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]
华润双鹤药业股份有限公司关于全资子公司华润紫竹药业有限公司地夸磷索钠滴眼液通过GMP符合性检查的公告