Core Points - The announcement details the results of GMP compliance inspections for two pharmaceutical companies in Shaanxi Province, confirming that both companies meet the required standards [1] Group 1: Company Inspections - Shaanxi Baiyun Pharmaceutical Co., Ltd. was inspected from September 9 to September 12, 2025, and was found to be compliant with GMP requirements [1] - Shaanxi Jingyang Jinlan Skin Disease Research Institute and Shaanxi Kanghui Pharmaceutical Co., Ltd. were inspected on July 22, 2025, and from July 30 to August 1, 2025, respectively, and both were also found to be compliant with GMP requirements [1]

Core Viewpoint - Beijing Tiantan Biological Products Co., Ltd. announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. has received the Drug GMP Compliance Inspection Notice and the updated Drug Production License, indicating the completion of the production site change for the product "Recombinant Human Coagulation Factor VIII" and the potential for expanded production capacity [1][4]. Group 1: GMP Compliance Inspection - Chengdu Rongsheng received the Drug GMP Compliance Inspection Notice from the Sichuan Provincial Drug Administration [1]. - The inspection was conducted from August 18 to August 21, 2025, and concluded that the company complies with the Drug Production Quality Management Standards (2010 revision) and related appendices [2]. Group 2: Drug Production License Changes - The production scope for Chengdu Rongsheng has been updated to include the production of "Recombinant Human Coagulation Factor VIII," limited to registered application use, following the successful GMP compliance inspection [3]. - The production address remains the same: No. 280, Jingyuan Road, Shuangliu District, Chengdu, Sichuan Province [3]. Group 3: Impact on the Company - The product "Recombinant Human Coagulation Factor VIII" was approved for market launch in September 2023, and the production site change was approved in July 2025 [4]. - The completion of the production site change allows for an increase in production scale for the product [4].

Group 1: GMP Compliance Announcement - Company’s subsidiary, China Resources Zizhu Pharmaceutical Co., Ltd., received GMP compliance notice for Diquafosol Sodium Eye Drops from Beijing Drug Administration [1] - The GMP inspection was conducted from March 12 to March 14, 2025, confirming compliance with the 2010 revised Drug Production Quality Management Standards [1][2] - The production capacity for Diquafosol Sodium Eye Drops is designed at 80 million bottles per year, with no additional investment made for the inspection [2] Group 2: Market Situation of Diquafosol Sodium Eye Drops - Diquafosol Sodium Eye Drops are used for treating dry eye patients with diagnosed tear film abnormalities, developed by Santen Pharmaceutical Co., Ltd. and launched in Japan in April 2010 [2][3] - In 2023, global sales of Diquafosol Sodium Eye Drops reached $161.3 million, with the product marketed as "Diquas" in Japan and "Liaisi" in China [2][3] - In China, 39 companies have approved production of Diquafosol Sodium Eye Drops, with the total sales in the domestic market amounting to 228 million RMB in 2023 [3] Group 3: Impact on Company - The successful GMP compliance indicates that the company can maintain stable product quality and production capacity to meet market demand [4] - The inspection results are not expected to have a significant impact on the company's financial performance [4] Group 4: Vitamin B6 Injection Announcement - The company’s subsidiary, China Resources Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd., received approval for Vitamin B6 Injection's consistency evaluation from the National Medical Products Administration [13] - The Vitamin B6 Injection is used for preventing and treating Vitamin B6 deficiency and related conditions, with a cumulative R&D investment of 3.89 million RMB [14][15] - In 2023, the total sales of Vitamin B6 Injection in the domestic market reached 453 million RMB, with the top five companies holding significant market shares [15]