the relevant drugs receive regulatory approval, production is expected to commence by the end of 2026.

Novartis China and Haiyan County, Zhejiang Province Signing Ceremony

"China is one of the most strategically important markets for Novartis," said Tiffany Zhang, President and Managing Director of Novartis China. "Guided by our commitment to China, Novartis has established deep roots in the country, continuously investing, promoting local collaborations, and comprehensively expanding its presence in the Chinese market while strengthening trust with Chinese society. Novartis is steadfast in its dedication to constantly developing and introducing innovative drugs with high clinical value for Chinese patients. We look forward to accelerating the introduction of radioligand therapy into China through the establishment of a new production base, meeting clinical needs while supporting the development of China's nuclear medicine industry and the clinical application of related therapies, contributing to the long-term growth of the healthcare industry and the well-being of the people."

The new radiopharmaceutical production base in Haiyan, Zhejiang, once completed, will become Novartis' second innovative drug production base in China. Currently, Novartis operates a plant in Changping, Beijing, which was established in 1987 with a total investment of over 700 million RMB. It has a maximum annual production capacity of 3 billion tablets and packaging capacity of 400 million boxes.

Radioligand therapy is a new generation of innovative targeted therapeutic radiopharmaceuticals. This therapy can selectively bind to the corresponding diseased tissues, utilizing radiation energy to kill the target lesions. Due to the appropriate radiation range, it minimizes damage to healthy cells, thereby achieving precise treatment.

As a company dedicated to innovative medicines, Novartis focuses on four core therapeutic areas: cardiovascular, renal and metabolic, immunology, neuroscience, and oncology, as well as five technology platforms: chemotherapy, biologics, gene and cell therapy, radioligand therapy, and xRNA therapy, continuously expanding its R&D capabilities and production scale.

Novartis is a pioneer and leader in the development of radioligand precision-targeted therapies. In March 2022, an innovative drug from Novartis' targeted radioligand therapy received approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are positive for prostate-specific membrane antigen (PSMA) and have progressed after prior treatment with androgen receptor pathway inhibitors and taxane chemotherapy. In December 2022, this innovative drug was approved in the European Union, but it has not yet been approved in China. Novartis has already initiated international multicenter clinical research on this therapy in China. As of 2023, Novartis has approximately 10 radioligand therapy-related products under development globally, covering a range of oncological diseases.

Novartis has established radiopharmaceutical production bases in Italy, Spain, and the United States respectively. Novartis is also evaluating the necessity of setting up radiopharmaceutical production bases in other key markets to meet global patient needs.

Steffen Lang, Novartis Operations President, stated: "Radioligand therapy requires sophisticated manufacturing technology to ensure that the drug reaches patients just hours after production. Establishing a new production base in Haiyan, Zhejiang will ensure that patients in need of these therapies, along with their medical teams, receive consistent and reliable treatment experiences. China is an important market for Novartis, and this new facility will enable us to further expand the reach of Novartis' innovative medicines."

The radiopharmaceuticals industry in China has become one of the key strategic emerging industries supported by the state, and is one of the foundational industries promoting the high-quality development of healthcare. In June 2021, eight government departments — the National Defense Science and Technology Industry Bureau, the Ministry of Science and Technology, the Ministry of Public Security, the Ministry of Ecology and Environment, the Ministry of Transport, the National Health Commission, the National Healthcare Security Administration, and the National Medical Products Administration — officially released the "Medium- and Long-Term Development Plan for Medical Isotopes (2021-2035)," establishing an overall framework to further advance the radiopharmaceuticals industry.

In April 2023, the National Medical Products Administration (NMPA) issued the "Opinions on Reforming and Improving the Review and Approval Management System for Radiopharmaceuticals," encouraging innovation in radiopharmaceuticals guided by clinical value, promoting the import registration in China of original research radiopharmaceuticals already marketed overseas, and proposing to grant priority review and approval to marketing authorization applications for radiopharmaceuticals that are urgently needed clinically.