Core Viewpoint - Prolo Pharmaceutical's subsidiary, Zhejiang Prolo Jiayuan Pharmaceutical Co., Ltd., has received the CEP certificate for Venlafaxine Hydrochloride from the European Directorate for the Quality of Medicines (EDQM), indicating the product's compliance with European quality standards and enhancing the company's potential for international market expansion [1] Group 1 - Prolo Pharmaceutical's subsidiary has been recognized with a CEP certificate for Venlafaxine Hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat various types of depression and generalized anxiety disorder [1] - The receipt of the CEP certificate signifies the recognition and affirmation of the quality of the raw material by the European regulatory market [1] - This certification allows the product to enter the EU market and other markets that recognize the CEP certificate, positively impacting the company's international market expansion efforts [1]

Core Viewpoint - The announcement highlights that Zhejiang Prolo Home Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Prolo Pharmaceutical, has received the Certificate of Suitability (CEP) for Venlafaxine Hydrochloride from the European Medicines Agency, indicating the quality recognition of this active pharmaceutical ingredient in the European market [1] Group 1 - The CEP certificate for Venlafaxine Hydrochloride signifies the product's compliance with European pharmacopoeia standards [1] - Venlafaxine Hydrochloride is used for treating various types of depression, including anxiety-related depression and generalized anxiety disorder [1] - The certification allows the product to enter the EU market and other markets that recognize the CEP certificate, facilitating international market expansion for the company [1]

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]

Industry Overview - Recent flu activity in China has significantly increased, with most provinces entering the flu epidemic period [1] - The latest data from the Chinese Center for Disease Control and Prevention indicates that flu viruses have surpassed other respiratory viruses, becoming the most prevalent this autumn and winter [1] - Experts suggest that this year's flu season may start earlier and involve a higher number of infections, with the dominant strain being H3N2, which has lower immunity in the population compared to last year's H1N1 strain [1] Company Insights - Borui Pharmaceutical is an integrated enterprise specializing in raw materials and formulations, primarily supplying the domestic market with oseltamivir [3] - The company has established a complete industrial chain from starting materials to high-difficulty intermediates, and has obtained approvals for oseltamivir capsules and dry suspensions [3] - Core antiviral products of Borui include entecavir and oseltamivir [3] - Puluo Pharmaceutical offers oseltamivir and amantadine, which are effective against flu viruses [4]

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].

Market Overview - The CITIC Pharmaceutical Index decreased by 2.36%, underperforming the CSI 300 Index by 3.18 percentage points, ranking 30th among 30 CITIC first-level industries [8] - The top ten stocks with the highest gains this week included Hezhong Pharmaceutical, Fuxiang Pharmaceutical, and Hualan Biological, while the biggest losers were He Yuan Biological-U and Changshan Pharmaceutical [8] Overall Investment Viewpoints - Traditional Chinese Medicine: The basic drug catalog is expected to be released, with unique basic drugs projected to grow faster than non-basic drugs, leading to market fluctuations [10] - Innovative Drugs: The domestic innovative drug industry is transitioning from quantity to quality, focusing on differentiated and internationalized pipelines, with an emphasis on products that can generate profits [10] - Medical Devices: The bidding volume for imaging equipment has rebounded, and home medical device markets are benefiting from subsidy policies [10] - Pharmaceutical Industry: The specialty raw materials market is expected to see cost improvements, leading to a new growth cycle [10] Retail Pharmacy Market Analysis - The retail scale of the physical pharmacy market in China for January to August 2025 is projected to be 395.2 billion yuan, a year-on-year decline of 2.2% [17] - The retail scale for July and August 2025 was 99.1 billion yuan, with a year-on-year decline of 2.5% [17] - The market is under pressure from policies such as tightened medical insurance and increased competition due to industry expansion from 2019 to 2024 [17] Category Market Analysis - In the first eight months of 2025, the drug category accounted for 81.4% of the market share, with a year-on-year increase of 1.1 percentage points, while the health product category saw a decline of over 17% [18] - The retail scale of drugs in physical pharmacies for January to August 2025 was 321.7 billion yuan, a year-on-year decline of 1.2% [24] - The retail scale of traditional Chinese medicine for the same period was 30.2 billion yuan, down 4.7% year-on-year [25] Specific Product Analysis - The top 20 chemical drug categories in July and August 2025 showed a combined market share of 78.0% and 78.5%, respectively, with significant growth in categories like hemostatic drugs and immunosuppressants [36] - The top 20 traditional Chinese medicine categories had a combined market share of 83.8% in July and 84.5% in August, with notable declines in categories such as heat-clearing and detoxifying drugs [39] Future Outlook - The pharmacy sector is expected to benefit from the acceleration of prescription outflow and an improved competitive landscape, with a focus on the integration of online and offline channels [49] - The medical device market is anticipated to see continued growth driven by bidding recovery and government subsidies for home medical devices [42]

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]