证券代码：300636 证券简称：同和药业 公告编号：2026-005 江西同和药业股份有限公司 关于取得发明专利证书的公告 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。 江西同和药业股份有限公司（以下简称"公司"）于近日收到国 家知识产权局颁发的发明专利证书，具体情况如下： 发明名称：一种瑞色替罗中间体及其制备方法以及瑞色替罗的制 备方法 专利号：ZL 2024 1 0362114.4 专利申请日：2024.03.27 授权公告日：2026.03.27 专利权人：江西同和药业股份有限公司 注：该专利证书标注名称"瑞色替罗"为产品申报专利时暂定命名，国家主管部门 最终核定产品正式通用名称为"瑞司美替罗"。 本发明涉及公司产品瑞司美替罗（Resmetirom），瑞司美替罗临 床用于治疗非酒精性脂肪性肝炎和肝硬化。 本发明提供一种瑞司美替罗新的中间体化合物及其制备方法，以 及将其用于制备瑞司美替罗的方法，该新中间体化合物的应用可显著 提高瑞司美替罗的生产效率，降低生产成本。 上述发明专利的取得不会对公司近期生产经营产生重大影响，但 有利于强化公司自主知识产权技术 ...

Core Viewpoint - The company Tonghe Pharmaceutical has received approval from the National Medical Products Administration (NMPA) for its active pharmaceutical ingredient, Fumaric Acid Venlafaxine, which is primarily used for the treatment of gastroesophageal reflux disease [1] Group 1 - The approval was obtained through the CDE's "Raw and Auxiliary Material Registration Information Publicity" platform [1] - Fumaric Acid Venlafaxine is indicated for the treatment of reflux esophagitis [1]

Group 1 - The core point of the article is that Tonghua Dongbao Pharmaceutical (300636.SZ) has received approval from the National Medical Products Administration (NMPA) for its active pharmaceutical ingredient, Fumaric Acid Vorinostat, which is primarily used for the treatment of gastroesophageal reflux disease [1] Group 2 - The approval was obtained through the CDE's "Raw and Auxiliary Material Registration Information Publicity" platform [1] - Fumaric Acid Vorinostat is specifically indicated for the treatment of reflux esophagitis [1]

Core Viewpoint - The approval of "Fumaric Acid Vorinostat" active pharmaceutical ingredient (API) by the National Medical Products Administration (NMPA) indicates that the product meets China's drug review technical standards, allowing for its use in domestic formulations and enhancing the company's market presence both domestically and internationally [1] Group 1 - The company has received approval for its "Fumaric Acid Vorinostat" API from the CDE, which signifies compliance with relevant drug review standards in China [1] - This approval facilitates the company's expansion of product sales in the domestic market, contributing to a synchronized sales strategy in both domestic and international markets [1]

证券代码：300636 证券简称：同和药业 公告编号：2026-004 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 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"富马酸伏诺拉生"原料药通过了CDE审批。具 体情况如下： 一、 原料药登记信息 | 登记号 | Y20240000857 | | --- | --- | | 品种名称 | 富马酸伏诺拉生 | | 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长乐大道699 | | | 号 | | 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） | 二、 其他相关信息 富马酸伏诺拉生主要用于治疗反流性食管炎。 江西同和药业股份有限公司董事会 二〇二六年二月二十五日 三、 对公司的影响及风险提示 公司"富马酸伏诺拉生"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， ...

Group 1: Company Project Progress - The company has over 30 research and development projects, with global patent expirations concentrated between 2028 and 2033. Some products, such as Vabigatran and Rosuvastatin, are already in the registration submission stage [2] - The company plans to continuously add new product projects each year to create a tiered product structure. Additionally, its affiliate, Boya Biotech, focuses on high-difficulty specialty formulations, which may lead to business synergies [2] Group 2: Business Development - On February 4, 2026, the company announced that the raw material for Edoxaban passed the approval of the National Medical Products Administration (NMPA), which is expected to boost sales in the domestic market and synchronize with international market expansion [3] - The company is implementing a "first generic, one supply" strategy, with approved new products like Vildagliptin and Agomelatine set to join the domestic sales lineup and actively expand into emerging markets [3] Group 3: Business Status - Currently, domestic business revenue accounts for approximately 20% of total revenue. The company plans to bind with leading generic drug companies as main suppliers, with an average of 3-5 core customers per product, to further expand its domestic market share [4] - Seventeen technically mature new products are capable of global supply, and the company will rely on the early layout of the supply chain for products with upcoming patent expirations [4] Group 4: Company Situation - The company has recently obtained several invention patents, such as methods for catalyst regeneration, but has not disclosed specific timelines for industrialization [5] - As of the end of January 2026, there was a net outflow of main funds, but market sentiment changes should be observed in conjunction with subsequent performance and order fulfillment [5]

Core Viewpoint - Tonghua Pharmaceutical has recently been granted three invention patents by the National Intellectual Property Administration, which are expected to enhance the company's competitive edge in the pharmaceutical industry [2] Group 1 - The company received three invention patent certificates with patent numbers ZL202311220522.8, ZL202411365642.1, and ZL202410014759.9 [2] - The announcement date for the patent grants was February 6, 2026, and the patents have a validity period of 20 years [2]

Group 1 - Company Tonghe Pharmaceutical recently announced the receipt of three invention patent certificates from the National Intellectual Property Administration of China [1] - The patents include methods for the preparation of key intermediates for Resmetirom, as well as methods and applications for pyrazine compounds and their nitro derivatives, and the preparation method for Upatacitinib intermediates [1]

证券代码：300636 证券简称：同和药业 公告编号：2026-003 江西同和药业股份有限公司 关于取得三个发明专利证书的公告 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。 江西同和药业股份有限公司（以下简称"公司"）于近日收到国 家知识产权局颁发的三个发明专利证书，具体情况如下： 1、发明名称：一种Resmetirom关键中间体III的制备方法 专利号：ZL 2023 1 1220522.8 专利类型：发明专利 专利申请日：2023.09.21 授权公告日：2026.02.06 专利权人：江西同和药业股份有限公司 2、发明名称：一种吡嗪类化合物及其制备方法和应用、硝基吡嗪 类化合物及其制备方法和应用、乌帕替尼中间体的制备方法 专利号：ZL 2024 1 1365642.1 专利类型：发明专利 专利申请日：2024.09.29 授权公告日：2026.02.06 专利权人：江西同和药业股份有限公司 专利类型：发明专利 专利权人：江西同和药业股份有限公司 注：专利权自授权公告之日起生效。专利权期限为二十年，自申请日起算。 1/ 2 3、发明名称：一种阿普昔腾坦 ...

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]