Leading Chinese Radiopharmaceutical Company YUAN DA Pharma Reports Nearly 300% Revenue Growth in Core Nuclear Medicine Products and Advances Innovative RDC Drug ITM-11 into Phase III Clinical Trial

On March 24, Grand Pharmaceutical Group Limited announced that its globally innovative radiopharmaceutical drug conjugate (RDC), ITM-11, indicated for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), has recently received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical trial (the COMPOSE study). The approved COMPOSE study is a prospective, randomized, controlled, open-label, international, multicenter Phase III clinical trial. This milestone further expands Grand Pharmaceutical’s strategic layout in radiopharmaceuticals and significantly enhances the internationalization of its clinical development efforts in the field of oncology diagnosis and therapy using radiopharmaceuticals.

Just prior to this announcement, on March 20, Grand Pharmaceutical Group Limited released its 2023 annual results: the company achieved full-year revenue of approximately HK$10.53 billion, gross profit of approximately HK$6.52 billion, and normalized net profit of approximately HK$2.04 billion. Notably, the nuclear medicine oncology segment generated revenue of approximately HK$220 million, with full-year revenue growth for core products nearing 300%.

ITM-11, which has recently received clinical trial approval, is a radiopharmaceutical drug conjugate (RDC) that leverages radionuclide conjugation technology to deliver targeted cytotoxic therapy for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This product couples carrier-free Lutetium-177 (¹⁷⁷Lu) with a somatostatin analog, enabling targeted killing of tumor cells by binding to somatostatin receptors (SSTRs) highly expressed on the surface of GEP-NETs. Compared with currently widely used carrier-added ¹⁷⁷Lu radiopharmaceuticals, carrier-free ¹⁷⁷Lu offers higher specific activity and purity, generates fewer long-half-life impurities during production, and results in lower radioactive contamination.

Currently, ITM-11 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Reportedly, in addition to its inherent innovativeness, a major advantage of ITM-11 lies in its ability to form a product portfolio with TOCscan®, the company’s other radiopharmaceutical diagnostic compound (RDC) for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), thereby enabling integrated diagnosis and therapy for GEP-NETs and holding promise to provide novel diagnostic and therapeutic solutions for patients with GEP-NETs in China.

In terms of domestic radiopharmaceutical market layout, Grand Pharmaceutical Group Limited can be described as the leader. Currently, Grand Pharmaceutical is the company with the largest reserve of diagnostic and therapeutic RDC innovative drugs entering Phase III clinical trials in China, and it is also one of the innovative pharmaceutical companies globally with the richest product pipeline and integrated diagnosis and treatment layout in the field of nuclear medicine for anti-tumor purposes.

Centered on the integrated theranostic concept for tumor diagnosis and treatment, Grand Pharmaceutical’s radiopharmaceutical oncology division has currently built a pipeline of 14 innovative products. Among these, nine are Radiopharmaceutical Drug Conjugate (RDC) innovator drugs, utilizing six radionuclides including 68Ga, 177Lu, 131I, 90Y, 89Zr, and 99mTc, and covering seven cancer types such as liver cancer, prostate cancer, and brain cancer. In terms of product categories, the portfolio includes both diagnostic and therapeutic radiopharmaceuticals, providing patients with multi-indication treatment options and globally leading, multimodal, integrated theranostic anti-tumor solutions.

Currently, Grand Pharmaceutical Group Limited has four innovative radiopharmaceutical drug conjugate (RDC) candidates approved for clinical trials in its oncology theranostics portfolio, three of which have entered Phase III clinical development. These include TLX591-CDx for the diagnosis of prostate cancer, TLX250-CDx for the diagnosis of clear cell renal cell carcinoma, and ITM-11 for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

In addition to its multiple radiopharmaceutical product pipelines already in clinical development, Grand Pharmaceutical’s marketed product, YiganTai Yttrium [90Y] Microspheres for Injection, delivered outstanding performance in 2023 and gained strong market recognition.

Yttrium [90Y] Microsphere Injection is Grand Pharmaceutical Group Limited’s flagship radiopharmaceutical product. Introduced from overseas, the drug was approved in China in February 2022 and officially launched for clinical use in May of the same year. It is primarily indicated for the treatment of patients with unresectable colorectal cancer liver metastases who have failed standard therapy, and it is the first product approved in China for the treatment of colorectal cancer liver metastases. 2023 marked the first full year of commercial sales for YiganTai.

According to Grand Pharmaceutical Group Limited’s annual report, since Yigantai was launched in China, nearly 60 hospitals have completed the radionuclide transfer procedures. Formal surgical procedures have been carried out at nearly 40 hospitals across 17 provinces and municipalities. Seven centers for surgery, treatment, and training have been established, and the company has provided theoretical or practical surgical training on Yigantai to more than 1,000 physicians from over 70 hospitals. By the end of 2023, Yigantai had been included in the supplementary medical insurance schemes (Huiminbao) of 36 provinces and municipalities. The comprehensive industry chain layout generated approximately HK$220 million in revenue for Grand Pharmaceutical’s radiopharmaceutical oncology segment.

In the future, Grand Pharmaceutical Group Limited’s growth in the radiopharmaceutical sector will extend far beyond this.

In terms of innovative therapeutic radiopharmaceuticals, only a handful are currently marketed in China. For instance, while yttrium-90 (⁹⁰Y) resin microspheres have been available overseas for 20 years, targeted innovative therapeutic radiopharmaceuticals remain extremely scarce in the domestic market.

The absence of innovative drugs has not only constrained the rapid expansion of the radiopharmaceutical market size in the short term, but also widened the gap in therapeutic benefits for patients with unmet medical needs both domestically and internationally. For instance, while some patients with pancreatic neuroendocrine tumors can achieve a survival period exceeding 10 years after receiving novel targeted radiopharmaceutical therapy, the survival rate in China generally remains below five years. These factors are collectively driving the accelerated development of the radiopharmaceutical market.

According to Debon Pharmaceutical data, the domestic nuclear medicine market size was approximately $1.3 billion in 2020, with a compound annual growth rate (CAGR) of 9.9% from 2017 to 2020. The market is projected to grow steadily at a rate of 10.7% between 2022 and 2026, reaching nearly $2.4 billion by 2026.

Under this trend, the future growth of Grand Pharmaceutical’s Yigan Tai will extend far beyond its current trajectory. Meanwhile, as three of the company’s innovative radiopharmaceuticals advance into Phase III clinical trials, Grand Pharmaceutical’s radiopharmaceutical portfolio is set to expand further, creating a synergistic combination that covers a broader range of cancer types and unlocks wider market opportunities.

For instance, ITM-11, which has just entered Phase III clinical trials, is indicated for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). According to Frost & Sullivan data, there were 71,300 newly diagnosed cases of GEP-NETs in China in 2020, with the incidence rate rising year by year. Its diagnostic product, TLX591-CDx, targets prostate cancer, which ranks as the fourth most common newly diagnosed cancer globally and the ninth in China, with an upward trend in case numbers. In 2015, there were 60,300 new cases and approximately 26,600 deaths from prostate cancer in China, with an overall incidence rate of 10.23 per 100,000 people and a mortality rate of 4.36 per 100,000 people. By 2020, the incidence rate of prostate cancer in China had risen to approximately 15.6 per 100,000 people, with over 110,000 new cases and more than 50,000 deaths. Similarly, the patient population for kidney cancer targeted by Grand Pharmaceutical’s diagnostic product TLX250-CDx has been expanding annually, reaching 440,000 in 2020 and projected to reach 480,000 by 2025.

As multinational corporations (MNCs) such as Novartis, BMS, and AstraZeneca continue to expand their footprint in the radiopharmaceutical sector, Grand Pharmaceutical Group Limited has accelerated its domestic and international strategic layout, showcasing to the industry the greater innovation and potential of Chinese pharmaceutical companies in this field.

Reference Article:

1. Grand Pharmaceutical’s Globally Innovative Radionuclide Conjugate Drug ITM-11 Approved for Phase III Clinical Trial in China

2. A Dominant Player in Domestic Radiopharmaceutical M&A Emerges