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。 8、审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品此次申请事项符合药品 注册的有关要求，批准本品增加"每片含磷酸西格列汀50mg（以C??H??F?N?O计）和盐酸二甲双胍 500mg"规格，核发新的药品批准文号。 近日，上海宣泰医药科技股份有限公司（以下简称"公司"）全资子公司江苏宣泰药业有限公司收到国家 药品监督管理局（以下简称"国家药监局"）核准签发的《药品补充申请批准通知书》，西格列汀二甲双 胍缓释片增加"每片含磷西格列汀50mg（以C??H??F?N?O计）和盐酸二甲双胍500mg"规格的补充申请已 获得国家药监局批准。现将相关情况公告如下： 一、药品基本情况 1、药品名称：西格列汀二甲双胍缓释片 2、注册分类：化学药品 3、申请事项：增加"每片含磷酸西格列汀50mg（以C??H??F?N?O计）和盐酸二甲双胍500mg"规格 4、药品批准文号：国药准字H20258134 5、剂型：片剂 6、规格：每片含磷酸西格列汀50mg（以C??H??F?N ...

智通财经APP讯，宣泰医药(688247.SH)公告，公司全资子公司江苏宣泰药业有限公司收到国家药品监 督管理局核准签发的《药品补充申请批准通知书》，西格列汀二甲双胍缓释片增加"每片含磷西格列汀 50mg和盐酸二甲双胍500mg"规格的补充申请已获得国家药监局批准。西格列汀二甲双胍缓释片适用于 正在接受西格列汀和二甲双胍缓释片联合治疗的成人2型糖尿病患者。 ...

宣泰医药公告，全资子公司江苏宣泰药业有限公司收到国家药品监督管理局核准签发的《药品补充申请 批准通知书》，西格列汀二甲双胍缓释片增加"每片含磷酸西格列汀50mg（以 C₁₆H₁₅F₆N₅O 计）和盐酸 二甲双胍500mg"规格的补充申请已获得国家药监局批准。目前上市销售的规格为每片含磷酸西格列汀 50mg（以 C₁₆H₁₅F₆N₅O 计）和盐酸二甲双胍1000mg，新获批规格有助于更好地满足患者的用药需求， 提升产品市场竞争力和占有率，对公司未来业绩产生积极影响。 ...

Summary of Yuheng Pharmaceutical Conference Call Company Overview - **Company**: Yuheng Pharmaceutical - **Period**: First half of 2025 Key Points Financial Performance - Yuheng Pharmaceutical reported a revenue of 1.1 billion RMB in the first half of 2025, a decrease of 10% year-on-year [4] - Net profit attributable to shareholders was 134 million RMB, an increase of 7.56% [4] - Non-recurring net profit reached 107 million RMB, up 13.28% [4] - Operating cash flow was 155 million RMB, with a weighted average return on equity of 6.78% [4] - Total and net assets showed slight growth [4] Revenue Decline Reasons - Revenue decline was primarily due to price reductions from centralized procurement, notably the price of core product 12 Wei dropping from 80 RMB to 40 RMB per unit [5] - Despite the revenue drop, overall business growth was maintained with significant increases in products like An Nao series and Lu Guo Duo Peptide [5] Cost Control Measures - Effective cost control led to a sales expense reduction of over 20% year-on-year [6] - Management expenses decreased, and financial expenses approached zero, significantly improving profitability and asset quality [6] Future Business Strategy - The company plans to continue its existing management philosophy, focusing on improving asset quality and profitability while introducing new products like Peima Beite and Nike Bao [7] - Peima Beite tablets are expected to enter the national medical insurance negotiation directory in Q4 2025, with a target market of over 300 million patients with lipid abnormalities in China [8] Sales and Expense Ratios - Sales expense ratio decreased to 26%, below the industry average [9] - Management expense ratio maintained at a low level of 5.16% [9] - The company anticipates stable profit margins for the remainder of the year [10] Product Growth and New Introductions - New products like Xigrelitin Metformin sustained significant sales contributions, covering over 600 hospitals with expected terminal sales of 100 million RMB [11] - Collaboration with Eisai on Mecobalamin injection is projected to generate over 20 million RMB in revenue [13] - The company expects significant sales growth from new products in 2026, with optimistic revenue forecasts [14] E-commerce and Market Expansion - Yuheng Pharmaceutical is actively expanding e-commerce channels, partnering with platforms like JD Health, expecting e-commerce to account for 20-30% of total sales [3][17] - The company is also exploring international development opportunities through acquisitions and partnerships [3] Core Product Performance - Core products like An Nao series and Vitamin B12 maintained stable growth, with An Nao series expected to exceed 10 million boxes in sales [16][20] - The market for An Nao series is supported by a large patient base, with projections for continued high growth [20] Acquisition Strategy - The company has a successful history of acquisitions, contributing significantly to gross profit [21] - Yuheng Pharmaceutical has over 600 million RMB in cash reserves and a low debt ratio of 26%, facilitating future acquisitions [22] Internationalization Efforts - Yuheng Pharmaceutical has initiated international collaborations and plans to expand its international business further [24] Future Outlook - The company aims to create value and meet shareholder expectations while maintaining open communication with investors [25] - Yuheng Pharmaceutical is optimistic about stable growth in the coming years, supported by new product launches and strategic management [23]

Core Viewpoint - Harbin Yuheng Pharmaceutical Co., Ltd. reported a decline in revenue for the first half of 2025, but net profit increased, indicating a mixed performance with potential for future growth through product expansion and cost management [1][2]. Financial Performance - The company's revenue for the first half of 2025 was 1.1 billion yuan, a year-on-year decrease of 9.97% [1]. - Net profit attributable to shareholders was 134 million yuan, an increase of 7.56% year-on-year [1]. - The net profit after deducting non-recurring items was 107 million yuan, up 13.28% year-on-year [1]. - Operating cash flow was 155 million yuan, with a weighted average return on equity of 6.78% [1]. Operational Highlights - The company achieved significant sales growth in key products: - Sales of An Nao Wan/Pian increased by over 30% year-on-year - Revenue from potassium chloride sustained-release tablets also grew by over 30% - The market coverage for Sitagliptin Metformin sustained-release tablets expanded to over 600 terminals [2]. - Management, sales, and financial expenses all saw reductions, with sales expenses down 31.28% to 294 million yuan, management expenses down 21.58% to 56.75 million yuan, and financial expenses down 48.03% to 601,300 yuan [2]. Future Development Strategy - The company plans to enhance asset quality and profitability through: - Continued growth in existing products like Lugu Peptide Injection and multi-vitamin injections - Accelerating sales channel development for new products like Sitagliptin Metformin sustained-release tablets and expanding market reach for new cooperative products [2]. - The company has over 20 projects in development, aiming to obtain approvals for 4 to 6 products this year [2]. - Cost control measures will continue to be a focus, with potential for further reductions in management and sales expenses [2]. Market Expectations - The company expressed optimism about the sales of Pemafibrate tablets, anticipating entry into national negotiations by Q4 2025, which could lead to significant market progress [3]. - The commercial cooperation for Methylcobalamin Injection is expected to contribute to revenue growth [3]. - The Sitagliptin Metformin sustained-release tablets are projected to achieve terminal sales of around 100 million yuan for the year [3]. - The company is exploring international collaborations and has begun exporting products, generating revenue from exports to Central Asia [3]. Investment Outlook - The company is open to investor engagement and is focused on creating value through performance improvement and strategic initiatives [4].

Financial Performance - In the first half of 2025, the company's operating revenue was 11.00 billion CNY, a year-on-year decrease of 9.97% [2] - Net profit attributable to shareholders was 1.34 billion CNY, an increase of 7.56% year-on-year [2] - The net profit after deducting non-recurring gains and losses increased by 13.28% [2] - Operating cash flow was 1.55 billion CNY, with a weighted average return on equity of 6.78% [2] Sales Growth Drivers - Sales of the main product, An Nao Wan/Pian, increased by over 30% year-on-year [3] - Revenue from potassium chloride sustained-release tablets also grew by over 30% [3] - The sales of the drug Siglitin Metformin sustained-release tablets have expanded to over 600 terminals, with expected continued growth [3] Cost Management - Sales expenses decreased by 31.28% to 294 million CNY [3] - Management expenses fell by 21.58% to 56.75 million CNY [3] - Financial expenses reduced from 60.13 million CNY to 48.03 million CNY [3] Future Strategies - Focus on existing product growth, particularly for Luguapeptide injection and multi-vitamin injections [3] - Accelerate the sales channel expansion for Siglitin Metformin sustained-release tablets and explore new markets for Meloxicam tablets [3] - New product Pema Bet tablets expected to launch in September, with high market expectations [3] - The company aims to maintain low levels of financial, management, and sales expenses [3] Market Expectations - Pema Bet tablets projected to enter the national catalog in Q4 2025, with significant market potential [4] - Siglitin Metformin sustained-release tablets expected to achieve sales of approximately 100 million CNY by year-end [4] - An Nao Wan/Pian expected to exceed 10 million boxes in sales, with a target of over 1 billion CNY in the next five years [6] International Expansion - The company has accumulated experience in international cooperation over the past decade and plans to continue exploring new opportunities [7] - Sodium creatine phosphate sales in Central Asia generated 2.46 million CNY in revenue in the first half of 2025 [7] Cost Efficiency - Sales expense ratio has decreased to 26.76% due to refined management and drug procurement policies [8] - Management expense ratio is among the lowest in the industry, with potential for further reduction [8] E-commerce Development - The company has established a professional e-commerce team, expecting online sales to contribute approximately 20% of product revenue [8]

Core Insights - Xuantai Pharmaceutical (688247) reported a slight increase in revenue but a significant decline in net profit for the first half of 2025, indicating challenges in profitability despite stable sales growth [1] Financial Performance - Total revenue for the first half of 2025 reached 220 million yuan, a year-on-year increase of 0.74% [1] - Net profit attributable to shareholders was 45.59 million yuan, down 15.82% compared to the previous year [1] - Gross margin decreased to 41.23%, a decline of 15.76% year-on-year [1] - Net margin also fell to 20.76%, down 16.44% from the previous year [1] - Operating expenses increased by 18.16%, totaling 21.60 million yuan, which accounted for 9.84% of revenue [1] Cash Flow and Assets - Operating cash flow per share decreased by 24.1% to 0.11 yuan [1] - Cash and cash equivalents dropped by 21.71% to 209 million yuan [2] - Accounts receivable increased by 15.24% to 82.12 million yuan, indicating potential cash collection issues [1][2] Liabilities and Expenses - Interest-bearing liabilities decreased by 29.72% to 38,200 yuan [1] - Employee compensation liabilities fell by 63.89% due to the payment of last year's bonuses [6] - Financial expenses rose by 62.43%, attributed to decreased interest income from bank deposits and currency fluctuations [6] Investment and Capital Expenditure - The company’s capital expenditures are crucial for its performance, and the effectiveness of these investments should be closely monitored [7] - The return on invested capital (ROIC) for the previous year was 9.94%, indicating average capital returns [7]

Group 1 - The company reported a revenue of 220 million yuan and a net profit of 45.5857 million yuan for the first half of 2025, with a proposed cash dividend of 0.25 yuan per 10 shares, totaling 11.2251 million yuan, which accounts for 24.62% of the net profit [1] - The company has implemented a strategy focusing on "first generics and high activity," expanding its product pipeline across various therapeutic areas, including antifungal, psychiatric, diabetes, cancer, digestive, hypertension, kidney, and pain management [1] - The company has received approval for 16 products, including several first generics in China and the U.S., establishing market barriers and enhancing product competitiveness [1] Group 2 - In the CRO/CMO sector, the company has deepened collaborations with domestic and international innovative pharmaceutical companies, adding 8 new clients and advancing 11 innovative drug formulation developments [2] - The company has successfully facilitated the market approval of two innovative drugs and has completed over 100 innovative drug formulation developments for global clients, with 8 new drugs approved for commercialization [2] - The company aims to leverage its dual registration capabilities and GMP production base to enhance collaborations with leading innovative pharmaceutical companies and foster new business growth [2] Group 3 - The company maintains a rigorous quality management system, ensuring compliance with international standards and enhancing product quality [3] - The company has successfully passed 12 audits from domestic and international drug regulatory agencies this year, including first-time approvals from the Saudi FDA and EMA [3] - The company plans to continue its dual strategy of innovation-driven and international expansion, aiming to enhance its core competitiveness and global influence in the pharmaceutical industry [3]

Group 1 - The company announced that its wholly-owned subsidiary, Baoding Tianhao Pharmaceutical Co., Ltd., received approval from the Hebei Provincial Drug Administration for changes in the production scope and entrusted production situation of its Drug Production License [1] - The production license includes various forms of medications such as ointments, tablets, solutions, and capsules, with the license valid until July 7, 2030 [1] - Changes in production lines include specific formulations such as "Oseltamivir Phosphate Oral Suspension" and "Donepezil Hydrochloride Tablets" [2][3] Group 2 - Baoding Tianhao Pharmaceutical Co., Ltd. has entrusted Shandong Buchang Pharmaceutical Co., Ltd. to produce Donepezil Hydrochloride Tablets, with the entrusted production valid until July 7, 2030 [3] - The changes in the Drug Production License are expected to optimize the production structure and maintain stable production capacity, positively impacting the company's future operations [4]

Core Viewpoint - The announcement highlights the approval of changes to the drug production license of Baoding Tianhao Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Shandong Buchang Pharmaceutical Co., Ltd., which is expected to optimize production structure and maintain stable production capacity to meet market demand [1][4]. Summary by Sections Drug Production License Information - Baoding Tianhao Pharmaceutical Co., Ltd. has received permission from the Hebei Provincial Drug Administration to change the production scope and drug commissioning details of its drug production license [1]. - The production address is located at 128 Xinghua East Road, Dingxing County, Hebei Province, and the license is valid until July 7, 2030 [1]. Changes in Production Lines - The production line at Tianjin Hanrui Pharmaceutical Co., Ltd. has changed from "oral suspension" to "oral suspension (Oseltamivir phosphate dry suspension)" [2]. - The production line at Shandong Buchang Pharmaceutical Co., Ltd. has changed from "tablets" to "tablets (Donepezil hydrochloride tablets)" [2]. - The production line at Yangling Buchang Pharmaceutical Co., Ltd. has changed from "tablets" to "tablets (Sitagliptin and Metformin sustained-release tablets), tablets (Compound Sodium Sulfate tablets)" [2]. Commissioning Details - Baoding Tianhao Pharmaceutical Co., Ltd. has commissioned Shandong Buchang Pharmaceutical Co., Ltd. to produce Donepezil hydrochloride tablets, with the production address at 1566 Zhonghua West Road, Heze City, and the commissioning is valid until July 7, 2030 [3]. Impact on Future Operations - The changes in the drug production license are expected to positively impact the company's future operations by optimizing production structure and ensuring stable production capacity to meet market demand [4].