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信达生物(01801) - 2020 - 年度财报
2021-04-29 08:50
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].
信达生物(01801) - 2020 - 中期财报
2020-09-28 12:14
Sales Performance - Sales revenue from Darbuxo (Sintilimab injection) reached RMB 920.9 million for the six months ended June 30, 2020, representing a growth of approximately 177.7% compared to the same period in 2019[4]. - Total revenue for the six months ended June 30, 2020, was RMB 984.2 million, an increase of 184.9% compared to RMB 345.5 million for the same period in 2019[11]. - Revenue from the product 达伯舒 (信迪利单抗注射液) reached RMB 920.9 million for the six months ended June 30, 2020, up 177.7% from RMB 331.6 million in the same period of 2019[11]. - Revenue from pharmaceutical product sales reached RMB 920,888 thousand, a significant increase from RMB 331,630 thousand in the same period last year, representing a growth of approximately 177%[102]. - Revenue from external customers in China reached RMB 948,920 thousand for the six months ended June 30, 2020, compared to RMB 345,517 thousand for the same period in 2019, representing a growth of 174%[107]. Financial Performance - Gross margin for the six months ended June 30, 2020, was 81.2%, slightly down from 88.1% for the same period in 2019[11]. - The company reported a pre-tax loss of RMB 604.7 million for the six months ended June 30, 2020, compared to a loss of RMB 714.4 million for the same period in 2019, indicating an improvement in financial performance[40]. - The total comprehensive loss for the period was RMB 608,194 thousand, compared to RMB 714,406 thousand in the same period last year, showing a reduction in losses[90]. - The adjusted loss and total comprehensive expenses for the six months ended June 30, 2020, were RMB 453.5 million, a decrease from RMB 667.6 million for the same period in 2019, representing an improvement of about 32.1%[49]. - The company incurred financing costs of RMB 32,613 thousand, a slight decrease from RMB 36,734 thousand in the previous year[90]. Research and Development - The company has established a product pipeline with 23 high-value products under development and over 50 ongoing clinical trials, covering various therapeutic areas including oncology and immunology[6]. - R&D expenses increased to RMB 808.0 million for the six months ended June 30, 2020, from RMB 670.7 million in the same period of 2019, primarily due to key trials for 达伯舒 and other late-stage products[11]. - The company plans to conduct key clinical trials for IBI-188 and IBI-318 in China, targeting r/r AML and MDS patients, respectively[5]. - Over 20 clinical studies are currently ongoing to evaluate the efficacy and safety of DABOSHU® (sintilimab injection) for various cancer indications, including 12 registration or pivotal clinical trials[21]. - The company has received IND approval for multiple studies involving DABOSHU® (sintilimab injection) in combination with other therapies for various cancer types[23]. Strategic Partnerships and Collaborations - In August 2020, the company entered a strategic agreement with Eli Lilly to grant exclusive rights for the commercialization of its drug, IBI-305, outside of China, receiving an upfront payment of $200 million and potential milestone payments of up to $825 million[6]. - The company entered into a strategic collaboration with Eli Lilly for the exclusive rights to commercialize Darbesh (sintilimab injection) outside of China, receiving an upfront payment of USD 200 million[17]. - The company is collaborating with MD Anderson Cancer Center to co-develop DABOSHU® (sintilimab injection) for various rare cancers in the U.S.[25]. Employee and Workforce Expansion - The company expanded its employee count from approximately 700 to over 1,100 as of June 30, 2020[4]. - The workforce increased from approximately 2,000 employees at the end of 2019 to over 2,600 by June 30, 2020, with over 750 employees dedicated to R&D[6]. - The number of sales and marketing employees increased from 408 to 1,176 between June 30, 2019, and June 30, 2020[11]. - Total employee count as of June 30, 2020, was 2,673, with 44% in sales and marketing, 28% in R&D, and 20% in production[58]. Market Expansion and Product Development - The company plans to submit additional sNDA for Darbuxo (Sintilimab injection) for second-line NSCLC and first-line HCC by the end of 2020 or early 2021[4]. - The company is actively pursuing global opportunities for its products through appropriate R&D plans and commercialization activities[6]. - The company is focused on research and development in the field of oncology, specifically targeting mCCA, MDS, and NSCLC[162]. - The company is exploring market expansion opportunities, particularly in the United States and China[164]. Capital and Funding - As of June 30, 2020, the company had a cash balance of approximately $1.2 billion, supporting R&D, production facility expansion, and international clinical trial needs[6]. - The company successfully raised approximately HKD 2.3 billion and HKD 2.8 billion through share placements in February and July 2020, respectively[6]. - The company raised approximately HKD 2.3 billion through a share placement in February 2020 to support its operations and clinical trials[14]. - The company plans to gradually utilize the remaining proceeds from the placements over the next 36 months based on market conditions and business needs[81]. Corporate Governance and Compliance - The company has established various committees, including an audit committee, to ensure high standards of corporate governance and compliance with regulations[86]. - The company is committed to maintaining compliance with the National Medical Products Administration (NMPA) regulations in China[162]. Stock and Shareholder Information - The total number of issued shares as of June 30, 2020, is 1,343,125,710[67]. - The company issued a total of 78,000,000 ordinary shares on February 20, 2020, raising net proceeds of approximately RMB 2,099.67 million[135]. - The company has a post-IPO employee stock ownership plan to align employee interests with shareholder value[162].
信达生物(01801) - 2019 - 年度财报
2020-04-27 08:39
Financial Performance - In the fiscal year 2019, Innovent's product "Daboshu" (信迪利单抗注射液) achieved approximately RMB 1 billion in revenue during its first year of sales[3]. - Total revenue for the year ended December 31, 2019, was RMB 1,047.5 million, significantly up from RMB 9.5 million for the year ended December 31, 2018, primarily driven by sales of Darbesh (Sintilimab Injection) which generated RMB 1,015.9 million[10]. - The gross profit for the year ended December 31, 2019, was RMB 922.6 million, resulting in a gross margin of 88.1%[54]. - The total loss and comprehensive expenses for the year ended December 31, 2019, were RMB 1,719.9 million, a significant decrease of 70.7% from RMB 5,873.0 million for the year ended December 31, 2018[10]. - The company reported a net loss of RMB 1,719.9 million for the year ended December 31, 2019, a decrease from a loss of RMB 5,873.0 million in the previous year[60]. Research and Development - Innovent has a robust pipeline with 22 high-value products in development, including three products under priority review status for NDA (IBI-303, IBI-305, and IBI-301)[3]. - R&D expenses for the year ended December 31, 2019, were RMB 1,294.7 million, an increase from RMB 1,221.7 million for the year ended December 31, 2018, mainly due to key trials for Darbesh[10]. - The company plans to conduct 17 key registration clinical trials in 2020, with over 50 clinical studies currently ongoing[8]. - The company has established collaborations and other arrangements to develop and commercialize candidate drugs, indicating a strategic focus on partnerships[58]. - The company is focused on expanding its clinical development plans for Daboshu across various cancer indications[23]. Market Expansion and Sales Strategy - The company has established a sales network for DABOSHU® covering over 300 cities, 500 pharmacies, and 1,500 hospitals across China[7]. - Innovent's strategic partnerships and integrated platform are expected to drive sales growth in 2020 and beyond[3]. - The company has expanded its international presence by establishing its first U.S. office in San Francisco[18]. - The company anticipates that inclusion in the NRDL and its growing commercial capabilities will enhance market penetration in China over the coming years[22]. - The company is conducting over 20 clinical studies for Daboshu, including more than 10 ongoing registration or pivotal trials in China and the United States[23]. Financial Position and Funding - The company has raised approximately HKD 2.4 billion and HKD 2.3 billion through share placements in October 2019 and February 2020, respectively, with significant oversubscription from international and local investors[46]. - Cash net inflow from financing activities for the year ended December 31, 2019, was RMB 2,109.3 million, primarily from a successful placement in October 2019[11]. - The company recorded revenue from customer contracts of RMB 1,047.5 million for the year ended December 31, 2019, compared to RMB 9.5 million for the year ended December 31, 2018, representing a significant increase[61]. - The company raised RMB 2,168,920,000 from issuing ordinary shares in 2019, while it had no similar activity in 2018[147]. - The company’s cash flow from financing activities was RMB 2,109,315,000 in 2019, a decrease from RMB 4,433,863,000 in 2018[147]. Corporate Governance - The board includes two executive directors, one non-executive director, and three independent non-executive directors, ensuring diverse governance[106]. - The company has confirmed no incidents of non-compliance with governance standards during the reporting period[115]. - The company has adopted standard codes for securities trading to govern transactions by directors and relevant employees[115]. - The company has established a clear framework for the appointment, re-election, and removal of directors, ensuring that one-third of directors retire and are eligible for re-election at each annual general meeting[119]. - The company emphasizes the importance of effective communication with shareholders to enhance investor relations and understanding of business performance and strategy[130]. Employee and Operational Metrics - The company expanded its team to approximately 2,000 members by the end of 2019, enhancing its drug development and commercialization capabilities[3]. - The total employee compensation cost for the year ended December 31, 2019, was RMB 796.6 million, significantly higher than RMB 371.2 million in 2018, marking an increase of about 114.4%[68]. - The company employed a total of 1,982 employees as of December 31, 2019, with 35% in R&D and 35% in sales and marketing[68]. - The company has implemented measures to protect employee safety and ensure drug supply during the COVID-19 pandemic, with business operations gradually returning to normal by early March 2020[45]. - The company has not encountered any significant labor disputes or difficulties in recruiting employees as of December 31, 2019[74]. Product Development and Clinical Trials - The company is conducting over 10 clinical development programs for "Daboshu," targeting common advanced indications such as lung cancer and liver cancer[3]. - The company announced the initiation of a pivotal Phase 2 registration clinical trial for IBI-375 (pemigatinib) in China for the treatment of FGFR2 gene fusion or rearrangement in second-line metastatic cholangiocarcinoma[16]. - IBI-303 (Adalimumab biosimilar) has been granted priority review status by NMPA for treating rheumatoid arthritis, ankylosing spondylitis, and psoriasis[29]. - IBI-305 (Bevacizumab biosimilar) received priority review status from NMPA for treating metastatic colorectal cancer and advanced, metastatic, or recurrent NSCLC[30]. - The company expects to obtain NDA approval for IBI-305 in 2020, with preparations for commercialization already underway[32]. Risk Factors and Challenges - The company faces risks related to COVID-19 impacting sales, clinical development, and business operations[71]. - The ability to secure additional financing for operations is a key risk factor[71]. - The company anticipates limited impact from the global pandemic on its operations in 2020, maintaining confidence in future growth[9]. - The company has not engaged in any major acquisitions or disposals during the year ended December 31, 2019[65]. - The company is committed to fulfilling social responsibilities and achieving sustainable growth[71].
信达生物(01801) - 2019 - 中期财报
2019-09-27 08:31
Company Overview - As of June 30, 2019, Innovent Biologics has expanded its team to 1,445 members, enhancing its drug development capabilities[5]. - The company aims to leverage its comprehensive integrated platform to explore, develop, manufacture, and sell innovative drugs across major therapeutic areas[5]. - The company is focusing on global markets, including China, Hong Kong, Macau, and Taiwan for its drug development efforts[6]. - The company has established collaboration agreements with Shenzhen Micron Biotech Co., Ltd. and Shengnuoji Pharmaceutical Technology Co., Ltd. to evaluate the combination of Dabrush (sindilizumab injection) with their respective products in China[18]. Product Development and Pipeline - Innovent has a robust pipeline with 21 innovative products covering oncology, metabolic diseases, and other major therapeutic areas, including three biosimilars that have received NDA acceptance from NMPA[5]. - The flagship product, Tyvyt (sintilimab injection), generated revenue of RMB 331.6 million within four months of its launch on March 9, 2019[5]. - The company is actively expanding its pipeline with innovative drugs targeting various cancers, including non-Hodgkin lymphoma and solid tumors[6]. - The company has submitted IND applications for three small molecule drugs to NMPA, which have been accepted, indicating strong progress in its development pipeline[5]. - The company has received IND approval from the FDA for multiple products, including IBI-188 (a novel anti-CD47 antibody) and IBI-318 (a first-in-class dual-specificity antibody targeting PD-1/PD-L1) which are currently in clinical trials[7]. - The company is exploring the potential of sintilimab injection in various therapeutic areas, leveraging its multifunctional integrated platform for drug development[22]. Clinical Trials and Research - Ten clinical trials have completed the first patient dosing, including trials for innovative candidates such as IBI-318 and IBI-302[5]. - The company is conducting over 20 clinical studies for sintilimab injection to evaluate its safety and efficacy across various cancer indications, including three pivotal trials[17]. - Key clinical trials for sintilimab include ORIENT-3 for second-line squamous NSCLC, ORIENT-12 for first-line squamous NSCLC, and ORIENT-11 for first-line non-squamous NSCLC[22]. - The company has made significant advancements in its clinical development, with 16 new drugs entering clinical development[5]. - The company is collaborating with partners in China to promote IBL-308 and JBF-301, with a focus on various cancer indications[6]. Financial Performance - Total revenue for the six months ended June 30, 2019, was RMB 345.5 million, a significant increase from RMB 4.4 million for the same period in 2018, driven by the commercialization of the drug达伯舒 (信迪利单抗注射液) which generated sales of RMB 331.6 million[12]. - Gross margin for the six months ended June 30, 2019, was 88.1%, indicating stable production quality for the commercialized product达伯舒 (信迪利单抗注射液)[12]. - Research and development expenses increased to RMB 670.7 million for the six months ended June 30, 2019, up from RMB 420.0 million in the same period of 2018, primarily due to payments related to IND submissions and increased clinical trial costs[12]. - Total loss and comprehensive expenses for the six months ended June 30, 2019, increased to RMB 714.4 million from RMB 57.6 million in the same period of 2018, influenced by increased R&D and marketing expenses[12]. - The company reported a net loss of RMB 714,406,000 for the six months ended June 30, 2019, compared to a loss of RMB 57,596,000 for the same period in 2018, indicating a significant increase in losses[86]. Production and Capacity - The company has completed GMP commissioning and validation of a second production facility with a capacity of 3,000 liters, increasing total capacity to 21,000 liters[5]. - Six sets of 3,000-liter stainless steel bioreactors are now operational, providing additional capacity for commercial production and clinical trials[5]. - The company has expanded its patent portfolio, holding 21 granted patents and 48 patent applications in China, 4 granted patents and 7 patent applications in the U.S., and 19 granted patents and 97 patent applications in other regions[21]. Employee and Management - Total employee count as of June 30, 2019, was 1,445, with 36.3% in R&D, 28.0% in production, and 28.2% in sales and marketing[52]. - The company has adopted various employee incentive plans, including a pre-IPO share incentive plan and a post-IPO employee shareholding plan[53]. - The total compensation for key management personnel increased to RMB 30,747 thousand for the six months ended June 30, 2019, compared to RMB 36,180 thousand for the same period in 2018[173]. Regulatory and Compliance - The company has adhered to all applicable provisions of the corporate governance code as of June 30, 2019, with no significant deviations reported[79]. - The interim financial statements were reviewed by Deloitte, confirming compliance with International Accounting Standard 34[80]. - The company is subject to the Securities and Futures Ordinance of Hong Kong, which governs its operations and compliance[180]. Shareholder Information - FIL Limited holds a significant stake of 145,804,169 shares, representing 12.60% of the total equity[60]. - The total number of issued shares as of June 30, 2019, is 1,156,997,710[60]. - The company has granted stock options totaling 71,910,000 shares under its pre-IPO share incentive plan[67]. Future Outlook - The company plans to continue the commercialization of Darbeshou® and accelerate the regulatory approval process for its late-stage pipeline products in China and the U.S.[33]. - The company anticipates that the strong sales momentum of Darbeshou® will continue throughout the remainder of 2019[33]. - The company aims to provide affordable high-quality innovative drugs as part of its mission to combat diseases and improve lives[33].
信达生物(01801) - 2018 - 年度财报
2019-04-26 09:45
Drug Development and Pipeline - The company has 20 drug candidates in development, including IBI-305 (Bevacizumab biosimilar) and IBI-303 (Adalimumab biosimilar), which are currently under NMPA review[3]. - IBI-301 (Rituximab biosimilar) has completed Phase III clinical trial enrollment, while IBI-306 (new anti-PCSK9) has completed Phase I single-dose escalation[3]. - The company has initiated Phase I clinical trials for IBI-101 (new anti-OX40), IBI-188 (new anti-CD47), and IBI-318 (new anti-PD-1/bispecific antibody) in China[3]. - IBI-375 (FGFR1/2/3 inhibitor), IBI-376 (PI3K δ inhibitor), and IBI-377 (JAK1 inhibitor) have received licensing from Incyte Biosciences International Sàrl and are preparing for IND submission in China[3]. - The company aims to develop high-quality, affordable drugs for the public, leveraging its integrated platform for research, development, production, and commercialization[3]. - The company is focused on innovative drug development in oncology, ophthalmology, autoimmune diseases, and metabolic disorders[3]. - The company has received IND approval from the US FDA for IBI-101 (new anti-OX40), allowing for clinical development in the United States[3]. - The company is preparing to submit IND applications for several drug candidates in both China and the United States[3]. - The company has registered a total of nine clinical trials, an increase from six, indicating ongoing expansion in clinical research efforts[8]. - The company has received approvals for IBI-301 (rituximab biosimilar), IBI-303 (adalimumab biosimilar), and IBI-305 (bevacizumab biosimilar) from the National Health Commission for development and commercialization in various oncology fields[19]. - The NDA for IBI-303 (a biosimilar to Adalimumab) was accepted by NMPA on November 13, 2018, targeting autoimmune diseases such as ankylosing spondylitis and rheumatoid arthritis[18]. - The company has made clinical progress in the United States for its candidate drugs, including IBI-101 and IBI-308, with IND approvals obtained[17]. - The company is advancing multiple clinical trials for various indications, including non-Hodgkin lymphoma and solid tumors, with a focus on unmet medical needs globally[17]. - The company reported significant advancements in its pipeline, with multiple IND submissions and approvals since its IPO[17]. Financial Performance - The total revenue and other income for the year ended December 31, 2018, was RMB 103.3 million, compared to RMB 82.9 million for the year ended December 31, 2017[11]. - The adjusted loss and total comprehensive expenses for the year ended December 31, 2018, amounted to RMB 1,481.7 million, an increase of RMB 846.0 million from RMB 635.7 million for the year ended December 31, 2017, primarily due to increased R&D and marketing expenses[10]. - The company reported a net loss and total comprehensive expenses of RMB 5,872.98 million for the year ended December 31, 2018, compared to RMB 716.05 million for the previous year[11]. - R&D expenses for the year ended December 31, 2018, were RMB 1,221.7 million, compared to RMB 611.9 million for the previous year, reflecting a significant increase in investment in drug development[11]. - The company recorded a total loss and comprehensive expenses of RMB 5,872.98 million for the year, compared to a loss of RMB 716,050 thousand in 2017, reflecting a substantial increase in losses[103]. - The company’s other income increased by RMB 29.4 million or 46% to RMB 93.8 million for the year ended December 31, 2018, primarily due to interest earned from E-round financing and government subsidies[28]. - The company reported a total comprehensive loss of RMB 5,872,982 thousand for the year, compared to a loss of RMB 716,050 thousand in 2017, reflecting a substantial increase in losses[103]. - The company’s financing costs for the year ended December 31, 2018, were RMB 68.97 million, compared to RMB 57.23 million in 2017, indicating an increase of 20%[25]. Strategic Partnerships and Collaborations - The company has established strategic partnerships to enhance its drug development capabilities and expedite clinical trials[3]. - The company signed a collaboration and licensing agreement with Incyte, enhancing its research capabilities in both biologics and small molecule drugs[8]. - A global collaboration agreement was established with Hutchison China MediTech to evaluate the safety and tolerability of DABOSHU in combination with fruquintinib for treating advanced solid tumors[13]. - The company has entered into a collaboration agreement with Incyte, receiving an upfront licensing fee of $40 million, along with potential milestone and royalty payments for three clinical-stage candidates[19]. - The company has established a joint supervisory committee with Eli Lilly to oversee the development and commercialization of products in China[170]. Market Presence and Commercialization - The company has begun sales of its PD-1 monoclonal antibody, which has been approved by the NMPA for the treatment of relapsed/refractory classical Hodgkin lymphoma[3]. - DABOSHU (sintilimab) received NMPA approval for the treatment of r/r cHL and has commenced commercialization activities, marking a significant milestone for the company[13]. - The company aims to improve the accessibility of high-quality medicines for Chinese patients, addressing the current challenges in the biopharmaceutical market[8]. - The company aims to commercialize its core products, including the successful launch of Darbesh (sindilizumab) and the biosimilars IBI-305 and IBI-303, to benefit shareholders and patients in need[22]. - The company is committed to expanding its market presence in China and internationally through strategic partnerships and product development[18]. Research and Development Focus - The company is focused on innovative drug development in oncology, ophthalmology, autoimmune diseases, and metabolic disorders[3]. - The company aims to leverage its integrated platform to enhance drug development speed and success rates while reducing costs across various therapeutic areas, including oncology and autoimmune diseases[15]. - The company has a robust pipeline of drug candidates, with ongoing clinical trials and regulatory submissions to support future growth[17]. - The company has developed three "National Class 1 New Drugs" and led the development of innovative therapies, including "Ankore" (recombinant human adenovirus type 5 injection), which pioneered the use of viruses for tumor treatment[71]. - The company has over 60 patents granted and pending, showcasing its strong focus on innovation and research in biopharmaceuticals[71]. Corporate Governance and Compliance - The company is committed to maintaining high standards of corporate governance and transparency, as evidenced by its independent board members and adherence to regulatory requirements[72]. - The company has established arrangements for shareholders to raise concerns regarding financial reporting and internal controls[92]. - The company has appointed a joint company secretary to assist in corporate governance matters and ensure adherence to board policies[92]. - The board consists of two executive directors, one non-executive director, and three independent non-executive directors, ensuring compliance with listing rules regarding independent directors[81]. - The company has adopted a board diversity policy to enhance competitive advantage and attract diverse talent, considering factors such as gender, age, and professional qualifications[85]. Employee and Compensation - The total number of employees in the group was 959, an increase from 415 in 2017, representing a growth of approximately 130%[46]. - Employee compensation costs for the year ended December 31, 2018, amounted to RMB 371.2 million, compared to RMB 135.8 million for the year ended December 31, 2017, reflecting an increase of approximately 173%[47]. - The company has implemented various employee incentive plans, including pre-IPO share incentive plans and post-IPO employee stock ownership plans[47]. - The total remuneration for executive directors reached RMB 112,865 thousand in 2018, significantly higher than RMB 7,666 thousand in 2017[180]. - The company granted 17,260,038 stock options to 145 participants under the employee stock ownership plan, with 4,142,857 options allocated to a key individual[67]. Financial Reporting and Compliance - The company’s financial statements for the year ended December 31, 2018, reflect a true and fair view of its financial position and performance in accordance with international financial reporting standards[95]. - The independent auditor has confirmed that the financial statements have been prepared in compliance with the disclosure requirements of the Hong Kong Companies Ordinance[95]. - The company has not made any significant changes to its articles of association during the period from October 31, 2018, to December 31, 2018[94]. - The company has complied with all applicable provisions of the corporate governance code since its listing[81]. - The company has not been involved in any significant litigation or arbitration as of December 31, 2018[69].