2019 Annual Report 3 Corporate Information
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Annual ReportAnnual 2019 Hansoh Pharmaceutical Group Company Limited Hansoh Pharmaceutical Group 翰森製藥集團有限公司 liability) Islands with limited in the Cayman (Incorporated Stock Code : 3692 ANNUAL REPORT 2019 年報 Contents 2 Corporate Overview 4 Corporate Information 6 Financial Highlights 7 Chairlady’s Statement 8 Management Discussion and Analysis 15 Corporate Governance Report 25 Directors’ Report 35 Biographical Details of Directors and Senior Management 41 Independent Auditor’s Report 46 Consolidated Statement of Profit or Loss 47 Consolidated Statement of Comprehensive Income 48 Consolidated Statement of Financial Position 50 Consolidated Statement of Changes in Equity 51 Consolidated Statement of Cash Flows 53 Notes to Financial Statements 110 Environmental, Social and Governance Report Corporate Overview The Company is one of the leading research and development-driven pharmaceutical companies in the People’s Republic of China (“PRC” or “China”), devoting itself to meet the unmet clinical needs of patients and improve the health and well-being of human beings through continuing innovation. The Company has established a leading position in some of the largest and fastest-growing therapeutic areas in the PRC with significant unmet clinical needs, including central nervous system (“CNS”) diseases, oncology, anti-infectives and diabetes. The core driving force of the Company is its focus on innovation. The Company has continuously increased its investments in research and development (“R&D”) over the years, established a sound R&D platform and mastered a number of proprietary technologies. It has successfully launched and developed a series of innovative drugs and first-to-market generic drugs. During the year under review, the Company successfully launched seven new drugs in total, including two innovative drugs, Fulaimei (polyethylene glycol loxenatide for injection) and Hansoh Xinfu (flumatinib mesylate). The Company attaches great importance to product quality. It has maintained the advanced nature of its production quality system through overseas certification, while at the same time constantly expanding the business pipeline of its principal businesses. In addition, it continues to introduce advanced management concepts and tools to improve the overall operation efficiency of the Group. As the innovative drugs are approved for marketing from time to time, the Company devotes efforts to improve its professional marketing capability and increase the understanding and knowledge of medical professionals regarding the innovative drugs. MAIN PRODUCTS CNS disease drugs: Oulanning (olanzapine tablets) and Ameining (agomelatine tablets) Oncology drugs: Pulaile (pemetrexed disodium for injection), Zefei (gemcitabine hydro chloride for injection), Hansoh Xinfu (flumatinib mesylate), Xinwei (imatinib mesylate tablets), Xinmei (decitabine for injection), Xintai (bortezomib for injection) and Tanneng (fosaprepitant dimeglumine for injection) Anti-infective drug: Mailingda (morinidazole sodium chloride injection), Zetan (tigecycline for injection), Hengjie (linezolid glucose injection) and Hengsen (micafungin sodium for injection) Others: Fulaimei (polyethylene glycol loxenatide for injection), Fulaidi (repaglinide tablets), Fulairui (canagliflozin tablets), Ruibote (rabeprazole sodium enteric- coated tablets), Zexin (apixaban tablets) and Ruiyisheng (prucalopride succinate tablets) In 2013, the Company was first awarded with the State Science and Technology Award (second prize) (國家科技獎(二等獎)) by the PRC State Council (中國國務院) (the “State Council”). During the same year, we obtained United States Food and Drug Administration (“U.S. FDA”) certification for our oncology injectable products, including Zefei, which was approved for sale by the U.S. FDA. We obtained the latest versions of Chinese Good Manufacturing Practice (藥品生產品質管制規範) (“GMP”) certifications for all our production lines. In 2014, the Company was once again awarded with the State Science and Technology Award (second prize) (國家科技獎(二等獎)) by the State Council. During the same year, our first self-developed innovative drug Mailingda (morinidazole sodium chloride injection) was approved for sale in China. 2 HANSOH PHARMACEUTICAL GROUP COMPANY LIMITED Corporate Overview In 2017, the Company ranked 22nd among the “Top 100 Pharmaceutical Industrial Enterprises of China” (2017年中國醫藥工業企業百強) by the China National Pharmaceutical Industry Information Center (中國 醫藥工業信息中心). In both 2018 and 2019, the Company ranked second for “R&D-driven Pharmaceutical Companies in China” (中國醫藥研發產品線最佳工業企業) by the China National Pharmaceutical Industry Information Center (中國醫藥工業信息中心) for two years consecutively. In May 2019, our self-developed GLP-1 receptor agonist and a long-acting Category 1.1 innovative drug indicated for the treatment of Type-II diabetes, Fulaimei (polyethylene glycol loxenatide for injection), was approved for sale in China. In May 2019, the Company was awarded with the “Green Enterprise Management Award” (2019年度綠色 企業管理獎). On June 14, 2019 (the “Listing Date”), the shares of the Company were successfully listed (the “Listing”) on the Main Board of The Stock Exchange of Hong Kong Limited (the “Stock Exchange”), creating a milestone for the Group and laying a solid foundation for our future development. In August 2019, the Company was named as an enterprise with “Excellence in Performing Social Responsibilities Among Chinese Pharmaceutical Enterprises” (中國醫藥企業社會責任優秀) by the China National Pharmaceutical Industry Information Center (中國醫藥工業信息中心). In November 2019, Hansoh Xinfu (flumatinib mesylate), a Category 1.1 innovative drug self-developed by the Company, obtained the approval for marketing in China and is indicated for the treatment of chronic myelogenous leukemia. The website of the Group: www.hspharm.com 2019 ANNUAL REPORT 3 Corporate Information BOARD OF DIRECTORS AUTHORISED REPRESENTATIVES Executive Directors Miss Sun Yuan (孫遠) Ms. Li Yan Wing Rita (李昕穎) Ms. Zhong Huijuan (鍾慧娟) (Chairlady and Chief Executive Officer) STOCK CODE Mr. Lyu Aifeng (呂愛鋒) Miss Sun Yuan (孫遠) Stock Code: 3692 Non-executive Director REGISTERED OFFICE IN THE CAYMAN ISLANDS Ms. Ma Cuifang (馬翠芳) PO Box 309, Ugland House Grand Cayman, KY1-1104 Independent Non-executive Directors Cayman Islands Mr. Lin Guoqiang (林國強) PRINCIPAL PLACE OF BUSINESS AND HEAD Mr. Chan Charles Sheung Wai (陳尚偉) OFFICE IN THE PEOPLE’S REPUBLIC OF CHINA Ms. Yang Dongtao (楊東濤) 9 Dongjin Road AUDIT COMMITTEE Economic & Technical Development Zone Lianyungang Mr. Chan Charles Sheung Wai (陳尚偉) (Chairman) Jiangsu, 222069 Mr. Lin Guoqiang (林國強) The People’s Republic of China Ms. Ma Cuifang (馬翠芳) PRINCIPAL PLACE OF BUSINESS IN HONG KONG REMUNERATION COMMITTEE Level 54, Hopewell Centre Ms. Yang Dongtao (楊東濤) (Chairlady) 183 Queen’s Road East Ms. Zhong Huijuan (鍾慧娟) Hong Kong Mr. Lin Guoqiang (林國強) COMPANY’S WEBSITE STRATEGY AND DEVELOPMENT COMMITTEE www.hspharm.com Ms. Zhong Huijuan (鍾慧娟) (Chairlady) Mr. Lyu Aifeng (呂愛鋒) AUDITOR Mr. Chan Charles Sheung Wai (陳尚偉) Ms. Yang Dongtao (楊東濤) Ernst & Young Certified Public Accountants JOINT COMPANY SECRETARIES 22nd Floor, CITIC Tower 1 Tim Mei Avenue Ms. Zhong Shengli (鍾勝利) Hong Kong Ms. Li Yan Wing Rita (李昕穎) 4 HANSOH PHARMACEUTICAL GROUP COMPANY LIMITED Corporate Information HONG KONG LEGAL ADVISOR HONG KONG BRANCH SHARE REGISTRAR AND TRANSFER OFFICE Cleary Gottlieb Steen & Hamilton (Hong Kong) 37/F, Hysan Place Tricor Investor Services Limited 500 Hennessy Road Level 54, Hopewell Centre Causeway Bay 183 Queen’s Road East Hong Kong Hong Kong COMPLIANCE ADVISOR PRINCIPAL BANK Guotai Junan Capital Limited Lianyungang Branch of the Bank of Communications 27th Floor, Low Block No.45 Huanghe Road Grand Millennium Plaza Economic & Technical Development Zone 181 Queen’s Road Central Lianyungang Hong Kong Jiangsu The People’s Republic of China CAYMAN ISLANDS PRINCIPAL SHARE REGISTRAR AND TRANSFER OFFICE Maples Fund Services (Cayman) Limited PO Box 1093, Boundary Hall Cricket Square Grand Cayman, KY1-1102 Cayman Islands 2019 ANNUAL REPORT 5 Financial Highlights RESULTS 2019 2018 2017 2016 RMB’000 RMB’000 RMB’000 RMB’000 REVENUE 8,682,746 7,722,278 6,185,537 5,432,960 Cost of sales (729,540) (603,100) (455,171) (397,279) Gross profit 7,953,206 7,119,178 5,730,366 5,035,681 Other income 221,219 77,953 93,230 85,811 Selling and distribution expenses (3,266,380) (3,208,680) (2,704,200) (2,378,040) Administrative expenses (777,692) (790,158) (614,075) (537,972) Research and development costs (1,120,681) (881,288) (575,544) (403,065) Other (expenses)/gains, net (8,747) (7,680) 3,014 5,274 Finance cost – – – (3,411) PROFIT BEFORE TAX 3,000,925 2,309,325 1,932,791 1,804,278 Income tax expense (444,183) (406,277) (337,318) (328,244) PROFIT FOR THE YEAR 2,556,742 1,903,048 1,595,473 1,476,034 ASSETS AND LIABILITIES 2019 2018 2017 2016 RMB’000 RMB’000 RMB’000 RMB’000 Total assets 19,575,204 8,414,371 5,874,048 4,820,951 Total liabilities 6,530,882 5,946,473 1,355,358 1,846,613 Total equity 13,044,322 2,467,898 4,518,690 2,974,338 6 HANSOH PHARMACEUTICAL GROUP COMPANY LIMITED Chairlady’s Statement As a pharmaceutical enterprise founded in 1995, we have been continually committed to the innovation and development in fields with unmet clinical needs during the past 25 years. The product portfolio of our Group covers major therapeutic areas such as the central nervous system, oncology, anti-infective and diabetes, and our core products have established market-leading positions in their respective sub- fields. In 2019, the