Yuanda Pharmaceutical (00512) mid-report view: Nuclear drug leaders have realized their potential, and diversified innovation has built a solid foundation for long-term growth

Standing at the crossroads of innovation, the global nuclear drug market is in a critical cycle of pattern restructuring and value realization. As overseas giants such as Novartis, Eli Lilly, Roche, and BMS have successively landed on the nuclear drug circuit and once again pushed them into the spotlight of the industry, the market ushered in a development window with sharp increases in volume and price. The industry logic is also quietly iterating, and the focus of future competition has shifted to a comprehensive competition in the entire industry chain ecosystem.

In this context, on August 26, Yuanda Pharmaceutical (00512), one of the leading nuclear drug companies, announced its 2026 interim results. During the year, the company continued to implement innovation-driven and “Go Global” development strategies, focusing on high barriers such as nuclear drugs against cancer and severe infections. At the same time, it also laid out cutting-edge fields such as innovative mRNA drugs and innovative ophthalmology drugs, and built a short, medium- and long-term stepped innovation pipeline, and R&D transformation efficiency continued to improve. Benefiting from this, the company achieved revenue of about HK$6.39 billion during the period, an increase of about 3.2% year on year, and the adjusted net operating profit to be accounted for by the company's owners was about HK$970 million; the company's nuclear drug anti-tumor diagnosis and treatment segment achieved revenue of about HK$660 million, maintaining a rapid increase of about 55% year over year.

After a long period of intensive cultivation, the company's global clinical and “China and US Double Report” registration system is now mature. A number of products have obtained clinical approval from international drug regulatory agencies during the period; the clinical results of the core product, Yigantai® Yttrium [90Y] microsphere injection, have been included in top international journals and have successively been included in authoritative diagnosis and treatment guidelines at home and abroad, which strongly supports the commercialization process. At present, the company has reserved more than 30 high-value research and innovation projects. It is expected to achieve R&D milestones in 2027-2028. Sufficient pipeline reserves will bring growth momentum for long-term development.

Behind Yuanda Pharmaceutical's steady growth in performance, the nuclear drug anti-tumor diagnosis and treatment sector has played the most critical role. In recent years, Yuanda Pharmaceutical has repeatedly succeeded in the field of nuclear drugs, achieved all-round systematic breakthroughs, and its position as a global leader in nuclear medicine is gradually being consolidated.

From “diagnosis” to “treatment”, global innovation capabilities rank in the first tier of nuclear medicine

As the global precision medicine industry accelerates iteration, nuclide conjugated drugs have become a core track with high barriers and high certainty in the field of innovative drugs with precise targeting and integrated diagnosis and treatment. In an industry context where innovative domestic pharmaceutical companies are accelerating their global layout and industrial competition is shifting to competition for core technical barriers, Yuanda Pharmaceutical has relied on the “nuclear drug core” strategy that it has been adhering to for a long time and ushered in a critical window period for concentrated implementation of pipeline results.

In the first half of 2026, the company made substantial progress in developing products in the field of nuclear medicine, and its strategic value continued to be implemented. In the field of accurate diagnosis and treatment of prostate cancer, the company's core diagnostic product TLx591-cdx was officially accepted by the NMPA in January, and is expected to become the next major commercial product in the company's nuclear medicine sector.

According to our understanding, this product can accurately target prostate cancer lesions, and can achieve early screening, accurate staging, and dynamic monitoring of efficacy after surgery for prostate cancer. The overseas market performance of TLx591-CDx has already proven its commercial value. In 2025, the annual overseas revenue was about 600 million US dollars, an increase of more than 20% over the previous year, and was widely recognized by clinicians around the world for its highly specific clinical effects. It is expected to replicate the rapid overseas dosage trend after domestic marketing in the future.

At the same time, the associated therapeutic drug TLX591 is simultaneously promoting international multi-center phase III clinical trials. The “diagnosis+treatment” closed-loop program formed by the two major products is expected to fill the gap in the domestic market for accurate nuclear drug diagnosis and treatment of prostate cancer. Relying on global clinical data support, the pipeline has broad commercialization prospects and room for long-term growth.

If breakthroughs in the field of diagnosis are for “early detection,” then breakthroughs in the treatment circuit are anchored in “living longer.” In the field of precise interventional treatment for liver cancer, the company's core commercial product sir-spheres® (sir-spheres®) achieved a key clinical breakthrough during the period and became the “fault leader” in efficacy data on this racetrack.

In April of this year, Yuanda Pharmaceutical released DoorWay90 core clinical data. In the treatment of unresectable hepatocellular carcinoma (HCC), yttrium [90Y] microsphere injection achieved 100% local tumor control rate, and 75% of patients remained in remission for more than 6 months.

According to public information, HCC is the most common primary liver cancer (accounting for about 90%) and is also the most common cause of death in patients with liver cirrhosis. According to the CSCO guidelines, treatment options for HCC vary according to the stage of the disease: early HCC patients mainly use surgical resection and local area treatment, while systemic treatment is recommended for advanced patients.

Judging from this, the reason DoorWay90 clinical data is impressive is that traditional radiotherapy or interventional treatment is often accompanied by damage to liver function, and while E-Gantai® effectively kills tumors, more than 95% of patients maintained stable liver function over 12 months. This means that the vision of “high-quality survival with tumors” for patients with advanced liver cancer is becoming a reality. Based on this, this product has become the world's first and only dual-indication product approved by the FDA for unresectable HCC and colorectal cancer liver metastases.

In terms of market size, the number of new cases of liver cancer in China increased to 389,600 in 2025, with a compound annual growth rate of 2.1% from 2020 to 2025. It is expected to reach 436,000 cases in 2030 and 481,000 cases in 2035. China's HCC drug market increased from 7.2 billion yuan in 2020 to 16.7 billion yuan in 2025, with a compound annual growth rate of 18.4%. The market is expected to expand further to RMB 43.9 billion in 2035.

Currently, the company is cooperating with Chinese and foreign experts to develop other indications for yttrium [90Y] microsphere injections, and will use the “China and US Double Newspaper” international registration path to accelerate the global market expansion of this product. The impressive data from the DoorWay90 study not only further consolidates E-Gantai®'s leading position in the global liver cancer interventional treatment circuit, but also provides a core clinical basis for expanding domestic market indications, which will significantly accelerate the domestic market launch of products and further explore the domestic market potential for precise liver cancer treatment.

More importantly, on August 9, GPN01530-2, a FAP target radionuclide conjugation drug independently developed by Yuanda Pharmaceutical, obtained the Fast Track Qualification (FTD) granted by the US FDA. Fast Track eligibility is mainly granted to drugs under development to treat serious diseases and have the potential to address unmet medical needs. The aim is to speed up the review process for high-value pipelines. GPN01530-2 is the world's first FAP target diagnostic nuclear drug for solid tumors to obtain FDA Fast Track certification.

This authoritative certification marks that Yuanda Pharmaceutical's self-developed nuclear drug technology has officially entered the first tier of the world, breaking the technological monopoly of overseas companies in the field of pan-cancer nuclear drugs. The FDA's fast-track qualification will also significantly simplify its overseas approval process, shorten the R&D and marketing cycle, help the company take the lead in seizing the first-mover advantage on the global accurate diagnosis and treatment circuit for pan-cancer, and build differentiated technical barriers for it.

In terms of targets, FAP is not expressed or underexpressed in normal tissues, but is highly expressed in 90% of epithelial tumor tissues and tumor-related fibroblasts in various tumor microenvironments, and can cover a wide range of solid tumors, including lung cancer, colorectal cancer, pancreatic cancer, etc. This target is also regarded by the industry as one of the targets with the most clinical transformation value, attracting large multinational pharmaceutical companies, including Novartis, to take the lead.

Compared with traditional methods of diagnosis and treatment, GPN01530-2 has the core advantages of high targeting accuracy, excellent sensitivity, and wide cancer coverage. By optimizing the structure of FAP ligands, its uptake in tumor tissue is increased, and its uptake in normal tissues is reduced. Whether compared to similar FAP target products or fluorine [18F] -fluoride deoxyglucose (18F-FDG), which is currently the mainstream PET/CT imaging agent in the market, GPN01530-2 has shown significant advantages and great potential for BIC.

Judging from the market space, GPN01530-2 has plenty of potential for commercialization. According to public information, measuring the alternative market for 18F-FDG alone, there is a potential market space of over 5 billion US dollars, and the number of solid tumor patients it targets is still growing. As the number of patients grows, the global oncology drug market continues to expand. Frost & Sullivan data predicts that the global oncology drug market will reach 702.7 billion US dollars by 2035. In the huge and continuously growing cancer diagnosis and treatment market, an accurate, efficient and safe integrated diagnosis and treatment solution has become the core requirement of the industry, which also creates an excellent competitive opportunity for GPN01530-2.

In addition to continuous breakthroughs in the product pipeline, Yuanda Pharmaceutical's global industrial layout advantages continue to be highlighted. The company has established a global R&D, production and commercial sales network, making the entire chain of nuclear drugs autonomous and controllable from target research, clinical research, and isotope production to global commercialization.

As of mid-2026, the company is the only domestic nuclear drug enterprise with complete capabilities of “global authorization introduction+independent source innovation+full-chain industrial production+global commercialization”. The mature multinational management system and barriers throughout the industry chain make it extremely resilient to risks and continuous optimization capabilities in global nuclear drug industry competition. The prototype of a leading global nuclear medicine industry has taken full shape.

Multiple tracks work together to build barriers to long-term steady corporate growth

While continuing to lead the nuclear drug core circuit, Yuanda Pharmaceutical focuses on unmet clinical medical needs, and relies on a mature new drug research and development system, clinical transformation capabilities, and commercial implementation experience to refine a differentiated and innovative product matrix on multiple segments. The company adheres to the development strategy of precise layout and differentiated competition in multiple fields, and has achieved continuous breakthroughs in innovative product tracks specializing in respiratory and critical illness, innovative eye medicine, cardiovascular and cerebrovascular, etc., forming a comprehensive innovation system empowered by the core circuit and multiple businesses, and building a multi-level and highly resilient long-term growth barrier.

In the field of facial medicine, the company has been deeply involved in innovative ophthalmology for many years. Relying on a perfect R&D and innovation system, the company continues to lay out innovative products with both technical advantages and clinical advantages. Indications cover dry eye syndrome, demodex blepharitis, post-operative anti-inflammatory pain, pterygium, and myopia. With excellent efficacy and safety, the company has formed differentiated competitiveness in the specialist diagnosis and treatment market.

In March 2026, Yuanda Pharmaceutical's innovative global ophthalmic drug GPN01768 (lotirana eye drops) for the treatment of demodex blepharitis was approved for sale in China. This product is the world's first and currently the only medicine dedicated to the treatment of demodex blepharitis. Since the product was launched in the US in 2023, sales revenue has exploded. In 2025, it achieved revenue of about 450 million US dollars in the US, an increase of more than 150% over the previous year. The peak sales volume is expected to exceed 2 billion US dollars. It is expected to become another popular single product of Yuanda Pharmaceutical in the future.

In addition, the company's respiratory and critical care research pipeline also has great potential. The phase II clinical study of STC3141, a global innovative small-molecule compound with a new mechanism of action independently developed by Yuanda Pharmaceutical, has already successfully reached the clinical end in China. With its unique causal treatment idea centered on regulating the body's immune status, it is expected to become the world's first treatment plan for sepsis centered on reestablishing immune homeostasis.

Clinical study data showed that the improvement in the 7-day sequential organ failure assessment (SOFA) score in the pharmacotherapy group was significantly superior to that of the placebo group; furthermore, STC3141 had good safety and tolerability, and pharmacokinetics were in line with expectations. The results of this excellent clinical study have brought new hope for global sepsis treatment.

According to information, the sepsis treatment market is a blue ocean containing over 10 billion US dollars. This disease is the leading cause of death in intensive care units around the world, and there is still no specific treatment. The incidence of sepsis in intensive care units in China is as high as 20.6% to 50.8%, and the number of deaths due to sepsis worldwide every year is about 11 million. With the high mortality rate, the cost of treating sepsis remains high. If successfully marketed later, STC3141 will not only break the long-term treatment dilemma of untargeted drugs for this disease, but is also expected to fill the gap in the market for treatment of sepsis and completely disrupt the critical care pattern.

At the same time, in the field of cutting-edge biotechnology, Yuanda Pharmaceutical has also carried out a forward-looking layout. With Nanjing Aolo Biotechnology Co., Ltd. as the core, the company has built the world's leading mRNA technology platform, a high-quality track for strategic card position mRNA. According to information, Oro Biotech has two core mRNA underlying technologies for mRNA nucleic acid drug development and lipid nanoparticle (LNP) delivery with independent intellectual property rights, which address key pain points in many industries, such as vaccine antigen design, targeted delivery within LNP, and process development. The technical base has cross-project reuse capabilities, is highly expandable, and can support the development of diverse mRNA drug candidates.

Currently, Auro Biotech's research and development mainly focuses on areas with major clinical and public health significance, such as cancer treatment and infectious disease prevention. It is currently focusing on promoting research and development of two therapeutic mRNA vaccines for HPV-16 cervical cancer and HSV-2 genital herpes, and is carrying out concept verification for a number of early R&D projects based on self-developed platform technology.

Multi-track collaborative breakthroughs have fully demonstrated Yuanda Pharmaceuticals' accurate strategic layout capabilities and efficient product implementation capabilities. The company is not limited to cultivating the advantages of a single nuclear drug circuit, but instead continues to extend the high-quality medical circuit outward with innovative technology as the core. Through technology accumulation and resource integration in multiple fields, it has consolidated the industry position of a comprehensive innovative pharmaceutical enterprise with “nuclear drugs as the core, diversified collaboration”.

epilogue

According to statistics from Guoxin Securities, since this year, the cumulative net inflow of capital from the Hong Kong Stock Exchange to the south has exceeded HK$360 billion, and recently, due to fluctuations in the Hong Kong stock market, southbound capital has shown an overall inflow. On the other hand, foreign investors have maintained a bullish trend in the Hong Kong stock market as a whole. As of July this year, the total net inflow of active foreign capital and passive foreign capital in Hong Kong stocks has exceeded 18 billion US dollars.

It is easy to see that global capital is increasing the Hong Kong stock market at an accelerated pace. The underlying logic is that the US dollar credit margin has recently been under pressure, and the momentum for the allocation of Hong Kong stocks has increased. Meanwhile, in the segmented circuit, based on the number of individual stocks that hit a 250-day high, the new efficiency of the pharmaceutical sector should be the most obvious. In this market context, Yuanda Pharmaceutical, which has begun to take the prototype of the global nuclear drug MNC, is undoubtedly expected to continue to be sought after by the Hong Kong Stock Exchange Southbound Fund.

From a long-term perspective, with continuous breakthroughs in core products under development and gradual implementation in the global market, Yuanda Pharmaceutical is expected to grow from a leading domestic nuclear drug company to an international innovative pharmaceutical company with global competitiveness. Its strategic value of “nuclear drugs as the core” will continue to be unleashed, and the valuation will be re-evaluated by the market.

In response, many major brokerage firms, including Changjiang Securities, Huatai Securities, Guoxin Securities, and Tianfeng Securities, have expressed their unanimous optimism about the future development of Yuanda Pharmaceutical. Among them, Huatai Securities gave the company a “buy” rating, with a target price of HK$12; Guoxin Securities believes that since 2015, Yuanda Pharmaceutical has accelerated innovation and transformation and has built a “gradation+differentiation” pipeline in the three sectors of nuclear drug anti-tumor, precise cardiovascular and cerebrovascular intervention, and pharmaceutical technology, looking forward to clinical progress and commercialization volume in the nuclear drug sector.

Considering Yuanda Pharmaceutical's strong competitive advantage in differentiated innovation and global commercialization, as well as its huge space as a nuclear drug leader, the company's long-term value trend clearly conforms to the current tone of Hong Kong pharmaceutical investment. Therefore, at a time when market sentiment is picking up and sector trend reversals are established, the company's stock price is expected to usher in a “double hit by Davis”, showing considerable upward elasticity to market investors.