Market Position and Share - The company holds a 72.1% market share in the platelet reduction treatment market in mainland China for its product Tevazo, according to IQVIA data[5]. - The company has a 42.4% market share in the rhEPO market in mainland China, maintaining its leadership for the past 20 years[5]. - The company’s product Yisaipu captured a 29.5% market share in the TNFα market in mainland China in 2021[5]. - Tebiao accounted for 30.2% of the market share by volume and 72.1% by sales in the mainland China market for treating thrombocytopenia in 2021[23]. - Yibiao has maintained a dominant position in the rhEPO market in mainland China since 2002, with continued sales growth attributed to increased coverage of primary healthcare institutions and its inclusion in the National Essential Medicines List[24]. - Yisai Pu captured 29.5% of the TNFα inhibitor market share in mainland China in 2021, with sales occurring in over 3,700 hospitals[26]. - Mandi achieved a market share of 71.2% in mainland China in 2021, with sales growth of 63.7% year-on-year[29]. Financial Performance - In 2021, the company achieved a revenue of RMB 6,382,009 thousand, representing a growth of 14.3% compared to 2020[9]. - The normalized EBITDA for 2021 was RMB 2,190,250 thousand, an increase of 36.4% from RMB 1,606,119 thousand in 2020[9]. - The company reported a net profit attributable to shareholders of RMB 1,651,247 thousand in 2021, up 97.5% from RMB 835,791 thousand in 2020[9]. - The total assets of the company increased to RMB 19,212,575 thousand in 2021, up from RMB 17,678,195 thousand in 2020[9]. - The group’s revenue for the year ended December 31, 2021, was approximately RMB 6,382.0 million, an increase of about RMB 794.4 million or 14.2% compared to RMB 5,587.6 million for the year ended December 31, 2020[49]. - The group's gross profit increased to approximately RMB 5,275.7 million, a rise of about RMB 751.0 million or approximately 16.6% from RMB 4,524.7 million in the previous year, with a gross margin of approximately 82.7%[52]. - The company's net profit for the year ended December 31, 2021, was RMB 1,627,573,000, representing a significant increase of 111% compared to RMB 771,106,000 in 2020[199]. Research and Development - The company has 33 products in its pipeline, with 26 being developed as innovative drugs in mainland China[5]. - The R&D expenses for 2021 reached RMB 753,872 thousand, reflecting a 27.6% increase from RMB 590,343 thousand in 2020[9]. - The company is focusing on research and development to provide innovative therapies for patients in mainland China and globally[6]. - The company is actively developing 33 pipeline products, with 26 of them being innovative drugs in mainland China, including 10 oncology products and 16 targeting autoimmune diseases[35]. - The R&D team consists of nearly 600 experienced scientists focused on accelerating clinical development and seeking breakthrough therapies to meet unmet medical needs[35]. - The company has made significant contributions to drug research and development, with key scientists leading the successful development of innovative drugs[78]. Clinical Trials and Approvals - The company has made significant progress in clinical trials, with 7 advancements in Phase I and II trials in 2021[12]. - The phase III clinical trial for TRK-820, a treatment for refractory pruritus in patients undergoing maintenance hemodialysis, has successfully met its primary endpoints, with NDA submission completed and accepted by NMPA[38]. - The company has initiated phase III clinical trials for TPO in children with immune thrombocytopenic purpura (ITP), with patient enrollment completed in February 2022[38]. - The company has received IND approval for the anti-IL17A monoclonal antibody (608) to treat plaque psoriasis, with phase III trials expected to start by the end of 2022[41]. - The company has completed phase I clinical trials for the anti-PD1 monoclonal antibody (609A) in the U.S., with ongoing phase II trials in mainland China[41]. Strategic Initiatives and Partnerships - The company aims to expand its product marketing to developed countries and has received approvals for its products in multiple countries, including 9 for Tevazo and 23 for Yibiao[6]. - The company is actively pursuing global partnerships to enhance its product offerings and expand into international markets[13]. - The company has established a CDMO business platform to empower domestic biotech companies and accelerate the launch of high-quality domestic new drugs[47]. - The company has entered into a collaboration with Toray to introduce TRK-820, targeting the unmet clinical needs of dialysis itch patients in China[47]. - The company signed a licensing agreement with Syncromune for the global development and commercialization of its anti-PD-1 monoclonal antibody (code: 609A), which has shown stronger anti-tumor activity in early models compared to existing drugs[19]. Corporate Governance and Management - The company has a strong leadership team with extensive experience in the pharmaceutical and investment sectors, enhancing its strategic planning and capital operations[80]. - The company is committed to maintaining high standards of corporate governance through its independent directors and audit committees[80]. - The company has established service contracts for executive directors with a term of three years, automatically renewable[159]. - The company has adopted a board diversity policy to enhance its competitive advantage, considering factors such as gender, age, and professional qualifications[155]. - The company encourages continuous professional development for its directors, providing necessary training and updates on company performance and responsibilities[156]. Market Expansion and Future Outlook - The company is focused on expanding its market presence and exploring new technologies to drive growth[79]. - The company anticipates significant growth in the hair restoration market, with over 250 million individuals suffering from hair loss in China, driven by increased awareness of hair health[46]. - Future guidance indicates a projected revenue growth of approximately 15% year-over-year, driven by new product launches and market expansion efforts[83]. - The company is exploring potential mergers and acquisitions to enhance its competitive position and broaden its product offerings in the market[85]. Compliance and Risk Management - The company has established detailed internal rules regarding environmental protection and has complied with national and local environmental laws and regulations[140]. - The audit committee reviewed the accounting principles and policies adopted by the group and found the risk management and internal control systems to be effective and sufficient[145]. - The company has established a comprehensive risk management and internal control system, with no significant internal control deficiencies identified as of December 31, 2021[175]. - The company emphasizes the importance of timely and comprehensive information disclosure to facilitate informed investment decisions by shareholders and investors[180].
三生制药(01530) - 2021 - 年度财报