[年报]华东医药(000963):2023年年度报告（英文版）
原标题:华东医药:2023年年度报告（英文版） 2023 Annual Report April 2024 A Letter to the Shareholders Distinguished shareholders, As time flies, we usher in a new year with endless possibilities. Over the past year, we have witnessed and experienced profound changes brought by the era. The pharmaceutical industry is marching towards a new track of increasingly healthy and compliant high-quality development driven by continuous pressures it withstands, accelerated industrial clearing due to medical anti-corruption, and continuously increased values of innovative medicines. We are keenly aware that we can tide over the difficulties only by constantly fostering our resilience for development, which will be achieved through our down-to-earth efforts. Since we started our innovation and transformation, we have gradually defined development strategies for our four major business segments of pharmaceutical industry, pharmaceutical business, aesthetic medicine and industrial microbiology. Thanks to our consistent practice, we have transformed our innovative R&D system from external introduction to “self-development + introduction” step by step and have successfully achieved historic breakthrough in both innovative R&D team building and its capacity, with an industry chain for the complete cycle of innovation medicine R&D fostered. To date, we have established over 100 pharmaceutical product pipelines, including more than 60 pipelines for innovative products, and built the R&D ecology with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. as the core. In 2023, our constant efforts have been bearing fruits. The Liraglutide Injection was successfully launched, and had its marketing authorization application for diabetes, obesity or overweight applications approved successively, being the first of its kind in China and playing a leading role in the GLP-1 track. In the meantime, applications for launching of multiple blockbuster products were submitted. Mirvetuximab Soravtansine Injection, a global pioneering ADC medicine, was firstly launched in Hainan, benefiting over 30 patients. Its application for launching in China was accepted in October 2023. Ustekinumab Injection (QX001S) was the first of its kind in China submitting the BLA, which was already accepted. Marketing authorization applications of Rilonacept Injection for Cryopyrin-Associated Periodic Syndromes and recurrent pericarditis were accepted by NMPA, expecting to benefit patients with rare diseases as soon as possible. In addition, the Company has also seen achievements in R&D of innovative medicines. Applications on IND of HDM1002, a small-molecule GLP-1 receptor agonist with global innovation level, were accepted in both China and the U.S. Its clinical trials are now progressing smoothly. The application on IND of HDM1005, a GLP-1 and GIP dual-target innovative medicine, in China was successfully approved, and its clinical trials have been officially launched. The application on IND of HDM2005, the first ADC innovative medicine independently developed by the Company, was submitted and accepted. A variety of independent innovation achievements of the Company have also debuted at diverse key international academic conferences and journals, further showcasing our unremitting endeavors and positive results in independent innovation. All these have laid a solid foundation for our future development and expansion. In 2023, we embraced more exchanges through opening up, expanded cooperation, and consolidated resilience for development. Zevorcabtagene Autoleucel Injection, a CAR-T product introduced in early 2023, was successfully launched in 2024. The Company will continue to roll out its businesses in the field of cell therapy. The Company introduced various types of global innovative external preparations from Arcutis in the U.S. and MC2 in Denmark, further enriching our pipelines of external preparations in the field of immunity and fostering a “golden combination” that features a multi-target point and multi-acting mechanism in psoriasis treatment. In the aesthetic medicine field, the Company introduced ATGC-110 from ATGC in South Korea and YY001 from Chongqing Yuyan in China, two new botulinum toxin products under research, fully enriching the Company’s pipelines in facial injection products through differentiated positioning. In the industrial microbiology segment, the Company set foot in the field of animal health through its holding subsidiary Jiangsu Nanjing Nongda Animal Pharmaceutical Co., Ltd. and won the exclusive ? selling right of Baoshining , the first new opioid veterinary drug for central analgesia in China. The Company has continued to optimize its layout of pet protection products. Looking into 2024, we will always place our focus on “development of the innovative medicine industry”. In this year’s government work report, the term “innovative medicine” was mentioned for the first time. It will occupy an increasingly important position in the future, validate and guide our strategic orientation. Being “scientific research-based and patient-centered”, the Company will give priority to three core therapeutic fields of oncology, endocrinology and autoimmunity, follow the development trends of cutting-edge technologies, and focus on the field of chronic diseases with significant unmet clinical needs oriented at unmet clinical needs of global patients. In the meantime, we will keep strengthening and improving our independent innovation and R&D abilities, consolidate established technology platforms for R&D, exploit potentialities of the featured global R&D ecosystem of Huadong Medicine, and foster new quality productive forces for vigorous growth. As for the aesthetic medicine segment, one of the Company’s core strategic areas, the Company will continue to implement its unique strategy of “global operation layout and dual-circulation operation & development”. Insisting on the high-end and natural treatment, our patent-oriented professional teams in China further enhance promotion of product brands and enterprise brands, and actively advance registration and launching of more high-end aesthetic medicine products in China. As for pharmaceutical business, the Company will further optimize business structure, facilitate transformation of innovative businesses, keep increasing proportion of innovative businesses, and improve operating benefits. In the industrial microbiology segment, the Company will conduct in-depth study on trends of market change, optimize layout of core businesses, focus on expansion of international market, and endeavor to foster core varieties revolving around four key business directions, thus injecting vitality for the Company’s vigorous development. Taking informed and decisive actions, the Company will surely be rewarded for its unremitting endeavors. The year of 2024 is full of unknowns and variables. In the face of increasingly fierce industry competitions, the Company encounters a deep end and enters the critical stage of innovation and transformation. Therefore, we must forge ahead steadily. This year also marks the end of our 7th three-year planning. We must get ready to start again from zero, define strategic goals, pool system capacities, strengthen team building, and consolidate foundation for development. In 2024, a crucial year for securing our achievements and continuing our great efforts, the Company will remain goal-oriented and problem-oriented, benchmark our 2030 vision plan, deepen transformation of diverse businesses, and advance the high-quality development through active reflection, bold challenging, and brave pioneering. Forging ahead despite strong wind and heavy rains, the Company has now harvested fruits. My sincere thanks go to all staff for their selfless dedication, and to our investors and shareholders for their trust and support. It is the responsibility of Huadong Medicine, a pharmaceutical enterprise, to keep strengthening our ability in creating values, to continuously improve our core values, and to maintain consistent profitability to reward the society and shareholders. In 2024, we increase the total amount of our annual dividend to 1 billion yuan for the first time and propose to launch an interim dividend distribution to reward our shareholders. We hope to boost confidence through practical actions, forge ahead and work hard to unfold a brilliant new chapter. Finally, I would like to share with you a few lyrics. Let’s encourage each other and show our respect to the new era and those who struggle ahead bravely. “We all race ourselves for a better future and a significant victory. There is no end ahead and we will never stop our steps ...” Lv Liang, Chairman Huadong Medicine Co., Ltd. April 2024 2023 Annual Report 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 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 accounting department (accounting supervisor) hereby declare and guarantee that the financial statements in this annual report are authentic, accurate and complete. All directors have attended the Board of Directors meeting to review this annual report. The future plans, development strategies and other forward-looking statements in this annual report shall not be considered as substantial commitment of the Company to investor. 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 including 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 “v. Potential risks and responses” under “XI. Prospect of future development” in “Section III. Management’s Discussion and Analysis”. Therefore, investors are kindly reminded to pay attention to possible investment risks. The dividend distribution scheme approved at the meeting of the Board of Directors is as follows: On the basis of 1,754,327,548 shares of the total share capital of the Company, 5.8 yuan (before tax) of cash dividends per ten common shares will be distributed to all shareholders; a total of 0 bonus share (before tax) will be issued; and no capital reserve will be converted to increase the capital stock. According to “Stock Listing Rules of the Shenzhen Stock Exchange”, if listed companies have both Chinese and 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.................................. 7 Section II. Company Profile and Key Financial Indicators ................................. 14 Section III Management’s Discussion and Analysis ............................................. 19 Section IV. Corporate Governance ........................................................................ 95 Section V Environmental and Social Responsibilities ........................................ 128 Section VI. Important Matters ............................................................................ 146 Section VII. Share Change and Shareholders..................................................... 181 Section VIII. Information on Preferred Shares .................................................. 197 Section IX. Information on Bonds ....................................................................... 198 Section X. Financial Report ................................................................................. 199 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) Original audit report stamped by public accountants, and signed and stamped by certified public accountant. (III) 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
Certified public accountants
Financial consultant for continuous supervision and guidance during the reporting period □ Applicable ? N/A VI. Key accounting data and financial indicators Whether the Company needs to perform a retroactive adjustment or restatement of previous accounting data □Yes ?No
are all negative, and the audit report of last year shows doubt about the Company’s ability to continue as a going concern. □Yes ?No The Company’s net profit before and after deducting non-recurring gains/losses, whichever is lower, is negative. □Yes ?No The Company’s total share capital as of the trading day prior to disclosure:
VII. Differences in accounting data under domestic and overseas accounting standards 1. Differences in net profit and net assets disclosed in financial statements under international and 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. VIII. Key financial indicators by quarter Unit: yuan
quarterly and semiannual reports by the Company □Yes ?No IX. 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 Gains/Losses 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 Gains/Losses as a recurring gain/loss. Section III Management’s Discussion and Analysis I. Industry Situation during the Reporting Period In 2023, the world economy recovered sluggishly and struggled to move forward amid the turmoil as a result of intensified international geopolitical conflicts and complicated global development and security situations. The year of 2023 marks the start of fully implementing the guiding principles of the 20th CPC National Congress. Superpower games and capital winter have posed great challenges to the bio-pharmaceutical industry in China. The pharmaceutical industry in China has also entered the stage of accelerated adjustment, and the pharmaceutical R&D, production and management structure in China is undergoing a historic reconstruction. Since the 18th CPC National Congress, the CPC Central Committee with Comrade Xi Jinping as the core has always given strategic priority to safeguarding people’s health, included the deepening of medical reform in the all-round deepening of reform, facilitated the transformation from “centering on disease curing” to “centering on people’s health”, and launched a series of important reform measures revolving around two key challenges of “difficulty and high cost of getting medical services”, with remarkable phased results achieved. In 2023, China’s volume-based procurement of medicines was institutionalized and normalized. The optimization of rules for centralized bulk purchase was gradually weakened the impacts on the industry and the mechanism for dynamic adjustment of health insurance directory got increasingly mature. Medical insurance negotiations on innovative medicines were normalized, further accelerating the commercialization of Chinese innovative medicines. The reform of payment method was accelerated and DRG mode further drove the revolution of the industry. Laws, regulations and policy systems that motivate innovation in medicines were optimized at an accelerated pace. The National Medical Products Administration continuously deepened the reform of review and approval systems, accelerated the launching of new medicines in urgent need for clinical purpose, as well as medicines for rare diseases and children, and supported the pharmaceutical innovation to continuously inject vitality into R&D and innovation of medicines in China. Due to increasing influence from clinical values, pharmaceutical enterprises began to pay increasing attention to R&D and innovation of medicines. The development of innovative medicines is becoming an important link that drives the new quality productive forces. Since the 14th Five-year Plan Period, the R&D input throughout the industry in China has witnessed a mean annual growth of over 20%, pushing China to the second place in the world in terms of number of new medicines. China witnessed continuously enhanced strength in R&D of innovative medicines and contributed more to global medicine R&D, receiving international recognition and seeing constantly increased international competitiveness and influence. China continuously made positive progresses in overseas registration and commercialization of its local new medicines, and hit a new high in the number of varieties with externally licensed technologies and transaction amount. The pharmaceutical industry in China has stepped up a new level in international operation and entered the key period for independent innovation-driven transformation and innovation. In July 2023, ten ministries and commissions including the National Health Commission of the People’s Republic of China printed and issued the Guiding Opinions on Carrying out the Centralized Rectification of Corruption in the Pharmaceutical Industry in China, launching the one-year national centralized rectification of corruption in the pharmaceutical industry. The campaign is aimed at systematically rectify problems in production, supply, sales, use, reimbursement, “critical minorities” and other key links in the pharmaceutical industry, with all chains and fields covered. With unprecedented input, the anti-corruption campaign helps to create a compliant industry environment, regularize enterprises’ operations, facilitate the benign competition among enterprises, and reshape the industrial order. In 2023, major economic indicators in China’s pharmaceutical industry witnessed year-on-year decline caused by such factors as decreased sales of products related to prevention and control of special health events, reduced prices of medicines, and rising prices of raw materials. According to National Bureau of Statistics, in 2023, the added value of the pharmaceutical industry above designated size was about 1.3 trillion yuan, down 5.2% year on year in constant price. Enterprises above designated size achieved 2.95525 trillion yuan of operating revenue and 412.72 billion yuan of profits, down 4% and 16.2% year on year, respectively. The growth rates of the aforesaid three indicators were negative for the first time over the years. The business differentiation of enterprises became more serious under the backdrop of overall decline in the growth rate of the industry. （未完）  |