Spring gives rise, summer nurtures growth, autumn brings harvest, and winter stores strength. Standing at the turning point of time and looking back on 2025, we witnessed an era of rapid change and a powerful wave of innovation.
In 2025, Grand Pharmaceutical Group pursued development through innovation and advanced its position through perseverance. With steady steps on the path of high-quality growth, the Company delivered a substantial year-end report marked by breakthrough achievements and strategic milestones.
Rekindling our original aspirations and gathering strength for the journey ahead, we revisit the “highlight moments” of Grand Pharma people and reflect on those unforgettable milestones.
I. Innovation-Driven Growth: Breakthroughs in R&D
In 2025, Grand Pharma achieved a series of major R&D milestones across radiopharmaceuticals, innovative ophthalmic drugs, traditional Chinese medicine innovation, and multiple cutting-edge therapeutic areas.
1. ITM-11 Achieves Multiple Clinical Milestones
Towards Full-Course Coverage of GEP-NETs
In March, ITM-11, an innovative radiopharmaceutical drug conjugate (RDC) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), enrolled and dosed its first patient in China in an international multicenter Phase III clinical trial. In December, its New Drug Application (NDA) was officially accepted by the U.S. FDA.
2. TLX101 Phase II Overseas Trial Releases Preliminary Results
A New Dawn for Glioma Treatment
In April, preliminary results from the overseas Phase II IPAX-Linz study of TLX101—an innovative global RDC for the treatment of glioblastoma—demonstrated confirmed patient benefits.
3. GPN02006 Achieves Landmark Progress in China
A New Option for Precision Diagnosis of HCC
In April, investigator-initiated clinical research (IIT) of GPN02006, a globally innovative RDC for hepatocellular carcinoma (HCC) diagnosis, achieved landmark progress in China. The clinical results were publicly presented at the 2025 Future XDC New Drug Conference in Chengdu.
4. STC3141 Phase II Trial in China Successfully Meets Endpoint
Potentially Filling a Clinical Gap in Sepsis Treatment
In May, the Phase II clinical trial of STC3141 for the treatment of sepsis in China successfully met its clinical endpoint. The program ranks among the most advanced globally and represents the world’s first sepsis therapy centered on immune homeostasis reconstruction.
5. CBT-001 Achieves Major Clinical Progress
New Breakthrough in Ophthalmology
In June, the global multicenter Phase III clinical trial of CBT-001 (GPN00153), an innovative ophthalmic drug for pterygium, completed enrollment of all patients worldwide.
6. SIR-Spheres® Y-90 Receives Approval for New Indications
Strengthening Global Leadership in Radiopharmaceuticals
In July, SIR-Spheres® Y-90 resin microsphere injection (YiGanTai®), from associate company Sirtex Medical Pty Ltd, received FDA approval for a new indication in the U.S. In September, it also obtained CE mark approval for a new indication in Europe.
7. TLX591 Achieves New Clinical Milestone
Further Enriching the Radiopharmaceutical Portfolio
In July, TLX591, an innovative RDC for prostate cancer, received implicit approval from China’s NMPA to join an international multicenter Phase III clinical trial.
8. aXess Reports Successful Pivotal Clinical Data
Transformative Potential in Hemodialysis
In October, the innovative endogenous tissue repair product aXess reported successful pivotal clinical trial data, demonstrating revolutionary potential in the hemodialysis field.
9. GPN00289 Completes Patient Enrollment
Reinforcing Global Leadership in Radiopharmaceuticals
In October, the registrational clinical trial of GPN00289, a temperature-sensitive embolic agent for TACE treatment of primary liver cancer in China, completed full patient enrollment.
10. GPN00884 Achieves New Clinical Progress
Strengthening Leadership in Ophthalmology
In October, the Phase IIa clinical trial of GPN00884, an innovative ophthalmic drug for delaying myopia progression in children, enrolled its first patient in China.
11. TLX591-CDx Phase III Trial in China Meets Primary Endpoint
A Key Step Toward Precision Diagnosis of Prostate Cancer
In December, the Phase III clinical trial of TLX591-CDx in China successfully met its primary clinical endpoint.
12. GPN01530 Approved for Clinical Trials in the U.S.
A New Breakthrough in Global Radiopharmaceutical Expansion
In December, the U.S. FDA approved Grand Pharma’s self-developed RDC GPN01530 to initiate Phase I/II clinical trials for solid tumor diagnosis.
13. GPN01360 Phase II Trial in China Succeeds
A New Option for Depression Treatment
In December, the Phase II clinical trial of GPN01360, an innovative traditional Chinese medicine for depression, successfully met its endpoint, marking a major milestone in Grand Pharma’s otolaryngology-focused TCM pipeline.
II. Pipeline Acceleration: Product Approvals and Market Launches
In 2025, multiple globally innovative and domestically developed flagship products of Grand Pharma were approved for market launch, benefiting a broad patient population.
1. NeoNova® Transcatheter Mitral Valve Repair System Approved
A Milestone in Precision Cardiovascular Intervention
On February 8, NeoNova®, jointly launched with Trulive, received marketing approval from China’s National Medical Products Administration (NMPA). In May, the first batch of commercial implantations was officially initiated across multiple centers nationwide. On November 16, two-year follow-up data were unveiled for the first time at PCR London Valves, a leading global conference on transcatheter heart valve therapies.
2. Distal Radial Access Catheter Approved
A New Option for Neurovascular Intervention
In April, the distal radial access catheter received marketing approval, providing patients with additional minimally invasive treatment options.
3. Fluticasone Propionate Nasal Spray Approved
Major Progress in Respiratory and Critical and Severe Disease
In April, fluticasone propionate nasal spray obtained its drug registration certificate from the NMPA. As China’s first generic version, the product has been included in both the National Reimbursement Drug List (NRDL) and the National Essential Medicines List.
4. First Prescription Issued for Early Urological Cancer Screening Product
Strengthening Diagnostic Advantages in Urological Oncology
In April, the first commercial prescription of UI-SEEK (优爱®)—jointly developed with AcornMed—was issued at Huadong Hospital affiliated with Fudan University in Shanghai. This marked the clinical application of China’s only approved early screening product for urothelial carcinoma based on a dual mechanism of methylation and gene mutation detection.
5. GPN01768 Approved in Macao, China
Poised to Fill Domestic Clinical Gaps
In May, GPN01768 (TP-03, lotilaner ophthalmic solution 0.25%), a globally innovative ophthalmic drug, was officially approved for marketing in Macao, China.
6. Coronary Intravascular Lithotripsy System Approved
New Breakthrough in Precision Cardiovascular Intervention
In July, the coronary intravascular lithotripsy system (DEEPQUAKE-C), developed by Jiangsu Trulive and promoted by Grand Pharma, received NMPA approval for market launch.
7. New Specification of Treprostinil Injection Approved
Major Advancement in Cardiovascular Emergency Care
On September 22, a new specification (20 ml: 50 mg) of treprostinil injection received its drug registration certificate from the NMPA. As a reimbursed drug, this approval represents a significant milestone in Grand Pharma’s rare disease portfolio within cardiovascular emergency care.
8. Varenicline Tartrate Nasal Spray Launched Nationwide
Ushering in a New Era of Dry Eye Treatment
On October 25, the “2025 Conference on Advances in Dry Eye Diagnosis and Treatment and Ocular Surface Health Ecosystem” was held in Beijing, during which Grand Pharma officially announced the nationwide launch of varenicline tartrate nasal spray.
9. Ryaltris® Combination Nasal Spray Approved
Further Strengthening the Respiratory and Criticaland Severe Disease Pipeline
In November, Ryaltris® (GSP301NS), a globally innovative combination nasal spray co-developed with Glenmark Specialty S.A., received marketing approval from the NMPA and was approved for launch with zero supplementary data requests.
III. Deepening Global Reach: Advancing the “Go Global” Strategy
In 2025, Grand Pharma continued to advance its “Go Global” strategy through international partnerships, capital market recognition, and industrial chain deployment, accelerating global expansion.
1. Strategic Partnership with Trulive
Jointly Shaping a New Cardiovascular Landscape
On March 11, Grand Pharma entered into a strategic cooperation agreement with Jiangsu Trulive, under which the two companies will collaborate to advance cardiovascular product offerings by leveraging respective expertise and resources.
2. Strategic Cooperation with Six Health Technology Companies
Exploring Innovation in Commercial Health Insurance
On March 26, Grand Pharma formed strategic partnerships with six enterprises, including Medi Cover and MediTrust Health, to explore inclusive commercial insurance models and innovative payment solutions.
3. World’s First Fully Integrated Intelligent Radiopharmaceutical R&D and Manufacturing Base Commences
A Key Milestone in Radiopharmaceutical Strategy
In June, the global radiopharmaceutical R&D and manufacturing base in Wenjiang, Chengdu officially commenced operations. Signed at the end of 2022, the facility obtained a Class A Radiation Safety License from China’s Ministry of Ecology and Environment on May 15, 2025, completing construction in a record-breaking two-year timeframe.
4. Strategic Cooperation with Belgium’s IRE ELiT
Securing Core Resources in the Radiopharmaceutical Supply Chain
In July, Grand Pharma entered into a deep strategic partnership with IRE ELiT, a global leader in radioisotope technology, becoming its sole supplier and service provider of medical-grade germanium–gallium generators in China.
5. Participation in BIOHK 2025
Sharing Global Radiopharmaceutical Development Insights
In September, Grand Pharma was invited to the Hong Kong International Biotechnology Forum and Exhibition (BIOHK), where it shared its strategic achievements in global radiopharmaceutical value chain development and discussed industry trends.
6. Collaboration on VTAS
Building a Comprehensive Urological Treatment Portfolio
In September, Grand Pharma signed a cooperation agreement with Shanghai Yingte Weiluo, securing global exclusive commercialization rights for VTAS, a steam ablation system for benign prostatic hyperplasia.
7. Joint Innovation Research Center with Jiangxia Laboratory
Industry–Academia–Research Collaboration for World-Class R&D
On November 19, Grand Pharma signed an agreement with Hubei Jiangxia Laboratory to establish a Joint Innovation Research Center, creating a leading domestic biomedical R&D platform.
8. Participation in the Jefferies Global Healthcare Conference
Showcasing a Benchmark Model for Radiopharmaceutical Globalization with “Go Global” strategy
In November, Grand Pharma participated in the Jefferies Global Healthcare Conference, systematically presenting its “Go Global” strategy and demonstrating its transition from a leading Chinese pharmaceutical company to a large multinational pharmaceutical enterprise.
9. Inclusion in the Hang Seng Stock Exchange Technology 100 Index
Capital Markets Affirm Innovation Strength
In December, Grand Pharma was successfully included as a constituent of the Hong Kong Exchange Technology 100 Index, reflecting authoritative recognition of its market value and growth potential.
10. Introduction of the World’s First Epinephrine Nasal Spray for Severe Allergic Reactions
Strengthening the Cardiovascular Emergency Portfolio
In December, Grand Pharma entered into a cooperation agreement with Pediatrix Therapeutics, securing exclusive commercialization rights in Mainland China and non-exclusive rights in Hong Kong SAR for Neffy® (优敏速®), the world’s first epinephrine nasal spray.
IV. Fulfilling Responsibility: Expanding Industry and Social Impact
In 2025, Grand Pharma empowered industry progress through technological innovation and conveyed corporate responsibility through public welfare initiatives, continuously enhancing its social value.
1. Release of 2024 Annual Results
Continued Growth in Innovation Investment
In March, Grand Pharma released its 2024 annual results, reporting revenue of approximately HKD 11.64 billion and total R&D and project investment of approximately HKD 2.27 billion, with 63 major milestone achievements during the year.
2. “Y-90 Little Red Flower” Patient Assistance Program
Supporting Thousands of Liver Cancer Patients
In April, Phase III of the “Y-90 Little Red Flower Health Fund – Patient Assistance Program” was launched in Zhengzhou, providing financial support to low-income patients with hepatocellular carcinoma and colorectal cancer liver metastases. Combined with regional inclusive insurance programs, the initiative has benefited thousands of patients to date.
3. Y-90 Research Achievements Presented on the Global Stage
Core Radiopharmaceutical Clinical Data Gains Global Attention
In May, multiple research achievements related to SIR-Spheres® Y-90 resin microsphere injection (YiGanTai®) were presented internationally. Two abstracts were accepted by the ASCO Annual Meeting, and 15 Chinese studies were selected for the 2025 Asia-Pacific Primary Liver Cancer Expert Meeting.
4. Donation of Mosquito Control Agents for Epidemic Prevention
Building a Closed-Loop Public Welfare Model
In August, in response to a chikungunya outbreak in Guangdong, Grand Pharma urgently donated one ton of Kono Bti biological mosquito control agents to Foshan’s Gaoming District, accompanied by on-site technical support, forming a closed-loop “product + technology + service” public health assistance model.
5. 2025 Interim Results Briefing and Investor Open Day
Showcasing the Radiopharmaceutical Strategy
On August 20, Grand Pharma hosted its interim results briefing and investor open day, sharing operational highlights and innovation strategies in radiopharmaceuticals and critical care, and organizing on-site visits to the Wenjiang radiopharmaceutical base.
6. Cineole Enteric Capsules Published in International Journal
Growing Global Academic Influence
In September, a multicenter clinical study on Cineole Enteric Capsules, led by Professor Wang Dehui of Fudan University Eye & ENT Hospital and involving 13 regional medical centers, was published in International Immunopharmacology. This marked the first large-scale clinical study of domestically developed mucolytic expectorants published in a high-impact international journal.
7. 能气朗® Coenzyme Q10 Donation Program
Safeguarding the Health of DMD Patients
Grand Pharma continued its Coenzyme Q10 donation program for patients with Duchenne muscular dystrophy (DMD), donating 6,000 boxes of 能气朗® CoQ10 tablets throughout the year, benefiting over 400 patients across more than 20 provinces.
8. Launch of the Science & Technology Center
Creating a Biomedical Innovation Benchmark in Central China
In December, Grand Pharma officially inaugurated its Science & Technology Center, focusing on major disease areas such as anti-infectives, oncology, ophthalmology, and cardiovascular diseases, and covering core directions including advanced formulations and peptide drugs. Leveraging international resources, the Center aims to become a leading innovation hub and benchmark in Central China.
Advancing Through Turbulence, Growing Stronger Through Innovation
In the year ahead, Grand Pharma will continue to uphold its strategy of “global operational deployment and dual-circulation development,” contributing greater strength to the Healthy China initiative and striving to become a technology-driven, international pharmaceutical enterprise respected by doctors, trusted by patients, and committed to giving back to society.
