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2023年6月30日止六個月 中期業績公告 信達生物製藥（「本公司」或「 信達生物」，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2023年6月30日止六個月（「報告期」） 的未經審核簡明綜合業績。該等中期業績已經本公司審核委員會（「審核委員會」） 及本公司核數師德勤•關黃陳方會計師行審閱。 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。 ...

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].

Financial Performance - 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[3]. - The net loss for the year was RMB 2,461.8 million, an increase of RMB 433.4 million from RMB 2,028.4 million in the previous year, mainly due to sustained R&D investments[4]. - The company reported a net loss attributable to shareholders of RMB 2,179,270,000 for the year ended December 31, 2022, compared to a net loss of RMB 2,728,755,000 in 2021, indicating an improvement in financial performance[98]. - The company reported a loss before tax of RMB 2,170.5 million for 2022, an improvement from a loss of RMB 2,641.7 million in 2021[46]. - The gross profit for 2022 was RMB 3,625.4 million, compared to RMB 3,764.4 million in 2021, reflecting a decrease of approximately 3.7%[82]. Revenue Breakdown - Product revenue reached RMB 4,139.1 million, a growth of 3.4% from RMB 4,001.1 million in the previous year, driven by rapid sales growth and new product contributions[5]. - Pharmaceutical product sales accounted for RMB 4,139.1 million in 2022, up from RMB 4,001.1 million in 2021, indicating a growth of about 3.5%[48]. - Licensing fee income increased significantly to RMB 417.1 million in 2022 from RMB 268.7 million in 2021, reflecting a growth of approximately 55.3%[48]. - The total revenue from licensing fees increased significantly to RMB 20,304,000 in 2022 from RMB 8,863,000 in 2021, marking an increase of approximately 129.5%[90]. Research and Development - Research and development expenses increased to RMB 2,664.7 million, up RMB 546.0 million from RMB 2,118.7 million in the previous year, reflecting ongoing investment in clinical trials and pipeline development[3]. - Research and development expenses rose from RMB 2,322.5 million in 2021 to RMB 2,871.2 million in 2022, an increase of 23.6%[52]. - The company has established a strong pipeline with over 30 innovative drug candidates, including more than 20 oncology and 10 non-oncology products[19]. - The company is focusing on chronic disease areas such as cardiovascular and metabolic diseases, with several high-potential products advancing towards clinical trials[20]. Product Development and Approvals - New drug approvals included the launch of 希冉擇® (Remosiruab) for advanced gastric cancer and liver cancer, and 睿妥® (Sepantritinib) for specific types of lung and thyroid cancers[5]. - The NMPA approved two new indications for Daborhuzhu® (sindilizumab injection), making it the first PD-1 inhibitor in China for first-line treatment of five major cancers, including ESCC and GC[6]. - The NMPA accepted three new drug applications (NDA) for innovative candidates, including IBI-306 for primary hypercholesterolemia and mixed dyslipidemia, and IBI-326 for relapsed/refractory multiple myeloma[7]. - IBI-362 (mazdutide), a dual agonist for GLP-1R and GCGR, showed strong weight loss and blood sugar reduction effects in phase 2 studies, with phase 3 trials for obesity starting in November 2022[8]. Strategic Collaborations - The company established a strategic partnership with Eli Lilly in March 2022, obtaining exclusive commercialization rights for two drugs in mainland China and priority negotiation rights for a potential future drug[11]. - In August 2022, the company entered a strategic collaboration with Sanofi to accelerate the development and market access of innovative oncology drugs, including a €300 million initial strategic equity investment from Sanofi[12]. - The company has initiated a strategic collaboration with Eli Lilly in the oncology field, enhancing its international strategic cooperation model[23]. Operational Efficiency - Sales and marketing expenses were RMB 2,578.4 million, representing 56.6% of total revenue, compared to 59.6% in the previous year, indicating improved operational efficiency[3]. - The 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[18]. - The company aims to focus on fine management to expand product scale and enhance operational efficiency while developing innovative drugs[16]. Financial Health and Assets - As of December 31, 2022, the company had cash and short-term financial assets of approximately RMB 9.166 billion, equivalent to over $1.3 billion, bolstered by the strategic investment from Sanofi[23]. - Total current assets as of December 31, 2022, were RMB 11,506.7 million, compared to RMB 11,550.8 million in 2021, a slight decrease of 0.4%[59]. - The company had unused long-term bank loan financing of approximately RMB 2,291.2 million as of December 31, 2022[61]. - The company’s cash and cash equivalents stood at RMB 9,162.8 million as of December 31, 2022, compared to RMB 8,377.1 million in 2021[83]. Corporate Governance - The group has adhered to the corporate governance code and has not separated the roles of the chairman and CEO, believing it enhances decision-making efficiency[71]. - The company established an audit committee consisting of four independent non-executive directors, with the chair being Ms. Xu Yiyin[74]. - The board of directors includes a diverse group of members, ensuring a range of perspectives in decision-making[103].

Financial Performance - 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[3]. - The net loss for the year was RMB 2,461.8 million, an increase of RMB 433.4 million from RMB 2,028.4 million in the previous year, mainly due to sustained R&D investments[4]. - The adjusted net loss for the year was RMB 2,461.8 million, compared to RMB 2,028.4 million in the previous year, reflecting the impact of ongoing investments[4]. - The company recorded 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 2021, reflecting an improvement of approximately 20.2%[46]. - The basic and diluted loss per share for 2022 was RMB 1.46, compared to RMB 1.88 in 2021, indicating an improvement in loss per share[82]. Revenue Breakdown - Product revenue reached RMB 4,139.1 million, a growth of 3.4% from RMB 4,001.1 million in the previous year, driven by rapid sales growth and new product contributions[5]. - Pharmaceutical product sales accounted for RMB 4,139.1 million in revenue for the year ended December 31, 2022, up from RMB 4,001.1 million in 2021, indicating a growth of about 3.5%[90]. - Total revenue from external customers in China was RMB 4,132,539,000 in 2022, compared to RMB 3,967,517,000 in 2021, reflecting a growth of about 4.2%[96]. Research and Development - Research and development expenses increased to RMB 2,664.7 million from RMB 2,118.7 million, reflecting ongoing investment in clinical trials and pipeline development[3]. - Research and development expenses increased to RMB 2,871.2 million in 2022 from RMB 2,322.5 million in 2021, marking a rise of about 23.7%[46]. - The company has established a pipeline of over 30 innovative drug candidates, including more than 20 oncology and 10 non-oncology products, with 8 commercialized products[19]. - The company is advancing multiple innovative molecules with differentiated clinical potential, including IBI-363 (PD-1/IL-2) and IBI-311 (IGF-1R) for long-term pipeline growth[10]. Product Development and Approvals - New drug approvals included the launch of 希冉擇® (Remosiruab) and 睿妥® (Sepmetinib), targeting specific cancer treatments, which will support broader patient solutions[5]. - The NMPA approved two new indications for Daborhuzhu® (sindilizumab injection), making it the first PD-1 inhibitor in China for first-line treatment of five major cancers, including ESCC and GC[6]. - The NMPA accepted three new drug applications (NDA) for innovative candidates, including IBI-306 for primary hypercholesterolemia and mixed dyslipidemia, and IBI-326 for relapsed/refractory multiple myeloma[7]. - IBI-362 (mazdutide), a dual agonist for GLP-1R and GCGR, showed strong weight loss and blood sugar reduction effects in Phase 2 studies, with Phase 3 trials for obesity starting in November 2022[8]. Strategic Partnerships and Collaborations - The company established a strategic partnership with Eli Lilly in March 2022, obtaining exclusive commercialization rights for two drugs in mainland China and priority negotiation rights for a potential future drug[11]. - In August 2022, the company entered a strategic collaboration with Sanofi to accelerate the development and market access of innovative oncology drugs, including a €300 million initial strategic equity investment from Sanofi[12]. - The company has initiated a strategic collaboration with LG Chem for Tigulixostat, which is currently undergoing a Phase 3 clinical trial initiated in Q4 2022[44]. Operational Efficiency and Management - Sales and marketing expenses were RMB 2,578.4 million, representing 56.6% of total revenue, compared to 59.6% in the previous year, indicating improved operational efficiency[3]. - The company aims to implement a more sustainable and healthier business management model to enhance operational efficiency and support long-term growth[5]. - The company aims to focus on fine management to expand product scale and improve operational efficiency while developing innovative drugs[16]. Market Expansion and Future Plans - The company is actively exploring new drug development and market expansion strategies, including potential mergers and acquisitions to strengthen its market position[23]. - The company aims to enhance global quality and innovation standards while creating sustainable value for patients, employees, society, and shareholders[23]. - The company plans to gradually utilize the remaining proceeds from the placements based on market conditions and operational needs[80]. Financial Position and Assets - As of December 31, 2022, the company had cash and short-term financial assets of approximately RMB 9.166 billion, equivalent to over $1.3 billion, bolstered by the strategic investment from Sanofi[23]. - Total current assets as of December 31, 2022, were RMB 11,506.7 million, slightly down from RMB 11,550.8 million in 2021[59]. - The company had unused long-term bank loan facilities of approximately RMB 2,291.2 million as of December 31, 2022[61]. Governance and Compliance - The company has complied with all applicable provisions of the Corporate Governance Code for the year ended December 31, 2022, except for the separation of the roles of Chairman and CEO[70]. - The company established an audit committee consisting of four independent non-executive directors, with the chair being Ms. Xu Yiyin[74]. - The company has established a nomination committee, a remuneration committee, and a strategic committee in addition to the audit committee[75].

Financial Performance - Revenue from customer contracts for the six months ended June 30, 2022, was RMB 2,239,599 thousand, an increase of 15.4% compared to RMB 1,941,750 thousand for the same period in 2021[10]. - Gross profit for the same period was RMB 1,803,249 thousand, with a gross margin of approximately 80.5%[10]. - The company reported a net loss of RMB 1,085,326 thousand for the six months ended June 30, 2022, compared to a net loss of RMB 676,850 thousand in the prior year, indicating a 60.2% increase in losses[10]. - Total comprehensive loss for the period was RMB 1,004,294 thousand, compared to RMB 1,003,558 thousand in the prior year, indicating stable performance despite losses[90]. - The company reported a pre-tax loss of RMB 998,912 thousand for the six months ended June 30, 2022, compared to a pre-tax loss of RMB 1,003,406 thousand for the same period in 2021, indicating a slight improvement in performance[54]. Research and Development - Research and development expenses amounted to RMB 1,077,701 thousand, representing a 22.5% increase from RMB 879,628 thousand in the previous year[10]. - The company has a robust pipeline with 34 innovative molecules, including 7 approved products and 20 molecules in clinical research[6]. - The company aims to develop affordable high-quality innovative therapies to meet significant medical needs across various disease areas[5]. - R&D expenses increased to RMB 1,077.7 million from RMB 879.6 million, reflecting ongoing investments in late-stage clinical trials for priority development products[11]. - The company has established a fully operational R&D center in the U.S. with a team of 300 scientists collaborating on preclinical projects[22]. Market Expansion and Product Development - The company is actively pursuing market expansion and has 3 products under review by NMPA, with 4 in Phase III or pivotal clinical studies[6]. - The company entered into a strategic collaboration with Sanofi in August 2022 to develop innovative drugs for hard-to-treat cancer patients, with an initial equity investment of €300 million from Sanofi[19]. - The company is expected to receive approval for the RET inhibitor Retsevmo® (selpercatinib) in the second half of 2022, expanding its commercial product portfolio to eight products[20]. - The company plans to initiate Phase III clinical trials for IBI-362 in diabetes and obesity, and IBI-112 in psoriasis in the second half of this year to early next year[22]. - The company aims to submit two new drug applications to the NMPA by the end of 2022[174]. Sales and Marketing - Sales and marketing expenses were RMB 1,361.6 million, representing 60.8% of total revenue, up from 54.2% in the same period last year, attributed to an increase in approved products and a strategic expansion of the sales team from 2,117 to 2,745 employees[11]. - The company has established a sales team of nearly 3,000 people, covering over 5,000 hospitals and more than 1,000 DTP pharmacies nationwide[21]. - The commercial team, consisting of nearly 3,000 personnel, has upgraded its business structure to enhance operational efficiency and support sustainable business development[26]. Financial Position - The company has approximately RMB 8.3 billion (around USD 1.2 billion) in cash and short-term financial assets as of June 30, 2022[23]. - The total current assets as of June 30, 2022, were RMB 11,194.5 million, while total liabilities increased from RMB 5,913.3 million to RMB 6,567.5 million[48]. - The company's net asset value decreased to RMB 9,591,090 thousand from RMB 10,330,397 thousand, a decline of about 7.2%[92]. - The company has approximately RMB 2,619.9 million of undrawn long-term bank loan facilities available as of June 30, 2022[49]. - The group reported other income and losses of RMB 389.6 million for the six months ended June 30, 2022, compared to a loss of RMB 85.2 million in the prior year, mainly due to favorable exchange rate impacts[42]. Strategic Partnerships - The company has formed over 20 strategic partnerships with global pharmaceutical and biotech companies, enhancing its core competitiveness[22]. - The collaboration with Eli Lilly aims to enhance the availability of new drugs for more patients in China, expanding the long-term partnership scope[23]. - The strategic partnership with Sanofi will accelerate the development and commercialization of two core potential first-in-class oncology products[23]. - The company entered into a strategic cooperation and licensing agreement with Sanofi Group on August 4, 2022, for clinical development and commercialization of several products[169]. Employee and Governance - The company appointed Gary Zieziula as an independent non-executive director in June 2022, bringing over 40 years of experience in building sustainable sales operations in multinational companies[18]. - The total employee count as of June 30, 2022, was 5,538, with 50% in sales and marketing[55]. - The company has implemented various employee incentive plans, including stock options and restricted share plans, to attract and retain talent[56]. - The company continues to adhere to high standards of corporate governance, with ongoing reviews to ensure compliance with the latest measures and standards[88]. Challenges and Risks - The company faced some limitations in product sales growth due to the recurring COVID-19 pandemic and related government measures in mainland China during the second quarter of 2022[20]. - The company experienced a significant foreign exchange loss of RMB 367,902 thousand, compared to a gain of RMB 82,742 thousand in the prior year, impacting overall financial results[54]. - The company reported a significant increase in trade payables aged 0-30 days, which rose to RMB 214,033 thousand from RMB 132,269 thousand, marking an increase of about 61.7%[133].

Financial Performance - Total revenue for the year ended December 31, 2021, was RMB 4,260.9 million, an increase of 74.1% compared to RMB 2,446.7 million for the year ended December 31, 2020[11]. - Product revenue reached RMB 4,001.1 million, growing 69.0% from RMB 2,367.5 million in the previous year, driven by strong sales of the leading PD-1 product, Sintilimab[11]. - The company reported a loss of RMB 3,138.1 million for the year ended December 31, 2021, an increase of 214.3% compared to a loss of RMB 998.4 million for the year ended December 31, 2020, primarily due to ongoing R&D investments and increased share-based compensation expenses[13]. - Revenue from customer contracts for the year ended December 31, 2021, was RMB 4,269.7 million, an increase from RMB 3,843.8 million in 2020, representing a growth of approximately 11.1%[43]. - Gross profit for the year ended December 31, 2021, was RMB 3,696.7 million, up from RMB 3,456.1 million in 2020, indicating a growth of 7.0%[43]. - The company reported a loss before tax of RMB 3,051.0 million for the year ended December 31, 2021, compared to a loss of RMB 858.7 million in 2020, representing a significant increase in losses[43]. Product Development and Pipeline - The company has established a competitive product pipeline consisting of 32 clinical-stage products, including 7 approved products, 1 product under NMPA review, 5 in Phase III or pivotal studies, and 19 in Phase I or II clinical stages[8]. - The company has 29 innovative high-value pipelines, including six commercialized products and 23 in various clinical stages, with plans to submit at least three NDAs in 2022[15]. - The company plans to launch at least 10 commercialized products in the next two years and aims for at least 15 by 2025[9]. - The company has successfully advanced seven new drugs into the CMC stage in 2021, with plans to enter first-in-human clinical trials starting in 2022[23]. - The company aims to submit New Drug Applications (NDA) for at least three new products in 2022, including IBI-310 (CTLA-4), IBI-306 (PCSK-9), and IBI-326 (BCMA CAR-T)[22]. Research and Development - R&D expenses rose to RMB 2,116.0 million, an increase of RMB 398.2 million from RMB 1,717.8 million in the previous year, focusing on late-stage clinical trials and new drug development[11]. - The company has over 80 projects in the preclinical drug discovery phase, providing a diverse foundation for long-term sustainable growth in the market[21]. - The company has received FDA approval for IND for eight molecules, with several global products expected to report more data in 2022, including IBI-188 (CD47) and IBI-110 (LAG-3)[23]. - The company is focusing on developing new therapies for autoimmune diseases and metabolic disorders, showcasing a diverse therapeutic portfolio[25]. Strategic Collaborations - The company has formed strategic collaborations with international partners such as Eli Lilly, Adimab, Incyte, and MD Anderson Cancer Center to enhance its development capabilities[3]. - The company deepened its strategic collaboration with Eli Lilly in March 2022, gaining exclusive commercialization rights for certain oncology products in mainland China[19]. - The company has established a strategic collaboration with Eli Lilly to deepen cooperation in the oncology field, gaining exclusive commercialization rights for several products in mainland China[30]. Market Expansion and Sales - The commercialization team has over 2,700 experienced marketing and sales professionals, covering approximately 5,100 hospitals and 1,100 pharmacies across more than 320 cities as of December 31, 2021[27]. - The company is expanding its market presence in China, Hong Kong, Macau, and Taiwan, which are key regions for commercialization[25]. - The company anticipates receiving regulatory decisions from NMPA in 2022 for three sNDAs related to DABOSHU (sintilimab injection) for 1L ESCC, 1L GC, and EGFR-mutated non-squamous NSCLC post-EGFR-TKI treatment[28]. Financial Position and Cash Flow - The company maintains a solid financial position with approximately RMB 14 billion in cash, positioning itself favorably amid market fluctuations[10]. - As of December 31, 2021, the company's cash and short-term financial assets amounted to approximately $1,415.1 million, ensuring a solid financial position for strategic focus[13]. - The company raised approximately HKD 4.7 billion through a share placement in January 2021, enhancing its financial stability[13]. - The company’s cash and cash equivalents increased from RMB 8,121.1 million as of December 31, 2020, to RMB 9,021.9 million as of December 31, 2021, primarily due to the issuance of new shares raising approximately RMB 3,893.3 million[55]. Corporate Governance and Compliance - The company has established an audit committee, remuneration committee, nomination committee, and strategic committee to oversee various aspects of its operations[120]. - The board believes it has appropriately maintained a balance of diversity among its members without setting measurable targets[123]. - The company is committed to high levels of corporate governance and compliance with applicable laws and regulations[129]. - The company has implemented appropriate insurance for directors and senior personnel to cover legal liabilities arising from business operations[120]. Social Responsibility and Employee Welfare - The company is committed to fulfilling social responsibilities and enhancing employee welfare, aiming for sustainable growth[62]. - The group made charitable donations of approximately RMB 204.6 million for the year ended December 31, 2021, compared to RMB 72.9 million in 2020, representing an increase of 180%[67]. - The total number of employees increased to 5,568 as of December 31, 2021, up from 3,279 in 2020[63].

Financial Performance - The core product, Tyvyt® (sintilimab injection), generated sales revenue of RMB 2,289.8 million, representing a growth of approximately 125.4% compared to the previous year[4]. - Total revenue for the year ended December 31, 2020, was RMB 3,843.8 million, an increase of 266.9% compared to RMB 1,047.5 million for the year ended December 31, 2019[18]. - Product revenue reached RMB 2,367.5 million, a growth of 133.0% from RMB 1,015.9 million in the previous year, driven by strong growth of the leading product, DABOSHU (sintilimab injection)[18]. - The company reported a net loss and total comprehensive expenses of RMB 998.4 million for the year ended December 31, 2020, compared to RMB 1,719.9 million for the year ended December 31, 2019[59]. - The company recorded a pre-tax loss of RMB 858.7 million for the year ended December 31, 2020, a decrease from a loss of RMB 1,719.9 million in the previous year[52]. Product Development and Pipeline - The company has developed a rich pipeline of products covering various therapeutic areas, including oncology, metabolism, immunology, and ophthalmology[4]. - The company has established a product pipeline with 23 high-value products under development and over 50 ongoing clinical trials[11]. - The company is advancing its clinical pipeline with multiple ongoing trials, including IBI-188 and IBI-322, which are in Phase 1 and expected to progress further in 2021[5]. - The company has five late-stage products entering registration or critical clinical trials, including IBI-310 in Phase 3 for melanoma and IBI-376 in Phase 2 for relapsed or refractory follicular lymphoma[5]. - The company plans to submit nine NDA applications between 2021 and early 2022, including four for the drug DABOSHU (sintilimab injection) targeting various cancer treatments[7]. Strategic Partnerships and Collaborations - The company has established strategic partnerships with Eli Lilly and Roche, symbolizing a key step in introducing its innovative product portfolio to international markets[5]. - The strategic expansion licensing agreement with Eli Lilly for the drug Dabra (Sintilimab injection) in China represents a significant milestone for the company[5]. - The company is exploring and developing bispecific antibodies and multiple cell therapy products in collaboration with top global pharmaceutical companies[5]. - The company entered into a collaboration agreement with Coherus BioSciences, Inc. to grant commercialization rights for IBI-305 (bevacizumab biosimilar) in the United States and Canada[21]. - The company has entered multiple licensing agreements for its products DABOSHU and DANYOU (bevacizumab biosimilar) in 2020 and early 2021[10]. Production Capacity and Facilities - The production capacity has expanded from 5,000 liters to a total of 24,000 liters in 2020, with new production facilities under construction to meet commercialization needs[5]. - The new production facility (M2 base) will accommodate an additional twelve sets of 3,000-liter capacity, increasing total capacity to 60,000 liters upon completion[5]. - The company expanded its production capacity from 5,000 liters to 24,000 liters, with an additional 36,000 liters under construction[16]. - The company plans to complete the construction of the new commercial facility (M2 base) in Suzhou by the end of 2021, which will add twelve 3,000-liter production lines[10]. - The expansion of production capacity is expected to ensure sufficient supply for upcoming commercialized products and clinical candidates[27]. Financial Strategy and Funding - The company successfully raised approximately HKD 9.8 billion (or USD 1.3 billion) through three rounds of new share placements, supported by strong demand from international and regional investors[6]. - As of the report date, the company has approximately USD 1.8 billion in cash, providing strong support for drug development, potential business collaborations, production facility expansion, and increasing international operational needs[6]. - The company raised approximately HKD 2.3 billion through a placement of new shares in February 2020[21]. - The company raised approximately HKD 2.8 billion in July 2020 through a share placement to fund the expansion of production facilities and international clinical trial needs[22]. - The company plans to gradually utilize the remaining net proceeds over the next 30 months based on market conditions and business needs[112]. Market Expansion and Sales Strategy - The company aims to enhance its market coverage in major and secondary cities, leveraging its unique advantages as the only PD-1 inhibitor in the NRDL[4]. - The coverage of DABOSHU® increased from about 2,000 hospitals and 500 DTP pharmacies at the end of 2019 to approximately 4,000 hospitals and 900 DTP pharmacies across over 300 cities by the end of 2020[33]. - The company is focused on commercializing DABOSHU® in more hospital channels and expanding its commercialization team[32]. - The company plans to enhance academic marketing for DABOSHU® from 2021 to early 2022, targeting various cancer indications[32]. - The company is focused on achieving milestones in commercialization, CMC, R&D, and global expansion in 2021[27]. Governance and Corporate Structure - The company has maintained compliance with the corporate governance code throughout the year ending December 31, 2020, with no reported incidents of non-compliance[121]. - The board consists of two executive directors, one non-executive director, and three independent non-executive directors as of the report date[121]. - The company has established a remuneration committee to determine and recommend the remuneration policy for directors and senior management[100]. - The company has implemented appropriate insurance for directors and senior management to cover legal liabilities arising from business operations[126]. - The company has adopted a board diversity policy to enhance its competitive advantage and maximize the ability to attract and retain diverse talent[130]. Research and Development Focus - The company is committed to building a world-class R&D organization with a strong foundation in science and cutting-edge technology[10]. - The company is actively recruiting world-class scientists in both China and the US to enhance its drug discovery capabilities[10]. - The company is focused on developing first-in-class global products and achieving business globalization[26]. - The company is strategically enhancing its R&D to achieve its goal of becoming a global biopharmaceutical company, with plans to recruit world-class scientists in both China and the US[29]. - The company has successfully demonstrated the safety and efficacy of its candidate drugs, leading to regulatory approvals[68].