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微芯生物:国投证券股份有限公司关于深圳微芯生物科技股份有限公司2023年年度报告的信息披露监管问询函回复的核查意见
2024-05-20 12:40
关于深圳微芯生物科技股份有限公司 国投证券股份有限公司 1 对微芯新域剩余股权公允价值的确定方法、主要假设、具体依据,以及相应投 资收益的具体测算过程,是否符合企业会计准则的有关规定。(5)补充披露 2021 年至 2023 年期间公司与微芯新域的业务往来、交易金额、资金往来等,并说明 转让控制权前后是否存在重大变化及变化原因。(6)补充披露公司目前与微芯 新域其他投资方之间是否存在盈利担保、补偿承诺或者回购承诺等义务设置, 如存在,请说明公司在转让微芯新域控制权背景下仍承担上述义务的合理性, 以及公司对此类兜底补偿义务的会计处理及合规性;如不存在,请说明原回购 义务等的解除过程,是否为附条件的终止,是否存在其他替代性利益安排。 一、公司说明 (一)结合微芯新域的股权结构、董事会构成、重大事项决策情况和增资 前后高管等主要岗位人员变动等,说明公司是否仍实际控制微芯新域,不再将 其纳入合并报表范围是否符合企业会计准则相关规定 1、微芯新域的股权结构情况 2023 年年度报告信息披露监管问询函回复的 核查意见 上海证券交易所: 根据贵所出具的《关于深圳微芯生物科技股份有限公司 2023 年年度报告的 信息披露监管 ...
微芯生物(688321) - 投资者关系活动记录表2024年5日15日
2024-05-16 10:31
Group 1: Product Development and Market Positioning - The company introduced the selective HDAC inhibitor, chidamide, as the first of its kind globally, highlighting its selective advantages and potential in combination therapies [1] - Chidamide has shown efficacy in immune modulation, particularly affecting regulatory T cells, which may lead to different outcomes when used in combination with other treatments [1] - The company plans to include two new indications for its products in the national medical insurance, with PTCL being the fourth indication added and DLBCL expected to be approved by the end of the month [1] Group 2: Financial Health and R&D Investment - The company currently has approximately 1 billion RMB in cash reserves, including cash on hand, bank wealth management, and unutilized bond funds [3] - R&D investments are expected to remain stable over the next two years, with a focus on optimizing clinical trial designs to control costs while maintaining growth potential [3] - The company emphasizes cost reduction and efficiency to ensure ongoing R&D investments do not compromise future growth [3] Group 3: Market Strategy and Promotion - The market positioning of siglitazone focuses on type 2 diabetes patients, particularly those with insulin resistance, which affects 15-25% of this population [4] - Siglitazone has demonstrated good safety and pharmacokinetic profiles, showing clear efficacy in blood sugar and lipid control in T2DM patients [4] - The company has received approval for chidamide in combination with R-CHOP for first-line treatment of double-expressing DLBCL, with a complete response rate of 73% compared to 61.8% in the control group [5]
微芯生物:关于“微芯转债”回售结果的公告
2024-05-12 23:34
证券代码:688321 证券简称:微芯生物 公告编号:2024-051 转债代码:118012 转债简称:微芯转债 深圳微芯生物科技股份有限公司 关于"微芯转债"回售结果的公告 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、准确性和完整性承担法律责任。 重要内容提示: ●回售期间:2024 年 4 月 29 日至 2024 年 5 月 8 日 ●回售有效申报数量:0 张 2024 年 4 月 19 日,深圳微芯生物科技股份有限公司(以下简称"公司")召 开了 2023 年年度股东大会和"微芯转债"2024 年第一次债券持有人会议,会议 分别审议通过了《关于调整可转债募投项目的议案》,根据《深圳微芯生物科技 股份有限公司向不特定对象发行可转换公司债券募集说明书》(以下简称"《可转 债募集说明书》")的规定,"微芯转债"附加回售条款生效。 现依据《上市公司证券发行注册管理办法》《可转换公司债券管理办法》《上 海证券交易所科创板股票上市规则》和公司《可转换公司债券募集说明书》,就 本次回售结果公告如下: 一、本次可转债回售的公告情况 2024 年 4 月 22 ...
微芯生物:自愿披露关于西达本胺治疗结直肠癌III临床试验申请获得受理的公告
2024-05-12 08:08
证券代码:688321 证券简称:微芯生物 公告编号:2024-052 自愿披露关于西达本胺治疗结直肠癌 III 期临床试验申请获 得受理的公告 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: 深圳微芯生物科技股份有限公司(以下简称"公司")近日收到国家药品监 督管理局药物审评中心(以下简称"国家药监局药审中心")签发的境内生产药品 注册临床试验的《受理通知书》,西达本胺联合信迪利单抗和贝伐珠单抗治疗≥ 2 线标准治疗失败的晚期微卫星稳定或错配修复完整(MSS/pMMR)型结直肠癌 的随机、开放性、对照、多中心、Ⅲ期临床试验获得国家药监局药审中心受理。 本次申请为新药临床试验申请,在临床试验申请获得受理后,自受理之日起 60 日内未收到国家药监局药审中心的否定或质疑意见的,公司便可以按照提交 的方案开展临床试验。临床试验能否最终开展存在不确定性,敬请广大投资者注 意防范投资风险,谨慎决策。现将相关情况公告如下: 一、药品基本情况 1、产品名称:西达本胺片 受理号:CXHL2400462 适应症:西达本胺联合 ...
公司季报点评:大适应症驱动高增长,现金流扭亏为盈
Haitong Securities· 2024-05-10 06:32
市场表现 [Table_QuoteInfo] -43.09% -32.09% -21.09% -10.09% 0.91% 2023/5 2023/8 2023/11 2024/2 微芯生物 海通综指 [Table_InvestInfo] 投资评级 优于大市 维持 | --- | --- | --- | --- | |--------------------------|-------|-------|-------| | 沪深 300 对比 | 1M | 2M | 3M | | 绝对涨幅( % ) | 18.0 | 47.9 | 53.6 | | 相对涨幅( % ) | 14.3 | 44.5 | 44.7 | | 资料来源:海通证券研究所 | | | | 大适应症驱动高增长,现金流扭亏为盈 新品驱动高增长。公司 2024Q1 实现营业收入 1.3 亿元,同比增长 23%,主 要为西格列他钠销售增长所致,产品销量同比增长 666%,销售收入同比增 长 3127%。2023 年 12 月,西达本胺 PTCL 适应症第四次进入医保目录, 医保支付价格下调 6%;报告期内西达本胺销量同比增长 8%,销售收入同 比持 ...
微芯生物:关于“微芯转债”可选择回售的第三次提示性公告
2024-05-06 11:07
●风险提示:"微芯转债"持有人有权选择是否进行回售,本次回售不具有强 制性。投资者选择回售等同于以 100.49 元人民币/张(含当期利息)卖出持有的 "微芯转债"。截至本公告披露日,"微芯转债"的收盘价格高于本次回售价格。 投资者选择回售可能会带来损失,敬请投资者注意风险。 | 证券代码:688321 | 证券简称:微芯生物 公告编号:2024-050 | | --- | --- | | 转债代码:118012 | 转债简称:微芯转债 | 重要内容提示: ●回售价格:100.49 元人民币/张(含当期利息) ●回售期:2024 年 4 月 29 日至 2024 年 5 月 8 日 ●回售资金发放日:2024 年 5 月 13 日 ●回售期内"微芯转债"停止转股 深圳微芯生物科技股份有限公司 关于"微芯转债"可选择回售的第三次提示性公告 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、准确性和完整性承担法律责任。 2024 年 4 月 19 日,深圳微芯生物科技股份有限公司(以下简称"公司")召 开了 2023 年年度股东大会和"微芯转债"2024 年第一 ...
24年有望迎来估值+业绩+数据读出多个拐点
Huafu Securities· 2024-05-06 02:30
司 मे 微芯生物(688321.SH) 24 年有望迎来估值+业绩+数据读出多个拐点 投资要点: 产品研发失败的风险、产品销量不及预期的风险、专利权到期出 现仿制药的风险 医药生物 2024 年 04 月 29 日 | --- | --- | |--------------------------|---------------| | | | | 当前价格: | 21.79 元 | | 目标价格: | 34.11 元 | | 基本数据 | | | 总股本/流通股本(百万股 ) | 411.29/411.29 | | 流通 A 股市值(百万元 ) | 8,961.94 | | 每股净资产 (元) | 3.81 | | 资产负债率 (%) | 47.43 | | 一年内最高/最低价(元 ) | 26.00/12.47 | | | | 利润表 单位:百万元 2023A 营业收入 524 营业成本 57 税金及附加 8 销售费用 284 管理费用 84 研发费用 270 财务费用 16 信用减值损失 -4 资产减值损失 0 公允价值变动收益 1 投资收益 281 其他收益 15 营业利润 97 营业外收入 1 营业 ...
微芯生物:自愿披露关于西达本胺联合R-CHOP治疗弥漫大B细胞淋巴瘤适应症获批上市的公告
2024-04-30 07:44
证券代码:688321 证券简称:微芯生物 公告编号:2024-049 深圳微芯生物科技股份有限公司 自愿披露关于西达本胺联合 R-CHOP 治疗弥漫大 B 细胞淋 巴瘤适应症获批上市的公告 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: 注册分类:化学药品 2.4 类 申请事项:药品注册(境内生产) 适应症:联合 R-CHOP(利妥昔单抗、环磷酰胺、阿霉素、长春新碱和强的松) 用于 MYC 和 BCL2 表达阳性的既往未经治疗的弥漫大 B 细胞淋巴瘤(DLBCL)患 者。 近日,深圳微芯生物科技股份有限公司(以下简称"公司")收到国家药品 监督管理局核准签发的《药品注册证书》,西达本胺联合 R-CHOP 治疗弥漫大 B 细 胞淋巴瘤适应症获批上市,现将相关情况公告如下: 一、药品基本情况 1、药品名称:西达本胺片 商品名:爱谱沙®(Epidaza®) 剂型:片剂 规格:5mg 药品上市许可持有人:深圳微芯生物科技股份有限公司 药品批准文号:国药准字 H20140129 药品注册证书编号:2024S0070 ...
微芯生物(688321) - 2024 Q1 - 季度财报
2024-04-28 07:44
Revenue and Profitability - Revenue for the reporting period was RMB 130,604,180.46, representing a year-on-year increase of 22.60%[9] - Total operating revenue for Q1 2024 reached RMB 130,604,180.46, a 22.60% increase compared to the same period last year, driven by the growth in sales revenue of Chiglitazar Sodium[21][32] - Net profit attributable to shareholders of the listed company was RMB -18,304,645.53, indicating a loss[9] - Net profit for Q1 2024 was a loss of RMB -18,304,645.53, compared to a loss of RMB -35,783,904.58 in the same period last year[44] - Net profit attributable to shareholders of the listed company narrowed its loss by 43.63% year-over-year[24] - Basic earnings per share (EPS) was RMB -0.0448, reflecting a loss per share[9] Cash Flow and Investments - Net cash flow from operating activities was RMB 35,428,190.17, a significant improvement compared to the negative RMB -48,582,917.14 in the same period last year[9][16] - Cash received from investments was RMB 463,900,500.00, a significant increase from RMB 290,000,000.00 in the previous year[16] - Cash paid for investments was RMB 395,814,500.00, up from RMB 247,000,000.00 in the same period last year[16] - Net cash flow from financing activities was RMB 33,413,741.14, a decrease from RMB 159,495,539.79 in the previous year[16] - Cash and cash equivalents increased to RMB 467,877,634.95 as of March 31, 2024, up from RMB 375,437,648.61 at the end of 2023[20] - Cash and cash equivalents increased by RMB 94,475,089.34 in Q1 2024, with an ending balance of RMB 361,164,427.90[47] - Cash received from sales of goods and services increased significantly from 113,252,890.19 RMB to 207,095,989.01 RMB[52] Assets and Liabilities - Total assets as of March 31, 2024, amounted to RMB 3,213,475,496.86, a slight increase of 0.32% compared to the end of the previous year[32] - Total assets increased slightly from 3,203,249,429.12 RMB to 3,213,475,496.86 RMB[50] - Total liabilities as of March 31, 2024, were RMB 1,524,025,405.30, a slight increase from RMB 1,493,353,557.17 at the end of 2023[28] - Long-term loans increased to RMB 551,185,753.30, up from RMB 490,728,419.96 at the end of 2023[28] - Short-term borrowings decreased from 130,112,786.24 RMB to 111,092,757.07 RMB[50] - Accounts payable decreased from 8,975,080.04 RMB to 3,511,882.09 RMB[50] - Contract liabilities increased from 79,952.88 RMB to 742,648.52 RMB[50] - Deferred tax assets decreased from 2,082,893.55 RMB to 1,274,224.61 RMB[50] - Other non-current assets increased from 27,905,628.87 RMB to 37,898,788.36 RMB[50] - Fixed assets decreased from 692,222,974.82 RMB to 688,533,005.22 RMB[50] - Development expenditure increased from 398,561,645.92 RMB to 426,261,234.82 RMB[50] - Total non-current assets increased from 2,073,162,574.58 RMB to 2,109,399,387.15 RMB[50] Shareholders and Equity - The number of ordinary shareholders at the end of the reporting period was 21,150[25] - Boao Biotechnology Group holds 8.44% of the company's shares, totaling 34,705,162 shares[37] - Shenzhen Haideman Biotech Development Co., Ltd. holds 5.58% of the company's shares, totaling 22,936,008 shares[37] - LU XIANPING, an overseas individual, holds 5.41% of the company's shares, totaling 22,239,625 shares[37] - Shenzhen Haideruibo Investment Co., Ltd. holds 4.82% of the company's shares, totaling 19,817,445 shares[37] - Shenzhen Haidekangcheng Investment Partnership holds 3.72% of the company's shares, totaling 15,285,290 shares[37] - Vertex Technology Fund (III) Ltd holds 3.19% of the company's shares, totaling 13,125,918 shares[37] - Shenzhen Haidekangcheng Investment Partnership participated in the securities lending business, lending 130,000 shares to CITIC Securities for market-making activities[48] R&D and Operating Costs - R&D investment for Q1 2024 was RMB 80,200,838.60, accounting for 61.41% of the operating revenue, a decrease of 19.31 percentage points compared to the previous year[32] - Total operating costs for Q1 2024 were RMB 148,782,922.18, with sales expenses accounting for RMB 55,974,005.61 and R&D expenses at RMB 52,501,249.70[44] Comprehensive Income and Other Items - Comprehensive income attributable to owners of the parent company was RMB -18,191,945.95, compared to RMB -33,435,826.06 in the same period last year[3] - Foreign currency translation differences contributed RMB 112,699.58 to other comprehensive income, compared to a loss of RMB -958,990.66 in the previous year[3] - Non-recurring gains and losses amounted to RMB 3,671,431.72, including government subsidies of RMB 3,355,129.71[6][11] - Sales volume of Chiglitazar Sodium surged by 665.80% year-over-year, with sales revenue increasing by 3,126.77%[24]
微芯生物:关于“微芯转债”可选择回售的第二次提示性公告
2024-04-28 07:44
深圳微芯生物科技股份有限公司 关于"微芯转债"可选择回售的第二次提示性公告 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、准确性和完整性承担法律责任。 重要内容提示: ●回售价格:100.49 元人民币/张(含当期利息) | 证券代码:688321 | 证券简称:微芯生物 公告编号:2024-048 | | --- | --- | | 转债代码:118012 | 转债简称:微芯转债 | ●回售期:2024 年 4 月 29 日至 2024 年 5 月 8 日 ●回售资金发放日:2024 年 5 月 13 日 ●回售期内"微芯转债"停止转股 ●风险提示:"微芯转债"持有人有权选择是否进行回售,本次回售不具有强 制性。投资者选择回售等同于以 100.49 元人民币/张(含当期利息)卖出持有的 "微芯转债"。截至本公告披露日,"微芯转债"的收盘价格高于本次回售价格。 投资者选择回售可能会带来损失,敬请投资者注意风险。 2024 年 4 月 19 日,深圳微芯生物科技股份有限公司(以下简称"公司")召 开了 2023 年年度股东大会和"微芯转债"2024 年第一 ...