By the end of 2025, Grand Pharma (00512) successively announced new progress on multiple innovative products, covering cutting-edge therapeutic areas such as radiopharmaceuticals, traditional Chinese medicine for depression, and emergency care, comprehensively demonstrating the effectiveness of the company's "in-house R&D + introduction" innovation strategy. In early December, the Phase II clinical study in China for its innovative TCM for depression was successfully completed; subsequently, the company successively disclosed new clinical progress for two innovative RDC drugs, including its self-developed FAP-targeted diagnostic radiopharmaceutical for solid tumors receiving FDA approval to enter clinical studies, and an introduced diagnostic radiopharmaceutical for prostate cancer successfully reaching the primary endpoint in its domestic Phase III clinical study, with commercialization imminent; recently, the company's cardiovascular and cerebrovascular emergency care segment added another significant pipeline asset, with the world's first epinephrine nasal spray for treating Type I allergies landing in China. The four major innovative product milestone achievements within a short span of 30 days represent a concentrated release of the company's pipeline potential, confirming this established pharmaceutical company's unique vision in product layout and its deep accumulation in technology conversion capabilities. Simultaneously, based on its dual-track clinical research strategy for innovative drugs advancing both domestically and internationally, Grand Pharma has also outlined a clear path for Chinese innovative pharmaceutical companies to achieve a global breakthrough, poised to write a new chapter on sustainable development supported by Chinese innovation in the subsequent period.
The progress in radiopharmaceuticals is particularly formidable, with two differentiated products broadening the growth space. As the core engine of Grand Pharma's global layout, the radiopharmaceutical anti-tumor segment has witnessed a breakthrough of phenomenal proportions. Not only does GPN01530 validate the company's technological breakthrough in the radiopharmaceutical field, but TLX591-CDx is also on the verge of commercial launch, highlighting the strategic value of the company's "diagnosis and treatment integration" layout in radiopharmaceuticals and solidifying its leading global position in this area. Among them, GPN01530, a key radiopharmaceutical asset targeting FAP (Fibroblast Activation Protein) developed by Grand Pharma, recently received formal approval from the US FDA to initiate Phase I/II clinical studies for diagnosing solid tumors. This signifies the company's successful positioning in the promising FAP target space, and its overseas clinical development also attests to Grand Pharma's global capabilities in innovative drug development. Compared to current mainstream cancer diagnostic products and other FAP-targeting products, GPN01530 has demonstrated superior product performance, possessing the potential to become a "blockbuster." Specifically, versus the PET/CT imaging agent Fluorine-18 Fluorodeoxyglucose (18F-FDG) currently used for cancer diagnosis, GPN01530, targeting FAP, is expected to offer higher sensitivity in cancer detection, potentially replacing 18F-FDG as a mainstream product for pan-cancer diagnosis. Research indicates that FAP-targeting imaging agents achieve detection sensitivities of 80%-90% in gastric, colorectal, and liver cancers, significantly higher than the approximately 40%-68% sensitivity of 18F-FDG. Furthermore, GPN01530 has an optimized FAP ligand structure that increases uptake in tumor tissue while reducing uptake in normal tissues, potentially overcoming the technical bottlenecks of current FAP-targeting RDC drugs. Preclinical studies show that, compared to other FAP ligands, GPN01530 exhibits rapid tumor targeting, higher tumor uptake, and superior pharmacokinetic properties. This Best-in-Class (BIC) profile is expected to build significant differentiated advantages in the competitive FAP target landscape. It is foreseeable that, if successfully launched in the future, GPN01530 could not only replace 18F-FDG products due to its higher sensitivity but also potentially break through the competition among similar products more rapidly, supported by its BIC characteristics.
While GPN01530 showcases the company's technical strength, TLX591-CDx validates Grand Pharma's product layout vision. The prostate cancer diagnostic radiopharmaceutical TLX591-CDx, which the company acquired through introduction, has achieved positive topline results in its Phase III clinical trial conducted in China, successfully meeting the primary clinical endpoint. This marks a crucial step for Grand Pharma towards commercialization in the diagnostic radiopharmaceutical space. TLX591-CDx is a diagnostic radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA), suitable for diagnosing both initial and recurrent prostate cancer. The Phase III topline results indicated that TLX591-CDx demonstrated a high diagnostic rate, particularly for recurrences in the prostate region and non-bone metastatic tumors, with an overall Positive Predictive Value (PPV) reaching 100%. It also showed high sensitivity for patients with bone metastases and across different baseline Prostate-Specific Antigen (PSA) levels. TLX591-CDx also exhibited clearer clinical utility in the study, optimizing clinical treatment decisions for patients with suspected biochemical recurrence of prostate cancer. Following PET imaging with TLX591-CDx, treatment plans were adjusted from the initial baseline plan for over two-thirds of the patients. This achievement not only aids in improving the early detection rate and treatment outcomes for prostate cancer, providing a more precise diagnostic tool for Chinese patients, but also injects strong momentum into the rapid commercial realization of Grand Pharma's radiopharmaceutical segment. Referencing existing overseas sales data, since its approval in countries like Australia, the US, and Canada starting in 2021, the product achieved sales of approximately $517 million in 2024 and about $461 million in the first three quarters of 2025, representing year-on-year growth exceeding 25%, indicating robust commercial strength. With the domestic Phase III trial reaching its endpoint, the submission of its marketing application is on the final countdown, and it is expected to replicate its overseas market success in the near future, contributing substantial performance growth for the company.
The frequent progress in radiopharmaceuticals is an inevitable outcome of Grand Pharma's long-term adherence to an "innovation strategy." The company has built a dual-driven innovation system centered on radiopharmaceuticals, combining "in-house R&D + global introduction," continuously enhancing its "diagnosis and treatment integration" product matrix by integrating global high-quality resources and strengthening internal R&D capabilities. In terms of in-house R&D, the company relies on core R&D platforms like the Chengdu radiopharmaceutical base to continuously overcome key technical barriers in radioactive drug development. The successful R&D of GPN01530 and its FDA clinical approval are strong testaments to its independent innovation capabilities. Based on the radiochemical labeling platform and animal molecular imaging platform at its Chengdu base, the company independently completed the early research for GPN01530, performing labeling process development and animal imaging research in a one-stop manner, and achieved production and release of registration batches relying on GMP-compliant production lines. In global introduction, leveraging its deep insight into radiopharmaceutical industry trends and strong resource integration capabilities, the company precisely identifies and introduces innovative products with significant clinical value and market potential. The introduction of TLX591-CDx and its success in domestic Phase III trials exemplify the efficient implementation of the company's "global introduction" strategy. This dual-driven model of "in-house R&D + introduction" enables Grand Pharma to achieve efficient synergy between technological innovation and product commercialization in the radiopharmaceutical field, rapidly building a rich and competitive product pipeline. The company is already one of the innovative pharmaceutical companies globally with the richest product pipeline and an integrated diagnosis/therapy layout in the radiopharmaceutical anti-tumor field, and it holds the largest total reserve of diagnostic and therapeutic RDC innovative drugs in Phase III clinical studies in China. Its radiopharmaceutical products cover all stages from early R&D to commercial production, achieving a virtuous cycle of "R&D for one generation, clinical development for another, commercialization for yet another." The company currently has a pipeline of 16 innovative products in the R&D/registration stage, covering five radioactive nuclides including 68Ga, 177Lu, 131I, 90Y, and 89Zr, and targeting seven cancer types including liver cancer, prostate cancer, and brain cancer. Five innovative RDCs have been approved for registrational clinical trials, with four in Phase III. In the early R&D stage, focusing mainly on RDC drugs, the product reserve exceeds 10 assets, covering both diagnostic and therapeutic radiopharmaceuticals. More importantly, the "China-US dual submission" strategy actively pursued by Grand Pharma can not only accelerate the drug approval process in major global pharmaceutical markets but also significantly enhance the international influence and market value of its products, thereby further strengthening the global competitiveness of its radiopharmaceutical portfolio. This year, SIR-Spheres® Yttrium-90 [90Y] resin microspheres (Y-90 microspheres) successively gained new indication approvals in the US and Europe; the self-developed innovative radiopharmaceutical GPN02006 has been presented at international academic conferences, potentially becoming the world's first GPC-3-targeting diagnostic RDC product for hepatocellular carcinoma (HCC); and partner ITM SE's marketing application for ITM-11, a treatment for gastroenteropancreatic neuroendocrine tumors, has been accepted by the FDA. Beyond R&D and products, Grand Pharma's full-industry-chain layout provides strong support for its continued leadership in the high-barrier, high-growth golden track of radiopharmaceuticals. The company has established a global industrial network: R&D bases centered in Boston and Chengdu, a production network spanning Boston, Frankfurt, and Singapore, and a sales footprint covering over 50 countries and regions, forming an integrated chain encompassing R&D, production, distribution, and sales. The company's radioactive drug R&D and production base in Wenjiang, Chengdu, officially commenced operations in June this year. It is one of the smart factories globally with the most comprehensive range of nuclides and the highest level of automation, fully capable of meeting the multi-variety, large-scale preparation needs of Grand Pharma's therapeutic and diagnostic radiopharmaceuticals. These developments not only reflect Grand Pharma's forward-looking vision and strong execution in radiopharmaceutical R&D but also add significant weight to its competitiveness in the global radiopharmaceutical market, further consolidating its position as an innovative leader in the global radiopharmaceutical field. Currently, the global radiopharmaceutical market is rising rapidly. According to Precedence Research data, the global nuclear medicine market size is projected to grow from approximately $10.65 billion in 2023 to about $31.44 billion by 2033, representing a compound annual growth rate of approximately 11.45%. As one of the benchmark enterprises in the global radiopharmaceutical market, Grand Pharma is poised to fully benefit from this high-growth market红利, leveraging its comprehensive advantages in technology, products, and the industrial chain to continuously expand its market share and achieve sustainable high-speed growth.
Multiple segments breaking growth boundaries, with accelerated product iteration enabling sustainable development. A glimpse through a single aspect reveals the whole picture; the radiopharmaceutical anti-tumor diagnosis and treatment segment well reflects the developmental tone of Grand Pharma's technological innovation—under the innovation and globalization development strategy, the company's cardiovascular and cerebrovascular emergency care and ophthalmology & otorhinolaryngology business segments have also shown vitality in the recent month, with product pipelines rapidly iterating towards the dual goals of differentiated competition and value enhancement. In the cardiovascular and cerebrovascular emergency care field, Grand Pharma's布局 of the world's first epinephrine nasal spray, Neffy® (You Minsu®), for the emergency treatment of Type I allergic reactions (including anaphylaxis), has been successfully approved for marketing in China. You Minsu® is an innovative emergency product with significant market potential. As the first approved epinephrine nasal spray globally, it breaks the limitations of traditional epinephrine injections that require high operational skills. Utilizing intranasal administration, it is more convenient to use, allowing for rapid drug delivery in emergencies,争取宝贵的急救时间 for patients experiencing Type I allergic reactions. The product has already been approved in multiple countries and regions including the United States, the European Union, and Japan, achieving sales of $12.8 million in the US in the second quarter of 2025. Grand Pharma's布局 of this product not only enriches its product matrix in the cardiovascular and cerebrovascular emergency care field but also fills the gap for out-of-hospital use of severe allergic reaction emergency medications in China, holding significant clinical value and social importance. The company also indicated plans to achieve localized production within 24 months post-approval. It is foreseeable that, if successfully produced and marketed subsequently, this product could become another important performance growth engine for Grand Pharma. In the ophthalmology & otorhinolaryngology field, the company's Class 1.1 innovative TCM drug, GPN01360, successfully reached the endpoint of its domestic Phase II clinical study. The product demonstrated significant efficacy and safety advantages, potentially becoming a new treatment option for depression patients in China and contributing Chinese expertise to global depression treatment. GPN01360 utilizes modern pharmacology and clinical research to screen and optimize the ancient classical formula "Xiaoyaosan," possessing effects related to soothing the liver, strengthening the spleen, relieving depression, and calming the nerves. Its Phase II clinical results showed that after 148 patients received oral administration for 8 weeks, the change in the Hamilton Depression Rating Scale (HAMD-17) total score from baseline showed a significant difference compared to placebo (P<0.05), with notable improvements in symptoms like depression accompanied by anxiety and insomnia, and no significant toxic side effects were observed.
The successful launch and progress of Grand Pharma's various innovative products deeply align with the current direction of innovation and upgrading in the pharmaceutical industry. In recent years, policies supporting pharmaceutical innovation have extended from the review end to the payment end. The implementation of policies like the "Commercial Health Insurance Innovative Drug Directory" is expected to enhance the multi-payment capacity for innovative drugs, better safeguarding the market value of China's innovative drugs. Supported by industry policies, China's innovative drug industry is increasingly vibrant, and Grand Pharma's innovation strategy is also accelerating. In the first half of this year, the company's R&D and project investment reached 1.02 billion RMB. Among its 133 R&D projects, innovative projects accounted for over 30%, totaling 42. The related R&D projects are distributed across different stages from preclinical to New Drug Application (NDA), providing ample backup force for the company's performance growth. Furthermore, some innovative products have already become contributors to the company's performance increment. In the first half of this year, Grand Pharma's innovative and barrier products accounted for approximately 51.0% of total revenue, an increase of 14.9 percentage points year-on-year. "The duck knows first when the river warms in spring" – the value of the company's innovative drugs has already been reflected in the capital market. Since the beginning of this year, multiple research institutions have provided positive evaluations of Grand Pharma. Throughout the year, brokerages including CICC, Huatai Securities, and Tianfeng Securities have given it positive ratings such as "Outperform Industry" and "Buy." Notably, Tianfeng Securities set a target price of HKD 13.07 for the company, implying an upside potential of approximately 60% compared to the current stock price. In fact, compared to the beginning of the year, Grand Pharma's market capitalization has nearly doubled, reflecting the market's deep recognition of the company's innovation strategy and market prospects. Looking ahead, as the company's new innovative products successively enter the commercialization stage, Grand Pharma is expected to achieve continuous market share gains in multiple areas including radiopharmaceuticals for anti-tumor, cardiovascular and cerebrovascular emergency care, and ophthalmology & otorhinolaryngology, building a more resilient and competitive business ecosystem and laying a solid foundation for its long-term sustainable development.
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