证券代码：002007 证券简称：华兰生物 公告编号：2026-001 华兰生物工程股份有限公司 关于参股公司收到药品注册受理通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，没 有虚假记载、误导性陈述或重大遗漏。 近日，华兰生物工程股份有限公司（以下简称"公司"）参股公司华兰安康 生物股份有限公司（原名：华兰基因工程有限公司，以下简称"华兰安康"）收 到国家药品监督管理局签发的阿达木单抗注射液境内生产药品注册上市许可申 请《受理通知书》（受理号：CXSS2600006）。现将相关情况公告如下： 一、申请注册药品的基本情况 药 品 名 称 ：阿达木单抗注射液 申 请 事 项 ：境内生产药品注册上市许可 相互作用，从而有效抑制炎症反应、减轻组织破坏、改善临床症状，是临床重要 的免疫性疾病治疗药物。 经查询国家药监局网站显示，截至本公告披露日，国内已有神州细胞工程有 限公司等 8 家公司的阿达木单抗注射液获批上市，若华兰安康该产品最终获批上 市，将丰富其产品梯队，为其增加新的利润增长点。 三、对公司的影响及风险提示 根据国家相关法规规定，上述阿达木单抗注射液已获得注册上市申请受理， 报送国家 ...

华兰生物(002007.SZ)公告称，公司参股公司华兰安康收到国家药品监督管理局签发的阿达木单抗注射 液境内生产药品注册上市许可申请《受理通知书》。该药品为生物类似药，用于治疗类风湿关节炎、强 直性脊柱炎、银屑病等多类免疫性疾病。截至公告披露日，国内已有8家公司的阿达木单抗注射液获批 上市。该药品获得受理通知书对公司近期业绩不会产生影响，相关药品的注册批件取得时间和结果均具 有不确定性。 ...

证券日报网讯 1月8日，华兰生物在互动平台回答投资者提问时表示，股价受经营环境、经营业绩及行 业发展前景等多重因素综合影响。公司始终坚持稳健经营，持续提升核心竞争力，以扎实的业绩支撑公 司长期价值。未来，公司将进一步提高信息披露质量，保持稳定分红，积极传递公司内在价值，切实维 护投资者利益。 （文章来源：证券日报） ...

Quantitative Models and Construction Methods 1. Model Name: GAN_GRU - **Model Construction Idea**: The GAN_GRU model combines Generative Adversarial Networks (GAN) for feature generation and Gated Recurrent Unit (GRU) for time-series feature encoding to construct a stock selection factor[4][13][14] - **Model Construction Process**: 1. **GAN Component**: - The generator (G) learns the real data distribution and generates realistic samples from random noise \( z \) (Gaussian or uniform distribution). The generator's loss function is: $$ L_{G} = -\mathbb{E}_{z\sim P_{z}(z)}[\log(D(G(z)))] $$ where \( D(G(z)) \) represents the discriminator's probability of classifying generated data as real[24][25][26] - The discriminator (D) distinguishes real data from generated data. Its loss function is: $$ L_{D} = -\mathbb{E}_{x\sim P_{data}(x)}[\log D(x)] - \mathbb{E}_{z\sim P_{z}(z)}[\log(1-D(G(z)))] $$ where \( D(x) \) is the probability of real data being classified as real, and \( D(G(z)) \) is the probability of generated data being classified as real[27][29][30] - GAN training alternates between optimizing \( G \) and \( D \) until convergence[30] 2. **GRU Component**: - Two GRU layers (GRU(128, 128)) are used to encode time-series features, followed by a Multi-Layer Perceptron (MLP) with layers (256, 64, 64) to predict returns. The final output \( pRet \) is used as the stock selection factor[22] 3. **Feature Input and Processing**: - Input features include 18 price-volume characteristics (e.g., closing price, turnover, etc.) sampled over the past 400 days, with a shape of \( 40 \times 18 \) (40 days of features)[18][19][37] - Features undergo outlier removal, standardization, and cross-sectional normalization[18] 4. **Training Details**: - Training-validation split: 80%-20% - Semi-annual rolling training (June 30 and December 31 each year) - Hyperparameters: batch size equals the number of stocks, Adam optimizer, learning rate \( 1e-4 \), IC loss function, early stopping (10 rounds), max training rounds (50)[18] 5. **Stock Selection**: - Stocks are filtered to exclude ST stocks and those listed for less than six months[18] - **Model Evaluation**: The GAN_GRU model effectively captures price-volume time-series features and demonstrates strong predictive power for stock returns[4][13][22] --- Model Backtesting Results 1. GAN_GRU Model - **IC Mean**: 0.1119*** (2019-2025)[4][41] - **ICIR (non-annualized)**: 0.89[42] - **Turnover Rate**: 0.83X[42] - **Recent IC**: 0.0331*** (December 2025)[4][41] - **1-Year IC Mean**: 0.0669***[4][41] - **Annualized Return**: 37.40%[42] - **Annualized Volatility**: 23.39%[42] - **IR**: 1.60[42] - **Maximum Drawdown**: 27.29%[42] - **Annualized Excess Return**: 22.42%[4][42] --- Quantitative Factors and Construction Methods 1. Factor Name: GAN_GRU Factor - **Factor Construction Idea**: The GAN_GRU factor is derived from the GAN_GRU model, leveraging GAN for price-volume feature generation and GRU for time-series encoding[4][13][14] - **Factor Construction Process**: - The GAN generator processes raw price-volume time-series features (\( Input\_Shape = 40 \times 18 \)) and outputs transformed features with the same shape (\( Input\_Shape = 40 \times 18 \))[37] - The GRU component encodes these features into a predictive factor for stock selection[22] - The factor undergoes industry and market capitalization neutralization and standardization[22] - **Factor Evaluation**: The GAN_GRU factor demonstrates robust performance across various industries and time periods, with significant IC values and excess returns[4][41] --- Factor Backtesting Results 1. GAN_GRU Factor - **IC Mean**: 0.1119*** (2019-2025)[4][41] - **ICIR (non-annualized)**: 0.89[42] - **Turnover Rate**: 0.83X[42] - **Recent IC**: 0.0331*** (December 2025)[4][41] - **1-Year IC Mean**: 0.0669***[4][41] - **Annualized Return**: 37.40%[42] - **Annualized Volatility**: 23.39%[42] - **IR**: 1.60[42] - **Maximum Drawdown**: 27.29%[42] - **Annualized Excess Return**: 22.42%[4][42] 2. Industry-Specific Performance - **Top 5 Industries by Recent IC (October 2025)**: - Social Services: 0.4243*** - Coal: 0.2643*** - Environmental Protection: 0.2262*** - Retail: 0.1888*** - Steel: 0.1812***[4][41][42] - **Top 5 Industries by 1-Year IC Mean**: - Social Services: 0.1303*** - Steel: 0.1154*** - Non-Bank Financials: 0.1157*** - Retail: 0.1067*** - Building Materials: 0.1017***[4][41][42] 3. Industry-Specific Excess Returns - **Top 5 Industries by December 2025 Excess Returns**: - Banking: 4.30% - Real Estate: 3.51% - Environmental Protection: 2.18% - Retail: 1.76% - Machinery: 1.71%[2][45] - **Top 5 Industries by 1-Year Average Excess Returns**: - Banking: 2.12% - Real Estate: 1.93% - Environmental Protection: 1.50% - Retail: 1.46% - Machinery: 1.23%[2][46]

证券代码：002007 证券简称：华兰生物 公告编号：2025-048 华兰生物工程股份有限公司 关于参股公司完成股份制改造及更名的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，没有虚假 记载、误导性陈述或重大遗漏。 一、基本情况概述 2025 年 12 月 30 日，华兰生物工程股份有限公司（以下简称"公司"）收 到公司参股公司华兰基因工程有限公司（以下简称"华兰基因"）的通知，华兰 基因已完成股份制改造及相关工商变更登记，并已收到新乡市市场监督管理局换 发的营业执照，其企业类型由"其他有限责任公司"变更为"其他股份有限公司 （非上市）"。本次股份制改造完成后，华兰基因的名称已变更为"华兰安康生 物股份有限公司"（以下简称"标的公司"）。 二、变更后标的公司基本情况 公司名称：华兰安康生物股份有限公司 统一社会信用代码：9141070007139027X5 实际控制人安康先生持有标的公司 60%的股份。本次华兰基因的股份制改造，不 涉及本公司持股比例的变化。 华兰基因本次完成股份制改造，标志着其公司治理结构迈出了重要一步，有 助于其建立更加规范、透明的现代企业制度，完善法人治理结构，提升经 ...

Core Viewpoint - The biopharmaceutical sector experienced a slight decline of 0.34% on December 30, with Wanze Co., Ltd. leading the losses. The Shanghai Composite Index closed at 3965.12, down 0.0%, while the Shenzhen Component Index rose by 0.49% to 13604.07 [1]. Group 1: Market Performance - The biopharmaceutical sector's performance showed mixed results, with individual stocks experiencing varying degrees of gains and losses. Notably, Aidi Pharmaceutical saw a rise of 4.10% to close at 15.98, while Wanze Co., Ltd. fell by 6.76% to 21.94 [1][2]. - The trading volume for Aidi Pharmaceutical was 93,900 shares, with a transaction value of 150 million yuan, indicating strong investor interest [1]. Group 2: Capital Flow - The biopharmaceutical sector faced a net outflow of 330 million yuan from institutional investors, while retail investors contributed a net inflow of 349 million yuan, suggesting a shift in investor sentiment [2]. - The data indicates that while institutional investors withdrew funds, retail investors were more active in purchasing shares within the sector [2][3]. Group 3: Individual Stock Analysis - Ganne Pharmaceutical experienced a net outflow of 34.73 million yuan from institutional investors, while retail investors showed a net inflow of 129.36 million yuan, reflecting a divergence in investment strategies [3]. - Other notable stocks included Huashan Biological, which had a net inflow of 430.99 million yuan from institutional investors, indicating positive sentiment towards its performance [3].

Core Viewpoint - The company is actively engaged in the research and development of innovative drugs and biosimilars through its subsidiaries, with several products nearing market readiness [2]. Group 1: Product Development - Bevacizumab has obtained its drug registration certificate in November 2024, and will commence production and sales [2]. - Rituximab and Dexamethasone are expected to complete clinical studies and submit drug registration applications by November 2024 and December 2025, respectively, with their applications already accepted [2]. - Other products, including Adalimumab, Trastuzumab, Ipilimumab, and several monoclonal antibodies and fusion proteins, have received clinical approval and are undergoing related clinical studies, contributing to the company's new profit growth points and product portfolio enhancement [2].

证券日报网讯12月25日，华兰生物（002007）在互动平台回答投资者提问时表示，截至2025年12月20 日，公司共有14.9万多名投资者。 ...

证券日报网讯 12月16日，华兰生物发布公告称，近日参股公司华兰基因工程有限公司收到国家药品监 督管理局签发的帕博利珠单抗注射液境内生产药品注册临床试验申请《受理通知书》（受理号： CXSL2501079）。 （文章来源：证券日报） ...

目前国内除原研外，暂未有类似药获批上市 公司研发的帕博利珠单抗注射液为生物类似药。帕博利珠单抗原研产品(商品名：可瑞达?，Keytruda?) 由默沙东公司开发，是全球首个获批上市的PD-1抑制剂之一，已在全球范围内获批用于包括非小细胞 肺癌、黑色素瘤、头颈部鳞状细胞癌、食管癌、肝癌、胃癌、结直肠癌等在内的数十个重要肿瘤适应 症，临床价值得到广泛认可。 帕博利珠单抗是一种靶向程序性死亡受体-1(PD-1)的人源化单克隆抗体。PD-1 是免疫 T 细胞表面的一 种关键免疫检查点蛋白，肿瘤细胞可通过激活PD-1通路抑制 T 细胞的免疫活性，从而实现免疫逃逸。 帕博利珠单抗通过阻断PD-1与其配体 PD-L1/PD-L2 的结合，恢复 T 细胞的肿瘤杀伤功能，增强人体免 疫系统对抗肿瘤的能力。该药物作为免疫检查点抑制剂，已成为多种晚期恶性肿瘤的标准治疗方案之 一，革新了肿瘤治疗格局。 格隆汇12月16日丨华兰生物(002007.SZ)公布，近日公司参股公司华兰基因工程有限公司(以下简称"基因 公司")收到国家药品监督管理局签发的帕博利珠单抗注射液境内生产药品注册临床试验申请《受理通知 书》(受理号：CXSL2501 ...