Investment Rating - The report initiates coverage on Grand Pharmaceutical Group (0512 HK) with a "Buy" rating [6] Core Views - Grand Pharmaceutical Group is a long-established pharmaceutical company with three major business segments: pharmaceutical technology, nuclear medicine oncology, and precision cardiovascular intervention technology, along with biotech [2] - The company achieved revenue of HKD 10 53 billion in 2023, a 10 12% YoY increase, with net profit attributable to shareholders of HKD 1 88 billion, a 9 59% YoY decline [2] - The nuclear medicine oncology segment is expected to drive rapid growth, while the cardiovascular and respiratory segments are projected to maintain stable growth [6] - Revenue is forecasted to reach HKD 12 00 billion in 2024, HKD 13 92 billion in 2025, and HKD 15 32 billion in 2026, with EPS of HKD 0 64, HKD 0 68, and HKD 0 73 respectively [6] Business Segments Nuclear Medicine Oncology - The company is actively expanding its nuclear medicine oncology pipeline, with its flagship product Y-90 microspheres (Yigantai®) showing significant efficacy in treating primary liver cancer and colorectal cancer liver metastases [3] - Colorectal cancer is the third most common cancer globally, accounting for 10% of all cancer cases, while liver cancer is highly prevalent in China, with 47% of global new cases in 2018 [3] - Yigantai® has been approved for colorectal cancer liver metastases and is expected to gain approval for primary liver cancer soon, becoming a key growth driver [3] - The company has 14 innovative nuclear medicine products in its pipeline, including 9 RDC (radiopharmaceutical drug conjugate) products, with 4 in clinical trials in China [29] Precision Cardiovascular Intervention - The company entered the cardiovascular medical device field in 2015 through acquisitions and has built a comprehensive platform covering coronary, peripheral, structural heart, and electrophysiology [4] - Key products include drug-coated balloons (DCB), Novasight Hybrid intravascular imaging system, and HeartLightX3 laser ablation platform [4] - The DCB market in China is expected to grow from RMB 4 39 billion in 2019 to RMB 8 38 billion in 2024, driven by aging population and policy support [52] - The electrophysiology device market in China is projected to reach RMB 15 7 billion by 2025, with HeartLightX3 showing promising potential [57] Traditional Business Segments - The company has a strong presence in traditional segments such as cardiovascular emergency, ophthalmology, respiratory, and biotech products, with stable market share and brand influence [5] - In ophthalmology, products like polyethylene alcohol eye drops and He Xue Ming Mu tablets have shown steady sales growth [61] - The respiratory segment includes products like Xiao Qing Zao enteric-coated soft capsules, which have maintained a strong market position [61]

型 愛大健康 遠大醫藥集團 遠大醫藥集團有限公司 GRAND PHARMACEUTICAL GROUP LIMITED GRAND PHARMACEUTICAL GROUP (於百慕達註冊成立之有限公司) (股份代號 : 00512) | --- | --- | --- | --- | --- | |----------|-------|-------|-------|-------| | 9 | | | | | | 023 年報 | NH2 | | | | | HN | H,CC | | | | | nH | | | | | | | | | | | 目錄 頁次 公司資料2 主席報告3 企業概覽6 財務摘要 17 管理層討論及分析 19 企業管治報告 57 董事會報告 63 董事及高級管理人員履歷 74 獨立核數師報告 76 綜合損益及其他全面收益表 83 綜合財務狀況表 84 綜合權益變動表 86 綜合現金流量表 88 綜合財務報表附註 90 年度報告2023 公司資料 | --- | --- | |--------------------|--------------------------------- ...

Financial Performance - Revenue for the year ended December 31, 2023, was approximately HKD 10,529,590,000, a year-on-year increase of 10.1%, or 15.8% excluding the impact of RMB-HKD exchange rate fluctuations[2] - Gross profit for the year ended December 31, 2023, was approximately HKD 6,524,070,000, a year-on-year increase of 9.6%, or 15.3% excluding the impact of RMB-HKD exchange rate fluctuations[2] - Normalized profit attributable to owners of the company for the year ended December 31, 2023, was approximately HKD 2,036,240,000, a year-on-year decrease of 4.7%, or an increase of 0.2% excluding the impact of RMB-HKD exchange rate fluctuations[2] - Revenue for 2023 increased to HKD 10,529,590 thousand, up from HKD 9,562,285 thousand in 2022, representing a growth of approximately 10.1%[125] - Gross profit for 2023 rose to HKD 6,524,066 thousand, compared to HKD 5,951,479 thousand in 2022, an increase of about 9.6%[125] - Net profit for 2023 was HKD 1,895,442 thousand, down from HKD 2,098,251 thousand in 2022, a decrease of approximately 9.7%[125] - Total comprehensive income for 2023 was HKD 1,629,048 thousand, up from HKD 1,207,795 thousand in 2022, an increase of about 34.9%[126] - Basic and diluted earnings per share for 2023 were HKD 53.60 cents, down from HKD 58.70 cents in 2022, a decrease of approximately 8.7%[126] - Revenue from pharmaceutical technology products in 2023 was HKD 6,813,239 thousand, an 11.3% increase from HKD 6,120,145 thousand in 2022[138] - Revenue from biotechnology products in 2023 was HKD 3,380,958 thousand, a 6.9% increase from HKD 3,163,702 thousand in 2022[138] - Revenue from nuclear medicine and precision intervention products in 2023 was HKD 335,393 thousand, a 20.5% increase from HKD 278,438 thousand in 2022[138] - R&D expenses in 2023 were HKD 571,985 thousand, a 7.5% increase from HKD 531,924 thousand in 2022[141] - Marketing and promotional expenses in 2023 were HKD 567,201 thousand, a 13.7% increase from HKD 498,692 thousand in 2022[141] Dividends and Shareholder Returns - The company recommended a final dividend of 26 HK cents per share for 2023, totaling approximately HKD 905,140,000[2] - The proposed final dividend per share for 2023 is HKD 0.26, compared to HKD 0.14 in 2022, with total dividends payable to shareholders amounting to HKD 905,141 thousand[142] - The final dividend will be paid on or around June 27, 2024, to shareholders on the register as of June 11, 2024[120] R&D and Innovation - The company invested approximately HKD 1.441 billion in R&D, including capitalized R&D expenditures, prepayments for new projects, and other investments[2] - The company achieved 30 product approvals and completed 3 major acquisitions in 2023[4] - The company has 138 R&D projects, including 46 innovative projects, and achieved 77 major milestones in 2023[5] - 5 innovative products were launched in 2023, with 5 products entering the New Drug Application (NDA) stage and 8 products entering clinical trials[5] - The company's TLX591-CDx for prostate cancer diagnosis is in Phase III clinical trials in China and has become a new clinical diagnostic standard overseas[5] - The company's mRNA therapeutic vaccine ARC01 is the first mRNA tumor vaccine for HPV-positive related tumors to receive IND approval in China[5] - The company completed 77 significant milestones in 2023, including 42 innovative products, 16 generic products, 9 functional foods, 4 international certifications for raw material products, 3 major acquisitions, and 2 major construction projects[11] - The company's innovative nuclear medicine product TLX591-CDx for prostate cancer diagnosis completed the first patient enrollment in its Phase III clinical trial in China[12] - The company's innovative nuclear medicine product TLX250-CDx for clear cell renal cell carcinoma (ccRCC) diagnosis completed Phase I clinical trials in China and entered confirmatory clinical studies[12] - The company's innovative nuclear medicine product TLX101 for glioblastoma treatment was approved for Phase I clinical trials in China[12] - The company's innovative nuclear medicine product ITM-11 for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) treatment was approved for Phase I clinical trials in China[12] - The company's innovative liquid embolic agent LavaTM for treating peripheral vascular arterial hemorrhage received FDA approval and achieved commercialization[12] - The company's innovative medical device HeartLight X3 laser ablation platform for atrial fibrillation treatment completed the first特许准入 case in China at Ruijin Hainan Hospital[13] - The company's innovative medical imaging device NOVASIGHT Hybrid for intravascular diagnosis was approved for market launch in China[13] - The company's neurointerventional product GPN00493, an adjustable thrombectomy stent, successfully reached clinical endpoints and submitted a market application to the Chinese National Medical Products Administration[13] - Two innovative combination drugs for asthma treatment, Enzhu Run® Bisihail® and Enming Run® Bisihail®, successfully entered the 2022 National Medical Insurance Directory[14] - The innovative product Ryaltris® (GSP 301 NS) for allergic rhinitis completed Phase III clinical trials in China and submitted a marketing application to the regulatory authority[14] - The global innovative drug STC3141 completed Phase Ib clinical trials for sepsis treatment in Australia and Belgium, and initiated Phase II clinical trials in China[14] - 16 generic products were approved for market, including the first generic versions of Eplerenone Tablets and Carglumic Acid Dispersible Tablets in China[17] - 9 functional food products were launched in China[18] - The company's mRNA platform has completed the construction of mRNA production technology and LNP delivery technology, with ARC01 (A002) being China's first mRNA therapeutic tumor vaccine for HPV-positive related tumors to enter clinical trials[48] - The company's R&D pipeline includes projects like GPN00136 (BRM421), GPN00153 (CBT-001), and Ryaltris, targeting various therapeutic areas such as ophthalmology, respiratory, and cardiovascular diseases[84] - The company obtained drug registration certificates for 10 generic drugs, including Eplerenone Tablets and Carglumic Acid Dispersible Tablets, which are the first generic products in China[88] - The company added 17 core patents and 75 peripheral patents, with a total of 722 valid patents, including 412 invention patents[90] - The company's mRNA technology platform added 10 patent applications and 1 PCT application[90] Acquisitions and Investments - The company completed the acquisition of 87.5% equity in BlackSwan Vascular, Inc., strengthening its presence in the oncology intervention field[18] - Two major acquisitions in the cardiovascular field: 75.35% equity in Tianjin Tianbian Pharmaceutical Co., Ltd. and 90% equity in Chongqing Duputai Pharmaceutical Technology Co., Ltd.[18] - The company acquired 87.5% equity of BlackSwan for up to $37.5 million, gaining global rights to LavaTM and KonaTM products[94] - The company acquired 75.35% equity of Tianjin Tanabe for approximately HKD 400 million (RMB 3.677 billion) to expand its chronic disease market[95] - The company acquired 90% equity of Chongqing Duputai Pharmaceutical Technology for approximately RMB 631.8 million to strengthen its cardiovascular disease treatment portfolio[96] - The company acquired an 87.5% equity stake in BlackSwan Vascular, Inc. for a total consideration of approximately USD 32,537,000 (HKD 255,417,000), including a base cash consideration of USD 22,607,000 (HKD 177,464,000)[153] - The identifiable net assets acquired from BlackSwan include intangible assets of HKD 317,918 thousand and property, plant, and equipment of HKD 578 thousand[154] Nuclear Medicine and Oncology - The company achieved a nearly 300% year-on-year revenue growth in the nuclear medicine anti-tumor sector, with its core product Yttrium-90 microspheres being used in over 40 hospitals across 17 provinces and included in 36 provincial health insurance programs[6] - The company's flagship product, Y-90 microsphere injection, has been used by over 150,000 patients in more than 50 countries and regions[51] - Y-90 microsphere injection achieved an objective response rate of 60% in patients with liver malignancies who were followed up for 3 months or more[52] - The company has trained over 1,000 doctors from 70 hospitals on Y-90 microsphere injection procedures, with 38 physicians qualified for independent operations[53] - Y-90 microsphere injection is covered by 36惠民保 (Hui Min Bao) programs and 1特药险 (special drug insurance) across 20 provinces and 27 cities in China[53] - The company is constructing a Class A radionuclide production platform to strengthen its nuclear medicine anti-tumor diagnosis and treatment sector[50] - The company has established 7 surgical, treatment, and training centers for Y-90 microsphere injection in China[52] - The company's nuclear medicine anti-tumor diagnosis and treatment segment has over 320 global sales personnel, covering more than 50 countries and regions[91] Cardiovascular and Precision Intervention - The company's drug-coated balloons RESTORE DEB® and APERTO® OTW, utilizing the proprietary SAFEPAX technology, have gained significant market recognition and clinical acceptance since their launch[60] - The Novasight Hybrid System, a dual-modality intravascular imaging device, was approved in China in May 2023, offering both ultrasound and optical imaging capabilities for precise coronary interventions[60] - RESTORE DEB® is the first drug-coated balloon in China with dual indications for primary coronary lesions and in-stent restenosis, supported by clinical studies published in JACC Cardiovascular Interventions[61] - APERTO® OTW, the first drug-coated balloon for dialysis patients with arteriovenous fistula stenosis, shows superior target lesion patency rates at six months post-procedure compared to standard high-pressure balloons[62] - The Novasight system, combining IVUS and OCT imaging, is the first FDA-approved dual-modality intravascular imaging system, with applications in coronary imaging and endovascular interventions[62] - The company's self-developed intracranial balloon catheter, Caique®, is the first OTW-designed catheter in China for treating symptomatic intracranial atherosclerotic stenosis[62] - The Pelican® occlusion balloon catheter, part of the company's neurovascular intervention portfolio, is designed for temporary vascular occlusion and selective blood flow control[63] - The company's LEGFLOW® OTW, a drug-coated balloon for peripheral artery stenosis, completed patient enrollment for its registration clinical trial and is expected to submit a market application in China by the first half of 2024[65] - The IVL CAD/IAL PAD system, a next-generation vascular calcification treatment using shockwave lithotripsy integrated with balloon angioplasty, is currently in preclinical development[65] - LONG, a neurothrombectomy stent for ischemic stroke, extends the treatment window from 6 hours to 24 hours, with the product currently under regulatory review[66] - aXess, an endogenous tissue repair product for ESRD patients, is in the preclinical development stage and aims to reduce thrombosis and complications in dialysis patients[66] - Saturn, a mitral valve replacement system, is in the preclinical development stage and combines annuloplasty with valve replacement technology[66] - CoRISMA, a fully implantable ventricular assist device for end-stage heart failure, is being co-developed with a Yale University-incubated medical device company[67] - HeartLight X3, a laser ablation platform for atrial fibrillation, received FDA approval in May 2020 and completed its first case in China in February 2023[68] Legal and Regulatory Issues - The company was fined RMB 136 million (3% of 2019 domestic sales) and confiscated RMB 149 million in illegal gains for antitrust violations related to the sale of certain pharmaceutical raw materials[100] - The company paid approximately RMB 39,216,705 in compensation and legal fees related to product quality lawsuits involving its subsidiary, Tianjin Jingming[98] - The company recovered RMB 10,000,000 and interest from a jointly managed bank account following a court judgment[99] - The company's subsidiary, Tianjin Jingming, is involved in ongoing litigation, with 74 cases adjudicated and one still under review as of December 31, 2023[98] - The company's subsidiary, Tianjin Jingming, has recovered RMB 7,270,000 through court-enforced asset recovery from its former shareholders[98] - The company's antitrust penalties accounted for approximately 3.0% of its latest fiscal year's audited revenue and 16.82% of attributable profit, with no significant adverse impact expected[100] Financial Position and Liquidity - The company's current assets as of December 31, 2023, were HKD 7,016,150,000, compared to HKD 6,886,920,000 in the previous year, with a current ratio of 1.22, up from 1.07 in 2022[102] - Cash and bank balances as of December 31, 2023, were HKD 1,339,710,000, with 94.9% denominated in RMB and 5.1% in HKD, USD, AUD, and EUR[102] - Outstanding bank loans as of December 31, 2023, amounted to approximately HKD 3,284,520,000, a decrease from HKD 3,741,380,000 in 2022[103] - The debt-to-equity ratio (bank borrowings as a percentage of shareholders' equity) was approximately 21.5% as of December 31, 2023[103] - Capital commitments as of December 31, 2023, totaled approximately HKD 1,246,600,000, a significant increase from HKD 140,490,000 in 2022[106] - The company's operating lease commitments as of December 31, 2023, were approximately HKD 377,000, down from HKD 650,000 in 2022[106] - The company's financial resources are primarily in RMB and HKD, minimizing exposure to foreign exchange risk[103] - The company has not adopted any foreign exchange agreements, interest rate swaps, currency swaps, or other financial derivatives for hedging purposes[104] - The company's share incentive plan limits the cumulative number of shares awarded to no more than 5% of the issued shares at the time of the plan's adoption[109] - Non-current assets increased slightly from HKD 15,484,141 thousand in 2022 to HKD 15,499,181 thousand in 2023, with notable increases in intangible assets from HKD 1,397,992 thousand to HKD 1,656,879 thousand[127] - Current assets rose from HKD 6,886,920 thousand in 2022 to HKD 7,016,145 thousand in 2023, driven by increases in trade receivables and other receivables from HKD 2,997,384 thousand to HKD 3,068,059 thousand[127] - Net current assets significantly improved from HKD 432,319 thousand in 2022 to HKD 1,284,708 thousand in 2023, reflecting better liquidity management[127] - Total assets minus current liabilities increased from HKD 15,916,460 thousand in 2022 to HKD 16,783,889 thousand in 2023, indicating overall growth in the company's asset base[127] - Non-current liabilities decreased from HKD 1,707,800 thousand in 2022 to HKD 1,513,373 thousand in 2023, primarily due to reductions in bank borrowings and other loans[127] - Equity attributable to owners of the company increased from HKD 14,140,338 thousand in 2022 to HKD 15,157,718 thousand in 2023, reflecting growth in shareholder value[128] - Non-controlling interests rose from HKD 68,322 thousand in 2022 to HKD 112,798 thousand in 2023, indicating increased minority stakes in subsidiaries[128] Human Resources and Organizational Structure - The company employed approximately 10,534 staff and workers in Hong Kong and mainland China as of December 31, 2023, up from 10,175 in 2022[111] - The company's share incentive plan has a trust fund of approximately HKD 278,560,000, with HKD 268,730,000 used to purchase 47,761,500 shares, representing about 1.35% of the issued shares[109] - The company has over 3,900 sales personnel, covering nearly 70,000 hospitals and primary medical institutions in China, including 13,000 tiered hospitals[91] - The company's OTC sales team exceeds 1,000 personnel, covering over 250,000 pharmacies[91] - The company's R&D team, including joint ventures, comprises over 700 personnel, with nearly 450 holding master's or doctoral degrees, accounting for over 60% of the team[87] - The company has established multiple R&D centers globally, including the Wuhan Optics Valley International R&D Center in China, focusing on high-end pharmaceutical product development[86] - The mRNA technology platform in Nanjing, China, is dedicated to the development of anti-tumor and anti-infective mRNA drugs, with plans to expand into rare diseases and protein replacement therapies[86] - The oncology intervention technology platform and RDC technology platform are located in the Boston R&D Center in the US and the Shandong University Radiopharmaceutical Research Institute in China, respectively[86] - The company's high-end medical device R&D technology platform includes centers in Wuhan, Changzhou, and Shanghai, focusing on precision cardiovascular interventions[86] Awards and Recognition - The company received multiple awards in 2023, including the

OH Mo `Mo HO 100 F 5926 4 8 E BF3 140 15930 7 B 8 期 告 報 E ter 远大健康 遺大醫藥集團 EUTICAL GROUP 遠大醫藥集團有限公司 GRAND PHARMACEUTICAL GROUP LIMITED (於百嘉建註冊成立之有限公司) (股份代號 : 00512) 140 | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------| | | | | | | | | | Mo | | | | | 5926 4 8 C BF3014 5936 B8 目 錄 | --- | --- | |------------------|-------| | | | | 企業概覽 | 2 | | 管理層討論及分析 | 12 | | 其他資料 | 59 | | 財務資料目錄 | 64 | | 公司資料 | 84 | 企業定位 本集團是一家科技創新型國際化醫藥企業,核心業務橫跨製藥科技、核藥抗腫瘤診療及心 腦血管精準介入診療科技、生物科技三大領域。本集團以 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性或 完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴該等 內容而引致的任何損失承擔任何責任。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* (於百慕達註冊成立之有限公司) (股份代號: 00512) 二零二三年中期業績公佈 | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ...

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

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性或 完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴該等 內容而引致的任何損失承擔任何責任。 1 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* (於百慕達註冊成立之有限公司) (股份代號: 00512) 截至二零二二年十二月三十一日止年度之 全年業績公佈 | --- | --- | |-------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...