证券代码：000739 证券简称：普洛药业 公告编号：2025-68 普洛药业股份有限公司 关于获得药品注册证书的公告 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"）控股子公司浙江普洛康 裕制药有限公司收到国家药品监督管理局（以下简称"药监局"）签发的头孢地 尼胶囊《药品注册证书》。现将有关情况公告如下： 一、药品注册批准情况 1、产品名称：头孢地尼胶囊 2、剂型：胶囊剂 3、规格：0.1g 7、证书编号：2025S03340 8、药品批准文号：国药准字 H20255880 9、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， 本品符合药品注册的有关要求，批准注册，发给药品注册证书。 二、药品其他相关情况 头孢地尼胶囊，适应症为对头孢地尼敏感的葡萄球菌属、链球菌属、肺炎球 菌、消化链球菌、丙酸杆菌、淋病奈瑟氏菌、卡他莫拉菌、大肠埃希菌、克雷伯 菌属、奇异变形杆菌、普鲁威登斯菌属、流感嗜血杆菌等菌株所引起的下列感染: 咽喉炎、扁桃体炎、急性支气管炎、肺炎；中耳炎、鼻窦炎；肾盂肾炎、膀胱炎、 淋菌性尿道 ...

Core Viewpoint - Prolo Pharmaceutical (000739.SZ) announced that its subsidiary, Zhejiang Prolo Kangyu Pharmaceutical Co., Ltd., has received a drug registration certificate for Cefdinir capsules from the National Medical Products Administration [1] Group 1: Product Information - Cefdinir capsules are indicated for infections caused by bacteria sensitive to Cefdinir, including strains of Staphylococcus, Streptococcus, and others [1] - The specific infections treated by Cefdinir capsules include pharyngitis, tonsillitis, acute bronchitis, pneumonia, otitis media, sinusitis, pyelonephritis, cystitis, gonococcal urethritis, and various skin and soft tissue infections [1]

Core Viewpoint - Pro Pharmaceutical Co., Ltd. has received a drug registration certificate for Cefdinir capsules from the National Medical Products Administration, indicating a significant regulatory milestone for the company [1] Group 1: Company Developments - The subsidiary Zhejiang Pro Kangyu Pharmaceutical Co., Ltd. is responsible for the newly approved Cefdinir capsules [1] - Cefdinir is indicated for various infections caused by sensitive strains of bacteria, including Streptococcus, Staphylococcus, and Escherichia coli, among others [1] Group 2: Product Indications - The approved indications for Cefdinir capsules include infections such as pharyngitis, tonsillitis, acute bronchitis, pneumonia, otitis media, sinusitis, pyelonephritis, cystitis, and gonococcal urethritis [1] - Additional indications cover conditions like pelvic inflammatory disease, intrauterine infections, and various skin and soft tissue infections [1]

Core Viewpoint - Pro Pharmaceutical announced that its subsidiary, Zhejiang Pro Kangyu Pharmaceutical Co., Ltd., received a drug registration certificate for Cefdinir capsules, which is classified as a Class 4 chemical drug, indicating a significant step in expanding its market presence and competitiveness in the pharmaceutical industry [1] Group 1: Drug Registration and Market Potential - The drug registration certificate is for Cefdinir capsules with a specification of 0.1g, which is expected to have a wide range of indications [1] - The estimated market size for the drug in China's hospital market for 2024 is projected to be 380 million capsules, with a sales value of 310 million yuan [1] - The total R&D investment for this drug has reached 5.2818 million yuan as of the announcement date [1] Group 2: Competitive Advantage and Market Factors - The approval of the drug registration certificate is considered equivalent to passing the consistency evaluation, which is expected to enhance sales and improve competitive positioning [1] - However, the production and sales of the drug may be influenced by various factors, including policies and market conditions [1]

Core Viewpoint - Pro Pharmaceutical announced that its subsidiary, Zhejiang Pro Pharmaceutical Co., Ltd., has received a drug registration certificate for Cefdinir capsules from the National Medical Products Administration [1] Group 1: Product Information - Cefdinir capsules are indicated for infections caused by various bacteria, including Staphylococcus, Streptococcus, Pneumococcus, and others [1]

Core Viewpoint - The domestic R&D demand is showing marginal improvement, driven by the overseas expansion of innovative drugs, leading to a recovery in R&D orders and stabilization of industry prices after a decline in 2023. The CRO sector is expected to see better performance growth by 2026, while the CDMO industry has also reached a bottom and is poised for continued strong growth due to robust demand for new molecules and new orders [1][2][3]. CRO Sector - The domestic R&D demand is recovering, with an increase in orders and stabilization of prices, indicating a clear upward trend for CRO companies. Clinical CROs like Tigermed, Nossan, and Prasis are expected to see revenue growth turning positive by 2025, with significant contributions from overseas business [2][3]. - The recognition of domestic CRO clinical data is improving, which is beneficial for companies like Tigermed [2]. CDMO Sector - The CDMO sector has seen a recovery in performance, with new orders continuing to improve quarterly. The global demand for innovative drug R&D is driving growth in new orders and backlog [3]. - The industry is benefiting from increased capacity utilization and profitability, with a strong certainty of performance and profit growth expected to continue into 2026 [3]. Life Sciences Sector - The life sciences upstream sector is experiencing a dual drive from domestic substitution and overseas expansion, with urgent demand for domestic alternatives in areas like cell culture media and biological reagents. Companies are expected to capture market share through new product categories and cost-effective offerings [4]. - The demand for specific segments such as drug efficacy, antibodies, and proteins is increasing, indicating a clear long-term growth logic for the industry [4]. API Sector - The raw material pharmaceutical industry is currently in a phase of price bottoming and supply surplus, with traditional product performance under pressure. However, companies are extending their business into generics, innovative drugs, and specialty APIs, which may lead to value reconstruction through business structure optimization [5]. - The valuation of raw material pharmaceutical companies is at a low point, presenting opportunities based on changes in new business layouts [5]. Investment Recommendations - For clinical and preclinical CROs, companies like Tigermed, Nossan, and Yinos are recommended due to the gradual recovery of the industry and expected improvement in order structure [6]. - In the CDMO sector, companies such as WuXi AppTec, WuXi Biologics, and others with strong fundamentals and capacity advantages are highlighted for their potential benefits from industry recovery and high demand for new molecules [6]. - In the life sciences upstream sector, companies like Baitai Biotechnology and others are recommended due to accelerated domestic substitution and strong overseas growth [6]. - Companies like Pro Pharma and Huahai Pharmaceutical are noted for their new business layouts that are expected to contribute significant value increments [6].

新京报贝壳财经讯 11月19日，普洛药业发布公告称，公司拟使用自有资金及金融机构回购贷款通过深 圳证券交易所交易系统以集中竞价交易方式回购公司股份，回购股份价格不超过23元/股，回购资金总 额为不低于1.8亿元（含）且不超过3.6亿元（含）；预计可回购股份数量为783万股—1565万股，约占公 司总股本的0.68%—1.35%。回购期限为自董事会审议通过回购股份方案之日起12个月内。若公司在股 份回购完成后36个月内未能实施前述用途，未使用部分将依法履行相关程序后予以注销。 编辑 杨娟娟 ...

Core Viewpoint - The article highlights the positive outlook for the Chinese stock market, with foreign institutions increasing their investments and adjusting target indices upward for 2026, indicating a strong long-term investment potential in A-shares [1][2]. Group 1: Market Performance - As of November 20, 2025, the CSI 500 Quality Growth Index rose by 0.15%, with notable increases in constituent stocks such as Bluestar Technology (up 3.44%) and China National Materials (up 2.31%) [1]. - The CSI 500 Quality Growth ETF (560500) also saw a rise of 0.17%, reflecting overall positive market sentiment [1]. Group 2: Foreign Investment Trends - Multiple foreign institutions, including UBS and Morgan Stanley, have released optimistic reports for the Chinese stock market, collectively raising their target index levels for 2026 [1][2]. - Foreign institutional research and investment activities have been robust, with over 1,300 instances of foreign institutions conducting research on A-share companies since the beginning of the fourth quarter [1]. Group 3: Policy Developments - The China Securities Regulatory Commission (CSRC) has issued a plan to optimize the Qualified Foreign Institutional Investor (QFII) system, aiming to enhance cross-border investment facilitation [2]. - The ongoing improvements in the QFII system are expected to create a more stable and transparent environment for foreign investments in the Chinese capital market [2]. Group 4: Index Composition - The CSI 500 Quality Growth Index comprises 100 high-profitability, sustainable earnings, and cash-rich growth companies selected from the CSI 500 Index [2]. - As of October 31, 2025, the top ten weighted stocks in the index accounted for 21.64% of the total index weight, with companies like Huagong Technology and Kaiying Network being significant constituents [2].

Key Highlights - CICC plans to absorb and merge with Dongxing Securities and Xinda Securities, with stock suspension starting from November 20 [1] - Saiwu Technology has delivered a small batch of perovskite stacked component light-transmitting film, with minimal impact on performance [1] - Zhongfu Industrial intends to invest 259 million yuan in a green manufacturing project for aluminum-based new materials [1] - Dafeng Industrial has won a contract for the construction of stage craft equipment for an international performing arts center, valued at 165 million yuan [2] - Jinbei Automotive plans to invest a total of 158 million yuan to acquire 52% equity in Zhongtuo Technology [1] - Pro Pharmaceutical intends to repurchase shares worth between 180 million and 360 million yuan [1] - Yandong Micro plans to reduce its stake by up to 2.5% through shareholders Jingguorui and the National Integrated Circuit Fund [1][3] - Zhaomin Technology plans to issue convertible bonds to raise no more than 590 million yuan [1] - Dongsoft Group has received a notification from an automotive manufacturer for designated cooperation [1]

Policy Developments - The National Medical Products Administration (NMPA) is focusing on the quality supervision of selected drugs in centralized procurement, emphasizing the importance of quality safety and compliance in production [1] - The NMPA will implement comprehensive production inspections and product sampling for selected drugs, optimizing work mechanisms and exploring risk monitoring [1] - The NMPA acknowledges the development of the medical device industry in Chongqing and stresses the need for a robust quality safety responsibility system [2] Drug and Device Approvals - Baiyunshan's subsidiary Zhongyi Pharmaceutical received a registration certificate for the traditional medicine An Gong Niu Huang Wan from Vietnam's Ministry of Health, aiding market expansion [3] - Huyou Pharmaceutical announced that its subsidiary Seacross Pharmaceuticals Ltd. received marketing approvals for multiple products from regulatory authorities in Pakistan, the UK, and North Macedonia [4] - Zhifei Biological's recombinant herpes zoster vaccine (ZFA01) clinical trial application has been accepted by the NMPA, which may enhance vaccine efficacy [5] Capital Market Activities - Puluo Pharmaceutical plans to repurchase shares worth between RMB 180 million and RMB 360 million, with a maximum price of RMB 23 per share [6][7] - Sinovac Biotech received a delisting notice from NASDAQ due to failure to submit its annual report by the deadline, with potential trading suspension imminent [8] Industry Developments - Researchers published a detailed immune response map following pig kidney transplants in brain-dead patient models, identifying key factors for transplant success [9] - Haizheng Pharmaceutical's subsidiary plans to collaborate with the East China Institute for the biomanufacturing of heparin, with a project budget not exceeding RMB 120 million [10] Public Sentiment Alerts - Guangyuyuan announced the resignation of Vice President Wang Junbo due to work adjustments, effective immediately [11] - Medici's shareholder Chen Guoxing plans to reduce his stake by up to 1.64% through trading methods due to personal financial needs [12]