康智药业 2023 中期報告 康哲薬業控股有限公司 (股份代號:867) 康 哲® 執行董事 林剛先生 陳洪兵先生 陳燕玲女士 OH HN HS NH2 NH OH 目錄 | 公司資料 . | T | | --- | --- | | 財務摘要 | 2 | | 業務摘要 | 3 | | 管理層討論與分析 | ব | | 其他資料 . | ····· 25 | | 簡明合併損益及其他全面收益表 | | | 簡明合併財務狀況表 . | | | 簡明合併權益變動表 . | | | 簡明合併現金流量表 … | | | 簡明合併財務報表附注 | …… 35 | 公司資料 董事會 獨立非執行董事 梁創順先生 羅瑩女士 馮征先生 公司秘書 吳三燕女士 授權代表 吳三燕女士 林剛先生 審核委員會 馮征先生(主席) 梁創順先生 羅瑩女士 薪酬委員會 梁創順先生(主席) 羅瑩女士 馮征先生 提名委員會 羅瑩女士 (主席) 林剛先生 梁創順先生 馮征先生 環境、社會及管治委員會 陳燕玲女士 (主席) 梁創順先生 馮征先生 核數師 德勤 • 關黃陳方會計師行 註冊公眾利益實體核數師 主要往來銀行 招商銀行股份有限公司 渣打銀行（香港） ...

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的內容概不負責，對其準確性或完整性亦 不發表任何聲明，並表明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。 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康 哲 藥 業 控 股 有 限 公 司 * （於開曼群島註冊成立的有限公司） （股份代號：867） 截至二零二三年六月三十日止六個月之中期業績公告 China Medical System Holdings Limited（「本公司」）之董事（「董事」）會（「董事會」）欣然公佈本公 司及其附屬公司（「本集團」或「康哲藥業」）截至二零二三年六月三十日止六個月（「報告期」） 之未經審計簡明合併業績。 財務摘要 ⚫ 營業額增長 3.6%至人民幣 4,610.1 百萬元（二零二二年中期：人民幣 4,447.8 百萬元）；若全 按藥品銷售收入計算則營業額增長 7.1%至人民幣 5,536.6 百萬元（二零二二年中期：人民幣 5,170.0百萬元） ⚫ 毛利增長 4.9%至人民幣 3,605.9 百萬元（二零二二年中期：人民幣 3,436.2 百 ...

Financial Performance - Revenue increased by 9.8% to RMB 9,150.3 million, with pharmaceutical sales revenue growth of 13.7% to RMB 10,497.5 million[6] - Gross profit grew by 12.6% to RMB 7,035.8 million, with pharmaceutical sales gross profit growth of 14.4% to RMB 6,910.5 million[6] - Annual profit increased by 8.3% to RMB 3,276.2 million, with basic earnings per share rising by 8.6% to RMB 1.3281[6] - Total assets increased to RMB 17,753.5 million in 2022, while total liabilities rose to RMB 3,016.5 million[7] - The group’s revenue increased by 9.8% to RMB 9,150.3 million, compared to RMB 8,337.2 million in the previous year[68] - Gross profit grew by 12.6% to RMB 7,035.8 million, with a gross margin of 76.9%, up from 74.9% in the previous year[69] - Annual profit grew by 8.3% to RMB 3,276.2 million, driven by continuous revenue growth[80] - The company reported a pre-tax profit of RMB 3,762,850 thousand, up from RMB 3,456,589 thousand in the previous year, indicating an increase of 8.8%[200] - Net profit attributable to the owners of the company for 2022 was RMB 3,258,992 thousand, compared to RMB 3,017,402 thousand in 2021, marking a growth of 8.0%[200] - Basic earnings per share for 2022 was RMB 1.3281, an increase from RMB 1.2228 in 2021, representing a rise of 8.6%[200] Product Development and Innovation - The company plans to launch three innovative products that are currently in the clinical development and registration phase[8] - The company has secured exclusive rights for the commercialization of a topical JAK inhibitor and a glaucoma treatment device in China and Southeast Asia[9] - The company is advancing the clinical and registration processes for several innovative drugs, including a nasal spray and an injection for psoriasis[9] - The company has successfully developed a pipeline of 30 innovative products, with 3 products expected to be approved for market launch in China soon[22] - The company emphasizes innovation as a core strategy, transitioning from mature products to innovative patented products since 2018, establishing itself as an open platform for pharmaceutical innovation and commercialization[14] - The company aims to accelerate clinical development and commercialization of innovative products, with expectations of annual approvals for new products[16] - The company is actively developing new products such as CF101 for psoriasis and CMS-D001 for autoimmune diseases, which are in the preclinical or clinical trial phases[42] - The diazepam nasal spray NDA is under review in China, demonstrating a bioavailability of 77.55% to 86.21% in different dosage groups, indicating rapid absorption and good safety tolerance[33] - The innovative oral HIF-PHI drug, intended for treating anemia in chronic kidney disease (CKD), has completed its first subject dosing in a Phase III clinical trial with 150 subjects planned for enrollment[39] Market Expansion and Strategic Partnerships - The company is expanding its operations into Southeast Asia, aiming to broaden its business scope and depth[23] - The company has entered into an exclusive licensing agreement for a series of affordable insulin products in Southeast Asia, marking a significant entry into this market[12] - The company views Southeast Asia as a key growth market, leveraging its global investment and commercialization experience to meet the demand for high-quality pharmaceutical products[18] - The company has secured exclusive rights to register, market, and distribute insulin products in eleven Southeast Asian countries, marking a significant entry into this market[62] - The company has established a strategic partnership with Incyte for the development and commercialization of ruxolitinib cream, enhancing its dermatology product portfolio[26] - The company acquired a 60% stake in the dermatological skincare R&D platform Hezero Pharmaceuticals, enhancing its product lineup for sensitive skin[11] Financial Management and Governance - The company has a robust financial management structure, with experienced professionals overseeing financial and tax compliance[108] - The company has a strong management team with extensive experience in the pharmaceutical industry, including Mr. Lin Gang, who has been the executive director since December 18, 2006[96] - The board consists of six directors, including three executive directors and three independent non-executive directors[156] - The company emphasizes compliance and governance, with a dedicated legal and compliance team led by the company secretary[109] - The company has committed to high standards of corporate governance to enhance accountability and transparency, thereby increasing long-term shareholder value[151] - The company has established a whistleblowing system to ensure proper handling of reports related to fraud management[182] Research and Development - The company has implemented a systematic management mechanism for the entire process of innovative product development, ensuring efficient clinical research and commercialization[25] - The company is continuously working on enhancing its research and development capabilities to support the launch of new therapies and maintain a competitive edge in the market[43] - Research and development expenses for the year were RMB 125,431 thousand, compared to RMB 114,761 thousand in 2021, reflecting an increase of 9.2%[200] Regulatory and Compliance - The company has established a robust quality management system to comply with GMP and GSP standards, ensuring ongoing regulatory compliance[133] - The company has not obtained product liability insurance in China, which poses a risk of significant costs and damage to customer relationships in the event of product-related claims[134] - The Chinese healthcare system is undergoing significant reforms, with frequent changes in laws and regulations that could adversely affect the company's operations if strategies are not timely adjusted[135] - The company must participate in government-led bidding processes, and failure to win bids could impact product sales capabilities in specific provinces[136] Community Engagement and ESG Initiatives - The company made donations totaling approximately RMB 2.7 million for community welfare during the reporting period[142] - The company emphasizes environmental, social, and governance (ESG) initiatives as part of its long-term strategy[102] - The company has implemented environmental management measures in compliance with applicable laws, including the establishment of an environmental management committee[131] Operational Efficiency - The company has a robust commercialization system, focusing on specialized disease areas, which has been developed over 30 years, ensuring sustainable business growth and maximizing economic benefits[43] - The company has over 4,300 professional marketing and promotion personnel, covering more than 50,000 hospitals and medical institutions, and over 200,000 retail pharmacies in China[45] - The company is focused on academic promotion and market strategy formulation for innovative products post-launch, aiming to establish a strong academic influence quickly[44]

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的內容概不負責，對其準確性或完整性亦不 發表任何聲明，並表明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。 CHINA MEDICAL SYSTEM HOLDINGS LIMITED 康哲藥業控股有限公司* （於開曼群島註冊成立的有限公司） （股份代號：867） 截至二零二二年十二月三十一日止之年度業績公告 及 建議修訂現有組織章程大綱及細則 以及採納新組織章程大綱及細則 China Medical System Holdings Limited（「本公司」）之董事會（「董事會」）欣然公佈本公司及其附 屬公司（「本集團」或「康哲藥業」）截至二零二二年十二月三十一日止年度(「報告期」)之經審核合 併業績。 財務摘要 ⚫ 營業額增長 9.8%至人民幣 9,150.3百萬元（二零二一年：人民幣 8,337.2百萬元）；若全按藥品銷 售收入計算則營業額增長13.7%至人民幣10,497.5百萬元（二零二一年：人民幣9,230.2百萬元） ⚫ 毛利增長 12.6%至人民幣 7,035.8 百萬元（二零二一年：人民幣 6,24 ...

康 哲° CMS 康哲药业 2021年度報告 庚哲薬業控股有限公司 (服務代號:867) 目錄 | --- | --- | |-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------| | | | | | | | 公司資料 ..............................................................................................................................................1 | | | 財務摘要 .............................................................................................................. ...