[年报]健康元(600380):健康元药业集团股份有限公司2023年年度报告（英文版）
原标题:健康元:健康元药业集团股份有限公司2023年年度报告（英文版） I. The Board of Directors (the “Board”), the Board of Supervisors and directors, supervisors and senior management of the Company hereby warrant the truthfulness, accuracy and completeness of the contents of this annual report (the “Report”), and that there are no false representations, misleading statements or material omissions contained in the Report, and severally and jointly accept legal responsibility. II. All directors of the Company attended the Board meeting. III. Grant Thornton (Special General Partnership) issued a standard unqualified audit report for the Company. IV. Mr. Zhu Baoguo (朱保国), the person-in-charge of the Company, and Mr. Qiu Qingfeng (邱庆丰), the person-in-charge of accounting work and the person-in-charge of the accounting department (the head of the accounting department) declare that they hereby warrant the truthfulness, accuracy and completeness of the financial statements contained in the Report. V. Profit distribution plan or plan for conversion of capital reserve to share capital approved by the Board resolution during the Reporting Period Based on the audit conducted by Grant Thornton (Special General Partnership), in 2023, the Parent Company generated net profit of RMB1,241,411,898.00, 10% of which was contributed to the statutory surplus reserve, namely RMB124,141,189.80, the remainder of which, together with undistributed profits for the last year of RMB1,968,175,713.20 and gain on disposal of other equity investments of RMB1,245,892.23, subtracting cash dividends for the last year of RMB336,792,056.76, is the profits available for distribution to shareholders for the year of RMB2,749,900,256.87. The Company plans to distribute cash dividends for the fiscal year 2023, based on the total number of shares for dividend distribution, which is defined by the total shares of Company on the equity registration date designated by the annual profit distribution plan. The Company plans to distribute cash dividend of RMB1.80 (tax inclusive) for every 10 shares of to all shareholders of the Company, and the remaining undistributed profits will be carried forward to the following year. VI. Risk declaration for the forward-looking statements √Applicable □N/A The Report contains forward-looking statements which involve the future plans, development strategies, etc. of the Company, yet do not constitute substantive undertakings of the Company to investors. Investors should exercise caution prior to making investment decisions. VII. Whether there is non-operating use of funds by the controlling shareholder and their related parties No VIII. Whether there is a violation of the prescribed decision-making procedures to provide No IX. Whether more than half of directors cannot warrant the truthfulness, accuracy and completeness of the Report disclosed by the Company No X. Significant risk warnings There is no exceptionally significant risk that will have a material impact on the production and operation of the Company during the Reporting Period. In this Report, the Company has elaborated on the risks and countermeasures that the Company may face in the course of production and operation, including industry policy risk, market risk, risk of safety and environmental protection, risk in price and supply of raw materials and R&D risk. For more information, please refer to “Potential risks” part in Chapter 3 Management Discussion and Analysis. XI. Others □Applicable √N/A Table of Contents Important Notice ............................................................................................................................. 2 Chairman's Statement .................................................................................................................... 5 Financial Highlights ........................................................................................................................ 9 Chapter 1 Definitions .................................................................................................................... 11 Chapter 2 Company Profile and Major Financial Indicators ................................................... 13 Chapter 3 Management Discussion and Analysis ...................................................................... 18 Chapter 4 Corporate Governance ............................................................................................... 78 Chapter 5 Environmental and Corporate Social Responsibility ............................................ 100 Chapter 6 Major Events ............................................................................................................. 128 Chapter 7 Changes in Equity and Shareholders ...................................................................... 146 Chapter 8 Information on Preferred Shares ............................................................................ 153 Chapter 9 Information on Bonds ............................................................................................... 154 Chapter 10 Financial Statements ............................................................................................... 155
Dear shareholders, 2023 marked the first year of the implementation of the guiding principles of the 20th CPC National Congress. China’s health undertakings made new significant achievements and the construction of healthy China accelerated. This year, the pharmaceuticals industry underwent all-sector, full-chain and full-coverage system governance, while industry-friendly policies were introduced frequently amidst challenges and opportunities. Driven by policy support, scientific and technological innovation, and market demand, the pharmaceutical industry system witnessed notable optimization and upgrading, with innovation-led and high-quality development emerging as the prevailing theme. In retrospect of 2023, Joincare adhered to its dual-drive strategy of innovative medicines and high- barrier complex formulations, focusing on the high-quality development of the principal pharmaceutical business. Overcoming challenges, Joincare not only achieved substantial achievements in research, production, and marketing, but also enhanced its overall R&D capabilities and innovation levels by leveraging business development channels to swiftly expand its R&D and innovation pipeline reserves, which laid a solid foundation for the Group to achieve comprehensive innovative transformation. Facing various challenges such as price reductions in key varieties due to volume-based procurementand intensified competition in the APIs market, all employees of the Group worked diligently and unitedly and made concerted efforts to achieve the Group’s annual business objectives. In 2023, the Group realized total revenues of RMB16.646 billion, representing a year-on-year decrease of 2.90%; realized a net profit attributable to shareholders of the listed company of RMB1.443 billion, representing a year-on-year decrease of 3.99%; and realized a net profit attributable to shareholders of the listed company after deduction of the extraordinary gains and losses of RMB1.374 billion, representing a year-on-year decrease of 3.18%. We firmly believe that robust performance is the cornerstone of creating value for shareholders and we are committed to providing shareholders with excellent returns. Based on the operating results and overall financial position of the Group in 2023, the Board of Directors proposed that we continue to adopt a stable profit distribution scheme in 2023. Specifically, a cash dividend of RMB1.80 (tax inclusive) for every 10 shares will be distributed to all shareholders of the Company, based on the total number of shares on the equity registration date designated by the annual profit distribution plan for 2023. No bonus shares will be distributed and no conversion of capital reserve into share capital will be carried out. The profit distribution scheme for 2023 is yet to be reviewed and approved at the Company’s 2023 Annual General Meeting. In 2023, the Group further carried out and practiced the dual-drive strategy of innovative medicines and high-barrier complex formulations, implemented differentiated R&Dstrategy, and created a diversified product matrix and a rich pipeline. In terms of R&D innovation, the Group adhered to a development philosophy centered on R&D innovation, and differentially deployed innovative medicines and high-barrier complex formulations through self-research and introduction to achieve high-quality development. We continued to increase our R&D expenditures and made breakthroughs in the construction of several major platforms, including inhalation formulation, antibody, and sustained-release microspheres for injections. In 2023, the Group made great progress on various innovative medicines and high-barrier complex formulations in the R&D pipeline. In terms of innovative medicines, Ilaprazole Sodium for injection (注射用艾普拉唑钠) with new indication and indication were approved for launching; Recombinant SARS-COV-2 Bivalent (Original/Omicron XBB) Fusion Protein Vaccine (CHO Cell) (重組新型冠状病毒融合蛋白二价(原型株/Omicron XBB变异株)疫苗(CHO细胞)) was approved for EUA; and Aripiprazole Microspheres for Injection (注射用阿立哌唑微球) were applied for marketing launch. TG-1000 capsules and Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection (重组抗人 IL-17A/F人源化单克隆抗体注射液) had commenced the phase III clinical trials. In terms of high-barrier complex formulations, Formoterol Fumarate Inhalation Solution (富马酸福莫特罗吸入溶液), Long Chain Fat Emulsion Injection (长链脂肪乳注射液) (OO) and Tocilizumab Injection (托珠单抗注射液 ) were approved for market launch; and Salmeterol Xinafoate-Fluticasone Propionate Powder for Inhalation (沙美特罗替卡松吸入粉雾剂) completed Phase III clinical trial and was the first to apply for marketing launch after the issuance of new domestic regulations. We are deeply engaged in the construction of innovative R&D technology platforms for innovative and high-barrier complex formulations, so as to continuously improve our independent R&D capabilities and competitiveness. In December 2023, Meloxicam Nanocrystalline Injection (美洛昔康纳米晶注射液), which was independently developed by the Group, received approval for clinical trials. This success represents a significant breakthrough in the Group’s newly established R&D platform for complex injections, injecting fresh energy into the Group’s progress in this area. Meanwhile, Joincare Biopharmaceutical Research Institute also made a series of significant breakthroughs in the field of synthetic biology. As of the end of 2023, the Institute had applied for a total of 14 national invention patents (with 4 granted), 8 utility model patents (with 4 granted), Moreover, the Institute obtained 1 software copyright and published 2 high-level academic papers. In order to further deepen the implementation of the Group’s innovative development strategy, we strengthened independent innovation and foreign cooperation to accelerate R&D innovation and upgrading. In 2023, the Group successfully introduced innovative medicines such as TG-1000, a new anti-influenza medicine, and DBM-1152A, a new dual-targeted medicine of LABA+LAMA, further expanding the Group’s R&D pipeline in the sector of respiratory diseases. Additionally, the Group actively expanded into new sectors, and obtained the exclusive licensing rights for FZ008-145, an analgesic drug in the Greater China region. In terms of marketing innovation, in 2023, the Group continuously consolidated its user-centric digital marketing system and promoted steady performance growth with brand building. In the respiratory drug sector, the Group continued to promote the construction of its digital marketing platform through the establishment of a flat management ecosystem and the acceleration of digital marketing and other measures. Leveraging digital tools, the Group expedited its marketing progress. Meanwhile, through analyzing patients’ feedback on medicine taking and focusing on public awareness campaigns on respiratory diseases, the Group offered entire-process services from disease awareness to disease treatment, ultimately improving our brand recognition and influence. In the health care productsand OTC segment, the Group accomplished a successful marketing reform, showing robust growth in sales revenue. Through ongoing optimization and enhancement of its marketing strategy, which integrated online and offline channels, the Group established a data- driven DTC brand digital marketing system centered on user engagement. This initiative injected new vitality into the brand, resulting in significant performance-driven outcomes. In terms of international expansion, the Group steadily accelerated its internationalization strategy. In 2023, the revenues of the Group from overseas operations were RMB2,584 million, representing 15.64% of the Group’s revenues from principalbusinesses. In addition to maintaining its existing strengths in APIs exports, the Group proactively promoted the global planning and strategy for our key formulation products. In 2023, 4 chemical formulations of the Company were approved for registration in overseas markets, and 14 new registrations were submitted. Among them, Compound Ipratropium Bromide Solution was completed the registration review in Philippines and obtained the registration approval in January 2024, Levosalbutamol Hydrochloride Nebulizer Solution was submitted the registration application in Macao and obtained the registration approval in February 2024, and Cetrorelix Acetate for Injection was submitted the registration application to the United States. Leveraging the opportunity of the successful issuance of Global Depository Receipts (GDRs) on the Swiss Exchange in 2022, the Group’s Investor Relation Team actively engaged in overseas roadshows in countries such as Singapore, the United Arab Emirates, Switzerland. They showcased the Group’s business model, financial condition, and development strategy to overseas investors, effectively enhancing the Group’s international visibility and influence This initiative received positive responses from a wide range of investors. In addition to commitment to business development, we actively participated in social welfare undertakings, effectively fulfilled our social responsibilitiesby integrating ESG concepts into our strategic planning and daily operations. As a leading manufacturer of inhalation formulations in China, we consistently upheld our commitment to serving the nation and its people as a pharmaceutical company. Following the inclusion of three inhalation formulation products,雾舒?, 舒坦琳?, and 丽雾安?, in the fifth round of national volume-based procurement, and the ? inclusion of 特瑞通 in the seventh round of national volume-based procurement, Levosalbutamol Hydrochloride Nebulizer Solution (盐酸左沙丁胺醇雾化吸入溶液) successfully won the bidding in the ninth round of national volume-based procurement. As of the end of 2023, Tobramycin ? Solution for Inhalation (妥布霉素吸入溶液) (健可妥 ), the first independently developed inhaled antibiotics in China, was included in the latest National Reimbursement Drug List. This development is anticipated to enhance the drug’s accessibility and offer more convenient and effective treatment options for a large number of patients. In 2023, the inhalation formulation segment of Joincare recorded a revenue of RMB1,741 million, representing a year-on-year increase of 48.35%. This also means that more and more Chinese people are using domestically produced, high-quality and affordable new drugs. To improve public awareness of chronic disease diagnosis, treatment, and management, the Group orderly conducted public awareness campaigns through academic publications, public welfare actions, and the promotion of science popularization, thereby raising public health awareness and advancing universal healthcare development. As of the end of 2023, “Respiratory Experts’ Views” (呼吸专家说), a public welfare patient education platform in the domestic respiratory diseases sector under the Group, which is the first of its kind in the industry, has collaborated with over 5,000 doctors in popularizing the scientific concept on the prevention of chronic respiratory diseases among millions of followers. It focused on chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis and other respiratory diseases with high morbidity but low awareness and rate of standardized treatment, so as to support the “Healthy China 2030” initiative. Over the years, we have always kept in mind our responsibilities as a corporate citizen, actively responded to national call, and continued to devote ourselves to the construction of healthy China and the rural revitalization plan. Leveraging our industrial strengths, we consistently launched the “Access to Public Welfare for Chronic Diseases Prevention and Treatment (普惠慢病防治公益项目)” program. This program currently covers 8 provinces and 4 autonomous regions in China, effectively easing the financial burdens of low-income households and solidifying the gains made in poverty alleviation efforts. In 2023, the Group’s public welfare donations amounted to approximately RMB25.9846 million. presenting various challenges to the development of China’s pharmaceutical industry alongside new opportunities for growth. This year, for the first time “innovative medicines, bio-manufacturing, and life sciences” were collectively mentioned in the government work report during the National People's Congress and the Chinese People's Political Consultative Conference indicating potential breakthroughs for the industry. The Group will stay true to its original aspiration, be poised to seize opportunities, and steadfastly commit to achieving high-quality growth objectives by anchoring to the two pillars of “innovation” and “internationalization”, so as to promote the Group's all-around innovation and transformation. Firstly, we will continue to increase investment in innovation to improve R&D and business development capabilities, boost the Group’s R&D employment across various segments, and continuously enrich and consolidate the Group’s innovative product pipelines. Secondly, we will transform and upgrade our intelligent manufacturing to comprehensively enhance product competitiveness through quality improvements, cost reductions and efficiency enhancements. Thirdly, we will deepen digital marketing reforms to reshape brand positioning with a user-centric driver, thereby expanding product market shares. Fourthly, we will strengthen our partnership with global strategic customers, accelerate international product registrations and certifications, enhance the market development of our superior products, so as to further increase our overseas market shares, and propel the Group towards sustainable high-quality growth. In 2023, we faced challenges head-on and moved forward with courage. In 2024, we embrace our original aspirations, ready to embark on the journey with renewed vigor and determination. In the new year, we will continue to deepen the dual-drive strategy of innovative medicines and high-barrier complex formulations, deeply integrate the overall situation of “introduction” and “going global”, fully accelerate the progress of innovative research and development and the commercialization of new products, further enhance our competitive edges in the future, and continue to struggle for the Group’s all-around innovation, transformation and high-quality development. On behalf of the Board of the Company, I would like to take this opportunity to express my sincere gratitude to all Shareholders, employees and business partners of Joincare for your long-lasting care, companionship and support! Chairman: Zhu Baoguo 2 April 2024 Chapter 1 Definitions I. Definitions In this Report, unless the context otherwise requires, the following expressions shall have the following meanings:
Chapter 2 Company Profile and Major Financial Indicators I. Company profile
II. Contact persons and contact information
III. Introduction of the Company's basic information
IV. Information disclosure and place for inspection
V. Company stock profile
VI. Other relevant information
offering of new stocks or convertible corporate bonds by a listed company, the period of continuous supervision and guidance shall be the remaining time of the current year of the listing of securities and the following one full accounting year. As the Company issued shares to the public by allotment on 24 October 2018, the period of continuous supervision should start from the completion of this issuance and end on 31 December 2019. Furthermore, according to “Article 13 of the Guidelines of Shanghai Stock Exchange for Self-Regulation Rules for Listed Companies No. 11 - Continuous Supervision”, the sponsor shall continue to perform the obligations of continuous supervision if the funds raised have not been fully utilized upon the expiration of the continuous supervision period. During the Reporting Period, funds raised in this issuance have not yet been fully utilized, so the sponsor, Minsheng Securities, shall continue to perform its continuous supervision obligations in respect of the deposit and utilization of the funds raised. VII. Major accounting data and financial indicators in the last three years (1) Major accounting data Unit: Yuan Currency: RMB
(2) Major financial indicators
Statement on major accounting data and ?nancial indicators within three years before the End of the Reporting Period □Applicable √N/A VIII. Differences in accounting data under domestic and foreign accounting standards (1) Differences in net profit and net assets attributable to shareholders of the listed company disclosed in the financial statements according to international financial reporting standards (IFRS) and Chinese accounting standards (Chinese GAAP) (2) Differences in net profit and net assets attributable to shareholders of the listed company disclosed in the financial statements according to foreign accounting standards and Chinese accounting standards □ Applicable √ N/A (3) Explanations on differences under domestic and foreign accounting standards: □ Applicable √ N/A IX. Major financial indicators in 2023 by quarter
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