维生素B6注射液

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华北制药维生素B6注射液新增规格获批
Zheng Quan Ri Bao· 2025-06-06 16:47
Core Viewpoint - North China Pharmaceutical has received approval for two products: Vitamin B6 injection and injectable Isavuconazole, indicating a strategic expansion in both essential vitamins and high-end anti-infection markets [1][2][3] Group 1: Product Approvals - The company has been granted a supplementary approval for Vitamin B6 injection (1ml: 100mg) and a drug registration certificate for injectable Isavuconazole (0.2g) by the National Medical Products Administration [1][2] - Vitamin B6 is widely used in clinical settings for various metabolic disorders, with its indications expanding due to ongoing research [1] - The sales data from 2020 to 2023 shows fluctuations in Vitamin B6 injection sales, with a peak of 62.02 million yuan in 2021 and a decline to 46.37 million yuan in 2023 [1] Group 2: Market Strategy - The company plans to leverage its production and sales resources to expand sales channels and increase market coverage following the approval of the new Vitamin B6 injection specification [2] - North China Pharmaceutical aims to participate actively in national and provincial alliance procurement initiatives [2] - The company is considering further product pipeline development in the B vitamin sector based on market trends and strategic goals [2] Group 3: Financial and Competitive Position - The cumulative R&D investment for injectable Isavuconazole is reported to be 15.27 million yuan, and the product is expected to enhance the company's product line in the anti-infection sector [3] - The approval of Isavuconazole signifies the company's entry into the high-end anti-infection market, potentially providing new revenue growth opportunities [3] - The presence of five companies in the domestic market holding registration for injectable Isavuconazole indicates a competitive landscape, with the product achieving sales of 100 million yuan in 2023 [2][3]
宝利化再获发明专利,为制药行业注入创新活力
Bei Ke Cai Jing· 2025-04-23 02:29
Group 1 - Baoli Pharma (Nanjing) Co., Ltd. has successfully obtained a patent for "a preparation and purification device, method, and application of ursodeoxycholic acid," showcasing its strong R&D capabilities and providing new opportunities for the pharmaceutical industry [1] - Ursodeoxycholic acid plays a crucial role in the treatment of various liver and gallbladder diseases, helping to dissolve cholesterol stones and alleviate patient pain [3] - The patented technology significantly enhances the purity and quality stability of ursodeoxycholic acid, offering more reliable and effective treatment options for patients [4] Group 2 - Baoli Pharma has previously achieved success in patenting vitamin B6 injection solutions, marking the latest patent in its innovation journey as a significant milestone [4] - The company emphasizes its commitment to R&D innovation and continuous investment, reflecting its strong technical foundation and innovative capabilities [4] - Baoli Pharma aims to integrate global pharmaceutical technology to safeguard human health, focusing on developing safe and high-quality products and services for the healthcare sector [4]
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
Shang Hai Zheng Quan Bao· 2025-04-22 19:56
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]