Revenue and Financial Performance - Revenue for 2022 reached HKD 9,562,285 thousand, an increase from HKD 8,597,975 thousand in 2021[21] - Net profit for 2022 was HKD 2,098,251 thousand, compared to HKD 2,405,032 thousand in 2021[21] - Total assets increased to HKD 22,371,061 thousand in 2022 from HKD 21,057,030 thousand in 2021[22] - Total liabilities rose to HKD 8,162,401 thousand in 2022 from HKD 7,614,168 thousand in 2021[22] - Revenue for 2022 reached approximately HKD 9,562,290,000, a year-on-year increase of 11.2% (15.1% excluding currency impact)[100] - Net profit attributable to shareholders in 2022 was approximately HKD 2,137,330,000, up 11.5% year-on-year (15.4% excluding currency impact)[100] - Gross margin for 2022 was 62.2%, compared to 61.0% in 2021[100] - The company invested approximately HKD 2.45 billion in R&D and project development in 2022[101] R&D and Innovation - The company obtained 13 marketing approvals, 17 clinical progress milestones, and 3 international registrations, with 15 core patents granted[5] - The company launched 4 innovative products and initiated 42 R&D projects, showcasing significant innovation achievements[5] - The company has 136 R&D projects, including 55 innovative projects across various therapeutic areas[11] - The company's innovative product pipeline includes GPN00136 (BRM421) for dry eye, GPN00153 (CBT-001) for pterygium, and GPN00833 for anti-inflammatory eye diseases, with various stages of development[12] - The company's RDC drug TLX250-CDx for diagnosing ccRCC achieved clinical endpoints in overseas Phase III trials[13] - The company's global innovative drug STC3141 for treating ARDS reached clinical endpoints in China's Ib phase trials[13] - The company's RDC drug TLX591-CDx for diagnosing prostate cancer received IND approval from NMPA in China[13] - The company's oral small molecule anti-COVID-19 3CL protease inhibitor GS221 successfully progressed in clinical trials[13] - The company's global innovative drug STC3141 for severe diseases completed patient enrollment for its Ib phase clinical trial in China for treating ARDS, with the clinical study report expected within the next 6 months. The IIa phase clinical trial in Europe for treating severe COVID-19 successfully met the primary clinical endpoint[14] - The company's global innovative product, Yttrium [90Y] Microsphere Injection, received NMPA approval for treating unresectable colorectal cancer liver metastases, providing a new and effective treatment option for liver cancer patients in China[14] - The company achieved 38 significant milestones from 2022 to March 22, 2023, including 25 innovative products and 1 major acquisition[24] - The company's R&D team consists of over 700 personnel, with over 400 holding master's or doctoral degrees[105] - The company added 70 new patent applications, including 15 core patents and 55 peripheral patents, and obtained 136 new patent authorizations, with 71 invention patents accounting for 52.2% of the total. The cumulative number of valid patents reached 599, including 333 invention patents and 266 utility model and design patents[109] Product Launches and Approvals - The company achieved a revenue of over HKD 60 million in the first year of the launch of its innovative nuclear medicine product, Yitai® Yttrium [90Y] Microsphere Injection[5] - The company's Wuhan Innovation Medical Device R&D and Production Base was officially put into use, enhancing its domestic R&D and production capabilities[5] - The company's HeartLight X3 laser ablation platform completed the first特许准入 atrial fibrillation laser ablation surgery in China[5] - The company's respiratory and critical care anti-infective segment saw two innovative compound asthma products enter the national medical insurance catalog[5] - The company's Jext® pre-filled adrenaline auto-injector received特许准入 in the Guangdong-Hong Kong-Macao Greater Bay Area[5] - The company's Y-90 microsphere injection (易甘泰®) was approved for market launch in China[24] - TLX591-CDx, a global innovative nuclear medicine product, submitted and received approval for IND application in China[24] - TLX250-CDx, another global innovative nuclear medicine product, successfully reached clinical endpoints in overseas Phase III trials[24] - The neurointerventional product OTW intracranial balloon catheter (彩鷸®) was approved for market launch in China[24] - The HeartLight X3 laser ablation platform completed the first特许准入 laser ablation surgery for atrial fibrillation in China at Ruijin Hainan Hospital[24] - Two global innovative compound preparations for asthma treatment, Enzhu Run® and Enming Run®, successfully entered the 2022 National Medical Insurance Directory[25] - The innovative product Ryaltris nasal spray completed the first patient dosing in its Phase III clinical trial in China[25] - The global innovative drug STC3141 successfully met the primary clinical endpoints in its Phase IIa trial for severe COVID-19 treatment in Europe and Phase Ib trial for ARDS treatment in China[25] - The company's self-developed "Epinephrine Hydrochloride Injection (Pre-filled Syringe)" was approved for market launch in July 2022, making it the first adrenaline pre-filled syringe product in China[54] Acquisitions and Strategic Partnerships - The company completed 1 acquisition and introduced 16 amino acid raw materials, optimizing its biotech industry chain[4] - The company acquired 100% equity of Hubei Bafeng for no more than RMB 270 million, gaining 24 amino acid API registration certificates, covering over 70% of similar registrations[13] - The company sold approximately half of its shares in Telix (10,000,000 shares) for about AUD 73 million and plans not to sell the remaining 10,947,181 shares within the next 12 months[13] - The company's subsidiary Hongnian subscribed to 29,646,627 shares of Sirtex HoldCo for USD 35 million, resulting in Hongnian owning approximately 51.61% of Sirtex HoldCo's issued share capital[13] - The company invested €15 million to acquire approximately 11% equity in XELTIS and secured rights to the global innovative endogenous tissue repair product aXess and future products under the same technology platform in the Greater China region[14] - The company's subsidiary, Beijing Pure Weiye, was appointed as the exclusive distributor for Sirtex Medical's products in China[14] - The company signed a strategic cooperation agreement with Wenzhou Medical University Eye Hospital, paying RMB 70 million in stages to secure rights to technology and new ophthalmic formulations for myopia prevention in the Greater China region[14] - The company increased the registered capital of Wuhan Shetai by RMB 65 million, with the company contributing RMB 21.45 million based on its existing equity ratio[14] - The company signed a product licensing agreement with Novartis AG, paying up to $20 million and a percentage of sales royalties to obtain exclusive commercialization rights for two global innovative asthma treatments, Enerzair® Breezhaler® and Atectura® Breezhaler®, in mainland China[109] - The company invested $35 million to increase its stake in Grand Pharma Sphere Pte Ltd, holding approximately 51.61% of its shares, thereby strengthening its position in Sirtex's global innovative medical products[115] Market Expansion and Global Presence - The company's sales exceeded HKD 100 million for 17 products, and it established an overseas biopharmaceutical marketing center[4] - The company aims to strengthen its global leadership in nuclear medicine anti-tumor diagnostics and treatment through comprehensive R&D, production, and sales regulatory qualifications[8] - The company's strategy includes dual-driven development through independent R&D and global expansion, aiming for a dual-circulation model of domestic and international markets[9] - The company's Y-90 microsphere injection (Yigantai®) has seen a significant increase in patient consultations, with specialized clinics opening in multiple hospitals[8] - The global innovative product Y-90 microsphere injection has been used by over 150,000 patients in more than 50 countries and regions[65] - Y-90 microsphere injection was approved for marketing in China in January 2022, providing a new and effective treatment option for liver cancer patients[66] - The company has trained over 300 doctors from 70 hospitals on Y-90 microsphere injection surgery, with nearly 20 experts obtaining independent surgical qualifications[67] - Y-90 microsphere injection has been included in various insurance programs, covering 11 provinces and 33 cities, significantly increasing patient accessibility[68] - The company recorded approximately HKD 60,260,000 in revenue from Y-90 microsphere injection since its approval[68] - The company has established R&D and production bases in Wuhan and Changzhou, with overseas R&D centers in the U.S., Germany, Canada, and Italy[80] - The company has over 3,800 sales personnel, with nearly 3,300 in the pharmaceutical field, covering over 20,000 hospitals in China. The OTC sales team exceeds 1,000 people, reaching over 260,000 pharmacies. The cardiovascular precision intervention and nuclear medicine oncology sectors have 140 and 230 sales personnel, respectively, covering 1,400 hospitals and over 50 countries globally[109] Environmental, Social, and Governance (ESG) - The company's Environmental, Social, and Governance (ESG) report covers entities with significant financial and operational impacts, primarily located in China, with data from January 1, 2022, to December 31, 2022[154] - The Board is fully responsible for the company's ESG strategy and reporting, integrating ESG considerations into its structure and commitments, and regularly engaging with stakeholders[155] - The company prioritizes product safety and service quality in its ESG management goals, focusing on developing innovative drugs to meet unmet medical needs globally[156] - The company aims to complete the establishment of EHS management functions for mature business sectors, including the biotech sector, and strengthen internal EHS controls by 2023[161] - The company plans to achieve zero responsibility accidents, zero environmental pollution incidents, and zero occupational diseases across all enterprises by 2030[162] - The company targets a 10% reduction in total emissions of major pollutants by 2025 and a 15% reduction by 2030[162] - The company will conduct no less than 10 EHS inspections annually to ensure compliance and safety[162] - The company will initiate the construction of an EHS control platform to enable real-time visual inspections of key management areas by 2025[161] - The company plans to build and certify 3-4 green factories by 2025 and complete the construction of no less than 8 green factories by 2030[161] - The company will focus on energy conservation, clean production, and carbon reduction, guiding enterprises to achieve these goals by 2030[161] - The company will implement full automation for production lines involving hazardous processes, such as nitration, by 2023[162] - The company will establish an ESG database and set emission reduction targets based on enterprise conditions by 2025[161] - The company will ensure compliance with environmental laws and regulations, including emission standards for air pollutants and solid waste, to maintain a green corporate image[159] - The company has 2 green factory certifications, 9 occupational health and safety management system certifications (OHSAS18001/ISO45001), and 8 environmental management system certifications (ISO14001)[163] - The company has 1 energy management system certification (ISO500001) and 14 national safety production standardizations[164] - The company conducted 24 environmental facility operation checks in 2022, achieving a 100% compliance rate for pollutant emissions from waste treatment facilities[167] - The company invested over 30 million yuan in 2022 to complete more than 10 environmental protection projects, upgrading waste treatment facilities[167] - The company implemented 5 key environmental emission reduction projects, reducing air pollutants by approximately 503 tons, water pollutants by 3 tons, and solid waste by 110 tons[167] - The company obtained 8 environmental patents in 2022, including 3 invention patents, strengthening production barriers[170] - The company has 41 wastewater treatment facilities and 14 online monitoring facilities across its member enterprises[172] - All member enterprises achieved a 100% compliance rate for wastewater pollutant emissions, with continuous monitoring of water quality and quantity[174] - Total wastewater volume in 2022 was 1.64554 million tons, an increase from 1.2875 million tons in 2021[175] - Chemical Oxygen Demand (COD) in 2022 was 118.966 tons, a decrease from 127.824 tons in 2021[175] - Volatile Organic Compounds (VOCs) emissions in 2022 were 19.113 tons, slightly down from 19.369 tons in 2021[179] - Nitrogen oxides emissions in 2022 were 39.128 tons, up from 30.389 tons in 2021[179] - Sulfur dioxide emissions in 2022 were 28.972 tons, an increase from 25.438 tons in 2021[179] - Particulate matter emissions in 2022 were 13.529 tons, up from 7.437 tons in 2021[179] - General solid waste disposal in 2022 was 4,502 tons, with a density of 0.471 tons per million revenue[181] - Hazardous waste disposal in 2022 was 6,292 tons, with a density of 0.658 tons per million revenue[181] - The company has 85 sets of waste gas treatment facilities and 7 sets of online monitoring facilities across its enterprises[176] - The company has implemented energy-saving measures and is exploring new energy sources such as photovoltaic and energy storage[182] - Total coal consumption: 55,560.19 tons/year[183] - Total natural gas consumption: 1.185 million m³/year[183] - Total water consumption: 3.5246 million tons/year[183] - Total electricity consumption: 222.5412 million kWh/year[183] - Direct CO2 emissions: 68,362 tons/year[184] - Indirect CO2 emissions: 133,677 tons/year[184] - Water consumption per product decreased by 1.7% through water-saving measures[185] - Electricity savings of 1.3 million kWh/year by replacing Roots blowers with magnetic levitation blowers[185] - Natural gas savings of 15,000 m³/year through pipeline insulation and other measures[185] - Total number of employees: 10,172, with a female employee ratio of 45%[191] - Total number of employees in the group is 10,172, with 24% aged under 30, 25% aged 31-35, and 19% aged 36-40[192] - Xi'an Beilin Pharmaceutical Co., Ltd. has the highest number of employees at 1,483, followed by Beijing Jiuyuan Pharmaceutical Co., Ltd. at 1,283[193] - The group conducted 675 safety and environmental training sessions in 2022, with a total of 64,840 participants[196] - The group completed safety automation upgrades for 7 production lines and addressed 84 major safety hazards in 2022[197] - The group established a process safety laboratory equipped with advanced analytical instruments to ensure reaction safety risks are controlled from the R&D stage[199] - The group collected and classified 1,134 internal safety and environmental regulations into 28 categories for compliance awareness building[195] - The group conducted 8 centralized online safety and environmental training sessions in 2022, with a total of 2,005 participants and a 99.8% exam pass rate[196] - The Fuchi Industrial Park achieved compliance with the Hubei Province Chemical Park Certification Standards[198] - The group identified and mitigated 13 high-risk design issues in the sulfuric acid dimethyl ester continuous distillation unit and 12 high-risk issues in the nitromethane production process[199] - The group organized 19 sessions of process safety management training and established process safety teams across chemical enterprises[199] - 19 companies have initially completed the annual safety risk identification and hierarchical control work, identifying a total of 4,396 risks, including 449 major risks[200] - The company has implemented hierarchical control at the enterprise, department, workshop, and team levels, and established visual management tools such as risk color maps and risk notification cards[200] Corporate Governance and Compliance - The company's board of directors consists of 4 executive directors and 3 independent non-executive directors, with a clear separation of roles between the chairman and CEO[137] - The company has a diversity policy for its board and senior management, aiming for a balanced and sustainable development, with the current team comprising 8 men and 2 women[138] - The audit committee held two meetings in 2022 to review the Group's accounting principles and financial reporting, with no disagreements between management and external auditors[141] - The remuneration committee held two meetings in 2022 to review the remuneration policies for directors and senior management, with details disclosed in the consolidated financial statements[142] - The nomination committee held one meeting in 2022 to review the board structure, size, and composition, and assess the independence of independent non-executive directors[143] - All directors attended 23 out of 23 board meetings and 1 out of 1 annual general meeting in 2022, demonstrating full participation[144] - The audit fees paid to the external auditor, Kwok Wai CPA Limited, amounted to HKD 3,880,000 for the 2022 audit[145] - The board confirmed the effectiveness of the Group's risk management and internal control systems, with no significant issues identified during the annual review[147] - The risk management process includes identifying risks, assessing their impact, implementing control measures, and regularly reviewing the system's effectiveness[147] - The board is responsible for the overall risk management and internal control systems, with the audit committee regularly reviewing the Group's performance and risk management[147] - The company has implemented an insider information policy to ensure the authenticity, accuracy, completeness, and timeliness of public disclosures, with access restricted to a limited number of employees who are fully aware of their confidentiality obligations[149] - The Board of Directors has adopted a corporate governance function, including reviewing and monitoring compliance with legal and regulatory requirements, and ensuring adherence to corporate governance policies[150] - The company has established multiple communication channels with shareholders and investors, including printed annual and interim reports, and encourages shareholder attendance at general meetings[151] - Shareholders holding at least 10% of the company's paid-up capital with voting rights
远大医药(00512) - 2022 - 年度财报