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信达生物(01801) - 2022 - 年度财报
2023-04-28 12:50
Financial Performance - In 2022, Innovent achieved product revenue exceeding RMB 4.1 billion, representing a growth of 3.4% compared to the previous year[8]. - Total revenue for the year ended December 31, 2022, was RMB 4,556.4 million, an increase of 6.7% compared to RMB 4,269.7 million for the year ended December 31, 2021[15]. - Product revenue reached RMB 4,139.1 million, up 3.4% from RMB 4,001.1 million in the previous year, driven by rapid sales growth and new product contributions[15]. - The company reported a net loss of RMB 2,179.3 million for the year ended December 31, 2022, compared to a net loss of RMB 2,728.8 million in the previous year, showing an improvement of approximately 20.2%[60]. - The adjusted loss for the year was RMB 2,461.8 million, an increase of RMB 433.4 million compared to RMB 2,028.4 million in the previous year, mainly due to sustained R&D investments[16]. - The company recorded a gross profit of RMB 3,625.4 million for the year ended December 31, 2022, compared to RMB 3,764.4 million in the previous year, reflecting a decrease of approximately 3.7%[60]. Product Development and Pipeline - The product pipeline includes 35 innovative molecules, with 8 products approved, 3 under NMPA review, and 5 in Phase III or pivotal clinical studies[4]. - The company has established a strong pipeline with over 30 innovative drug candidates, including more than 20 oncology and 10 non-oncology products[33]. - The company plans to launch at least 15 to 20 products in the next four to five years, leveraging its strong product pipeline and commercial platform[11]. - The company has advanced multiple late-stage pipeline candidates, including IBI-362 (mazdutide), which showed strong weight loss and blood sugar reduction effects in Phase 2 studies for obesity and type 2 diabetes[21]. - The NDA submissions for two candidate products, IBI-110 (LAG3) and IBI-939 (TIGIT), have been accepted, enhancing coverage in the hematological malignancies field[10]. - The company is actively advancing multiple global innovative tumor immunotherapy molecules in early clinical development, including IBI-110 and IBI-363[10]. Strategic Collaborations and Partnerships - The company has established strategic collaborations with international pharmaceutical companies to expand its innovative boundaries[8]. - In August 2022, the company entered a strategic partnership with Sanofi to accelerate the development and market access of innovative oncology drugs, including SAR408701 (in Phase 3) and SAR444245 (in Phase 2), with a strategic equity investment of €300 million from Sanofi[25]. - The company entered into a strategic cooperation and licensing agreement with Sanofi on August 4, 2022, involving multiple projects for clinical development and commercialization[96]. - The company deepened its collaboration with Eli Lilly in oncology, securing exclusive commercialization rights for several products in mainland China[38]. Marketing and Sales Strategy - The company is focused on building an efficient and precise marketing system to support long-term sustainable business development[8]. - The company has established a sales team of nearly 3,000 people and a professional support system, solidifying its industry-leading position and brand advantage[9]. - The product sales expense ratio for 2022 was 62.6%, down from 65.5% in 2021, with a notable decrease to 56.9% in the second half of 2022 compared to 68.5% in the first half[9]. - New product revenue contribution has further increased, supporting sustained growth in commercialization[8]. Research and Development Investment - Research and development expenses increased by RMB 546.0 million to RMB 2,664.7 million, reflecting ongoing investment in clinical trials and early-stage pipeline development[15]. - The company has established a comprehensive integrated biopharmaceutical platform covering R&D, CMC, clinical development, and commercialization capabilities[28]. - The company is focusing on chronic disease areas such as cardiovascular, metabolic, and autoimmune diseases, aiming to build a strong product portfolio and long-term barriers[36]. Corporate Governance and Management - The company has established a remuneration committee to determine the remuneration policy for directors and senior management[160]. - The board consists of two executive directors and four independent non-executive directors as of December 31, 2022[185]. - The company has complied with all applicable corporate governance codes, except for the separation of the roles of chairman and CEO, which are currently held by the same individual[185]. - The independent non-executive directors constitute one-third of the board, meeting the listing rules' requirements[189]. Financial Position and Assets - As of December 31, 2022, the company had approximately RMB 9.166 billion (over USD 1.3 billion) in cash and short-term financial assets, supporting its long-term sustainable development[13]. - The group's current assets amounted to RMB 11,506.7 million, with cash and cash equivalents at RMB 9,162.8 million as of December 31, 2022[78]. - The total assets increased from RMB 16,243.7 million in 2021 to RMB 17,588.8 million in 2022, while total liabilities rose from RMB 5,913.3 million to RMB 6,858.9 million[77]. Employee and Workforce Management - The total employee count of the group was 5,294, with over 1,000 in R&D and CMC, and nearly 3,000 in sales and marketing[90]. - The total compensation cost for the group for the year ended December 31, 2022, was RMB 2,649.6 million, an increase from RMB 2,385.4 million for the year ended December 31, 2021[90]. - The overall gender diversity within the group is balanced at 50.13%, with 5,294 employees, including 2,654 women in senior management[199]. Market Expansion and Product Approval - The company has received NMPA approval for two new indications of Daborshu (sindilizumab injection), making it the first innovative PD-1 inhibitor for first-line treatment of five major high-incidence cancers in China[19]. - The company’s drug 达坦 (pemigatinib tablets) became the first targeted therapy approved for second-line treatment of advanced cholangiocarcinoma in mainland China and Hong Kong[30]. - The company has received approval for multiple cancers including 1L non-small cell lung cancer and 1L liver cancer[40]. Innovation and Technology Development - The company emphasizes high-quality innovation and has established a differentiated ADC technology platform to deliver high-quality molecules into clinical development[37]. - The company is focusing on various therapeutic areas including oncology and autoimmune diseases[40]. - The company has successfully delivered 6 innovative molecules into the IND preparation stage in 2022, focusing on immunology, tumor biology, and antibody engineering[37].
信达生物(01801) - 2022 - 年度业绩
2023-03-31 14:00
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。 信 達 生 物 製 藥 INNOVENT BIOLOGICS, INC. (於開曼群島註冊成立的有限公司) (股份代號:1801) 截至2022年12月31日止年度 年度業績公告 信達生物製藥(「本公司」,連同其附屬公司統稱「本集團」)董事(「 董事」)會(「董 事會」)欣然公佈本集團截至2022年12月31日止年度(「報告期」)的經審核綜合業 績,連同截至2021年12月31日止年度的比較數字。本集團於報告期的綜合財務報 表已獲本公司審核委員會(「審核委員會」)審閱及經本公司核數師德勤•關黃陳方 會計師行審核。 於本公告,「我們」及「我們的」指本公司,如文義另有所指,則指本集團。本公告 所載若干金額及百分比數字已約整或已四捨五入至小數點後一位或兩位數。任何 表格、圖表或其他地方所示總額與所列數額總和如有任何差異乃因四捨五入所致。 ...
信达生物(01801) - 2022 - 年度业绩
2023-03-28 10:00
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。 信 達 生 物 製 藥 INNOVENT BIOLOGICS, INC. (於開曼群島註冊成立的有限公司) (股份代號:1801) 截至2022年12月31日止年度 年度業績公告 信達生物製藥(「本公司」,連同其附屬公司統稱「本集團」)董事(「 董事」)會(「董 事會」)欣然公佈本集團截至2022年12月31日止年度(「報告期」)的經審核綜合業 績,連同截至2021年12月31日止年度的比較數字。本集團於報告期的綜合財務報 表已獲本公司審核委員會(「審核委員會」)審閱及經本公司核數師德勤•關黃陳方 會計師行審核。 於本公告,「我們」及「我們的」指本公司,如文義另有所指,則指本集團。本公告 所載若干金額及百分比數字已約整或已四捨五入至小數點後一位或兩位數。任何 表格、圖表或其他地方所示總額與所列數額總和如有任何差異乃因四捨五入所致。 ...