無錫藥明康德新藥開發股份有限公司 無錫藥明康德新藥開發股份有限公司 WuXi AppTec Co., Ltd.* WuXi AppTec Co., Ltd.* 288 Fute Zhong Road Waigaoqiao Free Trade Zone (A joint stock company incorporated in the People’s Republic of China with limited liability) Shanghai 200131, China Stock Code：2359 Tel: +86 (21) 5046-1111 Fax: +86 (21) 5046-1000 http://www.wuxiapptec.com WuXi AppTec Co., Ltd. AppTec WuXi * 2018 2018 Annual Report 2018 Annual Report * For identification purposes only 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.2 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.2 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.1 Contents 2 Corporate Information 4 Chairman’s Statement 8 Financial Highlights 9 Financial Summary 10 Management Discussion and Analysis 47 Profiles of Directors, Supervisors and Senior Management 64 Corporate Governance Report 84 Directors’ Report 109 Independent Auditor’s Report 116 Consolidated Statement of Profit or Loss and Other Comprehensive Income 118 Consolidated Statement of Financial Position 120 Consolidated Statement of Changes in Equity 123 Consolidated Statement of Cash Flows 126 Notes to the Consolidated Financial Statements 272 Definitions 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.2 Corporate Information BOARD OF DIRECTORS REMUNERATION AND APPRAISAL Executive Directors COMMITTEE Dr. Ge Li (李革) (Chairman and Chief Ms. Yan Liu (劉艷) (Chairperson) Executive Officer) Dr. Hetong Lou (婁賀統) Mr. Edward Hu (胡正國) (Co-Chief Dr. Ning Zhao (趙寧) Executive Officer) Mr. Xiaozhong Liu (劉曉鐘) NOMINATION COMMITTEE Mr. Zhaohui Zhang (張朝暉) Dr. Jiangnan Cai (蔡江南) (Chairperson) Dr. Ning Zhao (趙寧) Ms. Yan Liu (劉艷) Dr. Ge Li (李革) Non-executive Directors Mr. Xiaomeng Tong (童小幪) AUDITOR Dr. Yibing Wu (吳亦兵) Deloitte Touche Tohmatsu Certified Public Accountants Independent Non-executive Directors 35/F, One Pacific Place Dr. Jiangnan Cai (蔡江南) 88 Queensway Ms. Yan Liu (劉艷) Hong Kong Mr. Dai Feng (馮岱) Dr. Hetong Lou (婁賀統) REGISTERED OFFICE IN THE PRC Mr. Xiaotong Zhang (張曉彤) Mashan No. 5 Bridge Binhu District JOINT COMPANY SECRETARIES Wuxi Mr. Chi Yao (姚馳) Jiangsu Province Ms. Yuen Wing Yan Winnie (袁 欣) PRC 頴 AUTHORISED REPRESENTATIVES HEADQUARTERS AND PRINCIPAL Mr. Edward Hu (胡正國) PLACE OF BUSINESS IN THE PRC Mr. Chi Yao (姚馳) 288 Fute Zhong Road Waigaoqiao Free Trade Zone STRATEGY COMMITTEE Shanghai Dr. Ge Li (李革) (Chairperson) PRC Mr. Edward Hu (胡正國) Mr. Xiaomeng Tong (童小幪) PRINCIPAL PLACE OF BUSINESS IN Dr. Yibing Wu (吳亦兵) HONG KONG Dr. Jiangnan Cai (蔡江南) Level 54, Hopewell Centre 183 Queen’s Road East AUDIT COMMITTEE Hong Kong Dr. Hetong Lou (婁賀統) (Chairperson) Mr. Xiaotong Zhang (張曉彤) Ms. Yan Liu (劉艷) 2 WuXi AppTec Co., Ltd. 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.2 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.3 Corporate Information PRINCIPAL BANKERS COMPLIANCE ADVISER HSBC Bank (China) Company Limited Somerley Capital Limited (Shanghai Branch) 20th Floor, China Building 26th Floor, HSBC Building 29 Queen’s Road Central Shanghai IFC Hong Kong 8 Century Avenue Pudong District HONG KONG LEGAL ADVISER Shanghai Wilson Sonsini Goodrich & Rosati PRC Suite 1509, 15/F, Jardine House 1 Connaught Place, Central Shanghai Pudong Development Bank Hong Kong (Baoshan Branch) No. 1283 Mudanjiang Road PRC LEGAL ADVISER Baoshan District Fangda Partners Shanghai 24/F, HKRI Centre Two PRC HKRI Taikoo Hui 288 Shi Men Yi Road Agricultural Bank of China Limited Shanghai (Caojing Branch) PRC No. 118 Zhifu Road Caojing Town A SHARE REGISTRAR AND TRANSFER Jinshan District OFFICE IN THE PRC Shanghai China Securities Depository & PRC Clearing Corporation Limited (CSDCC) Shanghai Branch China Merchants Bank (Waigaoqiao Branch) China Insurance Building No. 333 Fute West 1st Road 166 East Lujiazui Road Pudong District Pudong District, Shanghai Shanghai PRC PRC H SHARE REGISTRAR JPMorgan Chase Bank (China) Company Limited Tricor Investor Services Limited 41st Floor, Park Place Level 22, Hopewell Centre No. 1601 West Nanjing Road 183 Queen’s Road East Jing’an District Hong Kong Shanghai PRC STOCK CODE Citibank A Share: 603259 Citi Tower H Share: 02359 No. 33 Hua Yuan Shi Qiao Road Lu Jia Zui Finance and Trade Zone COMPANY’S WEBSITE Shanghai www.wuxiapptec.com.cn PRC Annual Report 2018 3 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.4 Chairman’s Statement Dear Shareholders, 2018 was an extraordinary year for the global healthcare industry as well as for our Company. Innovative drugs, including those of our customers, are achieving remarkable results. In addition, regulatory approval timelines have accelerated and the number of new drugs coming to market in the U.S. and in China has reached a record high. We continued to strengthen our capabilities and capacities and provide quality services to our customers in this exciting, rapidly-evolving environment. We were proud to see that 39 out of the 59 new drugs approved by the U.S. Food and Drug Administration (“FDA”) came from our customers in 2018. In the past year, we continued to invest in new technologies and expand our service offering across all segments. By leveraging the strengths of our “integrated end-to-end” research and development (“R&D”) services platform, we were able to create multiple synergies amongst our different businesses. In May 2018, we were successfully listed on the Shanghai Stock Exchange and, in December 2018, we were selected as a foundation stock for four separate indices: SSE 50 Index, SSE 180 Index, CSI 300 Index, and the CSI 100 Index. Also in December, we were successfully listed on the Main Board of the Hong Kong Stock Exchange and were accepted by the Shenzhen-Hong Kong Stock Connect and Shanghai-Hong Kong Stock Connect in January and February 2019, respectively. We are grateful to our investors who continue to believe in our vision. The capital you provide drives our growth, reinforcing the confidence you have in our management team and our business model. To name just a few of our key 2018 highlights: 4 WuXi AppTec Co., Ltd. 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.4 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.5 Chairman’s Statement WE GREATLY ENABLED OUR PARTNERS TO ACHIEVE PHARMACEUTICAL INNOVATION Since our establishment in 2000, WuXi AppTec has strived to achieve our vision that “every drug can be made and every disease can be treated.” This is our goal. We believe that with an idea, a piece of paper, a pen and a credit card, anyone can be empowered to do new drug R&D through the WuXi AppTec platform. We are delighted to see that our platform facilitated the development and launch of various drugs in 2018 for patients all over the world. Increasingly more partners have cooperated with us to improve the health and well-being of patients. • We acquired 1,400+ new customers, and our active customer count reached 3,500+ in 2018. All the top 20 global pharmaceutical companies are our customers. • For our success-based drug discovery services, we filed 27 new-chemical-entity Investigational New Drug (“IND”) for our customers with the National Medical Products Administration (“NMPA”) and obtained 17 clinical trial authorization (“CTA”). As of December 31, 2018, we have cumulatively submitted 55 new-chemical-entity IND filings with the NMPA for our customers and obtained 34 CTAs. • Our small molecule CDMO/CMO segment provided services to 650+ projects, including 40 in Phase III clinical trials and 16 that have been commercialized. • We became the first CMO services provider under China’s newly implemented Market Authorization Holder (“MAH”) policy and began commercial manufacturing services for two products, including: Ganovo®, developed by Ascletis Pharma for treatment of Hepatitis C and Elunate®, developed by Hutchison MediPharma for treatment of colorectal cancer. • In the highly-specialized field of cell and gene therapy, we provided CDMO services for 30 clinical stage cell and gene therapies projects; 25 in phase I and 5 in phase II/III. • Our fast growing clinical research services business helped one multinational company’s PD-1 antibody obtain market approval in China. We also helped a domestic company’s break-through drug obtain market approval for the treatment of colorectal cancer. In addition, we assisted in the BLA submission of the first CD20 biosimilar product in China. Annual Report 2018 5 668300 (WuXi APPTEC)_Eng (210x285) \ 19/04/2019 \ M11 \ p.6 Chairman’s Statement STRENGTHENED OUR CAPABILITIES AND CAPACITIES TO FACILITATE PHARMACEUTICAL R&D We continuously strengthen the capabilities and capacities of our platform to lower entry barriers for pharmaceutical R&D. We have established laboratories and manufacturing facilities worldwide, and made significant investment in big data, artificial intelligence (“AI”) and other advanced technologies to facilitate the success of our business partners. • We had 27 operation sites and branch offices globally with approximately 14,000 scientists and research technicians, enabling pharmaceutical innovation worldwide. • Our manufacturing facility in Changzhou successfully passed its first inspection by the U.S. FDA with no Form 483 issued, and our manufacturing facility in Jinshan has successfully passed its fourth inspection by the U.S. FDA with no Form 483 issued. • We initiated oligonucleotide and peptide API process development in 2018 and will build affiliated research manufacturing and commercial manufacturing capabilities in 2019. • In July 2018, we acquired an Austin, Texas-based clinical research CRO WuXi Clinical Development, Inc. (formerly doing business as ResearchPoint Global). This acquisition has allowed us to expand our global clinical trial service offering to both China-based companies and US-based companies for their global clinical requirements. • To support future growth, we are significantly expanding capacities including: chemistry laboratory expansion in our Tianjin site and new Qidong site; new cell and gene therapy GMP facilities in our Philadelphia site and Wuxi Jiangsu site; API GMP manufacturing facilities in our Changzhou site; a new medical device testing laboratory in Suzhou, and a new biology research laboratory in San Diego, U.S.