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6月25日开幕,门票即将告罄!2025最Hot的抗体Plus创新峰会
生物世界· 2025-06-23 09:55
主办单位: BioPlus 承办单位: 迫界生物 执行单位: 苏州盛杰 特约支持: BioBAY 分论坛联合主办: 东曜药业、播禾创新、智药局 私董会联合主办: 科百特、纳微科技、恒驭生物 支持单位: 三优生物、 Twist Bioscience、 诺纳生物、布鲁克细胞分析、康源博创、大湾生物、中新生命科学园 Biosparc 合作媒体: 医药笔记、生物世界、新耀俱乐部管理有限公司、A ntibody Research、医药速览、小药说药、新药启航、 丁香园Insight数据库、研在云 基础门票:200元; 含2天公开会议,不含餐 会议门票:500元; 含2天公开会议,2天午餐 免费门票:0元;仅开放 生物医药投资人、Biotech/药企、临床/院校科学家; 兑换码;详情咨询: Times 150 6123 2737 主题: 2025抗体Plus创新峰会 时间:6 月25-26日(周三/四) 地点: 中国 苏州工业园区中茵皇冠假日酒店 参会报名 审核制;扫描下方二维码可报名 ▼ 免费门票即将告罄!符合申请条件的观众,转发本文到朋友圈集赞30个,即可领取。 背景介绍 从1986年FDA批准第一批单克隆抗体(An ...
科兴制药引进产品贝伐珠单抗获尼日利亚上市批准
news flash· 2025-06-05 07:02
Core Viewpoint - The collaboration between Kexing Pharmaceutical and Dongyao Pharmaceutical has led to the approval of a biosimilar product, Bevacizumab injection, by the Nigerian Food and Drug Administration, marking a significant advancement in the company's strategy in the African pharmaceutical market [1] Group 1 - The approved Bevacizumab injection is indicated for the treatment of metastatic colorectal cancer, advanced or metastatic or recurrent non-small cell lung cancer, recurrent glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer [1] - The approval signifies an important step for the company in establishing its presence in the core pharmaceutical market of Africa [1]
东曜药业(01875) - 2024 - 年度财报
2025-04-28 09:43
Financial Performance - The company achieved a significant milestone with annual revenue surpassing 1 billion RMB, marking its first profitable year[11]. - The company's revenue for 2024 reached RMB 1,098,329 thousand, a 41% increase from RMB 780,629 thousand in 2023[23]. - The net profit for 2024 was RMB 34,757 thousand, compared to a net loss of RMB 37,757 thousand in 2023, marking a turnaround[23]. - The company achieved an adjusted net profit of RMB 31,437 thousand in 2024, compared to an adjusted net loss of RMB 8,162 thousand in 2023[22]. - Adjusted EBITDA for 2024 was RMB 106,734 thousand, significantly up from RMB 40,041 thousand in 2023[22]. - The company's product sales revenue for 2024 reached RMB 877,410 thousand, an increase of RMB 247,203 thousand from RMB 630,207 thousand in 2023, primarily driven by steady growth in the core product Puxinting® sales[24]. - CDMO/CMO business revenue for 2024 was RMB 207,133 thousand, up RMB 66,235 thousand from RMB 140,898 thousand in 2023, due to continuous expansion in the CDMO/CMO sector[24]. - The company’s operating cash flow has been positive for three consecutive years, reaching RMB 116,403 thousand in 2024[55]. - The company turned a profit with a net profit of RMB 34,757 thousand for the year, marking a significant turnaround[57]. Research and Development - The company is focusing on the rapidly growing antibody-drug conjugate (ADC) market, which has seen increased global development and approval of ADC drugs[11]. - The newly launched BDKcellTM cell line construction technology platform can achieve a maximum expression level of 12g/L, significantly improving overall process efficiency[14]. - The DisacLinkTM glycoengineering technology platform has garnered significant attention from both domestic and international clients, accelerating the development and commercialization of innovative conjugated drugs[14]. - The company is actively pursuing strategic collaborations to build a biopharmaceutical R&D service platform, enhancing ADC drug development and CDMO services[14]. - The revenue and number of ADC projects in the company's pipeline are steadily increasing, with multiple pre-BLA projects progressing in an orderly manner[14]. - The company added 58 new projects in the year, including 48 ADC projects, bringing the total to 153 projects[57]. - The company has accumulated 8 pre-BLA (pre-Biologics License Application) projects, with 2 new additions in the year[69]. - The company has successfully completed multiple ADC and XDC projects, demonstrating strong delivery capabilities in late-stage clinical and commercialization projects, laying a solid foundation for long-term business development[78]. Market Strategy and Expansion - The company aims to deepen its international market presence and enhance cooperation with top global pharmaceutical companies[16]. - The company plans to continue investing in technological innovation and strengthen collaboration with research institutions[16]. - The company plans to complete its first overseas country approval and initiate commercialization by 2025[54]. - Future strategies include accelerating overseas market expansion and enhancing service quality to improve international operational levels and global market share[97]. - The ADC drug market is projected to grow from USD 10 billion in 2023 to USD 66.2 billion by 2030, with a compound annual growth rate of 30.3%[58]. Operational Excellence - The company has equipped four international-class commercial production lines to ensure high-standard production for client projects and improve production flexibility[13]. - The company has a unique integrated industrial platform with commercial production experience, positioning it as a leader in the CDMO sector[68]. - The company has received positive feedback from multinational pharmaceutical companies during audits, indicating high recognition of its quality system[69]. - The company established a comprehensive quality management system that meets the standards of China, the US, and the EU, ensuring compliance with regulatory requirements[70]. - The company has successfully passed 38 GMP audits in 2024, including 7 official GMP audits, demonstrating its commitment to quality management[70]. Governance and Management - The company appointed three independent non-executive directors, enhancing its governance structure[107]. - The new COO, Dr. Zhang Jian, has nearly 20 years of experience in the biopharmaceutical industry, focusing on production operations and supply chain management[110]. - The company’s new CTO, Ms. Yin Li, has over 30 years of experience in the chemical and biopharmaceutical sectors, overseeing ADC research and international business expansion[111]. - The company’s VP of Quality, Mr. Li Hongyang, brings extensive experience in quality management from multinational pharmaceutical companies[112]. - The company’s VP of Financial and Investor Relations, Ms. Xiao Bin, has a strong background in financial management and investor relations from previous roles in multinational firms[114]. - The board consists of a balanced mix of executive and non-executive directors, ensuring strong independence and effective decision-making[125]. - The company has established a strict written guideline for employees regarding securities trading, ensuring compliance with insider trading policies[124]. - The board has adopted a diversity policy, emphasizing the importance of board member diversity for maintaining competitive advantage[164]. Risk Management - The company is focused on risk management and has implemented measures to identify and manage overall business risks[123]. - The company confirmed their responsibility for the effectiveness of the risk management and internal control systems, which aim to manage significant risks rather than eliminate them[178]. - The company established a risk governance framework to identify, assess, resolve, monitor, and communicate key risks, including strategic, financial, operational, and compliance risks[178]. - The audit and related party transaction review committee assists the board in overseeing the design, implementation, and monitoring of risk management and internal control systems[182]. Corporate Social Responsibility - The company is committed to fulfilling social responsibilities by providing high-quality medicines to meet patient needs[16]. - The company aims to provide satisfactory and sustainable returns to its investors and shareholders while balancing the interests of stakeholders including employees, customers, and suppliers[123]. - The company is committed to becoming a trusted partner in the global biopharmaceutical field, contributing more to human health[97].
东曜药业-B:首次扭亏为盈,经营现金流连续三年正向-20250320
国证国际证券· 2025-03-20 11:12
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 ...
东曜药业(01875) - 2024 - 年度业绩
2025-03-11 14:47
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].
东曜药业(01875) - 2024 - 中期财报
2024-09-25 09:58
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].
东曜药业-B:朴欣汀推动业绩快速增长,ADC CDMO渐入佳境
国元国际控股· 2024-08-16 02:10
证 券 研 究 报 告 | --- | --- | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ...
东曜药业(01875) - 2024 - 中期业绩
2024-08-13 13:58
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 ...
东曜药业(01875) - 2023 - 年度财报
2024-04-26 10:01
Financial Performance - The company achieved a revenue of RMB 780,629 thousand, representing a year-on-year growth of 77%[13] - Product sales revenue reached RMB 630,207 thousand, a significant increase of 107% year-on-year, primarily driven by the strong sales performance of the core product, Puxintin (Bevacizumab injection)[13] - CDMO/CMO business revenue was RMB 140,898 thousand, reflecting a year-on-year growth of 94%[13] - The adjusted EBITDA was RMB 40,041 thousand, showing a substantial increase of 274% year-on-year[18] - The net loss narrowed to RMB 37,757 thousand, a reduction of RMB 12,289 thousand or 25% compared to the previous year[18] - The adjusted net loss for the year was RMB 37.76 million, a 25% improvement compared to the previous year, while total comprehensive loss decreased by 18% to RMB 36.02 million[28] - The adjusted net loss for 2023 was RMB 8,162 thousand, a decrease of RMB 25,773 thousand compared to the adjusted net loss of RMB 33,935 thousand in 2022[35] - Total revenue for 2023 reached RMB 780,629 thousand, representing a 77% increase from RMB 442,178 thousand in 2022[36] - Product sales revenue for 2023 was RMB 630,207 thousand, up from RMB 304,361 thousand in 2022, primarily due to a significant increase in sales of the core product, Puxintin®[37] - 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, attributed to large-scale expansion of the CDMO/CMO business segment[37] Operational Highlights - The company maintained a positive operating cash flow of RMB 56,431 thousand[18] - The company has established a high-standard commercial production platform integrating antibodies, ADC raw solutions, and formulations[22] - The CDMO business experienced a growth rate exceeding the industry average, with 39 new projects added in 2023, representing a 44% year-over-year increase, totaling 95 projects[23] - Among the new projects, 30 are related to ADC, highlighting the company's differentiated advantage in this field, with ADC projects now accounting for 65% of both revenue and project count among the 65 ongoing projects[23] - The company has accumulated 6 pre-BLA projects, with 4 being newly added, showcasing its strong capabilities in commercializing CDMO projects[23] - The company optimized its production lines, significantly enhancing flexibility and capacity, with annual production capacities of 300,000 liters for antibody raw materials and 20 million doses for formulations[25] - The second ADC formulation production line commenced operations in June 2023, with over 10 projects already produced, including 3 pre-BLA projects[25] - The total number of employees reached 551 as of December 31, 2023, with the CDMO team increasing by 34% compared to the end of 2022, now comprising 84% of the total workforce[24][26] Strategic Initiatives - Strategic collaborations have been formed with multiple companies, including Lepu Biopharma and Shijian Biopharma, to enhance ADC CDMO differentiation advantages[22] - The company initiated the construction of a global R&D service center in 2021, which officially opened on October 19, 2023, covering an area of 25,000 square meters[25] - The company expects to complete its first overseas approval in 2024, which will provide new treatment options for a broader patient population globally[26] - A strategic partnership was formed with Sugar Ridge Bio to develop the DisacLink™ ADC technology platform, enhancing the company's competitive edge in ADC drug development[70] - The company is focused on becoming a leading CDMO partner in the bioconjugate drug sector, enhancing service quality and technical capabilities to build customer loyalty[99] Research and Development - Research and development expenses for 2023 were RMB 103,890 thousand, down from RMB 151,168 thousand in 2022, mainly due to streamlining of product pipelines[38] - The company streamlined its R&D pipeline, leading to a continuous decrease in new drug R&D expenses while actively promoting sales of already launched products to improve cash flow[83] - The commercialization agreement for TAB014, aimed at treating wet age-related macular degeneration (wAMD), was signed with a subsidiary of Zhaoke Ophthalmology, with Phase III clinical trial patient enrollment completed ahead of schedule on September 16, 2023[83] Corporate Governance - The company has adopted the principles and provisions of the corporate governance code as outlined in Appendix C1 of the listing rules[142] - The board is committed to maintaining high ethical standards and ensuring activities are conducted with accountability, transparency, fairness, and responsibility[142] - The company has established its own corporate governance policy, which includes principles and practices from the corporate governance code[142] - The board of directors consists of seven members, including one executive director and three independent non-executive directors, ensuring a balanced skill set and independence[146] - The company has implemented strict written guidelines for employees regarding insider trading, ensuring adherence to ethical standards[144] Management and Leadership - Yin Li joined the company as Chief Technology Officer in November 2023, bringing over 30 years of experience in the chemical and biopharmaceutical industry[127] - Dr. Pan Zhiwei was appointed as Vice President of CMC in March 2023, responsible for process development and project management, with previous experience at Shanghai Junshi Biosciences[128] - Li Hongyang will join the company as Vice President of Quality in January 2024, with extensive experience in quality management from Novartis and other multinational pharmaceutical companies[129] - The management team has a strong background in biopharmaceuticals, with members having held significant positions in leading companies like Amgen and Bayer[127][128] Market Expansion - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by 2025[124] - The company initiated registration applications for market approval in 23 overseas countries, with 13 applications already accepted, aiming for the first overseas approval in 2024[87] Financial Position - The company's cash and cash equivalents decreased to RMB 351,600 thousand in 2023 from RMB 417,769 thousand in 2022, a reduction of RMB 66,169 thousand[60] - Operating cash inflow for 2023 was RMB 56,431 thousand, down from RMB 59,929 thousand in 2022, reflecting a decrease of approximately 5.8%[60] - The company's total liabilities rose to RMB 739,415 thousand in 2023 from RMB 546,592 thousand in 2022, marking an increase of about 35.1%[58] - The current ratio decreased to 1.8 in 2023 from 2.5 in 2022, indicating a decline in liquidity[62] Awards and Recognition - In 2023, the company achieved significant growth in the CDMO business, receiving multiple industry awards and recognition, including being ranked in the top 10 most growth-oriented CDMO companies in China[114]
朴欣汀快速增长,ADC CDMO业务优势明显
国元国际控股· 2024-03-21 16:00
Investment Rating - The report suggests a positive outlook on the company, indicating it is undervalued and recommends active attention to its growth potential [15]. Core Insights - The company is experiencing rapid growth, particularly in overseas markets, with a strong product quality and a 100% production qualification rate [4]. - The commercial promotion of listed products is progressing smoothly, contributing to significant revenue growth [5]. - The CDMO business is advancing quickly, with a notable competitive advantage in the ADC sector [6]. Summary by Sections Company Growth and Market Potential - The company has a robust presence in both domestic and international markets, covering multiple indications such as colorectal cancer and non-small cell lung cancer, with plans for further expansion [4]. - It has initiated registration applications in 23 overseas countries, with 13 applications already accepted, aiming for approval in the first overseas market by 2024 [4]. Financial Performance - In 2023, the company reported revenues of 781 million RMB, a 77% year-on-year increase, while net losses narrowed by 25% to 37.76 million RMB [8]. - Adjusted EBITDA reached 40.04 million RMB, reflecting a 274% increase, and operating cash flow remained positive for two consecutive years [8]. CDMO Business Development - The CDMO segment generated 140 million RMB in revenue in 2023, a 94% increase year-on-year, with over 137 million RMB in hand orders and 39 new projects, 30 of which are ADC projects [7]. - The workforce in the CDMO division has grown by 34% compared to the end of 2022, with a 46% increase in the ADC CDMO team [7]. - The company has established long-term partnerships for ADC projects, enhancing its service offerings from R&D to commercialization [7].