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宣泰医药:关于公司产品枸橼酸托法替布缓释片获得美国FDA批准文号的公告
2023-08-09 08:10
证券代码:688247 证券简称:宣泰医药 公告编号:2023-029 上海宣泰医药科技股份有限公司 关于公司产品枸橼酸托法替布缓释片获得美国 FDA 批准 文号的公告 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。 2023 年 8 月 8 日,上海宣泰医药科技股份有限公司(以下简称"公司")收到美国 食品药品监督管理局(以下简称"美国 FDA")的通知,公司向美国 FDA 申报的枸橼 酸托法替布缓释片的新药简略申请(ANDA,即美国仿制药申请)获得临时性批准,现 将相关情况公告如下: 枸橼酸托法替布缓释片的适应症为:适用于对一种或多种 TNF 阻滞剂反应不足或 不耐受的中度至重度活动性类风湿关节炎成年患者;适用于对一种或多种 TNF 阻滞剂 反应不足或不耐受的活动性银屑病关节炎成年患者;适用于对一种或多种 TNF 阻滞剂 反应不足或不耐受的中度至重度活动性溃疡性结肠炎(UC)的成人患者。使用限制:不建 议将枸橼酸托法替布缓释片与生物 DMARD 类药物或强效免疫抑制剂(如硫唑嘌呤和 环孢霉素)联用。不建议枸橼酸托法替布 ...
宣泰医药:关于召开2022年度暨2023年第一季度业绩说明会的公告
2023-06-06 07:36
证券代码:688247 证券简称:宣泰医药 公告编号:2023-024 上海宣泰医药科技股份有限公司 关于召开 2022 年度暨 2023 年第一季度业绩说明会 的公告 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。 重要内容提示: 会议召开时间:2023 年 6 月 16 日(星期五) 下午 15:00-16:00 会 议 召 开 地 点 : 上 海 证 券 交 易 所 上 证 路 演 中 心 ( 网 址 : http://roadshow.sseinfo.com/) 会议召开方式:上证路演中心网络互动 投资者可于 2023 年 6 月 9 日(星期五) 至 6 月 15 日(星期四)16:00 前登录 上证路演中心网站首页点击"提问预征集"栏目或通过上海宣泰医药科技股份有 限公司(以下简称"公司")邮箱 info@sinotph.com 进行提问。公司将在说明会上 对投资者普遍关注的问题进行回答。 公司已于 2023 年 4 月 28 日发布公司 2022 年度报告及 2023 年第一季度报 告,为便于广大投资者更全面 ...
宣泰医药(688247) - 2023 Q1 - 季度财报
2023-04-27 16:00
Financial Performance - The company's operating revenue for Q1 2023 was ¥42,418,265.20, a decrease of 32.86% compared to the same period last year[5] - The net profit attributable to shareholders was ¥7,716,721.48, down 61.92% year-on-year[5] - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥5,374,407.65, reflecting a decline of 72.57%[5] - Total revenue for Q1 2023 was ¥42,418,265.20, a decrease of 32.8% compared to ¥63,179,209.56 in Q1 2022[20] - Operating profit for Q1 2023 was ¥7,823,729.78, down 66.7% from ¥23,452,801.43 in Q1 2022[21] - Net profit for Q1 2023 was ¥7,716,721.48, a decline of 61.9% compared to ¥20,263,118.79 in Q1 2022[21] - Total comprehensive income for Q1 2023 was ¥7,692,372.68, a decrease of 62.0% from ¥20,255,766.17 in Q1 2022[22] - Basic earnings per share were ¥0.02, down 65.73% year-on-year[6] - Basic earnings per share for Q1 2023 was ¥0.02, down from ¥0.05 in Q1 2022[22] Cash Flow and Liquidity - The net cash flow from operating activities increased by 97.80% to ¥18,585,769.41, primarily due to the collection of receivables[6] - Cash flow from operating activities for Q1 2023 was ¥18,585,769.41, an increase of 97.5% compared to ¥9,396,461.26 in Q1 2022[25] - The net cash flow from financing activities was -$99,558.00, a decrease from -$190,392.00 in the previous period, indicating improved cash management[26] - The net increase in cash and cash equivalents was -$313,354,291.53, compared to -$222,102,490.77 in the prior year, reflecting a significant cash outflow[26] - The beginning balance of cash and cash equivalents was $763,148,303.68, up from $511,651,941.84 year-over-year, showing a strong starting position[26] - The ending balance of cash and cash equivalents was $449,794,012.15, a decrease from $289,549,451.07 in the previous period, indicating a decline in liquidity[26] Assets and Liabilities - The total assets at the end of the reporting period were ¥1,328,874,706.25, a slight decrease of 0.26% from the end of the previous year[6] - Total assets decreased slightly to ¥1,328,874,706.25 from ¥1,332,333,946.07, a decrease of about 0.3%[19] - Total liabilities decreased to ¥143,898,463.87 from ¥155,050,076.37, a reduction of approximately 7.2%[18] - The company’s equity attributable to shareholders increased to ¥1,184,976,242.38 from ¥1,177,283,869.70, an increase of about 0.7%[19] - The company reported a total current assets of ¥950,917,454.71, slightly down from ¥953,710,436.33[17] - The company’s non-current assets totaled ¥377,957,251.54, a minor decrease from ¥378,623,509.74[17] Research and Development - Research and development expenses totaled ¥10,885,029.09, a decrease of 41.50% compared to the previous year[6] - Research and development expenses decreased to ¥10,885,029.09 in Q1 2023 from ¥18,605,791.17 in Q1 2022, representing a reduction of 41.7%[20] - The company did not achieve revenue recognition for R&D technology transfer during the reporting period, resulting in a 100% year-on-year decline in related income[8] Market and Competition - The company faced increased competition in the U.S. market, leading to a 23% year-on-year decline in sales share[8] - The company’s product Posaconazole enteric-coated tablets and sustained-release bupropion hydrochloride tablets were included in the National Basic Medical Insurance Drug List, effective March 1, 2023, which is expected to enhance market accessibility[14] - The company’s Ursodeoxycholic acid capsules were selected in the eighth batch of national centralized procurement, effective July 2023, which is anticipated to boost sales growth[14] Inventory and Receivables - Accounts receivable decreased to ¥33,388,777.90 from ¥64,302,436.57, a reduction of about 48.0%[16] - Inventory increased to ¥34,621,655.40 from ¥29,376,771.68, reflecting an increase of approximately 17.3%[17] - The company reported a credit impairment loss of ¥1,619,789.58 in Q1 2023, compared to a loss of ¥606,233.66 in Q1 2022[21] Return on Equity - The return on equity (ROE) was 0.65%, a decrease of 2.18 percentage points compared to the previous year[6]
宣泰医药(688247) - 2022 Q4 - 年度财报
2023-04-27 16:00
Financial Performance - The total revenue for the year 2022 was CNY 247.56 million, a decrease of 21.53% year-on-year[3]. - The operating profit for 2022 was CNY 99.13 million, down 18.28% compared to the previous year[3]. - The total profit for the year was CNY 97.48 million, reflecting a decline of 34.59% year-on-year[3]. - The net profit attributable to shareholders was CNY 92.94 million, a decrease of 31.11% year-on-year[3]. - The net profit after deducting non-recurring gains and losses was CNY 74.20 million, down 15.17% year-on-year[3]. - The company's operating revenue for 2022 was ¥247,562,432.66, a decrease of 21.53% compared to 2021[21]. - The net profit attributable to shareholders decreased by 31.11% to ¥92,941,482.96, primarily due to intensified competition in the U.S. market[24]. - The net cash flow from operating activities fell by 49.80% to ¥73,183,720.97, attributed to reduced income from equity participation and government subsidies[24]. - Basic earnings per share decreased by 33.33% to ¥0.22, reflecting the decline in net profit attributable to shareholders[22]. - The weighted average return on equity decreased to 10.59%, down 10.63 percentage points from 2021[22]. - The company's total revenue for the reporting period was 247.56 million, a year-on-year decrease of 21.53%[33]. - The net profit attributable to the parent company was 92.94 million, down 31.11% year-on-year, while the net profit excluding non-recurring gains and losses was 74.20 million, a decrease of 15.17%[33]. Competition and Market Conditions - The company faced intensified competition in the U.S. market for its product Posaconazole enteric-coated tablets, leading to a significant decline in revenue from profit-sharing[3]. - The company has not experienced any major adverse changes in its core business or competitive capabilities, and its ability to continue operations is not at significant risk[3]. - The company has disclosed various risks it may face in its production and operation processes in the report[3]. - The company reported a significant decline in equity participation income, which fell by 80.17% to ¥120,341,000[24]. - The company is exposed to risks from potential changes in tax policies that could increase income tax expenses[104]. Research and Development - The R&D investment as a percentage of operating revenue was 30.71%, a decrease of 2.14 percentage points from the previous year[22]. - The company achieved technology transfer revenue of ¥6,485.95 million from self-developed projects during the reporting period[24]. - The company has established three core R&D technology platforms, enhancing its competitive edge in the high-end generic drug market[89]. - The total R&D investment for the year was approximately ¥76.02 million, a decrease of 26.64% compared to the previous year, with R&D investment accounting for 30.71% of operating revenue[82]. - The company has submitted multiple drug applications, including for Posaconazole enteric-coated tablets and Bupropion hydrochloride sustained-release tablets, which have been approved in China and the US[85]. - The company has established advanced drug formulation technology platforms, including solubility enhancement and controlled-release drug formulation[153]. Product Development and Approvals - The company received approvals for several products, including ursodeoxycholic acid capsules and paroxetine enteric-coated sustained-release tablets, enhancing its product portfolio[36]. - The company has obtained ANDA approvals for five generic drugs, including the first generic of Posaconazole delayed-release tablets approved by the FDA[45]. - The company has launched new drug products such as Orebatinib tablets and has received domestic approvals for several first-generic drugs[46]. - The company is in the process of developing new products, including Olaparib Tablets and Mesalazine Enteric-Coated Tablets, with submissions made in 2022[158]. Financial Management and Investments - The company plans to distribute a cash dividend of CNY 0.62 per share, totaling CNY 28.11 million, which represents 30.24% of the net profit attributable to shareholders[5]. - The cash flow from financing activities increased significantly due to the issuance of new shares in August 2022, resulting in a net cash inflow of CNY 375.65 million[114]. - The company invested 200 million yuan in Innodarbo and purchased property for a new R&D center, leading to increased cash outflow[139]. - The company reported a total of CNY 1.99 billion in financial derivatives purchased during the reporting period[174]. Market Expansion and Strategy - The company is focusing on market expansion and new product development, with a commitment to invest in innovative technologies[196]. - The management team has outlined a future outlook that includes a projected revenue growth of 20% for the next fiscal year[196]. - The company is actively pursuing mergers and acquisitions to enhance its market position and expand its product offerings[196]. - A new strategic initiative has been launched to improve operational efficiency, targeting a 15% reduction in costs over the next two years[196]. - The company plans to increase its R&D budget by 25% to accelerate the development of new technologies[196]. Governance and Compliance - The company strictly adheres to relevant laws and regulations, ensuring the governance structure and internal control systems are continuously improved[184]. - The board of directors and supervisory board members possess the necessary knowledge and skills to fulfill their responsibilities effectively[185]. - The company maintains independence from its controlling shareholder in terms of business, personnel, assets, and finance, ensuring no interference in decision-making[185]. - The company actively engages with investors through roadshows and performance briefings, effectively communicating its investment value[185].
宣泰医药(688247) - 2022 Q3 - 季度财报
2022-10-26 16:00
Financial Performance - The company's operating revenue for Q3 2022 was ¥59,050,376.49, a decrease of 21.29% compared to the same period last year[5] - Net profit attributable to shareholders of the listed company reached ¥23,542,682.47, a slight increase of 0.25% year-on-year[5] - Total operating revenue for the first three quarters of 2022 was CNY 186,903,609.72, a decrease of 19.1% compared to CNY 231,183,695.88 in the same period of 2021[20] - Net profit for the third quarter of 2022 was CNY 67,102,611.35, an increase of 10.4% from CNY 60,989,846.15 in the same quarter of 2021[22] - The company reported a total comprehensive income of CNY 67,293,856.17 for the third quarter of 2022, compared to CNY 60,976,227.94 in the same quarter of 2021[23] Assets and Liabilities - Total assets increased by 50.19% to ¥1,300,375,431.95 compared to the end of the previous year[6] - As of September 30, 2022, the total assets of the company amounted to RMB 1,300,375,431.95, an increase from RMB 865,805,176.29 at the end of 2021, representing a growth of approximately 50.0%[15] - The company's total liabilities decreased to RMB 150,676,111.78 from RMB 160,617,855.40, a reduction of approximately 6.0%[17] - The equity attributable to shareholders increased to RMB 453,340,000.00 from RMB 408,000,000.00, representing a growth of about 11.1%[17] - The company's equity attributable to shareholders reached CNY 1,149,699,320.17, an increase of 63.1% from CNY 705,187,320.89 in the previous year[18] Cash Flow - The net cash flow from operating activities was ¥53,938,348.13, a decrease of 6.02%[6] - The net cash flow from operating activities for the first three quarters of 2022 was CNY 53,938,348.13, compared to CNY 57,391,877.35 in the same period of 2021, reflecting a decrease of 7.9%[25] - The net cash flow from investing activities was -189,148,252.12, compared to -301,645,870.55 in the previous year, indicating an improvement[26] - Cash inflow from financing activities amounted to 389,930,139.63, while cash outflow was 13,507,380.76, resulting in a net cash flow of 376,422,758.87[26] - The overall cash increase was 245,021,205.94 compared to a decrease of 246,434,472.35 in the previous year[26] Research and Development - Research and development expenses totaled ¥16,116,208.02, down 18.09% from the previous year, representing 27.29% of operating revenue, an increase of 1.07 percentage points[6] - Research and development expenses for the first three quarters of 2022 were CNY 51,411,301.00, down 29.3% from CNY 72,799,581.02 in the previous year[20] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 11,077[10] - Major shareholder Shanghai Lianhe Investment holds 51.40% of the shares, totaling 233,000,000 shares[11] Investments - The company has a long-term investment of RMB 63,575,879.73, which increased from RMB 27,416,602.48, indicating a growth of about 132.5%[16] - The company invested 1,083,000,000.00 in cash for investments, an increase from 707,803,178.07 in the previous year[26] - The company reported a total investment cash outflow of 1,172,783,842.79, significantly higher than 718,849,773.97 from the previous year[26] Other Information - The company has not reported any new product developments or market expansion strategies in this quarter[14] - The company did not apply new accounting standards or interpretations for the year 2022[26]