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 - 年度财报