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1、The 2019 Annul Report of Huadong Medicine Co., Ltd. 1 Huadong Medicine Co., Ltd. The Annual Report 2019 April 2020 The 2019 Annul Report of Huadong Medicine Co., Ltd. 2 To the shareholders Dear Fellow Shareholders, 2019 was a year where the pharmaceutical industry in China underwent significant stru
2、ctural changes. It was also an incredibly important year for Huadong that we accelerated our transformation and took great strides toward a new era of growth. Look back on 2019, our employees had altogether accomplished outstanding results through commitment and relentless hard work. Overall, the co
3、mpany continued to deliver solid overall performance and business results. Our companys financial results again reached new high record, with consolidated net profit increased by 24.08% to RMB 2.813billion. Zhongmei Huadong achieved annual sales revenue of more than RMB 10 billion for the first time
4、, a historical milestone. Zhongmei Huadong invested RMB1.055 billion in research and development (R&D), a 49.14% increase compared to prior year. We successfully established Zhongmei Huadong - centered a global R&D strategic collaboration ecosystem and completed R&D project evaluation and approval s
5、ystem. We made significant breakthroughs in research and innovation, where we saw TTP273, the worlds first oral small molecular GLP-1 agonist drug receiving regulatory approval to commence Phase I clinical trial, and other key R&D projects, including Mafatinib and Liraglutide, entering Phase III cli
6、nical trials. We also entered into strategic collaborations with R2 and MediBeacon in the US and Kylane in Switzerland while obtained global commercialization rights to a number of innovative products, which enriched our product pipeline and drivers for future growth. In June 2019, we welcomed our n
7、ew board of directors and successfully completed the handover of the new and old management teams. We formulated a new growth strategy to focus on the pharmaceutical and healthcare sectors, led by the pharmaceutical industry division, while expanding in pharmaceutical distribution and aesthetics. We
8、 keep faith with our corporate philosophy of being “R&D based and patient centered” and we are dedicated to becoming a major global branded pharmaceutical company driven by research and innovation. The boom of generic drugs in China has come to an end, but the golden age of innovative drugs has alre
9、ady been emerging. Going forward, Huadong Medicine will stay primary focus on three core therapeutic areas of oncology, endocrinology and autoimmunology. We will focus on innovative products with The 2019 Annul Report of Huadong Medicine Co., Ltd. 3 meaningful clinical value and significant market p
10、otential. We will conduct a comprehensive review of our existing product portfolio to reduce the number of generic drugs with low barriers of entry and low commercial value. We will continue to solidify our leading position in diabetes and transplantation immunology in China, through establishing co
11、re competencies and strategies based on innovative drugs R&D and differentiated generic drugs with high technical barriers of entry, as well as targeting break-through sciences. We will continue to invest and expand our R&D capabilities. Our annual R&D expenditure will be at least equal up to 10% of
12、 Pharmaceutical Industry sales. Through both organic growth and in-organic transactions, establishing partnerships and collaborations horizontally and vertically across healthcare industries, we aim to rapidly expand and optimize our pipelines of innovative products in core areas of focus across var
13、ious stages of R&D. We will continuously improve our R&D capabilities and effectiveness to enable Huadong Medicine to be the leading pharmaceutical company with best-in-class R&D, strong scientific marketing promotion and state-of-the-art manufacturing capabilities. We endeavor to launch new product
14、s every year from 2022 onwards and by 2025 have sales contribution of innovative products to be 30% of total Pharmaceutical Industry sales and rising. 2020 is going to be a year of transformation for Huadong. We are prepared to embrace more intensive competitive environment and challenges. Any chall
15、enge would only ensure our continued success in the future. We are well positioned to rapidly respond and adapt to any emerging situation or issue as we make further advances in the transition period. We are committed to our transformation strategy to pursue innovation as high priority. We are posit
16、ioning for the longevity of the business and have great confidence that we could overcome any obstacle. We will make steady progress on course to innovation and transformation and target sustainable growth, cost saving and debt reduction, by optimizing organisational structure, attracting new talent
17、s and streamlining operating models. We will transform from being led to leading, from generic to innovation, from domestic to global and from success to excellence! We will fully leverage our great culture of exploration as well as capital and technology we have cumulated through the past years. We
18、 have embarked on a journey to innovation and transformation with a comprehensive plan and we are dedicated to make great progress towards achieving the goal by overcoming any challenge. We envisage by 2025 Huadong Medicine will be successfully transformed from a traditional generic drug manufacture
19、r to a leading innovative pharmaceutical company. We also envisage that going forward Huadong Medicine will become a leading global pharmaceutical company. The 2019 Annul Report of Huadong Medicine Co., Ltd. 4 This year is our 20th anniversary of our initial public offering. We sincerely thank all o
20、ur shareholders for your support in Huadong Medicine for the past 20 years. We are not afraid of change and committed to stay on course and work even more diligently to deliver best results. We will stay true to our purpose and core values and will continue to create long term and sustainable meanin
21、gful value for our shareholders! Lyu Liang, Chairman On behalf of Huadong Medicine April 2020 The 2019 Annul Report of Huadong Medicine Co., Ltd. 5 Section I. Important Declaration, Contents and Definitions The Board of Directors, Board of Supervisors, directors, supervisors and senior management of
22、 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
23、liabilities. Lyu Liang, the Companys 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
24、 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. Therefore, investors are kindly reminded to pa
25、y attention to possible investment risks. The profit distribution plan reviewed and adopted by this Board of Directors meeting is as follows: on the basis of 1,749,809,548 shares, a cash dividend of 2.8 yuan (tax included) is to be distributed to all shareholders for The 2019 Annul Report of Huadong
26、 Medicine Co., Ltd. 6 every 10 shares; no bonus share 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 or other language version of public notice, they shou
27、ld ensure the content of both versions are the same. In the case of discrepancy, the original version in Chinese shall prevail. The 2019 Annul Report of Huadong Medicine Co., Ltd. 7 Contents To the shareholders . 2 Section I. Important Declaration, Contents and Definitions . 5 Section II. Company Pr
28、ofile and Key Financial Indicators . 9 Section III. Overview of the Companys Business . 14 Section IV. Discussion and Analysis of Operations . 20 Section V. Important Matters . 66 Section VI. Share Change and Shareholders . 104 Section VII. Preferred Shares . 113 Section VIII. Convertible Corporate
29、Bonds . 114 Section IX. Directors, Supervisors, Senior Managers and Employees . 115 Section X. Corporate Governance . 126 Section XI. Information about Corporate Bonds. 132 Section XII. Financial Report . 136 The 2019 Annul Report of Huadong Medicine Co., Ltd. 8 Definitions Term refers to Definition
30、 Huadong Medicine/the Company/our Company refers to Huadong Medicine Co., Ltd. CGE refers to China Grand Enterprises, Inc. Huadong Medicine Group refers to Hangzhou Huadong Medicine Group Co., Ltd. Zhongmei Huadong refers to Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Xian Bohua refers to Hua
31、dong Medicine (Xian) Bohua Pharmaceutical Co., Ltd. Jiangdong Company refers to Hangzhou Zhongmei Huadong Pharmaceutical Jiangdong Co., Ltd. Huadong Ningbo Company refers to Huadong Ningbo Medicine Co., Ltd. Sinclair refers to Sinclair Pharma Limited Chongqing Peg-Bio refers to Chongqing Peg-Bio Bio
32、pharm Co., Ltd. CSRC refers to China Securities Regulatory Commission RAPT refers to RAPT Therapeutics, Inc. SSE refers to Shenzhen Stock Exchange GMP refers to Good Manufacturing Practice GSP refers to Good Supply Practice BE refers to Bioequivalence CDE refers to Center for Drug Evaluation (of Nat
33、ional Medical Products Administration) MAH refers to Marketing Authorization Holder FDA refers to (U.S.) Food and Drug Administration ANDA refers to (U.S.) Abbreviated New Drug Application ICH refers to International Council for Harmonisation (of Technical Requirements for Pharmaceuticals for Human
34、Use) IND refers to Investigational New Drug PK/PD refers to pharmacokinetics/pharmacodynamics CMC refers to Chemistry, Manufacturing and Control PMA refers to Premarket Application QA refers to Quality Assurance (department) prescription drugs refers to Drugs that can only be purchased and used acco
35、rding to prescriptions issued by physicians The 2019 Annul Report of Huadong Medicine Co., Ltd. 9 Section II. Company Profile and Key Financial Indicators I. Company information Stock name (abbreviation) Huadong Medicine Stock code 000963 Stock listed on Shenzhen Stock Exchange Company name in Chine
36、se 华东医药股份有限公司 Company name in Chinese (abbreviation) 华东医药 Company name in English (if any) Huadong Medicine Co., Ltd. Company name in English (abbreviation, if any) Huadong Medicine Legal representative Lyu Liang Registered address Floor 7, 9 and 10, Gate No. 1, Building No. 1, 468 Yanan Road, Hangz
37、hou Zip code of the registered address 310006 Office address 866 Moganshan Road, Hangzhou Zip code of the office address 310011 Official website Email address II. Contact persons and contact information Secretary of the Board of Directors Securities affairs representative Name Chen Bo Xie Lihong Con
38、tact address 866 Moganshan Road, Hangzhou 866 Moganshan Road, Hangzhou Tel. 0571-89903300 0571-89903300 Fax 0571-89903300 0571-89903300 Email address III. Channels of disclosure and location of preparation Media selected by the Company for information disclosure China Securities Journal, Securities
39、Times, and Shanghai Securities News Website designated by CSRC for publication of the http:/ The 2019 Annul Report of Huadong Medicine Co., Ltd. 10 annual report Location of preparation of the Companys annual report Office of the Companys Board of Directors IV. Registration changes Organization code
40、 91330000143083157E Changes of the Companys main business since its listing (if any) None Previous changes of controlling shareholder (if any) None V. Other relevant information The accounting firm hired by the Company Name of the accounting firm Pan-China Certified Public Accountants (special gener
41、al partnership) Office address of the accounting firm Floor 15, Block B, China Resources Building, 1366 Qianjiang Road, Jianggan District, Hangzhou, Zhejiang Province Certified public accountants (signatories) Wang Fukang, Xu Ping Sponsor(s) hired by the Company to fulfil the duty of continuous supe
42、rvision during the reporting period Applicable N/A Financial consultant(s) hired by the Company to fulfil the duty of continuous supervision during the reporting period Applicable N/A VI. Key accounting data and financial indicators Whether the Company needs to perform a retroactive adjustment or re
43、statement of previous accounting data Yes No Reason(s) for retroactive adjustment or restatement Other reason(s) 2019 2018 Percentage increase/decrease from last year to this year 2017 Before adjustment After adjustment After adjustment Before adjustment After adjustment Operating revenue (yuan) 35,
44、445,698,216.15 30,663,374,326.27 30,663,374,326.27 15.60% 27,831,823,148.07 27,831,823,148.07 Net profit attributable to 2,813,118,702. 2,267,229,174. 2,267,229,174.24.08% 1,779,506,061. 1,779,506,061.The 2019 Annul Report of Huadong Medicine Co., Ltd. 11 shareholders of listed companies (yuan) 11 0
45、8 08 59 59 Net profit attributable to shareholders of listed companies after deducting non-recurring gains/losses (yuan) 2,574,437,417.52 2,236,323,500.44 2,236,323,500.44 15.12% 1,740,064,200.10 1,740,064,200.10 Net cash flow from operating activities (yuan) 2,001,698,170.67 2,039,496,083.26 2,039,
46、496,083.26 -1.85% 1,661,118,663.70 1,661,118,663.70 Basic earnings per share (yuan/share) 1.61 1.55 1.29 (Note) 24.08% 1.83 1.02 (Note) Diluted earnings per share (yuan/share) 1.61 1.55 1.29 (Note) 24.08% 1.83 1.02 (Note) Weighted average return on equity (ROE) 25.29% 24.87% 24.87% 0.42% 23.02% 23.0
47、2% End of 2019 End of 2018 Percentage increase/decrease from the end of last year to the end of this year End of 2017 Before adjustment After adjustment After adjustment Before adjustment After adjustment Total assets (yuan) 21,463,974,146.63 19,217,357,282.33 19,217,357,282.33 11.69% 15,987,106,537
48、.46 15,987,106,537.46 Net assets attributable to shareholders of listed companies (yuan) 12,309,477,308.00 9,938,148,996.53 9,938,148,996.53 23.86% 8,393,269,796.56 8,393,269,796.56 Note: During the reporting period, the Company implemented Profit Distribution Plan 2018 in June 2019. On the basis of
49、 1,458,174,624 shares of the Companys capital stock, a cash dividend of 3.3 yuan (tax included) was distributed for every 10 shares, and the capital reserve was converted to increase 2 shares for every 10 shares. Data on earnings per share for 2017 and 2018 were adjusted on the basis of the latest c
50、apital stock according to relevant accounting standards. Capital stock of the Company as of the trading day before disclosure Capital stock 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 capital stoc