Part 1: Providers and Regulators

Getting information on the nuclear medicine market landscape, regulations, and market access environment in China can be challenging — especially due to its specialized nature within clinical practice. In this article, Betty Su, our go-to expert leading Veranex’s consulting services in China shares her insights on this topic.

The United States Nuclear Regulatory Commission (NRC) provides background information distinguishing and correlating nuclear medicine as a discipline with the materials used in its procedures, known as radiopharmaceuticals¹. According to the NRC, “About one-third of all patients admitted to hospitals are diagnosed or treated using radiation or radioactive materials. This branch of medicine is called nuclear medicine. The radioactive materials used are called radiopharmaceuticals.”

Now that we’ve clarified the terminology around nuclear medicine and radiopharmaceuticals, let’s dive into an exploration of the providers of nuclear medicine in China — hospitals.

Topic 1: Nuclear Medicine Providers in China

In April 2020, the Chinese Society of Nuclear Medicine conducted a biennial national survey on the status of nuclear medicine in China, reflecting the situation up until the end of 2019. The survey results, published in the ‘Chinese Journal of Nuclear Medicine and Molecular Imaging,’ offer a useful overview of the provider landscape. The highlights include^2,3:

• In China, there are 1,148 institutions, primarily large hospitals, that offer nuclear medicine services of some kind. For context, as of December 2019, China had 34,354 hospitals. Out of the 1,148 nuclear medicine providers, 968 are Class 3 hospitals. In China, there are a total of 2,749 Class 3 hospitals.
• The majority of the hospitals have dedicated nuclear medicine departments (822) or PET/CT centers (53), while the rest operate as a subspecialty within the Medical Imaging or Radiology departments of the hospital.
• Cancer diagnosis and screening are the primary applications of nuclear medicine imaging.

Table 1: A Comparative Overview of Installation and Procedure Numbers Across Different Types of Nuclear Imaging Modalities

Nuclear medicine imaging is primarily used for diagnosing cancer, which accounts for 94.5% (803,502 procedures) of all PET/CT procedures. An additional 1.7% (14,865) of procedures are for cancer screening, 1.7% (14,753) are for neurology, and 0.6% (4,846) are for cardiology.

• China lags behind in the field of advanced radionuclide therapy.

Out of the 1,148 nuclear medicine service providers, only 770 (67.1%) have radionuclide therapy capabilities. In 2019, these providers conducted a total of 528,480 cases.

China not only significantly lags behind more developed markets like the U.S., but it also trails in the field of advanced oncology radiology. Compared to the nuclear medicine imaging landscape in China and the global scenario, where the majority of applications are focused on cancer treatment, the survey results on radionuclide therapy applications in China suggest a distinctly different pattern. For instance, in 2019, the three most frequently used radionuclide therapies in China were:

• 131^I radiotherapy treatment for hyperthyroidism, which accounted for 145,660 procedures (27.6%).
• 90^Sr-90^Y applicator therapy for skin and eye diseases which accounted for 124,554 procedures (25.5%).
• 99 Tc-MDP treatment for rheumatoid arthritis therapy which accounted for 98,355 procedures (18.6%).

Hospitals that provide nuclear medicine services must obtain user licenses. According to the Regulations on the Administration of the Preparation of Positron Radiopharmaceuticals by Medical Institutions, hospitals are classified into four levels based on licensing conditions for the use and preparation of radiopharmaceuticals. The Class IV license is the highest level, granting hospitals the autonomy to dispense radioactive materials directly from their on-site facilities without the need to obtain product approval from the National Medical Products Administration (NMPA) in China. According to the survey, 65 hospitals held a Class IV license in 2019.

Topic 2: The Regulation and Approval of Radiopharmaceuticals in China

• The NMPA is responsible not only for approving individual radiopharmaceuticals but also for approving three key licenses crucial to nuclear medicine practices: manufacturing, distribution, and user licenses.

Whether utilized for diagnostic or therapeutic medical procedures, radioactive materials are designated as radiopharmaceuticals, falling within the regulatory framework of China’s pharmaceutical landscape. As is the case globally, the regulations governing medical isotopes are intricate, involving multiple regulatory bodies in China.

While the NMPA serves as the central authority for regulating radiopharmaceuticals and holds responsibility for approving three key licenses crucial to nuclear medicine practices — manufacturing, distribution, and user licenses — peers from the National Defense and National Environment agencies play substantial roles. Their involvement extends beyond overarching policymaking to implementation, enforcement, and day-to-day operations.

• The NMPA has approved fewer radiopharmaceuticals compared to the U.S. Food and Drug Administration (FDA).

Obtaining regulatory approval in China is notoriously difficult, resulting in a limited availability of nuclear medicine treatment options.

According to a conference paper presented by Dr. Vas Narasimhan, Chief Executive Officer of Novartis, as of March 2022, China’s NMPA had only approved 30 radiopharmaceuticals⁴. These approvals involved 11 types of radionuclides, including 99mTc, 18F, 131I, 125I, 153Sm, and 32P. No innovative radiopharmaceutical drugs have been approved in the past 10 years. Most radiopharmaceuticals used in clinical practice in China are generic drugs. Drugs undergoing clinical research are mainly for diagnostic purposes. In comparison, as of the same timeframe, the FDA had approved 60 radiopharmaceuticals, including 18 radioisotopes. These include Lutetium-177-DOTATATE and Lutetium-177-PSMA-617, which have breakthrough therapeutic effects on malignancies that pose a serious threat to human health.

Topic 3: A Market Segment That Is Set to Become More Competitive 

Radiopharmaceuticals are a niche subset within the pharmaceutical regulatory arena. Due to their unique nature, they have earned a reputation as one of the most guarded and mysterious areas to outsiders. The logistics challenge in delivering radiopharmaceuticals exemplifies how the lack of competent service providers and industry competition has affected and shaped the industry. Manufacturers frequently need to collaborate with local logistics providers, but options are often limited, and services may not meet expectations. This challenge is especially pronounced when dealing with short half-life radiopharmaceuticals. To address this issue, some manufacturers are taking proactive steps, such as establishing their own regional nuclear pharmacies, to improve their services for hospital customers with direct access. To do this, manufacturers would need to have deep pockets, which may not make economic sense for those with only one product. As a result, foreign manufacturers often partner with local companies.

The key players in nuclide medicine in China that have production and distribution capabilities are:

• China Isotope & Radiation Corporation, a stated-owned company
• Dongcheng Pharmaceutical Group Co., Ltd, a public listed company
• Sinotau Pharmaceutical Group, a private company, an emerging player in the market

Novartis has made a bold move with its recent announcement of constructing a new radiotherapy production facility in China^5,6. Anticipated to commence local production in 2026, this initiative positions Novartis as the first international player to embark on such a venture. Veranex is eager to closely monitor the project and stay abreast of its developments.

In our next article on this topic, we will discuss market access components, such as pricing and reimbursement, for radiopharmaceuticals.

At Veranex, precision medicine stands as a cornerstone of our offerings. As nuclear medicine and radiopharmaceuticals take on an increasingly pivotal role in personalized medicine and multidisciplinary approaches, our China team brings a wealth of experience drawn expertise to the forefront of this dynamic field. Seamlessly integrating our cross-disciplinary proficiency across pharmaceuticals and medical devices, we are uniquely positioned to navigate the nuanced landscape of nuclear medicine and radiopharmaceuticals in China. Through collaborative partnerships with investors and industry players in nuclear medicine, radiopharmaceuticals, and radiology, we empower our clients to navigate the evolving realm of this distinctive market segment with confidence.

Please contact us to see how we can help.

Betty Su, Vice President, Commercial Strategy and Market Access, Asia-Pacific

Betty Su specializes in market access and regulatory strategy in China, advising drug, device, and diagnostics companies on commercialization and business development opportunities.

Sources:

1. https://www.nrc.gov/reading-rm/doc-collections/fact-sheets/med-use-radioactive-materials.html
2. Chinese Society of Nuclear Medicine. A brief report on the results of the national survey of nuclear medicine in 2020. Chin J Nucl Med Mol Imaging. 2020;40(12):747–9 (in Chinese). http:// doi. org/ 10. 3760/ cma.j. cn321 828- 20201 109- 00403.
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8586637/
4. https://en.cdf.org.cn/cdf2023en/xzbg/11046.htm#content
5. https://www.fiercepharma.com/manufacturing/novartis-expands-radiotherapy-manufacturing-network-85m-plant-china
6. https://www.novartis.com.cn/news/nuohuaxuanbuzaizhongguotouzisheliquanxinshengchanjidejiakuaichuangxinxingfangshepeitiliaofayinru