GRAND PHARMA (00512) has achieved a milestone breakthrough in multiple areas: deeply cultivating core drugs with integrated diagnosis and treatment, all sectors are flourishing together, creating a new growth pole.

Currently, the global nuclear medicine anti-tumor diagnosis and treatment field is moving towards the era of "diagnosis and treatment integration" at an unprecedented speed. As one of the only four pharmaceutical companies in the world to successfully commercialize innovative nuclear medicine globally, GRAND PHARMA (00512) has recently achieved milestone progress in the nuclear medicine anti-tumor diagnosis and treatment sector, marking an acceleration in its global commercial layout: The company's independently developed heavyweight global innovative radiolabeled drug GPN01530 recently received approval from the FDA in the United States to conduct Phase I/II clinical studies for the diagnosis of solid tumors, achieving the "hard core going global" for its self-developed products. At the same time, the Phase III clinical trial of TLX591-CDx for prostate cancer diagnosis also achieved positive top-line results in China and successfully met key clinical endpoints. In addition to its absolute advantage in the nuclear medicine field, GRAND PHARMA has also achieved breakthroughs in differentiation and innovation in multiple advantageous areas: The company recently launched the world's first nasal spray adrenaline Neffy for emergency treatment of type I allergic reactions, which has been approved for market in China, filling a gap in the domestic outpatient emergency market. In addition, the company's Category 1 Chinese medicine innovative drug GPN01360 successfully reached clinical endpoints in a Phase II domestic clinical study, demonstrating significant efficacy and safety advantages in depression treatment, providing a "Chinese solution" for depression treatment. These breakthroughs not only validate GRAND PHARMA's first-mover advantage in multiple tracks but also reveal a deeper core competitiveness in its global innovation development represented by the nuclear medicine sector. In the company's most significant nuclear medicine sector with global advantages, GRAND PHARMA has built a complete industry chain closed-loop platform covering research, production, sales, and regulatory qualifications with the dual drive of "independent research and global expansion". With the commissioning of the intelligent nuclear medicine factory in Chengdu and the opening of the "dual reporting" mode for core pipelines in China and the US, GRAND PHARMA is steadily rising as a global leader in nuclear medicine, continuously enhancing the golden business card of "China Manufacturing" in the international pharmaceutical field. TLX591-CDx: Accelerating integrated diagnosis, explosive growth in overseas performance With GRAND PHARMA's deep layout in the field of prostate cancer diagnosis and treatment, it is entering an explosive period following the success of the TLX591-CDx Phase III clinical study in China. TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11) is a diagnostic radioligand therapeutic complex (RDC) drug targeting prostate-specific membrane antigen (PSMA). The Phase III clinical trial conducted in China has achieved positive top-line results, successfully meeting major clinical endpoints. The clinical results show that the total positive predictive value (PPV) of TLX591-CDx in cancer detection is extremely high, reaching 94.8% (confidence interval, CI: 85.9%-98.2%), and it performs excellently in subjects with different prostate-specific antigen (PSA) baseline levels, even in subgroups with very low PSA levels, the PPV remains above 90%. Moreover, more than two-thirds (67.2%) of patients who underwent TLX591-CDx testing had their treatment plans adjusted compared to their baseline treatment, demonstrating the critical value of the product in clinical decision-making. GRAND PHARMA plans to submit a new drug marketing application in China by the end of the year, aiming to provide a more precise and effective diagnostic standard for Chinese prostate cancer patients. In terms of product mechanism, TLX591-CDx forms a "diagnosis and treatment integration" combination with the therapeutic RDC drug TLX591 for prostate cancer. This strategy achieves "seeing as treating" through the same target, greatly enhancing the precision of clinical management. Currently, TLX591 has also been approved to join international multicenter Phase III clinical studies in China, and the combination of the two products is poised for success. The product has five core technological features: firstly, it can internalize into cells to enhance signal intensity; secondly, it has stable biological activity to ensure reliable detection; thirdly, it has a short half-life in circulation to reduce patient radiation exposure; fourthly, it has good penetration of tumor tissue for clearer imaging; finally, it can be rapidly cleared from non-target tissues, providing a high signal-to-noise ratio. In overseas markets, TLX591-CDx has been approved for marketing in Australia, the US, Canada, the UK, Brazil, and several European countries, demonstrating strong international market penetration. In terms of financial performance, 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 exceeding $461 million, a year-on-year growth of over 25%. The outstanding performance not only validates the clinical value of the product but also proves the core competitiveness of GRAND PHARMA's "diagnosis and treatment integration" strategy on a global scale. Behind this groundbreaking progress is the vast space in the prostate cancer diagnosis and treatment market. According to Mordor Intelligence data, the global prostate cancer market is expected to grow from $23.76 billion in 2025 to $36.26 billion in 2030, with a compound annual growth rate of 8.82%. According to Horizon Research data, the Chinese prostate cancer treatment market is expected to reach $1.514 billion by 2030, with a compound annual growth rate of 8.5% from 2025 to 2030. In the face of such a large market, the "diagnosis and treatment integration" in the nuclear medicine sector has become a core track for industry giants to compete in. It is worth mentioning that Novartis's blockbuster RDC drug Pluvicto generated approximately $1.39 billion in global revenue in 2024, becoming a benchmark in the nuclear medicine field, but it has not established an absolute monopoly in China yet. This leaves a crucial strategic window for GRAND PHARMA, with TLX591-CDx demonstrating outstanding diagnostic efficacy in Phase III clinical trials in China and collaborating on treatment-type RDC drug TLX591 in international multicenter Phase III clinical studies, GRAND PHARMA is poised to seize market opportunities in the domestic market. By implementing a closed-loop strategy of "seeing is treating," the company aims to build a market moat ahead of global giants in capturing the Chinese market. In addition to prostate cancer, GRAND PHARMA also has a multi-combination diagnosis and treatment layout, such as the TLX250-CDx/TLX250 combination for the diagnosis and treatment of clear cell renal cell carcinoma (ccRCC). TLX250-CDx has demonstrated a sensitivity of 86% and specificity of 87% in overseas Phase III clinical studies, making it a potential new gold standard for kidney cancer diagnosis, and is currently in the priority review track of the US FDA. This multidisease, multitarget "diagnosis and treatment integration" strategy has become a core competitiveness factor that continues to lead GRAND PHARMA in the nuclear medicine track. GPN01530: BIC potential and market prospects for FAP-targeted nuclear drugs If TLX591-CDx validates GRAND PHARMA's precise global strategic layout capabilities, then the successful approval of GPN01530 by the FDA for Phase I/II clinical studies marks a milestone step for the company in the field of self-developed nuclear medicine. As GRAND PHARMA's first self-developed RDC product to receive FDA approval for clinical trials, GPN01530 is an important milestone in the group's global research and registration process, reflecting the company's comprehensive strength in cutting-edge nuclear medicine technology platform construction, international clinical development, and registration declaration, and laying the groundwork for an international development path for its self-developed product pipeline. Through simultaneous development in the two major global core markets of China and the US, GRAND PHARMA can significantly shorten the global market launch cycle of innovative products, speeding up the capture of high ground in the nuclear medicine market. GPN01530 targets fibroblast activation protein (FAP), a target that shows high positive expression rates in over 90% of mainstream epithelial solid tumors, including breast cancer, pancreatic cancer, and lung cancer. Due to its potential for "pan-cancer" diagnosis and treatment, it has been praised by the global medical community as a "billion-dollar target for diagnosis and treatment integration." From a market potential perspective, FAP imaging agents can be compared to the tumor diagnostic market for FDG PET. Currently, China and the US perform approximately 1.3 million and 2 million FDG PET scans annually, respectively. Considering that FAPI drugs have a detection sensitivity of up to 99% (significantly better than the traditional FDG's 87%) and a higher detection rate for low-uptake metastases such as brain and bone, the industry estimates that it has a market value of at least RMB 1.5 billion in the diagnostic end in China alone, with the global diagnostic market expected to exceed $1 billion. If the treatment end is further taken into consideration, the market volume driven by this target is expected to be several times or even tens of times higher, which not only reflects its enormous commercial potential but also explains why global nuclear medicine giants such as Novartis are heavily investing in this target. In terms of diagnostic efficacy, GPN01530 demonstrates significant Best-in-Class (BIC) potential: traditional PET/CT imaging agent 18F-FDG has a lower sensitivity in certain cancer diagnoses, ranging from 40% to 68%, while GPN01530 has optimized the structure of the FAP ligand, showing faster tumor targeting, higher tumor uptake, and better pharmacokinetic properties. In human studies conducted to date, GPN01530 has shown good safety and rapid background clearance with strong and sustained lesion uptake. Compared to 18F-FDG, it has higher clinical image contrast and more accurate detection of positive lesions. In this context, GPN01530, with its significant diagnostic advantages, has the potential to be a key breakthrough in solving the diagnostic dilemma in solid tumors. With the advancement of clinical research, the product has the potential to reshape the landscape of solid tumor diagnosis, helping GRAND PHARMA seize a leading position in the global nuclear medicine market. Neffy and GPN01360: Differentiated innovation breakthroughs in emergency and chronic disease fields While deepening its presence in the nuclear medicine sector, GRAND PHARMA has also achieved successive commercialization of blockbuster products in the fields of cardiovascular emergency response and modernization of traditional Chinese medicine, continuing to expand the boundaries of its various business sectors through a differentiation and innovation strategy. GRAND PHARMA recently secured exclusive commercial rights for the world's first nasal spray adrenaline Neffy for the emergency treatment of type I allergic reactions in mainland China and non-exclusive commercial rights in the Hong Kong Special Administrative Region. This product, as the first non-injection adrenaline emergency solution approved by the FDA in nearly 35 years, breaks the long-standing reliance on injected medication, allowing patients to self-rescue rapidly in cases of severe allergic shock. Clinical research data has shown that Neffy significantly outperforms standard intramuscular injection in key pharmacodynamic indicators such as heart rate and systolic blood pressure, and its extended shelf-life of 30 months helps reduce patient burdens. According to Frost & Sullivan data, the allergic disease drug market in China is expected to reach $9.6 billion by 2025 and $16.2 billion by 2030, with the adrenaline market reaching $1.1 billion in 2025. Currently, the 2mg format of Neffy has been approved for sale in major global markets such as the US, Europe, and Japan, with sales showing exponential growth trends, validating its commercial value in the market. With the acceptance of the NDA application in China, GRAND PHARMA aims to rapidly penetrate emergency medications into various outpatient settings such as homes, schools, and travel through its unique portability and user-friendliness, filling the gap in emergency interventions for severe allergic reactions in China, and plans to achieve localized production within 24 months of approval, further consolidating the company's leading position in the emergency response field. In addition, GRAND PHARMA has achieved substantial breakthroughs in the exploration of modernization in traditional Chinese medicine and the field of neurology. Its self-developed Category 1 Chinese medicine innovative drug GPN01360 has shown excellent performance in a Phase II clinical study for depression treatment, successfully meeting primary clinical endpoints and demonstrating significant efficacy and safety advantages. Currently, the Chinese market for depression medications is expanding with the improvement of public health awareness. According to Eversight Consulting, the market is projected to grow at a compound annual growth rate of 8.1% to reach a scale of billions by 2029. The clinical success of GPN01360 not only meets the market demand for high safety Chinese medicine for treating depression but also demonstrates GRAND PHARMA's firm commitment to the path of "modernization of Chinese medicine". Through coordinated efforts and milestone breakthroughs in multiple core sectors such as nuclear medicine anti-tumor diagnosis and treatment, as well as cardiovascular emergency response and the modernization of traditional Chinese medicine, GRAND PHARMA is steadily building a comprehensive innovative map across treatment fields, providing quality treatment options for global patients while continually elevating the long-term investment value of the company. This cross-sector innovation breakthrough is not accidental but a systematic result of GRAND PHARMA's long-standing strategy of "independent research and global expansion." By differentiating deeply in multiple advantageous tracks, the company has formed a comprehensive innovation pattern of multi-point flowering and balanced development. As of now, the company has established 8 research centers and 5 core technology platforms globally, with a total of 133 research projects, including 42 highly clinically promising innovative projects. In addition, the company has maintained high-intensity investment in cutting-edge research, with an investment of over 1 billion Hong Kong dollars in the first half of 2025. Through continuous capital investment and resource integration, GRAND PHARMA ensures the stepwise implementation of innovative pipelines in various sectors, with the nuclear medicine sector taking the lead as a benchmark for the successful transformation of research achievements into commercial outcomes, and becoming the core growth engine of the company's "Go Global" strategy with explosive power and competitive barriers. Nuclear medicine full industry chain deep empowerment: "Go Global" strategy enters the realization phase of achievements, driving future high-quality growth Whether it's the commercial success of TLX591-CDx overseas or the "hard core going global" achievement of self-developed project GPN01530, the deep roots lie in GRAND PHARMA's construction of a globalized, all-encompassing industry chain in the field of nuclear medicine. Currently, GRAND PHARMA has achieved a full layout of nuclear medicine from early-stage research, clinical studies, registration declarations to production sales, regulatory qualifications, becoming one of the only four pharmaceutical companies in the world to successfully commercialize innovative nuclear medicine globally. As of now, around the "diagnosis and treatment integration" concept, GRAND PHARMA has deep reserves of 16 innovative global products in the research and registration stage, covering 5 radioactive isotopes including 68Ga, 177Lu, 131I, 90Y, 89Zr, and 7 major cancers such as liver cancer, prostate cancer, brain cancer, gastrointestinal neuroendocrine tumors, making it the enterprise with the most reserves of RDC innovative drugs in Phase III clinical research in China, and forming a strong first-mover advantage and competitive barrier. Now, the advantage of this whole industry chain layout is quickly transforming into strong commercial results, indicating that GRAND PHARMA's nuclear medicine sector has officially entered the value realization phase after years of deep cultivation. Taking GRAND PHARMA's core product Yttrium-90 microsphere injection Easygamite as an example, after gaining approval for market in China, the product exhibited explosive growth momentum, achieving nearly 500 million Hong Kong dollars in sales revenue in 2024 with a year-on-year growth rate exceeding 140%, and maintaining a strong trend of revenue doubling in the first half of 2025. Thanks to its outstanding clinical efficacy and increasingly perfected admission criteria, the product is expected to achieve a commercial milestone of 1 billion Hong Kong dollars this year. In terms of market space, the global radioactive drug market is expected to rise to $57.3 billion by 2035, with a compound annual growth rate of 17.5%, and the Chinese market is expected to reach 75.8 billion RMB during the same period. In this vast blue ocean track, the company is steadily releasing the strategic dividend of long-term accumulation with a comprehensive layout. After years of forward-looking layout and deep technological cultivation, GRAND PHARMA's global development with the representation of the nuclear medicine sector in its "Go Global" strategy has taken the lead with advantageous positioning, forming a system composed of research and development bases centered in Boston and Chengdu, and production bases located in Boston, Frankfurt, Singapore, and Chengdu, along with a sales network covering more than 50 countries and regions, constituting a globalized integrated system of research, production, and sales. Meanwhile, with the official launch of the world's first complete nuclear medicine industry chain platform - the Chengdu Nuclear Medicine Research and Production Base, GRAND PHARMA has achieved 100% self-produced isotopes and nuclear medicine preparations through 14 high-standard GMP production lines, addressing "bottleneck" challenges in nuclear medicine raw materials and production processes, fundamentally realizing complete self-control in the research, production, and sales chains of innovative nuclear medicine products, providing a solid guarantee for the domestic landing and large-scale commercialization of nuclear medicine products. Looking ahead, with more innovative products smoothly developed and registered globally, such as the FDA's formal acceptance of the market application for ITM-11, and the orderly progress of TLX591-CDx's application for listing in China, GRAND PHARMA is expected to further unlock synergistic value between self-developed and imported assets through its globalized full-industry chain advantages and achieve sustained strong growth, firmly establishing its leading position in the global nuclear medicine field.