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君实生物:君实生物关于收到公司控股股东、实际控制人之一兼董事长提议回购公司股份的提示性公告

2023-08-27 07:36
上海君实生物医药科技股份有限公司(以下简称"公司")于 2023 年 8 月 27 日收到公司控股股东、实际控制人之一兼董事长熊俊先生"关于使用部分超募资 金以集中竞价交易方式回购公司 A 股股份"的提议,具体内容如下: 证券代码:688180 证券简称:君实生物 公告编号:临 2023-050 上海君实生物医药科技股份有限公司 关于收到公司控股股东、实际控制人之一兼董事长 提议回购公司股份的提示性公告 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、准确性和完整性依法承担法律责任。 一、提议人提议回购股份的原因和目的 熊俊先生基于对公司未来持续发展的信心和对公司价值的认可,为了维护广 大投资者利益,增强投资者对公司的投资信心,同时促进公司稳定健康发展,有 效地将股东利益、公司利益和员工个人利益紧密结合在一起,提议公司通过集中 竞价交易方式进行股份回购。回购的股份将在未来合适时机全部用于股权激励及 /或员工持股计划。 二、提议人的提议内容 (一)回购股份的种类:公司发行的人民币普通股(A 股); (三)回购股份的方式:集中竞价交易方式; (二)回购股份的用 ...
君实生物:君实生物关于持股5%以上股东被动稀释及减持超过1%的提示性公告

2023-08-25 10:40
证券代码:688180 证券简称:君实生物 公告编号:临 2023-048 上海君实生物医药科技股份有限公司 关于持股 5%以上股东被动稀释及减持超过 1%的 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、准确性和完整性依法承担法律责任。 重要内容提示: 本次权益变动主要系 LVC Renaissance Fund LP(以下简称"LVC Renaissance Fund")基金临近到期减持上海君实生物医药科技股份有限公司(以 下简称"公司")H 股股份、公司 2020 年限制性股票激励计划归属、Loyal Valley Capital Advantage Fund LP(以下简称"LVC Fund I")基金临近到期减持公司 H 股股份所致。上述事项完成后,公司总股本由 982,871,640 股(包含 763,575,940 股 A 股和 219,295,700 股 H 股)增加至 985,689,871 股(包含 766,394,171 股 A 股 和 219,295,700 股 H 股)。上述事项完成后,公司持股 5%以上股东上海檀英 ...
君实生物:君实生物自愿披露关于senaparib用于晚期卵巢癌全人群一线维持治疗的新药上市申请获得受理的公告

2023-08-25 10:40
证券代码:688180 证券简称:君实生物 公告编号:临 2023-049 上海君实生物医药科技股份有限公司 自愿披露关于 senaparib 用于晚期卵巢癌全人群一线维持 治疗的新药上市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。 近日,上海君实生物医药科技股份有限公司(以下简称"公司")与上海瑛 派药业有限公司(以下简称"上海瑛派")共同投资的上海君派英实药业有限公 司(以下简称"君派英实")收到国家药品监督管理局核准签发的《受理通知书》, 聚腺苷二磷酸核糖聚合酶(以下简称"PARP")抑制剂 senaparib(产品代号: JS109/IMP4297)的新药上市申请已获得受理,用于国际妇产科联盟(以下简称 "FIGO")III-IV 期上皮性卵巢癌、输卵管癌或原发性腹膜癌患者对一线含铂化 疗达到完全或部分缓解后的维持治疗。由于药品的研发周期长、审批环节多,容 易受到一些不确定性因素的影响,本次新药上市申请能否获得批准存在不确定性, 敬请广大投资者谨慎决策,注意防范投资风险。现将相关情况公告如下: ...
君实生物:君实生物H股公告

2023-08-18 09:38
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) 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。 上海君實生物醫藥科技股份有限公司 熊俊先生 (股份代號:1877) 董事會召開日期 上海君實生物醫藥科技股份有限公司(「本公司」及其附屬公司「本集團」)董事會 (「董事會」)茲通告謹定於2023年8月30日(星期三)舉行董事會會議,以考慮及通 過本集團截至2023年6月30日止六個月的中期業績,以及處理其他事項。 承董事會命 主席 中國,上海,2023年8月18日 於本公告日期,本公司董事會包括執行董事熊俊先生、李寧博士、馮輝博士、張 卓兵先生、姚盛博士、李聰先生及鄒建軍博士;非執行董事武海博士及湯毅先 生;以及獨立非執行董事Roy Steven Herbst博士、錢智先生、張淳先生、馮曉源 博士及孟安明博士。 * 僅供識別之用 ...
君实生物(688180) - 2023 Q1 - 季度财报

2023-04-28 16:00
Financial Performance - The company's operating revenue for Q1 2023 was ¥255,154,522.24, representing a decrease of 59.47% compared to the same period last year[4]. - Total revenue for Q1 2023 was ¥255,154,522.24, a decrease of 59.5% compared to ¥629,519,132.31 in Q1 2022[16]. - Operating profit for Q1 2023 was -¥633,218,295.88, compared to -¥377,914,059.91 in Q1 2022, indicating a worsening loss[16]. - Net loss attributable to shareholders for Q1 2023 was -¥543,432,303.73, compared to -¥396,395,486.59 in Q1 2022[17]. - The company reported a comprehensive loss of -¥667,067,229.83 for Q1 2023, compared to -¥471,770,135.33 in Q1 2022[17]. - Basic and diluted earnings per share for Q1 2023 were both -¥0.55, compared to -¥0.44 in Q1 2022, indicating a deeper loss per share[17]. Cash Flow - The net cash flow from operating activities was -¥720,250,964.89, a decline of 226.26% year-on-year[4]. - In Q1 2023, the company reported cash inflows from operating activities of $302,002,091.08, a significant decrease from $1,544,045,956.19 in Q1 2022, reflecting a decline of approximately 80.5%[18]. - The net cash flow from operating activities was negative at -$720,250,964.89, compared to a positive $570,432,127.10 in the same quarter last year[18]. - Cash inflows from investment activities totaled $432,767,530.31, a substantial increase from $10,234,381.32 in Q1 2022[18]. - The net cash flow from investment activities was -$492,872,825.63, worsening from -$175,320,677.30 year-over-year[18]. - Cash inflows from financing activities amounted to $248,567,750.19, down from $380,000,000.00 in Q1 2022, representing a decline of approximately 34.6%[19]. - The net cash flow from financing activities was $211,453,160.70, compared to $357,189,314.87 in the previous year, indicating a decrease of about 40.9%[19]. - The company experienced a net decrease in cash and cash equivalents of -$1,012,308,195.11, contrasting with an increase of $753,748,651.03 in Q1 2022[19]. - As of the end of Q1 2023, the cash and cash equivalents balance stood at $4,984,627,802.72, compared to $4,258,353,489.75 at the end of Q1 2022[19]. Research and Development - R&D investment totaled ¥527,659,904.54, accounting for 206.80% of operating revenue, an increase of 125.64 percentage points compared to the previous year[5][8]. - Research and development expenses increased to ¥527,659,904.54 in Q1 2023, up from ¥510,912,040.65 in Q1 2022, reflecting a focus on innovation[16]. - The company has achieved primary endpoints in two Phase III clinical studies for Toripalimab in the treatment of operable non-small cell lung cancer and advanced triple-negative breast cancer[11]. - The company aims to submit and obtain approval for new drug applications for its late-stage products, including the PARP inhibitor Senaparib and a humanized anti-PCSK9 monoclonal antibody injection[11]. Assets and Equity - Total assets at the end of the reporting period were ¥12,130,928,476.30, down 3.40% from the end of the previous year[5]. - Total assets decreased to ¥12,130,928,476.30 in Q1 2023 from ¥12,558,496,175.43 in Q1 2022, a decline of 3.4%[15]. - Total liabilities increased to ¥2,856,550,964.10 in Q1 2023 from ¥2,782,035,912.21 in Q1 2022, an increase of 2.7%[15]. - Shareholders' equity attributable to the parent company was ¥8,949,235,488.32, a decrease of 5.63% from the previous year[5]. - The total equity attributable to shareholders decreased to ¥8,949,235,488.32 in Q1 2023 from ¥9,483,626,151.70 in Q1 2022, a decline of 5.6%[15]. Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 36,266[9]. - The largest shareholder, HKSCC NOMINEES LIMITED, held 22.25% of the shares, totaling 219,291,230 shares[9]. Product Performance - The revenue from the commercialized product, Toripalimab injection (brand name: Tuoyi®), reached approximately CNY 195.68 million, representing a year-on-year growth of about 77.84%[11]. - The sales revenue of Adalimumab injection (brand name: Junmaikang®) was approximately CNY 29.08 million, while the sales revenue of Dexamethasone Hydrochloride Tablets (brand name: Mindewi®) was approximately CNY 11.50 million[11]. - Mindewi® has received conditional approval for marketing from the National Medical Products Administration and has been temporarily included in the medical insurance payment scope[11]. Collaborations and Future Outlook - The company expects continued rapid revenue growth driven by the approval of new indications for Toripalimab and the commercialization of other late-stage clinical products[11]. - The company has established a collaboration with Rxilient Biotech Pte. Ltd. for the development and commercialization of Toripalimab in nine countries in Southeast Asia[11]. Other Information - The company received government subsidies amounting to ¥49,746,629.66 during the reporting period[6]. - The company did not apply new accounting standards or interpretations for the first time in 2023[20]. - The report was presented by the company's board on April 28, 2023[20].
君实生物(01877) - 2023 Q1 - 季度业绩

2023-04-28 12:37
Financial Performance - The company's revenue for Q1 2023 was ¥255,154,522.24, representing a decrease of 59.47% compared to the same period last year[5] - The net profit attributable to shareholders for Q1 2023 was -¥543,432,303.73, indicating a significant loss[5] - The net cash flow from operating activities was -¥720,250,964.89, a decrease of 226.26% year-on-year[5] - Operating profit for Q1 2023 was -¥633,218,295.88, compared to -¥377,914,059.91 in Q1 2022[16] - Net loss attributable to shareholders for Q1 2023 was -¥543,432,303.73, compared to -¥396,395,486.59 in Q1 2022[17] - The company reported a total comprehensive loss of -¥667,067,229.83 for Q1 2023, compared to -¥471,770,135.33 in Q1 2022[17] - Basic and diluted earnings per share for Q1 2023 were both -¥0.55, compared to -¥0.44 in Q1 2022[17] Assets and Liabilities - Total assets at the end of Q1 2023 were ¥12,130,928,476.30, down 3.40% from the end of the previous year[6] - Total assets decreased to ¥12,130,928,476.30 in Q1 2023 from ¥12,558,496,175.43 in Q1 2022[15] - Total liabilities increased to ¥2,856,550,964.10 in Q1 2023 from ¥2,782,035,912.21 in Q1 2022[15] - The company’s total equity decreased to ¥9,274,377,512.20 in Q1 2023 from ¥9,776,460,263.22 in Q1 2022[15] - The equity attributable to shareholders decreased by 5.63% to ¥8,949,235,488.32 compared to the end of the previous year[6] Cash Flow - As of March 31, 2023, the company's cash and cash equivalents amounted to CNY 5.02 billion, a decrease from CNY 6.03 billion as of December 31, 2022[13] - The company’s cash and cash equivalents decreased by 1,012,308,195.11, compared to an increase of 753,748,651.03 in Q1 2022[20] - The ending balance of cash and cash equivalents was 4,984,627,802.72, down from 4,258,353,489.75 in the previous year[20] - In Q1 2023, the company reported a net cash flow from operating activities of -720,250,964.89, a significant decrease compared to 570,432,127.10 in Q1 2022[19] - Total cash inflow from operating activities was 302,002,091.08, down from 1,544,045,956.19 in the same period last year[19] - The company experienced a cash outflow from investing activities of 925,640,355.94, compared to 185,555,058.62 in Q1 2022, resulting in a net cash flow from investing activities of -492,872,825.63[19] - Cash inflow from financing activities was 248,567,750.19, down from 380,000,000.00 in Q1 2022, leading to a net cash flow from financing activities of 211,453,160.70[20] Research and Development - R&D investment totaled ¥527,659,904.54, which accounted for 206.80% of the revenue, an increase of 125.64 percentage points compared to the previous year[6][9] - Research and development expenses for Q1 2023 were ¥527,659,904.54, an increase from ¥510,912,040.65 in Q1 2022[16] Revenue Sources - The decrease in revenue was mainly due to a reduction in technology licensing income compared to the previous year, which had significant contributions from collaborations with Eli Lilly and Coherus BioSciences[8] - The revenue from the commercialized product, Toripalimab injection (brand name: Tuoyi®), reached approximately CNY 195.68 million, representing a year-on-year growth of about 77.84%[12] - The sales revenue of Adalimumab injection (brand name: Junmaikang®) was approximately CNY 29.07 million, while the sales revenue of Dexamethasone tablets (brand name: Mindewi®) was approximately CNY 11.50 million[12] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 36,266[10] Strategic Developments - The company has expanded its production capacity for Junmaikang® by adding a second production line at its subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd.[12] - The company has entered into a collaboration with Rxilient Biotech Pte. Ltd. for the development and commercialization of Toripalimab in nine countries in Southeast Asia[12] - The company anticipates continued rapid revenue growth driven by the approval of new indications for Toripalimab and the commercialization of other products in late-stage clinical development[12] - The company received conditional approval for Mindewi® and it has been temporarily included in the medical insurance payment scope[12]
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:君实生物关于召开2022年度暨2023年第一季度业绩说明会的公告

2023-04-21 08:38
证券代码:688180 证券简称:君实生物 公告编号:临 2023-028 上海君实生物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: 投资者可于 2023 年 4 月 24 日(星期一)至 2023 年 4 月 28 日(星期五) 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 info@junshipharma.com 进行提问。上海君实生物医药科技股份有限公司(以下简 称"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 3 月 31 日在上海证券交易所网站(www.sse.com.cn)披露 公司 2022 年年度报告,并将于 2023 年 4 月 29 日披露公司 2023 年第一季度报 告,为加强与投资者的深入交流,在上海证券交易所的支持下,公司拟于 2023 年 5 月 4 日 10:00-11:00 召开 2022 年度暨 2023 年第一季度业绩 ...
君实生物(688180) - 2022 Q4 - 年度财报

2023-03-30 16:00
Financial Performance - The company has not achieved profitability during the reporting period due to high R&D costs and other expenses, despite significant advancements in drug discovery and commercialization [3]. - The company reported a total revenue of RMB 1.5 billion for the fiscal year 2022, representing a year-over-year increase of 25% [13]. - The company's operating revenue for 2022 was CNY 145,349.27 million, a decrease of 63.89% compared to CNY 402,484.09 million in 2021 [22]. - The net profit attributable to shareholders for 2022 was a loss of CNY 238,804.99 million, compared to a loss of CNY 72,090.97 million in 2021 [22]. - The net cash flow from operating activities for 2022 was a negative CNY 177,620.09 million, worsening from a negative CNY 60,505.00 million in 2021 [22]. - The company achieved a revenue of RMB 1.453 billion in 2022, a decrease of 63.89% year-on-year, primarily due to a reduction in technology licensing and royalty income from collaborations with Eli Lilly and Company and Coherus [29]. - The company's total sales revenue for the year reached 123,000,000 RMB, with the top five customers contributing 89,622.79 million RMB, accounting for 72.91% of total sales [141]. - The company reported a significant increase in revenue, achieving a total of 1.5 billion in 2022, representing a year-over-year growth of 25% [200]. Research and Development - The company plans to maintain substantial R&D investments for clinical trials and drug development, which may lead to further losses in the short term [4]. - Research and development expenses accounted for 40% of total revenue, underscoring the focus on new product development and technological advancements [15]. - The total R&D investment for the year reached ¥2,384,373,404.10, an increase of 15.26% compared to the previous year [115]. - R&D investment accounted for 164.04% of operating revenue, an increase of 112.64 percentage points year-on-year [115]. - The number of R&D personnel increased to 995, representing 33.60% of the total workforce, up from 31.94% in the previous year [120]. - The company has developed over 50 research products since its establishment in December 2012, with 4 products in the commercialization stage and nearly 30 in clinical trials [123]. - The company is actively collaborating with domestic and international biotech firms to expand its product pipeline and enhance drug combination therapies [123]. Product Pipeline and Innovation - The company is actively expanding its product pipeline across multiple disease treatment areas, indicating a commitment to innovation [4]. - The company aims to launch two new innovative drugs in the next 18 months, with projected sales of RMB 500 million in the first year post-launch [14]. - The company has initiated three new clinical trials for its leading monoclonal antibody products, with expected completion dates in Q4 2023 [14]. - The company has a comprehensive drug pipeline, including core product Toripalimab, which has received approval for 6 indications in China, marking significant milestones in its product portfolio [42]. - The company has over 50 drug candidates in various stages of development, reflecting its strong innovation capabilities and potential for global first-in-class drugs [103]. - The company is focusing on expanding its product portfolio with innovative therapies targeting various diseases, including cancer and autoimmune disorders [161]. Market Expansion and Strategy - The company plans to expand its market presence in Europe and North America, targeting a 15% market share in these regions by 2025 [14]. - The company is exploring potential acquisitions to enhance its market position, with a budget of 250 million allocated for this purpose [200]. - The company is actively pursuing new drug development, with several projects in various clinical trial phases, including Phase I and II [160]. - The company plans to increase its marketing budget by 15%, aiming to boost brand awareness and customer engagement [194]. - The company is committed to sustainability, with plans to reduce operational carbon footprint by 25% by 2025 [196]. Financial Risks and Challenges - The company faces risks related to long profit cycles typical in the biopharmaceutical industry, with significant R&D investments impacting short-term profitability [126]. - The company is exposed to financial risks related to foreign exchange fluctuations, particularly with assets and liabilities denominated in currencies like USD and EUR [130]. - The company reported a significant increase in net losses across its subsidiaries, with Suzhou Junmeng showing a net loss of RMB 9,786.54 million and Junshi Engineering reporting a net loss of RMB 25,815.22 million [178]. Corporate Governance and Management - The board has approved a profit distribution plan for 2022, which includes no profit distribution or capital reserve transfer to increase share capital [5]. - The company has established a robust internal information disclosure management system to ensure transparency and protect investor interests [187]. - The company conducted 11 board meetings and 9 supervisory meetings during the reporting period, with all resolutions passed in accordance with legal procedures [187]. - The total pre-tax compensation for the CEO was 915.67 million yuan, with no shares held at the beginning of the year, but 20,000 shares at the end of the year [191]. Clinical Trials and Approvals - The company has initiated over 30 clinical studies covering more than 15 indications for Tretinoin in multiple countries, including the U.S. and China, focusing on early-stage applications of immunotherapy [33]. - The company plans to submit supplemental new drug applications (sNDA) for two new indications of Tretinoin to the NMPA in 2023, based on positive interim analysis results [34]. - The company has received breakthrough therapy designation and orphan drug status for several of its products, enhancing their market potential [47]. - The company has received IND approvals for multiple drug candidates, including JS010 and JS105, which are currently in clinical trial phases [113].
君实生物(01877) - 2022 - 年度业绩

2023-03-30 13:37
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 overseas licensing income [2]. - The loss attributable to owners of the company was RMB 2,386 million, an increase of RMB 1,667 million compared to the same period in 2021, primarily due to decreased licensing income [3]. - The net loss for the year was RMB 2,582,095 thousand, compared to a net loss of RMB 728,181 thousand in 2021, representing a significant increase in losses [91]. - Basic and diluted loss per share for the year was RMB 2.60, compared to RMB 0.80 in 2021 [91]. - The total comprehensive expenses for the year ended December 31, 2022, amounted to RMB (2,650,714) thousand, a significant increase from RMB (718,579) thousand in 2021, reflecting a rise of approximately 269% [65]. - The adjusted total comprehensive expenses for the year ended December 31, 2022, were RMB (2,608,855) thousand, compared to RMB (485,888) thousand in 2021, indicating an increase of around 437% [65]. Revenue Sources - Sales revenue from Tuoyi® (Tirzepatide) was approximately RMB 736 million, an increase of about 79% compared to the same period in 2021, driven by enhanced commercialization capabilities and the approval of two new indications [2]. - Pharmaceutical revenue was approximately RMB 753 million, an increase of about 76% year-on-year, primarily due to enhanced commercialization capabilities and the approval of two new indications for the product Tuoyi® [59]. - The company recognized license income of RMB 221,508,000 from Coherus and RMB 254,967,000 from sales sharing agreements for the year ended December 31, 2022 [101]. 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 [2]. - The company has expanded its innovative R&D pipeline to include small molecules, peptides, antibody-drug conjugates, and nucleic acid drugs, covering five major therapeutic areas [4]. - The company is actively expanding its product pipeline, including small molecule drugs, peptide drugs, and next-generation innovative therapies targeting cancer and autoimmune diseases [11]. - The company plans to enhance its R&D pipeline by focusing on large molecule drug development and exploring new drug targets in small molecule research [58]. - The company plans to continue investing in R&D to drive future growth and innovation in drug development [96]. Clinical Trials and Approvals - As of the announcement date, four drugs have been commercialized in China or overseas, with nearly 30 drugs in clinical trials, including three in Phase III trials [4]. - The IND application for JS112 (Aurora A inhibitor) was approved by the NMPA in February 2022, indicating progress in the company's pipeline [4]. - The company achieved statistical superiority in a Phase III clinical study of Mindewi® for early treatment of COVID-19, with results published in a prestigious journal [5]. - The IND application for JS401, a small interfering RNA targeting ANGPTL3 mRNA, developed in collaboration with Runjia (Shanghai) Pharmaceutical Technology Co., Ltd., was accepted by the NMPA in January 2023 [8]. - The company is conducting multiple Phase Ib/II clinical trials for its first-in-human anti-tumor anti-BTLA monoclonal antibody, tifcemalimab, which has received IND approval from both FDA and NMPA [10]. Financing and Cash Flow - Net cash inflow from financing activities was RMB 4,643 million, mainly from the issuance of new A-shares and new bank loans, which increased cash reserves by RMB 2,492 million [3]. - Cash and cash equivalents increased from approximately RMB 3,505 million as of December 31, 2021, to approximately RMB 5,997 million as of December 31, 2022, primarily due to the completion of a new A-share issuance [63]. - The company raised approximately RMB 4,836 million from the A-share public offering, with net proceeds of about RMB 4,497 million after deducting issuance costs [68]. - Cash flow from financing activities included CNY 840,362,035.97 in borrowings received in 2022, up from CNY 500,000,000.00 in 2021, indicating a growth of 68.1% [133]. Market Presence and Commercialization - The company has established a commercialization team of nearly 1,000 people to enhance market presence and sales capabilities [11]. - Tuoyi® has been included in the National Medical Insurance Catalog for three indications, providing broader access to patients and reducing their medication burden [11]. - The company has successfully expanded Tuoyi® sales to over 4,000 medical institutions and approximately 2,000 pharmacies across China [26]. - The company is focusing on expanding its market presence in Southeast Asia and other regions through strategic partnerships [25]. Collaborations and Partnerships - The company signed a collaboration agreement with Coherus BioSciences, receiving an upfront payment of $35 million and potential milestone payments up to $255 million for the development of TAB006/JS006 in the U.S. and Canada [7]. - The company has entered into multiple collaborations, including a $35 million upfront payment from Coherus for the development of TAB006/JS006, with potential milestone payments up to $255 million [17]. - The company has entered into a shareholder agreement to acquire a 40% stake in Excellmab, with potential milestone payments of up to approximately $4.52 million, plus royalties based on net sales [9]. Regulatory and Compliance - The company has adhered to the corporate governance code as per Hong Kong listing rules during the reporting period [87]. - The company is committed to compliance with regulatory changes to mitigate policy risks and ensure operational adaptability [80]. - The company has received government subsidies related to R&D activities amounting to RMB 32,738,000 in 2022, down from RMB 89,061,000 in 2021 [104]. Risks and Challenges - The company faces risks related to prolonged non-profitability due to high R&D costs and market promotion expenses, which may lead to uncertainty in future profitability [74]. - The company is exposed to foreign exchange risks from holding foreign currency assets and liabilities, which may impact operating performance due to currency fluctuations [79].