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君实生物(01877) - 2023 - 年度业绩
2024-03-28 13:00
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倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1877) 截至2023年12月31日止年度的全年業績公告 上海君實生物醫藥科技股份有限公司(「本公司」)董事(「董事」)會(「董事會」)謹 此宣佈本公司及其附屬公司(「本集團」)截至2023年12月31日止年度(「報告期」) 的經審核綜合全年業績及截至2022年12月31日止年度的比較數字。本公司於報告 期的綜合財務報表已由本公司審計委員會(「審計委員會」)審閱,並由本公司核數 師審核。除非另有說明,否則本公告的財務數據乃根據國際財務報告準則編製。 於本公告,「我們」指本公司,如文意另有所指,則指本集團。 財務摘要 • 截至2023年12月31日,報告期內本集團收入總額約人民幣1,503百萬元,較 2022年同期增加約3%,主要由於醫藥 ...
君实生物(01877) - 2023 Q3 - 季度业绩
2023-10-27 12:17
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之內容概不負責,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份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1877) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.09(2)(a)條及第13.10B 條規則及《證券及期貨條例》(香港法例第571章)第XIVA部之內幕消息條例作出。 茲載列上海君實生物醫藥科技股份有限公司(「本公司」)在上海證券交易所網站刊 發之《上海君實生物醫藥科技股份有限公司2023年第三季度報告》,僅供參閱。本 公告所載未經審計財務數據乃根據中華人民共和國會計原則而非國際財務報告準 則編製,並且僅根據上海證券交易所科創板的要求編製。 股東及潛在投資者於買賣本公司證券時務請審慎行事。 承董事會命 上海君實生物醫藥科技股份有限公司 熊俊先生 主席 中國,上海,2023年10月27日 於本公告日期,本公司董 ...
君实生物(01877) - 2023 - 中期财报
2023-09-28 08:30
上海君實生物醫藥科技股份有限公司 Shanghai Junshi Biosciences Co., Ltd.* (於中華人民共和國註冊成立的股份有限公司) 股份代號: 1877 2023 中期報告 ...
君实生物(01877) - 2023 - 中期业绩
2023-08-30 12:10
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倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1877) 截至2023年6月30日止六個月的 中期業績公告 上海君實生物醫藥科技股份有限公司(「本公司」)董事(「董事」)會(「董事會」)謹 此宣佈本公司及其附屬公司(「本集團」)截至2023年6月30日止六個月(「報告期」) 的未經審核簡明綜合中期業績及2022年同期的比較數字。本集團於報告期的未經 審核簡明綜合財務報表已由本公司審計委員會(「審計委員會」)及本公司核數師德 勤•關黃陳方會計師行審閱。除非另有說明,否則本公告的財務數據乃根據國際財 務報告準則(「國際財務報告準則」)編製。 於本公告中,「我們」指本公司,如文意另有所指,則指本集團。 財務摘要 ...
君实生物(01877) - 2023 Q1 - 季度业绩
2023-04-28 12:37
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之內容概不負責,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倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1877) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.09(2)(a)條及第13.10B 條規則及《證券及期貨條例》(香港法例第571章)第XIVA部之內幕消息條例作出。 茲載列上海君實生物醫藥科技股份有限公司(「本公司」)在上海證券交易所網站刊 發之《上海君實生物醫藥科技股份有限公司2023年第一季度報告》,僅供參閱。本 公告所載未經審計財務數據乃根據中華人民共和國會計原則而非國際財務報告準 則編製,並且僅根據上海證券交易所科創板的要求編製。 股東及潛在投資者於買賣本公司證券時務請審慎行事。 承董事會命 上海君實生物醫藥科技股份有限公司 ...
君实生物(01877) - 2022 - 年度财报
2023-04-28 08:30
Financial Performance - For the year ended December 31, 2022, the total revenue of the group was approximately RMB 1,453 million, a decrease of about 64% compared to the same period in 2021, primarily due to a reduction in income from overseas licensing transfers[5]. - The loss attributable to owners of the company was RMB 2,386 million, an increase of RMB 1,667 million compared to 2021, primarily due to a decrease in licensing income[5]. - The net loss for 2022 was RMB 2,582.10 million, compared to a loss of RMB 728.18 million in 2021[16]. - The total revenue for 2022 was RMB 1,453.49 million, a decrease of 64.2% compared to RMB 4,024.84 million in 2021[16]. - Drug revenue amounted to approximately RMB 753 million, an increase of about 76% year-over-year, primarily due to enhanced commercialization capabilities and the approval of two new indications for Tuoyi®[78]. - Licensing revenue was approximately RMB 476 million, a decrease of about 86% year-over-year, mainly due to the completion of all milestone events in the agreement with Eli Lilly and Company in 2021[78]. - The basic loss per share for 2022 was RMB 2.60, consistent with the previous year's loss per share of RMB 0.80[18]. Research and Development - Research and development expenses totaled approximately RMB 2,384 million, an increase of about 15% compared to 2021, due to increased investment in R&D and the rapid advancement of existing clinical projects[5]. - The company has expanded its R&D from monoclonal antibodies to include small molecules, peptides, antibody-drug conjugates (ADCs), bispecific or multispecific antibodies, and nucleic acid drugs, covering five major therapeutic areas[7]. - The company has over 20 drugs in preclinical development, indicating a robust pipeline for future growth[7]. - The company has achieved multiple IND approvals for various drugs throughout 2022, reflecting its strong commitment to advancing its product pipeline[9]. - The company aims to establish a comprehensive R&D platform to capture opportunities in next-generation therapies, focusing on nucleic acid drugs, ADCs, and bispecific antibodies[23]. - The company is focused on developing innovative drugs and has a diverse pipeline including treatments for various cancers and metabolic diseases[38]. Product Development and Commercialization - The company achieved significant breakthroughs in innovative therapies and drug discovery, addressing unmet clinical needs and filling domestic gaps in several areas[6]. - As of the report date, the company has commercialized four drugs in China or overseas markets, with nearly 30 drugs in clinical trials, including three in Phase III trials[7]. - The core product Tuoyi® achieved a sales revenue growth of 78.77% year-on-year in the domestic market[22]. - Tuoyi® has been approved for six indications, with three included in the national medical insurance catalog, providing coverage in 137 cities for certain conditions[15]. - The company has submitted marketing applications for its product in the US, EU, and UK, which have been accepted by local regulatory authorities[22]. - The company has signed a collaboration agreement with Hikma for the exclusive development and commercialization of the drug Trelipril in 20 countries in the Middle East and North Africa, with potential payments up to $12 million[11]. Clinical Trials and Approvals - In May 2022, the company’s drug Mindev® demonstrated statistical superiority in a Phase III clinical study for early treatment of mild to moderate COVID-19, with a shorter median time to clinical recovery[8]. - The IND application for JS105 (a PI3K-α inhibitor) was approved by NMPA in May 2022, further enhancing the company's oncology pipeline[8]. - The IND application for JS116 (a KRASG12C small molecule inhibitor) was approved by NMPA in June 2022, showcasing ongoing innovation in targeted therapies[10]. - The company has successfully developed innovative drugs for COVID-19, including the oral antiviral drug Mindewi®, which was conditionally approved in China in January 2023[21]. - The company plans to submit sNDA for the two new indications to the NMPA in 2023[29]. - The company has multiple drugs in clinical trials, including JS007 targeting CTLA-4 and JS014 targeting IL-21, with several in Phase III and Phase II trials[39]. Financial Strategy and Funding - Net cash inflow from financing activities was RMB 4,643 million, mainly from the issuance of new A-shares on December 2, 2022, which generated a net cash inflow of RMB 3,748 million[5]. - In December 2022, the company raised RMB 3,776.50 million by issuing 70 million new A-shares at RMB 53.95 per share, funding innovative drug R&D and the Shanghai headquarters project[12]. - The company raised approximately RMB 4,836 million through the issuance of 87.13 million A-shares at a price of RMB 55.50 per share, with a net amount of RMB 4,497 million after deducting issuance costs[91]. - The company plans to utilize RMB 3,464 million for innovative drug research and development projects, expected to be fully utilized by December 31, 2026[98]. - The company has not declared or paid any dividends for the years ended December 31, 2022, and 2021[99]. Corporate Governance and Management - The company has implemented a corporate governance framework based on the corporate governance code, ensuring compliance with all applicable principles and provisions during the reporting period[149]. - The board consists of 14 members, including 7 executive directors, 2 non-executive directors, and 5 independent non-executive directors[152]. - The company has a commitment to high standards of corporate governance to protect shareholder interests and enhance corporate value[149]. - The management team emphasizes the importance of regulatory compliance and is actively working to ensure all new products meet the necessary standards[141]. - The company has established a shareholder communication policy to ensure effective responses to shareholder concerns and opinions[182]. Employee and Talent Development - The company emphasizes the importance of talent development and has implemented a performance management system to enhance employee capabilities and organizational performance[35]. - The company is committed to providing comprehensive employee benefits and improving the work environment to attract and retain talent[35]. - The company reported a significant increase in employee salaries and benefits by approximately 18% compared to the same period in 2021, despite overall reductions in sales and distribution expenses[80]. - The company has a total of 2,961 employees, with 995 in drug research and development, 989 in product commercialization, and 561 in production[35]. Market Expansion and Strategic Partnerships - The company is actively pursuing international clinical trials, indicating a strategy for global market expansion[36]. - The company is focused on innovation and aims to accelerate the clinical trial and market entry processes for new drugs, responding to industry and policy changes[126]. - The company has established partnerships with key industry players to enhance distribution networks, aiming for a 25% increase in market penetration[141]. - The company plans to acquire a 40% stake in Excellmab through a non-cash investment, enabling exclusive rights for developing and commercializing Trivapil monoclonal antibody in several Southeast Asian countries[14]. Risk Management - The company faces significant risks related to new drug development, including long R&D cycles, high investment, and low success rates, necessitating careful evaluation and potential discontinuation of underperforming projects[125]. - Financial risks include exposure to foreign exchange fluctuations, particularly with assets and liabilities denominated in HKD, USD, EUR, CHF, and GBP, which could impact operating performance[126]. - The company acknowledges operational risks related to the stability of supplier relationships and the potential impact of rising raw material costs on profitability[125]. - The company is aware of macroeconomic risks, particularly uncertainties in international trade relations, which could adversely affect overseas business operations[126].
君实生物(01877) - 2022 - 年度业绩
2023-03-30 13:37
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倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1877) 截至2022年12月31日止年度的全年業績公告 上海君實生物醫藥科技股份有限公司(「本公司」)董事(「董事」)會(「董事會」)謹 此宣佈本公司及其附屬公司(「本集團」)截至2022年12月31日止年度(「報告期」) 的經審核綜合全年業績及截至2021年12月31日止年度的比較數字。本公司於報告 期的綜合財務報表已由本公司審計委員會(「審計委員會」)審閱,並由本公司核數 師審核。除非另有說明,否則本公告的財務數據乃根據國際財務報告準則編製。 於本公告,「我們」指本公司,如文意另有所指,則指本集團。 財務摘要 • 截至2022年12月31日,報告期內本集團收入總額約人民幣1,453百萬元,較 2021年同期下降約64%,主要由於本 ...
君实生物(01877) - 2022 - 中期财报
2022-09-29 08:30
上海君實生物醫藥科技股份有限公司 Shanghai Junshi Biosciences Co., Ltd.* ( 於中華人民共和國註冊成立的股份有限公司 ) 股份代號 : 1877 2022 中期報告 * 僅供識別 目錄 | 2 | 公司資料 | | --- | --- | | 4 | 摘要 | | 9 | 管理層討論及分析 | | 36 | 其他資料 | | 53 | 簡明綜合財務報表審閱報告 | | 54 | 簡明綜合損益及其他全面收益表 | | 56 | 簡明綜合財務狀況表 | | 58 | 簡明綜合權益變動表 | | 60 | 簡明綜合現金流量表 | | 62 | 簡明綜合財務報表附註 | | 92 | 釋義 | 公司資料 執行董事 熊俊先生 (主席兼法定代表) 李寧博士 (首席執行官兼總經理) 李聰先生 (聯席首席執行官) 馮輝博士 張卓兵先生 姚盛博士 鄒建軍博士1 非執行董事 武海博士 湯毅先生 林利軍先生 獨立非執行董事 陳列平博士 Roy Steven Herbst博士 錢智先生 張淳先生 馮曉源博士 監事 鄔煜先生 (監事會主席) 王萍萍女士 霍依蓮女士 審計委員會 二零二二年中期報告 ...