Yuanda Pharmaceutical (00512)'s nuclear drug revenue increased 55% year-on-year in the first half of the year, and multi-sector business collaboration sparked innovative vitality
The Zhitong Finance App learned that in the first half of 2026, China's pharmaceutical industry has entered the development stage of centralized verification of innovative achievements. At this stage, Yuanda Pharmaceutical (00512) handed over a business questionnaire with both pipeline thickness and industry background. In the first half of the year, the company obtained revenue of about HK$6.39 billion, an increase of 3.2% over the previous year; adjusted operating net profit of about HK$970 million, with a steady profit level; during the period, the company achieved 18 important milestones, including 8 innovative products, accounting for nearly half, to intuitively verify the implementation results of the innovative strategy. The company has built a three-dimensional development pattern with innovative drugs breaking the game, using traditional dominant industries as the perfect foundation, and industrial cooperation.
The deep accumulation of products forms a solid foundation for the steady growth of Yuanda Pharmaceutical's performance. The company has included more than 130 products in the “National Essential Drugs Catalogue (2026 Edition)”, and more than 260 products have been selected in the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue (2025 Edition)”, fully demonstrating its depth of layout and market penetration ability on the track just needed for clinical use. At the same time, innovative and barrier products such as Yigantai® yttrium [90Y] microsphere injections and the liquid embolizer LavaTM continue to accelerate release. Yuanda Pharmaceutical's innovative products are accelerating the realization of commercial value and driving steady growth in the company's performance.
In recent years, Yuanda Pharmaceutical has continued to implement innovation-driven and “Go Global” development strategies, focusing on high barriers such as nuclear drugs against tumors and severe infections, while also laying out cutting-edge fields such as innovative mRNA drugs and innovative ophthalmology drugs. It has established a full-chain R&D platform, and can further promote global clinical trials and achieve the “China and US Double Newspaper” international development path for innovative products. The company has obtained clinical approval for a number of products from international drug regulatory agencies. The clinical results of the core products have been published in top international journals and included in authoritative diagnosis and treatment guidelines at home and abroad, which strongly supports the product commercialization process. Yuanda Pharmaceutical currently has more than 30 high-value research and innovation projects. It is expected that 2027-2028 will focus on achieving R&D milestones, sending steady growth momentum to the company's long-term steady development.
Integrated closed-loop molding of nuclear drug diagnosis and treatment, commercialization and R&D two-wheel drive
Nuclear drug anti-tumor diagnosis and treatment is Yuanda Pharmaceutical's most prominent business segment. It received revenue of about HK$660 million in the first half of the year, an increase of 55% over the previous year, and continued to grow rapidly. The core product, Yigantai® Yttrium [90Y] microsphere injection, is the world's first and currently the only selective internal radiation therapy (SIRT) product approved by the FDA to treat unresectable hepatocellular carcinoma (HCC) and colorectal cancer liver metastasis (mCRC). With clear clinical efficacy, the market penetration rate continues to increase. Currently, formal surgery has been carried out in more than 70 hospitals in 22 provinces and municipalities; in addition, Yigantai® has entered more than 50 beneficiaries and 1 specialty drug insurance, covering more than 30 provincial administrative regions and 100 cities, significantly improving the product accessibility.
While commercialization potential continues to be realized, E-Gantai® continues to receive widespread attention and recognition from the international academic community. In the first half of this year, its research results were once again listed at the American Society of Clinical Oncology Annual Meeting (ASCO). Currently, E-Gantai®'s high-value real-world data has published a total of 100 posters and 7 oral reports at top international academic conferences in the field of oncology and liver disease, and related research results continue to be published in authoritative international journals.
Overseas, the market potential of E-Gantai® is also expected to be further unleashed along with the expansion of new indications. Currently, this product has been approved for CE certification for liver cancer patients in Europe. Its clinical study for treating unresectable HCC in the US reached the end of clinical research in April this year, and obtained excellent data of 90% complete remission rate, 99% optimal overall remission rate, and 100% local tumor control rate. As clinical research on new indications progresses steadily, E-Gantai® has more potential for long-term growth and is expected to become the standard treatment for “pan-liver cancer”.
The steady development of E-Gantai® overseas can be described as a strong proof of Yuanda Pharmaceutical's overseas clinical registration capabilities and commercial operation capabilities, while GPN01530-2 further validates the strong strength of the company's global R&D and registration layout. GPN01530-2 is a globally innovative FAP targeted drug developed by Yuanda Pharmaceutical. It has been approved to carry out phase I/II clinical studies for solid tumor diagnosis in the US and has been granted Fast Track Qualification (FTD) by the FDA. This certification not only authoritative recognition of its clinical value, but also opens up policy channels for subsequent priority review to benefit global patients as soon as possible. It also marks a breakthrough in the field of cutting-edge FAP target nuclear drugs in the field of cutting-edge FAP target nuclear drugs.
Judging from clinical study results, GPN01530-2 has excellent best-in-class potential. Compared with 18F-FDG, which is currently the mainstream product for diagnosing solid tumors, this product shows better clinical image contrast and accurate detection rate of positive lesions. Furthermore, compared with FAP targeted products of the same type, GPN01530-2 also has advantages in terms of tumor targeting performance, tumor uptake rate, and pharmacokinetic characteristics. If subsequent development goes well, GPN01530-2 may become an important breakthrough in solving the problem of solid tumor diagnosis, profoundly benefiting about 20 million cancer patients worldwide.
Under the product echelon layout of “growing one batch, introducing one batch, and reserving one batch”, Yuanda Pharmaceutical's nuclear drug industry is methodically fulfilling its commercial value. In 2026, the New Drug Marketing Application (NDA) for TLx591-cdx, an RDC product used to diagnose prostate cancer, was accepted by the State Drug Administration. Since the product was launched overseas in 2021, it has shown strong commercial explosive power. It achieved more than 600 million US dollars in revenue for the full year of 2025, an increase of more than 20% over the previous year. If it is successfully launched in China in the future, it is expected to bring a new treatment experience to domestic prostate cancer patients, and quickly reach the clinical side through Yuanda Pharmaceutical's mature nuclear drug commercialization network, becoming another strong growth engine for the company's performance.
From marketed products to NDA stage products to clinical research stage products, from the Chinese market to the global market, Yuanda Pharmaceutical has built a well-structured and stepped forward nuclear drug matrix. It has 14 innovative products in the R&D registration stage and more than 10 products in the early R&D stage, which can provide patients with a world-leading anti-tumor solution with multiple treatment options, multiple methods, and integrated diagnosis and treatment. In terms of the industrial chain, as a leading nuclear drug company, Yuanda Pharmaceutical has achieved a comprehensive layout of R&D, production, distribution, and sales, providing strong support for the steady implementation of the pipeline. The company's Chengdu Nuclear Drug Base is the world's first closed-loop platform for the entire nuclear drug industry chain. It is currently one of the smart factories with the most complete range of nuclides and the highest degree of automation in the world. It can achieve 100% independent production, solved the “stuck neck” problem of nuclear drugs, and laid a solid foundation for the company's localization of radiopharmaceuticals and global competition.
Currently, nuclear drugs have become a strategic highland for global pharmaceutical giants to compete. According to data from The Business Research Company, the global radiopharmaceuticals market will reach 8.25 billion US dollars in 2026, and will increase to 13.68 billion US dollars in 2030 at a compound annual growth rate of 13.5%. The domestic radiopharmaceuticals market is expected to grow from RMB 9.3 billion in 2025 to RMB 26 billion in 2030. With the recent implementation of many cases of mergers and acquisitions of enterprises within the industry, the development pattern of the domestic nuclear drug industry may have quietly changed: enterprise competition has moved from competition in product pipelines to competition over the capabilities of the entire industry chain.
Based on a complete industrial chain layout, Yuanda Pharmaceutical has taken a leading position in this round of nuclear drug development boom, and is expected to fully accept the expansion opportunities of domestic and foreign nuclear drug markets by relying on a rich pipeline matrix and closed loop R&D and production platform. At the same time, the company's “China and US Double Report” product clinical registration strategy will also further expand the value space of the company pipeline in the global nuclear drug market and further strengthen its competitive strength in the global nuclear drug field.
Diverse business segments blossom collaboratively, and ecological advantages enable high-quality growth
While the development prospects of the anti-tumor segment of nuclear drugs are becoming more and more promising, Yuanda Pharmaceutical also continues to make significant progress in the facial, mRNA, respiratory and critical care business sectors.
In the facial services sector in particular, not only did TP-03 achieve “zero supplement” approval for listing, adding new impetus to the company's performance growth, but the company is also continuing to expand into the field of chronic disease treatment by relying on proprietary Chinese medicines. As the world's first and only product approved for the treatment of demodex blepharitis, TP-03 was launched to provide targeted treatment for 50 million patients with demodex blepharitis in China.
It is worth noting that in the blue ocean of innovative eye medicine, Yuanda Pharmaceutical has built a “specialized, full-range, and multi-variety” innovative drug product system, and has prepared a variety of innovative global products to treat “dry eye,” “demodex blepharitis,” “post-operative anti-inflammatory and analgesic pain in ophthalmology,” “pterygium,” and “myopia,” building a leading differentiated competitive advantage.
In terms of proprietary Chinese medicines, Yuanda Pharmaceutical continues to deepen the “classic formulation+modern technology” research and development path to promote standardization of proprietary Chinese medicines. In the first half of the year, two important Class 1.1 innovative traditional Chinese medicine drugs achieved new milestones. GPN01360, which treats depression, completed the first phase III clinical study in China to enroll patients; GPN01020, which is used as a preventative treatment for migraine, has been approved by the Drug Administration to carry out phase II clinical research. Based on traditional Chinese medicine resources, the two products were optimized through modern pharmacology and clinical research and screening, and complete clinical trials were carried out in accordance with modern evidence-based medical standards. They not only provided new practical samples for modern innovation in traditional Chinese medicine, but also brought the “China Solution” to the two major conditions of depression and migraine.
At the same time, the company's innovative strength in the respiratory and critical care sector is also outstanding. STC3141, a small molecule compound with a new mechanism of action independently developed by Yuanda Pharmaceutical and with global intellectual property rights, is the world's first treatment plan for sepsis centered on reconstructing immune homeostasis as a global FIC drug candidate. At present, the domestic phase II clinical study of this product has successfully reached the main end point. The study results showed that the improvement effect of the 7-day sequential organ failure assessment (SOFA) score in the high-dose group was significantly superior to that of the placebo group. Sepsis is a major medical need that is not being met by clinical practice in the world. The barriers to research and development are extremely high, and the success rate of developing new drugs in the past is extremely low, yet the market space is vast, with about 49 million new cases being released worldwide every year. If STC3141 clinical research progresses smoothly in the future, it is expected to fill the global gap in sepsis-specific treatment drugs and grow into a major variety for critical care.
In addition, in the field of mRNA, which has recently received widespread market attention, Yuanda Pharmaceutical has also carried out a forward-looking layout. The company has built the world's leading mRNA technology platform with Nanjing Aurobio as the core. The two major mRNA core underlying technologies for mRNA nucleic acid drug development and lipid nanoparticle (LNP) delivery with independent intellectual property rights address key pain points in many industries, such as vaccine antigen design, targeted delivery in LNP, and process development. The technical base has cross-project reuse capabilities, strong expandability, and can support the development of diverse mRNA drug candidates. Currently, the company's research and development mainly focuses on areas with major clinical and public health significance, such as cancer treatment and infectious disease prevention, focusing on promoting research and development of two therapeutic mRNA vaccines for HPV-16 cervical cancer and HSV-2 genital herpes, and carrying out concept verification of a number of early R&D projects based on self-developed platform technology. Relying on this forward-looking layout, Yuanda Pharmaceutical has achieved early access to products and technologies in the mRNA field, which also provides important cutting-edge support for the company's long-term innovation iteration and future product incremental reserves.
Relying on a forward-looking product layout, the company is progressing smoothly with the commercialization of differentiated new products on respiratory and critical care tracks. In the field of respiratory and critical care, the allergic rhinitis product Lightling® completed its first prescription in the first half of the year, filling the gap in compound treatment for severe hyperallergic rhinitis among children aged 6 and above; innovative products such as Enzhuorun® and Enmingrun® continued to be released, and as related new products with differentiated clinical value were introduced to the market one after another, it not only perfected Yuanda Pharmaceutical's product matrix, but also opened up a new source of performance growth, building a solid foundation for the company's long-term development.
In addition to launching new products, Yuanda Pharmaceutical is also actively consolidating its innovative strength and further improving the construction of an innovation platform through school-enterprise linkages, etc. In the first half of the year, the company reached a strategic cooperation with the University of Hong Kong and its wholly-owned subsidiary, Hong Kong University Keqiao, to carry out in-depth cooperation in academic research, resource sharing, talent training and product development. In the future, it may effectively break down various barriers in the transformation of scientific research results into marketable drugs, accelerate the industrialization process of innovative drugs, and efficiently achieve the industrial transformation of cutting-edge scientific research results.
Looking back on the business performance in the first half of 2026, Yuanda Pharmaceutical's core competitiveness has surpassed a single product or single track, and is more reflected in the systemic advantages of multi-business sector collaboration, multi-disease field coverage, and full-chain capability integration. The company's various sectors have not only achieved vertical industrial chain integration, but also formed efficient collaboration of technology, channels and clinical resources on a horizontal dimension.
As various business segments move from “single-point breakthrough” to “system collaboration”, Yuanda Pharmaceutical's R&D, production and growth logic is evolving from product-driven to ecology-driven. In the context of the continuous release of innovative potential, the company is expected to further consolidate its leading edge in high-quality development with a unique layout where multiple tracks go hand in hand and the whole chain runs through.