GRAND PHARMA (00512) disclosed its 2026 semi-annual report: The advantages of the nuclear medicine industry strengthen global competitiveness, and the collaboration among multiple sectors opens up new spaces for growth.
Yanda Pharma is committed to the platform management of its innovative pipeline, continuously optimizing the allocation of R&D resources during the reporting period, and enhancing its global clinical capabilities.
On August 26, GRAND PHARMA (00512) announced its interim results for 2026, reporting a revenue of approximately HKD 6.39 billion for the first half of the year, an increase of 3.2% year-on-year; adjusted operating profit was approximately HKD 970 million, maintaining a robust profit level. During this period, the company continued to deepen its innovation-driven and "Go Global" strategy, leveraging a comprehensive R&D platform to create a tiered innovation pipeline for the short, medium, and long term, forming a product ecosystem resonating with "commercialization realization, clinical advancement, and early-stage reserves." In the first half of the year, the company's innovative R&D and commercial transformation capabilities continued to yield results, achieving 18 significant milestone advancements, with core products continuing to scale up, supporting steady growth in the company's performance.
At the same time, GRAND PHARMA is dedicated to platform management of its innovation pipeline, continuously optimizing R&D resource allocation during the reporting period and enhancing global clinical capabilities. The company focuses on high-barrier fields such as radiopharmaceuticals for cancer treatment and critical care, while also venturing into cutting-edge areas like mRNA innovative drugs and ophthalmic innovative drugs, continuously improving R&D efficiency. In terms of global clinical capabilities, the company's "China-US dual reporting" registration system has matured, with several products obtaining clinical permissions from international drug regulatory agencies, and core product clinical results being published in top international journals, being incorporated into authoritative domestic and foreign clinical guidelines, which strongly supports the commercialization process. This will also provide a mature platform operational model, standardized R&D pathways, and experience in global commercialization for the company's other in-development products, propelling over 30 high-value innovative projects to achieve concentrated R&D milestones in 2027-2028.
Revenue from radiopharmaceuticals increased by 55% year-on-year, solidifying global competitiveness through the "China-US dual reporting" registration system.
The performance of the radiopharmaceuticals for cancer treatment sector is particularly noteworthy, as the selective internal radiation therapy (SIRT) product, Yttrium-90 microsphere injection, which is the world's first and currently the only FDA-approved treatment for both unresectable hepatocellular carcinoma (HCC) and metastatic colorectal cancer (mCRC), continues to scale up, driving rapid income growth within this segment. In the first half of the year, the company reported approximately HKD 660 million in revenue from its radiopharmaceutical sector, a year-on-year increase of 55%.
Since its domestic launch, numerous high-value real-world data regarding Yttrium-90 have been published by domestic scholars, with a cumulative total of 100 posters and 7 oral presentations at top international oncology and hepatology conferences such as the ASCO annual meeting, and related research findings have consistently appeared in authoritative international journals, continuously validating the product's potential.
In April this year, the clinical study DOORwaY90 of the Yttrium-90 microsphere injection in the United States successfully achieved its clinical endpoint, boasting impressive data with a 90% complete response rate, a 99% best overall response rate, and a 100% local tumor control rate, further validating the product's therapeutic value for the newly indicated treatment of unresectable HCC, and showcasing GRAND PHARMA's excellent overseas clinical registration capabilities. If subsequent clinical research continues to progress smoothly, Yttrium-90 is expected to further broaden its treatment indications, unlocking market potential for "pan-liver cancer" treatments and providing strong support for expanding indications in China.
Leveraging the global R&D strategy of "China-US dual reporting," GRAND PHARMA's self-developed radiopharmaceuticals are increasingly competitive internationally. Its first self-developed product for solid tumor diagnosis, GPN01530-2, has been granted fast track designation (FTD) by the FDA, signifying that the companys research capabilities targeting the FAP (fibroblast activation protein) are recognized by international regulatory agencies. GPN01530-2 targets the pan-cancer marker FAP, which offers potential applications for various solid tumors and high sensitivity advantages. Existing preclinical research results show that compared to the mainstream solid tumor diagnostic agent Fluorine-18 deoxyglucose (18F-FDG) and similar FAP-targeted radiopharmaceuticals, GPN01530-2 exhibits superior diagnostic efficacy, with the potential to provide a new tumor diagnostic solution for nearly 20 million new solid tumor patients worldwide each year. Benefiting from the advantages of FTD policies, GPN01530-2 may shorten the R&D and market launch timeline, allowing it to seize the first-mover advantage in the global solid tumor diagnostic market.
While overseas clinical research is steadily advancing, GRAND PHARMA's innovative radiopharmaceuticals in China are also about to enter a critical stage of commercialization. The domestic listing application for the prostate cancer diagnostic product TLX591-CDx has been accepted by the National Medical Products Administration; if it successfully obtains approval for market entry, it is expected to replicate its excellent market performance overseas, achieving annual sales of over USD 600 million.
Various business segments are progressing in tandem, and forward-looking layouts are steadily realizing product expectations.
Led by the radiopharmaceuticals for cancer treatment sector, GRAND PHARMA is simultaneously promoting coordinated advancement across diverse business lines, with its product pipeline blossoming at multiple points. Several core business sectors are reaching key milestones in commercialization and clinical research, adding momentum for the company's sustained growth.
In the field of otorhinolaryngology, the global innovative ophthalmic drug GPN01768 (TP-03, Loteprednol eye drops) has officially been approved for market entry by the National Medical Products Administration. This product is the worlds first and only innovative ophthalmic drug approved for the treatment of demodectic blepharitis, providing a new treatment option for over 50 million patients in China. This product is expected to achieve nearly USD 450 million in revenue in 2025 in the United States, with a year-on-year increase of over 150%, and it is poised to become another strong engine for GRAND PHARMA's performance growth.
Currently, GRAND PHARMA has established a "professional, full range, multi-variety" system of innovative drug products in the field of innovative ophthalmic drugs, reserving multiple innovative global products for the treatment of "dry eye syndrome," "demodectic blepharitis," "post-operative anti-inflammatory analgesia," "pterygium," and "myopia" through a strategy that combines collaborative introduction and independent R&D, building a differentiated competitive advantage.
In the respiratory and critical care fields, GRAND PHARMA's innovative strength is also prominent. The companys self-developed, globally patented small molecule compound STC3141, which has a novel mechanism of action, pioneers the etiology-based treatment for sepsis, marking the world's first sepsis treatment program focused on restoring immune homeostasis. This product has successfully met the pre-set endpoints in its Phase II clinical study in China, and its subsequent clinical development and registration application work are actively progressing. If future developments go smoothly, it is expected to usher in a new era for global sepsis treatment.
Additionally, in the mRNA field, GRAND PHARMA has built a globally leading mRNA technology platform centered around Nanjing Aurobio, currently focusing on the development of two therapeutic mRNA vaccines for HPV-16 cervical cancer and HSV-2 genital herpes. The company's mRNA technology platform possesses proprietary technologies for mRNA nucleic acid drug development and lipid nanoparticle (LNP) delivery, addressing several industry pain points such as vaccine antigen design, LNP targeted delivery in vivo, and process development. This technology base has cross-project reuse capabilities, strong scalability, and can support diversified mRNA candidate drug development, enabling the company to make forward-looking layouts in this cutting-edge field and continuously build its differentiated technological barriers.
After long-term cultivation, the company has now established a complete core technology and formulation capability for the entire mRNA production process, developing high-yield, high-quality, and low-cost in vitro transcription (IVT) processes; resolving the uniformity issue of multi-antigen LNP through process optimization; and building various quantitative detection platforms such as digital polymerase chain reaction (PCR), establishing a comprehensive quality assessment system and standards.
Overall, the first half of 2026 marks a stage where GRAND PHARMA's innovative value continues to be realized. On one hand, multiple core products in the radiopharmaceuticals for cancer treatment sector have achieved breakthroughs in both domestic and international clinical and registration efforts, solidifying the companys leading position in the global radiopharmaceuticals arena. On the other hand, the innovative product development in sectors such as otorhinolaryngology and mRNA continues to advance, continually reserving potential follow-up varieties, with the value of multiple business platforms being consistently released. Looking ahead, as many innovative products roll out, and with the ongoing iterative advancement of the R&D pipeline, the company's long-term growth momentum driven by innovation will continue to be unleashed.
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