Innovative products hit four times in a row, Yuanda Pharmaceutical's (00512) product ecosystem entered a harvest period, and the global layout opened a new chapter of development
The Zhitong Finance App learned that at the end of 2025, Yuanda Pharmaceutical (00512) successively unveiled new developments in a variety of innovative products, covering cutting-edge treatment fields such as nuclear medicine, traditional Chinese medicine for antidepressants, and first aid, fully demonstrating the results of the company's “self-development+introduction” innovation strategy.
At the beginning of December, the company's innovative anti-depressant traditional Chinese medicine achieved success in phase II clinical research; since then, the company has successively revealed new clinical developments in two innovative RDC drugs, including the self-developed FAP targeting solid tumor diagnostic nuclear drug being approved by the FDA, and the introduced prostate cancer diagnostic nuclear drug has successfully reached the end of phase III clinical research in China, and commercialization is imminent; recently, the company added another major pipeline to the cardiovascular emergency sector, and the world's first nasal spray to treat type I allergy adrenaline has landed in China.
The four major innovative product milestones in just 30 days are a concentrated release of the company's pipeline potential, confirming this established pharmaceutical company's unique vision of product layout and deep accumulation of technological transformation capabilities. At the same time, based on a two-tier clinical research strategy for innovative drugs at home and abroad, Yuanda has also outlined a clear path for innovative Chinese pharmaceutical companies to break through globalization, and is expected to write a new chapter in China's innovative drugs to support sustainable development in the future.
Nuclear drugs are progressing rapidly and the two differentiated products have broadened the room for growth
As the core engine of Yuanda Pharmaceutical's global layout, the nuclear drug anti-tumor sector has ushered in a phenomenal breakthrough. Not only does GPN01530 confirm the company's technological breakthrough in the nuclear medicine field, but TLx591-CDx is about to be commercialized, highlighting the strategic value of the “integrated diagnosis and treatment” layout of the company's nuclear drug products and consolidating its leading global position in this field.
Among them, GPN01530, as a major nuclear drug for FAP (fibroblast activating protein) target layout, has recently been officially approved by the US FDA to carry out phase I/II clinical studies to diagnose solid tumors, which means that the company has successfully achieved FAP as a star target, and its overseas clinical development has also confirmed Yuanda Pharmaceuticals' ability to globalize innovative drugs.
GPN01530 has shown better product performance compared to mainstream cancer diagnostic products in the current market and products targeting the same FAP, and has the potential to become a “hot model”. Specifically, compared to fluorine [18F] -fluoride deoxyglucose (18F-FDG), the PET/CT imaging agent currently used for cancer diagnosis, GPN01530, which targets FAP, will have higher cancer detection sensitivity, and is expected to replace 18F-FDG as a mainstream product for pan-cancer diagnosis. Some studies have shown that the detection sensitivity of FAP targeting imaging agents in gastric cancer, colorectal cancer, and liver cancer is 80% to 90%, which is significantly higher than the sensitivity of 18F-FDG of about 40% to 68%.
Furthermore, GPN01530 optimizes the structure of FAP ligands, increases uptake in tumor tissue, and reduces their uptake in normal tissues, which is expected to break through the current technical bottleneck of FAP target RDC drugs. Preclinical studies have shown that GPN01530 showed rapid tumor targeting, higher tumor uptake, and better pharmacokinetic properties compared to other FAP ligands. This best-in-class (BIC) will also provide it with a significant differentiating advantage in FAP target competition.
It is foreseeable that if successfully launched later, GPN01530 will not only replace 18F-FDG products with higher sensitivity, but is also expected to accelerate breakthroughs among similar products with the support of BIC characteristics.
While GPN01530 showcased the company's technical strength, TLx591-cdx verified Yuanda Pharmaceutical's vision of product layout. The company introduced TLx591-cdx, a diagnostic nuclear drug for prostate cancer. The phase III clinical trial conducted in China has achieved positive top-line results and successfully reached the main clinical end point, marking that Yuanda Pharmaceutical will soon take a key step in the commercialization process of diagnostic nuclear drugs.
TLx591-cdx is a diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), suitable for the diagnosis of initial and recurrent prostate cancer. The current phase III clinical tip-line results showed that TLx591-CDx showed a high level of diagnosis, especially for recurrent and non-bone metastatic tumors in the prostate region, the overall positive predictive value (PPV) was as high as 100%, and TLx591-cdx also showed high sensitivity for patients with bone metastases and different prostate specific antigen (PSA) baseline levels. TLx591-cdx also showed more clear clinical utility in clinical studies, which can optimize clinical treatment decisions for prostate cancer patients suspected of biochemical recurrence. More than two-thirds of patients had their treatment plans adjusted from the baseline after PET imaging tests with TLx591-cdx.
This achievement not only helps improve the early detection rate and treatment effect of prostate cancer, provides a more accurate diagnostic tool for Chinese prostate cancer patients, but also injects strong impetus into the rapid commercialization and monetization of Yuanda Pharmaceutical's nuclear medicine sector. Referring to existing overseas sales data, the product has achieved sales of approximately US$517 million in 2024 and US$461 million in the first three quarters of 2025 after being approved for sale in Australia, the United States, Canada and other countries since 2021, with strong commercialization strength. As the domestic phase III clinical trial of this product has reached its end, the submission of its marketing application has entered the countdown. It is expected that overseas market results will be replicated in the near future, contributing to a considerable increase in the company's performance.
Innovative strategies lead the sector's potential to soar, and China and the US both report to enhance the global competitiveness of nuclear drugs
Yuanda Pharmaceutical's frequent nuclear drug progress is an inevitable result of its long-term adherence to the “innovation strategy.” The company has built a “independent development+global introduction” two-wheel drive innovation system around nuclear drugs, and continues to improve the “integrated diagnosis and treatment” product matrix by integrating high-quality global resources and strengthening endogenous research and development capabilities.
In terms of independent research and development, the company relies on core R&D platforms such as the Chengdu Nuclear Drug Base to continuously overcome key technical barriers in radiopharmaceutical research and development. The successful development and FDA clinical approval of GPN01530 is a strong proof of its ability to innovate independently. Based on the company's radiological labeling platform and animal molecular imaging platform at the Chengdu Nuclear Drug Base, the company completely independently implemented early research on GPN01530, completed labeling process development and animal imaging research work in one stop, and relied on production lines that met pharmaceutical production quality management standards (GMP) to achieve registered production, inspection and release.
In terms of global introduction, the company relies on deep insight into nuclear drug industry trends and strong resource integration capabilities to accurately identify and introduce innovative products with great clinical value and market potential. The introduction of TLx591-CDx and its success in phase III clinical trials in China are a model for the efficient implementation of the company's “global introduction” strategy.
This “self-development+introduction” two-wheel drive model enables Yuanda Pharmaceutical to achieve efficient collaboration between technological innovation and product implementation in the field of nuclear medicine, and quickly build a rich and competitive product pipeline. The company is already one of the innovative pharmaceutical companies with the richest product pipeline and integrated diagnosis and treatment layout in the field of nuclear medicine anti-cancer treatment in the world. It is also the enterprise with the largest total reserves of innovative diagnostic and therapeutic RDC drugs in phase III clinical research in China. Its nuclear drug products have covered all stages from early R&D to commercial production, and has achieved a virtuous cycle of “R&D generation, clinical generation, and commercialization generation”. The company currently has 16 innovative products in the R&D registration stage, covering 5 types of radionuclides, including 68 Ga, 177 Lu, 131I, 90Y, and 89Zr, covering 7 types of cancer including liver cancer, prostate cancer, brain cancer, etc., 5 innovative RDC have been approved for clinical registration, and 4 have entered stage III; the early development stage is mainly RDC drugs, with more than 10 products. The product categories cover diagnosis and treatment of two types of nuclide drugs.
More importantly, the “China and US double reporting” strategy actively implemented by Yuanda Pharmaceutical can not only accelerate the marketing process of drugs in major global pharmaceutical markets, but also significantly enhance the international influence and market value of products, thereby further enhancing the global competitiveness of its nuclear drug products. Since this year, SIR-spheres® yttrium [90Y] microsphere injection (Yigantai®) has been approved for new indications in the US and Europe; the self-developed innovative nuclear drug GPN02006 has also appeared at international academic conferences and is expected to become the world's first diagnostic RDC product for hepatocellular carcinoma (HCC) targeting GPC-3; ITM-11, a treatment drug for gastrointestinal and pancreatic neuroendocrine tumors submitted by partner ITM SE, has been accepted for marketing by the FDA.
In addition to R&D and products, Yuanda Pharmaceutical's entire industry chain layout provides a strong guarantee for it to continue to lead the nuclear drug gold circuit with high barriers and high growth. The company has built an industrial network covering the world: R&D bases with Boston and Chengdu as the core, production networks covering Boston, Frankfurt, and Singapore, as well as a sales layout in more than 50 countries and regions, forming a full chain layout throughout R&D, production, distribution and sales. The company's radiopharmaceutical R&D and production base in Wenjiang, Chengdu was officially put into operation in June of this year. It is currently one of the smart factories with the most complete range of nuclides and the highest degree of automation in the world, which can fully meet the diverse and large-scale preparation needs of Yuanda Pharmaceutical's therapeutic and diagnostic nuclear drugs.
These developments not only reflect Yuanda Pharmaceutical's forward-looking vision and strong execution in the field of nuclear drug research and development, but also added important weight to its competition in the global nuclear drug market, further consolidating the company's position as a global leader in nuclear medicine innovation. Currently, the global nuclear medicine market is rising. According to Precedence Research data, the global nuclear medicine market is expected to grow from about 10.65 billion US dollars in 2023 to about 31.44 billion US dollars in 2033, with a compound annual growth rate of about 11.45%. As one of the benchmark companies in the global nuclear drug market, Yuanda Pharmaceutical will fully benefit from high market dividends, continuously expand its market share with its comprehensive advantages in technology, products and industrial chains, and achieve rapid sustainable development.
More blooming breaks growth boundaries and accelerates product iteration to achieve sustainable development
Looking at the full picture, the nuclear drug anti-tumor diagnosis and treatment sector well reflects the development trend of Yuanda Pharmaceutical's scientific and technological innovation — under the innovative and global development strategy, the company's cardiovascular first aid, facial surgery and other business sectors have also been revitalized in the past month, and the product pipeline is rapidly iterating towards the dual goals of differentiated competition and value enhancement.
In the field of cardiovascular first aid, Yuanda Pharmaceutical's first adrenaline nasal spray for emergency treatment of type I allergic reactions (including severe allergic reactions), was successfully approved for marketing in China.
Yousensitive® is an innovative first aid product with great market potential. As the world's first approved adrenaline nasal spray, it breaks the limitations of traditional adrenaline injections requiring high operating skills. It uses a nasal administration method, is more convenient to use, can be administered quickly in emergency situations, and saves valuable first aid time for patients with type I allergic reactions. The product has now been approved for sale in many countries and regions such as the United States, the European Union, and Japan, and the US achieved sales of 12.8 million US dollars in the second quarter of 2025.
Yuanda Pharmaceutical's layout of this product not only enriches the company's product matrix in the field of cardiovascular first aid, but also fills the gap in the use of emergency drugs for severe allergic reactions in China in out-of-hospital scenarios, and has important clinical value and social significance. The company also pointed out that it plans to achieve localized production within 24 months after the product is approved. It is foreseeable that if it is successfully put into production and sales in the future, the product is expected to become another important performance growth engine for Yuanda Pharmaceutical.
In the field of facial surgery, the company's 1.1 innovative traditional Chinese medicine drug GPN01360 successfully reached the end of phase II clinical research in China. The product showed remarkable efficacy and safety advantages. It is expected to become a new treatment choice for depressed patients in China and contribute China's strength to global depression treatment.
GPN01360 uses modern pharmacology and clinical research to screen and optimize the ancient classic formula “Xiaoyao San,” which has the effects of relieving the liver and spleen, relieving relaxation and calming the mind. The results of the phase II clinical study showed that after 8 weeks of oral administration in 148 patients, there was a significant difference (P<; 0.05) in the overall score of the Hamilton Depression Scale (HAMD-17) compared with placebo (P<; 0.05). The improvement in symptoms such as depression accompanied by anxiety and insomnia was significant, and no obvious toxic side effects were found.
Yuanda Pharmaceutical's various innovative products have blossomed, which is deeply in line with the current development direction of the innovative and upgraded pharmaceutical industry. In recent years, pharmaceutical innovation support policies have been extended from the review side to the payment side. The implementation of policies such as the “Commercial Insurance Innovative Drug Catalogue” is expected to improve the diversified payment capabilities of innovative drugs and better guarantee the market value of innovative drugs in China.
With production policy support, China's innovative drug industry is becoming more and more vigorous, and Yuanda Pharmaceutical's innovation strategy is also constantly being accelerated. In the first half of this year, the company invested 1.02 billion yuan in R&D and projects. Of the 133 ongoing research projects, innovation projects accounted for more than 30%, with a total of 42. Related research projects are distributed at various stages from pre-clinical to new drug marketing applications, providing sufficient backup for the company's performance growth, and some innovative products have already increased the company's performance. In the first half of this year, Yuanda Pharmaceutical's innovation and barrier products accounted for about 51.0% of total revenue, an increase of 14.9 percentage points over the previous year.
“Chunjiang Plumbing Duck Prophet”, the value of the company's innovative medicine has already been reflected in the capital market. Since this year, many research institutes have positively evaluated Yuanda Pharmaceutical. During the year, many brokerage firms, including CICC, Huatai Securities, and Tianfeng Securities, gave it positive reviews such as “outperforming the industry” and “buying.” Among them, Tianfeng Securities also gave the company a target price of HK$13.07. Compared with the company's current stock price, there is still room for an increase of about 60%. In fact, compared to the beginning of the year, Yuanda Pharmaceutical's market value has basically doubled, reflecting the market's deep recognition of the company's innovative strategy and market prospects.
In the future, as the company's new innovative products enter the commercialization stage one after another, Yuanda Pharmaceutical is expected to achieve a continuous increase in market share in various fields such as anti-tumor drugs, cardiovascular and cerebrovascular first aid, and facial features, build a more resilient and competitive business ecosystem, and lay a solid foundation for its long-term sustainable development.