Investment Rating - The industry investment rating is "Positive," indicating an expected overall return exceeding the CSI 300 Index by more than 5% in the next six months [11]. Core Insights - The pharmaceutical sector showed a slight increase of +0.02% on March 17, 2025, outperforming the CSI 300 Index by 0.26 percentage points, ranking 20th among 31 sub-industries [5]. - Notable performers within the pharmaceutical sub-industries included other biological products (+1.13%), blood products (+0.63%), and medical consumables (+0.34%), while hospitals (-1.28%), offline pharmacies (-1.04%), and medical devices (-0.53%) lagged [5]. - Geron announced the EU approval of its telomerase inhibitor Rytelo (imetelstat) for treating transfusion-dependent anemia in adult patients with myelodysplastic syndromes, marking a significant advancement in the industry [6]. Summary by Sections Market Performance - On March 17, 2025, the pharmaceutical sector's performance was +0.02%, outperforming the CSI 300 Index by 0.26 percentage points, with various sub-industries showing mixed results [5]. Industry News - Geron's Rytelo received EU approval as a monotherapy for treating transfusion-dependent anemia due to myelodysplastic syndromes, previously approved by the FDA in June 2024 [6]. Company News - WuXi AppTec reported a revenue of 39.241 billion yuan for 2024, a decrease of 2.73% year-on-year, with a net profit of 9.450 billion yuan, down 1.63% year-on-year [6]. - Dong-E E-Jiao announced a revenue of 5.921 billion yuan for 2024, an increase of 25.57% year-on-year, with a net profit of 1.557 billion yuan, up 35.29% year-on-year [6].

福建广生堂药业股份有限公司 关于乙肝治疗一类创新药 GST-HG131 联合 GST-HG141 针对乙肝经治患者的临床试验申请获得受理的公告 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。 福建广生堂药业股份有限公司（以下简称"公司"）创新药控股子公司福建广 生中霖生物科技有限公司（简称"广生中霖"）于近日收到国家药品监督管理局下 发的关于乙肝治疗创新药 GST-HG131 联合 GST-HG141 的临床试验申请《受理 通知书》，拟针对核苷（酸）类似物 NUC 经治乙肝患者，挑战临床治愈乙肝。 前述 II 期临床研究已于日前被纳入优化创新药临床试验审评审批试点项目，将 有效缩短本次临床试验申请的审评审批周期，详见公告编号：2025011。 一、《受理通知书》主要内容 1、药品名称： GST-HG141 奈瑞可韦片 申请事项：境内生产药品注册临床试验 受理号和规格： CXHL2500292（25mg）、CXHL2500293（100mg） 证券代码：300436 证券简称：广生堂 公告编号：2025012 申请事项：境内生产药品注册临床试验 受理号和规格：C ...

Investment Rating - The report does not explicitly state an investment rating for the chemical pharmaceutical industry or the specific company being analyzed. Core Insights - The company, Guangshentang, is focused on innovative drug development, particularly in the field of hepatitis B treatment, with its "Dengfeng Plan" showing significant potential for clinical breakthroughs [14][15][16]. - The inclusion of the company's clinical project in the national optimization pilot for innovative drug trials indicates strong recognition from regulatory authorities, which may expedite the drug approval process [14][15]. - The company's research team possesses extensive experience in innovative drug development, which is crucial for the success of the Dengfeng Plan [15][16]. Summary by Sections Company Overview - Guangshentang is transitioning from a generic drug manufacturer to an innovative drug developer, maintaining a strong focus on hepatitis B treatment [15][16]. - The company has established a robust research and development team with significant expertise in the field [15][16]. Clinical Development - The Dengfeng Plan includes a multi-target, all-oral treatment strategy for hepatitis B, combining several innovative components [15][16][20]. - Clinical trials for the drugs GST-HG131 and GST-HG141 are progressing, with GST-HG141 currently in Phase III and GST-HG131 in Phase II [17][18]. Market Position and Strategy - The company aims to address unmet needs in the hepatitis B treatment market, particularly for patients who do not respond well to existing nucleoside therapies [20][21]. - Guangshentang is exploring the integration of AI technology in its drug development processes to enhance efficiency [22]. Financial Outlook - Despite recent losses, the company is focused on increasing revenue and improving gross margins through strategic marketing and cost management [23]. - The company plans to leverage capital markets to support its innovative drug development initiatives [23].

Group 1: Company Overview and Strategy - Fujian Guangshengtang Pharmaceutical Co., Ltd. is focused on innovative drug development, particularly in the hepatitis B treatment area [2][3]. - The company has transitioned from a generic drug manufacturer to an innovative drug enterprise, maintaining a strong focus on hepatitis B while leveraging international cutting-edge technologies [4]. Group 2: Clinical Development and Innovations - The company’s "Dengfeng Plan" for hepatitis B treatment is recognized for its innovative approach, featuring a "fully oral regimen" and targeting cccDNA suppression [3][4]. - Clinical trials for GST-HG141 and GST-HG131 are progressing, with GST-HG141 in Phase III and GST-HG131 having completed patient enrollment for Phase II as of January 2025 [5][6]. Group 3: Regulatory Support and Market Position - The inclusion of the Dengfeng Plan in the innovative drug clinical trial optimization approval pilot reflects the regulatory body's recognition of the project’s innovation and clinical data [3][4]. - GST-HG141 has shown significant efficacy in clinical trials, with 84.0% and 81.5% of patients achieving HBV DNA levels below detection limits in the 50mg and 100mg dosage groups, respectively [6]. Group 4: Financial Performance and Future Outlook - The company reported continuous revenue growth, although it remains in a loss position due to high marketing and R&D expenses, with a cumulative R&D investment of approximately 567 million yuan from 2021 to 2023 [9]. - Management plans to enhance operational efficiency and focus on innovative drug development to achieve profitability [9]. Group 5: Collaborations and Strategic Partnerships - The company has formed strategic partnerships, including a significant investment from the Yuanshan Fund, which holds a 5.02% stake, aimed at enhancing collaboration in the health industry [9].

一、项目确认书主要内容 项目名称：评价 GST-HG131 联合 GST-HG141 在慢性乙型肝炎患者中的安 全性、有效性的随机、双盲、安慰剂对照组的 II 期临床研究 申请单位：福建广生中霖生物科技有限公司 证券代码：300436 证券简称：广生堂 公告编号：2025011 福建广生堂药业股份有限公司 关于乙肝治疗创新药 GST-HG131 联合 GST-HG141 的 II 期临床研究获得优化审评审批试点项目确认书的公告 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。 2024 年 7 月，国家药品监督管理局下发《国家药监局关于印发优化创新药 临床试验审评审批试点工作方案的通知》（国药监药注〔2024〕21 号），持续深 化药品审评审批制度改革，提升药品审评审批效能，支持创新药研发，并在之后 批复同意北京作为开展优化创新药临床试验审评审批试点的两个试点城市之一。 2025 年 3 月 10 日，福建广生堂药业股份有限公司（简称"公司"）创新药控股 子公司福建广生中霖生物科技有限公司收到北京市药品监督管理局下发的《优化 创新药临床试验审评审批试点项目确认书 ...

证券代码：300436 证券简称：广生堂 公告编号：2025010 福建广生堂药业股份有限公司 公司将按国家有关规定积极推进上述研发项目，并及时对项目后续进展情况 履行信息披露义务。 2024 年 12 月 26 日，国家药品监督管理局药品审评中心（以下简称"药审 中心"）组织福建广生堂药业股份有限公司（简称"公司"）创新药控股子公司 福建广生中霖生物科技有限公司召开了关于奈瑞可韦 GST-HG141 II 期临床试验 结果和 III 期临床试验方案的沟通交流会。近日，在药审中心创新药相关各部门 的专业指导与高效协作下，公司收到《GST-HG141（奈瑞可韦）完成Ⅱ期临床后 沟通交流会议纪要》。会议形成多项共识，进一步明确了 GST-HG141 在拟开展 的核苷（酸）类似物（NUC）应答不佳患者 III 期临床试验的主要疗效终点是 HBV DNA 低于检测下限的患者百分比，同时对 III 期临床试验的药效评价时间、患者 入选标准、对照组的选择和样本量等关键指标形成初步一致意见。公司将根据会 议达成的共识，积极完善 III 期临床试验方案并加速推进 III 期注册性临床试验。 奈瑞可韦 GST-HG141 是新 ...

证券代码：300436 证券简称：广生堂 公告编号：2025009 福建广生堂药业股份有限公司 关于公司抗新冠病毒一类创新药泰中定 参与的海外临床研究 PLATCOV 获得泰国临床批件的公告 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。 近日福建广生堂药业股份有限公司（以下简称"公司"）创新药控股子公司 福建广生中霖生物科技有限公司的抗新冠病毒口服小分子 3CL 蛋白酶抑制剂 一类创新药阿泰特韦片/利托那韦片组合包装（商品名：泰中定®，英文名：Tazovid®） 参与的海外临床研究 PLATCOV 获得泰国食品和药物监督管理局（TFDA）同意 批件。现将相关情况公告如下： 一、研究基本情况 研究项目名称：Finding treatments for COVID-19: A phase 2 multi-centre adaptive platform trial to assess antiviral pharmacodynamics in early symptomatic COVID-19 (PLATCOV)（探索 COVID-19 的治疗方法：一项评估 ...

证券代码：300436 证券简称：广生堂 公告编号：2025007 福建广生堂药业股份有限公司 关于控股股东协议转让公司部分股份引入战略投资者 过户登记完成的公告 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。 福建广生堂药业股份有限公司（以下简称"公司"）于近日获悉公司控股股 东福建奥华集团有限公司（以下简称"奥华集团"）与漳州圆山大健康产业投资 基金合伙企业(有限合伙)（以下简称"圆山基金"）的协议转让事项已在中国证 券登记结算有限责任公司办理完成过户登记手续，并取得《证券过户登记确认书》。 协议转让双方将共同推动公司与漳州大健康产业链的产业合作共建，增强产业协 同发展、优势互补，促进公司深化中药板块战略布局，提升公司在大健康领域的 竞争力和影响力。现将具体情况公告如下： 一、本次协议转让的基本情况 2024 年 11 月 14 日，公司控股股东奥华集团与圆山基金签署了《股份转让 协议》，拟以协议转让的方式向圆山基金转让其持有的公司无限售条件流通股合 计 8,000,000 股，占公司总股本 5.02%。圆山基金的执行事务合伙人/普通合伙人 是具备专业投资 ...

证券代码：300436 证券简称：广生堂 公告编号：2025008 福建广生堂药业股份有限公司 关于大股东部分股份提前解除质押的公告 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。 福建广生堂药业股份有限公司（以下简称"公司"）于近日收到公司控股股 东福建奥华集团有限公司（简称"奥华集团"）及实际控制人之一李国栋先生的 通知，获悉奥华集团、李国栋先生将所持有的本公司部分股份办理了提前解除质 押，奥华集团及其一致行动人累计质押股份比例下降，具体情况如下： | 一、股东股份解除质押的基本情况 | | --- | | 股东 | 是否为控股股东 | 本次解除 质押数量 | 占其所 持股份 | 占公司 总股本 | 起始时间 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 名称 | 或第一大股东及 | | | | | 解除时间 | | 质权人 | | | 其一致行动人 | （股） | 比例 | 比例 | | | | | | 奥华集团 | 是 | 6,000,000 | 22.17% | 3 ...

Financial Performance Expectations - The company expects a total profit loss between RMB 13,000,000 and RMB 16,800,000 for the year 2024, compared to a loss of RMB 29,802,910 in the previous year[4]. - The net profit attributable to shareholders is projected to be a loss between RMB 12,500,000 and RMB 16,300,000, down from a loss of RMB 34,858,980 in the same period last year[4]. - The operating revenue is estimated to be between RMB 43,500,000 and RMB 46,000,000, an increase from RMB 42,271,490 in the previous year[4]. - The net profit after deducting non-recurring gains and losses is expected to be a loss between RMB 15,700,000 and RMB 19,500,000, compared to a loss of RMB 35,423,280 last year[4]. - The company anticipates that non-recurring gains and losses will impact the net profit attributable to shareholders by approximately RMB 3,200,000[7]. - The final financial data for 2024 will be disclosed in the annual report, urging investors to make cautious decisions[8]. - The company has communicated with the accounting firm regarding the preliminary financial data, with no significant discrepancies noted[5]. Business Strategy and Operations - The company is actively expanding its market presence while implementing cost reduction and efficiency improvement strategies[7]. - Increased sales, management, and financial expenses are attributed to enhanced market promotion and team building efforts, alongside significant fixed asset investments[7]. - The company is continuing to advance clinical research for innovative drugs, resulting in a high proportion of R&D expenses[7].