远大医药(00512) - 2025 - 中期业绩

Company Information This section provides essential company details, including disclaimers and identification information Disclaimer Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited bear no responsibility for this announcement's content, make no representations, and expressly disclaim liability for any losses arising from or relying on its contents - Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited bear no responsibility for this announcement's content, make no representations, and expressly disclaim liability for any losses arising from or relying on its contents[1] Company Name and Stock Code This announcement is issued by Grand Pharmaceutical Group Limited, incorporated in Bermuda, with stock code 00512 - The company name is Grand Pharmaceutical Group Limited, stock code: 00512[2] Financial Highlights For the six months ended June 30, 2025, the company achieved record-high revenue, with innovation and barrier products significantly contributing to sustainable growth despite profit decline due to investment fair value changes and increased promotion expenses Key Financial Indicators for H1 2025 | Indicator | H1 2025 (HKD) | H1 2024 (HKD) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | 6,107,320,000 | 6,047,240,000 | +1.0% | | Revenue (RMB basis) | - | - | +2.0% | | Revenue (RMB basis, excluding VBP impact) | - | - | +13.0% | | Revenue contribution from innovative and barrier products | 51.0% | 36.1% | +14.9 percentage points | | Profit attributable to owners of the Company for the period | 1,169,020,000 | 1,557,950,000 | -25.0% | | Profit attributable to owners of the Company for the period (RMB basis) | - | - | -24.2% | | Fair value change and disposal gains from Telix investment | 151,730,000 | 476,630,000 | -324,910,000 | | Normalized profit (excluding Telix investment impact) | 1,017,290,000 | - | -5.9% (RMB basis -5.0%) | | Revenue from Nuclear Medicine Anti-tumor Diagnosis and Treatment segment | 421,780,000 | 207,240,000 | +105.5% (excluding exchange rate impact) | | R&D work and project investment | 1,022,000,000 | - | - | Letter to Shareholders This section outlines the company's strategic direction, industry review, business achievements, and future outlook, emphasizing innovation and global expansion Industry Review China's pharmaceutical industry is undergoing transformation, with traditional sectors facing price restructuring and policies encouraging innovation, creating broader development space for new drugs - China's pharmaceutical industry is undergoing transformation, with traditional sectors facing price restructuring, demanding higher requirements for product structure, cost control, and operational efficiency[5] - Policies encourage genuine innovation, and systems like commercial health insurance innovative drug catalogs are expected to open broader development space for innovative drugs[5] Business Summary Grand Pharmaceutical achieved revenue growth despite VBP impact, with innovative products driving performance and significant progress in nuclear medicine and global R&D platforms - The company adheres to the 'integrated advantages, innovation-led, global expansion' strategy, achieving high-quality sustainable growth and continuously strengthening development resilience[6][7] - Revenue from innovative and barrier products accounted for approximately 51.0% of total revenue, an increase of 14.9 percentage points year-on-year, with products like Yigantai® and LavaTM rapidly scaling up[3][7] - Revenue from the Nuclear Medicine Anti-tumor Diagnosis and Treatment segment doubled, with Yigantai® Yttrium [90Y] Microspheres Injection domestic revenue doubling and LavaTM rapidly increasing overseas[8][10] - Eight global R&D platforms have been established across three major countries/regions, covering cutting-edge technologies such as nuclear medicine, high-end medical devices, glycomics, and mRNA, fully enabling the global value realization path for innovative drugs[9] - Yigantai® Yttrium [90Y] Microspheres Injection received approval for a new HCC indication, becoming the world's first and only selective internal radiation therapy product approved by the FDA for dual indications of unresectable HCC and colorectal cancer liver metastases[10] Future Outlook The company is committed to a 'Go Global' strategy, expanding its global footprint, advancing R&D pipelines, and becoming a leading international pharmaceutical enterprise - The company will deeply implement the 'global expansion' strategy, becoming a leader in the global layout of Chinese pharmaceutical enterprises and a key definer of the global pharmaceutical innovation landscape[11] - Actively advance the R&D of high-potential blockbuster products like STC3141, with market potential reaching tens of billions, and incubate self-developed nuclear medicine products such as GPN02006[11] - Continue to improve the layout of various business segments through independent innovation and M&A, focusing on differentiated large-scale products, aiming to become a comprehensive enterprise with significant advantages in niche areas[12] - Firmly establish a 'Go Global' model to build a global pharmaceutical brand, holding global rights for multiple products like Yigantai® and STC3141, enhancing global market penetration and influence[12] - Committed to becoming a global pharmaceutical enterprise capable of competing with top international multinational pharmaceutical companies, bringing more hope for life and health to global patients[13] Corporate Positioning Grand Pharmaceutical Group is a technology-innovative international pharmaceutical enterprise focusing on nuclear medicine anti-tumor diagnosis, cardiovascular precision interventional diagnosis, pharmaceutical technology, and biotechnology - The Group is a technology-innovative international pharmaceutical enterprise, with core businesses spanning three major areas: nuclear medicine anti-tumor diagnosis and treatment, cardiovascular precision interventional diagnosis and treatment technology, pharmaceutical technology, and biotechnology[14] - Centered on patient needs and driven by technological innovation, the company increases investment in global innovative products and advanced technologies to enrich and improve its product pipeline[14] - Adhering to the development philosophy of 'integrated advantages, innovation-led, and global expansion,' the company adopts a strategy of 'dual-driven independent R&D and global expansion, global operational layout, and dual-cycle business development'[14] Business Review and Outlook This section reviews significant milestones, including product launches, clinical advancements, strategic acquisitions, and the construction of key R&D and production facilities Significant Milestone Progress As of the announcement date, Grand Pharmaceutical Group achieved 38 significant milestones in H1 2025, including product launches, clinical advancements, and strategic construction projects, with key products entering rapid growth phases - As of the announcement date, the Group achieved 38 significant milestones, including 16 innovative products, 13 generic products, 3 API products, 2 industrial layouts, and 4 major construction projects[15] - Products such as Yigantai® Yttrium [90Y] Microspheres Injection and LavaTM in the Nuclear Medicine Anti-tumor segment, Enzhuorun® Bisheler®, Enmingrun® Bisheler®, Budesonide Nasal Spray, and Fluticasone Propionate Nasal Spray in the Respiratory and Critical Care segment, and Nengqilang® Coenzyme Q10 Tablets in the Cardiovascular Emergency segment have entered a rapid ramp-up phase[15] Innovative Product Progress Innovative products in nuclear medicine, respiratory, and ophthalmology segments achieved significant clinical and commercial milestones, including FDA approvals and successful clinical trial endpoints - The innovative radionuclide-conjugated drug ITM-11 completed the first patient enrollment and dosing in its GEP-NETs Phase III clinical study in China[16] - The urinary tract tumor early detection product Youai® achieved its first commercial prescription in mainland China, being the only approved methylation + gene mutation dual-mechanism product for urothelial cancer early detection[16] - The global innovative radioactive product SIR-Spheres® Yttrium [90Y] Microspheres Injection received early FDA approval for a new indication to treat unresectable hepatocellular carcinoma[16] - The global innovative drug STC3141 successfully reached its clinical endpoint in the Phase II clinical study for sepsis conducted in China[16] - The innovative modified new drug CBT-001 completed enrollment and dosing of all patients in its international multi-center Phase III clinical study in China[19] - The global innovative ophthalmic drug GPN01768 (TP-03) received marketing approval from the Macao Pharmaceutical Administration Bureau of the Government of the Macao Special Administrative Region of China[19] - The world's first innovative product, Varenicline Tartrate Nasal Spray (OC-01), achieved its first commercial prescription in mainland China after official approval[19] Generic Product Progress During the reporting period, the Group obtained marketing approval from the China NMPA for 13 generic products - 13 generic products received marketing approval from the China NMPA[17] API Product Progress During the reporting period, the Group obtained marketing approval from the China NMPA for 3 API products - 3 API products received marketing approval from the China NMPA[18] Industrial Layout and Base Construction The Group strengthened its cardiovascular and traditional Chinese medicine segments through strategic acquisitions and completed construction of key R&D and production bases, enhancing nuclear medicine and pharmaceutical capacities - Completed the acquisition of 30.64% equity in Nanjing Kainer Medical Technology Co., Ltd., increasing its stake to 59.91%, strengthening the 'cardio-cerebral co-treatment' strategy in the cardiovascular precision interventional diagnosis and treatment segment[20] - Completed the acquisition of 80% equity in Qinghai Yixin Pharmaceutical Co., Ltd., obtaining exclusive rights to several traditional Chinese medicine products like Danzhen Headache Capsules, consolidating competitiveness in chronic disease treatment with TCM[20] - Grand Pharmaceutical Radioactive Drug R&D and Production Base, the world's first closed-loop platform for the entire nuclear medicine industry chain, officially commenced operations at the end of June 2025, achieving independent nuclear medicine production and addressing 'bottleneck' issues[22] - Grand Pharmaceutical Yongsheng Pharmaceutical Factory (Phase I) completed its main structure, expanding pharmaceutical technology production capacity; Huangshi Great Health Nutrition Product Production Base civil engineering is largely complete; Xiantao Amino Acid Production Base Phase II topped out, further expanding high-quality amino acid product capacity[23][24] Core Business Segment Details This section provides detailed insights into the Group's core business segments, including nuclear medicine anti-tumor, cardiovascular precision interventional, pharmaceutical technology, API, and biotechnology, highlighting key products, R&D pipelines, and strategic advantages Nuclear Medicine Anti-tumor Diagnosis and Treatment & Cardiovascular Precision Interventional Diagnosis and Treatment Technology The Group is a leader in nuclear medicine anti-tumor diagnosis and a comprehensive cardiovascular precision interventional platform, with over 30 products in its pipeline and multiple innovative devices approved for market - The Group has become a leading enterprise in China's nuclear medicine anti-tumor diagnosis and treatment and a comprehensive cardiovascular precision interventional diagnosis and treatment technology platform with international cutting-edge technologies[26] - This segment has a pipeline of over 30 products, with 22 products in the access management direction approved for marketing in China and 1 product in the structural heart disease direction approved for marketing in China[46] - Products such as the multi-polar renal denervation radiofrequency ablation system IberisTM, transcatheter mitral valve clip system NeoNova®, and coronary shockwave system DEEPQUAKE-CTM have received marketing approval from the China NMPA[46] Nuclear Medicine Anti-tumor Diagnosis and Treatment Segment This segment boasts a globalized R&D, production, and sales network, with 15 innovative products in its pipeline covering various radionuclides and cancer types, and multiple RDC drugs in Phase III clinical trials - The Nuclear Medicine Anti-tumor Diagnosis and Treatment segment has achieved a comprehensive global layout in R&D, production, distribution, and sales, with over 900 global employees and a sales network covering over 50 countries and regions[27] - The R&D and registration pipeline includes 15 innovative products, covering 5 radionuclides (68Ga, 177Lu, 131I, 90Y, 89Zr) and 7 cancer types (liver cancer, prostate cancer, brain cancer, etc.)[28] - Globally, five RDC drugs have been approved for clinical studies, with four already in Phase III clinical stages (TLX591-CDx, TLX591, TLX250-CDx, ITM-11)[29] Core Products Core products include Yigantai® Yttrium [90Y] Microspheres Injection, LavaTM liquid embolic agent, and Youai® urothelial cancer early detection product, each offering significant clinical advantages and global recognition - Yigantai® Yttrium [90Y] Microspheres Injection is the world's first and only SIRT product approved by the FDA for dual indications of unresectable HCC and colorectal cancer liver metastases, used in over 150,000 patient-times across more than 50 countries and regions globally[30] - LavaTM is the first liquid embolic agent approved in the US for treating peripheral arterial hemorrhage, offering convenient preparation (2 minutes), excellent imaging, and two viscosity options[33] - Youai® is currently the only methylation + gene mutation dual-mechanism urothelial cancer early detection product approved in China, with 92.5% sensitivity and 95.8% specificity, and has achieved commercial prescription rollout[34] Innovative R&D Pipeline The innovative R&D pipeline includes interventional therapies like GPN00289, KonaTM, and AuroLase®, alongside a robust RDC drug portfolio with multiple products in advanced clinical stages for various cancer indications - Interventional therapy pipeline includes: global innovative temperature-sensitive embolic agent GPN00289 (completed first patient enrollment in registrational clinical study); global innovative liquid embolic agent KonaTM (PMA application submitted to FDA); global innovative solid tumor ablation technology AuroLase® (PMA application submitted to FDA)[36][37][38] - RDC drug pipeline includes: TLX591/TLX591-CDx (TLX591 approved by China NMPA for international multi-center Phase III clinical trial, TLX591-CDx in China completed Phase III clinical patient enrollment); TLX250/TLX250-CDx (TLX250-CDx granted FDA Breakthrough Therapy designation, NDA accepted and granted Priority Review); ITM-11/TOCscan® (ITM-11 reached primary endpoint in overseas Phase III clinical trial, approved in China for international multi-center Phase III clinical study); GPN02006 (achieved breakthrough progress in HCC diagnostic IIT clinical study)[40][41][42][45] Cardiovascular Precision Interventional Diagnosis and Treatment Segment This segment has established a comprehensive 'passive + active' innovative device platform, with over 30 products in its pipeline, including multiple approved devices and advanced R&D projects for structural heart disease and heart failure - The Group has achieved comprehensive construction of a 'passive + active' innovative device platform in the cardiovascular precision interventional diagnosis and treatment segment, collaborating with clinical centers in the US, Canada, Germany, and other countries[47] - Products such as the multi-polar renal denervation radiofrequency ablation system IberisTM, transcatheter mitral valve clip system NeoNova®, and coronary shockwave system DEEPQUAKE-CTM have received marketing approval from the China NMPA[46] Core Products Core products include RESTORE DEB® coronary drug-eluting balloon, APERTO® OTW dialysis access drug-eluting balloon, NOVASIGHT/NOVASYNC dual-mode imaging devices, Cormorant® intracranial thrombectomy stent, IberisTM renal denervation system, DEEPQUAKE-CTM/DEEPQUAKETM shockwave systems, and NeoNova® transcatheter mitral valve clip system, all demonstrating significant technical advantages - RESTORE DEB® coronary drug-eluting balloon: China's first drug-eluting balloon with dual indications for primary coronary artery disease and in-stent restenosis, featuring unique SAFEPAX patented technology[48] - APERTO® OTW dialysis access drug-eluting balloon: 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-procedure[49] - NOVASIGHT intravascular dual-mode imaging device and its localized product NOVASYNC: Integrates IVUS and OCT technologies to provide precise intravascular images, with NOVASYNC being a localized iterative product[50] - Cormorant®: China's first domestically produced adjustable intracranial thrombectomy stent, featuring a round wire braided structure that allows manual diameter adjustment to match target vessels, improving recanalization rates and safety[51] - IberisTM multi-polar renal denervation radiofrequency ablation system: The world's only RDN product with CE Mark approval and dual radial and femoral artery access design, used for uncontrolled essential hypertension[52] - DEEPQUAKE-CTM and DEEPQUAKETM domestic coronary and peripheral shockwave systems: Uses pulsed acoustic pressure waves to disrupt calcified plaques, with adjustable energy and multiple electrodes to enhance treatment safety and efficacy[53] - NeoNova® domestic transcatheter mitral valve clip system: Performs edge-to-edge mitral valve repair via interventional approach, offering convenient operation, good safety, and an elastic self-locking mechanism[54] Innovative R&D Pipeline The innovative R&D pipeline includes aXess for ESRD patients, Saturn transcatheter mitral valve replacement system, and CoRISMA wireless-powered ventricular assist device for heart failure, all in advanced clinical development - Global innovative endogenous tissue repair product aXess: Used for establishing AVG in ESRD patients, with critical clinical study patient enrollment completed in the US and Europe[55] - Global innovative mitral valve replacement system Saturn: For mitral valve replacement, implanted via transseptal interventional approach, with clinical study patient enrollment completed in Europe[56] - Global innovative ventricular assist device CoRISMA: Treats Class III and end-stage heart failure, utilizing wireless power supply, developed in collaboration with Yale University[57] Pharmaceutical Technology The Group's pharmaceutical technology segment excels in respiratory, critical care, ophthalmology, and cardiovascular emergency fields, with leading market share, exclusive products, and a robust R&D pipeline supported by global research centers - The pharmaceutical technology segment holds leading market share with high-barrier and exclusive products in respiratory and critical care, ophthalmology, and cardiovascular emergency fields[58] - Established Wuhan Optics Valley International R&D Center, Australian Glycomics R&D Center, and Nanjing Auro mRNA R&D Center, combining global technological cooperation with independent R&D[59] Respiratory and Critical Care Segment This segment offers a wide range of products for respiratory diseases, featuring exclusive core products and a strong innovative R&D pipeline, including Ryaltris and STC3141, both showing promising clinical results - The Respiratory and Critical Care segment's products cover multiple indications such as rhinitis, bronchitis, pneumonia, asthma, and COPD, with core products Cherno®, Enzhuorun® Bisheler®, and Enmingrun® Bisheler® being national exclusive varieties[60] Respiratory Products Core respiratory products include Cherno® (mucolytic expectorant), Enzhuorun® Bisheler® (first triple-combination inhaler for asthma in China), Enmingrun® Bisheler® (innovative ICS/LABA combination), and Budesonide/Fluticasone nasal sprays, all widely recognized and included in medical guidelines - Cherno®: National exclusive variety, national TCM protection product, included in national medical insurance and essential drug catalogs, recommended by multiple guidelines, continuously leading the oral cough and expectorant drug market[62][63] - Enzhuorun® Bisheler®: China's first triple-combination inhaled preparation approved for asthma indication, administered once daily, significantly improving clinical symptoms and lung function in moderate-to-severe asthma patients, reducing acute exacerbation risk[63] - Enmingrun® Bisheler®: Innovative ICS and LABA dual-combination preparation, significantly improving patient lung function and reducing acute exacerbation risk, included in the national medical insurance catalog[64] - Budesonide Nasal Spray and Fluticasone Propionate Nasal Spray: First-line treatments for allergic rhinitis, first domestic generics, expected to change the competitive landscape dominated by foreign enterprises[65][66] Innovative R&D Pipeline The innovative R&D pipeline includes Ryaltris, a novel compound nasal spray for seasonal allergic rhinitis with successful Phase III clinical results in China, and STC3141, a global first-in-class sepsis treatment with promising Phase II clinical outcomes - Novel compound nasal spray Ryaltris (GSP 301 NS): Already marketed in multiple countries, China Phase III clinical trial successfully reached its endpoint, NDA accepted by NMPA, with superior efficacy compared to single-agent originator preparations[68] - STC3141: World's first sepsis treatment focusing on immune homeostasis reconstruction, with seven clinical approvals in China, Australia, Belgium, UK, and Poland[69] - STC3141's Phase II clinical study for sepsis in China successfully reached its primary clinical endpoint, showing a significant decrease in SOFA scores in the treatment group and good safety and tolerability[69] Ophthalmology, ENT, and Oral Care Segment This segment covers a broad range of ophthalmic, ENT, and oral diseases with a diverse product portfolio and a strong R&D pipeline of global innovative products for dry eye, blepharitis, and myopia - The Ophthalmology, ENT, and Oral Care segment covers diseases across ophthalmology, otolaryngology, and stomatology, with products including chemical preparations, traditional Chinese medicine preparations, and health products[70] - Through a strategy combining collaborative introduction and independent R&D, the company has a pipeline of global innovative products for dry eye, demodex blepharitis, post-ophthalmic surgery anti-inflammatory and analgesic, pterygium, and myopia[70] Ophthalmology, ENT, and Oral Care Products Core products include Hexuemingmu Tablets (exclusive TCM for eye diseases), Jinsang series (exclusive for throat diseases), Duoputai® (TCM for cardiovascular diseases), Reizhu® (preservative-free artificial tears), Nuotong (xylometazoline nasal spray), and Danzhen Headache Capsules (exclusive TCM for headaches), alongside OC-01 nasal spray for dry eye - Hexuemingmu Tablets: National exclusive variety, national TCM protection product, included in national medical insurance and essential drug catalogs, used for fundus diseases caused by yin deficiency, liver hyperactivity, and heat damaging collaterals[72][73] - Jinsang series products: National exclusive products, covering all throat diseases, with Jinsang Sanjie Capsules and Jinsang Kaiyin Capsules included in the national medical insurance catalog[74] - Duoputai® (Maixuekang Capsules and Maixuekang Enteric-coated Tablets): The only traditional Chinese medicine in China labeled with antithrombin activity units, used for cardiovascular and cerebrovascular diseases such as coronary heart disease and acute cerebral infarction[75] - Reizhu® (Polyvinyl Alcohol Eye Drops): Single-dose, preservative-free artificial tears, a first-line treatment for dry eye, awarded the CPhI Gold Award for nine consecutive years[76] - Nuotong (Xylometazoline Hydrochloride Nasal Spray/Nasal Drops): A nasal decongestant for relieving nasal congestion, with the nasal spray being a domestically exclusive dosage form[77] - Varenicline Tartrate Nasal Spray (OC-01): The world's first and only preservative-free nasal spray approved for treating mild, moderate, and severe dry eye, launched in the US, Macao, and mainland China[79] Innovative R&D Pipeline The innovative R&D pipeline features four drugs addressing post-ophthalmic surgery inflammation, pterygium, myopia, and demodex blepharitis, with GPN00833, GPN00153, GPN00884, and GPN01768 all in advanced development or approved - Hormone nanosuspension eye drops GPN00833: Approved for marketing by the US FDA, China Phase III clinical trial successfully reached its endpoint, NDA preparation underway, possessing high local anti-inflammatory activity[81] - Modified new drug GPN00153 (CBT-001) for treating pterygium: Phase II clinical trials completed in the US, all patients enrolled in China Phase III clinical trial[82] - Novel ophthalmic preparation GPN00884 for slowing the progression of myopia in children: China Phase I clinical study completed, no pupil dilation effect, potentially improving patient compliance[83] - Global innovative ophthalmic preparation GPN01768 (TP-03): Approved for marketing by the US FDA and Macao Pharmaceutical Administration Bureau, the first and only FDA-approved drug for demodex blepharitis, China NDA accepted[84] Cardiovascular Emergency Segment This segment manages both emergency and chronic cardiovascular diseases, offering over 30 products, including 14 in national emergency drug catalogs and 16 in shortage drug catalogs, with key products like Hexinshuang®, Nengqilang®, and Jext® - The Cardiovascular Emergency segment has over 30 products, with 14 included in China's national emergency drug catalog and 16 in the shortage drug catalog[85] Cardiovascular Emergency Products Core products include Hexinshuang®/Hebeishuang® (calcium channel blockers), Nengqilang® (Coenzyme Q10 tablets), Nuofukang (methoxamine hydrochloride injection), Limaitong® Eplerenone Tablets (novel MRA), Jext® pre-filled adrenaline auto-injector, and Runmode Lin® Treprostinil Injection, covering various cardiovascular needs - Hexinshuang®/Hebeishuang®: Classic calcium channel blockers, available in oral immediate-release, sustained-release, and injectable forms, widely used for hypertension, coronary heart disease, etc.[87] - Nengqilang® (Coenzyme Q10 Tablets): Used to improve myocardial metabolism and energy supply, significantly improving symptoms in patients with chronic heart failure, recommended by multiple authoritative guidelines[88] - Limaitong® Eplerenone Tablets: Novel MRA drug, filling the gap for second-generation selective aldosterone receptor antagonists in China, included in the national medical insurance catalog in November 2024[90] - Jext® pre-filled adrenaline auto-injector: For emergency treatment of severe allergic reactions, marketed in 21 countries or regions globally, and obtained approval for urgently needed imported Hong Kong and Macao drugs in the Guangdong-Hong Kong-Macao Greater Bay Area[91] - Runmode Lin® Treprostinil Injection: A rare disease drug for pulmonary hypertension, one of only two treprostinil products approved in China, included in the national medical insurance catalog in January 2023[92] API Segment The API segment features a rich product pipeline with global sales channels, supporting integrated pharmaceutical production and R&D across five major therapeutic areas, and an mRNA platform developing innovative anti-tumor and anti-infective drugs - The API segment has a rich product pipeline, with both bulk APIs and specialty APIs sold globally, and sales channels covering the world[93] - The API production and R&D layout focuses on five major areas: cardiovascular and cerebrovascular, anti-infective, antipyretic-analgesic, digestive system, and anti-tumor, achieving integrated upstream and downstream industrial advantages[93] mRNA Platform The mRNA platform focuses on developing anti-tumor and anti-infective mRNA drugs, having established mRNA production and LNP delivery technologies, with ARC01 (A002) being China's first HPV-positive related tumor mRNA therapeutic vaccine in clinical trials - 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[94] - The therapeutic tumor vaccine ARC01 (A002) was approved for Phase I clinical study in China in January 2024, making it China's first HPV-positive related tumor mRNA therapeutic vaccine approved for clinical trials[94] - ARC01 (A002) utilizes exclusive patented LNP delivery technology and TriMix® immune adjuvant, significantly enhancing the body's immune response[94] Biotechnology The biotechnology segment, centered on amino acid products, is a global high-quality amino acid service provider, emphasizing technological innovation, quality systems, and international expansion into high-value-added fields - The Biotechnology segment, with amino acid products as its core business, is positioned as a global high-quality amino acid service provider, committed to green, low-carbon, and sustainable development principles[95] - Holds over 200 invention patents, led and participated in formulating over 60 national, industry, and group standards, and received multiple national-level honors such as National Green Factory[95] - With over 20 years of experience in the amino acid field, the Group pioneered globally leading bio-manufacturing new technologies for various amino acids based on synthetic biology, filling industry gaps and undertaking national industrial strengthening projects[96] New Technologies The Group has established eight synthetic biology technology platforms, integrating new product development, engineering, and application solutions, leveraging collaborations with research institutions to develop innovative amino acid fermentation and enzyme expression systems that reduce carbon emissions - Eight technology platforms, including synthetic biology, enzyme engineering, and fermentation engineering, have been established, forming an integrated synergistic system for 'new product development, new technology engineering and industrialization, and application solutions'[97] - Established long-term deep cooperation with multiple research institutions, including Wuhan University and Huazhong University of Science and Technology, to develop novel amino acid fermentation technologies and enzyme expression systems[97] - Fermentation processes centered on strain construction optimization and enzyme conversion processes centered on immobilized enzymes can replace traditional chemical synthesis, significantly reducing carbon dioxide emissions and aligning with 'carbon peak and carbon neutrality' goals[97] High Quality The Group's amino acid products have comprehensive domestic and international quality certification systems, including EU GMP and US FDA certifications, ensuring compliance and market expansion - Amino acid products have obtained drug/food system certifications and registrations from multiple countries and regions, including EU GMP certification, EU REACH registration, US FDA certification, and South Korea KFDA registration[99] Industrial Chain The Group possesses nearly 50 amino acids and derivatives, with 26 API registration numbers, the most in China, and is actively expanding into functional dietary supplements and food products, with two products commercialized in the US - Owns 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[100] - Added multiple food-grade and feed-grade amino acid products, actively expanding into formulation products, with two independently developed functional dietary supplements certified by the US FDA and commercialized in the US[100] Internationalization The amino acid segment's sales network spans over 140 countries, with overseas business accounting for 40%, and future focus on high-value-added areas like parenteral nutrition, innovative peptides, and cell culture media - 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[101] - Future focus will be on high-value-added areas such as high-end parenteral nutrition preparations, innovative peptide drugs, cell culture media, and major health consumption areas like sports protection, to provide sustained strong development momentum[101] Financial Review This section provides a detailed financial overview, including revenue, profit, distribution and administrative costs, financial expenses, R&D investment, and changes in receivables and payables Revenue and Profit For H1 2025, the Group's revenue increased by 1.0% to HKD 6.107 billion, with innovative products driving growth, while profit attributable to owners decreased by 25.0% due to fair value changes and increased expenses H1 2025 Revenue and Profit Overview | Indicator | H1 2025 (HKD) | H1 2024 (HKD) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | 6,107,320,000 | 6,047,240,000 | +1.0% | | Revenue (RMB basis) | - | - | +2.0% | | Revenue (RMB basis, excluding VBP impact) | - | - | +13.0% | | Revenue contribution from innovative and barrier products | 51.0% | 36.1% | +14.9 percentage points | | Profit attributable to owners of the Company for the period | 1,169,020,000 | 1,557,950,000 | -25.0% | | Normalized profit (excluding Telix investment impact) | 1,017,290,000 | - | -5.9% | | Revenue from Nuclear Medicine Anti-tumor Diagnosis and Treatment & Cardiovascular Precision Interventional Diagnosis and Treatment Technology | 577,740,000 | 342,750,000 | +70.2% | | Revenue from Nuclear Medicine Anti-tumor segment | 421,780,000 | 207,240,000 | +105.5% | | Revenue from Pharmaceutical Technology products | 3,845,190,000 | 3,772,940,000 | +2.9% | | Revenue from Respiratory and Critical Care segment | 1,047,350,000 | 962,550,000 | +9.9% | | Revenue from Ophthalmology, ENT, and Oral Care segment | 1,494,710,000 | 1,230,820,000 | +22.6% | | Revenue from Cardiovascular Emergency segment | 904,410,000 | 1,167,410,000 | -21.8% | | Revenue from Cardiovascular Emergency segment (excluding VBP impact) | - | - | +64.3% | | Revenue from Biotechnology products | 1,684,390,000 | 1,931,540,000 | -11.9% | Distribution Costs and Administrative Expenses For H1 2025, distribution costs increased by HKD 304.34 million due to intensified new product promotion, and administrative expenses rose by HKD 85.55 million due to new subsidiary consolidation and business expansion Distribution Costs and Administrative Expenses | Item | H1 2025 (HKD) | H1 2024 (HKD) | YoY Change | | :--- | :--- | :--- | :--- | | Distribution Costs | 1,916,290,000 | 1,611,950,000 | +304,340,000 | | Administrative Expenses | 691,750,000 | 606,200,000 | +85,550,000 | - The increase in distribution costs was primarily due to intensified market promotion for new products during the year[107] - The increase in administrative expenses was primarily due to the consolidation of new subsidiaries and business expansion during the period[107] Finance Costs For H1 2025, finance costs decreased to HKD 80.35 million, primarily due to a lower comprehensive interest rate from loan replacement Finance Costs | Item | H1 2025 (HKD) | H1 2024 (HKD) | YoY Change | | :--- | :--- | :--- | :--- | | Finance Costs | 80,350,000 | 86,120,000 | -5,770,000 | - The decrease in finance costs was due to a lower comprehensive interest rate resulting from loan replacement[108] R&D and Project Investment For H1 2025, the Group invested approximately HKD 1.022 billion in R&D and projects, continuing to allocate resources for ongoing and new innovative initiatives - The Group's investment in R&D work and projects amounted to approximately HKD 1.022 billion[109] - Resources continue to be invested in advancing ongoing R&D projects and introducing innovative projects[109] Trade and Other Receivables and Payables As of June 30, 2025, trade and other receivables increased by HKD 1.296 billion to HKD 4.75 billion, and trade and other payables increased by HKD 664 million to HKD 3.592 billion, both primarily due to business expansion Changes in Trade and Other Receivables and Payables | Item | June 30, 2025 (HKD) | December 31, 2024 (HKD) | Change | | :--- | :--- | :--- | :--- | | Trade and other receivables | 4,750,240,000 | 3,454,590,000 | +1,295,650,000 | | Trade and other payables | 3,591,890,000 | 2,928,090,000 | +