The global field of nuclear medicine for oncology diagnosis and treatment is advancing at an unprecedented pace towards an era of "diagnosis-treatment integration." As one of only four pharmaceutical companies globally to have successfully commercialized innovative radiopharmaceuticals, GRAND PHARMA (00512) has recently achieved a series of milestone advancements in its nuclear medicine oncology segment, signaling a significant acceleration of its global commercial strategy: the company's self-developed, blockbuster global innovative radionuclide drug conjugate (RDC), GPN01530, recently received U.S. FDA approval to initiate Phase I/II clinical studies for diagnosing solid tumors, marking a "hardcore" overseas expansion for its proprietary product; concurrently, the Phase III clinical trial in China for TLX591-CDx, used in prostate cancer diagnosis, yielded positive topline results and successfully met its primary endpoints. Beyond its absolute advantage in nuclear medicine, GRAND PHARMA has also reported a succession of successes in differentiated innovation across its other key areas: the world's first epinephrine nasal spray, Neffy® (优敏速®), for the emergency treatment of Type I allergic reactions, recently approved for launch in China, filling a critical gap in the out-of-hospital emergency care market; furthermore, the company's Class 1.1 innovative traditional Chinese medicine drug, GPN01360, successfully reached the clinical endpoints in its domestic Phase II study, demonstrating significant efficacy and safety advantages in treating depression, offering a "Chinese solution" for this condition. These breakthroughs not only validate GRAND PHARMA's first-mover advantage across multiple therapeutic areas but also reveal the deeper core competencies underpinning its "Go Global" innovation strategy, spearheaded by the nuclear medicine segment.
In its most globally competitive nuclear medicine segment, GRAND PHARMA, driven by the dual engines of "independent R&D and global expansion," has established a fully integrated, closed-loop platform encompassing research, production, sales, and regulatory capabilities. From the operational commencement of its intelligent nuclear medicine facility in Chengdu to the initiation of a "dual submission to China and the U.S." model for its core pipeline, GRAND PHARMA is steadily ascending as a global leader in nuclear medicine, continuously burnishing the "Made with Chinese Wisdom" brand in the international pharmaceutical arena.
TLX591-CDx: Accelerating Diagnosis-Treatment Integration, Explosive Overseas Growth GRAND PHARMA's deep strategic focus on the prostate cancer diagnosis and treatment field is entering a phase of explosive growth following the success of the TLX591-CDx Phase III clinical trial in China. TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11) is a diagnostic RDC drug targeting Prostate-Specific Membrane Antigen (PSMA), and its Phase III clinical trial conducted in China achieved positive topline results, successfully meeting the primary clinical endpoints. The clinical results demonstrated that TLX591-CDx has an exceptionally high total Positive Predictive Value (PPV) for detecting tumors, reaching 94.8% (confidence interval, CI: 85.9%-98.2%), and performed excellently across patient subgroups with different baseline Prostate-Specific Antigen (PSA) levels, maintaining a PPV exceeding 90% even in the subgroup with extremely low PSA levels.
More significantly from a commercial perspective, the clinical data indicated that over two-thirds (67.2%) of patients had their treatment plans adjusted from the initial baseline plan following a TLX591-CDx scan, fully underscoring the product's critical value in clinical decision-making. GRAND PHARMA plans to submit a New Drug Application (NDA) in China within the year, potentially offering a new, more precise, and efficient diagnostic standard for Chinese prostate cancer patients. Mechanistically, TLX591-CDx forms a "diagnosis-treatment integration" duo with the therapeutic RDC drug TLX591 for prostate cancer; this strategy enables "treat what you see" through the same target, significantly enhancing the precision of clinical management. Currently, TLX591 has also been approved in China to join an international multi-center Phase III clinical study, positioning the combination for imminent deployment. The product is understood to possess five core technical characteristics: first, its ability to internalize into cells, enhancing signal intensity; second, stable biological activity ensuring reliable detection; third, a short circulatory half-life in vivo, reducing patient radiation exposure; fourth, excellent penetration into tumor parenchyma for clearer imaging; and finally, rapid clearance from non-target tissues, resulting in a high signal-to-noise ratio. In overseas markets, TLX591-CDx has already gained approval in Australia, the U.S., Canada, the U.K., Brazil, and several European countries, demonstrating strong international market penetration. Financially, the product has become a cash cow for the company, with global sales reaching $517 million in 2024, and sales in the first three quarters of 2025 amounting to approximately $461 million, representing year-on-year growth exceeding 25%. This stellar performance not only validates the product's clinical value but also proves the global competitiveness of GRAND PHARMA's "diagnosis-treatment integration" combination strategy.
This breakthrough is set against the backdrop of a vast prostate cancer diagnosis and treatment market. According to Mordor Intelligence data, the global prostate cancer market size is projected to grow from $23.76 billion in 2025 to $36.26 billion by 2030, at a compound annual growth rate (CAGR) of 8.82%. Separate Horizon research data estimates China's prostate cancer treatment market will reach $1.514 billion by 2030, with a CAGR of 8.5% from 2025 to 2030. Facing such a substantial blue ocean market, "diagnosis-treatment integration" in nuclear medicine has become a core battleground for major players. Notably, Novartis's blockbuster RDC drug, Pluvicto, generated approximately $1.39 billion in global revenue in 2024, establishing itself as a benchmark product in nuclear medicine, but it has yet to establish absolute dominance in China. This presents a critical strategic window for GRAND PHARMA. Leveraging the exceptional diagnostic efficacy demonstrated by TLX591-CDx in its Chinese Phase III trial, and synergizing with the therapeutic RDC drug TLX591, which is undergoing an international multi-center Phase III study, GRAND PHARMA is well-positioned to capture market opportunities domestically. Through its closed-loop "treat what you see" strategy, it aims to build a market moat before international giants solidify their presence in the Chinese market.
Beyond prostate cancer, GRAND PHARMA has a multi-pronged "diagnosis-treatment integration" portfolio, such as the TLX250-CDx/TLX250 combination for clear cell renal cell carcinoma (ccRCC) diagnosis and treatment. Notably, TLX250-CDx demonstrated 86% sensitivity and 87% specificity in its overseas Phase III trial, positioning it as a potential new gold standard for kidney cancer diagnosis, and it has entered the U.S. FDA's Priority Review pathway. This multi-tumor, multi-target "diagnosis-treatment integration" strategy has become a core competitive advantage for GRAND PHARMA in the nuclear medicine race.
GPN01530: BIC Potential and Market Outlook for FAP-Targeted Nuclear Medicine If TLX591-CDx validates GRAND PHARMA's precise global strategic deployment, then the successful FDA approval for GPN01530 to initiate Phase I/II clinical studies, potentially marking the first "hardcore" overseas expansion of a self-developed product, signifies a monumental step in the company's independent R&D capabilities in nuclear medicine. As GRAND PHARMA's first self-developed RDC product to receive FDA approval for clinical studies, GPN01530 represents a critical milestone in the group's global R&D and registration progress. It not only reflects the company's comprehensive strength in building cutting-edge nuclear medicine technology platforms, international clinical development, and regulatory submissions but also establishes a "dual submission to China and the U.S." regulatory pathway paradigm for the subsequent international development of its proprietary pipeline. By conducting R&D simultaneously in the two major global core markets of China and the U.S., GRAND PHARMA can significantly shorten the global launch timeline for innovative products, accelerating its capture of the nuclear medicine market high ground.
The breakthrough value of GPN01530 stems from its targeting of Fibroblast Activation Protein (FAP). This target exhibits extremely high expression positivity rates in over 90% of major epithelial-origin solid tumors, including breast, pancreatic, and lung cancers. Due to its immense potential for "pan-cancer" diagnosis and treatment, FAP is hailed globally as a "billion-dollar target for diagnosis-treatment integration." From a market potential perspective, FAP imaging agents can be benchmarked against the FDG PET tumor diagnosis market. Currently, approximately 1.3 million and 2 million FDG PET tumor imaging procedures are performed annually in China and the U.S., respectively. Considering that FAPI drugs boast a lesion detection sensitivity as high as 99% (significantly superior to the 87% of traditional FDG) and higher detection rates for metastases in organs with low FDG uptake like the brain and bones, industry estimates suggest a diagnostic market potential of at least RMB 1.5 billion in China alone, with the global diagnostic market size projected to exceed $1 billion. When the therapeutic segment is factored in, the market potential driven by this target could see a multiplier effect, expanding by several-fold or even ten-fold, reflecting its vast commercial potential and explaining why global nuclear medicine giants like Novartis are heavily investing in this target area.
In terms of diagnostic performance, GPN01530 has demonstrated significant Best-in-Class (BIC) potential: traditional PET/CT imaging agents like 18F-FDG have relatively low sensitivity (around 40%-68%) in diagnosing certain cancers, whereas GPN01530, through structural optimization of the FAP ligand, exhibits faster tumor targeting, higher tumor uptake, and superior pharmacokinetic properties. In initial Investigator-Initiated Trials (IITs) involving human subjects, GPN01530 showed a favorable safety profile, rapid background clearance, and strong, persistent lesion uptake. Compared to 18F-FDG, it produced clinical images with higher contrast and more accurate detection rates for positive lesions. Against this backdrop, GPN01530, with its marked diagnostic advantages, holds promise as a key breakthrough in addressing the challenges of solid tumor diagnosis. As clinical studies progress, this product has the strong potential to reshape the solid tumor diagnostic landscape, helping GRAND PHARMA seize a leading position in the global nuclear medicine market.
Neffy® and GPN01360: Differentiated Innovation Breakthroughs in Emergency and Chronic Disease Areas While deepening its focus on nuclear medicine, GRAND PHARMA has also achieved the sequential launch of significant products in the cardiovascular emergency care and modernization of traditional Chinese medicine (TCM) sectors, continuously broadening its business boundaries across segments through a differentiated innovation strategy. GRAND PHARMA recently secured the exclusive commercialization rights within its cooperative channels in mainland China and non-exclusive rights in the Hong Kong Special Administrative Region for Neffy® (优敏速®), the world's first epinephrine nasal spray for the emergency treatment of Type I allergic reactions. As the first non-injectable epinephrine emergency option approved by the FDA in nearly 35 years, this product fundamentally breaks the long-standing reliance on injectable formulations, enabling patients to rapidly self-administer treatment during severe anaphylactic shock. Clinical data prove that Neffy® is significantly superior to standard intramuscular injection in improving key pharmacodynamic indicators such as pulse rate and systolic blood pressure, and its extended 30-month shelf life effectively reduces the storage burden for patients. According to Frost & Sullivan data, China's market for allergic disease drugs is projected to reach $9.6 billion by 2025 and $16.2 billion by 2030, with the epinephrine market segment expected to hit $1.1 billion by 2025. The 2mg dosage strength of Neffy® is already approved in major global markets like the U.S., Europe, and Japan, where its sales have shown exponential growth,充分 validating its commercial value. With the NDA for this product accepted for review in China, GRAND PHARMA aims to leverage its unique portability and user-friendliness to drive the rapid penetration of emergency medication into various out-of-hospital settings such as homes, schools, and during travel, filling the gap in out-of-hospital intervention for severe allergic reactions in China. The company plans to achieve localized production within 24 months post-approval, further consolidating its leading position in the emergency care field.
Furthermore, GRAND PHARMA has made substantive breakthroughs in its exploration of TCM modernization and the neurology sector. Its self-developed Class 1.1 innovative TCM drug, GPN01360, performed excellently in a domestic Phase II clinical study for depression, successfully meeting the primary endpoints and demonstrating significant efficacy and safety advantages. Addressing common pain points of Western antidepressants, such as delayed efficacy and significant side effects, GPN01360 is a modernized改良 based on the ancient classical formula "Xiaoyaosan." It employs scientific methods to elucidate the innovative mechanism of TCM in regulating gut microbiota and metabolic pathways, not only providing a "Chinese solution" with superior efficacy and safety for depression patients but also marking GRAND PHARMA's successful expansion of its traditional strengths in proprietary Chinese medicines from the ENT sector into the more promising neurology赛道. Currently, China's depression drug market is expanding steadily with increasing public health awareness; CIC estimates project the market will grow at a CAGR of 8.1% to reach a scale of tens of billions of RMB by 2029. The clinical success of GPN01360 not only addresses the market need for high-safety antidepressant TCM but also reflects GRAND PHARMA's firm commitment to the "Modernization of TCM" path.
Through synergistic efforts and milestone breakthroughs across core segments like nuclear medicine oncology and cardiovascular emergency care, GRAND PHARMA is steadily constructing a comprehensive innovation map spanning multiple therapeutic areas. While providing more high-quality treatment options for global patients, this strategy continuously enhances the company's long-term investment value. These cross-domain innovation breakthroughs are not accidental but are systematic outcomes of GRAND PHARMA's long-term adherence to the "Independent R&D + Global Expansion" strategy. Through differentiated深耕 in multiple advantageous sub-segments, the company has formed a comprehensive innovation landscape characterized by simultaneous successes and balanced development. To date, the company has established 8 R&D centers and 5 core technology platforms globally, with a cumulative total of 133 R&D projects, including 42 highly promising innovative projects. Additionally, the company maintains a high level of investment in cutting-edge research, with expenditures exceeding HKD 1 billion in the first half of 2025. Through sustained capital allocation and resource integration, GRAND PHARMA ensures the阶梯式落地 of innovation pipelines across all segments. The nuclear medicine segment, with its unique "diagnosis-treatment integration" concept and fully integrated closed-loop, has率先 become a benchmark for the company's high-quality development and a core growth engine with explosive potential and strong competitive barriers within the "Go Global" strategy.
Nuclear Medicine Full Industry Chain Closed-Loop: "Go Global" Strategy Enters Value Realization Phase, Driving Future High-Quality Growth The deep-rooted foundation for both the commercial success of TLX591-CDx overseas and the "hardcore" overseas expansion of the self-developed GPN01530 project lies in the global, comprehensive industry chain closed-loop that GRAND PHARMA has built in nuclear medicine oncology. Currently, GRAND PHARMA has achieved a full-spectrum layout in nuclear medicine, spanning early-stage R&D, clinical research, regulatory registration, production, sales, and regulatory qualifications, making it one of only four pharmaceutical companies globally to have successfully commercialized innovative radiopharmaceuticals worldwide. To date, centered on the "diagnosis-treatment integration" concept, GRAND PHARMA has deeply储备 16 global innovative products in the R&D and registration pipeline. These cover 5 radioactive nuclides (including 68Ga, 177Lu, 131I, 90Y, 89Zr) and target 7 major cancer types, such as liver cancer, prostate cancer, brain cancer, and gastroenteropancreatic neuroendocrine tumors, establishing the company as the enterprise with the largest储备 of RDC innovative drugs in Phase III clinical studies in China, creating a formidable first-mover advantage and competitive barrier.
The advantages of this full industry chain layout are now rapidly translating into robust commercial outcomes, marking the official entry of GRAND PHARMA's nuclear medicine segment into its value realization phase after years of strategic cultivation. Taking the company's core product, SIR-Spheres® Y-90 resin microspheres (易甘泰®钇[90Y]微球注射液), as an example, the product demonstrated explosive growth momentum following its domestic approval, generating sales revenue of nearly HKD 500 million in 2024, a year-on-year increase exceeding 140%, and maintained a strong trend of revenue doubling in the first half of 2025. Benefiting from its excellent clinical efficacy and increasingly comprehensive hospital access, the product is expected to achieve the commercialization milestone of a HKD 1 billion blockbuster product within the year. From a market perspective, the global radiopharmaceuticals market size is projected to climb to $57.3 billion by 2035, with a CAGR of 17.5%, while the Chinese market is expected to reach RMB 75.8 billion during the same period. In this vast blue ocean赛道, the company is steadily unleashing the strategic红利 accumulated over the long term through its all-encompassing industrial layout.
After years of forward-looking strategic布局 and深耕 in frontier technologies, GRAND PHARMA's "Go Global" innovation and development, exemplified by its nuclear medicine segment, has gained a leading edge. It has formed a global integrated R&D, production, and sales system comprising R&D bases centered in Boston and Chengdu, production facilities located in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering over 50 countries and regions worldwide. Simultaneously, with the official operational commencement of the Chengdu Nuclear Medicine R&D and Production Base – the world's first full nuclear medicine industry chain closed-loop platform – GRAND PHARMA has achieved 100% in-house production of isotope preparation and radiopharmaceutical formulations through 14 high-standard GMP production lines. This彻底解决了 the "bottleneck" challenges associated with nuclear medicine raw materials and production processes, truly realizing complete self-sufficiency and control over the entire innovation chain from R&D and production to sales of innovative nuclear medicine products, providing a solid foundation for the domestic落地 and large-scale commercialization of the company's nuclear medicine portfolio.
Looking ahead, as more innovative products progress smoothly through global R&D and registration – such as the formal acceptance of the U.S. marketing application for ITM-11 by the FDA and the orderly advancement of the NDA submission for TLX591-CDx in China – GRAND PHARMA is poised to further unleash the synergistic value of its self-developed and引进 assets. Leveraging its global, full industry chain advantage, the company is positioned for sustained robust growth, continually solidifying its leadership position in the global nuclear medicine arena.
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