Suzhou Siti Kangchen Pharma Advances in High-Barrier Radiopharmaceutical Market with Integrated Theranostic Pipeline

As clinical demand for early diagnosis and precision treatment of cancer, cardiovascular diseases, and neurodegenerative disorders continues to grow, the radiopharmaceutical market is heating up. Amid a broader downturn in innovative drug development, the radiopharmaceutical sector has stood out as a notable exception. According to statistics from VCBeat, radiopharmaceuticals accounted for the highest proportion of financing rounds exceeding RMB 100 million within the innovative drug sector in 2022. Since 2023, enthusiasm for this sector has only intensified, with domestically produced radiopharmaceuticals progressively entering clinical trials and major funding announcements following one after another. In this high-barrier, high-growth market, Chinese innovative enterprises are beginning to exert their influence and make their mark on both domestic and international stages.

Recently, at the 36th Annual Congress of the European Association of Nuclear Medicine (EANM), Hong Hao, Chief Technology Officer of Suzhou SITI Kangchen Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “SITI Kangchen”), was invited to deliver a special report.Titled “Development of Computer-Aided Trop-2-Targeting Peptides and Their Application in Radionuclide Theranostics for Pancreatic Cancer,” it was selected as a highly rated presentation for the “Novel Imaging Targets in Oncology” breakout session.。

The EANM has highlighted the growing importance of three key areas—targeted radionuclide therapy, radionuclide imaging, and artificial intelligence (AI)—along with other innovative advancements. The Sitikangchen research team leveraged AI-assisted design to develop a series of peptides exhibiting sub-nanomolar targeting affinity for Trop-2, a protein highly expressed in various tumors. By conjugating these peptides with theranostic radionuclides, the team has successfully initiated the development of a novel radiolabeled compound for the targeted diagnosis and treatment of pancreatic tumors.

Also, not long ago, Sitikangchen signed an agreement with Nanjing Medical University to transfer the rights to a new drug achievement.Secured the global exclusive development rights to its Class I targeted alpha-particle radiopharmaceutical project for tens of millions of yuan, thereby accelerating the development and market launch of this innovative drug. Professor Zhang Tao’s team at Nanjing Medical University has designed and synthesized a series of novel compounds that can serve as tracers for the precise localization of PSMA-high-expressing tissues. These compounds are applicable to the precision diagnosis of prostate cancer and hold promise for the development of targeted therapeutic agents through labeling with alpha-emitting radionuclides. This collaboration will not only facilitate the translation and application of advanced academic research achievements, achieving breakthroughs in the diagnosis and treatment of clinically challenging diseases, but also further enrich Sitya Kangchen’s product pipeline.

Sitikangchen has built substantial strength through years of steady accumulation. As an enterprise that embraces innovation while maintaining a low-profile approach, its core team members have been deeply immersed in the field of nuclear medicine for many years. The company has established a presence in China, the United States, and Europe, driving its global development, andMultiple radiopharmaceutical theranostic pipelines are advancing rapidly, with a conservative estimate that IND applications for 1–2 radiopharmaceuticals will be submitted in 2024.。

The illness experience of a friend prompted Wang Guanli, founder of Sitikangchen, to resolutely enter the radiopharmaceutical market.

“In 2011, a close friend of mine was diagnosed with severe ‘Steve Jobs cancer’ (pancreatic neuroendocrine tumor). After receiving novel targeted radiopharmaceutical therapy in Germany, he has miraculously survived to this day. Subsequently, I conducted repeated assessments of German technologies and underwent multi-party verification; I believe that this novel diagnostic and therapeutic technology will significantly enhance the efficacy of cancer treatment, particularly for patients with mid-to-late stage cancer featuring systemic metastasis.”

This planted the seeds of entrepreneurship in his heart. Over the following eight years, Wang Guanli, acting as an investor, evaluated novel European precision-targeted radiopharmaceutical projects and facilitated their industrialization. He spearheaded China’s first investment in an overseas precision-targeted radiopharmaceutical project, achieving a successful exit, and simultaneously served as a senior advisor to several globally renowned medical radioisotope suppliers. His deep-rooted, hybrid background in healthcare and radiopharmaceutical investment has endowed him with both specialized expertise and acute industry insights, positioning him as a pioneer in promoting the integrated industrialization of radiopharmaceutical diagnostics and therapeutics in China. More importantly, during this period of intensive industry engagement, he encountered entrepreneurial partners who shared his ideals and vision.

Currently, Sitikangchen has established a professional and international team internally,It has assembled a team of experienced professionals from China, Europe, and the United States, covering the entire pharmaceutical development value chain—including management, technology, GMP manufacturing, clinical trials, IND submissions, and regulatory filings. Their expertise spans multiple disciplines such as nuclear medicine, molecular imaging, genetics, and clinical medicine, with more than half holding master’s or doctoral degrees.。

Hong Hao, Chief Technology Officer of Sitikangchen, served as a professor at Nanjing University Medical School. He has accumulated extensive expertise in frontier fields such as molecular imaging and functional nanomaterials, published more than 120 articles in internationally renowned journals including JACS and ACS Nano, and contributed to multiple book chapters. Professor Cai Weibo, Chief Scientific Officer of the company’s North America Division, is a Distinguished Tenured Professor at the University of Wisconsin–Madison. His research focuses on molecular imaging and nanobiotechnology, with profound expertise spanning radiology, medical physics, materials science, and engineering. He has published over 390 high-quality SCI-indexed academic papers (H-index > 101) and holds fellowships from the American Institute for Medical and Biological Engineering (AIMBE), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), and the Royal Society of Chemistry (RSC). According to the global ranking of scientists in molecular imaging updated by Expertscape, a prominent European institution, Professor Cai Weibo ranks first worldwide.

Meanwhile,Siti Kangchen has established collaborations with numerous renowned universities, medical institutions, research organizations, and multinational corporations both domestically and internationally, including Stanford University, the University of Wisconsin, MTR Germany, Memorial Sloan Kettering Cancer Center (MSKCC) in the United States, Shanghai Jiao Tong University and its affiliated hospitals.。

According to reports, as early as ten years ago, team members began collaborating with top-tier tertiary hospitals in China, organizing academic exchanges in nuclear medicine and sending several outstanding nuclear medicine physicians abroad to study advanced precision targeted radionuclide diagnosis and therapy techniques. It can be said that Sitikangchen has played a significant role in the cultivation of nuclear medicine talent, academic research, and clinical education in China, laying a solid foundation for the company’s subsequent industrial collaborations.

In the “hundred flowers blooming” radiopharmaceutical market, Sitikangchen has chosen a development path of “independent R&D + technology transfer.” Leveraging the national key laboratories of Nanjing University and Shanghai Jiao Tong University, as well as Nanjing Medical University, the companyEstablished an independent innovation R&D platform for radiopharmaceuticals, covering all key stages from early discovery, target validation, and drug discovery to preclinical and clinical studies. By integrating technologies such as artificial intelligence, the platform enables the rapid design of radiopharmaceuticals tailored to different disease types and druggable targets.。

Leveraging a comprehensive, interdisciplinary knowledge base spanning medicine, medicinal chemistry, radionuclide chemistry, and pharmaceutical sciences, the company has introduced leading-edge scientific achievements from both China and abroad to further enrich its product portfolio, thereby achieving “overtaking on the bend” in niche market segments.

Theranostic Radiopharmaceuticals: A Key Trend in the Future Upgrade of Clinical Oncology Care. In both solid and hematologic malignancies, radiopharmaceuticals enable sensitive, non-invasive detection of minimal residual disease and precise, safe treatment of multiple metastatic lesions.By substituting the radioactive isotope, the same targeted conjugate drug can be used for diagnostic imaging and precision therapy, respectively., such as in combination with¹⁸F、⁶⁴Cu、⁶⁸Diagnostic products formed by Ga and other radionuclides, combined with¹⁷⁷Lu、²¹¹Therapeutic products composed of radionuclides such as At enable the integration of diagnosis and therapy.

Established two years ago, Sitaikangchen has built a comprehensive industrial layout, with its pipeline covering the diagnosis and treatment of solid tumors, hematologic malignancies, cardiovascular diseases, and more. Currently, Sitaikangchen has eight theranostic paired pipelines (four for diagnosis and four for treatment) and one diagnostic pipeline.

Among themThe diagnostic pipelines targeting prostate cancer and those targeting hematologic malignancies/solid tumors have undergone investigator-initiated trials (IITs) in humans, confirming their diagnostic efficacy, and are expected to enter the Investigational New Drug (IND) application phase in 2024.；The therapeutic pipelines targeting prostate cancer and those targeting hematologic malignancies/solid tumors have completed the optimization and screening of compounds as well as the initial development of manufacturing processes. The investigational medicinal products obtained have been confirmed to be safe and effective in clinical settings. First-in-human (FIH) trials are expected to commence in 2024, with Investigational New Drug (IND) applications to be filed both domestically and internationally in 2025.。

The other two theranostic pairs targeting solid tumors have completed compound optimization and manufacturing process exploration. Clinical investigator-initiated trials (IIT) for the diagnostic pipeline are expected to commence in 2024, with first-in-human (FIH) trials for the therapeutic pipeline scheduled for 2025. The company is actively tracking novel targets and developing a diagnostic pipeline as a first-in-class product, which is poised to deliver strong performance in diagnosing both oncological and cardiovascular diseases. Human trials related to brain tumors and cardiovascular diseases are planned for 2024.

With the aging of the global population, the number of patients with cancer, cardiovascular diseases, and other conditions is steadily increasing, driving up clinical diagnosis and treatment demands and accelerating the growth of the radiopharmaceutical market. In the first half of 2023, Novartis’ Lutathera achieved sales of $291 million, a year-on-year increase of 57%; in the first three quarters of 2023, Pluvicto recorded sales of $707 million. The radiopharmaceutical industry chain is gradually maturing, and global competition is becoming increasingly intense. Key nodes across the entire development chain—including new target discovery, drug design, and radioisotope supply—are critical to determining whether innovative companies can rapidly capture market share.

Siti Kangchen has accumulated profound technical expertise in targeted molecular screening, molecular optimization, linker design, site-specific radionuclide conjugation, in vivo pharmacokinetic improvement, and dosimetry studies, and has achieved platform-based capabilities in radiopharmaceutical target screening and molecular design.Meanwhile, Siti Kangchen has adopted a development strategy of “in-house R&D plus technology transfer,” boasting stronger capabilities in industrial layout. It maintains close ties with the upstream and downstream segments of the radiopharmaceutical industry, particularly with clinical centers, thereby establishing a solid clinical foundation.

The supply of radionuclides is a major bottleneck in the development of nuclear medicine. Previously, China’s radionuclide supply relied heavily on imports and was limited in variety. In recent years, with the advancement of nuclear medicine, the Chinese government has vigorously promoted the production and supply of medical isotopes, such as by issuing the Medium- and Long-Term Development Plan for Medical Isotopes (2021–2035) and constructing nuclear reactors.

At the level of diagnostic radionuclides, Sitikangchen has opted for domestically self-sufficient radionuclides, ensuring a stable supply. Regarding therapeutic radionuclides, beta-emitting radionuclides used by the company are expected to see increased domestic production and availability starting in mid-2024, while alpha-emitting radionuclides will gradually ramp up domestic production over the next two years, progressively meeting clinical demand in China.

Wang Guanli stated, “Siti Kangchen aims to become an international, sustainably innovative, and continuously growing radiopharmaceutical enterprise, delivering tangible benefits to patients, contributing to the medical cause, and earning societal recognition.” In the future, the company will continue to deepen its efforts in radiopharmaceutical development, enhance its capabilities across the entire industry chain, andPromote a New Round of Financing, joining hands with “fellow travelers” on the innovative path of integrated radiopharmaceutical diagnosis and therapy.

Siti Kangchen Team's Perspective: RDC Is Not an Accurate Term for Radiopharmaceuticals; TRT Is More Precise.

Although TRT and ADC share similarities in principle—both are targeted therapies that exert potent cytotoxic effects by conjugating disease (tumor)-targeting molecules with therapeutic agents (chemical toxins for ADCs; diagnostic/therapeutic radionuclides for TRTs)—their differences are also evident:

1. The design philosophy of linkers differs significantly. For Antibody-Drug Conjugates (ADCs), the linker must be cleavable to release the cytotoxic payload within the target tissue, thereby exerting its therapeutic effect; thus, linker cleavability is critical for ADC efficacy. In contrast, Targeted Radionuclide Therapy (TRT) generally requires linkers with high stability, as the radionuclide can exert its therapeutic effect without being released from the targeting molecule. Furthermore, for certain alpha-emitting radionuclides, even more stable or multifunctional linkers are required to ensure that the daughter isotopes resulting from radioactive decay remain stably bound to the targeting molecule.

2. Differences in Duration of Action. Since TRT utilizes radioactive particles (alpha or beta particles, or Auger electrons) to induce DNA strand breaks, its resistance to drug resistance is significantly superior to that of ADCs. Regardless of the potency of the toxin in an ADC, cells can develop rescue pathways, leading to drug resistance and metastasis.

3. The concept of theranostics and drug visualization in TRT are not available in ADCs. Generally, through the pairing of diagnostic and therapeutic radionuclides, target compounds can be screened at a relatively low cost, and the path to clinical translation is relatively straightforward. Investigator-Initiated Trials (IITs) have opened the “black box” that may exist in drug development, thereby increasing the probability of success.

4. Due to the extremely low molecular doses of TRT used in clinical practice, the toxicity of the targeting molecule itself is not a primary concern; instead, in vivo dosimetry of the radionuclide-conjugated molecule serves as a critical indicator in clinical development.

Reference: “Expertise in Molecular Imaging: Worldwide” — Expertscape