綜合財務報表： 公司資料 2 首席執行官報告 3 若干財務項目的管理層討論及分析 6 若干業務環節的管理層討論及分析 14 董事及高級管理人員的個人簡歷 31 企業管治報告 37 董事會報告 57 獨立核數師報告 78 綜合全面收益表 83 綜合資產負債表 84 綜合權益變動表 86 綜合現金流量表 87 綜合財務報表附註 88 五年財務概要 152 釋義 153 環境、社會及管治報告2024 157 公司資料 執行董事 劉軍博士 （首席執行官） 非執行董事 付山先生 （董事長） 黃純瑩女士 （副董事長） 劉衛東博士 獨立非執行董事 1 目錄 胡蘭女士 張鴻仁先生 汪德潛博士 審計與關聯方交易審核委員會 1 胡蘭女士 （主席） 劉衛東博士 張鴻仁先生 薪酬委員會 1、2 劉衛東博士 （主席） 張鴻仁先生 汪德潛博士 提名委員會 1 付山先生 （主席） 胡蘭女士 汪德潛博士 戰略及ESG委員會 1 付山先生 （主席） 劉軍博士 黃純瑩女士 劉衛東博士 汪德潛博士 聯席公司秘書 陳一帆先生 呂穎一先生 （香港公司治理公會及英國特許公司治理公會會員） 授權代表 劉軍博士 呂穎一先生 附註： 股份過戶登記處 卓佳證券 ...

SDICSI 2025 年 3 月 19 日 东曜药业-B (1875.HK) 朴欣汀收入同比增长 42%，预计 2025 年完成首个海外国家获批。 2024 年公司产品收入为 8.77 亿元，同比增长 39%，主要来自核心产品朴欣汀的 贡献。朴欣汀于 2021 年上市，2022 年纳入乙类医保目录，已覆盖原研药 Avastin 在中国大陆获批的六项适应症。2024 年朴欣汀销售收入同比增长 42%。 截至 2024 年 12 月 31 日，公司已启动 34 个海外国家的上市注册申请工作，已 有 20 个国家的上市申请文件获得受理，产品已取得哥伦比亚、埃及以及印尼等 国家的 GMP 证书，预计 2025 年完成首个海外国家获批，为全球化战略发展奠 定重要里程碑。 投资建议：我们预计公司 2025-2027 年收入分别为 12.8 亿元/13.3 亿元/14.2 亿 元，净利润分别为 47 百万元/82 百万元/138 百万元。 首次扭亏为盈，经营现金流连续三年正向 事件：2024 年业绩首次扭亏为盈，经营活动现金净额连续三年持续正向。 报告摘要 首次扭亏为盈，经营活动现金净额连续三年持续正向。 2024 年公 ...

Financial Performance - The company achieved a revenue of RMB 1,098,329 thousand for the fiscal year ending December 31, 2024, representing a 41% year-over-year growth[5]. - Product sales revenue reached RMB 877,410 thousand, a 39% increase, primarily driven by steady growth in the core product, Puxinting® (Bevacizumab Injection)[5]. - CDMO/CMO business revenue was RMB 207,133 thousand, reflecting a 47% year-over-year growth, indicating strong operational cash flow with RMB 116,403 thousand net cash from operating activities for 2024[5]. - The company turned a profit for the first time, achieving a net profit of RMB 34,757 thousand for the fiscal year[5]. - The total comprehensive income for 2024 was RMB 36,956,000, compared to a total comprehensive loss of RMB 36,020,000 in 2023[18]. - The company reported a net profit attributable to equity holders of RMB 36,956 thousand for the year ended December 31, 2024, compared to a loss of RMB 36,020 thousand in 2023, indicating a significant turnaround in performance[19]. - Basic and diluted earnings per share for the year were RMB 0.06, compared to a loss of RMB 0.05 per share in the previous year[19]. - The net profit for 2024 was RMB 34,757 thousand, a turnaround from a net loss of RMB 37,757 thousand in 2023[70]. Project Development and Innovation - A total of 58 new projects were added during the year, including 48 ADC projects, bringing the cumulative total to 153 projects[6]. - The company secured 2 pre-BLA projects during the year, with a total of 8 projects in hand, showcasing its strong commercialization capabilities[6]. - The newly launched BDKcellTM technology platform has achieved a maximum expression level of 12g/L, significantly enhancing the efficiency of the overall process[12]. - The ADC project revenue and quantity have steadily increased, contributing to the company's ongoing stable development[12]. - The company has successfully completed multiple ADC projects for clients, ensuring timely delivery and receiving high recognition from customers[104]. - The company has established a leading domestic production line for biopharmaceutical commercialization, with antibody production capacity exceeding 10,000 liters, ensuring continuous supply of commercialized products[84]. - The company has provided over 100 projects in antibody, protein, ADC, and XDC development services, meeting registration requirements in China, the US, and the EU[84]. Financial Position and Assets - Total assets increased to RMB 1,508,772 thousand in 2024, up from RMB 1,426,101 thousand in 2023, reflecting a growth of approximately 5.8%[21]. - Total liabilities rose to RMB 779,117 thousand in 2024, compared to RMB 739,415 thousand in 2023, representing an increase of about 5.4%[23]. - The company's cash and cash equivalents increased to RMB 381,256 thousand in 2024 from RMB 351,600 thousand in 2023, showing a growth of approximately 8.4%[21]. - Trade and other receivables increased significantly to RMB 157,278 thousand in 2024, up from RMB 88,152 thousand in 2023, marking an increase of about 78.4%[21]. - The company’s total equity improved to RMB 729,655 thousand in 2024, compared to RMB 686,686 thousand in 2023, reflecting an increase of approximately 6.3%[21]. - Non-current assets totaled RMB 765,495 thousand in 2024, up from RMB 732,926 thousand in 2023, indicating a growth of about 4.4%[21]. Research and Development - Research and development expenses decreased to RMB 79,313 thousand in 2024 from RMB 103,890 thousand in 2023, indicating a reduction of approximately 23.8%[18]. - The company plans to continue its focus on research and development in anti-tumor drugs and expand its contract development and manufacturing organization (CDMO) services[25]. - The company has invested approximately RMB 180 million in the construction of a global R&D service center, with total expenditures related to this project amounting to RMB 43,489 thousand as of December 31, 2024[75]. - The company has streamlined its R&D pipeline, leading to a continuous reduction in new drug R&D expenses and effectively improving cash flow, achieving a milestone of turning losses into profits[110]. Market and Strategic Initiatives - The company aims to deepen its international market presence and enhance its operational capabilities by collaborating with leading global pharmaceutical companies[15]. - The company is positioned to benefit from favorable policies that support the transfer of overseas production drugs to domestic production, enhancing its opportunities in the global supply chain[82]. - The company aims to enhance its brand presence in the biopharmaceutical CDMO sector through various industry collaborations and exchanges in 2024, focusing on precise customer targeting and resource integration[119]. - The company aims to enhance international competitiveness by accelerating overseas market expansion and strengthening strategic cooperation with leading international pharmaceutical companies[132]. Corporate Governance and Compliance - The company has adopted the principles and provisions of the corporate governance code as a foundation for its corporate governance practices, ensuring high standards to protect shareholder rights[141]. - The company has confirmed compliance with the standard code for securities transactions by directors for the fiscal year ending December 31, 2024[142]. - The company’s financial statements for the fiscal year ending December 31, 2024, have been audited and received an unqualified opinion from the auditor[154]. Events and Recognition - Dongyao Pharmaceutical participated in the inaugural Future XDC New Drug Conference in April 2024, where it was recognized as a "Pioneer Enterprise in ADC/Nucleic Acid New Infrastructure"[120]. - The company showcased its innovative achievements in ADCs at the CBA-China annual meeting in June 2024, reinforcing its strategic positioning in the global biopharmaceutical industry[123]. - Dongyao Pharmaceutical held an ADC & XDC drug development and innovation technology exchange meeting in November 2024, promoting the GL-DisacLink® technology and enhancing collaboration with Sugar Ridge Biotech[125].

Financial Performance - The company achieved a revenue of RMB 520.6 million for the first half of 2024, representing a 59% increase year-on-year[5]. - The net profit for the first half of 2024 was RMB 31.6 million, marking a turnaround from previous losses[5]. - In the first half of 2024, the company's operating revenue reached RMB 520,603 thousand, an increase of RMB 192,540 thousand or 59% compared to RMB 328,063 thousand in the same period of 2023[41]. - The net profit for the first half of 2024 was RMB 31,559 thousand, a turnaround from a net loss of RMB 15,163 thousand in the same period of 2023[41]. - The basic and diluted earnings per share for the first half of 2024 was RMB 0.04, compared to a loss per share of RMB 0.02 in the same period of 2023[49]. - The company reported a net profit attributable to equity holders of RMB 31,559 thousand, a significant turnaround from a loss of RMB 15,163 thousand in the previous year[54]. - Revenue for the six months ended June 30, 2024, reached RMB 520,603 thousand, a 58.6% increase from RMB 328,063 thousand in the same period of 2023[50]. - Operating profit for the period was RMB 33,258 thousand, compared to an operating loss of RMB 14,576 thousand in the prior year[50]. Revenue Breakdown - Product sales revenue reached RMB 400.4 million, a 44% increase, primarily driven by the sales of the core product, Puxintin® (Bevacizumab Injection)[5]. - CDMO/CMO business revenue was RMB 113.8 million, showing a significant growth of 144% compared to the previous year[5]. - CDMO/CMO business revenue for the first half of 2024 was RMB 113,791 thousand, a significant increase of RMB 67,245 thousand or 144% from RMB 46,546 thousand in the same period of 2023[41]. - The company has a backlog of unfulfilled orders amounting to RMB 184 million, which is a 100% increase year-on-year[5]. Product Development and Market Expansion - The company plans to complete its first country approval for overseas market expansion in the second half of 2024, initiating commercial sales[3]. - The company has initiated registration applications for market entry in 31 overseas countries, with 17 applications already accepted, aiming for approval in the first overseas market by the end of 2024[11]. - The company is focusing on a differentiated sales strategy for its core product, which has gained a good market reputation and supports sustainable development[3]. - The company has successfully obtained 2 pre-BLA projects in the first half, totaling 8 in hand, showcasing its strong capabilities in later-stage commercialization[5]. - The company plans to continue focusing on the biopharmaceutical CDMO sector and advance more projects in the second half of 2024[38]. Research and Development - Research and development expenses for the first half of 2024 amounted to RMB 46,059 thousand, a decrease of RMB 3,910 thousand from RMB 49,969 thousand in the same period of 2023[41]. - The company has maintained a focus on research and development in anti-tumor drugs and biopharmaceuticals, indicating ongoing investment in innovation[56]. - The company is exploring new targeted methods in ADC development, indicating potential for significant market opportunities in the future[19]. Market Trends and Projections - The global ADC market is expected to grow from USD 7.9 billion in 2022 to USD 64.7 billion by 2030, with a CAGR of 30.0% from 2022 to 2030[15]. - The ADC drug market reached USD 10 billion in 2023, with five products exceeding USD 1 billion in sales, indicating a significant growth phase for ADC products[19]. - The global market for Bevacizumab is projected to reach nearly RMB 49 billion by 2030, with a CAGR of 7.6% from 2021 to 2030[10]. - The ADC CDMO market is projected to grow to USD 11 billion by 2030, with a CAGR of 28.4% from 2022 to 2030[20]. Operational Efficiency - The company has completed over 60 GMP audits as of June 30, 2024, including zero-defect passes for EU QP audits and successful audits from Colombia, Indonesia, and Egypt[24]. - The company maintains a high production operation efficiency with over 95% staffing rate in production positions and 90% in key ADC technical roles[29]. - The company has established a one-stop, end-to-end antibody and ADC service platform, positioning itself as a leading CDMO service provider in the industry[21]. Financial Position and Liabilities - Total liabilities to total assets ratio remained stable at 0.5 as of June 30, 2024, consistent with the ratio reported on December 31, 2023[43]. - As of June 30, 2024, the company had outstanding bank borrowings of RMB 383,008 thousand, an increase from RMB 344,285 thousand at the end of 2023[43]. - The company's total assets as of June 30, 2024, amounted to RMB 1,456,654 thousand, up from RMB 1,426,101 thousand at the end of 2023, indicating a growth of 2.1%[52]. Shareholder Information and Stock Options - The total number of shares issued by the company is 772,787,887, with major shareholders holding significant stakes, including 28.59% by Shengde Pharmaceutical Co., Ltd. and 15.04% by Suzhou Weiwang Management Consulting Partnership[101][102]. - The company has implemented a pre-IPO share option plan to attract and retain talent, with options granted to key personnel, including 1,000,000 shares to Dr. Liu Jun, which are subject to vesting conditions[107][108]. - The company has granted stock options to senior management and other employees totaling 5,247,100 shares, with various vesting periods[109]. Future Outlook - The company provided an optimistic outlook for the second half of 2024, projecting a revenue growth of 20% to 30% driven by new product launches and market expansion[132]. - The company aims to achieve a net profit margin of 15% by the end of 2024, up from 12% in the first half of the year[132]. - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2025[132].

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香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 – 1 – 本 公 告 載 有 涉 及 風 險 及 不 明 確 因 素 的 前 瞻 性 陳 述。除 過 往 事 實 陳 述 以 外 的 所 有 陳 述 均 為 前 瞻 性 陳 述。該 等 陳 述 涉 及 已 知 及 未 知 的 風 險、不 明 確 及 其 他 因 素，當 中 部 分 並 非 本 公 司 所 能 控 制，且 可 導 致 實 際 業 績、表 現 或 成 果 與 該 等 前 瞻 性 陳 述 所 明 示 或 暗 示 者 存 在 重 大 差 異。 閣下不應依賴前瞻性陳述作為未來 事 件 的 預 測。本 公 司 概 不 承 擔 任 何 更 新 或 修 訂 任 何 前 瞻 性 陳 述 的 責 任，無 論 是 否 由 於 新 資 料、未 來 事 件 或 其 他 因 素 所 致。 TOT BIOPHARM International Company ...

股份代號: 1875 目錄 2 公司資料 77 獨立核數師報告 綜合財務報表： 綜合全面虧損表 綜合資產負債表 綜合權益變動表 綜合現金流量表 綜合財務報表附註 159 五年財務概要 160 釋義 164 環境、社會及管治報告 3 首席執行官報告 6 若干財務項目的管理層討論及分析 14 若干業務環節的管理層討論及分析 83 84 30 董事及高級管理人員的個人簡歷 86 36 企業管治報告 87 56 董事會報告 88 公司資料 執行董事 劉軍博士（首席執行官） 獨立非執行董事 薪酬委員會 提名委員會 核數師 聯席公司秘書 陳一帆先生 呂穎一先生 （香港公司治理公會及英國特許公司治理公會會員） 非執行董事 付山先生（董事長） 黃純瑩女士 （副董事長； 自2023年1月1日起由執行董事調任為非執行董事） 裘育敏先生（自2023年8月12日起辭任） 劉衛東博士（自2023年8月12日起獲委任） 胡蘭女士 張鴻仁先生 汪德潛博士 審計與關聯方交易審核委員會 胡蘭女士（主席） 裘育敏先生（自2023年8月12日起辭任） 劉衛東博士（自2023年8月12日起獲委任為成員） 張鴻仁先生 裘育敏先生（自2023年8月12 ...

即时点评 朴欣汀快速增长，ADC CDMO 业务优势明显 点评观点： ➢ 朴欣汀高速增长，海外市场潜力大： 目前朴欣汀优势明显，产品质量十分优质，拥有 100%生产合格率， 目前在国内覆盖七个适应症，国外八个适应症，包括结直肠癌、非小 细胞肺癌、胶质母细胞瘤、上皮性卵巢癌、输卵管癌或原发性腹膜癌、 宫颈癌，其中肝癌，拥有两万升产能和 100%的生产合格率；产能充 足，拥有 2 万升规模一次性生物反应器，满足市场稳定供应。已经启 动 23 个海外国家的上市注册申请工作，已有 13 个国家的上市申请 文件获得受理，预计在 2024 年完成首个海外国家获批，打开海外市 场。对国内市场，公司选择与济民可信合作，重点布局市场空间巨大 的二三线城市及药店双通道省份，加强渗透三四线及县域级城市。对 海外市场，2022 上半年公司与科兴制药签订了产品在海外市场独家商 业化许可的合作协议。公司之前准确的商业化战略，奠定了业绩快速 增长的基础，未来业绩持续增长值得期待。 ➢ 我们的观点： ➢ 上市产品商业化推广顺利，业绩增长迅速： ➢ CDMO 业务推进迅速，ADC 方面竞争优势明显: 23 年公司 CDMO 业务实现收入 1. ...

Financial Performance - The group's total revenue for 2023 was RMB 780,629 thousand, representing a 77% year-on-year increase[1]. - The net loss for 2023 was RMB 37,757 thousand, a reduction of RMB 12,289 thousand or 25% compared to the net loss of RMB 50,046 thousand in 2022[6]. - Adjusted EBITDA for the year was RMB 40,041 thousand, reflecting a substantial increase of 274% year-on-year[14]. - The total comprehensive loss for the year ended December 31, 2023, was RMB 36,020 thousand, an improvement from RMB 43,732 thousand in 2022[21]. - The company reported total revenue of RMB 780,629 thousand for the year ended December 31, 2023, compared to RMB 442,178 thousand in 2022[31]. - The overall comprehensive loss for the year was RMB 36,020 thousand, a decrease from RMB 43,602 thousand in the previous year[44]. - The company's operating revenue for 2023 was RMB 780,629 thousand, an increase of RMB 338,451 thousand or 77% compared to RMB 442,178 thousand in 2022[66]. - The net loss for 2023 was RMB 37,757 thousand, a reduction of RMB 12,289 thousand or 25% from a net loss of RMB 50,046 thousand in 2022[66]. - The group's financial income for 2023 was RMB 2,974 thousand, an increase of RMB 709 thousand from RMB 2,265 thousand in 2022, primarily due to optimized fund allocation[124]. - The group's financial cost for 2023 was RMB 5,175 thousand, a decrease of RMB 1,427 thousand from RMB 6,602 thousand in 2022, mainly due to the repayment of part of the working capital loans[125]. Revenue Sources - Product sales revenue reached RMB 630,207 thousand, a 107% increase year-on-year, primarily driven by significant sales growth of the core product, Puxinting® (Bevacizumab Injection)[1]. - CDMO/CMO business revenue was RMB 140,898 thousand, up 94% year-on-year, with a total of 39 new projects added, a 44% increase compared to the previous year[7]. - The company achieved a stable cash flow contribution from product commercialization, with total sales revenue reaching RMB 630 million[38]. - The company's CDMO/CMO business revenue for 2023 was RMB 140,898 thousand, an increase of RMB 68,360 thousand from RMB 72,538 thousand in 2022, primarily due to large-scale expansion in the CDMO/CMO sector[91]. Research and Development - R&D expenses increased to RMB 103,890 thousand, up from RMB 71,563 thousand in 2022[42]. - Research and development expenses for 2023 amounted to RMB 103,890 thousand, down from RMB 151,168 thousand in 2022[66]. - The company has established a global R&D service center in October 2023, covering an area of 25,000 square meters, to enhance CDMO business capabilities[16]. - The company has formed strategic collaborations to accelerate the development and commercialization of innovative conjugated drugs[33]. Production and Capacity - The company has optimized its production lines, significantly enhancing flexibility and capacity, with annual production capacity of 300,000 liters for antibody raw materials and 20 million doses for formulations[16]. - The second ADC formulation production line commenced operation in June 2023, with over 10 projects, including 3 pre-BLA projects, already produced on this line[16]. - The company has built a large-scale ADC formulation commercial production line with an annual capacity of 5.3 million bottles, significantly improving production flexibility and capacity[33]. - The company has established a large-scale commercial production line for ADC raw materials and formulations, with an annual production capacity of 300,000 liters for antibody raw materials and over 20 million doses for formulations[144]. Strategic Collaborations - The company has formed multiple long-term strategic collaborations with various biopharmaceutical companies, enhancing its ADC CDMO competitive advantage[15]. - The company has partnered with Sugar Ridge Biologics to co-develop the DisacLinkTM ADC glyco-conjugation technology platform, promoting accelerated development in the ADC industry[161]. - The company established a strategic partnership with Shijian Biotech to support the clinical and commercial development of ADC drugs[164]. - A comprehensive CDMO strategic collaboration was formed with Borui Biotech to provide one-stop CDMO services for multiple ADC development projects[165]. Market Outlook - The core product, Puxinting®, has achieved a market size exceeding RMB 10 billion, with a projected global market size for Bevacizumab expected to reach nearly RMB 49 billion by 2030, growing at a CAGR of 7.6% from 2021 to 2030[179]. - The Chinese market for Bevacizumab is anticipated to grow to RMB 18.4 billion by 2030, with a CAGR of 8.3% from 2021 to 2030[179]. Operational Metrics - The CDMO team has increased by 34% compared to the end of 2022, now comprising 464 members, with a core technical team averaging over 12 years of experience in biopharmaceuticals[18]. - The company added 39 new projects in the CDMO business, a year-on-year increase of 44%, bringing the total to 95 projects, with ADC projects accounting for 30 of the new additions[160]. - The company has successfully secured 4 pre-BLA projects, totaling 6 pre-BLA projects, showcasing its strong capabilities in commercializing CDMO projects[160]. Financial Position - Total assets increased to RMB 1,426,101 thousand, up from RMB 1,262,031 thousand in 2022[46]. - The company's net assets as of December 31, 2023, were RMB 686,686 thousand, a decrease of RMB 28,753 thousand from RMB 715,439 thousand at the end of 2022, primarily due to the net loss incurred during the period[118]. - The total liabilities to total assets ratio increased to 0.5 as of December 31, 2023, compared to 0.4 at the end of 2022, primarily due to increased long-term bank loans for the global R&D service center construction[154]. Compliance and Quality - The company has established a quality management system compliant with commercial production standards, supporting the commercialization of two listed products[170]. - The company has successfully completed 7 regulatory inspections by NMPA and other global regulatory bodies, ensuring compliance with high industry standards[170]. - The company is committed to continuously improving its international quality management system to provide high-quality services to clients[170].

本集團於2023年6月30日並無按公允價值計量的資產。下表呈列本集團於2022年12月31日按公允價值計量的資 產。 5 分部及收益資料 2023年中期報告 東曜藥業股份有限公司 34 中期簡明綜合財務資料附註 折舊及攤銷費用 (16,583) (845) (1,244) | --- | --- | --- | |------------------------------------------|---------------------------------------|-----------------------------------| | | 截至 6 月 30 \n2023 年 \n人民幣千元 | 日止六個月 \n2022 年 \n人民幣千元 | | 於1月 1 日的期初結餘 | 40,278 | – | | 添置 | 280,000 | – | | 按公允價值計入損益的金融資產公允價值變動 | 937 | – | | 處置 | (321,215) | – | | 於6月 30 日的期末結餘 | – | – | (a) 貿易應收款項（續） 於2023年6月30日及2022年12月31日，合共4 ...