Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) for its active pharmaceutical ingredient, tolvaptan, which is now registered for use in formulations [1] Group 1: Approval Details - The active pharmaceutical ingredient "Tolvaptan" has been approved by the NMPA [1] - The registration number for the product is Y20240000672 [1] - The product is manufactured domestically by Jiangxi Tonghe Pharmaceutical Co., Ltd [1] Group 2: Product Information - The product name is tolvaptan, which is intended for use in approved formulations [1] - The approval rating from the review process is A, indicating it is approved for use in marketed formulations [1]

同和药业（300636）(300636.SZ)公告，公司提交的"甲苯磺酸艾多沙班"原料药通过了CDE审批。甲苯磺 酸艾多沙班是一种口服抗凝药物，主要用于预防非瓣膜性房颤患者的卒中及全身性栓塞，以及治疗或预 防深静脉血栓和肺栓塞。 ...

智通财经APP讯，同和药业(300636.SZ)公告，公司提交的"甲苯磺酸艾多沙班"原料药通过了CDE审批。 甲苯磺酸艾多沙班是一种口服抗凝药物，主要用于预防非瓣膜性房颤患者的卒中及全身性栓塞，以及治 疗或预防深静脉血栓和肺栓塞。 ...

证券代码：300636 证券简称：同和药业 公告编号：2026-002 江西同和药业股份有限公司 关于公司原料药通过 CDE 审批的公告 登记号 Y20240000672 品种名称 甲苯磺酸艾多沙班 企业名称 江西同和药业股份有限公司 企业地址 江西奉新高新技术产业园区天工大道888 号（注） 产品来源 境内生产 审评审批结果 A（已批准在上市制剂使用的原料） 一、 原料药登记信息 注：该地址为公司二厂区。 二、 其他相关信息 甲苯磺酸艾多沙班是一种口服抗凝药物，主要用于预防非瓣膜性 房颤患者的卒中及全身性栓塞，以及治疗或预防深静脉血栓和肺栓塞。 三、 对公司的影响及风险提示 公司"甲苯磺酸艾多沙班"原料药（二厂区）通过CDE审批，表 明该产品符合中国相关药品审评技术标准，已批准在国内上市制剂中 使用，公司两个厂区的该产品均获CDE批准，有利于公司拓展该产品 在国内市场的销售，形成国内国外市场同步销售的良好格局。 受市场环境等因素影响，上述原料药品种的具体销售情况存在一 1/ 2 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。 江西同和药业股份有限公司（以下简 ...

Core Viewpoint - Tonghua Pharmaceutical (300636) has completed technical upgrades at its first factory, leading to increased production capacity and reduced unit costs, which helps mitigate the impact of exchange rate fluctuations and depreciation pressure, thereby enhancing gross margins [1] Group 1: Production and Cost Management - The completion of technical upgrades at the company's first factory has resulted in an increase in production capacity [1] - The company has achieved a reduction in unit costs due to these upgrades [1] - These improvements are expected to effectively counterbalance the pressures from exchange rate fluctuations and depreciation [1] Group 2: Supply Chain Strategy - The company is diversifying its raw material procurement by certifying and sourcing from more than three suppliers across different provinces [1] - This strategy aims to mitigate risks associated with reliance on a single region or supplier, ensuring supply chain security [1]

Group 1 - The company has a total of 17 new products and over 30 research reserve varieties, with several global patent expirations scheduled between 2028 and 2033 [1] - Some products, such as Vabigatran, Rosuvastatin, and others, are already in the registration submission process, indicating ongoing development efforts [1] - The company plans to maintain multiple new product launches each year, creating a product lineup consisting of mature products, research (registration) products, and reserve products [1] Group 2 - Currently, there is no relevant layout in the innovative drug sector, indicating a focus on other areas [1] - The company's associate, Boya Biotech, primarily engages in the research and production of high-difficulty specialty formulations, which have high industry entry barriers [1] - Future business synergies are expected between the company and Boya Biotech, enhancing overall operational capabilities [1]

Core Viewpoint - Tonghua Pharmaceutical will disclose its 2025 annual report by the end of April 2026, indicating a commitment to transparency and future planning [2] Production Capacity - The second phase of the second plant is expected to achieve an annual production capacity of 1.5 to 1.6 billion yuan after the two workshops commence trial production [2] - Over the next 3-5 years, the total production capacity for raw materials is anticipated to exceed 2 billion yuan [2] - The utilization rate of the first plant is currently high, while the utilization rate of the second plant is gradually increasing [2] Orders and Demand - The company currently has a sufficient backlog of orders, suggesting strong demand for its products [2]

Core Viewpoint - Tonghua Pharmaceutical (300636.SZ) has received approval from the National Medical Products Administration (NMPA) for its active pharmaceutical ingredient, tolvaptan, which is an oral anticoagulant used for preventing strokes and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment or prevention of deep vein thrombosis and pulmonary embolism [1] Group 1 - The company has recently confirmed the approval of its active pharmaceutical ingredient, tolvaptan, through the CDE's public platform [1] - Tolvaptan is primarily used for preventing strokes and systemic embolism in patients with non-valvular atrial fibrillation [1] - The drug is also indicated for the treatment or prevention of deep vein thrombosis and pulmonary embolism [1]

关于公司原料药通过 CDE 审批的公告 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。 证券代码：300636 证券简称：同和药业 公告编号：2026-001 江西同和药业股份有限公司 江西同和药业股份有限公司（以下简称"公司"）近日从国家药 品监督管理局药品审评中心（CDE）"原辅包登记信息公示"平台查 询获悉，公司提交的"甲苯磺酸艾多沙班"原料药通过了CDE审批。 具体情况如下： 一、 原料药登记信息 三、 对公司的影响及风险提示 公司"甲苯磺酸艾多沙班"原料药通过CDE审批，表明该原料药 符合中国相关药品审评技术标准，已批准在国内上市制剂中使用，有 利于公司拓展产品在国内市场的销售，形成国内国外市场同步销售的 良好格局。 受市场环境等因素影响，上述原料药品种的具体销售情况存在一 定的不确定性。公司将按照相关法律法规的要求对后续进展情况履行 信息披露义务。敬请广大投资者理性投资，注意投资风险。 特此公告。 江西同和药业股份有限公司董事会 二〇二六年一月二十六日 1/ 1 | 登记号 | Y20200001211 | | --- | --- | | 品种名称 ...

Market Overview - The Shanghai Composite Index closed at 4120.10 points, above the annual line, with a change of 0.16% [1] - The total trading volume of A-shares reached 1,645.83 billion yuan [1] Stocks Above Annual Line - A total of 61 A-shares have surpassed the annual line today, with notable stocks showing significant deviation rates [1] - The stocks with the highest deviation rates include: - Huawi Design (华维设计) with a deviation rate of 24.42% - Hualing Co. (华岭股份) at 5.51% - Huilong Piston (汇隆活塞) at 4.81% [1] Detailed Stock Performance - The following table summarizes the performance of selected stocks that have crossed the annual line: - Huawi Design (华维设计): Today's change of 29.96%, turnover rate of 26.39%, annual line at 14.64 yuan, latest price at 18.22 yuan [1] - Hualing Co. (华岭股份): Today's change of 12.70%, turnover rate of 9.21%, annual line at 24.90 yuan, latest price at 26.27 yuan [1] - Huilong Piston (汇隆活塞): Today's change of 18.06%, turnover rate of 13.30%, annual line at 9.86 yuan, latest price at 10.33 yuan [1] - Other notable stocks include: - Wuhan Fangu (武汉凡谷) with a deviation rate of 4.17% - Meirui New Materials (美瑞新材) with a deviation rate of 3.81% [1] Additional Stocks with Minor Deviations - Stocks with smaller deviation rates that have just crossed the annual line include: - Gongdong Medical (拱东医疗) and Chongqing Gas (重庆燃气) [1] - The performance of these stocks indicates a cautious upward trend in the market [1]