Company Overview - The company is a leading biopharmaceutical firm in China, with core products including TPIAO, EPIAO, and CYB003, all of which are market leaders in their respective categories[7]. - The biopharmaceutical industry in China is recognized as a strategic emerging industry, supported by government initiatives[7]. - The company employs over 5,400 staff across its operational facilities in Shenyang, Shanghai, Hangzhou, Shenzhen, and Como, Italy[8]. Product Development and Market Position - The company has 32 products in development, with 22 classified as national new drug development projects in China[7]. - The company has a strong focus on research and development, with 23 of the 32 products in development being biologics[7]. - The company has maintained a leading position in the rhEPO market in China, holding a 41.2% market share as of the first half of 2020[7]. - The sales of Tevizo (特比澳) have shown exceptional growth, with a market share of 25.5% by volume and 72.8% by revenue in the treatment of thrombocytopenia in mainland China as of the first half of 2020[23]. - The sales of Enbrel (益賽普) accounted for a dominant market share of 54.5% in the TNFα market in mainland China during the first half of 2020, covering over 3,000 hospitals[24][25]. - Erythropoietin (益比奧) has maintained a dominant position in the rhEPO market in mainland China since 2002, with a unique dosage of 36,000 IU per vial[25]. Financial Performance - Revenue increased by RMB 52.2 million or 2.0% to RMB 2,695.2 million compared to the six months ended June 30, 2019[13]. - Gross profit rose by RMB 32.6 million or 1.5% to RMB 2,217.1 million, with a gross margin decrease from 82.7% to 82.3%[13]. - Net profit attributable to equity holders increased by RMB 381.2 million or 118.6% to RMB 702.5 million, while normalized net profit decreased by RMB 2.9 million or 0.4% to RMB 749.0 million[13]. - EBITDA increased by RMB 415.2 million or 70.7% to RMB 1,002.9 million, with normalized EBITDA rising by RMB 31.2 million or 3.1% to RMB 1,049.4 million[13]. - The company's gross profit increased to approximately RMB 2,217.1 million, up by about RMB 32.6 million or approximately 1.5%, with a gross profit margin of approximately 82.3%[47]. Strategic Initiatives - The company aims to expand its product marketing to developed countries and has received approvals for TPIAO in eight countries, EPIAO in 15 countries, and EPIAO in 22 countries[7]. - The company is actively pursuing strategic collaborations for the development and marketing of its pipeline products[7]. - Strategic collaborations with companies like AstraZeneca and Eli Lilly are aimed at expanding the product portfolio and enhancing market potential[40]. Clinical Trials and Approvals - The company has initiated a Phase III clinical trial for Tevizo in pediatric ITP, and a Phase I trial for patients with liver dysfunction at risk of thrombocytopenia has been completed[23]. - The company has completed Phase III trials for the pre-filled Enbrel syringe and has applied for production approval, which has been accepted by the National Medical Products Administration[25]. - The IND application for the biosimilar Bevacizumab SB8 was accepted by the National Medical Products Administration[21]. - The group has received IND approval for a clinical trial of an anti-IL-5 antibody (code: 610) for treating patients with severe eosinophilic asthma, with patient recruitment already underway[32]. Shareholder Information - The total number of shares issued by the company was 2,538,526,132[73]. - Dr. Liu Jing holds a total of 527,220,563 shares, representing approximately 20.77% of the total issued shares[72]. - The company’s major shareholders, as recorded, hold interests in the company’s shares as of June 30, 2020[76]. - The company’s stock options are subject to vesting conditions as per the trust agreement established for The Empire Trust[70]. Cash Flow and Liquidity - Cash inflow from operating activities for the six months ended June 30, 2020, was approximately RMB 708.2 million, with cash and bank balances at approximately RMB 3,793.1 million[58]. - The company reported a significant increase in other comprehensive income, totaling RMB 255,608 thousand compared to a loss of RMB 18,216 thousand in 2019[93]. - The company’s net current assets increased to RMB 5,220,407 thousand from RMB 2,984,452 thousand, indicating improved short-term financial health[96]. Capital Expenditure and Investments - The group estimates total capital expenditure of between RMB 2,000 million and RMB 2,500 million over the next three years, primarily for capacity expansion and maintenance of existing facilities[62]. - The company has no significant investments as of June 30, 2020[62]. Regulatory Compliance and Governance - The audit committee reviewed the unaudited interim financial information for the six months ended June 30, 2020, and found the internal control and risk management systems to be effective and adequate[67]. - The independent review report concluded that no significant issues were found regarding the interim financial data's compliance with International Accounting Standard 34[90].

(Incorporated in the Cayman Islands with limited liability) Stock Code: 1530 Convertible Bonds Code: 5241 2019 ANNUAL REPORT ANNUAL REPORT 2019 年度報告 (於開曼群島註冊成立的有限公司) 股份代號：1530 可換股債券代號：5241 2019 年 度報告 恪守承諾，傳遞希望 Keep Commitment, and Deliver Hope. MDX Puper Posts responsible Borowe FBC" C020667 liza 目錄 | --- | --- | |-------------------------------|-------| | | | | 公司概況 | 2 | | 公司資料 | 3 | | 財務摘要 | 5 | | 主席報告 | 6 | | 管理層討論及分析 | 8 | | 董事及高級管理層 | 31 | | 董事會報告 | 38 | | 企業管治報告 | 58 | | 獨立核數師報告 | 75 | | 綜合財務報表 | | | ...

Market Position and Product Development - The company holds a dominant market share of 72.5% in the platelet reduction treatment market in mainland China for its product Tevazo[6]. - The company has a market share of 61.9% for its anti-tumor necrosis factor α product, Yisaipu, in mainland China[6]. - The company has maintained a dominant position in the rhEPO market for nearly 20 years, with a market share of 41.3%[6]. - The company is actively developing 32 products, with 22 classified as new drugs in mainland China[6]. - The company has 11 oncology products in development and 12 targeting autoimmune diseases, including rheumatoid arthritis[6]. - The company aims to market its products in developed countries and has received approvals for Tevazo in seven countries, Yisaipu in 14 countries, and Yibiao in 22 countries[6]. - The company has 32 products in active development, with 22 classified as new drugs in China[29]. - The company is developing innovative biopharmaceutical products, including 302H for metastatic breast cancer and 304R for non-Hodgkin lymphoma, among others[33]. Financial Performance - Revenue rose by approximately RMB 469.0 million or about 21.6% to approximately RMB 2,642.9 million[12]. - Gross profit increased by approximately RMB 437.9 million or about 25.1% to approximately RMB 2,184.5 million, with gross margin rising from 80.3% to 82.7%[12]. - Normalized net profit attributable to the parent company increased by approximately RMB 191.1 million or about 34.1% to approximately RMB 751.9 million, while net profit attributable to the parent company decreased by approximately RMB 192.9 million or about 37.5% to approximately RMB 321.3 million[12]. - EBITDA for the period was approximately RMB 587.7 million, a decrease of about RMB 204.2 million or 25.8% from RMB 791.8 million in 2018, while normalized EBITDA increased to RMB 1,018.3 million, up 21.4%[55]. - The company reported a profit of RMB 514,197 thousand for the six months ended June 30, 2019, compared to RMB 509,985 thousand for the same period in 2018, indicating a year-over-year growth of approximately 0.4%[112]. Research and Development - The company focuses on research and development to provide innovative therapies for patients in mainland China and globally[6]. - The company has a comprehensive R&D platform that includes expertise in antibody discovery, molecular cloning, and clinical trial management[32]. - Research and development costs increased to RMB 263,891,000, up 48.2% from RMB 178,005,000 in the previous year[146]. Sales and Distribution - The company has established a national distribution network selling products to over 15,000 hospitals and medical institutions in mainland China[7]. - The company’s sales team covers over 2,000 tertiary hospitals and more than 14,000 secondary or lower-level hospitals across all provinces in mainland China as of June 30, 2019[38]. - The company has a sales and distribution network comprising approximately 3,375 marketing personnel, 506 distributors, and 1,937 third-party promoters as of June 30, 2019[38]. Collaborations and Partnerships - The company entered into a collaboration agreement with Samsung Bioepis to develop and commercialize multiple biosimilar products in mainland China, including SB8, a biosimilar of Bevacizumab[16]. - A collaboration agreement was established with Verseau Therapeutics to develop innovative monoclonal antibodies for cancer treatment, with the company investing USD 15 million in Series B preferred shares[17]. Employee and Operational Insights - The company employs over 5,000 staff across its operational facilities in Shenyang, Shanghai, Hangzhou, Shenzhen, and Como, Italy[7]. - Employee costs for the six months ended June 30, 2019, were approximately RMB 896.0 million, compared to RMB 474.1 million for the same period in 2018, with a total of 5,246 employees as of June 30, 2019[65]. Financial Position and Capital Management - As of June 30, 2019, the group's cash and cash equivalents were approximately RMB 1,394.9 million, with net cash inflow from operating activities of approximately RMB 699.6 million[59]. - The estimated total capital expenditure for the next three years is expected to be between RMB 1,200 million and RMB 1,400 million, mainly for maintaining existing facilities and expanding capacity[64]. - The group’s total capital commitments included RMB 267,553,000 for property, plant, and equipment, and RMB 721,667,000 for contributions to funds[187]. Shareholder Information - As of June 30, 2019, the total number of issued shares was 2,534,992,051[87]. - Executive director Lou Jing holds a total of 647,973,040 shares, representing 25.56% of the total issued shares[79]. - The company has authorized the issuance of up to 242,439,857 ordinary shares under the stock option plan, representing approximately 9.56% of the issued shares as of June 30, 2019[74]. Regulatory and Compliance - The company received clinical trial approval from the U.S. FDA for a PD1 antibody (609A) for cancer patients, with patient recruitment currently underway[16]. - The company submitted a new drug production application for a pre-filled syringe product, which is the first of its kind developed independently in mainland China, expected to improve patient compliance[20].

[Company Overview](index=4&type=section&id=Company%20Overview) 3S Bio is a leading Chinese biopharmaceutical company focused on biotech product R&D, manufacturing, and marketing, with market-leading core products and a robust pipeline 2018 Core Product Market Share | Product | Therapeutic Area | 2018 China Market Share (%) | | :--- | :--- | :--- | | TPIAO | Thrombocytopenia | 65.3% | | Yisaipu | TNF-α Inhibitor | 64.0% | | rhEPO products (Epiao/Saibao) | Erythropoietin | 41.0% | - The company boasts a strong R&D pipeline, with **32 pipeline products** as of December 31, 2018, including **22 National Class 1 new drugs** and **22 biologics**[5](index=5&type=chunk) - The company maintains an extensive sales network, distributing products to approximately **17,000 hospitals and medical institutions** nationwide and employing over **5,000 staff** as of late 2018[6](index=6&type=chunk) [Company Information](index=5&type=section&id=Company%20Information) This section provides essential company details, including registration information, board and committee members, principal place of business, share registrar, auditor, and legal advisors - The company's Board of Directors comprises executive, non-executive, and independent non-executive directors, with an Audit Committee, Remuneration Committee, and Nomination Committee established under it[8](index=8&type=chunk) - Ernst & Young is the company's auditor[9](index=9&type=chunk) [Financial Highlights](index=7&type=section&id=Financial%20Highlights) This section summarizes the company's key financial data from 2014 to 2018, demonstrating continuous growth in revenue, gross profit, EBITDA, net profit, and asset size Five-Year Financial Highlights (RMB thousands) | Metric | 2014 | 2015 | 2016 | 2017 | 2018 | | :--- | :--- | :--- | :--- | :--- | :--- | | Revenue | 1,130,854 | 1,673,126 | 2,797,289 | 3,734,334 | 4,583,869 | | Gross Profit | 1,043,373 | 1,431,215 | 2,395,021 | 3,058,099 | 3,706,614 | | EBITDA | 399,528 | 660,705 | 1,144,383 | 1,476,817 | 1,892,824 | | Net Profit | 291,728 | 526,230 | 714,254 | 924,404 | 1,277,246 | | Profit Attributable to Owners of the Parent | 291,728 | 526,280 | 712,564 | 935,389 | 1,277,167 | | Total Assets | 2,306,441 | 6,630,432 | 11,038,802 | 13,752,971 | 13,839,655 | | Total Equity | 943,592 | 5,635,465 | 6,766,342 | 7,629,646 | 8,907,370 | [Chairman's Report](index=8&type=section&id=Chairman's%20Report) Chairman and CEO Dr. Lou Jing highlights strong 2018 growth, significant R&D progress, and strategic international partnerships that enrich the product portfolio and support global expansion - In 2018, total sales of the company's core commercial products, TPIAO, Yisaipu, Epiao, and Saibao, increased by approximately **22.7%**, with TPIAO sales growing over **71%**[12](index=12&type=chunk) - Significant R&D advancements include 302H (Septrin) receiving priority review for its new drug application, Yisaipu pre-filled syringe completing Phase III trials, long-acting rhEPO product NuPIAO obtaining Phase II/III clinical approvals, and anti-PD1 antibody 609A receiving US FDA IND approval[12](index=12&type=chunk) - The company actively pursued international collaborations with Toray, Refuge, Samsung Bioepis, Verseau, and TLC, enriching its commercial and pipeline product portfolios[13](index=13&type=chunk) [Management Discussion and Analysis](index=9&type=section&id=Management%20Discussion%20and%20Analysis) [Business Review](index=9&type=section&id=Business%20Review) This section reviews significant business developments in 2018, including new product launches, R&D milestones, strategic collaborations, and industry recognition, while outlining future prospects amidst healthcare reform [Significant Events and Post-Reporting Period Events](index=9&type=section&id=Significant%20Events%20and%20Post-Reporting%20Period%20Events) In 2018 and post-reporting period, the company achieved multiple key milestones, including new product approvals, strategic partnerships, and significant R&D advancements - In January 2018, Bydureon, China's first weekly GLP-1 receptor agonist, received NMPA approval and launched in May[14](index=14&type=chunk) - The company established strategic collaborations with several international companies, including Toray for anti-pruritic drug TRK-820, Refuge for cell therapy, Samsung Bioepis for biosimilars (e.g., SB8 bevacizumab), Verseau for immuno-oncology antibodies, and TLC for liposomal products[14](index=14&type=chunk)[15](index=15&type=chunk)[17](index=17&type=chunk)[18](index=18&type=chunk) - Key R&D pipeline progress includes clinical trial approvals for TPIAO pediatric ITP indication, NuPIAO (long-acting EPO), and new indications for anti-VEGF antibody (601A)[15](index=15&type=chunk) - Post-reporting period, anti-PD1 antibody 609A received US FDA IND approval, demonstrating the company's global R&D capabilities[17](index=17&type=chunk) [Key Products](index=13&type=section&id=Key%20Products) This section details the market performance and growth drivers of the company's four core products and key licensed-in products, highlighting their market leadership and future growth potential - TPIAO (rhTPO), the world's only commercialized recombinant human thrombopoietin, experienced rapid sales growth after its inclusion in the 2017 National Medical Insurance Catalog, with estimated penetration rates of **20% to 24%** in China for CIT and ITP indications, indicating significant growth potential[19](index=19&type=chunk) - Yisaipu (Etanercept) maintains a dominant position in the Chinese market with a **64.0% market share**, and its pre-filled syringe formulation, having completed Phase III trials, is expected to be submitted for production approval in the first half of 2019, enhancing patient convenience[20](index=20&type=chunk)[21](index=21&type=chunk) - Epiao and Saibao (rhEPO) product portfolio continues to lead the Chinese market, with future growth driven by increased dialysis penetration and expanded applications in CIA and perioperative surgery[22](index=22&type=chunk) - The diabetes product line has been strengthened by the introduction of GLP-1 receptor agonist Byetta and the long-acting weekly formulation Bydureon, offering more treatment options for Type 2 diabetes patients[23](index=23&type=chunk) [Pipeline Products and R&D Platform](index=15&type=section&id=Pipeline%20Products%20and%20R%26D%20Platform) The company operates a comprehensive R&D platform from drug discovery to clinical trials and registration, with 32 pipeline products as of late 2018, including 22 National Class 1 new drugs, covering oncology, autoimmune, and nephrology Pipeline Products Overview (As of Dec 31, 2018) | Therapeutic Area | Number of Pipeline Products | | :--- | :--- | | Oncology | 11 | | Autoimmune and Others | 12 | | Nephrology | 6 | | Metabolic | 2 | | Dermatology | 1 | | **Total** | **32** | - The company's R&D platform boasts strong comprehensive capabilities, covering the entire process from antibody discovery to clinical trials and registration, supported by an R&D team of over **330 scientists**[27](index=27&type=chunk)[31](index=31&type=chunk) - Key pipeline product progress: - **302H (Septrin)**: New drug application for HER2-positive metastatic breast cancer received priority review from the NMPA - **NuPIAO (SSS06)**: Second-generation long-acting rhEPO, obtained Phase II/III clinical trial approvals - **602 (Anti-EGFR Antibody)**: Completed Phase I trials, with plans for late-stage clinical trials in colorectal cancer - **601A (Anti-VEGF Antibody)**: New clinical approvals for three ophthalmic indications, with patient enrollment ongoing for neovascular AMD trials[28](index=28&type=chunk)[31](index=31&type=chunk) [Sales, Marketing, Distribution, and Outlook](index=18&type=section&id=Sales,%20Marketing,%20Distribution,%20and%20Outlook) The company possesses an extensive sales network covering over 16,000 hospitals nationwide, and anticipates benefiting from healthcare reforms by enhancing market penetration, advancing R&D, and pursuing strategic collaborations for long-term growth - As of late 2018, the sales network covered over **2,000 tertiary hospitals** and more than **14,000 secondary or lower-tier hospitals and medical institutions**[32](index=32&type=chunk) - The company anticipates benefiting from medical reform policies supporting innovative drugs and plans to sustain long-term growth by enhancing product penetration, advancing R&D, leveraging its approximately **38,000-liter antibody production capacity**, and seeking strategic collaborations[33](index=33&type=chunk)[34](index=34&type=chunk) [Financial Review](index=20&type=section&id=Financial%20Review) In fiscal year 2018, the company demonstrated strong financial performance with total revenue increasing by 22.7% to RMB 4.58 billion, driven by core product sales, particularly TPIAO, leading to a 36.5% rise in profit attributable to owners of the parent and improved financial stability [Revenue, Cost, and Gross Profit](index=20&type=section&id=Revenue,%20Cost,%20and%20Gross%20Profit) In 2018, the company's total revenue reached RMB 4.584 billion, a 22.7% year-over-year increase, primarily driven by strong sales of core products, resulting in a gross profit of RMB 3.707 billion with an 80.9% gross margin 2018 Key Product Sales and Growth (RMB millions) | Product | 2018 Sales (RMB millions) | Year-over-Year Growth Rate (%) | | :--- | :--- | :--- | | TPIAO | 1,669.5 | 71.3% | | Yisaipu | 1,111.4 | 9.7% | | Epiao and Saibao | 896.6 | 4.8% | | **Total Revenue** | **4,583.9** | **22.7%** | - Gross margin slightly decreased from **81.9%** in 2017 to **80.9%**, primarily due to the consolidation of lower-margin Humulin promotion service revenue[39](index=39&type=chunk) [Operating Expenses and Profitability](index=22&type=section&id=Operating%20Expenses%20and%20Profitability) In 2018, the company's sales and distribution expenses increased by 26.9% to RMB 1.691 billion, while administrative expenses remained stable, and R&D expenses significantly rose, contributing to a 36.5% increase in profit attributable to owners of the parent - R&D expenses significantly increased by approximately **41%**, from **RMB 257 million** in 2017 to **RMB 363 million** in 2018[43](index=43&type=chunk) 2018 Profitability Metrics (RMB millions) | Metric | 2018 | 2017 | Year-over-Year Growth (%) | | :--- | :--- | :--- | :--- | | EBITDA | 1,892.8 | 1,476.8 | 28.2% | | Normalized EBITDA | 1,781.8 | 1,445.5 | 23.3% | | Profit Attributable to Owners of the Parent | 1,277.2 | 935.4 | 36.5% | | Normalized Net Profit | 1,166.1 | 904.0 | 29.0% | [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintained strong liquidity with RMB 1.15 billion in net cash generated from operating activities in 2018, significantly reducing its leverage ratio to 11.2% through loan repayments, and anticipates RMB 1.2-1.4 billion in capital expenditures over the next three years for capacity expansion - Net cash inflow from operating activities was approximately **RMB 1.15 billion**[49](index=49&type=chunk) - The leverage ratio (total borrowings/total equity, excluding convertible bonds) significantly decreased from **28.0%** at the end of 2017 to **11.2%** at the end of 2018, primarily due to loan repayments[51](index=51&type=chunk) - Capital expenditures are projected to be between **RMB 1.2 billion and RMB 1.4 billion** over the next three years, primarily for maintaining existing facilities and expanding production capacity[53](index=53&type=chunk) [Key Risks and Uncertainties](index=26&type=section&id=Key%20Risks%20and%20Uncertainties) The company faces significant risks from intense market competition, potential exclusion from national/provincial medical insurance catalogs, unsuccessful provincial tenders, improper promotional activities, R&D failures, and unfulfilled M&A/collaboration benefits, all of which could adversely impact sales, profitability, and business prospects - The company faces intense competition from domestic and international pharmaceutical companies, some of which may possess greater resources[55](index=55&type=chunk) - The company's sales and profitability are highly dependent on its core products being included and retained in national and provincial medical insurance catalogs[56](index=56&type=chunk) - New drug development is characterized by long cycles, high costs, and low success rates, with R&D failures potentially adversely affecting the company's long-term competitiveness[58](index=58&type=chunk) [Directors and Senior Management](index=30&type=section&id=Directors%20and%20Senior%20Management) This section provides detailed backgrounds and résumés of the company's Board of Directors and senior management team, highlighting their extensive expertise in pharmaceuticals, finance, and law, and their leadership in drug development and operations - The executive director team is led by Dr. Lou Jing (Chairman and CEO), a co-founder of the company, and includes Mr. Tan Bo (CFO), Ms. Su Dongmei, and Mr. Huang Bin, all playing pivotal roles in the company's development[61](index=61&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk) - The senior management team includes Dr. Zhu Zhenping, President of Drug R&D and Chief Scientific Officer, who has led the discovery and early development of multiple successfully launched anti-tumor antibodies[72](index=72&type=chunk) [Board Report](index=38&type=section&id=Board%20Report) This report presents the Board's formal statement on the company's business and financial position for the year ended December 31, 2018, covering statutory disclosures such as principal business, performance, dividend policy, key customers and suppliers, share capital changes, equity-linked agreements, share repurchases, convertible bond issuance, and connected transactions - The Board does not recommend the payment of a final dividend for the year ended December 31, 2018[79](index=79&type=chunk) - As of the end of 2018, sales to the top five customers accounted for **18.1%** of total revenue, with the largest single customer accounting for **5.7%**; the top five suppliers accounted for **38.7%** of total purchases[82](index=82&type=chunk) - During the reporting period, the company repurchased a total of **4,730,000 shares** on the Stock Exchange for a total consideration of approximately **HKD 46.27 million**, reflecting management's confidence in the business outlook[118](index=118&type=chunk)[119](index=119&type=chunk) - The **EUR 300 million zero-coupon convertible bonds** issued by the company in 2017 remain outstanding, with net proceeds partially used for loan repayment, M&A, and R&D; approximately **RMB 1.183 billion** of the bond proceeds remained unutilized as of the end of 2018[121](index=121&type=chunk)[122](index=122&type=chunk) [Corporate Governance Report](index=57&type=section&id=Corporate%20Governance%20Report) This report details the company's corporate governance practices and compliance with the Corporate Governance Code for 2018, outlining the Board's structure, responsibilities, and operations, including the roles of Chairman and CEO, director appointments and training, and the functions of the Audit, Nomination, and Remuneration Committees - The company's Chairman, Dr. Lou Jing, also serves as Chief Executive Officer, an arrangement the Board believes ensures consistent leadership direction and is subject to periodic review[159](index=159&type=chunk) - The Board has established an Audit Committee, Nomination Committee, and Remuneration Committee, all chaired by or predominantly composed of independent non-executive directors to ensure independence and professionalism[171](index=171&type=chunk)[175](index=175&type=chunk)[178](index=178&type=chunk) 2018 Board and Annual General Meeting Attendance | Director | Board Meetings Attended / Eligible | Annual General Meeting Attended | | :--- | :--- | :--- | | **Executive Directors** | | | | Dr. Lou Jing | 4/4 | 1/1 | | Mr. Tan Bo | 4/4 | 0/1 | | Ms. Su Dongmei | 4/4 | 1/1 | | Mr. Huang Bin | 4/4 | 1/1 | | **Non-Executive Directors** | | | | Mr. Liu Dong | 4/4 | 0/1 | | Mr. Wang Dasong | 4/4 | 0/1 | | **Independent Non-Executive Directors** | | | | Mr. Pu Tianruo | 4/4 | 1/1 | | Mr. David Ross PARKINSON | 4/4 | 1/1 | | Mr. Ma Jun | 4/4 | 1/1 | - The Board confirms its responsibility for the company's risk management and internal control systems, having reviewed their effectiveness for 2018 and deeming them effective and adequate[185](index=185&type=chunk)[186](index=186&type=chunk) [Independent Auditor's Report](index=73&type=section&id=Independent%20Auditor's%20Report) Ernst & Young, as the company's independent auditor, issued an unqualified opinion on the consolidated financial statements for the year ended December 31, 2018, affirming their fair presentation and compliance with IFRS and Hong Kong Companies Ordinance, while highlighting key audit matters related to impairment of indefinite-lived intangible assets and goodwill - The auditor issued an unqualified audit opinion on the company's consolidated financial statements for the year 2018[199](index=199&type=chunk) - Key audit matters include: 1. **Impairment of other intangible assets with indefinite useful lives**: Involves significant judgments and estimates regarding growth rates, royalty rates, and discount rates 2. **Goodwill impairment**: Involves assessing complex assumptions related to future cash flow forecasts, profit margins, and discount rates for cash-generating units[201](index=201&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk) [Consolidated Financial Statements](index=81&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Statement of Profit or Loss](index=81&type=section&id=Consolidated%20Statement%20of%20Profit%20or%20Loss) For the year 2018, the company achieved revenue of RMB 4.584 billion, a 22.7% year-over-year increase, with gross profit reaching RMB 3.707 billion, leading to a 38.2% increase in profit for the year to RMB 1.277 billion, of which RMB 1.277 billion was attributable to owners of the parent 2018 Consolidated Statement of Profit or Loss Key Data (RMB thousands) | Item | 2018 | 2017 | | :--- | :--- | :--- | | Revenue | 4,583,869 | 3,734,334 | | Gross Profit | 3,706,614 | 3,058,099 | | Profit Before Tax | 1,495,511 | 1,102,017 | | Profit for the Year | 1,277,246 | 924,404 | | Profit Attributable to Owners of the Parent | 1,277,167 | 935,389 | | Basic Earnings Per Share (RMB) | 0.50 | 0.37 | [Consolidated Statement of Financial Position](index=83&type=section&id=Consolidated%20Statement%20of%20Financial%20Position) As of December 31, 2018, the company's total assets were RMB 13.84 billion, largely stable year-over-year, with non-current assets increasing and total liabilities decreasing due to loan repayments, resulting in an optimized asset-liability structure and increased total equity 2018 Consolidated Statement of Financial Position Key Data (RMB thousands) | Item | Dec 31, 2018 | Dec 31, 2017 | | :--- | :--- | :--- | | **Assets** | | | | Total Non-current Assets | 9,402,122 | 8,476,755 | | Total Current Assets | 4,437,533 | 5,276,216 | | **Total Assets** | **13,839,655** | **13,752,971** | | **Liabilities and Equity** | | | | Total Current Liabilities | 1,655,541 | 2,195,809 | | Total Non-current Liabilities | 3,276,744 | 3,927,516 | | **Total Liabilities** | **4,932,285** | **6,123,325** | | **Total Equity** | **8,907,370** | **7,629,646** | [Consolidated Statement of Cash Flows](index=86&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) In 2018, the company generated a robust RMB 1.15 billion in net cash from operating activities, while investing activities resulted in a net outflow of RMB 406 million, and financing activities saw a net outflow of RMB 1.39 billion primarily due to significant loan repayments, leading to a year-end cash and cash equivalents balance of RMB 1.79 billion 2018 Consolidated Statement of Cash Flows (RMB thousands) | Item | 2018 | 2017 | | :--- | :--- | :--- | | Net Cash Flows from Operating Activities | 1,150,251 | 1,074,098 | | Net Cash Flows Used in Investing Activities | (405,912) | (643,215) | | Net Cash Flows (Used in) / From Financing Activities | (1,389,678) | 1,317,732 | | Net (Decrease) / Increase in Cash and Cash Equivalents | (645,339) | 1,748,615 | | Cash and Cash Equivalents at Year-End | 1,792,605 | 2,398,621 | [Environmental, Social and Governance Report](index=213&type=section&id=Environmental,%20Social%20and%20Governance%20Report) [Corporate Social Responsibility Management](index=215&type=section&id=Corporate%20Social%20Responsibility%20Management) This section outlines the company's social responsibility philosophy, governance structure, and stakeholder engagement, emphasizing its mission to benefit human health, its ESG working group, and its recognition for social contributions in 2018 - The company established an Environmental, Social, and Governance (ESG) working group, led by the Board Office and Public Relations Department, to enhance ESG management performance[502](index=502&type=chunk) - Through stakeholder engagement, high-priority issues were identified, including product and service quality, compliance operations, anti-corruption, innovative operations, employee health and safety, and employee rights and benefits[505](index=505&type=chunk)[510](index=510&type=chunk) [Compliance Operations](index=221&type=section&id=Compliance%20Operations) The company prioritizes compliance as a fundamental safeguard for development, establishing a robust risk management system, compliance management policies, and employee codes of conduct, reinforced by training, integrity programs, and a whistleblowing system to ensure ethical and transparent operations - The company integrates compliance management into employee performance evaluations through a Compliance Integrated Performance Card (IPCA) and continuously promotes a culture of integrity via its "Integrity Ambassador Program"[516](index=516&type=chunk)[518](index=518&type=chunk) - In 2018, **184 offline compliance training sessions** were conducted, reaching **7,487 participants**, primarily focusing on sales center employees[518](index=518&type=chunk) - The company has established a whistleblowing system with public hotlines and email addresses, committing to protect whistleblowers[522](index=522&type=chunk) [Environmental Protection Responsibility](index=224&type=section&id=Environmental%20Protection%20Responsibility) The company is committed to environmentally sustainable operations, implementing a GMP-compliant environmental management system, and employing measures such as equipment upgrades, energy-efficient lighting, waste heat recovery, and wastewater recycling to conserve resources and ensure pollutant emissions meet or exceed standards - The company has established a comprehensive environmental management system, with its subsidiary 3S Bio-Guojian obtaining ISO14001:2015 certification and Zhejiang Wansheng passing clean production audits[525](index=525&type=chunk) - Through measures like wastewater treatment and reuse, the company achieved **5,385 cubic meters** of recycled water in 2018, used for landscaping and other purposes[528](index=528&type=chunk)[530](index=530&type=chunk) - The company manages waste by classification, with non-hazardous waste handled by sanitation departments or qualified agencies, and hazardous waste regularly processed by qualified institutions[536](index=536&type=chunk) [Product and Customer Service Responsibility](index=231&type=section&id=Product%20and%20Customer%20Service%20Responsibility) The company prioritizes product quality and patient well-being, maintaining a comprehensive quality control system across all processes, a robust pharmacovigilance system, continuous R&D investment in 32 pipeline products, and a customer service system with recall mechanisms to ensure product safety and customer satisfaction - The company has established a comprehensive quality control system, with all pharmaceutical subsidiaries certified under China's **2010 GMP standards**[541](index=541&type=chunk) - The company operates a pharmacovigilance center with a robust system for collecting, processing, and reporting adverse drug reactions to ensure drug safety[543](index=543&type=chunk) - As of late 2018, the company had **32 pipeline products** covering five major therapeutic areas, including **22 National Class 1 new drugs** in China[551](index=551&type=chunk) - In 2018, the company experienced no product recalls due to quality defects and no confirmed incidents of customer data breaches[557](index=557&type=chunk)[558](index=558&type=chunk) [Supply Chain Responsibility](index=241&type=section&id=Supply%20Chain%20Responsibility) The company is committed to building a responsible and sustainable supply chain, managing suppliers from sourcing to delivery through comprehensive policies that emphasize compliance, quality, safety, and environmental protection, and enhancing supplier evaluations in environmental, labor, and ethical aspects - The company categorizes suppliers into four types and requires Type I, II, and III suppliers to sign a "Supplier Compliance Statement," committing to adhere to legal, ethical, social, and environmental standards[566](index=566&type=chunk)[567](index=567&type=chunk) - In 2018, the proportion of suppliers assessed for environmental, labor, and ethical aspects increased from **9.2% to 45%**[567](index=567&type=chunk) [Employee Development Responsibility](index=244&type=section&id=Employee%20Development%20Responsibility) The company values employees as core resources, ensuring legal employment practices, protecting employee rights in compensation, promotion, leave, and benefits, strictly prohibiting discrimination, child labor, or forced labor, and providing career development opportunities through a comprehensive safety management system and a three-tier training program - The company has established a comprehensive equity incentive mechanism, granting equity to senior management, middle management, and core employees (accounting for **6% of total staff**) to align company and employee interests[574](index=574&type=chunk) - The company established a Production Safety Management Committee, with all production bases certified as National Production Safety Standardization Level 3 enterprises, and regularly conducts safety training and emergency drills[582](index=582&type=chunk) - The company has implemented a comprehensive 3S training system covering all employees and launched internal trainer programs like "Jiangshan Team" to promote continuous learning and development among staff[586](index=586&type=chunk)[588](index=588&type=chunk) [Social Contribution Responsibility](index=252&type=section&id=Social%20Contribution%20Responsibility) The company actively fulfills its corporate social responsibility through drug donations, public welfare projects, patient communication platforms, and education, enhancing access to medicines and healthcare services, while also supporting medical research and industry advancement 2018 Key Philanthropic Donation Project Progress | Project Name | Partner Organization | 2018 Progress | | :--- | :--- | :--- | | "Guarding Happiness" Bethune • TPIAO | Beijing Bethune Philanthropic Foundation | Donated drug value RMB 8.86 million, covering 3,758 patients | | "Yi + Hope" Bethune • Yisaipu | Beijing Bethune Philanthropic Foundation | Donated drug value RMB 71.91 million, covering 22,794 patients | | "Love Reaches the Heart" Diabetes Patient Aid | China Primary Health Care Foundation | Newly covered 2,174 individuals, donated drug value RMB 43.38 million | - The company has established multiple doctor-patient communication platforms, such as "Red All Over China" and "Yi You Tong," to provide patients with information management, popular science education, and medical consultation services[594](index=594&type=chunk) - The company actively supports industry development, participating in the compilation of various expert consensuses and guidelines, and supporting research projects such as the "Liaoyuan Plan" and the "Chinese Nephrology Young Physician Research Fund"[601](index=601&type=chunk)[604](index=604&type=chunk)