Group 1 - The company has received approval from the National Medical Products Administration for the marketing of injectable isavuconazole, which is indicated for the treatment of invasive aspergillosis and mucormycosis in adult patients [1][4] - The original product was developed by Pfizer and was approved for marketing in China in June 2022, subsequently included in the Class B medical insurance catalog, leading to rapid market growth [1][2] - According to sales data from MoSheng Pharmaceuticals, the projected sales for the product are RMB 204 million for the year 2024 and RMB 172 million for the first half of 2025 [1] Group 2 - The approval of injectable isavuconazole is expected to enrich the company's product line and enhance its competitiveness, positively impacting future operating performance [2] - However, the specific sales performance may be influenced by various factors such as market conditions and channel expansion, introducing a degree of uncertainty [2]

Core Viewpoint - Xuantai Pharmaceutical (688247) has received approval from the National Medical Products Administration for the marketing of injectable isavuconazole, which is expected to enhance the company's product line and competitiveness, positively impacting future operating performance [1] Group 1 - The company announced the approval of injectable isavuconazole on January 6 [1] - The approval is seen as a strategic move to enrich the company's product offerings [1] - The introduction of this product is anticipated to have a positive effect on the company's future financial performance [1]

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。 近日，上海宣泰医药科技股份有限公司（以下简称"公司"）收到国家药品 监督管理局（以下简称"国家药监局"）核准签发的《药品注册证书》，批准公司 注射用硫酸艾沙康唑上市。现将相关情况公告如下： 一、药品基本情况 二、药品的其他相关情况 注射用硫酸艾沙康唑适用于治疗成人患者下列感染：侵袭性曲霉病，侵袭性 毛霉病。 证券代码：688247 证券简称：宣泰医药 公告编号：2026-001 上海宣泰医药科技股份有限公司自愿披露 关于注射用硫酸艾沙康唑获得国家药品监督管理局 批准的公告 2026 年 1 月 7 日 注射用硫酸艾沙康唑原研产品为辉瑞公司开发，于 2022 年 6 月在国内获批 上市，同年谈判纳入医保乙类品种目录，随后迎来医院市场快速放量。根据摩熵 医药销售数据，该产品 2024 年年度及 2025 年上半年度销售额分别为人民币 2.04 亿元、1.72 亿元。 三、对公司的影响及风险提示 本次注射用硫酸艾沙康唑获得国家药监局批准上市，有利于进一步丰富公司 的产品线，提升公司 ...

Core Viewpoint - XuanTai Pharmaceutical (688247) has received approval from the National Medical Products Administration for the marketing of injectable isavuconazole, which is indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adult patients [1] Group 1 - The company announced the receipt of the drug registration certificate on January 6 [1] - Injectable isavuconazole is specifically approved for treating two serious fungal infections: invasive aspergillosis and invasive mucormycosis [1]

Core Viewpoint - The company, Xuantai Pharmaceutical (688247.SH), has received approval from the National Medical Products Administration (NMPA) for the marketing of its injectable Isavuconazole sulfate, which is indicated for the treatment of invasive fungal infections in adult patients [1] Group 1 - The injectable Isavuconazole sulfate is approved for the treatment of invasive aspergillosis and invasive mucormycosis [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing of injectable Isavuconazole, which is expected to enhance its product line and competitiveness, although sales performance remains uncertain [1] Group 1: Product Approval - The company announced the approval of injectable Isavuconazole with the registration number H20256410, in a specification of 0.2g [1] - This drug is indicated for the treatment of adult invasive aspergillosis and invasive mucormycosis [1] Group 2: Market Potential - The original product is projected to generate sales of 204 million yuan in 2024 and 172 million yuan in the first half of 2025 [1] - The approval is expected to enrich the company's product portfolio and enhance its competitive position in the market [1]

Core Viewpoint - The company, Xuantai Pharmaceutical (688247.SH), has received approval from the National Medical Products Administration (NMPA) for the marketing of its injectable Isavuconazole sulfate, which is indicated for the treatment of invasive fungal infections in adult patients [1] Group 1 - The injectable Isavuconazole sulfate is approved for the treatment of invasive aspergillosis and invasive mucormycosis [1]

Group 1 - The core viewpoint of the news is that Xuantai Pharmaceutical has experienced a decline in stock performance and financial metrics, indicating potential challenges in its business operations [1][2]. - As of December 31, Xuantai Pharmaceutical's stock fell by 0.21%, with a trading volume of 16.61 million yuan. The net financing buy was -1.30 million yuan, with a total financing and securities balance of 119 million yuan [1]. - The company’s financing balance of 119 million yuan accounts for 2.71% of its market capitalization, which is above the 90th percentile level over the past year, indicating a high level of financing activity [1]. - The company’s revenue composition includes 69.85% from product sales, 9.38% from CRO services, and smaller contributions from other services [1]. Group 2 - As of September 30, the number of shareholders for Xuantai Pharmaceutical was 7,759, a decrease of 3.25% from the previous period, while the average circulating shares per person increased by 229.25% to 58,427 shares [2]. - For the period from January to September 2025, Xuantai Pharmaceutical reported a revenue of 331 million yuan, a year-on-year decrease of 8.59%, and a net profit attributable to shareholders of 63.46 million yuan, down 31.45% year-on-year [2]. - The company has distributed a total of 85.59 million yuan in dividends since its A-share listing [3].

Core Viewpoint - The company announced a restricted stock incentive plan aimed at enhancing governance structure and motivating key employees to support long-term development and shareholder returns [1][2][3] Group 1: Incentive Plan Details - The incentive plan involves granting up to 6.23 million shares, representing 1.37% of the total share capital, with an initial grant of 4.99 million shares (80.06% of the total grant) [1] - The plan targets senior management, core technical personnel, middle management, and key employees to create a shared interest among shareholders, the company, and employees [1][3] Group 2: Performance Assessment Criteria - The performance assessment for the restricted stock includes metrics such as return on equity, revenue growth, R&D expenditure, and the number of approved drugs, with specific growth targets set for 2026-2028 [2] - Revenue growth targets are set at no less than 30%, 59%, and 80% for the respective years, with all growth rates required to exceed industry averages [2] Group 3: Product Development and Market Expansion - The company has developed a product matrix covering various therapeutic areas, including antifungal, psychiatric, diabetes, cancer, digestive, hypertension, kidney, and pain management [2] - Recent approvals from the FDA include the formal approval of tofacitinib citrate sustained-release tablets and temporary approval for other products, indicating a growing product pipeline [2] - In the domestic market, the company has received approvals for new specifications and has successfully participated in national drug procurement, enhancing its market presence [3]

Core Viewpoint - The company announced a restricted stock incentive plan aimed at enhancing corporate governance and aligning the interests of shareholders, the company, and employees, while also motivating and retaining key personnel [1][2]. Group 1: Incentive Plan Details - The incentive plan involves granting up to 6.23 million shares, representing approximately 1.37% of the company's total equity, with an initial grant of 4.99 million shares (80.06% of the total grant) [1]. - The plan targets senior management, core technical staff, middle management, and key personnel, aiming to establish a stable incentive mechanism [1]. Group 2: Performance Assessment Criteria - The plan includes performance assessment criteria based on multiple dimensions such as return on equity, revenue growth, R&D expenses, and the number of approved drugs, with specific growth targets set for 2026-2028 [2]. - The revenue growth targets are set at no less than 32%, 59%, and 80% for the respective years, with each year's growth rate required to exceed the industry average [2]. Group 3: Business Development and Product Pipeline - The company is actively investing in high-tech products and enhancing its research in injection formulations, with a product matrix covering various therapeutic areas including antifungal, psychiatric, diabetes, cancer, digestive, hypertension, kidney, and pain management [2]. - Recent international approvals include the formal approval of tofacitinib citrate extended-release tablets by the FDA and temporary approval for sitagliptin and metformin extended-release tablets, expanding the company's product offerings [2]. Group 4: Domestic Market Progress - In the domestic market, the company received approval for a new specification of sitagliptin and metformin extended-release tablets, enhancing its product portfolio in the diabetes sector [3]. - The successful selection of opaganib in the national drug centralized procurement and the inclusion of sitagliptin and metformin extended-release tablets in the national medical insurance directory are expected to boost market promotion and sales scale [3].