[中报]华东医药(000963):2023年半年度报告（英文版）
原标题:华东医药:2023年半年度报告（英文版） Semi-Annual Report 2023 August 16, 2023 Section I. Important Declaration, Contents and Definitions The Board of Directors, Board of Supervisors, directors, supervisors and senior managers of Huadong Medicine Co., Ltd. (hereinafter referred to as the “Company”) hereby guarantee that the information presented in this semi-annual report is authentic, accurate and complete and free of any false records, misleading statements or material omissions, and shall undertake individual and joint legal liabilities. Lv Liang, the Company’s legal representative and the officer in charge of accounting, and Qiu Renbo, head of the Accounting Department (accounting supervisor) hereby declare and guarantee that the financial statements in this semi-annual report are authentic, accurate and complete. All directors have attended the board meeting to review this semi-annual report. The future plans, development strategies and other forward-looking statements in this semi-annual report shall not be considered as substantial commitment of the Company to investors. Investors and related parties should be fully aware of the risks, and understand the differences between plans, forecasts and commitments. The risks the Company faces in operation include industry policy and product price reduction risk, new drug R&D risk, investment and M&A risk, and exchange rate fluctuation risk. For details, please refer to “X. Potential risks and responses” in “Section III. Management Discussion and Analysis”. Therefore, investors are kindly reminded to pay attention to possible investment risks. The Company does not plan to distribute cash dividends, no bonus share will be issued, and no capital reserve will be converted to increase the share capital. According to “Stock Listing Rules of the Shenzhen Stock Exchange”, if listed companies have both Chinese or other language version of public notice, they should ensure the content of both versions are the same. In the case of discrepancy, the original version in Chinese shall prevail. Contents Section I. Important Declaration, Contents and Definitions ............................................................................... 2 Section II. Company Profile and Key Financial Indicators ................................................................................. 9 Section III Discussion and Analysis of the Management .................................................................................... 13 Section IV. Corporate Governance ....................................................................................................................... 60 Section V Environmental and Social Responsibilities ........................................................................................ 63 Section VI. Important Matters ............................................................................................................................. 78 Section VII. Share Change and Shareholders ..................................................................................................... 98 Section VIII. Information on Preferred Shares ................................................................................................ 104 Section IX. Information on Bonds ...................................................................................................................... 105 Section X. Financial Report ................................................................................................................................ 106 Contents of Reference File I. Financial statements signed and stamped by the legal representative, the person in charge of accounting work, and the head of accounting institution (accounting manager). II. The original of all Company’s documents publicly disclosed in the press designated by CSRC during the reporting period and the original of announcements. Definitions
Section II. Company Profile and Key Financial Indicators I. Company information
1. Company’s contact information Whether there is any change in the Company’s registered address, office address, zip code, company website or company email address during the reporting period. ? Applicable □ N/A
Whether there is alteration in channels of disclosure and location of preparation □ Applicable ? N/A The website of the stock exchange, media and website for disclosing the semi-annual report, and the location of preparation of the Company’s semi-annual report have not changed during the reporting period. For details, please refer to the 2022 Annual Report. 3. Other information Changes of other related materials □ Applicable ? N/A IV. Key accounting data and financial indicators Whether the Company needs to perform a retroactive adjustment or restatement of previous accounting data □Yes ?No
Chinese accounting standards □ Applicable ? N/A There are no differences in net profit and net assets disclosed in financial statements under international and Chinese accounting standards during the reporting period. 2. Differences in net profit and net assets disclosed in financial statements under overseas and Chinese accounting standards □ Applicable ? N/A There are no differences in net profit and net assets disclosed in financial statements under overseas and Chinese accounting standards during the reporting period. VI. Items and amounts of non-recurring gains/losses ? Applicable □ N/A Unit: yuan
Details of other items of gains/losses meet the definition of non-recurring gains/losses. Explanation for recognizing an item listed as a non-recurring gain/loss in the Interpretative Announcement No. 1 on Information Disclosure Criteria for Public Companies — Non-Recurring Profit/Loss as a recurring gain/loss □ Applicable ? N/A Explanation for recognizing an item listed as a non-recurring gain/loss in the Interpretative Announcement No. 1 on Information Disclosure Criteria for Public Companies - Non-Recurring Profit/Loss as a recurring gain/loss. Section III Discussion and Analysis of the Management I. Main business of the company during the reporting period (1) Main businesses Founded in 1993 and headquartered in Hangzhou, Zhejiang Province, Huadong Medicine Co., Ltd. (stock code: 000963) was listed on Shenzhen Stock Exchange in December 1999. With its businesses covering the entire pharmaceutical industry chain thanks to over 30 years of vigorous development, the Company has now fostered four major business segments of pharmaceutical industry, pharmaceutical business, aesthetic medicine and industrial microbiology, and has been a large comprehensive listed pharmaceutical enterprise specialized in pharmaceutical R&D, production and marketing. Specialized in the R&D, production and marketing of specialized and chronic diseases, as well as special medicines for years, the Company has established complete pharmaceutical production and quality research systems, and fostered core product lines focusing on chronic nephrosis, transplantation immunity, internal secretion, digestive system and other fields. With multiple first- line clinical medicines with market advantages in China, the Company has made layout in R&D of innovative and high technology barrier generic medicines in three core therapeutic fields of oncology, endocrinology and autoimmunity through independent development, external introduction, project cooperation and by other means. The Company has continued to engage in international registration, international certification, consistency evaluation, etc. of products, with successive results achieved. Moreover, the Company has fostered the internationally-oriented pharmaceutical industry system, established and maintained R&D and project cooperation with multiple international innovative R&D enterprises. With regard to the pharmaceutical business, the Company has vigorously consolidated its foundation in Zhejiang Province and has been ranked among top 10 pharmaceutical business enterprises in China for consecutive years. To date, the Company has established 11 regional subsidiaries in Zhejiang Province, with its customers distributed in 11 cities and 90 districts, counties and county-level cities throughout Zhejiang Province. The Company has four business segments of Chinese & western medicine, medical apparatus, medicine materials and ginseng & antler, and health industry that cover the pharmaceutical wholesale & retailing, third-party medical logistics featuring cold chain, medical e-commerce, hospital value-added services and featured massive health industry. Further expanding the product agency and market development, the Company has formed the whole industry chain from planting in bases to processing of prepared pieces, automatic decoction, own-brand functional products for its traditional Chinese medicine industry. As the leader of pharmaceutical business in Zhejiang Province, the Company has always focused on strengthening the policy affairs, reserve, distribution and marketing ability, established service platforms, and fostered the competitive advantages of regional enterprises to offer customers comprehensive solutions. In terms of aesthetic medicine, the Company has created a comprehensive and differentiated product matrix by following the strategy of “global operation layout and dual-circulation operation & development” with an international vision through forward-looking layout, and now ranks in the forefront of the industry in terms of product quantity and coverage. Specifically, over 20 products have been launched in China and abroad, and more than a dozen innovative global products are in development. Now, the Company is committed to becoming a global leading aesthetic medicine comprehensive solution provider by offering patients with more professional, efficient, comprehensive and safer integrated solutions through diversified combined therapy techniques that combine “noninvasive and micro-invasive”, “facial and body filling”, “products + technologies”, and “injection + energy source equipment”. Headquartered in UK, the Company’s wholly-owned subsidiary Sinclair is its global aesthetic medicine operation platform that has R&D centers in UK, the Netherlands, France, Switzerland, Spain and Israel, and production bases in the Netherlands, France, the U.S., Switzerland, Bulgaria and Israel. Promoting and marketing sustained-release microspheres for injection, hyaluronic acid, facial thread lifting and other products in global markets, Sinclair researches, develops and expands its energy-source aesthetic medicine apparatus businesses through its wholly-owned subsidiaries High Tech and Viora. As for the aesthetic medicine segment, the Company also has Sinclair (Shanghai), a wholly-owned subsidiary and its market operation platform in China, as well as R2 in the U.S. and Kylane in Switzerland, two overseas technical development type joint-stock subsidiaries. With profound industrial base and powerful industrial transformation ability thanks to over 40 years of development in the industrial microbiology sector, the Company has successfully developed and manufactured multiple types of microbiological medicines, and established the key technology system for R&D and production of microbiological products, ranking in the forefront of the industry in terms of scale and technological level of microbiological fermented products. Being market demand-oriented, R&D technology-driven and industrial resource-coordinative in the industrial microbiology segment, the Company has placed its focus on two business scenarios of application of synthetic biology technology system and innovative development of bio-fields of xRNA, featured APIs, massive health &biomaterials and animal health. The Company has also established the R&D clusters with Industrial Microbiology of Zhongmei Huadong, HIT Institute of Synthetic Biology, Huida Biotech, Hizyme Biotech and Perfect mRNA as the core, and seven industrial bases in Hangzhou Xiangfuqiao, Qiantang New Area, Jiangsu Joyang Laboratories, Magic Health, Twisun Hi-tech, Wuhu Huaren, and NAU Animal Pharmaceutical. Moreover, the Company has set up the largest fermentation monomer plants in Zhejiang, formed the industry-leading microbiological medicine production ability and high-level R&D capacity that covers all stages of microbiological engineering technologies from strain construction, metabolic regulation, enzymatic catalysis, synthetic modification to separation and purification, and built a complete manufacturing system for R&D, pilot test, commercial production, engineering and public system guarantee of microbiological projects. To date, the Company has a total of over 230 R&D programs in the industrial microbiology sector. (2) Overview of the Company’s operations during the reporting period The global economic recovery faces continuous challenges due to accelerated changing international order in turmoil, dramatically adjusted geopolitical pattern, continuously accumulated risks in global financial sectors, multiple downside risks, and rising inflationary pressure since 2023. The year 2023 is the first year to practice the guiding principles of the 20th CPC National Congress, and also a critical year to implement the “Fourteenth Five-year Plan”. In the face of tough external environment, China has resumed normalized operation in economy and society in full swing since the first half of 2023, witnessing upturn of national economy thanks to the efficient macro policies. The reform of the pharmaceutical industry in China has also been deepened, with diverse reform policies launched and implemented. The pharmaceutical industry still faces changes and challenges in diverse aspects such as policy regulation, structural reform, technological innovation, and intensified market competition, while it is continuously transformed driven by innovation. In the meantime, new bio-pharmaceutical technologies, continuously advancement of technological innovation, as well as rapid application of AI, big data and other new technologies in the pharmaceutical sector bring new opportunities for the transformation and development of the pharmaceutical industry. During the reporting period, the Company has steadily facilitated the innovative transformation and international development strategy, made concerted efforts to tide over diverse difficulties, and solidly promoted the innovation in scientific research, production and operation to a new level revolving around its annual operation plan and the seventh third-year plan. In the first half of 2023, the Company achieved the operating revenue of 20.385 billion yuan, up 12.02% year of listed companies after deducting non-recurring gains/losses of 1.427 billion yuan, up 12.24% year on year (up 8.45% year on year in the first quarter). During the reporting period, after deducting the equity incentive expenses and the profits and losses of participating and holding R&D institutions, the Company achieved the net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses of 1.656 billion yuan, up 20.61% year on year. The Company achieved the double-digit growth in both operating revenue and net profits for the first time since 2020 and witnessed favorable upturn of the overall operation, laying a solid foundation for fully attaining its annual work goals. During the reporting period, four major business segments of the Company, i.e. pharmaceutical industry, pharmaceutical business, aesthetic medicine and industrial microbiology, all achieved positive growth in business indicators, accelerating the release of the Company’s momentum in overall growth. As its operating revenue in the first quarter exceeded 10 billion yuan for the first time, the Company achieved a total operating revenue of 10.271 billion yuan in the second quarter, up 10.85% year on year. The net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses was 670 million yuan, up 16.85% year on year. Specific operation of each business segment during the reporting period: 1. The production and operation of the pharmaceutical industry saw and kept positive trend During the reporting period, the Company’s core subsidiary Zhongmei Huadong witnessed positive growth as a whole and achieved the operating revenue (including CSO business) of 6.054 billion yuan, up 10.04% year on year, and the consolidated net profit after deducting net profits attributable to the parent company of 1.226 billion yuan, up 15.11% year on year. The net return on equity was 12.38%. During the reporting period, the Company has further consolidated its three core therapeutic fields of oncology, endocrinology and autoimmunity. In the first half of 2023, the Company’s key varieties of products maintained steady and rapid growth, and core products subject to national centralized procurement and medical insurance negotiations still maintained stable market share. In the meantime, the Company kept enriching its product lines through independent R&D and introduction of external products, and formed differentiated and innovative product lines that cover multiple indications and feature reasonable product echelon layout, becoming a leading enterprise in the field of endocrinology and autoimmunity in China. In the field of oncology, the Company kept enriching its pipelines around the key layout of ADC products and continued to maintain its dominant position in the field of ADC in China. During the reporting period, the Company’s innovative R&D kept advancing in an orderly manner, with positive results achieved. Please refer to “(III) R&D situation” below in this section for details. During the reporting period, Hangzhou Zhongmei Huadong Pharmaceutical Service Corporation continued to build its multi-dimensional market access and professional promotion capabilities, strengthen the academic driving, stabilize the hospital markets, expand the out-of-hospital markets, strengthen the online markets, promote and optimize the construction of the regional marketing department and KA system, enhance the market coverage of grassroots terminals, and continuously promote the digital transformation of pharmaceutical services by taking the opportunity of its product strategic cooperation with RLD multinational pharmaceutical companies. During the reporting period, the Company’s production systems kept making innovative in production and operation modes and deepening the integrated management of production systems with “high quality and high efficiency” as its goal. While ensuring the market supply, the Company continued to promote the standardization construction of workshops and consolidate the basic management. In the meantime, it further deepened the implementation of lean production and actively promoted the reduction of production costs, witnessing continuous improvement in skill level and per capita labor efficiency of employees. Moreover, the quality compliance and GMP normalization management were further strengthened, and international registration and certification of products were advanced. During the reporting period, the Tacrolimus Capsules of Zhongmei Huadong was approved for marketing by the FDA, becoming another product of the Company that is approved following Pantoprazole Sodium for Injection, Acarbose Tablets and Daptomycin for Injection, China’s first Tacrolimus Preparation approved for marketing in the U.S. and an important achievement of the international strategy of the Company’s preparation products. 2. The industrial microbiology achieved good results in four fields The Company kept practicing the industrial microbiology development strategy, clarifying its strategic layout focusing on four major fields of xRNA, featured APIs & intermediates, massive health & biomaterials and animal health. In the meantime, the Company continuously enriched the product lines in four major strategic segments of high innovation, high technology barrier and high added-values and optimized its product structures through R&D. During the reporting period, the overall sales revenue of the Company’s industrial microbiology segment deducting that of specific commercial products businesses achieved a year-on-year increase of 27.47%. During the reporting period, the field of xRNA expanded the application market in China with low-cost and high-quality products, developed international businesses and created an efficient of three technical platforms of synthetic biology, fermentation and enzyme engineering and maximized the production and manufacturing resources, making the Company an international, distinctive and differentiated API enterprise featuring highly active APIs. Focusing on such industrial orientations as bone health, brain health, antioxidation, personal care and aesthetic medicine, high barriers, and import substitution of injectable medicinal materials, the field of massive health & biomaterials created the automatic and standard industrial manufacturing system and stepped out of C-end product markets with the technical support from the HIT Institute of Synthetic Biology. In the field of animal health, the Company focused on three orientations of pet treatment, pet nutrition, and water nutrition and water environment, and endeavored to become a leader in China’s pet and aquatic animal health industry driven by R&D, led by markets and guaranteed by production. xRNA: In January 2023, the Company established Hangzhou Perfect mRNA Biotechnology Co., Ltd. (hereinafter referred to as “Perfect mRNA”), which is mainly engaged in the development of raw materials of mRNA enzyme and molecular diagnostic enzyme, as well as mRNA CDMO services, together with the upstream enzyme raw materials and downstream preparation services. Perfect mRNA comprised industrial collaboration with Anhui Meihua and Wuhu Huaren in the field of xRNA, further optimizing the whole-industrial chain layout of xRNA. Featured APIs & intermediates: The Company’s core subsidiaries Huida Biotech, Hizyme Biotech and Jiangsu Joyang Laboratories vigorously expanded international key customers, established the key customer service system, cultivated multiple new product lines, endeavored to develop ADC drug toxin raw materials and services, senior intermediates and other businesses, and gave full play to the advantages of industrial technologies of industrial microbiology, successfully building a favorable reputation of “high technology, high quality and high efficiency” in this field. Massive health & biomaterials: The Company’s core subsidiary Meiqi Health further strengthened its sales manpower in overseas markets, built the core dealers network, and put in place its channel layout in Asia Pacific, Europe, America, and China. It also set up the application service system to create market opportunities for the differentiation of application services. Animal health: Being optimistic about the development of animal health industry, the Company acquired Jiangsu NAU Animal Pharmaceutical Co., Ltd. (herein after referred to as “NAU Animal Pharmaceutical”) in April 2023, quickly setting foot in pet and aquatic animal health segments. In the field of animal health, the Company has reserved more than 10 varieties of high-end raw materials for pet health care, application and development of a variety of massive health raw materials in the field of animal health, and more than 10 potential opportunities for people-to- preparations in the future. NAU Animal Pharmaceutical will become an important development platform for the Company’s animal health businesses in the field of industrial microbiology. The Company’s existing industrial ecological chain, R&D resources and financial guarantee will keep empowering and promoting the rapid development of NAU Animal Pharmaceutical in the field of animal health. At present, the Company’s industrial microbiology field has set up an international marketing team with about 50 staff, forming a business structure featuring sales and market management system of the industrial microbiology headquarters + professional sales team of subsidiaries, further establishing an overseas localized marketing team and enhancing the ability to serve overseas customers. In the future, the industrial microbiology field will further increase the proportion of international business, with R&D, quality, service and regulatory registration as its main competitiveness, thus forming a competitive advantage in international businesses. 3. The pharmaceutical business kept a stable growth trend as a whole and continued to develop innovative businesses. During the reporting period, the Company’s pharmaceutical business segment kept consolidating its hospital markets and expanding out-of-hospital markets, and actively advanced its innovative businesses. The Company’s pharmaceutical business segment achieved the operating revenue of 13.631 billion yuan, up 11.19% year on year, and the net profit of 216 million yuan, up 9.14% year on year. Adhering to the development principle of “High Quality + High Efficiency”, the Company’s pharmaceutical business segment actively endeavored to build itself into an enterprise with leading （未完）  |