[三季报]华东医药:2021年第三季度报告（英文版）
原标题:华东医药:2021年第三季度报告（英文版） Stock code: 000963 Stock abbreviation: Huadong Medicine Announcement No.: 2021-076 Huadong Medicine Co., Ltd. The Third Quarterly Report 2021 The Company and all members of the Board of Directors hereby guarantee that the information presented in this report is authentic, accurate and complete and free of any false records, misleading statements or material omissions. Important Declaration: 1.The Board of Directors, Board of Supervisors, directors, supervisors and senior management of Huadong Medicine Co., Ltd. (hereinafter referred to as the “Company”) hereby guarantee that the information presented in this 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. 2.The Company’s legal representative and the officer in charge of accounting, and head of accounting department (accounting supervisor) hereby declare and guarantee that the financial statements in this quarter report are authentic, accurate and complete. 3.Has the third quarterly report been audited? □ Yes √ No This report is prepared both in Chinese and English. Should there be any discrepancy between the Chinese and English versions, the Chinese version shall prevail. I. Key financial data (I) Key Accounting Data and Financial Indicators Whether the Company needs to perform retroactive adjustment or restatement of previous accounting data □ Yes √ No The current reporting period Change of the current reporting period over the same period last year From the beginning of the year to the end of the reporting period Change from the beginning of the year to the end of the reporting period over the same period last year Operating revenue (yuan) 8,748,039,460.66 -1.04% 25,927,477,363.27 1.67% Net profit attributable to shareholders of listed companies (yuan) 595,038,254.49 -9.88% 1,895,384,579.34 -20.74% Net profit attributable to shareholders of listed 568,039,187.19 -9.00% 1,762,020,074.37 -13.24% companies after deducting non-recurring gains/losses (yuan) Net cash flow from operating activities (yuan) —— —— 2,105,916,826.72 10.73% Basic earnings per share (yuan/share) 0.3401 -9.88% 1.0832 -20.74% Diluted earnings per share (yuan/share) 0.3401 -9.88% 1.0832 -20.74% Weighted average return on equity (ROE) 3.75% -1.00% 12.28% -5.41% End of the current reporting period End of last year Change of the end of the current reporting period over the end of last year Total assets (yuan) 27,687,711,922.81 24,201,348,154.75 14.41% Owners’ equity attributable to shareholders of listed companies (yuan) 16,250,585,502.88 14,619,821,308.60 11.15% Share capital of the Company as of the trading day before disclosure: Share capital of the Company as of the trading day before disclosure (share) 1,749,809,548 Fully diluted earnings per share calculated on the basis of the latest Share capital Dividends paid on preferred shares 0.00 Perpetual bond interest paid (yuan) 0.00 Fully diluted earnings per share calculated on the basis of the latest Share capital (yuan/share) 1.0832 (II)Items and amounts of non-recurring gains/losses √ Applicable □ N/A Item Amount of the current reporting period Amount (from the beginning of the year to the end of the reporting period) Note Gains/losses on disposal of non-current assets (including the written-off part of the accrued assets impairment reserve) -356,832.47 -466,951.55 Government grants included in current gains/losses(excluding those closely related to normal operating activities, in line with national policies and measured according to unified national standards) 19,665,596.43 157,973,691.62 Receivables subject to separate impairment test and reversal of reserve for impairment 5,388,185.00 Other non-operating income or expenditure 2,888,378.89 -2,028,188.08 Less: Amount affected by income tax -2,745,429.38 19,349,865.15 Amount affected by minority interest (after tax) -2,056,495.07 8,152,366.87 Total 26,999,067.30 133,364,504.97 -- Details of other gains/losses items satisfying the definition of non-recurring gains/losses: □ Applicable √ N/A No such case. If the Company recognizes a non-recurring gain/loss listed in the “Interpretative Announcement No. 1 on Information Disclosure Criteria for Public Companies – Non-Recurring Profit/Loss” as a recurring gain/loss, reasons should be specified. □ Applicable √ N/A No such case. (III)Changes in key accounting data and financial indicators and their reasons √ Applicable □ N/A Unit: RMB yuan Balance sheet item End of the period Beginning of the period Change rate Notes on cause of changes Accounts receivable financing 572,080,968.64 828,659,217.25 -30.96% Mainly due to banker’s acceptance discount in the current period Accounts receivable 8,147,812,875.63 6,137,675,568.82 32.75% Mainly due to income growth and capital return fluctuation Other receivables 299,688,469.54 87,269,489.82 243.41% Mainly due to the increase of equity transfer accounts receivable and suspense accounts receivable Other current assets 38,039,156.52 85,654,691.58 -55.59% Mainly due to the decrease of input VAT to be deducted at the end of the period Other equity instruments investment 129,841,291.42 225,453,120.05 -42.41% Mainly due to the transfer of equity instrument investment of Ningbo Donghai Bank and the sale of some RAPT shares in the current period Goodwill 2,100,106,651.09 1,469,617,262.10 42.90% Mainly due to the acquisition of Doer Biologics and High Tech in the current period Notes payable 1,381,336,643.84 554,336,058.71 149.19% Mainly due to the increase of bill payment in the current period Contract liabilities 186,487,690.02 94,384,629.77 97.58% Mainly due to the increase of advance drug payments in the current period Non-current liabilities due within one year 23,288,386.11 67,813,886.68 -65.66% Mainly due to the decrease of long-term payables and long-term borrowing due within one year Long-term payables 164,454,591.48 26,812,354.90 513.35% Mainly due to the increase in contingent and deferred consideration resulting from the acquisition of external companies by the subsidiaries Long term loan 287,439,900.00 151,611,367.86 89.59% Mainly due to the increase of subsidiaries’ long-term borrowing Other comprehensive income 91,912,418.43 -2,191,069.45 4294.87% Mainly due to the increase in the exchange differences from translation of foreign currency statements Income statement item Amount of the current period Amount of the previous period Change rate Notes on cause of changes Gains on assets disposal -149,966.61 304,146,257.99 -100.05% Mainly due to the income from asset disposal of Sinclair in the previous period Investment income -60,001,493.40 -20,950,134.64 -186.40% Mainly due to the increase of discount interest and the decrease of net profit of joint ventures in the current period Cash flow statement item Amount of the current period Amount of the previous period Change rate Notes on cause of changes Net cash flows from investing activities -1,406,864,147.47 -920,040,870.59 -52.91% Mainly due to the increase of equity investment in the current period II. Shareholder information (I) Total number of shareholders of common shares and number of shareholders of preferred shares with voting rights restored, as well as information about top 10 shareholders Unit: share Total number of shareholders of common shares at the end of the reporting period 195,693 Total number of shareholders of preferred shares whose voting rights have been restored at the end of the 0 reporting period (if any) Information about top 10 shareholders Name Nature Shareholding ratio Number of shares held Number of shares held with sale restrictions Pledged, marked or frozen Status Number China Grand Enterprises, Inc. Domestic non-state-owned legal person 41.77% 730,938,157 0 Pledged 238,450,000 Hangzhou Huadong Medicine Group Co., Ltd. State-owned legal person 16.46% 288,000,000 0 Hong Kong Securities Clearing Company Ltd. Overseas legal person 1.75% 30,641,915 0 China Securities Finance Co., Ltd. Domestic non-state-owned legal person 1.27% 22,186,818 0 National Social Security Fund Portfolio 503 Others 0.49% 8,500,086 0 #Liu Li Domestic natural persons 0.34% 6,000,000 0 Basic Endowment Insurance Fund Portfolio 15041 Others 0.27% 4,682,950 0 #Chen Shaoming Domestic natural persons 0.21% 3,744,388 0 Norges Bank－ own funds Overseas legal person 0.16% 2,776,229 0 China Merchants Bank Co., Ltd.－ Xingquanheyuan 2-year Holding Mixed Securities Investment Fund Others 0.15% 2,609,639 0 Shares held by the top 10 shareholders of Non- restricted shares Name Number of shares held without sale restrictions Type of shares Type Number China Grand Enterprises, Inc. 730,938,157 RMB common shares 730,938,157 Hangzhou Huadong Medicine Group Co., Ltd. 288,000,000 RMB common shares 288,000,000 Hong Kong Securities Clearing Company Ltd. 30,641,915 RMB common shares 30,641,915 China Securities Finance Co., Ltd. 22,186,818 RMB common shares 22,186,818 National Social Security Fund Portfolio 503 8,500,086 RMB common shares 8,500,086 #Liu Li 6,000,000 RMB common shares 6,000,000 Basic Endowment Insurance Fund Portfolio 15041 4,682,950 RMB common shares 4,682,950 #Chen Shaoming 3,744,388 RMB common shares 3,744,388 Norges Bank－own funds 2,776,229 RMB common shares 2,776,229 China Merchants Bank Co., Ltd.－ Xingquanheyuan 2-year Holding Mixed Securities Investment Fund 2,609,639 RMB common shares 2,609,639 Notes on relations and concerted actions among the shareholders mentioned above The Company does not know whether the shareholders mentioned above are related parties with each other or whether they are acting-in-concert parties with each other. Notes on financing and securities loan conducted by top 10 shareholders (if any) At the end of the current reporting period, Liu Li, the sixth shareholder of the Company, held 6,000,000 shares of the Company through financing and securities loan, Chen Shaoming, the eighth shareholder of the Company, held 3,651,388 shares of the Company through financing and securities loan. (II)Total number of shareholders of preferred shares and information about top 10 shareholders of preferred shares □ Applicable √ N/A III. Other important matters √ Applicable □ N/A (I) Overview of operations 1. The Company’s operations during the reporting period In the first three quarters of 2021, the Company deepened the transformation and innovation work. The performance of business indicators in the reporting period decreased year-on-year, but has been significantly improved compared with the first half of the year, and the overall operation maintained a stable and positive trend. The core subsidiary Zhongmei Huadong actively overcame the business and market pressure brought about by the reform of the domestic pharmaceutical industry, accelerated the process of innovation and internationalization, and strengthened the development of out-of-hospital and grass-roots markets. In the first three quarters of 2021, the operating income reached RMB7.804 billion, down 11.4% year on year, and the net profit was RMB1.72 billion, down 11.1% year on year. While the sales volume of main products was increasing, the income from immunity and cardiovascular products continued to increase rapidly. The export of customized high-end bulk drugs (Contract Development and Manufacturing Organization, CDMO) and e-commerce business continued to develop, reflecting the resilience and growth potential of the Company’s pharmaceutical manufacturing business as a whole. In the third quarter, Zhongmei Huadong was affected by product price reduction continuously, with the operating income decreasing by 12.7% year on year but increasing by 2.0% quarter on quarter, and the net profit decreasing by 5.2% year on year (compared with 14.6% year-on-year decline of the first quarter of 2021 and 11.7% year-on-year decline of the second quarter of 2021, indicating the trend of narrowing decline and stabilization) but increasing by 14.8% quarter on quarter, which has laid a solid foundation for returning to growth in 2022. In the fourth quarter, the Company will make every effort to manage the operation, strive to achieve growth in the quarter, and endeavor to achieve the operating objectives of the whole year. Ellansé., the core aesthetic medicine product of the Company, has been officially placed on the Chinese mainland market at the end of August. It has been accurately positioned for high-end regeneration market with its unique advantages of “immediate filling, lasting effect and being metabolizable”. Currently, the number of contracted cooperative hospitals for the product exceeds 120, the number of trained and certified doctors exceeds 200, and its sales and promotion was ready. Ellansé. has received extensive attention and popularity from the market since its launch, with a stack of orders from aesthetic medicine institutions and good feedback from customers. As of the release date of this report, the Company has received advances of more than RMB100 million for the product, and is expected to beat the annual sales target, and drive the Company’s domestic aesthetic medicine business to achieve new growth in 2022 based on the head start this year. Facing the strong demand in the domestic market, the Company requires Sinclair’s Dutch factory to give priority to the supply in the domestic market, thus shortening the waiting time of customers. At the same time, the Company will strictly select cooperative institutions and constantly increase the training and certification of doctors to provide responsible and high-quality services to customers. Moreover, to meet the demand growth of Ellansé. in the global market, in addition to the factory in Utrecht in the Netherlands, Sinclair built a new factory in Almere, Netherlands, to expand its capacity. At present, the new factory is completed and put into use after passing the certification and approval, so as to fully ensure the subsequent supply of Ellansé. around the globe. During the reporting period, the Company’s overseas aesthetic medicine business continued to show rapid growth with the relaxation of pandemic containment measures in various countries. The sales of Ellansé., the core product of Sinclair UK, MaiLi. series product, a newly-launched high-end hyaluronic acid filler in Europe, Lanluma., a collagen stimulant, and other products continued to outperform the expectation. In the first three quarters of 2021, Sinclair’s operating income (including acquired Spanish company High Tech) was GBP53.06 million (approximately RMB473 million) with a year-on-year increase of 127.4%. Specifically, Sinclair’s own income increased by 79.24%, and its annual income is expected to reach the highest level in history. Driven by good sales in the end market, High Tech received sufficient orders during the year, which has provided a strong guarantee for the rapid growth of annual income. In the first three quarters of 2021, affected by factors such as non-recurring expenses for the acquisition of High Tech’s equities, Sinclair’s net profit in the overall consolidated statement still showed a loss, but its earnings before interest, taxes, depreciation and amortization (i.e. EBITDA) was GBP5.06 million (consolidated specifications), the highest EBITDA since the Company completed the buyout of Sinclair in 2018, and also important evidence of the Company’s ability to run the aesthetic medicine business around the globe. Huadong Pharmaceutical Distribution Company has actively optimized the in-hospital market and expanded the out-of-hospital market, and the overall business maintained a stable growth. In the first three quarters of 2021, the Company’s pharmaceutical commerce segment achieved an operating income of RMB17.268 billion with a year-on-year increase of 7.03%. The establishment of product promotion teams has been accelerated, and the number of innovative drugs introduced to sell by proxy during the year has exceeded that in 2020. The third-party logistics business of pharmaceutical commerce continued with rapid growth, with the phased task of the distribution of COVID-19 vaccines in Zhejiang Province being fully completed. The construction of Jinhua logistics center entered the final stage. During the reporting period, the Company was also selected as a key e-commerce platform enterprise in 2021-2022 in Zhejiang Province. The main reason for the difference between year-on-year decrease in the Company’s net profit and the net profit after deducting non-recurring profits and losses in the reporting period is that the Company’s non-recurring profits and losses in the first quarter of 2020 were RMB290 million, including a net income of GBP30.65 million from the transfer of regional product distribution rights by Sinclair to Galderma, which greatly increased the Company’s overall income in the first quarter of 2020. No such matters occurred during the reporting period, and other non-recurring gains and losses totaled RMB133 million in the first three quarters of 2021, resulting in a decrease in the net profit attributable to shareholders of the listed company year on year. 2. Building an R&D ecosystem of the Company and accelerating the process of innovation and internationalization During the reporting period, Zhongmei Huadong and Huadong Medicine Investment Holding (Hong Kong) Co., Ltd. (hereinafter referred to as the “Investment Holding”), wholly-owned subsidiaries of the Company, signed an equity investment agreement and exclusive product license agreement with Ashvattha Therapeutic, Inc. (hereinafter referred to as “Ashvattha”). Investment Holding will subscribe for Series B preferred shares issued by Ashvattha in stages. Meanwhile, Zhongmei Huadong will obtain the exclusive license of Ashvattha’s 8 products under research in 20 Asian countries and regions such as China, Singapore and Malaysia, including the use of Ashvattha’s relevant intellectual property rights for R&D, production and commercialization. Ashvattha is an innovative biopharmaceutical enterprise focusing on the development of hydroxyl dendrimer (HD) therapeutics (HDTs). Based on interdisciplinary transformation research of dendrimers that can cross the tissue barrier, its scientific research team connects active pharmaceutical ingredients (API) or imaging agent with HD to form new patented drugs, which can achieve precise treatment by targeting disease cells and have clinical significance and application prospect. Ashvattha applies the technology of nanomedicine and nano materials. Its unique HD platform is the only hydroxyl dendrimer platform capable of producing highly selective drugs in the world. Ashvattha has a reasonable patent portfolio and has the potential to develop a variety of therapeutic drugs. Ashvattha was founded by three scientists, namely, Dr. Kannan Rangaramanujam, the Arnall Patz distinguished professor of ophthalmology and co-director of center for nanomedicine at the Wilmer Eye Institute at Johns Hopkins School of Medicine, Dr. Sujatha Kannan, the Richard J. Traystman Professor and Vice chair of research in Anesthesiology and Critical Care Medicine (ACCM) at Johns Hopkins School of Medicine, and Dr. Jeffrey Cleland, who graduated from Massachusetts Institute of Technology in chemical engineering, worked for Genentech and committed to new drug research and development for more than ten years. The three founders have made achievements in the field of medicine, published a large number of academic articles and owned dozens of invention patents. In addition, Ashvattha also has a team of professional consultants with rich research experience and professional experience. The Company introduced eight products under research from Ashvattha, covering the fields of tumor, metabolic comorbidity, inflammation, etc.. One of the products has entered phase II clinical trial in the United States, and two products will be submitted for IND review in the United States in the first quarter of 2022. This cooperation will further enrich the Company’s innovative product pipeline in the fields of tumor, immunity and endocrinology, and help to improve the Company’s internationalization and scientific research innovation level. In the future, the products will also provide doctors and patients with more precise and scientific diagnosis and treatment and medication options after launching. The Company has invested, held shares in and incubated a number of domestic biotechnology companies with leading technology. For example, it invested in Peg-Bio Biopharm featuring a peptide technology platform, Qyuns Therapeutics, an antibody company focusing on immune diseases, and Nuoling Biomedical Technology featuring ADC linker and coupling technology; it incubated Huida Biotech which has a full line of toxin ingredients used to develop ADC drugs; and it holds stakes in Doer Biologics which focuses on the development of a Polyclonal antibody platform. Through those efforts, the Company has gradually formed its own medical R&D ecosystem. The cooperation with Ashvattha and the introduction of its HD platform technology will become an important part of the Company’s efforts to build an R&D ecosystem and accelerate its process of innovation and internationalization. 3. Continuing to enrich product lines and enhancing the competitiveness of diabetes medicine During the reporting period, the application for marketing authorization regarding the indications for diabetes of the Company’s GLP-1 receptor agonist Liraglutide injection was accepted in September 2021. In addition to the original research company, there is no domestic manufacturer applying for its marketing authorization. Therefore, the Company is expected to become the first enterprise in China to obtain approval for the marketing authorization of Liraglutide’s biosimilar. Furthermore, the Company has carried out phase III clinical research on the indication for weight loss of Liraglutide injection. At present, the enrollment has been completed and a follow-up visit is underway. It is planned to carry out the application for marketing authorization by the end of 2021. In September 2021, the Company granted the exclusive development, production and commercialization rights of the world’s first small-molecule oral GLP-1 receptor agonist TTP273 in Korea to Daewon Pharmaceutical Co., Ltd. of South Korea, which is the Company’s first license-out of innovative products (see the relevant announcement issued by the Company on September 30, 2021). In October, the Company entered into strategic cooperation with Takeda Pharmaceuticals Company Ltd. (hereinafter referred to as “Takeda”) on the commercialization rights of globally innovative DPP-4 inhibitor Nesina. (Alogliptin Benzoate Tablets) in China, which has been launched in China, further enriching the Company’s diabetes product portfolio, forming synergy with the Company’s existing key products in the field of diabetes, and continuously consolidating and enhancing the competitiveness and leading position of the Company in the field of diabetes medicine in China. The alliance with Takeda also shows the industry’s affirmation of the commercialization ability of the Company in the local market of diabetes medicine. The company has been engaged in the field of diabetes medicine for nearly 20 years, has established a product matrix of core therapeutic targets and mainstream clinical drugs, and already has more than 20 commercialized products and products under research. The diabetes medicine market will continue to be a core area for the Company to expand its layout in the future. The Company will actively accelerate the process of innovation and industrialization through independent research and development, cooperation, equity investment and other diversified modes, continuously provide cutting-edge and advanced drugs in the world, continuously broaden the road of internationalization and make progress towards the world’s leading diabetes medicine manufacturing enterprise. 4. Building a non-invasive + minimally invasive high-end product pipeline to bring a new growth momentum to the global aesthetic medicine business During the reporting period, Sinclair cooperated with KiOmed in Belgium to obtain the exclusive license of four globally innovative KiOmedine. chitosan products under research and all subsequent chitosan related aesthetic medicine products in the field of aesthetic medicine for skin in other regions of the world except the United States, including the use of KiOmed related intellectual property rights for R&D, production and commercialization. The cooperation is another important strategic measure for global layout of the Company in the field of light aesthetic medicine, will further enrich the Company’s innovative filler product pipeline of aesthetic medicine, and realize the full coverage of products in the fields of hyaluronic acid, collagen stimulant, skin booster and so on. KiOmedine. is a high-purity natural (non-animal-sourced) medical chitosan derivative developed by KiOmed using its unique patented technology. Compared with hyaluronic acid, KiOmedine. is characterized by deep moisturizing, increasing collagen level and anti-aging. In addition, KiOmedine. series fillers are expected to further prolong the action time of hyaluronic acid and achieve long-acting filling effect. At present, there is no similar product in the market all over the world. The future launch of the product is expected to change the product landscape of the hyaluronic acid market and will become another potential blockbuster product in the field besides high-end hyaluronic acid MaiLi.. The Company introduced a cold-touch cosmetic instrument from R2 Company, Glacial SpaTM (F0, life cosmetology version of a frozen freckle-removing medical device), has obtained marketing approval in Korea and Taiwan of China, and the Non-medical Devices Management Certification from NMPA. It is expected to be officially marketed in China in the fourth quarter of 2021. Cooperation intentions have been reached with some beauty institutions. In addition, the Company has made launching plans in China for the main products on sale overseas and innovative products under research of the wholly-owned subsidiary High Tech in Spain engaged in energy source aesthetic medicine devices, and the relevant registration preparations have been carried out orderly. In particular, the registration of cryolipolysis product Cooltech Define and laser hair removal device Primelase in China will be officially launched before the end of 2021. Safyre, an RF product marketed overseas and suitable for facial rejuvenation and body shaping, is expected to be rolled out in China in the second quarter of 2022. The Company will continue to accelerate the progress of clinical registration and promotion of core aesthetic medicine products at home and abroad, and continuously improve the competitive advantage in the industry by penetrating the global high-end aesthetic medicine market. After three years of rapid development, the Company’s aesthetic medicine business has achieved phased strategic objectives, and developed more than 20 products in the field of non-invasive + minimally invasive aesthetic medicine, with the number and coverage among the front rank of the industry. Of those products, several are expected to be released and sold at home and abroad before 2025, bringing new growth momentum to the Company’s global aesthetic medicine business. 肉毒素埋线 Ellansé.伊妍仕. 注射用聚己内酯微球 Lanluma. （聚左旋乳酸类胶 原蛋白刺激剂） MaiLi.系列 新型高端含利多 卡因透明质酸 Perfectha.系列 双相透明质酸 与Kylane公司合 作两款重点研发 产品 皮肤动能素 （天然<非动物源> 羧烷基壳聚糖注射 剂） 3款KiOmedine. 填充剂 （天然<非动物源> 羧烷基壳聚糖和透 明质酸注射剂） Botulinum Toxin 1（A型肉毒素） 美容埋线 Silhouette.Instalift. 用于皮下层植入 以纠正中到重度 鼻唇沟皱纹 面部和身体填充剂面部填充面部填充面部和身体填充剂 抗衰 改善肤质 唇部、面部 填充塑形 除皱 适用于中面部提拉手术 短暂固定并提拉 脸颊下真皮位置 中国已上市 全球 60 多个国家或 地区获注册认证 或上市准入 欧盟 CE 认证 欧洲已上市 欧盟 CE 认证 欧洲已上市 全球 60 多个国家 或地区获注册认 证或上市准入 欧盟 CE 认证 研发阶段 预计将于 2026 年 获得欧盟CE 认证 研发阶段 预计 2023 年获得 欧盟 CE认证 研发阶段 预计 2024 年后陆 续获得欧盟 CE 认证 中国注册上市推进中 美国 FDA 认证 全球 60 多个国家获地区 获注册认证或上市准入 预计 2024 年在中国上市 填充 皮肤美白提亮 祛除皮肤的良性色素 性病变和低温缓解 疼痛、 肿胀、炎症 和血肿 全身美白身体减脂塑形身体减脂塑形身体减脂塑形紧肤塑形紧肤塑形紧肤塑形 面部年轻 化及身体 塑形 脱毛脱毛脱毛 美国、韩国获批上市 中国台湾已递交上市 申请 2021 年四季度 登陆中国市场 美国 FDA 510(k)认证 预计 2024 年 在中国上市 海外研发阶段 预计 2024 年在 美国上市 欧盟 CE 认证 欧洲已上市 欧盟 CE 认证 澳洲 TGA 认证 海外已上市 海外已上市 海外研发阶段 预计 2023 年 获得欧盟 CE 认证 海外研发阶段 预计 2024 年 获得欧盟 CE 认证 海外研发阶段 预计 2022年 获得欧盟 CE 认证 预计2022年 中国上市 全球 11 个 国家或地 区获 注册 认证或上 市准入 海外研发阶段 预计 2023 年 获得欧盟 CE 认证 全球 7 个 国家或地 区获注册 认证或上 市准入 皮肤管理身体塑形脱毛 酷雪.Glacial Spa. （F0） F1（Glacial Rx.）F2（Glacial Ai）CooltechCooltech DefineCrystileDefine2.0Define3.0TitaniaSafyrePrimelasePrimelase ProElysion Note 1: Due to the liquidation of Huadong Ningbo after its operations expire, there is still uncertainty about the subsequent ownership of the interests in the commercialization of botulinum toxin products in China with Jetema of South Korea. (II) Research and development and registration During the reporting period, the Company continued to accelerate the R&D work, with a total R&D investment of RMB904 million in the pharmaceutical industry, a year-on-year increase of 8.9%. The clinical study and registration of products under research in the Company’s core areas is advancing in an orderly manner. As of the release of the report, the main R&D and registration progress of the Company’s medicine business is as follows: 1. Diabetes The application for marketing authorization regarding the indication for diabetes of GLP-1 receptor agonist Liraglutide injection was accepted in September 2021. The non-clinical study of Insulin Aspart injection was completed, and it is expected that the application for IND review will be submitted in the first quarter of 2022. HDM1003 (SCO-094) is a dual agonist that targets both GLP-1R and GIPR for the treatment of diseases such as type 2 diabetes, obesity and non-alcoholic steatohepatitis (NASH), jointly developed by the Company and SCOHIA PHARMA, Inc. in Japan. Its Phase I clinical trial is being carried out in the United Kingdom, and the Pre-IND application in China has been submitted. DR10624 is a multiple agonist under research by the holding subsidiary Zhejiang Doer Biologics Corporation that targets GLP-1R/GCGR/FGF21, which can be used for the treatment of diseases such as type 2 diabetes, obesity and NASH. The preparations of its phase I clinical trial overseas and pre-IND application in China in 2022 are underway. 2. Tumor HDM2002 (IMGN853), developed jointly by the Company and ImmunoGen of the United States, is the world’s first ADC drug for FR α-positive ovarian cancer. Its phase III multi-regional clinical trial has been initiated in China, and it is expected that clinical enrollment will be completed in 2022. The clinical enrollment of another key single-arm clinical trial of the drug has been completed in the United States and Europe in the second quarter, and preliminary test results are expected to be obtained by the end of 2021. Mefatinib for the treatment of advanced non-small cell lung cancer is under phase III clinical trial, and the enrollment of the subjects for the phase III clinical trial has been completed. It is expected to carry out application for marketing authorization after the completion of phase III clinical trial in 2022. DR30303 is a product under research of the holding subsidiary Zhejiang Doer Biologics Corporation for the treatment of gastric cancer and pancreatic cancer, and feedback has been received from CDE concerning its application for pre-IND. Its phase I clinical trial will be launched in China in 2022 after IND approval. 3. Autoimmunity The Company introduced HDM3002 (PRV-3279), a bispecific antibody under research of Provention Bio (USA) for the treatment of systemic lupus erythematosus (SLE) and for preventing or reducing the immunogenicity of gene therapy. At present, pre-IND materials have been submitted in China and feedback has been received. The phase II multi-regional clinical trial of this product will be initiated in China. HDM3001 (QX001S) is a biosimilar of the original drug ustekinumab (Stelara.) jointly developed by the Company and its partially-owned company Qyuns Therapeutics and used to treat moderate-to-severe psoriasis of adults. Its phase III clinical trial is underway. 4. Rare diseases Sirolimus Oral Solution produced by the Company has been used clinically to treat a rare pediatric disease tuberous sclerosis complex (TSC) for many years. In view of the urgent clinical needs of children with TSC for approved effective treatment, the Company has submitted a pre-IND application to CDE and plans to carry out a real-world study to support the expansion of the indications. 5. Medicine/medical device HD-NP-102 (MB102, dynamic TGFR monitoring system): A product jointly developed by the Company and Medibeacon, Inc. of the United States for the evaluation of the renal function of healthy people and patients through real-time percutaneous monitoring of glomerular filtration rate. With its accurate diagnosis and risk assessment of early renal injury, the product is of ground-breaking clinical significance. The Company has submitted an application for innovative medical devices to the Center for Medical Device Evaluation of National Medical Products Administration, and the phase III multi-regional clinical trial will be launched by the end of 2021. (III) Other important matters In August 2021, the natural person shareholders of the Company’s holding subsidiary Huadong Ningbo Medicine Co., Ltd. (hereinafter referred to as “Huadong Ningbo”) filed a lawsuit to the People’s Court of Beilun District of Ningbo for an order to dissolve Huadong Ningbo in advance on the grounds that there were serious difficulties in the operation and management of Huadong Ningbo and that the continuing operation of Huadong Ningbo would cause material losses to shareholders. The Company claimed that Huadong Ningbo should enter the legal liquidation after its operation expires on December 31, 2021, but did not agree to dissolve Huadong Ningbo in advance. The case was heard in People’s Court of Beilun District of Ningbo on September 22, 2021, and has not been sentenced yet. Afterward, the Company held meetings with natural person shareholders and management representatives of Huadong Ningbo on relevant matters. The two parties have reached a consensus that Huadong Ningbo has entered the liquidation preparation period, will mainly carry out capital withdrawal before the end of 2021, and will not conduct new business. The parties agree to speed up the preparations for the liquidation of Huadong Ningbo. To be responsible to all shareholders and safeguard the interests of all shareholders, the Company will properly carry out the subsequent liquidation of Huadong Ningbo according to law. IV. Quarterly financial statements (I) Financial Statements 1. Consolidated balance sheet Prepared by Huadong Medicine Co., Ltd. Unit: RMB yuan Item September 31, 2021 December 31, 2020 Current assets: Monetary funds 3,366,668,781.24 3,198,080,997.82 Settlement reserve Lending to other banks and other financial institutions Financial assets for trade Derivative financial assets Notes receivable Accounts receivable 8,147,812,875.63 6,137,675,568.82 Accounts receivable financing 572,080,968.64 828,659,217.25 Advance payments 291,583,511.06 250,916,482.07 Premiums receivable Reinsurance accounts receivable Reinsurance contract reserve receivable Other receivables 299,688,469.54 87,269,489.82 Including: Interests receivable 15,972,701.53 Dividends receivable 832,286.37 4,195,666.37 Financial assets purchased for resale Inventories 4,129,417,606.73 4,067,635,254.80 Contract assets Assets held for sale Non-current assets due within one year Other current assets 38,039,156.52 85,654,691.58 Total current assets 16,845,291,369.36 14,655,891,702.16 Non-current assets: Loans and prepayments issuance Debt investments Other debt investments Long-term receivables Long-term equity investments 950,889,474.55 850,072,053.02 Other equity instrument investments 129,841,291.42 225,453,120.05 Other non-current financial assets Real estate properties for investment 17,082,267.95 17,792,735.95 Fixed assets 3,106,575,021.33 2,420,366,582.92 Constructions in progress 1,864,058,365.39 2,240,201,926.65 Biological assets for production Oil & gas assets Right-of-use assets 161,568,723.35 Intangible assets 1,707,792,705.74 1,463,242,463.99 Development expenditures Goodwill 2,100,106,651.09 1,469,617,262.10 Long-term unamortized expenses 10,511,051.56 8,811,339.43 Deferred income tax assets 151,508,607.37 137,829,774.40 Other non-current assets 642,486,393.70 （未完）  |