山东新华制药股份有限公司 关于获得《药品补充申请批准通知书》等相关情况的公告 证券代码：000756 证券简称：新华制药 公告编号：2025-40 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，山东新华制药股份有限公司（以下简称"新华制药"或"本公司"）收到国家药 品监督管理局核准签发的马来酸阿伐曲泊帕片（以下简称"本品"）《药品补充申请批准通知 书》，批准本品上市许可持有人转让补充申请。现将相关情况公告如下： 一、基本情况 药品名称：马来酸阿伐曲泊帕片 剂型：片剂 规格：20mg（按 C₂₉H₃₄Cl₂N₆O₃S₂计） 药品分类：处方药 申请人：山东新华制药股份有限公司 申请事项：上市许可持有人变更申请 受理号：CYHB2501163 原药品批准文号：国药准字H20249585 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，本品此次申请事 项符合药品注册的有关要求，同意按照《药品上市后变更管理办法（试行）》相关规定，批 准本品上市许可持有人变更。 二、其他相关信息 新华制药与上海迪赛诺医药集团股份有限公司（以下简称"上海迪赛诺"）于2 ...

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the registration certificate of Ivabradine Hydrochloride Tablets, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The full subsidiary Shandong Zibo Xinda Pharmaceutical Co., Ltd. has been granted the drug registration certificate for Ivabradine Hydrochloride Tablets [1] - This medication is indicated for patients with chronic heart failure of NYHA II-IV class, who have sinus rhythm and a heart rate of ≥75 beats per minute, and is to be used in conjunction with standard treatments including beta-blockers or when beta-blockers are contraindicated or not tolerated [1] Group 2: Market Potential - The estimated sales revenue for Ivabradine Hydrochloride Tablets in urban public medical institutions in China is approximately 350 million yuan in 2024 [1]

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the market launch of arginine ibuprofen, which is primarily used for alleviating pain symptoms such as toothache and dysmenorrhea [1] Company Summary - The newly approved product is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] - The estimated sales revenue for arginine ibuprofen formulations in Chinese public medical institutions is approximately 114 million yuan in 2024 [1] - The approval of this product is expected to enhance the company's product line and improve its core competitiveness [1] Industry Summary - The approval of arginine ibuprofen aligns with the growing demand for pain relief medications in the healthcare sector [1] - The inclusion of this product in the national insurance catalog may increase its accessibility and market penetration [1]

证券代码：000756 证券简称：新华制药 公告编号：2025-39 山东新华制药股份有限公司 关于获得《药品补充申请批准通知书》等相关情况的公告 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，山东新华制药股份有限公司（以下简称"新华制药"或"本公司"）收到国家药 品监督管理局核准签发的腺苷钴胺胶囊（以下简称"本品"）《药品补充申请批准通知书》， 批准本品上市许可持有人转让补充申请。现将相关情况公告如下： 一、基本情况 药品名称：腺苷钴胺胶囊 剂型：胶囊剂 规格：0.5mg 药品分类：处方药 申请人：山东新华制药股份有限公司 申请事项：上市许可持有人变更申请 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，本品此次申请事 项符合药品注册的有关要求，同意按照《药品上市后变更管理办法（试行）》相关规定，批 准本品上市许可持有人变更。 二、其他相关信息 新华制药与北京柏雅联合药物研究所有限公司（以下简称"北京柏雅"）于2024年9月签 订了生产技术及MAH转让合同，合同约定：北京柏雅将拟取得的腺苷钴胺胶囊上市许可持有 人及所涉及的技术权属（生产 ...

Core Viewpoint - The company XinHua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the supplemental application of Adenosylcobalamin capsules, allowing the transfer of the marketing authorization holder [1] Group 1: Regulatory Approval - The approval notification allows the company to transfer the supplemental application without the need for board or shareholder meeting reviews, in accordance with the Shenzhen Stock Exchange listing rules and the company's articles of association [1] - The transaction does not constitute a related party transaction or a major asset restructuring as defined by the regulations [1] Group 2: Product Indications - Adenosylcobalamin capsules are primarily indicated for the treatment of megaloblastic anemia, nutritional anemia, anemia during pregnancy, multiple neuritis, radiculitis, trigeminal neuralgia, sciatica, and nerve paralysis [1] - The product can also be used as an adjunctive treatment for nutritional disorders and leukopenia caused by radiation and drugs [1]

据了解,"十四五"以来,该公司投入研发经费超17亿元,累计获得药品注册批件90项,仿制药一致性评价24 项,主持或参与制定国家药品标准57项,取得专利113项,获得省部级以上科技奖励8项,新增3个创新平台,各 类创新成果均超以往同期两倍以上。治疗阿尔茨海默症的重大创新药进入Ⅱ期临床,治疗痛风的 LXH2301进入三期临床…… 不仅如此,通过柔性引才、校园招聘、人才合作等方式,新华制药已汇聚起了一支包括10名院士、6名国家 重点人才工程专家、6名外国专家、16名泰山产业领军人才以及500余名硕士、博士等组成的高端创新人 才队伍。同时,该公司与中南大学、中国药科大学、沈阳药科大学等高校共建研发平台。建立科研创新 全生命周期激励机制,设立科技创新"绿色通道",对推进重磅创新药物、重大创新产品、重大创新技术、 重大创新资源等重大创新成果落地实施重奖。通过一系列创新成效,为该公司"十五五"高质量发展注入 强劲动能。 (扈艳华) 原料药的竞争核心,实际上是生物合成法逐步替代传统化学合成工艺的竞争。 近年来,新华制药联合山东省药学科学院、厦门大学等科研院所和高校,通过不断的技术创新和工艺改进, 攻克了一道道技术难题,解决了 ...

Summary of Conference Call Records Industry and Company Involved - The conference call discusses the investment landscape for 2025, focusing on the non-banking financial sector and emerging investment themes such as new consumption, robotics, artificial intelligence (AI), and innovative pharmaceuticals. Core Points and Arguments 1. **Market Drivers**: The primary drivers of the current market are improved liquidity and risk appetite, supported by a historically weak dollar, unprecedented policy support, and a favorable overall liquidity environment. Geopolitical risk reduction and global stock market gains also contribute positively to market sentiment [2][3][12]. 2. **Investment Focus**: The investment strategy for the second half of 2025 emphasizes "track investment," similar to the peaks seen in 2020-2021. Key sectors include new consumption, robotics, AI, and innovative pharmaceuticals, with a focus on structural growth areas supported by policy and technological breakthroughs [1][5][16]. 3. **Active vs. Passive Investment**: Unlike previous peaks, passive investments (like ETFs) hold more influence in 2025. However, active equity investments are expected to outperform in new tracks due to rapid technological iterations and complex business models, allowing for the identification of hidden champions and flexible portfolio adjustments [6][7][8]. 4. **Impact of Fund Flows**: Significant fund inflows can create positive feedback for new track investments. For instance, a fund that saw net subscriptions exceeding 7 billion yuan in Q1 2025 could drive stock price increases and generate excess returns [9]. 5. **Sector Performance**: Recent pullbacks in new consumption and innovative pharmaceutical sectors are attributed to a shift in high-risk capital and weak performance of related Hong Kong stock indices. The potential tightening of liquidity due to the Hong Kong dollar's weak side guarantee is a concern [12][14]. 6. **Short-term Market Disturbances**: The Hong Kong market has faced disturbances from geopolitical tensions and reduced capital inflows, although these factors are expected to be temporary [13]. 7. **Recommended Sectors**: The recommended sectors for investment include AI, semiconductors, and the science and technology innovation board. The AI sector is experiencing upward trends, with significant breakthroughs in chip technology and supportive policies enhancing the sector's attractiveness [15][16]. 8. **Future Investment Strategy**: The mid-term strategy suggests maintaining dividends as a base while actively engaging in emerging tracks and thematic hotspots. Key areas of focus include AI technology, semiconductors, humanoid robotics, and related themes like stablecoins and solid-state batteries [10][11][17]. Other Important but Possibly Overlooked Content - The conference highlights the importance of monitoring the Hong Kong dollar's weak side guarantee, as it may impact liquidity and market performance in the medium term, particularly affecting new consumption and innovative pharmaceutical sectors [14]. - The call emphasizes the need for active management in sectors with high complexity and rapid technological change, suggesting that investors should be prepared to adapt their strategies in response to market dynamics [8][9].

Company Overview - Shandong Lukang Pharmaceutical Co., Ltd. was established on February 15, 1993, and is located at 88 Deyuan Road, Jining High-tech Zone, Shandong Province [18] - The company is listed on the Shanghai Stock Exchange with the stock code 600789, and its actual controller is the State-owned Assets Supervision and Administration Commission of the Shandong Provincial Government [18][19] - As of December 31, 2024, the total share capital of the company is 898,669,632 shares, with 100% being unrestricted shares [19] Issuance Plan - The company plans to issue shares to no more than 35 specific investors, including its controlling shareholder, Hualu Group, which intends to subscribe for 23.81% of the shares, amounting to no more than 64,201,417 shares [2][3][6] - The total amount of funds raised from this issuance is not expected to exceed 1.2 billion yuan (120,000 million yuan) [8] - The final issuance price will be determined based on the average trading price of the company's shares over the 20 trading days prior to the pricing benchmark date, with a minimum price set at 80% of this average [4][5] Industry Context - The global chemical pharmaceuticals market has shown stable growth, increasing from USD 924.8 billion in 2016 to USD 1,104.7 billion in 2022 [20] - The Chinese chemical pharmaceuticals market reached a scale of 801.2 billion yuan in 2016, experiencing fluctuations due to global public health events but is expected to recover starting in 2023 [20] - Chronic diseases, particularly cardiovascular diseases and diabetes, are key focus areas for the company, with significant patient populations and high medical costs associated with these conditions [21][20] Market Trends - The market for cardiovascular drugs in China has maintained growth from 2015 to 2019, with fluctuations from 2020 to 2022 due to public health events [21] - The market for type 2 diabetes treatment drugs in China has experienced volatility from 2018 to 2022 but is projected to grow steadily due to the introduction of innovative diabetes medications and increased awareness of comprehensive health management [21] - The antibiotic market in China has grown from 145 billion yuan in 2016 to 208 billion yuan in 2023, despite regulatory restrictions on antibiotic use [22]

Group 1: Short Drama Market Growth - The short drama market in China has experienced explosive growth, with the user base exceeding 600 million by 2024 [1] - The market size for micro short dramas reached 50.5 billion yuan in 2024, surpassing annual box office revenue for films for the first time [2] - The market is projected to grow to 63.43 billion yuan by 2025 and 85.65 billion yuan by 2027 [2] Group 2: Industry Developments - Major companies like Tencent and Douyin are investing in the short drama sector, with Tencent launching a new short drama mini-program [1] - Douyin Group established a short drama copyright center to enhance copyright management and improve quality [1] - Collaborations between platforms such as iQIYI and Mango TV with Douyin's Hongguo Short Drama aim to produce more quality micro short dramas [1] Group 3: International Expansion - Chinese short drama platforms are seeking international opportunities, becoming mainstream in regions like Southeast Asia and the United States [2] - Over 80% of the top 50 short drama applications globally are Chinese products, indicating strong international presence [2] - Current Chinese small and medium enterprises in the overseas short drama market are positioned for high revenue growth with manageable competition risks [2]

证券代码：000756 证券简称：新华制药 公告编号： 2025-38 山东新华制药股份有限公司 关于 OAB-14 干混悬剂完成Ⅱ期临床中国首例患者入组的公告 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。 二、药物的研究情况 诚如巨潮资讯网 2024 年 8 月 23 日公告编号为 2024-38 的本公司《关于 OAB-14 干混悬 剂临床试验的进展公告》，在目前试验条件下，OAB-14 干混悬剂在健康成年受试者中安全 性和耐受性良好，多次给药后人体内无明显蓄积。 OAB-14 干混悬剂Ⅱ期药物临床试验由首都医科大学宣武医院联合全国多中心共同参与， 于 2025 年 6 月 19 日完成 OAB-14Ⅱ期临床中国首例患者入组。 三、药物的其他情况 OAB-14 是新华制药与沈阳药科大学合作研制的具有自主知识产权的新化学结构创新药， 属于 1 类创新药，适应症拟定为轻至中度阿尔茨海默病（AD）。 2019 年本公司开始合作进行非临床研究，研究结果表明 OAB-14 能显著改善 APP/PS1 双 转基因 AD 模型小鼠学习记忆和社交活动等多种行为障碍。OA ...