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].

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]

Group 1 - Company Biao Bang Co., Ltd. has decided to terminate the planning of a change in control due to failure to reach consensus on key terms with the trading party, and will resume trading on November 7, 2025 [1] - Company Su Da Wei Ge plans to acquire 51% of Changzhou Weipu Semiconductor Equipment Co., Ltd. for 510 million yuan, making it a subsidiary [2] - Company Bei Ji Shen Zhou expects its revenue for 2025 to be between 36.2 billion yuan and 38.1 billion yuan, an increase from the previous forecast of 35.8 billion to 38.1 billion yuan [3] Group 2 - Company Hua Hong Semiconductor reported a revenue of approximately 12.58 billion yuan for the first three quarters of 2025, a year-on-year increase of 19.82% [4] - Company Jie Neng Wind Power plans to raise no more than 3.6 billion yuan through a private placement to fund various green power projects [5] - Company Zhen Ai Mei Jia is in the process of transferring control, with trading suspended since November 5, 2025, and expected to remain suspended for up to three trading days [7] Group 3 - Company Xin Hope plans to establish a joint venture with state-owned funds with a total registered capital of 2.87 billion yuan, where Xin Hope will contribute 2.1 billion yuan [8] - Company Yun Nan Ge Ye has approved a project to establish a new semiconductor materials company with an investment of 500 million yuan [8] - Company Tian Ci Materials has signed contracts for the supply of electrolyte products with two major clients, with expected total volumes of 87,000 tons and 72,500 tons for the years 2026-2028 [9][10]

Core Viewpoint - Pro Pharmaceutical has signed a strategic cooperation framework agreement with Jiaxing Andikang Biotechnology Co., Ltd. to enhance long-term collaboration in innovative drug development and improve market competitiveness and supply stability [2] Group 1 - The agreement is based on principles of equality, mutual benefit, and complementary advantages [2] - The collaboration aims to create more long-term projects in the field of innovative drugs [2] - The partnership seeks to strengthen industry competitiveness and enhance the ability to maintain stable drug supply [2]

Core Viewpoint - Pro Pharmaceutical (普洛药业) has signed a strategic cooperation framework agreement with Jiaxing Andikang Biotechnology Co., Ltd. (安帝康生物) to enhance long-term collaboration in innovative drug development and strengthen market competitiveness [1] Group 1: Strategic Cooperation - The agreement establishes a strategic partnership between Pro Pharmaceutical and Andikang Biotechnology based on mutual benefits and complementary advantages [1] - The collaboration aims to explore more long-term projects in the field of innovative drugs, enhancing the competitive edge in the pharmaceutical market [1] Group 2: CDMO Business Expansion - The partnership will involve long-term cooperation on CDMO (Contract Development and Manufacturing Organization) projects, which is expected to facilitate the expansion of Pro Pharmaceutical's CDMO business [1] - This collaboration is anticipated to further enhance the competitiveness of the company's CDMO operations [1]

Core Viewpoint - The strategic cooperation agreement between Prolog Pharma and Antekang Bio aims to enhance the development and production capabilities in the CDMO (Contract Development and Manufacturing Organization) sector, focusing on innovative drug raw materials and intermediates [1][2]. Group 1 - The agreement establishes a long-term partnership for CDMO projects, allowing both parties to seek additional collaborative opportunities in innovative drug development [1][2]. - Antekang Bio will prioritize Prolog Pharma for CDMO project development and production, ensuring a stable supply and competitive advantage in the market [1]. - Prolog Pharma commits to using the processes and technologies provided by Antekang Bio solely for the collaborative CDMO projects, adhering to relevant Chinese laws and project agreements [1]. Group 2 - The collaboration is expected to expand Prolog Pharma's CDMO business and enhance its competitive position in the industry [2].