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 ...

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。 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 Limite ...

2024 # 東曜藥業股份有限公司 TOT BIOPHARM International Company Limited (於香港註冊成立的有限公司) 股份代號: 1875 目錄 2 公司資料 3 管理層討論及分析 17 財務回顧 綜合財務資料： 21 中期簡明綜合全面收益╱（虧損）表 22 中期簡明綜合資產負債表 24 中期簡明綜合權益變動表 25 中期簡明綜合現金流量表 26 中期簡明綜合財務資料附註 40 其他資料 53 釋義 | --- | --- | --- | |-------|------------------------------------------------|---------------------------------------------------------| | | 公司資料 公司資料 公司資料 | 東曜藥業股份有限公司 \| 2024 年中期報告 | | | | | | | | | | | | | | | | | | | 執行董事 | 股份過戶登記處 | | | 劉軍博士 （首席執行官） | 卓佳證券登記有限公司 | | | | 香港 | | | 非執行董事 | ...

证 券 研 究 报 告 | --- | --- | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ...

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 ...

Financial Data and Key Metrics Changes - The company's total revenue for the first half of 2023 reached RMB 328 million, representing an 80% year-on-year increase. Excluding the impact of licensing fees from the previous year, the revenue growth was 147% [11][13][17] - Adjusted EBITDA turned positive for the first time at RMB 13.5 million, compared to a loss of RMB 37.49 million in the same period last year [19][15] - Operating cash flow for the first half of 2023 was RMB 62.41 million, a significant increase of 116% year-on-year [20][11] Business Line Data and Key Metrics Changes - The CDMO revenue was RMB 46.55 million, reflecting a 105% increase compared to the previous year [11][17] - The company has focused on ADC technology, with the number of ADC projects increasing from 8 to 28, a growth of 250% [9][31] - The company has established the largest ADC commercial production line in China, with an annual production capacity of 530,000 units [11][16] Market Data and Key Metrics Changes - The market for ADCs is expected to grow significantly, with the potential for the market size of Bevacizumab in China to reach RMB 18.4 billion [5][9] - The company has initiated registration applications in 20 overseas countries, with 8 applications already accepted [7][9] Company Strategy and Development Direction - The company aims to continue focusing on the ADC CDMO market and expand into XDC and other antibody-based therapies [11][15] - The strategy includes enhancing the production capabilities and maintaining a competitive edge through a fully integrated ADC production platform [12][19] - The company plans to leverage its established relationships and technology to capture a larger share of the ADC market [11][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about maintaining growth momentum in the second half of 2023, expecting at least similar performance to the first half [11][15] - The company acknowledges the challenges in the financing environment for biotech firms but remains confident in the demand for ADCs [11][27] - The management highlighted the importance of strategic partnerships and collaborations to enhance market presence and operational efficiency [12][31] Other Important Information - The company has achieved a project success delivery rate of 100%, indicating strong operational capabilities [12][19] - The workforce in the CDMO segment has increased by 13% since the end of 2020, with a focus on enhancing technical expertise [9][10] Q&A Session Summary Question: What is the current status of the company's orders and future timelines? - The company has a total order backlog of RMB 1.2 billion, with RMB 900 million expected to convert into revenue [20][21] Question: How does the company plan to expand its overseas market presence? - The company is focusing on emerging markets and has initiated collaborations to enhance its international footprint [27][30] Question: What are the key differences in customer structure compared to competitors? - The company has a strong focus on ADC projects, with a higher proportion of late-stage clinical projects compared to competitors [32][33]