2024年04月12日 公 司点评 公 买入 / 维持 司 三生制药(01530) 研 究 目标价: 昨收盘:6.08 医药 特比澳儿童 ITP 适应症获批，有望支撑收入端持续增长 事件  走势比较 2024年4月11日，公司宣布重组人血小板生成素注射液（特比澳） 新适应症已于 4 月 2 日获得批准，用于治疗儿童或青少年的持续性或慢 10% 性原发免疫性血小板减少症（ITP）。 太 0% 点评 平 (10%)11/4/32 12/6/32 13/8/32 01/11/32 02/1/42 13/3/42 主研发特 的比 重澳 组收 人入 血快 小速 板增 生长 成，适 素应 注增 射覆 液盖 ，此人 前群 已持 获续 批增 成加 人。 实特 体比 瘤澳 化是 疗由 后公 血司 小自 洋 (20%) 板减少症（CIT）和成人原发免疫性血小板减少症（ITP）适应症，近年来 证 (30%) 通过适应症覆盖人群的不断扩展，实现了销售收入的快速增长。2022 版 券 (40%) CSCO 肿瘤治疗所致血小板减少症（CTIT）诊疗指南将特比澳列为Ⅰ级推 股 荐，2023 年医保报销范围由实体瘤化疗后导致的严重血小板减 ...

Investment Rating - The report maintains a "Buy" rating for the company [1][4][17]. Core Views - The company achieved a revenue of 7.816 billion yuan in 2023, representing a growth of 13.8%. Gross profit reached 6.642 billion yuan, with a gross margin of 85.0%, an increase of 2.4 percentage points. However, the net profit attributable to shareholders decreased by 19.1% to 1.549 billion yuan, while the adjusted operating net profit increased by 17.7% to 1.952 billion yuan [1][5][12]. - The sales performance of key products, such as Tebiou and Mandi, was strong, with Tebiou sales reaching 4.205 billion yuan (+23.8%) and Mandi sales at 1.124 billion yuan (+25.8%). Mandi captured a market share of 72.6% in domestic medical institutions [1][12][16]. - The company is focusing on both self-research and business development in key therapeutic areas, with numerous pipelines in nephrology, hematology and oncology, autoimmune diseases, and hair and skin health [1][12][16]. Financial Performance Summary - Revenue for 2023 was 78.16 billion yuan, up 13.8% from the previous year. The gross profit was 66.42 billion yuan, reflecting a 17.1% increase, with a gross margin of 85.0% [1][5][12]. - The company’s R&D expenses were 7.95 billion yuan (+14.6%), with an R&D expense ratio of 10.2%. Sales expenses were 30.06 billion yuan (+16.5%), and management expenses were 4.81 billion yuan (+22.2%) [1][5][12]. - The forecast for net profit attributable to shareholders for 2024-2026 is 1.93 billion yuan, 2.15 billion yuan, and 2.42 billion yuan, respectively, with growth rates of 24.7%, 11.4%, and 12.6% [1][17][18]. Product Performance Summary - Tebiou's sales are expected to continue growing due to the increasing number of hospitals covered and the expansion of indications. The product holds a market share of approximately 65.0% in the treatment of thrombocytopenia [1][12][16]. - Mandi's sales in the hair loss sector reached 11.42 billion yuan, with a strong growth trend and a market share of 72.6% in domestic medical institutions [1][12][16]. - The company has a robust pipeline in various therapeutic areas, with several products in late-stage clinical trials, indicating a promising future for its product portfolio [1][12][16].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price set at 5.50 HKD [1][10]. Core Insights - The company's main business shows steady growth, with a 2023 revenue of 78.16 billion HKD, reflecting a year-on-year increase of 13.8%. However, the net profit attributable to shareholders decreased by 19.1% to 15.49 billion HKD. The adjusted operating net profit increased by 17.7% to 19.52 billion HKD [2][4]. - The company plans to pay a final dividend of 0.25 HKD per share for the year ending December 31, 2023, corresponding to an expected dividend yield of 4.5% [2][4]. - The revenue growth is primarily driven by the sales increase of key products, while the decline in net profit is attributed to changes in the fair value of trading financial assets and foreign exchange losses [2][4]. - The company has a robust pipeline of innovative products, with several expected to be launched in 2024, including treatments for psoriasis and chronic kidney disease anemia [2][4]. Financial Summary - For 2023, the company reported a revenue of 78.16 billion HKD, with a growth rate of 14%. The projected revenues for 2024, 2025, and 2026 are 87.44 billion HKD, 95.35 billion HKD, and 102.69 billion HKD, respectively, with growth rates of 12%, 9%, and 8% [4][8]. - The net profit attributable to shareholders for 2023 was 15.49 billion HKD, with projections of 20.13 billion HKD, 22.44 billion HKD, and 25.08 billion HKD for the following years, reflecting growth rates of 30%, 12%, and 12% [4][8]. - The company's gross margin for 2023 was 85.0%, an increase of 2.4 percentage points year-on-year, indicating continuous improvement in profitability [2][4]. Product Performance - Key products showed stable performance, with revenue from Teva and Mandi increasing by 23.77% and 26.16%, respectively. However, revenue from the dual-brand Erythropoietin decreased by 16.71% [2][4]. - The company is advancing its research pipeline, with multiple products receiving approval for market launch in 2023, indicating a strong commitment to innovation [2][4].

Investment Rating - The report maintains a "Buy" rating for the company [2][3] Core Insights - The company achieved a revenue of 7.82 billion RMB in 2023, representing a year-on-year growth of 13.8%. The adjusted net profit was 1.95 billion RMB, up 17.7% from the previous year [1][2] - The core product, Tevizo, continues to show strong growth, holding a 65% market share in the platelet reduction treatment market in mainland China. Tevizo's sales revenue reached 4.205 billion RMB in 2023, a 23.8% increase year-on-year [1][2] - The company is a leader in the hair health sector with its Minoxidil product, which captured 72.6% of the market share in 2023, generating revenue of 1.12 billion RMB, a 25.8% increase from the previous year [1][2] - The company has a robust pipeline with 13 products in hematology/oncology and 11 in autoimmune diseases, indicating a diverse therapeutic focus [1][2] Financial Summary - Revenue projections for 2024, 2025, and 2026 are 8.801 billion RMB, 9.925 billion RMB, and 11.116 billion RMB, respectively, with growth rates of 12.6%, 12.8%, and 12.0% [2][4] - Net profit estimates for the same years are 1.891 billion RMB, 2.280 billion RMB, and 2.746 billion RMB, with corresponding growth rates of 22.1%, 20.6%, and 20.4% [2][4] - The company’s P/E ratios are projected to be 7, 5, and 4 for 2024, 2025, and 2026, respectively, indicating a favorable valuation trend [2][4]

Financial Performance - Revenue increased by RMB 950.2 million or 13.8% to RMB 7,815.9 million[2] - Gross profit rose by RMB 970.0 million or 17.1% to RMB 6,641.6 million, with a gross margin of 85.0%[2] - Net profit attributable to equity holders decreased by RMB 366.5 million or 19.1% to RMB 1,549.2 million, while adjusted operating profit increased by RMB 293.3 million or 17.7% to RMB 1,952.4 million[2] - EBITDA decreased by RMB 226.0 million or 8.6% to RMB 2,389.1 million, while adjusted operating EBITDA increased by RMB 464.6 million or 20.2% to RMB 2,768.4 million[2] - Total revenue for 2023 reached RMB 7,815,938 thousand, a 13.8% increase from RMB 6,865,735 thousand in 2022[18] - The company reported a net profit of RMB 1,586.3 million for the year, down from RMB 1,908.9 million in the previous year[5] - Basic earnings per share decreased to RMB 0.64 from RMB 0.78 year-on-year[4] - The group reported a net loss from the fair value changes of financial assets amounting to RMB 358,548 thousand in 2023, with no such loss reported in 2022[28] Assets and Liabilities - Total non-current assets increased to RMB 14,432.3 million from RMB 12,258.4 million year-on-year[7] - Current assets increased to RMB 9,750.5 million from RMB 7,906.6 million year-on-year[7] - Total liabilities increased to RMB 3,727.6 million from RMB 1,843.9 million year-on-year[7] - Non-current liabilities decreased from RMB 4,801,470 thousand in 2022 to RMB 3,383,818 thousand in 2023, a reduction of approximately 29.5%[8] - The net asset value increased from RMB 15,363,581 thousand in 2022 to RMB 16,513,600 thousand in 2023, representing a growth of about 7.5%[9] - Total equity attributable to owners of the parent rose from RMB 12,925,805 thousand in 2022 to RMB 14,033,771 thousand in 2023, an increase of approximately 8.6%[9] Market and Product Development - The company is focused on expanding its biopharmaceutical product development and marketing efforts in mainland China, aiming to enhance market presence[10] - The company has a strategic focus on research and development of new products and technologies to drive future growth and market expansion[10] - The company is committed to maintaining a strong financial position while exploring potential mergers and acquisitions to enhance its portfolio[10] - The company holds a 65.0% market share in the platelet reduction treatment market in mainland China as of 2023, according to IQVIA[52] - The company has a 42.2% market share in the rhEPO market in mainland China as of 2023[52] - The company’s product Mandi holds a dominant market share of 72.6% in the milo-dex market in mainland China as of 2023[52] - The company’s TNFα inhibitor product Yisai Pu has a market share of 22.7% in the TNFα market in mainland China as of 2023[52] Research and Development - The company is actively developing 29 pipeline products, with 25 of them being innovative drugs in mainland China, including 15 antibodies and 7 small molecule drugs[80] - The research and development team consists of over 600 experienced scientists focused on accelerating clinical development and seeking breakthrough therapies to meet unmet medical needs[79] - The company emphasizes the importance of its comprehensive R&D platform, which includes antibody discovery, molecular cloning, and clinical trial management[77] Financial Management and Governance - The financial statements are prepared in accordance with International Financial Reporting Standards, ensuring compliance and transparency in financial reporting[11] - The company maintains control over its subsidiaries, which are consolidated into the financial statements from the date control is obtained until it ceases[12] - The company has adopted the corporate governance code as per the Hong Kong Stock Exchange listing rules to enhance shareholder rights and corporate value[122] - The roles of the Chairman and CEO are not separated, with the same individual holding both positions to ensure consistent leadership direction[123] Shareholder Information - The board proposed a final dividend of HKD 0.25 per share for the year ended December 31, 2023, compared to HKD 0.10 in 2022[2] - The proposed final dividend for the year ended December 31, 2022, is HKD 0.10 per share, subject to shareholder approval[34] - The company will suspend the registration of shareholders from June 20, 2024, to June 25, 2024, for the annual general meeting[120] - The company will also suspend the registration of shareholders from July 24, 2024, to July 26, 2024, for the final dividend entitlement[121] Compliance and Audit - Ernst & Young confirmed that the financial data in the preliminary performance announcement aligns with the consolidated financial statements for the reporting period[128] - The audit committee, consisting of three independent non-executive directors, has reviewed and approved the accounting principles and annual performance for the reporting period[127]

三生制药（1530.HK）深度研究 基本面稳健，生发产品蔓迪及后续管线持续发力 2024年03月08日 ➢ 主营业务稳健，特色产品持续发力。2023H1 实现营业收入 37.8 亿元，同 推荐 首次评级 比增长22.3%；2023H1实现归母净利润9.8亿元，同比增长1.4%。2023H1生 当前价格： 4.94港元 物制品板块收入同比增长 20%；毛发健康板块收入同比增长 36%，618 及双十 一大促电商销售再摘榜首；CDMO收入同比增长72%。 [Table_Author] ➢ 核心产品特比澳以销售额计，继续居于升血小板市场首位。特比澳是 2005 年上市的全球唯一商业化重组血小板生成素。2023 年上半年销售额同比增长 28.2%，主要系于2023年特比澳的医保谈判价格没有下降，此外特比澳产品在 2023 年争取到的政策环境有利产品放量，过去纳入《中国肿瘤化疗相关性血小 板减少症专家诊疗共识》，现在已纳入《中国肿瘤药物相关血小板减少诊疗专家 共识》的推荐用药，覆盖治疗人群得到进一步扩大。按比例计算，今年特比澳产 分析师 王班 品贡献接近40亿元报表收入，特比澳产品营收占总集团营收一半。 执业证书： S ...

Market Share and Product Performance - The company holds a 64.6% market share in the treatment of thrombocytopenia in mainland China for its product Tevazo, according to IQVIA data for the first half of 2023[5]. - The company has a 42.9% market share in the rhEPO market in mainland China, maintaining its leadership for the past 20 years[5]. - The company’s product Mandi has a dominant market share of 70.3% in the minoxidil solution market in mainland China as of the first half of 2023[5]. - The company’s TNFα inhibitor product Yisai has captured 23.7% of the TNFα market in mainland China during the same period[5]. - Tebentafusp holds a 33.1% market share by volume and 64.6% by sales in the treatment of thrombocytopenia in mainland China as of the first half of 2023[13]. - Yibiao has maintained a dominant position in the rhEPO market in mainland China since 2002, with a significant market share alongside Cybor[14]. - Yisaipu's market share in the TNFα inhibitor market in mainland China was 23.7% in the first half of 2023, reflecting a decline due to increased competition and price adjustments[15]. - Mandi holds a 70.3% market share in mainland China with a sales growth of 35.3% year-on-year in the first half of 2023[18]. Financial Performance - Revenue increased by RMB 689.3 million or 22.3% to RMB 3,783.8 million for the six months ended June 30, 2022[10]. - Gross profit rose by RMB 636.4 million or 24.8% to RMB 3,201.6 million, with gross margin increasing from 82.9% to 84.6%[10]. - Net profit attributable to equity holders increased by RMB 13.7 million or 1.4% to RMB 980.6 million, while normalized net profit rose by RMB 199.3 million or 20.1% to RMB 1,191.5 million[10]. - EBITDA grew by RMB 37.5 million or 2.9% to RMB 1,330.5 million, with normalized EBITDA increasing by RMB 228.4 million or 17.7% to RMB 1,518.1 million[10]. - The company's revenue for the reporting period was approximately RMB 3,783.8 million, an increase of about RMB 689.3 million or 22.3% compared to RMB 3,094.5 million for the same period last year[36]. - The gross profit increased to approximately RMB 3,201.6 million, up by about RMB 636.4 million or 24.8%, with a gross margin rising from approximately 82.9% to 84.6%[40]. - The company reported a total comprehensive income of RMB 933,638 thousand for the first half of 2023, compared to RMB 892,185 thousand in 2022[92]. Research and Development - As of June 30, 2023, the company is actively developing 30 pipeline products, with 25 being innovative drugs in mainland China[6]. - The company is focusing on expanding its CDMO business to increase revenue scale, which has been operational since December 2021[5]. - The company is advancing multiple innovative biopharmaceuticals and small molecule drugs, including SSS06 (NuPIAO) for anemia and 608 for autoimmune diseases[26]. - The R&D team consists of nearly 600 experienced scientists focused on accelerating clinical development and seeking breakthrough therapies[26]. - The company is actively promoting the long-term efficacy and safety of Yisaipu through post-marketing clinical studies[15]. Clinical Trials and Approvals - The first patient has been enrolled in the Phase III clinical study of Tebentafusp for chronic liver disease-related thrombocytopenia[12]. - The NDA for Remitch® has been approved for treating pruritus in hemodialysis patients, marking it as the first selective opioid κ receptor agonist approved for this indication in China[12]. - Yibiao has been approved for three indications: anemia due to chronic kidney disease (CKD), chemotherapy-induced anemia (CIA), and perioperative red blood cell mobilization[14]. - The pre-filled Yisaipu injection has been approved by the National Medical Products Administration in March 2023, expected to enhance patient convenience and drive further growth[15]. - The company has initiated a Phase III clinical trial for anti-IL-17A monoclonal antibody (608) for plaque psoriasis, with primary endpoint data expected in the second half of 2023[30]. Distribution and Market Presence - The company has established a national distribution network selling products to approximately 8,700 hospitals and medical institutions across mainland China[6]. - The sales and marketing network consists of approximately 2,704 sales and marketing personnel, 1,144 distributors, and 1,889 third-party promoters[33]. - The company’s products are sold in nearly 2,700 tertiary hospitals and over 6,000 secondary or lower-level hospitals across all provinces in mainland China[33]. Employee and Operational Metrics - The company employs 5,311 staff across its operational facilities in Shenyang, Shanghai, Hangzhou, Shenzhen, and Como, Italy[6]. - The group employed a total of 5,311 employees as of June 30, 2023, compared to 5,213 employees as of December 31, 2022, with employee costs amounting to approximately RMB 604.4 million during the reporting period[59]. Debt and Financing - As of June 30, 2023, the total interest-bearing bank borrowings of the group amounted to approximately RMB 3,725.7 million, an increase from RMB 2,315.0 million as of December 31, 2022, reflecting new bank borrowings of approximately RMB 1,640.9 million during the reporting period[54]. - The group’s leverage ratio increased from approximately 29.2% as of December 31, 2022, to approximately 30.9% as of June 30, 2023[54]. - The financing costs increased to approximately RMB 88.9 million, an increase of about RMB 52.4 million or approximately 143.6% compared to RMB 36.5 million for the six months ended June 30, 2022[47]. Shareholder Information and Stock Options - The company has authorized the issuance of up to 242,439,857 shares under the stock option plan, representing approximately 9.94% of the issued shares as of the report date[67]. - The stock option plan is designed to provide selected participants with an opportunity to acquire ownership interests in the company, encouraging efforts to enhance the company's value[67]. - The stock options granted to employees (excluding directors) as of June 30, 2023, included 15,656,000 options, with 50,000 options exercised during the period[70]. - The company adopted the 2019 Share Award Scheme on July 16, 2019, allowing a maximum of 10% of the total issued shares at the adoption date for awards, which amounted to 253,500,255 shares[72]. Regulatory and Compliance - The independent review report concluded that no matters were found that would lead to a belief that the interim financial information was not prepared in accordance with International Accounting Standard 34[88]. - The company has applied new and revised International Financial Reporting Standards from January 1, 2023, with no impact on the interim consolidated financial information[106].

Financial Performance - Revenue increased by RMB 689.3 million or 22.3% to RMB 3,783.8 million compared to the six months ended June 30, 2022[2]. - Gross profit rose by RMB 636.4 million or 24.8% to RMB 3,201.6 million, with a gross margin increase from 82.9% to 84.6%[2]. - Net profit attributable to equity holders of the parent increased by RMB 13.7 million or 1.4% to RMB 980.6 million, while normalized net profit rose by RMB 199.3 million or 20.1% to RMB 1,191.5 million[2]. - EBITDA increased by RMB 37.5 million or 2.9% to RMB 1,330.5 million, with normalized EBITDA up by RMB 228.4 million or 17.7% to RMB 1,518.1 million[2]. - The company reported a total comprehensive income of RMB 933.6 million for the period, compared to RMB 892.2 million for the same period last year[9]. - The company’s basic earnings per share increased to RMB 0.40 from RMB 0.39 year-on-year[5]. - The profit attributable to equity holders of the parent company for the six months ended June 30, 2023, was RMB 980,577,000, compared to RMB 966,893,000 for the same period in 2022, representing an increase of approximately 1.1%[31]. - Basic earnings per share for the first half of 2023 were RMB 0.402, compared to RMB 0.394 in the same period of 2022[30]. Assets and Liabilities - Total non-current assets amounted to RMB 12,918.6 million as of June 30, 2023, compared to RMB 12,258.4 million as of December 31, 2022[10]. - Current assets totaled RMB 10,251.3 million as of June 30, 2023, an increase from RMB 9,750.5 million as of December 31, 2022[10]. - Current liabilities increased to RMB 3,559.6 million as of June 30, 2023, compared to RMB 1,843.9 million as of December 31, 2022[10]. - The net asset value was RMB 15,964.4 million as of June 30, 2023, up from RMB 15,363.6 million as of December 31, 2022[11]. - The total equity attributable to owners of the parent company increased to RMB 13,520,757 thousand as of June 30, 2023, compared to RMB 12,925,805 thousand in the previous year, reflecting a growth of approximately 4.6%[12]. - The total borrowings as of June 30, 2023, were RMB 4,937,483,000, compared to RMB 4,478,742,000 as of December 31, 2022, reflecting an increase of about 10.2%[43]. - The total interest-bearing bank borrowings increased to approximately RMB 3,725.7 million from RMB 2,315.0 million as of December 31, 2022, reflecting an increase of approximately RMB 1,640.9 million during the reporting period[96]. Revenue Sources - Revenue for the six months ended June 30, 2023, reached RMB 3,783,833 thousand, a 22.3% increase from RMB 3,094,460 thousand in the same period of 2022[20]. - Revenue from the sale of biopharmaceutical products and contract development and manufacturing services was RMB 3,688,923 thousand for the first half of 2023, up from RMB 3,039,146 thousand in the prior year, representing a growth of 21.5%[20]. - The company reported external customer revenue from mainland China of RMB 3,684,591 thousand for the first half of 2023, compared to RMB 3,019,862 thousand in the same period of 2022, marking an increase of 22%[18]. - Total customer contract revenue for 2023 reached RMB 3,783,833 thousand, a 22.2% increase from RMB 3,094,460 thousand in 2022[21]. - The CDMO business generated approximately RMB 95 million in customer orders in the first half of 2023, showcasing strong demand for biopharmaceutical services[67]. - The revenue from CDMO business rose to approximately RMB 94.9 million, an increase of about RMB 39.6 million or 71.6% compared to RMB 55.3 million in the previous year[82]. Market Position and Products - The company reported a market share of 64.6% for its core product, Teplizumab, in the platelet reduction treatment market in China for the first half of 2023[51]. - The company has a 42.9% market share in the rhEPO market, maintaining its position as a leader for the past 20 years[51]. - Tebipenem, a proprietary product developed by the company, has a market share of 33.1% in terms of volume and 64.6% in terms of sales for the treatment of thrombocytopenia in mainland China as of the first half of 2023[56]. - The market share of Erythropoietin in the rhEPO market is primarily held by the company and its competitor, accounting for a significant portion of the 10,000 IU dosage market[57]. - The market share of Etanercept in the TNFα inhibitor market in mainland China was 23.7% in the first half of 2023[59]. - The sales of the innovative anti-HER2 monoclonal antibody, Eniotuzumab (Saiputing), expanded to over 1,300 hospitals in mainland China in the first half of 2023, with an increasing average treatment duration per patient[60]. - Mandi (Minoxidil) captured a market share of 70.3% in mainland China in the first half of 2023, with a year-on-year sales growth of 35.3%[62]. Research and Development - The company has 30 products in active development, with 25 of them being innovative drugs in mainland China, including 14 antibody products and 10 small molecule drugs[72]. - The research and development team consists of nearly 600 experienced scientists focused on accelerating clinical development and seeking breakthrough therapies[71]. - The company is conducting clinical trials for various innovative biological products and small molecule drugs targeting diseases such as renal disease, tumors, autoimmune diseases, and skin conditions[70]. - The company is actively preparing for bioequivalence studies for several small molecule generic products in the fields of nephrology, autoimmune diseases, and dermatology[70]. - The company has initiated a Phase III clinical study for Teplizumab to treat chronic liver disease-related thrombocytopenia, with the first patient enrolled recently[53]. - The company is actively pursuing clinical development for TRK-820 in chronic liver disease to meet the clinical needs of patients in China[66]. Expenses and Financial Management - Sales and distribution expenses amounted to approximately RMB 1,374.8 million, an increase of about RMB 224.5 million or 19.5% compared to RMB 1,150.3 million for the six months ended June 30, 2022[86]. - Administrative expenses were approximately RMB 214.4 million, up by about RMB 16.3 million or 8.2% from RMB 198.1 million for the six months ended June 30, 2022[87]. - R&D costs increased to approximately RMB 306.6 million, a rise of about RMB 12.3 million or 4.2% compared to RMB 294.3 million for the six months ended June 30, 2022[88]. - Financing costs rose to approximately RMB 88.9 million, an increase of about RMB 52.4 million or 143.6% compared to RMB 36.5 million for the six months ended June 30, 2022[90]. - Income tax expenses increased to approximately RMB 207.6 million, up by about RMB 43.6 million or 26.6% from RMB 164.0 million for the six months ended June 30, 2022[91]. Strategic Initiatives - The company is focusing on increasing brand awareness and market penetration, currently at only 2-3% among the 250 million people suffering from hair loss in mainland China[62]. - The company aims to enhance its digital marketing strategy by expanding its online presence to new platforms like Douyin and Xiaohongshu, targeting potential customers more effectively[62]. - The company plans to focus on accelerating the development of autoimmune products and exploring multiple indications in the second half of 2023[80]. - The company is preparing for clinical trial applications for Winlevi® in mainland China, aiming to provide new treatment options for millions of acne patients[68]. - The company is committed to continuous market education and resource investment to promote scientific hair restoration and enhance brand recognition[62]. Corporate Governance - The audit committee reviewed the group's unaudited interim results and found the internal control and risk management systems to be effective and sufficient[108]. - The board of directors includes executive directors Dr. Liu Jing and Ms. Su Dongmei, as well as non-executive director Mr. Huang Bin, and independent non-executive directors Mr. Pu Tianruo, Ms. Yang Kaidi, Mr. Huang Zuyao, and Dr. Zhang Dan[110].

Market Position and Share - The company holds a 64.8% market share in the platelet reduction treatment market in mainland China for its product Teplizumab, according to IQVIA data[5]. - The company has maintained a leading position in the rhEPO market in mainland China with a market share of 44.5%[5]. - The company’s product Mandi has a dominant market share of 71.7% in the minoxidil tincture market in mainland China[5]. - Tebipenem's market share for treating thrombocytopenia in mainland China is 26.2% by volume and 64.8% by sales revenue[27]. - Yisaipu's market share in the TNFα inhibitor market in mainland China was 27.1% in 2022[30]. - Yibiao has maintained a dominant position in the rhEPO market in mainland China since 2002, with a significant market share in the 10,000 IU dosage[28]. - Mandi holds a 71.7% market share in mainland China with a sales growth of 48.1% year-on-year in 2022[35]. Product Development and Pipeline - The company has 31 products in the pipeline, with 26 being developed as innovative drugs in mainland China[6]. - The company has 7 oncology products, 13 products targeting autoimmune diseases, 9 nephrology products, and 2 dermatology products in its pipeline[6]. - The company has completed the new drug application for the anti-TNFα pre-filled injection (301S) in 2022, which was approved for market launch in March 2023[14]. - The company has made significant advancements in clinical trials, including the completion of patient enrollment for several phase II and III studies[15]. - The clinical trial for the oral disintegrating tablet TRK-820, aimed at treating pruritus in patients undergoing maintenance hemodialysis, has successfully met its primary endpoint[51]. - The group plans to initiate Phase III clinical trials for Peg-EPO (RD-01) in the second half of 2023[52]. - The Phase II clinical trial for HIF-117 (SSS17), a small molecule HIF prolyl hydroxylase inhibitor for treating anemia, has been initiated[53]. - The group is preparing for clinical trial applications for several small molecule generics in nephrology, autoimmune, and dermatological fields[46]. Financial Performance - The company's revenue for the fiscal year 2022 reached RMB 6,859,433,000, marking a continuous growth trend across its core business segments[12]. - The normalized net profit attributable to the parent company was RMB 2,162,807,000, reflecting a significant increase compared to previous years[12]. - The company reported a normalized EBITDA of RMB 2,796,255,000, showcasing its operational efficiency and profitability[12]. - The company's total assets increased to RMB 21,988,704,000, while total liabilities rose to RMB 6,588,254,000, indicating a solid financial position[12]. - The revenue from medical institutions accounted for approximately 14% of Mandi's total revenue, with a year-on-year growth of about 2%[35]. - Revenue from retail pharmacies represented around 25% of Mandi's total revenue, showing a year-on-year increase of approximately 65%[35]. - E-commerce revenue constituted about 60% of Mandi's total revenue, with a year-on-year growth of around 58%[35]. - The sales revenue of Yisai Pu decreased to approximately RMB 511.6 million, a decrease of about RMB 277.1 million or approximately 35.1% compared to RMB 788.7 million for the year ended December 31, 2021[61]. Strategic Partnerships and Collaborations - The company has entered into global strategic partnerships, including licensing agreements for antibody-drug conjugates and PD-1 monoclonal antibodies, with potential milestone payments totaling hundreds of millions of dollars[16]. - The company has signed a licensing agreement with Syncromune for the global development and commercialization of its anti-PD1 monoclonal antibody (code: 609A) for tumor immunotherapy, receiving an upfront payment and potential future milestone payments[20]. - The company has entered into a licensing agreement with Kelingyuan for the global rights to develop and commercialize the antibody sequence of CAPTIV for ADC development, receiving an upfront payment and potential milestone payments[21]. - The company has established partnerships with research institutions and companies to leverage expertise in developing competitive new products, but maintaining these relationships is not guaranteed[87]. Corporate Governance and Leadership - The company has a strong leadership team, including Dr. Liu Jing, who has been instrumental in the development of key products and has extensive experience in the pharmaceutical industry[91]. - The company emphasizes high standards of corporate governance to protect shareholder interests and enhance corporate value[177]. - The board consists of two executive directors, one non-executive director, and four independent non-executive directors, ensuring compliance with the Hong Kong Stock Exchange listing rules[179]. - The company has adopted a board diversity policy to enhance competitive advantage, considering factors such as gender, age, cultural background, and professional qualifications[179]. - The company provides necessary onboarding training for new directors and encourages continuous professional development to update their knowledge and skills[183]. Market Expansion and Future Outlook - The company aims to market its products in developed countries and collaborates with international partners for product development and marketing[6]. - The company aims to optimize the structure of chronic disease medications and deepen its presence in grassroots markets in response to national healthcare initiatives[17]. - The company expects a comprehensive recovery in drug demand in 2023, driven by the release of medical consumption needs and new national medical insurance policies[57]. - The company aims to accelerate the launch of multiple products in its research pipeline in 2023, including the unique Minoxidil foam for sensitive scalp patients[57]. - The company is likely to leverage the extensive network and experience of its directors to explore new market opportunities and partnerships[96][97]. Compliance and Risk Management - The group faces intense competition in the biotechnology and pharmaceutical industry, which may hinder its ability to compete effectively with existing and future competitors[83]. - The company has adhered to all relevant rules and regulations that significantly impact its operations during the reporting period[167]. - There were no serious violations of internal rules or relevant Chinese laws by employees or distributors in promoting the company's pharmaceutical products[169]. - The company confirmed compliance with the relevant Hong Kong Stock Exchange rules regarding related party transactions[160]. Shareholder Information - The company proposed a final dividend of HKD 0.10 per share for the year ended December 31, 2022, down from HKD 0.20 in 2021[102]. - As of December 31, 2022, the company's distributable reserves were approximately RMB 3,624.9 million, compared to RMB 4,082.3 million as of December 31, 2021[110]. - The company has a total of 2,438,870,412 shares issued as of December 31, 2022[125]. - Major shareholders include Decade Sunshine Limited and Century Sunshine Limited, each holding 476,774,553 shares, representing 19.55% of the total issued shares[135].

Financial Performance - The company's revenue for the year ended December 31, 2022, was RMB 6,859.4 million, representing a 7.5% increase from RMB 6,382.0 million in 2021[5] - Gross profit for the same period was RMB 5,671.9 million, with a gross margin of 82.7%[5] - Normalized EBITDA increased to RMB 2,162.8 million, reflecting a growth of 25.2% compared to the previous year[2] - Net profit attributable to the parent company was RMB 1,914.9 million, up from RMB 1,651.2 million in 2021, marking a year-on-year increase of 16.0%[5] - Total customer contract revenue for 2022 reached RMB 6,859,433 thousand, an increase of 7.46% from RMB 6,382,009 thousand in 2021[21] - Revenue from the sale of biopharmaceuticals was RMB 6,693,558 thousand in 2022, up from RMB 6,271,104 thousand in 2021, reflecting a growth of 6.73%[22] - Revenue from contract development and manufacturing operations increased to RMB 165,875 thousand in 2022, compared to RMB 110,905 thousand in 2021, marking a growth of 49.6%[22] - Other income for 2022 amounted to RMB 233,010 thousand, an increase of 51.0% from RMB 154,258 thousand in 2021[25] - The pre-tax profit for the group was RMB 355,885 thousand in 2022, compared to RMB 184,023 thousand in 2021, representing an increase of 93.1%[27] - The group’s interest income rose significantly to RMB 150,655 thousand in 2022 from RMB 74,448 thousand in 2021, an increase of 102.5%[25] Assets and Liabilities - Total current assets increased to RMB 9,760.9 million from RMB 7,790.7 million in the previous year[9] - Non-current assets rose to RMB 12,227.8 million, compared to RMB 11,421.9 million in 2021[9] - Total equity increased to RMB 15,400.5 million from RMB 14,657.8 million in the previous year[12] - The company’s cash and cash equivalents decreased to RMB 2,150.3 million from RMB 2,868.1 million in the previous year[8] - The total trade receivables as of the end of 2022 were RMB 1,282,926,000, a decrease from RMB 1,346,626,000 in 2021[34] - Trade payables and notes payable totaled RMB 249,495,000, an increase from RMB 230,407,000 in the previous year[39] - The company has bank loans totaling RMB 4,065,483,000, with a range of interest rates from 1.48% to 6.27%[40] - The total interest-bearing bank borrowings increased to approximately RMB 2,265.0 million as of December 31, 2022, from approximately RMB 314.3 million as of December 31, 2021, reflecting an increase of RMB 2,081.8 million in new bank loans[96] - The group's leverage ratio increased from approximately 2.1% as of December 31, 2021, to approximately 14.7% as of December 31, 2022, primarily due to the increase in bank borrowings[97] Market and Product Development - The company operates solely in the biopharmaceutical sector, focusing on the development, production, marketing, and sales of biopharmaceutical products[19] - The company’s core products include Tevazo, which holds a 64.8% market share in the platelet reduction therapy market in China[43] - The company has a 44.5% market share in the rhEPO market, maintaining its leadership for over 20 years[43] - The company’s product, Mandi, dominates the minoxidil market with a 71.7% market share[43] - The company has initiated a contract development and manufacturing operations (CDMO) business to enhance revenue since December 2021[43] - The 5% minoxidil foam application for androgenetic alopecia has been accepted by the National Medical Products Administration, aiming to be the first approved minoxidil foam product in mainland China[45] - The company has entered into a licensing agreement with Cosmo Pharmaceuticals for the exclusive rights to develop and commercialize Winlevi® in Greater China, along with a right of first refusal for Breezula®[48] - The company has 31 products in active development, with 26 of them being innovative drugs in mainland China[68] - The company is actively developing innovative biological products, including monoclonal antibodies and small molecule drugs targeting various diseases such as kidney disease, tumors, and autoimmune diseases[68] Research and Development - R&D costs decreased to approximately RMB 693.2 million, down about RMB 60.7 million or approximately 8.1% year-over-year, with an R&D cost ratio of about 10.1%[86] - The company has a research team of nearly 600 experienced scientists focused on accelerating clinical development and seeking breakthrough therapies[67] - The company plans to initiate Phase III clinical trials for Peg-EPO (RD-01) in the second half of 2023 after completing discussions with the National Medical Products Administration[71] - The company has completed patient enrollment for the Phase III clinical trial of NuPIAO (SSS06) by the end of 2022[71] - The Phase II trial for the anti-IL17A monoclonal antibody (608) in plaque psoriasis patients has achieved its primary endpoint, with Phase III enrollment expected to complete in the first half of 2023[71] Shareholder Returns and Dividends - The company proposed a final dividend of HKD 0.10 per share for the year ended December 31, 2022[2] - The board proposed a final dividend of HKD 0.10 per share for the year ended December 31, 2022, down from HKD 0.20 per share for the previous year[104] Corporate Governance - The audit committee, consisting of three independent non-executive directors, reviewed and approved the accounting principles and practices adopted by the group during the reporting period[112] - Ernst & Young confirmed that the financial data in the preliminary performance announcement was consistent with the draft consolidated financial statements, although no formal audit was conducted[113]