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诺诚健华:中国国际金融股份有限公司关于诺诚健华医药有限公司2023年半年度持续督导跟踪报告

2023-08-29 11:14
| 一、持续督导工作情况 | | --- | | 序号 | 工作内容 | 持续督导情况 | | --- | --- | --- | | 1 | 的持续督导工作制定相应的工作计划 | 保荐机构已建立健全并有效执 | | | 建立健全并有效执行持续督导工作制度,并针对具体 | 行了持续督导制度,并制定了 | | | | 相应的工作计划 | | 2 | 根据中国证监会相关规定,在持续督导工作开始前, | 保荐机构已与诺诚健华签订 | | | 与上市公司或相关当事人签署持续督导协议,明确双 | 《保荐协议》及《持续督导协 | | | 方在持续督导期间的权利义务,并报上海证券交易所 | 议》,该协议明确了双方在持 | | | 备案 | 续督导期间的权利和义务,并 | | | | 报上海证券交易所备案 | | 3 | 持续督导期间,按照有关规定对上市公司违法违规事 | 2023年1-6月诺诚健华在持续督 | | | 项公开发表声明的,应于披露前向上海证券交易所报 | 导期间未发生按有关规定需保 | | | | 荐机构公开发表声明的违法违 | | | 告,并经上海证券交易所审核后在指定媒体上公告 | 规情况 | | | 持 ...
诺诚健华:诺诚健华医药有限公司2023年半年度募集资金存放与实际使用情况的专项报告

2023-08-29 11:14
| A 股代码:688428 | A 股简称:诺诚健华 公告编号:2023-025 | | --- | --- | | 港股代码:09969 | 港股简称:诺诚健华 | 诺诚健华医药有限公司 2023 年半年度募集资金存放与实际使用情况 的专项报告 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。 一、 募集资金基本情况 (一)实际募集资金金额、资金到位时间 诺诚健华医药有限公司(以下简称"诺诚健华"或"公司")首次公开发行股票 并在科创板上市的注册申请于 2022 年 7 月 15 日经中国证券监督管理委员会同 意注册(证监许可[2022]1524 号《关于同意诺诚健华医药有限公司首次公开发行 股票注册的批复》),公司据此采用向战略投资者定向配售、网下向符合条件的 投资者询价配售和网上向持有上海市场非限售 A 股股份和非限售存托凭证市值 的社会公众投资者定价发行相结合的方式公开发行了 264,648,217 股股票,每股 发行价格为人民币 11.03 元,募集资金总额为人民币 291,906.98 万元。扣除新股 发行费用 ...
诺诚健华:诺诚健华医药有限公司关于召开2023年半年度业绩说明会的公告

2023-08-22 08:19
| A | 股代码:688428 | A | 股简称:诺诚健华 | 公告编号:2023-024 | | --- | --- | --- | --- | --- | | 港股代码:09969 | 港股简称:诺诚健华 | | | | 诺诚健华医药有限公司 关于召开 2023 年半年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 8 月 30 日(星期三)上午 11:00-12:00 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 8 月 23 日(星期三)至 8 月 29 日(星期二)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 公 司 邮 箱 IR@innocarepharma.com 进行提问。公司将在说明会上对投资者普遍关 ...
诺诚健华:诺诚健华医药有限公司2023年第一次临时股东大会(股东特别大会)会议资料

2023-08-15 10:02
此乃要件 請即處理 閣下如對本通函任何方面或應採取的行動有任何疑問,應咨詢股票經紀或其他註冊證券交易商、銀行經 理、律師、專業會計師或其他專業顧問。 閣下如已將名下所有諾誠健華醫藥有限公司的股份出售或轉讓,應立即將本通函交予買主或承讓人或經手 買賣的銀行、股票經紀或其他代理商,以便轉交買主或承讓人。 香港交易及結算所有限公司及香港聯合交易所有限公司對本通函的內容概不負責,對其準確性或完整性亦 不發表任何聲明,並明確表示,概不就本通函全部或任何部分內容而產生或因倚賴該等內容而引致的任何 損失承擔任何責任。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 (於開曼群島註冊成立的有限公司) (股份代號:9969) (1)建議採納二零二三年股權激勵計劃;及 (2)股東特別大會通告 諾誠健華醫藥有限公司謹訂於二零二三年八月三十一日(星期四)上午十時正假座中國北京市昌平區中 關村生命科學園生命園路8號院8號樓舉行股東特別大會,大會通告載於本通函第EGM-1至EGM-3頁。 隨函亦附上股東特別大會適用的代表委任表格。代表委任表格亦將於香港聯合交易所有限公司網站 ( www.hkexnews.hk)及本 ...
诺诚健华:诺诚健华医药有限公司关于召开2023年第一次临时股东大会(股东特别大会)的通知

2023-08-15 10:01
关于召开 2023 年第一次临时股东大会(股东特别大 会)的通知 本公司董事会及全体董事保证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: 一、 召开会议的基本情况 (一) 股东大会类型和届次 2023 年第一次临时股东大会(股东特别大会) 召开日期时间:2023 年 8 月 31 日 10 点 00 分 网络投票系统:上海证券交易所股东大会网络投票系统 | A 股代码:688428 | A 股简称:诺诚健华 公告编号:2023-023 | | --- | --- | | 港股代码:09969 | 港股简称:诺诚健华 | 诺诚健华医药有限公司 (七) 涉及公开征集股东投票权 网络投票起止时间:自 2023 年 8 月 31 日 股东大会召开日期:2023年8月31日 本次股东大会采用的网络投票系统:上海证券交易所股东大会网络投票 系统 (二) 股东大会召集人:董事会 (三) 投票方式:本次股东大会所采用的表决方式是现场投票和网络投票相结 合的方式 (四) 现场会议召开的日期、时间和地点 召开地点:北京市昌平区中关村生命科学园生命园路 ...
诺诚健华:港股公告:董事会召开日期

2023-08-14 10:02
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 承董事會命 諾誠健華醫藥有限公司 主席兼執行董事 崔霽松博士 香港,2023年8月14日 InnoCare Pharma Limited 諾誠健華醫藥有限公司 (於開曼群島註冊成立的有限公司) (股份代號:9969) 董事會召開日期 諾誠健華醫藥有限公司(「本公司」)董事會(「董事會」)謹此宣佈,本公司將於 2023年8月29日(星期二)舉行董事會會議,藉以(其中包括)考慮並批准本公司及 其附屬公司截至2023年6月30日止六個月中期業績及其發佈。 於本公告日期,董事會包括主席兼執行董事崔霽松博士;執行董事趙仁濱博士; 非執行董事施一公博士、謝榕剛先生及金明先生;以及獨立非執行董事胡蘭女士 及陳凱先博士。 ...
诺诚健华:港股公告:暂停办理股份过户登记手续

2023-08-11 09:16
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 為確定股東出席股東特別大會並於會上投票的資格,本公司將由二零二三年八月 二十八日(星期一)至二零二三年八月三十一日(星期四)(首尾兩日包括在內)暫 停辦理股份過戶登記手續,期間將不會辦理任何股份的過戶登記。 為符合資格出席股東特別大會並於會上投票,所有股份過戶文件連同有關股票最 遲須於二零二三年八月二十五日(星期五)下午四時三十分前送達本公司的證券過 戶登記處香港中央證券登記有限公司的辦事處(地址為香港灣仔皇后大道東183號 合和中心17樓1712-1716號舖)以作登記。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 (於開曼群島註冊成立的有限公司) (股份代號:9969) 暫停辦理股份過戶登記手續 諾誠健華醫藥有限公司(「本公司」)董事(「董事」)會(「董事會」)謹此宣佈,本公 司將於二零二三年八月三十一日(星期四)舉行特別大會(「股東特別大會」),以供 本公司股東(「股東」 ...
诺诚健华(688428) - 2023 Q1 - 季度财报

2023-05-09 16:00
Financial Performance - The company's revenue for Q1 2023 was RMB 189,387,628.40, representing a year-on-year increase of 58.99%[4] - Pharmaceutical sales revenue reached RMB 151,370,102.78, an increase of 43.46% compared to the same period last year[4] - The net profit attributable to shareholders was a loss of RMB 12,406,466.71, with a year-on-year decrease of 89.51%[4][8] - Total revenue for Q1 2023 was RMB 189.39 million, a 59% increase from RMB 119.12 million in Q1 2022[19] - Net profit for Q1 2023 was a loss of RMB 14.23 million, significantly improved from a loss of RMB 120.62 million in Q1 2022[20] - Comprehensive income for Q1 2023 was a loss of RMB 100.50 million, compared to a loss of RMB 141.11 million in Q1 2022[21] Cash Flow and Liquidity - The net cash flow from operating activities was negative at RMB -153,933,775.03[4] - Operating cash inflow totaled $187.54 million, up from $139.50 million year-over-year[23] - Cash outflow from operating activities reached $341.47 million, compared to $277.49 million in the previous year[23] - Net cash flow from operating activities was -$153.93 million, worsening from -$137.99 million year-over-year[23] - Cash inflow from investment activities was $41.31 million, down from $55.79 million in the previous year[23] - Cash outflow from investment activities amounted to $43.22 million, significantly lower than $1.67 billion in the previous year[23] - Net cash flow from investment activities was -$1.92 million, compared to -$1.61 billion year-over-year[23] - Cash flow from financing activities resulted in a net outflow of -$9.03 million, compared to -$8.51 million in the previous year[25] - The ending balance of cash and cash equivalents was $3.99 billion, down from $1.47 billion year-over-year[25] Research and Development - R&D expenses totaled RMB 140,950,687.03, accounting for 74.42% of revenue, a decrease of 34.20 percentage points year-on-year[5][8] - R&D expenses increased to RMB 140.95 million, up from RMB 129.40 million, reflecting a growth of about 8.5%[19] Assets and Liabilities - Total assets at the end of the reporting period were RMB 10,215,914,005.30, a decrease of 1.09% from the end of the previous year[5] - The total assets of the company decreased to approximately ¥10.22 billion from ¥10.33 billion, a decline of about 1.1%[18] - Total liabilities decreased slightly to approximately ¥2.65 billion from ¥2.68 billion, a reduction of about 1.4%[17] - The company reported a total equity of approximately ¥7.57 billion, down from ¥7.64 billion, indicating a decrease of about 1.1%[18] - The company’s total current liabilities amounted to approximately ¥2.04 billion, a slight decrease from ¥2.07 billion, reflecting a reduction of about 1.6%[17] Shareholder Information - The company had a total of 23,135 common shareholders at the end of the reporting period[9] - HKSCC NOMINEES LIMITED held 41.13% of the shares, making it the largest shareholder[10] Other Income and Expenses - The company reported a government subsidy of RMB 11,137,224.44 included in non-recurring gains and losses[6] - Other income decreased to RMB 11.14 million from RMB 21.40 million, a decline of approximately 48.2%[19] - Investment loss improved to RMB -0.71 million from RMB -3.16 million, indicating a positive trend[20] - The company reported a foreign exchange loss of RMB -6.46 million, compared to a loss of RMB -5.55 million in the previous year[20] Employee Compensation - The company reported a significant increase in cash paid to employees, totaling $146.72 million, compared to $117.42 million in the previous year[23]
诺诚健华(09969) - 2023 Q1 - 季度业绩

2023-05-09 09:49
Financial Performance - The company's revenue for Q1 2023 was RMB 189,387,628.40, representing a year-on-year increase of 58.99%[5] - Pharmaceutical sales revenue reached RMB 151,370,102.78, an increase of 43.46% compared to the same period last year[5] - The net profit attributable to shareholders was a loss of RMB 12,406,466.71, with no applicable year-on-year comparison[5] - Total operating revenue for Q1 2023 was RMB 189,387,628.40, an increase of 59% compared to RMB 119,120,479.12 in Q1 2022[21] - The net loss attributable to shareholders of the parent company was RMB -12,406,466.71, compared to a loss of RMB -118,242,516.18 in the same period last year, indicating a significant improvement[22] - The comprehensive loss for the period was RMB -100,502,461.88, compared to RMB -141,110,240.31 in the previous year, showing an improvement of approximately 29%[23] - Basic earnings per share for Q1 2023 was -0.01, compared to -0.08 in Q1 2022, indicating a reduction in loss per share[23] Cash Flow and Liquidity - The net cash flow from operating activities was negative at RMB -153,933,775.03[5] - In Q1 2023, the total cash inflow from operating activities was CNY 187,540,094.29, an increase from CNY 139,499,711.45 in Q1 2022, representing a growth of approximately 34.4%[25] - The net cash flow from operating activities was negative at CNY -153,933,775.03, compared to CNY -137,986,042.27 in the same period last year, indicating a decline in operational cash generation[25] - The total cash and cash equivalents at the end of Q1 2023 were CNY 3,993,788,388.71, down from CNY 1,466,666,021.40 at the end of Q1 2022, reflecting a decrease of approximately 72.8%[26] - The company reported a total cash outflow of CNY 186,195,342.28 in Q1 2023, compared to a much larger outflow of CNY 1,770,818,284.18 in Q1 2022, indicating a significant improvement in cash management[26] Research and Development - R&D expenses totaled RMB 140,950,687.03, accounting for 74.42% of revenue, a decrease of 34.20 percentage points year-on-year[6] - Research and development expenses increased to RMB 140,950,687.03, up from RMB 129,396,070.62, reflecting a growth of about 8.5%[21] Assets and Liabilities - The total assets at the end of the reporting period were RMB 10,215,914,005.30, a decrease of 1.09% from the end of the previous year[6] - The total assets as of March 31, 2023, amounted to CNY 10,215,914,005.30, a decrease from CNY 10,328,783,979.11 at the end of 2022[17] - The total liabilities decreased to RMB 2,647,592,989.19 from RMB 2,684,457,313.64, a reduction of approximately 1.4%[22] - The total equity attributable to shareholders of the parent company was RMB 7,522,918,266.25, down from RMB 7,597,101,016.92, a decrease of about 1%[20] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 23,135[10] - The top ten shareholders hold a combined 41.13% of shares, with HKSCC NOMINEES LIMITED holding the largest share at 725,666,837 shares[12] - Vivo Capital Fund VIII, L.P. and its concerted actions hold 129,668,118 shares, representing 7.35%[14] Foreign Exchange and Financial Expenses - The company experienced a negative impact of CNY -21,312,065.11 from foreign exchange fluctuations on cash and cash equivalents[26] - The company reported a financial expense of RMB -101,409,201.80, which is a significant increase from RMB -37,723,802.06 in the previous year[21] Inventory and Receivables - Accounts receivable increased to CNY 131,389,817.39 from CNY 127,824,970.72[17] - Inventory rose significantly to CNY 98,915,173.76 compared to CNY 65,321,825.92[18] Investment Activities - The cash inflow from investment activities totaled CNY 41,307,536.32, down from CNY 55,785,270.27 in Q1 2022, a decrease of approximately 26.0%[25] - The net cash flow from investment activities was negative at CNY -1,915,385.25, compared to CNY -1,613,305,227.02 in the previous year, indicating a significant reduction in investment losses[25] - Cash outflows for the acquisition of fixed assets and intangible assets were CNY 43,222,921.57, significantly lower than CNY 204,862,322.68 in Q1 2022, showing a decrease of about 78.9%[25] Collaboration and Rights - The company regained global rights for the drug Oubatinib after terminating a collaboration agreement with BeiGene, which included a one-time payment of USD 125 million[16]
诺诚健华(688428) - 2022 Q4 - 年度财报

2023-04-26 16:00
Financial Performance - The company reported a net loss of 894 million yuan for 2022, with a cash-adjusted loss of 474 million yuan after excluding non-cash items[3]. - The company does not plan to distribute profits for the 2022 fiscal year, pending approval at the annual shareholders' meeting[5]. - The company reported a revenue of RMB 1.2 billion for the fiscal year, representing a year-over-year increase of 25%[13]. - The company's operating revenue for 2022 was ¥625,404,169.95, a decrease of 40.04% compared to ¥1,043,032,783.04 in 2021[21]. - The net profit attributable to shareholders was -¥886,593,114.73, worsening from -¥64,546,012.27 in the previous year[21]. - The net cash flow from operating activities was -¥490,583,554.63, a decline of 393.66% compared to ¥167,058,314.75 in 2021[21]. - The company reported a significant increase in revenue, achieving a total of 1.2 billion RMB for the year, representing a 25% growth compared to the previous year[17]. - The company reported a revenue of 625 million yuan for 2022, a decrease of 418 million yuan compared to 1.043 billion yuan in the previous year, while product sales revenue increased by 163.6%[153]. Research and Development - Research and development expenses increased by 28.05% year-on-year to 649 million yuan, excluding one-time licensing fees[3]. - The company is investing RMB 500 million in R&D for new technologies and drug development[13]. - The company is investing 150 million RMB in new technology development to improve drug delivery systems[17]. - Research and development expenses accounted for 103.73% of operating revenue, an increase of 33.48 percentage points from 70.25% in 2021[22]. - The company has 13 products in clinical trials, with a focus on oncology and autoimmune diseases, and has received conditional approval for Tafasitamab from the National Medical Products Administration as of April 26, 2023[29]. - The company has established a comprehensive R&D platform, including compound optimization and drug solubility enhancement technologies, to accelerate drug discovery[29]. - The company has established four core technology platforms, including compound optimization and drug solubility enhancement, to accelerate drug discovery and development[136]. - The company has established a research and development team of over 410 personnel and a commercialization team of over 260 personnel, but risks exist regarding the potential loss of key personnel due to industry competition[200]. Product Pipeline and Innovation - The company has established a rich product pipeline in hematological malignancies, autoimmune diseases, and solid tumors, with its core product, Orelabrutinib, already commercialized[3]. - Tafasitamab has been approved in Hong Kong and is being used as a clinically needed imported drug at the Boao Super Hospital[3]. - The company emphasizes a commitment to innovation driven by science and patient needs, focusing on drug development in oncology and autoimmune diseases[3]. - The company has highlighted various risk factors in its operations, which are detailed in the management discussion and analysis section of the report[4]. - The company aims to establish a leadership position in the hematological malignancies field, leveraging Obatoclax and a robust pipeline of investigational drugs[35]. - The company is developing multiple products targeting B-cell and T-cell signaling pathways for autoimmune diseases, aiming to meet unmet clinical needs globally[31]. - The company is actively pursuing market expansion and new product development across various therapeutic areas, including oncology and autoimmune diseases[50]. Market Expansion and Strategic Partnerships - Market expansion plans include entering two new international markets by Q3 2024[13]. - The company is exploring potential acquisitions to enhance its product portfolio and market presence[13]. - A strategic partnership with a leading biotech firm was announced to accelerate drug development timelines[13]. - The company aims to increase its market share by 10% in the next two years through targeted marketing strategies[13]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share within the next two years[17]. Clinical Trials and Regulatory Approvals - The company is conducting multiple I/II phase clinical trials for its self-developed products ICP-192 and ICP-723 in China, the US, and Australia, targeting various solid tumors[150]. - The company is conducting over 30 clinical trials across more than 100 clinical centers globally as of April 26, 2023[146]. - The company is actively communicating with the FDA regarding the clinical trial suspension and has submitted a revised clinical trial protocol[65]. - The FDA has requested additional information and data from the company to resolve the clinical trial suspension issues as soon as possible[65]. - The company is conducting a phase III clinical trial for Obatoclax as a first-line treatment for CLL/SLL, with patient recruitment over halfway completed[36]. Risks and Challenges - There is a risk of continued losses in the future due to the long and costly process of drug development and commercialization[3]. - The company acknowledges the risk of not achieving profitability in the near term due to ongoing R&D costs and the need for substantial investment in clinical trials and market preparation[152]. - The company faces risks related to delays in clinical trial progress, which may increase development costs and delay product launches compared to competitors[156]. - The company faces risks related to the inability to timely respond to changes in pharmaceutical industry regulations or policies, which could adversely affect its business[170]. - The company may experience supply shortages or interruptions if it cannot establish stable relationships with suppliers for raw materials and equipment[171]. Financial Position and Investments - The company has a strong cash flow situation despite ongoing investments in clinical trials and new drug preparations[3]. - The company's total assets increased by 39.30% to ¥10,328,783,979.11 at the end of 2022, up from ¥7,414,969,891.00 in 2021[21]. - The net assets attributable to shareholders rose by 35.55% to ¥7,597,101,016.92, compared to ¥5,604,559,524.19 at the end of 2021[21]. - The company raised funds through its initial public offering on the Sci-Tech Innovation Board, which contributed to the increase in total and net assets[22]. - The company successfully raised 2.919 billion CNY through the issuance of 264 million shares on the STAR Market, enhancing its capital structure[49].