Core Viewpoint - The company, Tonghe Pharmaceutical, has successfully passed the cGMP inspection by the FDA, indicating compliance with U.S. drug production quality standards [1] Group 1: FDA Inspection - The company underwent an FDA cGMP inspection from August 4 to August 7, 2025, covering six major systems: quality system, materials, production, packaging and labeling, equipment facilities, and laboratory controls [1] - The company has received confirmation from the FDA's official website that it has passed the inspection [1]

Core Viewpoint - The company successfully passed the FDA's cGMP inspection, which is a significant achievement reflecting its adherence to high international quality management standards and enhancing its prospects in the U.S. and international markets [1] Group 1: FDA Inspection - The company underwent an FDA cGMP inspection from August 4 to August 7, 2025, covering six major systems: quality system, materials, production, packaging and labeling, equipment facilities, and laboratory controls [1] - The company achieved a zero-defect result in the FDA inspection, indicating full compliance with cGMP regulations [1] Group 2: Implications - The successful inspection is a strong affirmation of the effective operation of the company's management system [1] - This accomplishment is expected to positively impact the company's ability to expand into the U.S. market and other international markets [1]

证券代码：300636 证券简称：同和药业 公告编号：2025-056 江西同和药业股份有限公司 关于通过美国 FDA 现场检查的公告 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 2025 年 8 月 4 日至 2025 年 8 月 7 日接受了美国食品药品监督管理局（以下简称 "美国 FDA"）的 cGMP（现行药品生产质量管理规范）现场检查，检 查范围涵盖质量体系、物料、生产、包装与标签、设备设施、实验室 控制六大系统。 近日，公司从美国 FDA 官网（https://datadashboard.fda.gov /oii/cd/inspections.htm)获悉公司已通过了上述现场检查，符合美 国 FDA 的 cGMP 管理规范。 一、 FDA 现场检查的相关信息 1、企业名称：江西同和药业股份有限公司 2、企业地址：江西省奉新高新技术产业园区 3、检查时间：2025 年 8 月 4 日-2025 年 8 月 7 日 4、检查范围：公司一厂区涉及原料药产品（加巴喷丁、塞来昔 布等）的生产制造 5、FDA ...

Core Viewpoint - Tonghe Pharmaceutical is a leading enterprise in the domestic specialty API sector, focusing on the R&D, production, and sales of chemical APIs and pharmaceutical intermediates, with strong technical R&D capabilities and a complete industry chain advantage [1] Financial Performance - In Q3 2025, Tonghe Pharmaceutical achieved revenue of 636 million yuan, ranking 26th among 47 companies in the industry, with the industry leader, Pro Pharmaceutical, generating 7.764 billion yuan [2] - The net profit for the same period was 83.66 million yuan, ranking 22nd in the industry, with the top performer, Zhejiang Pharmaceutical, reporting a net profit of 867 million yuan [2] Financial Ratios - As of Q3 2025, the company's debt-to-asset ratio was 27.09%, lower than the previous year's 29.91% and below the industry average of 27.75%, indicating good solvency [3] - The gross profit margin for the same period was 30.70%, down from 33.66% year-on-year and below the industry average of 35.38%, suggesting a need for improvement in profitability [3] Management Compensation - The chairman, Pang Zhengwei, received a salary of 928,100 yuan in 2024, an increase of 12,300 yuan from 2023 [4] Shareholder Information - As of September 30, 2025, the number of A-share shareholders decreased by 3.02% to 15,500, while the average number of circulating A-shares held per shareholder increased by 3.12% to 23,800 [5] Growth Prospects - The company reported a year-on-year revenue growth of 11.63% for Q1-Q3 2025, with Q3 revenue reaching 209 million yuan, also reflecting an 11.14% increase year-on-year [5] - New products are being launched, with significant market approvals, including the registration of Vildagliptin in China [5] - The company anticipates total production capacity to reach 2 billion yuan over the next 3-5 years, with revenue projections of 850 million yuan, 980 million yuan, and 1.17 billion yuan for 2025, 2026, and 2027 respectively [5][6]

Group 1: Company Operations and Production Capacity - The company has completed the construction of 5 workshops in the second phase of its second factory, with 2 workshops currently in trial production and 4 workshops in the first phase officially in operation [1] - By 2026, the company plans to achieve an annual production capacity of 1.5-1.6 billion units, with total raw material production capacity expected to exceed 2 billion units in the next 3-5 years [2] Group 2: Product Development and Market Position - The company has 17 new products in the second tier expected to see significant growth in the next 3-5 years, with 8 products in the third tier currently in the registration process [2] - The company maintains a competitive edge in the raw material drug market due to its complete industrial chain and strong manufacturing capabilities, despite the intense competition from countries like India [2] Group 3: Financial Performance and Challenges - In the third quarter, the company reported a decrease in revenue of 31.7 million, a decline of 13.18% compared to the second quarter, primarily due to the suspension of production for some older products [5] - The company recorded an asset impairment loss of over 30 million in the first three quarters, mainly due to the high costs associated with the production of new product validation batches [4] Group 4: Talent Acquisition and Retention - The company offers competitive salaries for high-end talent, with PhD salaries above the level in first-tier cities, along with government subsidies and stock incentive opportunities [4] Group 5: Future Outlook and Shareholder Returns - The company emphasizes long-term value creation for shareholders through performance improvement and increased communication with the capital market, in addition to cash dividends [5] - The CDMO business is expected to achieve rapid growth by 2027-2028, with current orders amounting to approximately 50 million, including 23 million expected in the fourth quarter [4]

Group 1 - The core viewpoint of the article is that Pacific Securities has given a "buy" rating for Tonghua Pharmaceutical (300636.SZ) based on several positive factors [1] - New products are continuously gaining market traction, and regulatory approvals for market registration are ongoing [1] - The first phase of production capacity in the second factory is being released, and two workshops in the second phase are expected to begin trial production within the year [1] Group 2 - The report highlights potential risks including intensified industry competition, product price declines, underwhelming capacity deployment, environmental risks, and exchange rate risks [1]

证券代码：300636 证券简称：同和药业 公告编号：2025-055 公司董事会对刘海燕女士在担任公司保荐代表人期间所作出的 贡献表示衷心的感谢！ 特此公告。 江西同和药业股份有限公司董事会 二〇二五年十月二十七日 江西同和药业股份有限公司 关于更换保荐代表人的公告 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"）于近日收到公 司保荐机构招商证券股份有限公司（以下简称"招商证券"）出具的 《关于更换保荐代表人的函》。招商证券作为公司向特定对象发行股 票项目的保荐人及主承销商，原委派刘海燕、孙经纬为该项目的签字 保荐代表人，负责保荐工作及持续督导工作。 2024年12月13日，公司披露《关于更换保荐代表人的公告》（公 告编号：2024-065），原保荐代表人孙经纬先生变更为鄢坚先生，具 体内容详见公司在巨潮资讯网（http://www.cninfo.com.cn）上披露 的相关公告。 本次因原保荐代表人刘海燕女士工作变动，招商证券拟委派贾音 先生（简历附后）接替刘海燕女士负责公司向特定对象发行股票项目 的持续督导工作 ...

Financial Performance Overview - The company achieved a sales revenue of 636.24 million yuan, a year-on-year increase of 11.63% [2] - Foreign sales amounted to 504.75 million yuan, growing by 8.94%, while domestic sales reached 131.49 million yuan, increasing by 23.36% [2] - New products generated sales of 301.17 million yuan, up by 9.93%, and mature products contributed 335.07 million yuan, with a growth of 13.21% [2] - CMO/CDMO business revenue was 56.99 million yuan, reflecting a decrease of 10.25% [2] Profitability Metrics - The net profit for the period was 83.66 million yuan, down by 12.61%, with a non-recurring net profit of 76.29 million yuan, a decline of 18.02% [2] - Gross margin stood at 30.70%, a decrease of 2.96 percentage points, while net margin was 13.15%, down by 3.65 percentage points [2] Sales Breakdown - Non-contract custom business revenue increased by 14.38%, while contract custom projects saw a decline of 10.25% [3] - Sales of pharmaceutical raw materials rose by 18.95%, but gross margin decreased by 3.58 percentage points [3] - Domestic sales increased by 23.36%, with a gross margin increase of 3.98 percentage points, while foreign sales grew by 8.94% but saw a gross margin decline of 4.08 percentage points [3] Future Development Outlook - The company plans to enhance domestic raw material market efforts, aiming for continuous growth in both domestic and foreign sales [6] - New product exports will focus on becoming the first supplier of generic drugs globally, with an annual target of launching around 10 new raw material drug projects [7] - CMO/CDMO business is expected to recover, with new projects being actively pursued to compensate for the decline in existing orders [8] Capacity Expansion - The first plant's technical upgrades are expected to increase production capacity, while the second plant's phase one is already operational, and phase two is under construction [8] - The second plant's two workshops are projected to contribute significantly to production capacity by 2026 [10] Cost and Expense Management - Sales expenses increased by 7%, while management and financial expenses saw slight decreases [2] - R&D expenses rose by 4.67%, reflecting the expansion of the R&D team [5] Market Trends and Challenges - The company anticipates that the prices of mature products will remain low, but sales volume is expected to grow [9] - The outlook for new products includes a projected revenue increase of 100-150 million yuan in the next two to three years [9]

Group 1 - The core point of the article is that Tonghua Pharmaceutical (SZ 300636) held its fourth board meeting on October 24, 2025, to review proposals including amendments to the company's articles of association [1] - For the first half of 2025, Tonghua Pharmaceutical's revenue composition shows that pharmaceutical manufacturing accounted for 99.51%, while other businesses contributed 0.49% [2] - As of the report date, Tonghua Pharmaceutical has a market capitalization of 3.7 billion yuan [3]

Core Insights - Tonghua Dongbao Pharmaceutical (300636.SZ) released its Q3 2025 report on October 25, 2025, indicating a total of 63.9184 million A-shares held by three institutional investors, accounting for 15.22% of the company's total share capital [1] - The institutional holding percentage decreased by 1.80 percentage points compared to the previous quarter [1] Institutional Investors - The three institutional investors include: - Fong Lung Industrial Co., Ltd. - Guotai Junaq Securities' special pension product from China Merchants Bank - Jiangxi Chinese Media Blue Ocean International Investment Co., Ltd. [1] - The total institutional holding ratio stands at 15.22% [1] Public Funds - A total of 58 public funds were not disclosed in the current period compared to the previous quarter, including: - Galaxy Medical Mixed A - Industrial Bank Healthcare A - Galaxy Kang Le Stock A - Fuanda Medical Innovation Mixed - Xiangcai Medical Health Mixed A [1]