Nuclear drugs are progressing rapidly! Yuanda Pharmaceutical (00512)'s innovative RDC drug TLx591-cdx has reached the main clinical end point in China, and the integrated layout of diagnosis and treatment is ready to go
The Zhitong Finance App learned that Yuanda Pharmaceutical's (00512) nuclear drug pipeline is fully exploding! Following FDA approval for the US phase I/II clinical trial of GPN01530, a globally innovative FAP target radionuclide conjugate drug (RDC) independently developed by the company, on December 21, Yuanda Pharmaceuticals reported again — the phase III clinical trial of the company's innovative RDC drug TLx591-cdx (Illuccix®, gallium Ga 68 PSMA-11) in China has achieved positive top-line results and successfully reached major clinical endpoints. This also means that TLx591-CDx is about to enter the new drug application stage and is about to fulfill commercialization expectations.
The nuclear drugs sector has made significant progress one after another, not only further deepening Yuanda Pharmaceutical's product layout blueprint based on integrated nuclear drug diagnosis and treatment, but also shows that the company's global layout of the nuclear drug industry has made phased progress, and its global core competitiveness in the nuclear medicine field continues to improve.
TLx591-CDx clinical data has significant advantages, and the integrated diagnosis and treatment nuclear drug combination is ready to go
According to the announcement, TLx591-CDx is a globally innovative diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) based on radionuclide small molecule coupling technology, suitable for initial diagnosis and diagnosis of recurrent prostate cancer. According to public data, the target agent psMA-11 in TLx591-cdx can specifically bind to highly expressed PSMA in prostate cancer in a way with high affinity, and has five major characteristics: internalization into cells, stable biological activity, short internal circulation half-life, good permeability to tumor matter, and can be quickly removed by non-target tissues.
According to the current clinical headline results, TLx591-cdx showed a high level of diagnosis. The overall positive predictive value (PPV) of the product was 94.8%, and the PPV for recurrent and non-bone metastatic tumors in the prostate bed region reached 100.0%; at the same time, for patients with bone metastases and different prostate specific antigen (PSA) baseline levels, TLx591-cdx also showed high PPV. Excellent clinical results suggest that PET imaging testing of TLx591-cdx has very positive clinical significance for early diagnosis of prostate cancer patients suspected of biochemical recurrence. It is expected to indicate disease progression earlier and secure a valuable treatment time window for patients.
Furthermore, after PET imaging of TLx591-cdx, more than two-thirds of patients had their treatment plan adjusted compared to the initial baseline plan, indicating that PET imaging testing of this product has an important influence on clinical decisions and can optimize clinical treatment strategies for prostate cancer patients suspected of biochemical recurrence. The remarkable and outstanding clinical study results not only fully verified the high accuracy and clinical utility of TLx591-CDx in prostate cancer diagnosis, but also provided solid evidence-based medical evidence for its subsequent application for new drug marketing in China.
In fact, the commercial potential of TLx591-CDx has been proven by its excellent performance in the global market. This product has been approved for sale in many countries around the world, including the United States, Australia, Canada, Brazil, and the United Kingdom. According to public data, TLx591-cdx achieved sales of approximately US$517 million in 2024; sales in the first three quarters of 2025 were approximately US$461 million, an increase of more than 25% over the previous year. This strong sales performance provides strong support for its commercialization prospects in the Chinese market.
It is worth noting that the success of TLX591-cdx in the phase III clinical trial in China also means that Yuanda Pharmaceutical has taken a key step in building an “integrated diagnosis and treatment” prostate cancer nuclear drug product portfolio — in terms of prostate cancer treatment, the company's other innovative RDC product, TLX591, has been approved in China to join the international multi-center phase III clinical study, and judging from clinical results, the product has shown clinical potential beyond existing anti-PSMA small peptide RLT molecules, which is expected to redefine PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) Treatment standards.
According to reports, prostate cancer is a common type of cancer among the male population in China, and the incidence rate and case fatality rate of prostate cancer patients in China is showing a clear upward trend as the aging population worsens. According to Frost & Sullivan data, the incidence rate of prostate cancer in China may exceed 165,000 by 2030, and the size of the prostate cancer drug market in China is expected to reach about 37.6 billion yuan during the same period.
In the future, the above two integrated product combinations for diagnosis and treatment of Yuanda Pharmaceutical are poised to be launched. They are expected to bring more accurate and efficient diagnosis and treatment plans to Chinese prostate cancer patients, significantly improve patients' quality of life, and form a strong commercial synergy, unleash huge market value, and consolidate Yuanda Pharmaceutical's comprehensive advantages in the field of nuclear medicine.
The advantages of the entire industrial chain layout are highlighted, contributing to the “Chinese strength” of global nuclear drugs
Many breakthroughs in the field of nuclear medicine are an inevitable result of Yuanda Pharmaceutical's years of deep cultivation in this field. At present, the company has achieved a comprehensive layout of R&D, production, distribution, and sales in the nuclear drug anti-tumor diagnosis and treatment sector. The company has achieved a global nuclear drug industry chain layout based on R&D bases in Boston and Chengdu, production bases in Boston, Frankfurt, Singapore, and Chengdu, and sales networks covering more than 50 countries and regions around the world.
In terms of product pipeline, Yuanda Pharmaceutical currently has 16 innovative products in the R&D and registration stage, covering 5 types of radionuclides, including 68 Ga, 177Lu, 131I, 90Y, and 89Zr, covering 7 types of cancer including liver cancer, prostate cancer, brain cancer, etc.; the early development stage is mainly RDC drugs, with more than 10 products. The product range covers diagnosis and treatment of two types of nuclide drugs, providing patients with multiple treatment options, multiple methods, and integrated diagnosis and treatment.
At present, Yuanda Pharmaceutical has approved six innovative RDCs to carry out registered clinical studies. Of these, four have entered phase III clinical stage, and the company has entered the harvest period for innovative nuclear drug products. In July of this year, SIR-spheres® yttrium [90Y] microsphere injection (Yigantai®) was officially approved in advance for the treatment of unresectable HCC in the US, and received European CE certification in September of this year to add a variety of liver cancer indications. It became the first and only selective internal radiation therapy product approved by the FDA for dual indications of unresectable HCC and colorectal cancer liver metastasis, and its market space has been strategically expanded. In addition, the company's self-developed innovative clinical study (IIT clinical study), a diagnostic radiopharmaceutical GPN02006 targeting phosphatidylinositol proteoglycan 3 (GPC-3) based on radionuclide and antibody coupling technology, also achieved a landmark breakthrough, and received an oral report at the 2025 North American Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting, which is expected to become the world's first RDC product targeting hepatocellular carcinoma (HCC) targeting GPC-3.
It is particularly worth mentioning that GPN01530, a globally innovative FAP target small molecule RDC drug independently developed by the company, was recently approved by the FDA to conduct phase I/II clinical trials to diagnose solid tumors in the US. This product is the company's first self-developed RDC product approved by the FDA to carry out clinical research. Judging from the pre-clinical research results, GPN01530 has the potential to be “best-in-class” and is expected to provide new tumor diagnosis solutions in the future. This also provides an important paradigm for the international development of the company's nuclear drug product pipeline, and also shows the outstanding pre-clinical development and international registration capabilities of the company's nuclear drug technology platform.
In terms of industrial layout, Yuanda Pharmaceutical has also achieved fruitful results, continuing to consolidate its “moat” in the field of nuclear medicine — the company's nuclear drug R&D and production base in Chengdu, Sichuan is the world's first closed-loop platform for the entire nuclear drug industry chain, and has established a closed loop system covering the entire “R&D, production and sales” industry chain, and has truly achieved complete autonomy and control of the entire R&D, production and sales industry chain of innovative nuclear drug products. According to reports, the base obtained a Class A “Radiation Safety License” in May 2025 and was officially put into operation in June of this year. It is currently one of the smart factories with the most complete range of nuclides and the highest degree of automation in the world, which can fully meet the company's multi-variety and large-scale preparation needs for therapeutic and diagnostic nuclear drugs.
In the future, as the global nuclear drug market continues to expand, Yuanda Pharmaceutical is expected to use its first-mover advantage and full industry chain capabilities to further implement its “Go Global” development strategy, further expand the company's share in the global nuclear drug market, provide better diagnosis and treatment solutions for global cancer patients, and promote China's nuclear drug industry to achieve greater breakthroughs on the global stage and become an indispensable “Chinese power” in the global nuclear medicine field.