Core Viewpoint - The company emphasizes the importance of overseas market opportunities for its pharmaceutical products and is actively pursuing international clinical applications and registrations [1] Group 1 - The company is committed to expanding the overseas market for its product, Anglatide Tablets [1] - The company plans to explore more possibilities to accelerate its internationalization efforts [1]

Group 1 - The company’s subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., successfully passed an unannounced FDA CGMP inspection from June 16 to June 24, 2025, indicating ongoing international recognition of its high-quality manufacturing system [1][2] - The inspection report confirms that Suzhou Zhonghe has met the necessary standards for the production of its product, Toripalimab injection, which is crucial for its overseas commercialization efforts [1][2] - 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, enhancing its ability to supply the overseas market [1] Group 2 - The successful FDA inspection is a significant step for the company’s strategy to expand in the US market, providing a solid foundation for future growth and positively impacting its 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 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]