远大医药(00512) - 2025 - 中期财报

Company Information This section provides essential company details, including board composition, committees, and key operational contacts Board of Directors and Committees This chapter lists the company's executive and independent non-executive directors, company secretary, authorized representatives, and details the composition of the Audit, Remuneration, and Nomination Committees - The Board of Directors comprises executive directors including Dr. Tang Weikun (Chairman), Mr. Zhou Chao (CEO), Mr. Yang Guang, Ms. Lin Zhiyi, and independent non-executive directors including Ms. Su Caiyun, Dr. Xing Lina, Dr. Pei Geng, and Mr. Hu Yebi[5] - The Audit Committee, Remuneration Committee, and Nomination Committee are all chaired by independent non-executive director Ms. Su Caiyun[5] Company Basic Information This chapter provides the company's official website, auditor, legal counsel, share registrar, principal bankers, registered office, and principal place of business - The company's website is www.grandpharm.com[5](index=5&type=chunk) - The auditor is National Alliance CPA Group Limited, and the Hong Kong share registrar is Computershare Hong Kong Investor Services Limited[5] - Principal bankers include The Hongkong and Shanghai Banking Corporation Limited, Bank of China, and Bank of Communications[6] Letter to Shareholders This section provides an overview of the industry, a summary of the company's business performance, and its future outlook Industry Review China's pharmaceutical industry is undergoing transformation, with policy guidance optimizing the industrial landscape, reshaping prices for traditional sectors, and encouraging innovation - China's pharmaceutical industry is advancing amidst transformation, with the industrial landscape continuously optimizing under policy guidance[7] - Some traditional industries face price system reshaping, demanding higher requirements for enterprises' product structure, cost control, and operational efficiency[7] - Policies encourage genuine innovation, and systems like the commercial health insurance innovative drug catalog are expected to open up broad development space for innovative drugs[7] Business Summary Grand Pharma achieved positive revenue growth in a complex industry environment, with innovative and barrier products accounting for 51.0% of revenue, a 14.9 percentage point year-on-year increase - In the first half of the year, the company achieved positive revenue growth despite pressure from centralized procurement price reductions[9] - Revenue from innovative and barrier products accounted for approximately 51.0% of total revenue, a 14.9 percentage point year-on-year increase[9] - The nuclear medicine anti-tumor diagnosis and treatment segment achieved doubled revenue growth, with Yigantai® and LavaTM seeing increased sales[11] - The company has established eight R&D platforms covering three major countries or regions globally, encompassing nuclear medicine, high-end medical devices, glycomics, and mRNA and other cutting-edge technologies[12] Strategy and Performance Grand Pharma adheres to its "integrated advantages, innovation-driven, global expansion" strategy, achieving positive revenue growth despite centralized procurement price reductions, with innovative and barrier products accounting for 51.0% of revenue - The company adheres to its "integrated advantages, innovation-driven, global expansion" strategy, evolving from an innovation newcomer to a leader in niche segments[8] - Revenue achieved a 12.1% compound annual growth rate over five years, with positive revenue growth in the first half of the year despite the impact of centralized procurement price reductions[9] - First Half Innovative and Barrier Product Revenue Share | Indicator | H1 2025 | Change | | :--- | :--- | :--- | | Innovative and barrier product revenue share | 51.0% | 14.9 percentage points year-on-year increase | Core Business Segment Highlights The company achieved doubled revenue growth in nuclear medicine anti-tumor diagnosis and treatment, significant growth in cardiovascular and cerebrovascular emergency care through M&A, synergistic product development in respiratory and critical care, and continuous launch of innovative ophthalmic products in ENT & Ophthalmology - The nuclear medicine anti-tumor diagnosis and treatment segment saw increased sales of Yigantai® Yttrium [90Y] Microspheres Injection and liquid embolic agent LavaTM, driving doubled revenue growth for the segment[11] - In the cardiovascular and cerebrovascular emergency segment, Nengqilang® Coenzyme Q10 Tablets continued to lead, and Grand Pharma (Tianjin) Co., Ltd. achieved significant growth after acquisition[11] - In the respiratory and critical care segment, Enzhuorun® Bisihaler®, Enmingrun® Bisihaler®, and Budesonide Nasal Spray synergistically drove stable growth[11] - In the ENT & Ophthalmology segment, innovative ophthalmic products such as GPN01768 (TP-03) and Varenicline Tartrate Nasal Spray (OC-01) were successively launched in regional markets, fueling growth momentum[11] Innovation and R&D The company maintains high R&D investment, establishing eight global R&D platforms covering nuclear medicine, high-end medical devices, glycomics, and mRNA, with a pipeline of innovative projects progressing globally - The company maintains high R&D investment, establishing eight R&D platforms covering three major countries or regions globally, encompassing nuclear medicine, high-end medical devices, glycomics, and mRNA and other cutting-edge technologies[12] - The innovative pipeline spans the entire process from "early R&D to clinical development and registration application," with R&D projects expanding to mainstream global markets such as the US, Australia, and Europe[12] - The disruptive innovative drug STC3141 (for sepsis treatment) has completed animal models, overseas Phase II, and China Phase II clinical studies, laying the foundation for global pivotal registration clinical studies[12] - Significant innovation advantages in nuclear medicine, with Yigantai® Yttrium [90Y] Microspheres Injection achieving doubled domestic revenue and approval for a new HCC indication, becoming the world's first and only FDA-approved selective internal radiation therapy product for both unresectable HCC and colorectal cancer liver metastases[13] Globalization Expansion The company is steadily advancing its global expansion, with the world's first closed-loop nuclear medicine full industry chain platform in operation and exclusive agency rights for pharmaceutical-grade Germanium-68/Gallium-68 generators in China - The world's first closed-loop nuclear medicine full industry chain platform has been put into operation, securing exclusive agency rights for globally leading pharmaceutical-grade Germanium-68/Gallium-68 generators in China[13] - Self-developed innovative nuclear medicines adhere to a "dual US-China submission" strategy, with products like TLX591 and ITM-11 joining international multi-center Phase III clinical trials[13] Future Outlook Grand Pharma is prepared for global expansion, committed to becoming a leader in global pharmaceutical enterprise layout and a key definer of the global pharmaceutical innovation landscape - The company will deeply implement its "global expansion" strategy, aiming to become a leader in the global layout of Chinese pharmaceutical enterprises and a significant definer of the global pharmaceutical innovation landscape[14] - R&D will continue to advance, ensuring early fruition of core pipelines, especially STC3141, which has a market potential of tens of billions[14] - Through independent innovation and external M&A, the company will identify differentiated blockbuster products and improve product and industrial layouts across various business segments[16] - The company is committed to building a global pharmaceutical brand with a "Go Global" strategy, independently operating international multi-center clinical trials, exploring diverse international cooperation forms, and increasing global market penetration[16] Company Overview This section outlines the company's strategic positioning, R&D status, material matters, and definitions of key terms Company Positioning Grand Pharma is positioned as a technology-innovative international pharmaceutical enterprise, with core businesses spanning nuclear medicine anti-tumor diagnosis & treatment, cardiovascular & cerebrovascular precision intervention technology, pharmaceutical technology, and biotechnology - The Group is a technology-innovative international pharmaceutical enterprise, with core businesses spanning nuclear medicine anti-tumor diagnosis & treatment and cardiovascular & cerebrovascular precision intervention technology, pharmaceutical technology, and biotechnology[18] - Adhering to the development philosophy of "integrated advantages, innovation-driven, and global expansion," the company employs a strategy of "dual-driven independent R&D and global expansion, globalized operational layout, and dual-cycle business development"[18] - Profitability continues to strengthen, with good M&A and integration capabilities, API-formulation integration, and diversified businesses and entities, effectively enhancing overall advantages[18] R&D Status Grand Pharma has 133 R&D projects, including 42 innovative projects, with R&D investment of approximately HKD 1.02 billion, focusing on nuclear medicine anti-tumor diagnosis & treatment, cardiovascular & cerebrovascular precision intervention, and ENT & Ophthalmology - R&D Project Overview | Indicator | Quantity/Amount | | :--- | :--- | | Total R&D projects | 133 | | Innovative projects | 42 (32%) | | Generic projects and others | 91 (68%) | | R&D work and project investment | Approximately HKD 1.02 billion | | R&D centers | 8 | | R&D platforms | 5 | - Distribution of 42 Innovative Projects by Area | Area | Percentage | | :--- | :--- | | Nuclear Medicine Anti-tumor Diagnosis & Treatment | 40% | | Cardiovascular & Cerebrovascular Precision Intervention | 19% | | ENT & Ophthalmology | 17% | | Respiratory and Critical Care | 14% | | Cardiovascular & Cerebrovascular Emergency | 5% | | Others | 5% | R&D Project Overview The company has a total of 133 R&D projects, with 32% being innovative projects and 68% generic or other projects, with R&D investment of approximately HKD 1.02 billion, achieving 38 major milestones - A total of 133 R&D projects, including 42 innovative projects and 91 generic projects and others[20] - R&D work and project investment amounted to approximately HKD 1.02 billion[20] - 38 major milestones have been achieved[20] Innovation Project Area Distribution Among the 42 innovative projects, nuclear medicine anti-tumor diagnosis & treatment accounts for the highest proportion at 40%, followed by cardiovascular & cerebrovascular precision intervention (19%) and ENT & Ophthalmology (17%), demonstrating the company's strategic focus in these areas - Innovation Project Area Distribution | Area | Percentage | | :--- | :--- | | Nuclear Medicine Anti-tumor Diagnosis & Treatment | 40% | | Cardiovascular & Cerebrovascular Precision Intervention | 19% | | ENT & Ophthalmology | 17% | | Respiratory and Critical Care | 14% | | Cardiovascular & Cerebrovascular Emergency | 5% | | Others | 5% | Innovation Product Pipeline Layout The company's innovative product pipeline covers pharmaceutical technology (ENT & Ophthalmology, respiratory and critical care, mRNA platform) and nuclear medicine anti-tumor diagnosis & treatment and cardiovascular & cerebrovascular precision intervention technology, involving various products and indications at different R&D stages - The pharmaceutical technology segment includes ophthalmic products GPN00153, TP-03, GPN00884, respiratory products Ryaltris, STC3141, and the mRNA platform oncology product ARC01[24] - The nuclear medicine anti-tumor diagnosis & treatment and cardiovascular & cerebrovascular precision intervention technology segment includes Yttrium [90Y] Microspheres Injection, Lava, Kona, AuroLase, Youhu, Youai MRD, TLX591, TLX250, TLX101, ITM-11, ITM-41, GPN02006, covering various cancer diagnoses and treatments[24] - The cardiovascular & cerebrovascular precision intervention segment includes peripheral vascular access management products aXess, GPG03961, neuro-interventional product GPN01037, structural heart disease product Saturn, and heart failure product CoRisma[24] Material Matters As of the reporting date, the company has achieved multiple significant advancements in innovative product R&D, commercialization, and industrial base construction, including TLX591's approval for international multi-center Phase III clinical trials, OC-01's commercial launch in mainland China, and FDA approval for a new indication for Yigantai® Yttrium [90Y] Microspheres Injection - TLX591 (prostate cancer RDC drug) received NMPA approval to join international multi-center Phase III clinical trials[25] - OC-01 (Varenicline Tartrate Nasal Spray, dry eye disease) completed its first commercial prescription in mainland China[25] - SIR-Spheres® Yttrium [90Y] Microspheres Injection received formal FDA approval for a new indication for the treatment of unresectable hepatocellular carcinoma[25] - The world's first closed-loop nuclear medicine full industry chain platform (Wenjiang District, Chengdu) obtained a Class A "Radiation Safety Permit" and commenced operations[25] - STC3141 (sepsis) Phase II clinical study in China successfully reached its clinical endpoint[25] - Youai® early detection product for urological tumors achieved its first commercial prescription in mainland China[26] Definitions This chapter provides definitions for key terms and abbreviations used in the report, covering medical conditions, drug types, regulatory bodies, company entities, and research projects, ensuring a clear understanding of the report's content - Defines various medical terms such as AR (Allergic Rhinitis), ARDS (Acute Respiratory Distress Syndrome), HCC (Hepatocellular Carcinoma), GEP-NETs (Gastroenteropancreatic Neuroendocrine Tumors), etc[27] - Explains drug types and technologies such as RDC (Radiopharmaceutical Drug Conjugate), mRNA (messenger ribonucleic acid), LNP (Lipid Nanoparticle), etc[28] - Lists regulatory body abbreviations such as FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), NMPA or China NMPA (National Medical Products Administration of China)[27][28] - Includes names of company-related entities such as Sirtex, Telix, ITM SE, Macao Pharmaceutical Administration Bureau, Grand Pharma (China), etc[28][29] Financial Highlights This section presents key financial data for the company from 2022 to the first half of 2025, including revenue and net profit attributable to owners, illustrating overall financial performance during the reporting period Key Financial Indicators This chapter provides the company's key financial data from 2022 to the first half of 2025, including revenue and net profit attributable to owners, showing the company's overall financial performance during the reporting period - Key Financial Data (HKD thousands) | Indicator | 2022 | 2023 | 2024 | H1 2024 | H1 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | 9,562,285 | 10,529,590 | 11,644,892 | 6,047,236 | 6,107,323 | | Net Profit Attributable to Owners | 2,079,419 | 1,879,998 | 2,468,375 | 1,557,945 | 1,169,019 | Management Discussion and Analysis This section provides a comprehensive review of the company's business, financial performance, R&D, commercialization capabilities, internationalization, significant investments, and other material matters Business Review and Outlook As of the 2025 reporting period, the company achieved 38 major milestones in innovative products, generic products, APIs, and industrial layout, with core products in nuclear medicine anti-tumor, respiratory and critical care, and cardiovascular and cerebrovascular emergency segments entering rapid growth phases - As of the 2025 reporting period, the Group achieved 38 major milestones, including 16 innovative products, 13 generic products, 3 API products, 2 industrial layouts, and 4 major construction projects[32] - Core products in the nuclear medicine anti-tumor segment (Yigantai® Yttrium [90Y] Microspheres Injection and liquid embolic agent LavaTM), respiratory and critical care segment (Enzhuorun® Bisihaler®, Enmingrun® Bisihaler®, Budesonide Nasal Spray, and Fluticasone Propionate Nasal Spray), and cardiovascular and cerebrovascular emergency segment (Nengqilang® Coenzyme Q10 Tablets) have entered a rapid growth phase[32] - Completed the acquisition of a 30.64% equity stake in Nanjing Kainer Medical Technology Co., Ltd., increasing its holding to 59.91%, strengthening the layout in the cardiovascular and cerebrovascular precision intervention segment[38] - Completed the acquisition of an 80% equity stake in Qinghai Yixin Pharmaceutical Co., Ltd., obtaining exclusive rights to several proprietary Chinese medicines, consolidating competitiveness in the ENT & Ophthalmology segment[38] - The world's first closed-loop nuclear medicine full industry chain platform in Wenjiang District, Chengdu, has been completed, accepted, and put into operation[40] Innovation Product Progress The company has made significant progress in innovative products across nuclear medicine anti-tumor diagnosis & treatment, respiratory and critical care, and ENT & Ophthalmology, with multiple RDC drugs entering Phase III clinical trials or approved for market, STC3141 sepsis treatment drug successfully completing Phase II clinical trials, and several innovative ophthalmic drugs approved for market or completing clinical studies - In nuclear medicine anti-tumor diagnosis & treatment, RDC drugs such as ITM-11, TLX591, TLX591-CDx, and GPN02006 have made clinical progress in China or internationally, and Youai® early detection product for urological tumors has achieved commercialization[33] - Yigantai® Yttrium [90Y] Microspheres Injection received FDA approval for a new indication for the treatment of unresectable hepatocellular carcinoma[34] - In the respiratory and critical care segment, GPN00204 entered Phase I clinical trials, and STC3141 (sepsis) Phase II clinical trials successfully reached their endpoint[34] - In the ENT & Ophthalmology segment, CBT-001 (pterygium) completed patient enrollment for Phase III, GPN00884 (pediatric myopia) completed Phase I clinical trials, GPN01768 (demodex blepharitis) received approval for market by the Macao Pharmaceutical Administration Bureau, OC-01 (dry eye disease) achieved commercial prescription in mainland China, and innovative ophthalmic device GPN00646 was approved for market[34] Generic and API Products During the reporting period, the company had 13 generic products and 3 API products approved for market by the China NMPA, further enriching its product line - 13 generic products received NMPA approval for market[36] - 3 API products received NMPA approval for market[37] Industrial Layout and Base Construction The company strengthened its industrial layout in cardiovascular and cerebrovascular precision intervention and ENT & Ophthalmology through acquisitions of Nanjing Kainer and Qinghai Yixin, while making significant progress in constructing multiple global leading R&D and production bases - Acquired a 30.64% equity stake in Nanjing Kainer, increasing its holding to 59.91%, strengthening the "cardiovascular and cerebrovascular co-treatment" strategy in the cardiovascular and cerebrovascular precision intervention segment[38] - Acquired an 80% equity stake in Qinghai Yixin, obtaining exclusive rights to several proprietary Chinese medicines, consolidating market competitiveness in the traditional Chinese medicine chronic disease treatment segment[38] - Grand Pharma's radioactive drug R&D and production base (the world's first closed-loop nuclear medicine full industry chain platform) in Wenjiang District, Chengdu, has been completed, accepted, and put into operation[40] - The main structure and masonry work of the Yongcheng formulation factory construction project (Phase I) in Yangxin County, Huangshi City, Hubei Province, have been completed, which will expand pharmaceutical technology production capacity[41] - The civil engineering work for the large health nutrition product production base construction project in Huangshi City, Hubei Province, has been largely completed, serving as the core production hub for high-end health nutrition products in the amino acid segment[41] - Phase II of the amino acid production base project in Xiantao City, Hubei Province, has completed its main structure and masonry work, further expanding the production capacity of high-quality amino acid varieties[43] Business Introduction Grand Pharma leverages strong technological innovation, internationalization, and robust industrial foundation to comprehensively deploy in nuclear medicine anti-tumor diagnosis & treatment, cardiovascular & cerebrovascular precision intervention, pharmaceutical technology, and biotechnology - The Group possesses strong technological innovation capabilities, outstanding internationalization, and a solid industrial foundation, with a complete industrial chain and significant integrated advantages in API-formulation integration[44] - Over 130 products are listed in the "National Essential Drug List" (2018 edition), and over 260 products are included in the "National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug List (2024 edition)"[44] - Focusing on the "nuclear medicine anti-tumor diagnosis & treatment" and "cardiovascular & cerebrovascular precision intervention" segments, the company has become a leading enterprise in China's nuclear medicine anti-tumor diagnosis & treatment and a comprehensive cardiovascular & cerebrovascular precision intervention technology platform with international cutting-edge technology[45] Nuclear Medicine Anti-tumor Diagnosis & Treatment and Cardiovascular & Cerebrovascular Precision Intervention Technology The company has a comprehensive layout in nuclear medicine anti-tumor diagnosis & treatment and cardiovascular & cerebrovascular precision intervention, with leading international technology platforms and a rich pipeline of innovative products - The nuclear medicine anti-tumor diagnosis & treatment segment has over 900 global employees, with R&D bases centered in Boston and Chengdu, production bases in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering over 50 countries and regions, achieving a global nuclear medicine industry chain layout[46] - In the R&D and registration phase, 15 innovative products are reserved, covering 5 radionuclides including 68Ga, 177Lu, 131I, 90Y, 89Zr, and 7 cancer types such as liver cancer, prostate cancer, and brain cancer[47] - Globally, five RDC drugs have been approved for clinical research, with four having entered Phase III clinical trials[48] - The cardiovascular and cerebrovascular precision intervention segment has laid out over 30 products, with 22 products in vascular access management approved for market in China, and 1 product in structural heart disease approved for market in China[69] Nuclear Medicine Anti-tumor Diagnosis & Treatment Segment The nuclear medicine anti-tumor diagnosis & treatment segment has achieved a global industry chain layout, possessing international leading tumor intervention and RDC technology platforms, with 15 innovative products covering 5 radionuclides and 7 cancer types Core Products Core products in the nuclear medicine anti-tumor diagnosis & treatment segment include the global innovative Yigantai® Yttrium [90Y] Microspheres Injection, the global innovative liquid embolic agent LavaTM, and the urothelial cancer early detection product Youai® - Yigantai® Yttrium [90Y] Microspheres Injection received NMPA marketing approval in January 2022 and FDA approval for a new indication for unresectable HCC in July 2025, making it the world's first and only SIRT product approved by the FDA for both unresectable HCC and colorectal cancer liver metastases[50] - Yigantai® has entered over 50 hospitals in 22 provinces and cities in China and has been included in over 50 inclusive insurance plans and 3 special drug insurance plans, covering over 24 provincial-level administrative regions and over 100 cities[52] - LavaTM is the first liquid embolic agent approved in the US for the treatment of peripheral arterial hemorrhage, featuring radiopacity, easy preparation (2 minutes), and two viscosity options[53] - Youai® urothelial cancer early detection product uses a dual methylation + gene mutation target design, achieving 92.5% sensitivity and 95.8% specificity, making it the only dual-mechanism urothelial cancer early detection product approved for market in China[55] Innovative R&D Pipeline The nuclear medicine anti-tumor diagnosis & treatment segment's innovative R&D pipeline includes interventional therapies and RDC drugs, with multiple products advancing through clinical trials or approved for market, and GPN02006 achieving breakthrough clinical results for HCC diagnosis - Interventional Therapy: The global innovative temperature-sensitive embolic agent GPN00289 has completed the first patient enrollment for registration clinical studies; the global innovative liquid embolic agent KonaTM has submitted a PMA application to the FDA; the global innovative solid tumor ablation therapy AuroLase® has submitted a PMA application to the FDA[57][58][59] - RDC Drugs: TLX591/TLX591-CDx (prostate cancer diagnosis and treatment) TLX591 is undergoing international multi-center Phase III clinical trials overseas, TLX591-CDx has been approved for market in multiple countries and is planned for China marketing application submission this year[61] - RDC Drugs: TLX250/TLX250-CDx (clear cell renal cell carcinoma diagnosis and treatment) TLX250-CDx achieved successful overseas Phase III clinical trials and received FDA priority review, with the first patient enrolled in China Phase III clinical trials[63] - RDC Drugs: ITM-11/TOCscan® (gastroenteropancreatic neuroendocrine tumor diagnosis and treatment) ITM-11 reached its primary endpoint in overseas Phase III clinical trials, and China has approved its participation in international multi-center Phase III clinical studies[64] - RDC Drugs: GPN02006 (hepatocellular carcinoma diagnosis) achieved breakthrough progress in China IIT clinical studies, demonstrating excellent safety and imaging efficacy, expected to improve early diagnosis rates for HCC[67] Cardiovascular & Cerebrovascular Precision Intervention Segment The cardiovascular & cerebrovascular precision intervention segment has laid out over 30 high-end medical device products focusing on vascular access management, structural heart disease, and heart failure, with multiple products approved for market - The cardiovascular and cerebrovascular precision intervention segment has laid out over 30 products, with 22 products in vascular access management approved for market in China, and 1 product in structural heart disease approved for market in China[69] - A comprehensive "passive + active" innovative device platform has been established, with the Wuhan Optics Valley active device R&D and production base, Changzhou passive device R&D and production base, and Shanghai device R&D center all in operation[70] - The R&D team comprises over 65% with master's and doctoral degrees, possessing comprehensive backgrounds in medicine, pharmacy, materials, mechanics, and electronics[70] Core Products Core products in the cardiovascular & cerebrovascular precision intervention segment include RESTORE DEB®, APERTO® OTW, NOVASIGHT, NOVASYNC, Cormorant®, IberisTM, DEEPQUAKE-CTM, DEEPQUAKETM, and NeoNova®, all demonstrating innovation, clinical advantages, and market potential in their respective sub-segments - RESTORE DEB® is China's first drug-eluting balloon with dual indications for primary coronary artery disease and in-stent restenosis, featuring unique SAFEPAX patented technology[71] - APERTO® OTW is the first drug-eluting balloon specifically for arteriovenous fistula stenosis in dialysis patients, showing significant advantages in target lesion patency rate at six months post-surgery[72] - NOVASIGHT and NOVASYNC integrate IVUS and OCT imaging technologies, providing histological and morphological information on intravascular plaques and vessel walls, with NOVASYNC being a domestically produced iterative product[73] - Cormorant® is the first domestically produced adjustable intracranial thrombectomy stent, designed with a circular wire braided structure, allowing manual diameter adjustment to match target vessels and improve recanalization rates[74] - IberisTM is a multi-polar renal denervation system for uncontrolled primary hypertension, the world's only RDN product with CE mark approval and dual radial and femoral artery access design[76] - DEEPQUAKE-CTM and DEEPQUAKETM are domestically produced coronary and peripheral shockwave systems that break down calcified plaques through pulsed acoustic pressure waves, offering diverse treatment options[77] - NeoNova® is a domestically produced transcatheter mitral valve clip system that repairs mitral regurgitation through interventional means, offering convenient operation, good safety, and an elastic self-locking mechanism[78] Innovative R&D Pipeline The cardiovascular & cerebrovascular precision intervention segment's innovative R&D pipeline includes the global innovative endogenous tissue repair product aXess, the global innovative mitral valve replacement system Saturn, and the global innovative ventricular assist device CoRISMA, all addressing unmet clinical needs and in clinical research or collaborative development stages - aXess (endogenous tissue repair product) for establishing graft arteriovenous fistulas in ESRD patients, with the first patient enrolled in a pivotal clinical study in the US and all patients enrolled in Europe[79] - Saturn (mitral valve replacement system) is implanted via transseptal intervention, with the first patient enrolled in a transfemoral venous access clinical study in Europe[80] - CoRISMA (ventricular assist device) is a transcatheter fully implantable ventricular assist medical device for treating Class III and end-stage heart failure, utilizing wireless power supply technology, and is being co-developed with a Yale University incubated company[81] Pharmaceutical Technology The company has deep roots in pharmaceutical technology, covering respiratory and critical care, ENT & Ophthalmology, cardiovascular and cerebrovascular emergency, APIs, and mRNA platforms, with multiple core products leading market share and continuous layout of innovative product pipelines - The Group has been deeply involved in respiratory and critical care, ENT & Ophthalmology, cardiovascular and cerebrovascular emergency, and other fields for many years, now possessing multiple high-barrier products and exclusive varieties with leading market shares[82] - Established Wuhan Optics Valley International R&D Center, Australian Glycomics R&D Center, and Nanjing Aoruo mRNA R&D Center, providing technical support for R&D innovation in the pharmaceutical technology segment[84] Respiratory and Critical Care Segment The respiratory and critical care segment covers multiple indications such as rhinitis, bronchitis, pneumonia, and asthma, with core products Chernor®, Enzhuorun® Bisihaler®, and Enmingrun® Bisihaler® being exclusive national varieties - Products on sale cover multiple indications such as rhinitis, bronchitis, pneumonia, asthma, and chronic obstructive pulmonary disease[85] - Core products Chernor®, Enzhuorun® Bisihaler®, and Enmingrun® Bisihaler® are all exclusive national varieties, holding leading positions in their respective sub-segments[85] - Innovative layout includes multiple R&D products covering major unmet clinical needs such as allergic rhinitis, sepsis, and ARDS[85] Respiratory Products Key respiratory products include Chernor® (Eucalyptol, Limonene, Pinene Enteric-coated Capsules), Enzhuorun® Bisihaler®, Enmingrun® Bisihaler®, Budesonide Nasal Spray, and Fluticasone Propionate Nasal Spray, all being exclusive national varieties or first generics with significant market positions - Chernor® (Eucalyptol, Limonene, Pinene Enteric-coated Capsules) is an exclusive national variety in China, included in the National Medical Insurance and Essential Drug Catalog, continuously leading the oral antitussive and expectorant market[87] - Enzhuorun® Bisihaler® is China's first triple combination inhaled preparation approved for asthma indication, administered once daily, using an advanced Bisihaler® inhaler device, significantly reducing the risk of acute exacerbations[88] - Enmingrun® Bisihaler® is an innovative ICS mometasone furoate and LABA indacaterol acetate dual combination preparation, significantly improving patient lung function and reducing the risk of acute exacerbations[88] - Budesonide Nasal Spray and Fluticasone Propionate Nasal Spray are both first-line treatments for allergic rhinitis and are the first domestic generics to be launched, expected to change the competitive landscape dominated by foreign enterprises[91][92] Innovative R&D Pipeline The respiratory and critical care segment's innovative R&D pipeline includes Ryaltris (GSP 301 NS), a novel compound nasal spray for seasonal allergic rhinitis, and STC3141, a global innovative drug for critical care, with STC3141 successfully completing Phase II clinical studies for sepsis - Ryaltris (GSP 301 NS) is a novel corticosteroid and antihistamine compound nasal spray, approved for market in multiple countries, with successful China Phase III clinical trials and NDA accepted by the NMPA[94] - STC3141 is the world's first sepsis treatment solution centered on reconstituting immune homeostasis, with China Phase II clinical studies successfully reaching the primary clinical endpoint, confirming efficacy and safety[96] - STC3141 has obtained seven clinical approvals in five countries across three continents, covering four indications: sepsis, ARDS, severe COVID-19, and ARDS caused by COVID-19[96] ENT & Ophthalmology Segment The ENT & Ophthalmology segment covers diseases across ophthalmology, otolaryngology, and stomatology, with products including chemical preparations, traditional Chinese medicine preparations, and health products, adhering to a strategy of integrated traditional Chinese and Western medicine and combined drug-device treatment - The ENT & Ophthalmology segment covers diseases across ophthalmology, otolaryngology, and stomatology, with products including prescription drugs, OTC, devices, and consumer goods[97] - Adhering to a development strategy of integrated traditional Chinese and Western medicine and combined drug-device treatment, continuously enriching its series of product clusters, providing comprehensive diagnostic and treatment solutions in hospitals, and building eye health consumer brands in retail[97] - In terms of innovative R&D, the company has reserved multiple global innovative products for "dry eye disease," "demodex blepharitis," "post-ophthalmic surgery anti-inflammatory and analgesic," "pterygium," and "myopia"[97] ENT & Ophthalmology Products Core ENT & Ophthalmology products include Hexuemingmu Tablets, Jinsang series, Duoputai® Maixuekang Capsules and Enteric-coated Tablets, Ruizhu® Polyvinyl Alcohol Eye Drops, Nuotong® Xylometazoline Hydrochloride Nasal Spray/Drops, Danzhen Headache Capsules, and Varenicline Tartrate Nasal Spray (OC-01), which is the world's first and only nasal spray approved for treating mild, moderate, and severe dry eye - Hexuemingmu Tablets are an exclusive national variety in China, a national traditional Chinese medicine protected variety, and included in the National Medical Insurance and Essential Drug Catalog, used for fundus diseases caused by yin deficiency, liver hyperactivity, and heat damaging collaterals[99] - Jinsang series products are exclusive national products, covering all laryngeal diseases, including Jinsang Sanjie Capsules, Jinsang Liyan Capsules, Jinsang Kaiyin Capsules, etc., with multiple products included in the National Medical Insurance Catalog[101] - Duoputai® Maixuekang Capsules and Enteric-coated Tablets have anticoagulant, antithrombotic, and anti-fibrotic effects, and are the only traditional Chinese medicine in China labeled with antithrombin activity units[102] - Ruizhu® Polyvinyl Alcohol Eye Drops are single-dose preservative-free artificial tears, a first-line treatment for dry eye, and have won the CPhI Gold Award for nine consecutive years[103] - Nuotong® Xylometazoline Hydrochloride Nasal Spray/Drops are nasal decongestants for relieving nasal congestion, with the nasal spray being an exclusive domestic dosage form[104] - Danzhen Headache Capsules are an exclusive national variety, included in the National Medical Insurance and Essential Drug Catalog, used for headaches caused by hyperactivity of liver yang and blood stasis obstructing collaterals[105] - Varenicline Tartrate Nasal Spray (OC-01) is the world's first and only preservative-free nasal spray approved for treating mild, moderate, and severe dry eye, approved for market in the US and Macao, China, and achieved commercial prescription in mainland China in July 2025[107] Innovative R&D Pipeline The ENT & Ophthalmology innovative R&D pipeline includes the improved new drug GPN00833 for post-ophthalmic surgery anti-inflammatory and analgesic, GPN00153 (CBT-001) for pterygium, GPN00884 for slowing pediatric myopia progression, and GPN01768 (TP-03) for demodex blepharitis and meibomian gland dysfunction, all targeting clear clinical needs and achieving various stages of clinical progress or market approval - Hormone Nanoparticle Suspension Eye Drops GPN00833 (post-ophthalmic surgery anti-inflammatory and analgesic) were approved for market by the US FDA in March 2024, with successful China Phase III clinical studies and NDA preparation underway[108] - GPN00153 (CBT-001, pterygium) completed Phase II clinical trials in the US, entered Phase III clinical stage for global development in June 2022, and completed patient enrollment for China Phase III clinical trials[109] - GPN00884 (slowing pediatric myopia progression) was approved for Phase I clinical studies in China in March 2024 and completed Phase I clinical studies in March 2025[110] - GPN01768 (TP-03, demodex blepharitis and meibomian gland dysfunction) was approved for market by the US FDA in July 2023, making it the first and only FDA-approved drug for demodex blepharitis, and was approved for market by the Macao Pharmaceutical Administration Bureau in May 2025[110] Cardiovascular & Cerebrovascular Emergency Segment The cardiovascular & cerebrovascular emergency segment addresses both emergency rescue and chronic disease management, with over 30 varieties, including 14 in the National Emergency Rescue Drug Catalog and 16 in the Shortage Drug Catalog - The cardiovascular and cerebrovascular emergency segment has over 30 varieties, with 14 varieties included in China's National Emergency Rescue Drug Catalog and 16 varieties included in the Shortage Drug Catalog, ranking among the top in the industry for pipeline quantity[112] - Core products such as Nengqilang®, Limaitong® Eplerenone Tablets, Hexinshuang®/Hebeishuang®, continue to lead their respective sub-markets[112] - Hexinshuang®/Hebeishuang® (Diltiazem Hydrochloride Tablets/Sustained-release Capsules, Injection) as a classic calcium channel blocker, offers oral immediate-release, sustained-release, and injectable formulations, meeting clinical needs for hypertension, coronary heart disease, etc., and is included in multiple authoritative guidelines[114] - Nengqilang® Coenzyme Q10 Tablets are used to improve myocardial metabolism and energy supply, significantly improving symptoms in patients with chronic heart failure, and are included in numerous authoritative guidelines and expert consensuses[115] - Limaitong® Eplerenone Tablets are a novel MRA drug, filling the gap in China's second-generation selective aldosterone receptor antagonist drugs, and were included in the National Medical Insurance Catalog in November 2024[118] - Jext® pre-filled adrenaline auto-injector has been approved for market in multiple countries and received approval for urgently needed imported Hong Kong and Macao drugs in the Guangdong-Hong Kong-Macao Greater Bay Area in January 2023[119] - Runmode Lin® Treprostinil Injection is an orphan drug for pulmonary hypertension, one of only two treprostinil products approved for market in China, and was included in the National Medical Insurance Catalog in January 2023[120] API Segment The API segment boasts a rich product pipeline, with both bulk and specialty APIs sold globally, serving as the front-end of the API-formulation integrated supply chain, with modern API production bases focusing on cardiovascular, anti-infective, antipyretic-analgesic, digestive system, and anti-tumor fields - The API segment has a rich product pipeline, with both bulk APIs and specialty APIs sold globally, and sales channels covering the world[121] - Possesses multiple modern API production bases with complete equipment, exquisite craftsmanship, outstanding industrialization capabilities, and standardized quality control[121] - The API production and R&D layout focuses on five major areas: cardiovascular, anti-infective, antipyretic-analgesic, digestive system, and anti-tumor, fully supporting the formulation production and R&D work in the pharmaceutical technology segment[121] mRNA Platform The company's mRNA platform focuses on developing anti-tumor and anti-infective mRNA drugs, having established mRNA production and LNP delivery technology platforms, with ARC01 (A002), a therapeutic oncology vaccine for HPV16-positive solid tumors, approved for Phase I clinical studies in China - The mRNA platform focuses on developing anti-tumor and anti-infective mRNA drugs, having completed the establishment of mRNA production technology and LNP delivery technology platforms[123] - The therapeutic oncology vaccine ARC01 (A002) for HPV16-positive solid tumors was approved for Phase I clinical studies in China in January 2024, making it China's first HPV-positive related tumor mRNA therapeutic vaccine approved for clinical trials[123] - Utilizes LNP delivery technology and TriMix® adjuvant to significantly enhance the body's immune response and improve the immunotherapeutic effect of the vaccine[123] Biotechnology The company's biotechnology segment centers on amino acid products, positioning itself as a global high-quality amino acid service provider, leveraging synthetic biology to produce various amino acids using new biological methods, filling industry gaps - The biotechnology segment's core business is amino acid products, positioning itself as a global high-quality amino acid service provider[124] - Adheres to green, low-carbon, and sustainable development concepts, promoting high-quality development of the segment with globally leading synthetic biology manufacturing innovation technology[124] - The amino acid segment holds over 200 invention patents, has led or participated in formulating over 60 national, industry, and group standards, and has received numerous honors such as National Green Factory and National Manufacturing Single Champion Demonstration Enterprise[124] Amino Acid Segment The amino acid segment has been deeply cultivated for over 20 years, using synthetic biology as its core to produce various amino acids with globally leading new biological methods, filling industry gaps - The amino acid segment has been deeply cultivated for over 20 years, using synthetic biology as its core, pioneering globally leading new biological methods in China to produce various amino acids, filling industry gaps[125] - Undertakes China's National Industrial Strengthening Project and Industrial Foundation Rebuilding Project, and is the first enterprise in China to obtain the "Same Line, Same Standard, Same Quality" (Three Sames) certification for amino acids[125] New Technologies The company's amino acid segment has established eight technology platforms around synthetic biology, including synthetic biology, enzyme engineering, and fermentation engineering, possessing an integrated system for "new product development, new technology engineering and industrialization, and application solutions" - Eight major technology platforms have been established, including synthetic biology, enzyme engineering, fermentation engineering, process optimization, quality research, and application transformation[126] - Established long-term deep cooperation relationships with multiple research institutions such as Wuhan University and Huazhong University of Science and Technology to develop new amino acid fermentation technologies and enzyme expression systems[126] - Fermentation processes centered on strain construction optimization and enzyme conversion processes centered on immobilized enzymes can replace traditional chemical synthesis processes, significantly reducing carbon dioxide emissions[126] High Quality The company's amino acid products have comprehensive domestic and international quality certification systems, with many core products passing drug/food system certifications and registrations in Europe, the US, and Japan, ensuring overseas operational compliance and laying the foundation for expanding into new market applications - Amino acid products have passed EU GMP certification, EU REACH registration, US FDA certification, South Korea KFDA registration, ISO quality management system certification, FSSC22000 food system certification, etc[129] - Comprehensive international system certifications and registrations demonstrate the Group's strong competitiveness in expanding overseas market business[129] Industrial Chain The company possesses nearly 50 types of amino acids and their derivatives, with 26 API registration numbers, making it the pharmaceutical enterprise with the most amino acid API registration numbers in China, while actively expanding into formulation products and functional dietary supplements - Possesses nearly 50 types of amino acids and their derivatives, with 26 amino acid API registration numbers, making it the pharmaceutical enterprise with the most amino acid API registration numbers in China[130] - Added multiple food-grade and feed-grade amino acid products, opening up growth space through differentiated pathways[130] - Two independently developed functional dietary supplements have obtained US FDA certification and achieved commercialization in the US, with over ten functional food products approved for market domestically[130] Internationalization The amino acid segment's sales network covers over 140 countries and regions globally, with overseas business accounting for approximately 40%, and some amino acid varieties ranking among the top three in market share - The amino acid segment's sales network covers over 140 countries and regions globally, with overseas business accounting for approximately 40%, and some amino acid varieties ranking among the top three in market share[131] - Core products have long served high-quality domestic and international clients, including Fortune 500 companies, establishing long-term stable cooperative relationships[131] - Future focus will be on high-value-added areas related to pharmaceuticals such as high-end parenteral nutrition formulations, innovative peptide drugs, cell culture media, and large health consumer areas such as sports protection, functional dietary supplements, special medical and infant formula foods, cosmetics, and pet foods[131] Financial Review For the six months ended June 30, 2025, revenue increased by 1.0% year-on-year (2.0% in RMB terms), or approximately 13.0% excluding the impact of the tenth round of centralized procurement, while net profit attributable to owners decreased by 25.0% - H1 2025 Financial Performance | Indicator | H1 2025 (HKD thousands) | H1 2024 (HKD thousands) | Year-on-year Change | | :--- | :--- | :--- | :--- | | Revenue | 6,107,320 | 6,047,240 | +1.0% | | Net Profit Attributable to Owners | 1,169,020 | 1,557,950 | -25.0% | | Fair Value Change Gain from Telix Investment | 151,730 | 476,630 | -324,900 | | Normalized Net Profit Attributable to Owners | 1,017,290 | 1,081,320 | -5.9% | - Excluding the impact of the tenth round of centralized procurement, revenue in RMB terms increased by approximately 13.0% year-on-year[133] - Revenue from innovative and barrier products accounted for approximately 51.0% of total revenue, a 14.9 percentage point year-on-year increase[133] - Normalized profit slightly decreased by approximately