证券日报网讯 众生药业（002317）11月11日在互动平台回答投资者提问时表示，公司始终重视药品的 国外市场机会，积极推动产品在海外临床申请和注册，将适时开展昂拉地韦片海外市场的拓展，探索更 多可能性，加快国际化推进步伐。 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性依法承担法律责任。 此次是苏州众合继2023年首次通过FDA现场检查以来，第二次通过FDA现场检查，表明公司高质量生产 制造体系持续获得国际认可。截至本公告披露日，苏州吴江生产基地拥有4,500升（9*500升）发酵能 力，已获得中国内地、中国香港、美国、欧盟、英国、澳大利亚、新加坡、印度、约旦、阿联酋、科威 特、巴基斯坦等多个国家和地区的GMP认证和批准，主要负责特瑞普利单抗海外市场的商业化供应。 美国市场是公司海外商业化战略的重要构成部分，本次通过FDA现场检查，为公司持续拓展美国市场提 供了坚实的保障，将对公司生产经营产生积极影响。 三、风险提示 公司预计本次检查短期内不会对公司业绩产生重大影响。由于药品的生产和销售容易受市场环境变化等 因素影响，存在不确定性，敬请广大投资者谨慎决策，注意防范投资风险。 上海君实生物医药科技股份有限公司（以下简称"公司"）全资子公司苏州众合生物医药科技有限公司 （以下简称"苏州众合"）于2025年6月16日 ...

Core Points - Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Junshi Biosciences, successfully passed an unannounced CGMP inspection by the FDA from June 16 to June 24, 2025, marking the second successful inspection since 2023 [1] - The successful inspection indicates that the company's high-quality manufacturing system continues to receive international recognition [1] - The Suzhou Wujiang production base has a fermentation capacity of 4,500 liters and has obtained GMP certifications from multiple countries and regions, including the US, EU, and Australia, primarily for the commercialization supply of Toripalimab in overseas markets [1] Business Impact - The successful FDA inspection is a significant component of the company's overseas commercialization strategy, providing solid assurance for the continued expansion into the US market [2] - This achievement is expected to have a positive impact on the company's production and operations [2]

Core Points - Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Junshi Biosciences, successfully passed an unannounced CGMP inspection by the FDA from June 16 to June 24, 2025, marking the second successful inspection since 2023 [1] - The successful inspection indicates that the company's high-quality manufacturing system continues to receive international recognition [1] - The Suzhou Wujiang production base has a fermentation capacity of 4,500 liters and has obtained GMP certifications from multiple countries and regions, including the US, EU, and Australia, primarily for the commercialization supply of Toripalimab in overseas markets [1] Business Impact - The successful FDA inspection is a significant component of the company's overseas commercialization strategy, providing solid assurance for the continued expansion into the US market [2] - This development is expected to have a positive impact on the company's production and operations [2]

Core Viewpoint - Tong Ren Tang (600085.SH) has received a Traditional Medicine Registration License from the Ministry of Health of Cambodia, allowing its product "Tong Ren Tang An Gong Niu Huang Wan" to be sold in Cambodia [1] Group 1: Regulatory Approvals - The subsidiary Beijing Tong Ren Tang Guo Yao Co., Ltd. has obtained the Traditional Medicine Registration License, which follows the previously granted import license for the same product [1] - This license enables the distribution of Tong Ren Tang An Gong Niu Huang Wan in Cambodia, enhancing the product's market presence [1] Group 2: Market Expansion - The acquisition of the registration license is expected to enrich the distribution channels for key products of Tong Ren Tang Guo Yao, facilitating market expansion [1] - The impact of this license on the company's production operations and overall performance is not anticipated to be significant at this time [1]

Core Viewpoint - Company Tong Ren Tang has received a Traditional Medicine Registration License from the Ministry of Health of the Kingdom of Cambodia, allowing the sale of "Tong Ren Tang An Gong Niu Huang Wan" in Cambodia, which will enhance the distribution channels for the company's key products and support market expansion [1] Group 1 - The license permits the sale of "Tong Ren Tang An Gong Niu Huang Wan" under the guidance of licensed traditional Chinese medicine practitioners [1] - The Ministry of Health of Cambodia had previously issued an import license for "Tong Ren Tang An Gong Niu Huang Wan" [1] - The acquisition of the license will not have a significant immediate impact on the company's production operations and performance [1] Group 2 - The sales of the medicine may be influenced by changes in Cambodia's policy environment, exchange rate fluctuations, and market competition [1]

Core Viewpoint - The company *ST Shuangcheng (002693.SZ)* has received marketing approval from the Australian Therapeutic Goods Administration for its injectable drug, Bivalirudin, which is used to treat patients with moderate to high-risk acute coronary syndrome (ACS) [1] Group 1: Regulatory Approvals - The drug has previously received a drug registration certificate from the National Medical Products Administration (NMPA) in China [1] - The company has also passed the consistency evaluation of quality and efficacy for injectable generic drugs by the NMPA [1] Group 2: Market Impact - The approval in Australia is expected to positively impact the company's efforts to expand into overseas markets and enhance its performance [1] - However, the drug export business is subject to various factors, leading to uncertainties regarding sales timelines, market size, and future expansion progress [1]