一品红药业集团股份有限公司 关于全资子公司获得羧甲司坦口服溶液注册证书的公告 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。 一品红药业集团股份有限公司（以下简称"公司"）全资子公司广州市联瑞 制药有限公司于近日收到国家药品监督管理局核准签发的关于羧甲司坦口服溶 液的《药品注册证书》，现将有关事项公告如下： 一、药品注册证书主要信息 药品通用名称：羧甲司坦口服溶液 英文名/拉丁名：Carbocysteine Oral Solution 证券代码：300723 证券简称：一品红 公告编号：2025-040 主要成份：羧甲司坦 剂 型：口服溶液剂 注册分类：化学药品 3 类 规 格：125ml:2.5g 药品注册标准编号：YBH11032025 药品有效期：18 个月 申请事项：药品注册（境内生产） 包装规格：每盒 1 瓶 处方药/非处方药：处方药 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。质量标准、说明书、 标签及生产工艺照所附执行。药品生产企业应当符合药品生产质量管理规范要求 方可生 ...

Core Viewpoint - The company has successfully obtained the production license for the innovative gout drug AR882, indicating that its production capabilities meet national drug standards and regulatory requirements, which supports the drug's future market launch [1] Group 1: Company Developments - The subsidiary Guangdong Ruishi Pharmaceutical Technology Co., Ltd. has passed the comprehensive review by the Guangdong Provincial Drug Administration and obtained the production license for the active pharmaceutical ingredient (API) deuterated probenecid (AR882) [1] - The innovative API base of Ruishi Pharmaceutical is designed according to international standards such as FDA and EU GMP, covering an area of 110 acres with over 50,000 square meters of constructed area and multiple advanced production lines [1] - The production workshop for AR882 utilizes fully enclosed automated production equipment, achieving industry-leading standards in China [1] Group 2: Product Information - AR882 is a next-generation, highly selective URAT1 inhibitor that promotes uric acid excretion and prevents renal toxicity, with a once-daily dosage to maintain healthy serum uric acid levels [2] - The drug has received Fast Track Designation (FTD) from the FDA for gout stone research, potentially filling a global gap in oral medications for gout stone treatment [2] - The global prevalence of hyperuricemia and gout is projected to reach 1.42 billion by 2030, with approximately 200 million individuals affected in China, indicating a significant clinical demand for effective treatments [2] Group 3: Clinical Progress - AR882 has enrolled over a thousand participants globally in its Phase III clinical trials, showing promising efficacy in three key areas: precise acid control, dissolution of gout stones, and safety without renal toxicity [3] - The company has agreed to acquire the remaining 15.25% stake in its subsidiary Guangzhou Ruianbo from Arthrosi for approximately 6.8 million USD, increasing its ownership to 100% to enhance its market position for AR882 in China [3]

Group 1 - China Energy Construction won a major coal-fired power project with a bid amount of approximately 14.586 billion yuan, involving six 660 MW supercritical coal-fired generating units and supporting environmental facilities, with a total construction period of about 36.5 months [1] - Taiji Industry plans to repurchase company shares with a total amount not less than 1 billion yuan and not exceeding 1.2 billion yuan, with a maximum repurchase price of 10.38 yuan per share [1] - Youxun Technology won a project from State Grid with a bid amount of approximately 176 million yuan, accounting for 17.44% of the company's audited revenue for 2024 [2] Group 2 - Daili New Materials established an investment fund with a total subscribed capital of 163.3 million yuan, with Daili contributing 10 million yuan, accounting for 6.12% of the fund [4] - Wanyi Technology received a government subsidy of 2.3475 million yuan, which has been confirmed and classified according to relevant accounting standards [6] - Anke Biotech received a drug registration certificate for Acetate Atosiban Injection, which is used for treating preterm labor [7] Group 3 - Renfu Pharmaceutical received a drug registration certificate for Progesterone Soft Capsules, which are used to treat functional disorders caused by progesterone deficiency [9] - Linyang Energy is a recommended candidate for a major contract with State Grid, with a total expected bid amount of approximately 165 million yuan [11] - Hongtian Technology plans to invest 200 million to 300 million yuan to establish a wholly-owned subsidiary in Gansu Province [28] Group 4 - Hunan Xiang Electric received a total of 40 million yuan in government subsidies, which accounts for 16.07% of the company's audited net profit for 2024 [44] - Nengke Technology plans to repurchase shares with a total amount not less than 10 million yuan and not exceeding 20 million yuan, with a maximum repurchase price of 43.00 yuan per share [46] - Xiamen XGMA received 10 million yuan in historical debt repayment, which is expected to increase the company's net profit for 2025 by 3.186 million yuan [48]

Core Viewpoint - Yipinhong Pharmaceutical Group Co., Ltd. has recently obtained a drug production license for its wholly-owned subsidiary, Guangdong Ruishi Pharmaceutical Technology Co., Ltd., marking a significant milestone in its new drug development process [1]. Group 1: Drug Production License Details - The drug production license was issued by the Guangdong Provincial Drug Administration [1]. - The license is valid until May 21, 2030, and pertains to the production of the raw material drug, Deutetrabenazine [1]. - The production facility is located in the manufacturing industrial park in Wengyuan County, Shaoguan City, Guangdong Province [1]. Group 2: Impact on the Company - The acquisition of the drug production license is not expected to have a significant impact on the company's current performance, as commercial production can only commence after obtaining the drug marketing approval number [1]. - The license represents a milestone in the new drug research and development process, but there are uncertainties regarding the subsequent clinical trial phases and the ability to obtain production permits and market qualifications [1]. - The company will actively promote the related R&D projects and fulfill its information disclosure obligations regarding the project's progress [1].

一、《药品生产许可证》主要情况 企业名称：广东瑞石制药科技有限公司 社会信用代码：91440229MA7DEP2B9F 注册地：广东省韶关市翁源县翁城镇制造工业园 HC0305-04 地块 证券代码：300723 证券简称：一品红 公告编号：2025-038 一品红药业集团股份有限公司 关于全资子公司取得药品生产许可证的公告 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。 一品红药业集团股份有限公司（以下简称"公司"）全资子公司广东瑞石制 药科技有限公司（以下简称"瑞石制药"）于近期取得了广东省药品监督管理局 下发的药品生产许可证。《药品生产许可证》具体内容如下： 生产地址和生产范围：广东省韶关市翁源县翁城镇制造工业园 HC0305-04 地块；原料药（氘泊替诺雷）。 二、对公司的影响 本次瑞石制药取得《药品生产许可证》，预期不会对公司当前业绩产生重大 影响，相关产品待获得药品上市批准文号后方可进行商业化生产。取得《药品生 产许可证》仅是新药研发进展中阶段性里程碑，后续临床试验阶段是否顺利、能 否获得生产批件、具备上市资格尚存在诸多不确定。公司将积极推进上述研 ...

Core Viewpoint - The pharmaceutical sector in A-shares has shown significant performance in 2025, with many stocks experiencing substantial price increases, despite a recent pullback in the market [1][2]. Group 1: Market Performance - As of May 26, the A-share market saw the Shanghai Composite Index drop by 0.05% to 3346.84 points, with the Shenzhen Component Index down 0.41% and the ChiNext Index down 0.8% [1]. - The biopharmaceutical sector has had a strong year, with five stocks rising over 100% and 35 stocks increasing by more than 50% since the beginning of 2025 [1][2]. Group 2: Individual Stock Performance - Notable performers include Yong'an Pharmaceutical, which has seen a price increase of 171.34%, and other companies like Yipin Pharmaceutical and Sanofi National Health, with increases of 169.87% and 138.47%, respectively [3][4]. - The Wind data indicates that the Wande Innovation Drug Index and the Pharmaceutical and Biological Index have risen by 11.21% and 3.17%, respectively, outperforming major indices like the Shanghai Composite and CSI 300 [2]. Group 3: Factors Driving Stock Prices - Yong'an Pharmaceutical's stock price surge is attributed to rising international prices of taurine and strong sales performance of its functional beverage brand "Yijianeng" on e-commerce platforms [5]. - The recent authorization deal between Sanofi Pharmaceutical and Pfizer for a breakthrough PD-1/VEGF bispecific antibody has also driven stock prices, with potential total transaction value exceeding $6 billion [9]. - The acceleration of innovative drug development and the increasing focus on AI in healthcare are contributing factors to the rising stock prices of several pharmaceutical companies [10]. Group 4: Future Outlook - Analysts are optimistic about the investment opportunities in innovative drugs for the second half of 2025, citing the international competitiveness of China's innovative drug development [12]. - The pharmaceutical industry is expected to benefit from ongoing innovation, demographic trends, and favorable policy environments, with a focus on innovative drugs and consumer recovery [12].

Investment Rating - The report maintains a "Buy" rating for the company [4] Core Views - The company has acquired the remaining 15.25% stake in its subsidiary, Guangzhou Rui'an Bo, making it a wholly-owned subsidiary, which enhances its control over the innovative drug AR882 [1][2] - The clinical trials for AR882 are progressing smoothly, with significant milestones achieved, including FDA's Fast Track designation and completion of patient enrollment for key Phase III trials [2] - The company has a diverse pipeline with 71 projects under development, focusing on metabolic, inflammatory, and neurological diseases, which positions it for long-term competitive advantage [3] Financial Projections - The company is projected to achieve net profits of CNY 200 million, CNY 255 million, and CNY 321 million for the years 2025 to 2027, representing growth rates of 137%, 27.5%, and 25.8% respectively [3][8] - The expected P/E ratios for 2025, 2026, and 2027 are 112X, 88X, and 70X respectively [3] Stock Information - As of May 23, the closing price was CNY 49.45, with a total market capitalization of CNY 22,336.21 million [4]

Group 1 - The recombinant protein sector experienced a decline of 1.53%, ranking among the top declines in concept sectors as of the market close on May 26 [1][2] - Within the recombinant protein sector, notable declines were observed in companies such as Sanofi (三生国健) and Yipin Pharmaceutical (一品红), while a few companies like ST Wanfang (*ST万方) and Xilong Science (西陇科学) saw increases of 3.19% and 2.76% respectively [1][2] Group 2 - The recombinant protein sector faced a net outflow of 276 million yuan, with 33 stocks experiencing net outflows, and 17 stocks seeing outflows exceeding 10 million yuan [2] - The stock with the highest net outflow was Sanofi (三生国健), which had a net outflow of approximately 46.36 million yuan, followed by companies like Betta Pharmaceuticals (贝达药业) and Xilong Science (西陇科学) with net outflows of 32.77 million yuan and 29.11 million yuan respectively [2][3] Group 3 - The top gainers in the recombinant protein sector included ST Wanfang (*ST万方) and Kaiyin Technology (凯因科技), which saw net inflows of 9.82 million yuan and 11.86 million yuan respectively [3] - Other companies with significant net inflows included Guoyao Modern (国药现代) with 14.46 million yuan and Rejing Biological (热景生物) with 35.44 million yuan [3]

Core Viewpoint - The National Healthcare Security Administration (NHSA) has initiated an investigation into six companies for collusion and price negotiation during the national drug procurement process, marking the first instance of such violations since the implementation of centralized drug procurement in China [1][4]. Group 1: Investigation and Penalties - Six companies have been disqualified from the seventh round of national drug procurement due to collusion in bidding and have been placed on a "blacklist," facing a suspension of participation for 6 to 12 months [3][7]. - This incident is referred to as the "largest collusion case" in national drug procurement history [4]. - The involved companies include Chengdu Xinjie High-tech Development Co., Ltd., Renhe Yikang Group Co., Ltd., Guangzhou Yipin Hong Pharmaceutical Co., Ltd., Shijiazhuang Fourth Pharmaceutical Co., Ltd., Shanghai Xudong Haipu Pharmaceutical Co., Ltd., and Jiangxi Yiyou Pharmaceutical Co., Ltd. [7]. Group 2: Financial Impact - The collusion has resulted in a loss of approximately 266 million yuan for the procurement side, with Yipin Hong committing to refund the entire amount based on sales data from 2022 to present [8]. - The average winning price for the involved drug, Ambroxol Hydrochloride Injection, was 17.95 yuan, with a price drop of 22%, making it one of the least reduced products in the procurement [9]. Group 3: Market Implications - The blacklisting of these companies may lead to increased competition among other firms for the market share of Ambroxol Hydrochloride Injection, as the involved companies accounted for over 90% of its sales in public hospitals [11]. - The NHSA has emphasized the importance of compliance with laws and regulations in drug procurement, warning that collusion will lead to penalties and damage to corporate reputation [11].

Core Viewpoint - The company reported a significant net loss for the fiscal year 2024, with a net profit attributable to shareholders of -540.39 million yuan and a net profit of -288.94 million yuan after deducting non-recurring gains and losses, indicating financial challenges ahead [1][2]. Group 1: Stock Trading and Financial Performance - The company's stock experienced abnormal trading fluctuations, with a cumulative closing price increase exceeding 30% over three consecutive trading days on May 19, 20, and 21, 2025, as per Shenzhen Stock Exchange regulations [2]. - The board confirmed that there are no undisclosed significant matters that could impact the company's stock price, and previous disclosures do not require correction or supplementation [2][3]. Group 2: Related Transactions and Regulatory Approvals - A proposal regarding the equity of minority shareholders and related transactions is pending approval from the shareholders' meeting, which introduces uncertainty [3]. - The product AR882 has not yet been approved for market sales, and thus has not generated any sales revenue, which will not significantly impact the company's recent performance [3][4]. Group 3: Risk Factors in Pharmaceutical Development - The pharmaceutical development process is characterized by high investment, high risk, and high potential returns, with long timelines and multiple stages that are susceptible to unpredictable factors [4].