Dongcheng Biochem(002675)

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东诚药业:关于合肥核药生产中心投入运营的公告
2024-06-13 11:02
证券代码:002675 证券简称:东诚药业 公告编号:2024-045 关于合肥核药生产中心投入运营的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有 虚假记载、误导性陈述或重大遗漏。 近日,烟台东诚药业集团股份有限公司(以下简称"公司")收到全资子公 司南京江原安迪科正电子研究发展有限公司(以下简称"安迪科")的通知,通 知其收到江苏省药品监督管理局下发的《放射性药品生产许可证》,新增安徽合 肥核药生产中心。相关信息如下: 企业名称:安徽安迪科药业有限公司 地址:安徽省合肥市包河经济开发区繁华大道与吉林路交口联东U谷一期51 号楼 药品名称:氟[ 18F]脱氧葡糖注射液 药品批注文号:国药准字[H20103293] 烟台东诚药业集团股份有限公司 结论:经材料审查,符合法规要求,同意安徽合肥核药生产中心投入生产运 营。 此次审查的通过标志着安迪科的安徽合肥核药生产中心已达到投产要求,安 迪科将新增一个核药生产中心。核药生产中心投产后,将有利于安迪科开拓市场、 提升销售收入,进一步完善全国核药网络化建设布局。 特此公告。 烟台东诚药业集团股份有限公司董事会 2024 年 6 月 14 日 ...
东诚药业:关于为子公司及其下属公司提供担保的进展公告
2024-06-05 10:25
证券代码:002675 证券简称:东诚药业 公告编号:2024-044 烟台东诚药业集团股份有限公司 关于为子公司及其下属公司提供担保的进展公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有 虚假记载、误导性陈述或重大遗漏。 一、 本次担保情况概述 近日,烟台东诚药业集团股份有限公司(以下简称"公司")与上海浦东发 展银行股份有限公司天津分行(以下简称"上海浦发银行"或"债权人")签订 了《保证合同》,约定公司为全资子公司南京江原安迪科正电子研究发展有限公 司的全资子公司天津安迪科药业有限公司(以下简称"天津安迪科"或"债务人") 向上海浦发银行申请的15,000万元贷款提供连带责任担保。 二、 担保事项审议及额度使用情况 公司于2024年4月26日召开第六届董事会第四次会议,审议通过了《关于2024 年度为子公司及其下属公司提供担保额度预计的议案》,同意公司对合并报表范 围内的子公司及其下属公司提供担保,预计2024年度上述担保额度合计不超过人 民币9亿元(或等值外币),额度内可循环滚动操作。授权公司及子公司法定代 表人或其授权人员根据实际经营需要,在前述额度内分别代表其所在公司签署相 关 ...
东诚药业:核医药行业领军者,创新资产引领价值重塑
GF SECURITIES· 2024-05-29 03:31
Company Overview - Dongcheng Pharmaceutical is a leading domestic nuclear medicine company with three major business segments: nuclear medicine, APIs, and formulations [19] - The company has a stable equity structure, with Chairman You Shouyi directly holding 12.53% of shares and indirectly holding 15.15% through Dongyi Biotech [22] - In 2023, the company achieved revenue of 3.276 billion yuan, a year-on-year decrease of 8.6%, and net profit attributable to the parent company of 210 million yuan, a year-on-year decrease of 31.7% [25] Nuclear Medicine Business - The nuclear medicine business achieved revenue of 1.017 billion yuan in 2023, a year-on-year increase of 11.2%, with key products 18F-FDG and Yunke Injection growing 12% and 19.52% respectively [31] - The company has formed a complete nuclear medicine industry chain from diagnosis to treatment through strategic acquisitions and internal R&D [19][86] - Dongcheng has 7 single-photon drug production centers and 20 positron drug production centers in operation, with 8 more under construction, covering 93.5% of the domestic population [96] API and Formulation Business - The API business revenue declined 18.61% to 1.678 billion yuan in 2023, mainly due to weak global heparin market demand and customer inventory accumulation [31] - Formulation business revenue decreased 17.2% to 400 million yuan, impacted by price reduction of Nadroparin Calcium Injection in the 8th national drug procurement [31] - The company has a diversified formulation product portfolio covering anticoagulation, cardiovascular, oncology, urology, orthopedics and anti-infective fields [115] R&D and Innovation - Dongcheng established Lannacheng as an innovative nuclear medicine R&D platform in 2021, focusing on tumor, neurodegenerative and cardiovascular diseases [107] - The company has 392 R&D personnel, accounting for 16.8% of total employees, with R&D investment reaching 313 million yuan in 2023, a 77.2% year-on-year increase [38] - Key pipeline products include 99mTc-Tetrofosmin, 18F-APN-1607, 18F-Alfatide II and 99mTc-GSA, with several in late-stage clinical trials [103][104] Industry and Market - The domestic PET/CT installation is expected to reach 1,667 units by the end of the 14th Five-Year Plan period, driving demand for nuclear medicine diagnostic agents [92] - Novartis leads the global nuclear medicine industry through strategic acquisitions and partnerships, with key products Lutathera and Pluvicto achieving sales of 605 million USD and 980 million USD respectively in 2023 [64][65] - The α-emitter radiopharmaceuticals, such as 225Ac and 212Pb, are emerging as promising therapeutic options due to their higher energy and shorter range compared to β-emitters [48][49] Financial Projections - The company is expected to achieve revenue of 2.934 billion yuan in 2024, with nuclear medicine business contributing 1.151 billion yuan and maintaining a gross margin of 74% [125] - API business revenue is projected to be 1.165 billion yuan in 2024, while formulation business is expected to reach 401 million yuan [125] - Dongcheng's EPS is forecasted to be 0.37, 0.45 and 0.55 yuan/share for 2024-2026, with a target price of 16.60 yuan based on 45x 2024 PE [132]
东诚药业:关于控股子公司获得药物临床试验批准通知书的公告
2024-05-24 08:25
证券代码:002675 证券简称:东诚药业 公告编号:2024-043 2、SSTR2 是一种 G 蛋白偶联受体(GPCR),主要与生长抑素(Somatostatin) 结合,参与调节多种激素,包括生长激素、胰岛素和胃肠激素的分泌。NETs 在 烟台东诚药业集团股份有限公司 关于控股子公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 2024 年 5 月 23 日,烟台东诚药业集团股份有限公司(以下简称"公司"或 "上市公司")控股子公司烟台蓝纳成生物技术有限公司(以下简称"蓝纳成") 收到中国国家药品监督管理局(以下简称"国家药监局")核准签发的关于 177Lu- LNC1010 注射液的药物临床试验批准通知书,将于近期开展临床试验。 | | | | 药物名称 | 177Lu-LNC1010 注射液 | | --- | --- | | 剂型 | 注射剂 | | 申请事项 | 临床试验 | | 受理号 | CXHL2400286 | | 审批结论 | 根据《中华人民共和国药品管理法》及有关规定,经审查, | | | 你公司提 ...
东诚药业20240523
2024-05-24 04:29
Summary of the Conference Call for Dongcheng Pharmaceutical Company Overview - **Company**: Dongcheng Pharmaceutical - **Industry**: Pharmaceutical, specifically focusing on nuclear medicine and related products Key Points and Arguments 1. **Financial Performance**: - The company reported a decline in revenue for Q1 2024 compared to Q1 2023, primarily due to price trends in Gansu, which saw a decrease in prices starting from Q1 2023 [2][3] - Despite revenue pressure, profit margins remained stable, indicating effective cost management [3][5] 2. **Market Trends**: - The price of steel wire and ammonium sulfate has stabilized and is expected to improve in the second half of the year, contrasting with the previous year's downward trend [3][4] - The company anticipates a positive trend in Gansu's market, with expectations of price stability and potential increases in the latter half of 2024 [15][16] 3. **Product Development**: - The company is progressing with its nuclear medicine products, particularly the FDG (Fluorodeoxyglucose) segment, which is expected to show improvement in sales in the upcoming months [4][5] - A new product, a targeted therapy for myocardial function assessment, is in the main review stage and is expected to be approved in the first half of 2024 [9][12] 4. **Regulatory and Market Approval**: - The company submitted an NDA for a new product in late 2023, with expectations for approval and market entry by mid-2024 [9][27] - The company is actively engaging in academic promotion and establishing sales channels for new products [10][12] 5. **Sales and Marketing Strategy**: - The company is focusing on enhancing its sales and marketing strategies, particularly in the nuclear medicine sector, to ensure effective product distribution and market penetration [52][55] - There is an emphasis on building a comprehensive distribution network to support the delivery of nuclear medicines [50][51] 6. **Research and Development**: - Ongoing R&D efforts are aimed at expanding the product pipeline, with several products in various stages of clinical trials [17][22] - The company is exploring innovative treatment combinations and is positioned to leverage its R&D capabilities to meet market demands [20][22] 7. **Market Potential**: - The company sees significant market potential for its products, particularly in the context of increasing cancer prevalence in China, which could drive demand for its innovative therapies [21][33] - The expected market size for certain products is projected to reach several billion dollars, indicating strong growth prospects [31][33] 8. **Challenges and Risks**: - The company faces challenges related to price pressures in the Gansu region and the overall impact of market fluctuations on revenue [13][44] - Regulatory hurdles and the competitive landscape in the pharmaceutical industry pose risks to timely product launches and market share [35][44] Additional Important Information - The company is actively working on integrating its diagnostic and therapeutic offerings to create a comprehensive healthcare solution [39][55] - There is a focus on enhancing the clinical and operational capabilities of its nuclear medicine facilities to meet growing demand [56][59] - The company is also exploring partnerships and collaborations to expand its market reach and enhance its product offerings [34][35]
东诚药业线上交流会
Zhong Jin Cai Fu Qi Huo· 2024-05-23 03:21
Summary of the Conference Call for Dongcheng Pharmaceutical Company Overview - The conference call was held by Dongcheng Pharmaceutical on May 23, 2024, facilitated by China International Capital Corporation (CICC) [7][8]. Key Points Discussed Financial Performance - Dongcheng Pharmaceutical reported a decline in revenue for Q1 2024 compared to Q1 2023, primarily due to price trends in Gansu [8][9]. - The price of products in Gansu has been stable since Q1 2024, which is expected to stabilize further in the coming months [9][10]. - The company anticipates a better performance in the second half of 2024 compared to Q3 2023, despite facing pressure on absolute income due to the impact of centralized procurement [11][12]. Product Updates - The company is optimistic about the sales of its key products, particularly in the nuclear medicine sector, with expectations of significant improvements in sales for FDG and other related drugs in the upcoming months [13][14]. - Dongcheng has submitted a product for approval that is currently in the main review stage at the CDE, with hopes for approval in the first half of 2024 [18][19]. Market Trends - The company noted an increase in export volumes from Gansu, despite a decrease in prices, indicating a potential recovery in demand [22][23]. - The management expects that the price trends will not decline further and may even show an upward trend in the second half of 2024 [24][25]. R&D and Future Products - Dongcheng is making progress in its R&D efforts, with several products entering different clinical trial phases [16][30]. - The company is focusing on developing innovative treatments, particularly in the field of targeted therapies for cancer, with promising market potential [26][29]. Strategic Initiatives - Dongcheng is enhancing its collaboration efforts and financing strategies to support its product pipeline and market expansion [16][30]. - The company is also working on building a comprehensive supply chain and distribution network to improve its operational efficiency [56][57]. Challenges and Risks - The company acknowledged the volatility in its earnings over the past two years, primarily due to the impacts of the COVID-19 pandemic and changes in the healthcare reimbursement landscape [50][51]. - There are ongoing concerns regarding the pricing pressures in the Gansu region and the overall market dynamics affecting revenue stability [50][52]. Additional Insights - The management emphasized the importance of maintaining a robust pipeline of products and the need for strategic partnerships to navigate the competitive landscape [41][42]. - Dongcheng is also exploring opportunities in international markets and potential collaborations to enhance its product offerings [41][42]. This summary encapsulates the key discussions and insights from the conference call, highlighting the company's current status, market outlook, and strategic initiatives.
东诚药业:2023年度股东大会决议公告
2024-05-17 11:01
证券代码:002675 证券简称:东诚药业 公告编号:2024-042 烟台东诚药业集团股份有限公司 2023 年度股东大会决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有 虚假记载、误导性陈述或重大遗漏。 特别提示: 1.本次股东大会未出现否决提案的情形。 2.本次股东大会未涉及变更前次股东大会决议。 一、会议召开情况 (一)召开时间: 现场会议时间:2024年5月17日(星期五)14:30; 网络投票时间:通过深圳证券交易所交易系统进行网络投票的具体时间为: 2024年5月17日9:15-9:25,9:30-11:30,13:00-15:00;通过深圳证券交易所 互联网投票系统投票的具体时间为:2024年5月17日9:15-15:00期间的任意时间。 (二)现场会议地点:烟台经济技术开发区长白山路7号公司会议室; (六)本次股东大会的召集、召开程序符合《公司法》《上市公司股东大会 规则》等法律、法规、规范性文件和《公司章程》的规定。 二、会议出席情况 参加本次会议的股东及股东代理人共24人,代表公司有表决权的股份 237,642,899股,占公司有表决权股份总数的28.8193%。 ...
东诚药业:北京市中伦律师事务所关于烟台东诚药业集团股份有限公司2023年度股东大会的法律意见书
2024-05-17 11:01
北京市朝阳区金和东路 20 号院正大中心 3 号南塔 22-31 层 邮编:100020 22-31/F, South Tower of CP Center, 20 Jin He East Avenue, Chaoyang District, Beijing l00020, P.R. China 电话/Tel : +86 10 5957 2288 传真/Fax : +86 10 6568 1022/1838 www.zhonglun.com 北京市中伦律师事务所 关于烟台东诚药业集团股份有限公司 2023 年度股东大会的 法律意见书 致:烟台东诚药业集团股份有限公司 根据《中华人民共和国公司法》(以下简称《公司法》)、《中华人民共和 国证券法》及中国证券监督管理委员会发布的《上市公司股东大会规则》等规定, 北京市中伦律师事务所(以下简称本所)接受烟台东诚药业集团股份有限公司(以 下简称公司)的委托,指派本所律师对公司 2023 年度股东大会(以下简称本次 股东大会)进行见证并就相关事项出具本法律意见书。 为出具本法律意见书,本所律师查阅了公司提供的相关文件,包括但不限于: 1. 现行《烟台东诚药业集团股份有限 ...
东诚药业:关于下属公司被认定为河北省专精特新中小企业的公告
2024-05-15 10:18
证券代码:002675 证券简称:东诚药业 公告编号:2024-041 河北安迪科本次被认定"专精特新"中小企业,是对其创新能力、技术实力、 产品质量、服务水平、专业化程度等综合发展实力的充分认可,有利于提升公司 的品牌形象,对公司的长远发展具有积极作用。 本次"专精特新"认定不会对公司当期经营业绩产生重大影响,敬请广大投 资者谨慎决策,注意投资风险。 三、备查文件 河北省工业和信息化厅关于公布 2024 年第一批河北省专精特新中小企业 名单的通知 烟台东诚药业集团股份有限公司 关于下属公司被认定为河北省专精特新中小企业的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 一、基本情况 根据《河北省工业和信息化局关于公布 2024 年第一批河北省专精特新中小 企业名单的通知》,烟台东诚药业集团股份有限公司(以下简称"公司")下属公 司河北安迪科正电子技术有限公司(以下简称"河北安迪科")被认定为河北省 "专精特新"中小企业。 二、对公司的影响 "专精特新"是指具备"专业化、精细化、特色化、新颖化"特征的中小企 业,旨在培育一批在细分行业内技术实力强、产品质量 ...
肝素业务扰动业绩,核药产业链布局领先
INDUSTRIAL SECURITIES· 2024-05-13 02:02
Investment Rating - The report maintains a "Buy" rating for the company [2][8]. Core Views - The company reported a revenue of 3.276 billion yuan in 2023, a year-on-year decrease of 8.58%, and a net profit attributable to shareholders of 210 million yuan, down 31.75% year-on-year. The decline in performance is primarily attributed to asset impairment provisions totaling 90 million yuan in 2023. In Q1 2024, the company achieved a revenue of 647 million yuan, representing a year-on-year increase of 23.90%, and a net profit of 64 million yuan, up 28.38% year-on-year [1]. - Financial metrics for 2023 include a gross margin of 44.87% (up 1.93 percentage points), a net margin of 7.76% (down 2.09 percentage points), and a research and development expense ratio of 6.02% (up 1.46 percentage points). In Q1 2024, the gross margin was 43.79% (down 3.65 percentage points), while the net margin improved to 10.19% (up 2.79 percentage points) [1]. - The nuclear medicine segment generated revenue of 1.017 billion yuan in 2023, an increase of 11.2% year-on-year, with key products like 18F-FDG contributing 420 million yuan (up 12%) and Y-90 labeled drugs generating 100 million yuan (down 3.23%). The raw material drug segment saw revenue of 1.678 billion yuan (up 18.61%), while the formulation segment declined to 400 million yuan (down 17.20%) [1]. - The company is focused on the nuclear medicine sector, with several products in clinical registration stages, including LNC1001 for prostate cancer and 99mTc-GSA for liver function diagnosis, which is preparing for market registration [1]. - Earnings forecasts for 2024-2026 predict EPS of 0.36, 0.45, and 0.53 yuan, corresponding to PE ratios of 37.33, 29.83, and 25.53 times, respectively [1]. Financial Summary - In 2023, the company reported a gross profit margin of 44.87% and a net profit margin of 7.76%. The gross profit margin is expected to decrease to 43.79% in Q1 2024, while the net profit margin is projected to increase to 10.19% [1]. - The company’s total assets were reported at 8.529 billion yuan, with a net asset value of 5.008 billion yuan [7]. - The projected revenue growth rates for 2024-2026 are 0.1%, 9.5%, and 13.2%, respectively, with net profit growth rates of 41.8%, 25.1%, and 16.8% [14].