GRAND PHARMA (00512) Mid-Year Report Observations: The Leading Nuclear Medicine Company Delivers on Potential, Diverse Innovations Strengthen Long-Term Growth Foundation

Standing at the crossroads of innovation, the global nuclear medicine market is currently undergoing a critical period of restructuring and value realization. With overseas giants such as Novartis, Eli Lilly, Roche, and BMS entering the nuclear medicine arena one after another, the industry is once again brought into the spotlight, welcoming a development window characterized by simultaneous increases in both quantity and price. The industry logic is quietly evolving, with the future competition shifting focus to a comprehensive contest within the entire industrial chain ecosystem. Against this backdrop, on August 26, GRAND PHARMA (00512), one of the leading enterprises in nuclear medicine, announced its mid-term performance for 2026. Throughout the year, the company has consistently implemented an innovation-driven and "Go Global" development strategy, focusing on high-barrier niches including nuclear medicine for oncology and severe infections, while also venturing into cutting-edge fields such as mRNA innovative drugs and ophthalmic innovation. It has created a stepwise innovative pipeline for the short, medium, and long term, with continuous improvement in R&D transformation efficiency. Benefiting from this, the company achieved revenues of approximately HKD 6.39 billion during the period, reflecting a year-on-year increase of about 3.2%. The adjusted operating profit attributable to shareholders was around HKD 970 million; the nuclear medicine oncology segment generated approximately HKD 660 million in revenue, maintaining rapid year-on-year growth of about 55%. After years of deep cultivation, the company's global clinical and "China-U.S. dual reporting" registration system is now mature, with several products receiving clinical licenses from international regulatory bodies during the period. The clinical outcomes of the core product, Yttrium-90 microsphere injection (), have been published in top international journals and have been incorporated into authoritative domestic and international clinical guidelines, effectively supporting the commercialization process. Currently, the company has accumulated over 30 high-value innovative projects in the pipeline, expected to reach multiple R&D milestones between 2027 and 2028, with a robust pipeline reserve providing growth momentum for long-term development. Behind the steady growth of GRAND PHARMA's performance, the nuclear medicine oncology segment has played a crucial role. In recent years, the company has achieved numerous successes in the nuclear medicine field, realizing comprehensive systematic breakthroughs. Its status as a global leader in nuclear medicine is gradually solidifying. From "diagnosis" to "treatment," global innovation capabilities are now among the top tier in nuclear medicine. As the global precision medicine industry accelerates its evolution, radiopharmaceuticals, characterized by precise targeting and integrated diagnosis and treatment, have become a core high-barrier and high-certainty track in the field of innovative drugs. In the context of domestic innovative pharmaceutical companies accelerating their global deployment, with industry competition shifting toward core technological barriers, GRAND PHARMA is leveraging its long-standing "core nuclear medicine" strategy to reach a critical window for concentrated pipeline realization. In the first half of 2026, the company's nuclear medicine field has made substantial progress with its research products, with strategic value continuously being realized. In the field of precision diagnosis and treatment for prostate cancer, the company's core diagnostic product, TLX591-CDx, received acceptance by the NMPA for its domestic NDA in January, poised to become the next major commercial product in its nuclear medicine segment. This product can accurately target prostate cancer lesions, enabling early screening, precise staging, and dynamic monitoring of post-operative efficacy. Data from the overseas market has already validated its commercial value, with approximately USD 600 million in revenue projected for 2025, marking year-on-year growth of over 20%, and gaining widespread recognition from global clinicians due to its high specificity clinical outcomes. Following its domestic launch, it is expected to replicate the rapid scaling trend observed overseas. Simultaneously, its companion therapeutic drug TLX591 is advancing through international multi-center Phase III clinical trials, with the two products forming a "diagnosis + treatment" closed-loop solution expected to fill a market gap in domestic prostate cancer precision nuclear medicine diagnosis and treatment. Supported by global clinical data, this pipeline possesses vast commercialization prospects and long-term growth potential. If the breakthrough in the diagnostic field aims for "early detection," then the breakthrough in the treatment track aims to anchor on "living longer." In the field of precision interventional treatment for liver cancer, the company's core commercialized product SIR-Spheres () has achieved critical clinical breakthroughs during this period, leading the efficacy data in this niche. In April this year, GRAND PHARMA announced the core clinical data from the DOORwaY90 study, revealing that Yttrium-90 microsphere injection achieved a 100% local tumor control rate in the treatment of unresectable hepatocellular carcinoma (HCC), with 75% of patients maintaining relief duration exceeding 6 months. Public information shows that HCC accounts for about 90% of primary liver cancer cases and is the most common cause of death among patients with cirrhosis. According to CSCO guidelines, treatment options for HCC vary according to disease stage: early-stage HCC patients predominantly use surgical resection and local regional therapies, while systemic therapy is recommended for advanced patients. From this perspective, the impressive clinical data of DOORwaY90 stands out compared to traditional radiotherapy or interventional treatments, which are often accompanied by liver function damage; however, maintained stable liver function in over 95% of patients at the 12-month mark while effectively eliminating tumors. This means that the vision of "high-quality survival with tumors" for middle-to-late stage liver cancer patients is becoming a reality. Based on this, the product has become the world's first and only FDA-approved dual-indication product for unresectable HCC and colorectal cancer liver metastases. From a market size perspective, by 2025, new cases of liver cancer in China are expected to rise to 389,600, with a compound annual growth rate of 2.1% from 2020 to 2025, and it is projected to reach 436,000 by 2030, and 481,000 by 2035. The HCC drug market in China is expected to grow from CNY 7.2 billion in 2020 to CNY 16.7 billion in 2025, with a compound annual growth rate of 18.4%, and is projected to further expand to CNY 43.9 billion by 2035. Currently, the company is collaborating with experts from both domestic and overseas to develop other indications for Yttrium-90 microsphere injection, adopting a "China-U.S. dual reporting" international registration pathway to accelerate the product's global market expansion. The impressive data from the DOORwaY90 study not only further consolidates 's leading position in the global liver cancer interventional treatment field but also provides core clinical evidence for expanding domestic market indications, significantly accelerating domestic market growth and deeply exploring the market potential for precision treatment of liver cancer. Even more significantly, on August 9, GRAND PHARMA's independently developed FAP-targeted radiopharmaceutical conjugate GPN01530-2 was granted Fast Track Designation (FTD) by the U.S. FDA. Fast Track Designation is primarily awarded to investigational drugs that are intended to treat serious conditions and have the potential to address unmet medical needs, aimed at expediting the evaluation process for high-value pipelines. GPN01530-2 is the first FAP-targeted diagnostic radiopharmaceutical for solid tumors to receive Fast Track recognition from the FDA globally. This authoritative certification marks GRAND PHARMA's self-developed nuclear medicine technology entering the global first tier, breaking the technical monopoly of overseas companies in the field of pan-cancer nuclear medicine. The FDA's Fast Track designation will also significantly simplify its overseas approval processes and shorten R&D timelines, helping the company to seize the first-mover advantage in the global pan-cancer precision diagnosis and treatment arena and build differentiated technological barriers. In terms of targets, FAP is not expressed or is lowly expressed in normal tissues but is highly expressed in 90% of epithelial tumor tissues and in tumor-associated fibroblasts within various tumor microenvironments, allowing for broad coverage of various solid tumors such as lung cancer, colorectal cancer, and pancreatic cancer. This target is also viewed by the industry as one of the most clinically translatable targets, attracting major multinational pharmaceutical companies, including Novartis, to vie for early positioning. Compared to traditional diagnostic and therapeutic methods, GPN01530-2 possesses core advantages of high targeting accuracy, superior sensitivity, and broad cancer type coverage. By optimizing the structure of the FAP ligand, it has enhanced uptake in tumor tissues while reducing uptake in normal tissues. Both compared to similar products targeting the FAP site and the mainstream PET/CT imaging agent Fluorine-18-deoxyglucose (18F-FDG), GPN01530-2 demonstrates significant advantages and great BIC potential. From a market space perspective, GPN01530-2 holds substantial commercialization potential. Public data shows that the estimated market space for alternatives to 18F-FDG exceeds USD 5 billion, and the patient population targeted is still growing. As the patient population expands, the global oncology drug market is continuously increasing, with Frost & Sullivan data projecting that the global oncology drug market size will reach USD 702.7 billion by 2035. In this vast and continuously growing oncology treatment market, precise, efficient, and safe integrated therapeutic solutions have become a core necessity of the industry, creating excellent competitive opportunities for GPN01530-2. In addition to its ongoing breakthroughs in product pipelines, GRAND PHARMA's global industrial layout advantages are becoming increasingly notable. The company has established a globally covering R&D, production, and commercialization sales network, achieving full independent control from target research and clinical studies to isotope production and global commercialization of nuclear medicine. As of mid-2026, the company is the only nuclear medicine enterprise in China with complete capabilities for "global authorized introduction + self-initiated innovation + full-chain industrialization production + globalization." Its mature multinational operating system and entire industry chain barriers endow it with strong risk resistance and continuous optimization abilities in the global nuclear medicine industry competition, and the embryonic form of a global leader in nuclear medicine has fully taken shape. By synergistically driving multiple tracks, the company is building long-term, stable growth barriers. While leading in the core nuclear medicine track, GRAND PHARMA focuses on clinical unmet medical needs, leveraging its mature new drug R&D system, clinical transformation capabilities, and commercialization experience to refine differentiated innovative products across several sub-tracks. The company adheres to a multi-dimensional precision layout and differentiated competitive development strategy, achieving continuous breakthroughs in innovation product tracks in respiratory and critical care, innovative ophthalmic drugs, and cardiovascular and cerebrovascular specialties, forming a comprehensive innovation system that empowers the core track and diversified business synergy, creating multi-layered, high-resilience long-term growth barriers. In the field of otolaryngology, the company has been deeply involved in innovative ophthalmic drugs for many years, leveraging a complete R&D innovation system to continuously develop innovative products with both technical and clinical advantages. The indications cover dry eye syndrome, Demodex blepharitis, postoperative anti-inflammatory analgesia, pterygium, and myopia, with several products gaining differentiated competitive advantages in the specialty treatment market due to their excellent efficacy and safety. In March 2026, GRAND PHARMA's globally innovative ophthalmic drug GPN01768 (loteprednol etabonate eye drops) for the treatment of Demodex blepharitis was approved for listing in China. This product is the world's first and currently the only drug specifically designed for treating Demodex blepharitis. Following its launch in the U.S. in 2023, sales revenue achieved explosive growth, with approximately USD 450 million in revenue in the U.S. in 2025, a year-on-year increase of over 150%, with projected peak sales exceeding USD 2 billion, expected to become another blockbuster product for GRAND PHARMA. Additionally, the companys pipeline in respiratory and critical care also shows great potential. The globally innovative small molecule compound STC3141, developed independently by GRAND PHARMA, successfully reached its clinical endpoint in a Phase II clinical trial targeting sepsis in China. With its unique approach centered on regulating the immune state of the body, it is expected to become the world's first treatment option for sepsis focused on rebuilding immune homeostasis. Clinical research data shows that the drug treatment group had a significantly better improvement in SOFA scores on the 7th day compared to the placebo group; moreover, STC3141 demonstrated good safety and tolerance, and its pharmacokinetics met expectations. These excellent clinical research findings bring new hope for global sepsis treatment. It is reported that the sepsis treatment market is a blue ocean containing over USD 10 billion in scale. This disease is the primary cause of death in global intensive care units, and there are currently no specific treatment drugs. The incidence of sepsis in intensive care units in China ranges from 20.6% to 50.8%, with approximately 11 million deaths globally each year attributed to sepsis. Given the high mortality rate, treatment costs for sepsis remain high. If STC3141 successfully reaches the market, it would not only break the long-standing lack of targeted drugs for this disease but also potentially fill the market gap for etiology-based treatment for sepsis, fundamentally transforming the treatment landscape for severe cases. Additionally, in the cutting-edge biotechnology sector, GRAND PHARMA is also making forward-looking arrangements. The company has established a globally leading mRNA technology platform centered on Nanjing Aurobiotech Co., Ltd., strategically positioning itself in this high-quality sector. It is reported that Aurobiotech holds proprietary intellectual property for mRNA nucleic acid drug development and lipid nanoparticle (LNP) delivery, addressing several critical industry pain points such as vaccine antigen design, LNP targeting delivery in vivo, and process development, with its technological foundation having strong cross-project reuse capabilities and strong scalability to support diversified mRNA candidate drug development. Currently, Aurobiotech's R&D is primarily focused on significant clinical and public health directions such as cancer treatment and infectious disease prevention, with key projects advancing the development of therapeutic mRNA vaccines for HPV-16 cervical cancer and HSV-2 genital herpes, alongside multiple early-stage R&D projects based on self-developed platform technologies. The synergistic breakthroughs across multiple tracks fully showcase GRAND PHARMA's precise strategic layout capability and efficient product landing ability. The company does not limit itself to deepening its advantages in the nuclear medicine track but continues to extend high-quality medical tracks centered on innovative technology, solidifying its positioning as a comprehensive innovative pharmaceutical company that embodies "nuclear medicine as the core, with diversified synergy. Conclusion According to statistics from Guosen, as of this year, the cumulative net inflow of southbound funds via Hong Kong Stock Connect has exceeded HKD 360 billion, and recently, with the fluctuations in the Hong Kong stock market, southbound funds have shown an overall inflow trend. On the other hand, foreign capital maintains a bullish stance toward the Hong Kong stock market overall. By July of this year, active foreign investment and passive foreign investment in Hong Kong stocks had combined for a net inflow of over USD 18 billion. It is evident that global capital is accelerating its allocation to the Hong Kong stock market, driven by recent marginal pressure on U.S. dollar credit and the enhanced momentum for allocation in Hong Kong stocks. Among the sub-tracks, the pharmaceutical sector has shown the most pronounced effect of reaching new highs based on the number of stocks hitting new highs in the past 250 days. In this market backdrop, GRAND PHARMA, which has begun to take shape as a global nuclear medicine multinational corporation, is undoubtedly poised to attract sustained interest from southbound funds through Hong Kong Stock Connect. From a long-term perspective, as core pipeline products continue to break through and gradually land in the global market, GRAND PHARMA is expected to grow from a leading domestic enterprise in nuclear medicine to an internationally competitive innovative pharmaceutical company. Its strategic value of "nuclear medicine as the core" will continue to be released, and its valuation will be reassessed by the market. In this regard, numerous brokerage firms, including Changjiang, Huatai, Guosen, and Tianfeng, have expressed a consistent optimistic view on GRAND PHARMA's future development. Among them, Huatai has given the company a "buy" rating with a target price of HKD 12; Guosen believes that since 2015, GRAND PHARMA has accelerated its innovative transformation and has constructed a "gradient + differentiated" pipeline in nuclear medicine oncology, cardiovascular and cerebrovascular precision intervention, and pharmaceutical technology, looking forward to clinical progress and commercialization scale-up in the nuclear medicine segment. Considering GRAND PHARMA's strong competitive advantages in differentiated innovation and global commercialization, along with the substantial scope for its leadership in nuclear medicine, the company's long-term value trend aligns well with the current trend of investment in Hong Kong pharmaceuticals, making it likely that the companys stock price will welcome a "Davis Double Play," demonstrating considerable upward elasticity to market investors as market sentiment rebounds and the sector's trend reverses.