On September 3, 2022, the Nuclear Medicine Sub-forum of the “SAPA-China 2022 International Summit on Frontier Technological Innovation and Cooperation in Medical Devices” was held in Suzhou, gathering a significant portion of China’s nuclear medicine community.

Previously, radiopharmaceutical conferences were mostly sidelines of nuclear medicine meetings and rarely held alongside mainstream pharmaceutical forums. At the event, a senior radiopharmaceutical industry expert remarked, “This is a beneficial attempt,”Nuclear Medicine Has Reached the Time to Break Out of Its Niche。”

As a pioneer in the field of innovative radiopharmaceuticals in China, Xiantong Medicine was invited to participate in this forum. Over the past eight years, Xiantong Medicine has been engaged in the research and development of innovative radiopharmaceuticals, giving it direct insight into the recent surge in the radiopharmaceutical industry. In late 2019, Xiantong Medicine completely divested its generic drug business segment, and 2020 marked the inaugural year of its focused commitment to innovative radiopharmaceuticals.

Over the past two years, Xiantong Medicine has raised a record-breaking nearly RMB 1 billion in financing; its team now numbers close to 300 employees and continues to expand rapidly.

It can be said that,Beijing Xiantong International Technology Co., Ltd. entered the market as an industry pioneer, directly participating in the development of China’s innovative radiopharmaceutical sector while also benefiting from its growth. Today, in addition to focusing on the R&D of innovative radiopharmaceuticals, the company has established a presence across the entire industry chain, becoming an enabler of China’s radiopharmaceutical industry development.

2015 marked Year One of reform in China’s pharmaceutical market. Since then, policies such as the “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices,” the generic drug consistency evaluation, the two-invoice system, and the “4+7” volume-based centralized procurement have been implemented successively. As a result, China’s generic drug market has gradually declined, compelling pharmaceutical companies to shift their focus toward innovative drug R&D.

Prior to this, Xiantong Pharma had already foreseen that China would usher in a new era of innovative drug development. As early as 2013, the company began actively exploring pathways to transition from generic drugs to the innovative drug sector, experimenting with various different directions.Finally, in the summer of 2014, it entered the innovation track best suited to its strengths—innovative radiopharmaceuticals.

In June 2014, Navidea, a U.S. nuclear medicine company, launched its novel receptor-targeted radiopharmaceutical, Lymphoseek^®(Technetium Tc 99m Tilmanocept) Injection Approved by the FDA, Lymphoseek^®It is the only new 99mTc-labeled drug approved by the FDA in the previous decade, used for sentinel lymph node localization during solid tumor surgery. Navidea hopes to tap into the Chinese market and is therefore actively seeking partners in China.

In China, although the national drug regulatory authorities had previously approved approximately 40 radiopharmaceuticals for marketing, these were all legacy products. Since 2008, only one new radiopharmaceutical has been approved for market entry. At that time, few domestic stakeholders paid attention to the innovative radiopharmaceutical sector, and companies engaged in the research and development of innovative radiopharmaceuticals were exceedingly rare. Consequently, Navidea had limited options.Xiantong Medicine seized this opportunity by acquiring the Chinese rights to Technetium (99mTc) Tilmanocept, officially entering the radiopharmaceutical sector and thereby securing a first-mover advantage in this field.

Tang Yanmin, CEO of Xiantong Medicine, visited the U.S. to survey the radiopharmaceutical market in 2015. She candidly stated that this trip had a “profound impact” on her, truly instilling in Xiantong Medicine the confidence and determination to establish a presence in the radiopharmaceutical sector. She led her team to visit more than a dozen radiopharmaceutical companies in the United States and found that while radiopharmaceuticals attracted little attention in China, they were highly sought-after in the U.S. market. “One company specializing in preclinical CRO services for radiopharmaceuticals alone had over 200 preclinical radiopharmaceutical projects under development.”

The fact that few players are vying for attention also indicates that this is a potential blue-ocean market. The radiopharmaceutical industry has high barriers to entry, and breaking into this field requires a considerable amount of time; therefore, Beijing Xiantong International Technology Co., Ltd. (Xiantong Medicine) has been able to solidify its foundation with relative ease. Meanwhile, with fewer competitors and less intense rivalry, it is relatively easier to reach cooperation agreements with foreign manufacturers possessing advanced technologies and mature products. Furthermore, due to the short half-life of radiopharmaceuticals, long-distance transportation poses significant challenges, making it difficult for foreign companies to enter the Chinese market. As a result, Xiantong Medicine holds inherent advantages in competing with foreign radiopharmaceutical enterprises for share in the Chinese market.

Now ViewingIndeed, the innovative radiopharmaceutical track is the optimal choice for Xiantong Pharma’s transition into the innovative drug sector.

Since its initial foray into radiopharmaceuticals in 2014, Beijing Xiantong International Technology Co., Ltd. has keenly sensed the impending boom in the sector as its understanding of the field has deepened.

At the end of 2019, Xiantong Pharma completely divested its other traditional pharmaceutical business segments and officially ushered in its inaugural year of focusing on innovative radiopharmaceuticals in 2020, accelerating the development of its radiopharmaceutical R&D. This progress has been further bolstered by factors such as the growing recognition of the radiopharmaceutical sector in the capital markets and the steady advancement of the company’s pipeline.Beijing Xiantong International Technology Co., Ltd. completed RMB 280 million in Series A financing in 2020 and RMB 640 million in Series B financing in 2021, setting a record for fundraising by domestic nuclear medicine companies.

To narrow the gap between China and developed countries in Europe and America in the development of nuclear medicine, Xiantong Pharma has adopted “Xiantong"technology introduction, followed by independent research and development" development strategy,Through its joint venture, Cerveau, the company has collaborated with leading international radiopharmaceutical enterprises and research institutions in the United States, Europe, and other regions, securing development and commercialization rights for multiple radiopharmaceutical products in China and globally.

Through continuous dedication to the field of radiopharmaceuticals, Xiantong Medicine has developed deeper industry insights, built a professional talent team, and accumulated a robust product pipeline. In recent years, the company has increasingly focused all its efforts on independent research and development.

“We still receive partnership invitations from overseas radiopharmaceutical companies every month. We are not opposed to collaboration, but our requirements have become more stringent and our criteria more selective,” said Tang Yanmin.

Meanwhile, Xiantong PharmaAdopted a “start with the easy, then tackle the difficult” development strategy, initially prioritizing diagnostic radiopharmaceuticals with more mature technological products, shorter R&D cycles, and lower R&D risks.Currently, its diagnostic products cover two major fields: cardiovascular diseases and neurodegenerative diseases. In the cardiovascular sector, Xiantong Medicine has two radiopharmaceutical products in Phase II clinical trials, which are expected to enter Phase III clinical trials next year. In the field of neurodegenerative diseases, Xiantong Medicine has developed two radiopharmaceutical products for the diagnosis of Alzheimer's disease: one targeting amyloid-beta (Aβ) plaques, for which a New Drug Application (NDA) has been submitted and approval is expected next year; and another targeting Tau protein, which has received clinical trial approval.

As diagnostic radiopharmaceuticals advance rapidly, Xiantong Pharma’s therapeutic radiopharmaceuticals are also gaining strong momentum.Its therapeutic radiopharmaceuticals primarily target the oncology field, with an innovative approach centered on “tumor marker antibodies + therapeutic radionuclides.” Currently, the first patient has been enrolled in the Phase III clinical trial of its lead therapeutic drug. “We have many other therapeutic radiopharmaceuticals under development, most of which are designed for integrated diagnosis and therapy (theranostics). Some of these candidates will gradually enter clinical studies next year,” added Tang Yanmin.

Currently, the primary global applications of radiopharmaceuticals are concentrated in the fields of neurology, cardiology, and oncology. Beijing Xiantong International Technology Co., Ltd. has completed comprehensive coverage across these three therapeutic areas and established a robust product pipeline comprising 12 key candidates, two of which have entered the New Drug Application (NDA) review stage.

"As one of the earliest enterprises to enter the field of innovative radiopharmaceuticals in China, Xiantong Medicine has been in the industry for eight years and has the most intuitive perception of the development of China's radiopharmaceutical industry."Although the domestic radiopharmaceutical sector has gradually heated up in recent years, the industry’s fundamentals have not seen significant improvement.。“Tang Yanmin stated that the domestic nuclear medicine industry in China remains significantly underdeveloped, with immature supporting infrastructure across all sectors. It faces challenges such as long-term reliance on imported medical isotopes, lagging regulatory policies, and a lack of CRO services.”

In its early years, Xiantong Medicine was “forced by circumstances” to extend its industrial chain, covering both upstream and downstream sectors. This posed challenges but also presented opportunities, upon which Xiantong Medicine based its strategyBuilt an integrated platform for research, production, education, and sales., which not only facilitates the in-house R&D of innovative radiopharmaceuticals but also drives industry development.

The production of radiopharmaceuticals relies on a stable supply of medical isotopes. In terms of upstream isotope production and supply, Xiantong Pharma has adopted a “collaboration + in-house production” strategy. By partnering with the China Academy of Engineering Physics (Mianyang Ninth Institute) and Atom High-Tech, and leveraging its two Class B-qualified production bases, the company has successfully achieved⁶⁸Ga、⁶⁴Cu、¹⁷⁷Lu、⁹⁰Sustained supply of medical isotopes such as Y for diagnostic or therapeutic purposes.

While addressing the challenge of ensuring a stable supply of upstream raw materials, Xiantong Medicine has successfully established a networked supply system for radiopharmaceuticals, covering key provinces and cities in the Yangtze River Delta, the Pearl River Delta, and Southwest China. Chinese regulations classify radiation workplaces into Class A, Class B, and Class C based on the maximum daily equivalent operational quantity of radionuclides. Xiantong Medicine has established two Class B-qualified production bases primarily focused on radiopharmaceutical diagnostics (in Guangdong and Jiangsu), with its Jiangsu base having formed a strategic partnership with Joinn Laboratories to jointly build a nuclear medicine CRO/CDMO platform; additionally, it operates one Class A-qualified production base primarily focused on radiopharmaceutical therapeutics (in Sichuan).

“As a pioneer in the field of innovative radiopharmaceuticals in China, having accumulated certain resources and experience, we aim to enhance domestic CRO services and promote the development of the radiopharmaceutical industry.“Tang Yanmin stated that, based on this, in September 2021, Xiantong Medicine and Joinn Laboratories entered into a deep collaboration to build a leading radiopharmaceutical R&D service platform in China.

According to Tang Yanmin, the collaboration between the two parties initially began as “just a business deal,” with Joinn Laboratories seeking a facility from Xiantong Pharma to conduct CRO services for the safety evaluation of radiopharmaceuticals. However, Tang Yanmin recognized that beyond merely “doing business,” this partnership could empower industry development, benefiting Xiantong Pharma as the sector advances.

Since venturing into the radiopharmaceutical sector, Xiantong Medicine has encountered numerous pitfalls. “Just as one issue was resolved, another immediately emerged, presenting a high degree of unpredictability,” remarked Tang Yanmin. She cautioned that if the fundamental weaknesses underpinning China’s radiopharmaceutical industry remain unaddressed, emerging radiopharmaceutical companies are likely to follow the same trajectory as Xiantong Medicine. “The challenges we have faced will inevitably confront them as well, and the difficulties that we have struggled to overcome—or found insurmountable—will likewise require them to invest considerable time and effort to resolve.”

Ultimately, Xiantong Medicine and Joinn Laboratories jointly increased their capital investment in Jiangsu Xiantong and co-established Wuxi Joinn. Leveraging its GLP-certified non-clinical safety assessment laboratory for radiopharmaceuticals, Wuxi Joinn collaborates with Jiangsu Xiantong to provide comprehensive professional technical services to domestic radiopharmaceutical R&D institutions and enterprises. These services span synthesis, process development, and quality research, as well as efficacy, pharmacokinetics, and safety evaluation, thereby further integrating and connecting upstream and downstream resources within China’s radiopharmaceutical industry chain.

Furthermore, Xiantong Pharma actively assists hospitals in addressing various challenges. Due to their radioactivity, radiopharmaceuticals must be administered in nuclear medicine departments equipped with radiation protection facilities; however, patients are typically referred from clinical departments. “Historically, there has been limited interaction between these two departments. Clinicians often lack sufficient knowledge of radiopharmaceuticals, while most nuclear medicine specialists have not undergone formal Good Clinical Practice (GCP) training,” explained Tang Yanmin. To address this, Xiantong Pharma has established its own clinical team to assist nuclear medicine departments with issues such as qualification approvals, standardization of administration procedures, development of imaging protocols and image interpretation guidelines, and supply of medical isotopes. Simultaneously, the company promotes nuclear medicine-related knowledge among clinical departments.Today, Xiantong Medicine has established cooperative relationships with more than 30 hospitals, and the content of cooperation is gradually deepening.

Behind Xiantong Pharma’s establishment of an “integrated industry-academia-research-and-sales full-chain platform” lies the support of its talent team. In contrast to most biotech companies that are primarily driven by R&D personnel, Xiantong Pharma has structured its workforceExpanded to cover the entire industry chain, including qualification acquisition, radionuclide production and procurement, nuclear security assurance, drug R&D, clinical trials, business development (BD), manufacturing, and sales.Assembled a professional team of nearly 300 members, with its size continuing to expand.

As a pioneer in the field of innovative radiopharmaceuticals in China, Xiantong Pharma has been participating in and promoting the development of China’s radiopharmaceutical industry over the past eight years, and will continue to focus on advancing the R&D of innovative radiopharmaceuticals and empowering the industrial ecosystem in the future.