证券日报网讯 11月10日晚间，普洛药业发布公告称，近日，公司全资子公司浙江普洛家园药业有限公 司收到欧洲药品质量管理局签发的盐酸文拉法辛欧洲药典适用性证书（简称"CEP证书"）。 （文章来源：证券日报） ...

据悉，盐酸文拉法辛一种选择性5-羟色胺和去甲肾上腺素再摄取抑制剂(SNRI)，用于治疗各种类型抑郁 症(包括伴有焦虑的抑郁症)和广泛性焦虑症。 本次公司盐酸文拉法辛原料药获得CEP证书，显示欧洲规范市场对该原料药质量的认可和肯定，标志着 该产品具备以原料药形式进入欧盟及承认CEP证书的其他市场的资质，为公司进一步拓展国际市场带来 积极影响。 智通财经APP讯，普洛药业(000739.SZ)发布公告，近日，公司全资子公司浙江普洛家园药业有限公司 (以下简称"家园药业")收到欧洲药品质量管理局(以下简称 "EDQM")签发的盐酸文拉法辛欧洲药典适用 性证书(以下简称"CEP证书")。 ...

普洛药业公告，近日，全资子公司浙江普洛家园药业有限公司收到欧洲药品质量管理局签发的盐酸文拉 法辛欧洲药典适用性证书。盐酸文拉法辛用于治疗各种类型抑郁症(包括伴有焦虑的抑郁症)和广泛性焦 虑症。本次公司盐酸文拉法辛原料药获得CEP证书，显示欧洲规范市场对该原料药质量的认可和肯定， 标志着该产品具备以原料药形式进入欧盟及承认CEP证书的其他市场的资质，为公司进一步拓展国际市 场带来积极影响。 ...

Core Viewpoint - Prolo Pharmaceutical (000739.SZ) announced that its wholly-owned subsidiary, Zhejiang Prolo Jiayuan Pharmaceutical Co., Ltd., received the Certificate of Suitability (CEP) for Venlafaxine Hydrochloride from the European Directorate for the Quality of Medicines (EDQM) [1] Group 1 - The CEP certificate is significant for Venlafaxine Hydrochloride, which is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) [1] - Venlafaxine Hydrochloride is used for treating various types of depression, including depression with anxiety, and generalized anxiety disorder [1]

Core Viewpoint - Pro Pharmaceutical's subsidiary, Jiayuan Pharmaceutical, has received the CEP certificate for Venlafaxine Hydrochloride, enabling the product to enter the EU and other markets that recognize the CEP certificate [1] Company Summary - Pro Pharmaceutical's subsidiary, Jiayuan Pharmaceutical, has been granted the European Pharmacopoeia Certificate of Suitability (CEP) for Venlafaxine Hydrochloride [1] - This certification allows the product to qualify for entry into the European Union and other markets that acknowledge the CEP certificate [1] Industry Summary - Venlafaxine Hydrochloride is classified as a selective serotonin and norepinephrine reuptake inhibitor (SNRI) [1] - It is utilized for the treatment of various types of depression, including depression accompanied by anxiety, as well as generalized anxiety disorder [1]

证券代码：000739 证券简称：普洛药业 公告编号：2025-63 普洛药业股份有限公司 关于获得化学原料药欧洲 CEP 证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 近日，普洛药业股份有限公司（以下简称"公司"）全资子公司浙江普洛家 园药业有限公司（以下简称"家园药业"）收到欧洲药品质量管理局（以下简称 "EDQM"）签发的盐酸文拉法辛欧洲药典适用性证书（以下简称"CEP 证书"）。 现将有关情况公告如下： 一、药品注册批件情况 1、化学原料药名称：VENLAFAXINE HYDROCHLORIDE 盐酸文拉法辛 2、生产商/持有人：浙江普洛家园药业有限公司 盐酸文拉法辛一种选择性 5-羟色胺和去甲肾上腺素再摄取抑制剂（SNRI）， 用于治疗各种类型抑郁症（包括伴有焦虑的抑郁症）和广泛性焦虑症。 三、对公司的影响 本次公司盐酸文拉法辛原料药获得 CEP 证书，显示欧洲规范市场对该原料药 质量的认可和肯定，标志着该产品具备以原料药形式进入欧盟及承认 CEP 证书的 其他市场的资质，为公司进一步拓展国际市场带来积极影响。 国际原料药业务易受海外市 ...

Core Viewpoint - The announcement indicates that the company's wholly-owned subsidiary, Jiayuan Pharmaceutical, has received the CEP certificate for Venlafaxine Hydrochloride from EDQM, effective from October 28, 2025, which signifies the product's quality recognition in the European market [1] Group 1 - The CEP certificate number is CEP2023 - 219 - Rev00, which validates the quality of Venlafaxine Hydrochloride used for treating various types of depression and generalized anxiety disorder [1] - The certification marks the product's qualification to enter the EU and other markets, positively impacting the company's international market expansion efforts [1] - The international active pharmaceutical ingredient (API) business remains uncertain, prompting a cautionary note for investors regarding potential risks [1]

据智通财经11月9日报道，近期我国流感活动上升明显，绝大多数省份都已进入流感流行期，有奥司他 韦生产企业称，10月中旬以来，相关药物销量出现增长，产能方面目前已经7*24小时不间断生产。 博瑞医药：公司是原料药制剂一体化特色企业，公司的奥司他韦原料药及制剂主要供给国内市场。此外 公司贯通了从"起始物料→高难度中间体→特色原料药→制剂"的全产业链，取得了磷酸奥司他韦胶囊、 磷酸奥司他韦干混悬剂等药品批件。公司抗病毒领域的核心产品包括恩替卡韦、奥司他韦等。 普洛药业：公司的奥司他韦、金刚乙胺等品种可用于流感病毒。 *免责声明：文章内容仅供参考，不构成投资建议 *风险提示：股市有风险，入市需谨慎 其指出，很多专家认为今年流感季可能会更早一些，另外感染人数会更多。从流感毒株类型上来说，今 年报告的毒株主要是甲型H3N2，而去年是甲型H1N1，因此大众对今年流行的H3N2毒株的免疫力就会 更低一些。临床上来看，甲型H1N1、甲型H3N2和乙型流感主要症状都是发热、咳嗽、咽痛，全身的酸 痛、乏力和头痛都比较明显。 此外根据国家卫生健康委发布的《流行性感冒诊疗方案（2025年版）》，流感流行季，应尽早进行抗病 毒治疗，发病 ...

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1]. Core Views - The report highlights a positive change in the specialty raw materials sector, recommending companies such as Aorite and Prolo Pharmaceuticals [1]. - The report suggests that the Q3 performance of raw material pharmaceutical companies has reached a bottom, indicating potential recovery in profitability as high-cost inventory is consumed [19][20]. Summary by Sections Investment Highlights - The recommended sub-industry rankings are: Innovative Drugs > Research Services > CXO > Traditional Chinese Medicine > Medical Devices > Pharmacies [3][12]. - Specific stock recommendations include: - From raw materials: Aorite, Qianhong Pharmaceutical - From Traditional Chinese Medicine: Zorui Pharmaceutical, Fangsheng Pharmaceutical, Dong'e Ejiao - From medical devices: United Imaging Healthcare, Yuyue Medical - From AI pharmaceuticals: Jingtai Holdings - From GLP-1 sector: Lianbang Pharmaceutical, Borui Pharmaceutical, Zhongsheng Pharmaceutical, and Innovent Biologics - From PD-1/VEGF dual antibodies: Sanofi Biopharmaceuticals, Kangfang Biologics, and Rongchang Biopharmaceuticals - From innovative drugs: Innovent Biologics, BeiGene, HengRui Medicine, Zai Lab, Baillie Tianheng, Kelun Pharmaceutical, Dize Pharmaceutical, and Haizheng Pharmaceutical [3][15]. Industry Trends - The A-share pharmaceutical index has seen a year-to-date increase of 18.2%, while the Hang Seng Biotechnology Index has increased by 76.6% [6][11]. - The report notes that the raw material pharmaceutical sector is under pressure due to high base effects and declining prices, with significant revenue impacts [19][20]. R&D Progress and Company Dynamics - Recent approvals include Novartis' radioligand therapy drug, which received dual indications for prostate cancer treatment [2]. - The report provides an overview of ongoing clinical trials and drug approvals, emphasizing the importance of innovation in the pharmaceutical sector [30]. Market Performance - The report indicates that the pharmaceutical sector has experienced adjustments, with notable stock performances including significant gains for companies like Hezhong China (+61%) and Wanze Shares (+30%) [11]. - The report also highlights the performance of various pharmaceutical stocks, noting both gains and losses in the market [16][17]. Raw Material Pricing Trends - The price of 6-APA has dropped significantly, from 370 RMB/kg in 2022 to 180 RMB/kg in October 2025, a decrease of 51% [23]. - The price of Amoxicillin has also decreased from 320 RMB/kg in January 2023 to 190 RMB/kg in October 2025, a decline of 41% [23]. Conclusion - The report suggests that as high-cost inventory is depleted, the gross margins for raw material producers are expected to improve, indicating a potential recovery in profitability for companies like Fuxiang Pharmaceutical and Lukang Pharmaceutical [19][23].

Group 1 - Company plans to raise no more than 3.6 billion yuan through a private placement to fund seven projects, including a 500,000 kW green power project in Inner Mongolia [1] - Company has received acceptance for a clinical trial application for its self-developed drug for metastatic pancreatic ductal adenocarcinoma [1] - Company intends to establish a joint venture to implement a high-quality gallium arsenide chip construction project with a total investment of 272 million yuan [2] Group 2 - Company reported a revenue of 142 million yuan from pig sales in October, with a total sales volume of 162,800 pigs [3] - Company signed an annual procurement contract to supply 870,000 tons of electrolyte products from 2026 to 2028 [5] - Company plans to reduce its shareholding by up to 3% through various trading methods [7] Group 3 - Company intends to purchase 100 hydrogen fuel cell vehicles for a total price of 78.32 million yuan [9] - Company plans to acquire a 51% stake in a semiconductor equipment company for 510 million yuan [10] - Company has regained eligibility to participate in military procurement activities after being removed from the banned list [12] Group 4 - Company plans to establish a joint venture with state-owned funds for rural development with a total registered capital of 2.87 billion yuan [14] - Company reported a revenue of 1.918 billion yuan from pig sales in October, with a significant year-on-year increase [16][17] - Company plans to distribute a cash dividend of 0.01 yuan per share, totaling 7.9801 million yuan [18] Group 5 - Company has submitted an application for H-share listing on the Hong Kong Stock Exchange [19] - Company received approval for its convertible bond issuance application [20] - Company plans to establish a wholly-owned subsidiary with an investment of 70 million yuan focused on innovative medical research [22] Group 6 - Company reported a 33.87% year-on-year increase in sales volume for October [26] - Company has received a product designation from a leading new energy vehicle brand, with an expected total revenue of approximately 470 million yuan [28] - Company has initiated a key Phase III clinical trial for an innovative eye drop treatment for moderate to severe dry eye syndrome [30] Group 7 - Company reported a total automobile sales volume of 170,700 units in October, a year-on-year decrease of 8.1% [30] - Company plans to invest 16 million USD in establishing a production base in Vietnam [33] - Company has received a warning letter from the regulatory authority due to a breach of commitment by its controlling shareholder [52]