Market Position and Share - The company holds a 65.0% market share in the platelet reduction therapy market in mainland China for its product Tevazo as of 2023[6]. - The company has a 42.2% market share in the rhEPO market in mainland China, maintaining its leadership for over 20 years[6]. - The company’s product Mandi has a dominant market share of 72.6% in the minoxidil tincture market in mainland China as of 2023[6]. - Te Bi Ao has captured a 33.4% market share by volume and a 65.0% market share by sales in the treatment of thrombocytopenia in mainland China[24]. - Yisaipu holds a 22.7% market share in the TNFα inhibitor market in mainland China as of 2023, having been the first TNFα inhibitor launched in the region[26]. Financial Performance - The company's revenue for 2023 reached RMB 7,815,938 thousand, marking a significant increase from RMB 6,865,735 thousand in 2022, representing a growth of approximately 13.8%[10]. - Gross profit for 2023 was RMB 6,641,640 thousand, up from RMB 5,671,574 thousand in 2022, reflecting a growth of about 17.1%[10]. - The adjusted operating EBITDA for 2023 was RMB 2,768,353 thousand, compared to RMB 2,303,777 thousand in 2022, indicating an increase of approximately 20.2%[10]. - The company's total assets reached RMB 23,625,028 thousand in 2023, an increase from RMB 22,008,962 thousand in 2022, reflecting a growth of approximately 7.3%[10]. - The total liabilities increased to RMB 7,111,428 thousand in 2023 from RMB 6,645,381 thousand in 2022, representing a growth of about 7.0%[10]. Research and Development - The company has 29 active R&D projects, with 25 being innovative drugs developed in mainland China[6]. - The company has 29 products in its research pipeline, with 5 products approved for market or passed consistency evaluation in 2023[13]. - The company is actively developing 29 products, with 25 of them focused on innovative drug development in mainland China[38]. - The R&D team consists of over 600 experienced scientists focused on accelerating clinical development and seeking breakthrough therapies[37]. - The company is developing multiple innovative biological products, including SSS06 (NuPIAO) for anemia and CS1003 (anti-PD-1 antibody) for advanced liver cancer[36]. Strategic Initiatives - The company aims to expand its product marketing to developed countries and has established operations in 25 countries as of 2023[7]. - The company is focusing on developing therapies for unmet medical needs, particularly in the biotechnology sector, which is supported by the Chinese government[6]. - The company has established strategic partnerships, including exclusive rights for the anti-PD-1 monoclonal antibody Nofazinlimab (CS1003) in mainland China, enhancing its product portfolio[15]. - The company plans to submit a New Drug Application (NDA) for NuPIAO (rESP, SSS06) in 2024 after completing Phase III clinical trials for treating anemia in chronic kidney disease[13]. - The company aims to optimize the structure of chronic disease medications and deepen its presence in grassroots markets as part of its future development strategy[16]. Market Expansion and Product Launches - The launch of the Minoxidil foam product, Man Di, has been approved, which is the first domestically produced minoxidil foam in China, showing comparable efficacy to ROGAINE®[22]. - The NDA for Li Mei Zhi has been approved for the treatment of pruritus in hemodialysis patients, marking it as the first selective opioid kappa receptor agonist approved for this indication in China[20]. - TRK-820, a drug for treating pruritus in hemodialysis patients, has received NDA approval in mainland China, addressing a significant unmet medical need[30]. - The company plans to continue expanding the clinical application and market penetration of its products, focusing on middle and lower-tier cities[26][27]. - The company aims to launch new drugs into commercialization each year starting in 2024, including long-acting erythropoietin and other self-developed or collaborative products[48]. Corporate Governance and Management - The company has a comprehensive leadership structure with experienced executives overseeing various subsidiaries and initiatives[85]. - The board consists of two executive directors, one non-executive director, and four independent non-executive directors, ensuring compliance with the minimum requirements set by the Hong Kong Stock Exchange[156]. - The company emphasizes the importance of compliance with anti-corruption laws to maintain its market position and access to public procurement[79]. - The independent non-executive directors collectively bring over 28 years of experience in the financial sector, with significant roles in major financial institutions such as Deutsche Bank and UBS[87]. - The company has established a remuneration committee to review the remuneration policies for all directors and senior management, considering the company's performance and market practices[113]. Employee and Operational Insights - The company employs 5,412 staff across its operational facilities in Shenyang, Shanghai, Hangzhou, Shenzhen, and Como, Italy[7]. - Employee costs for the reporting period amounted to approximately RMB 1,271.5 million, compared to RMB 1,254.4 million in the same period of 2022[75]. - The company emphasizes the importance of attracting, recruiting, and retaining quality employees, providing regular training to maintain employee quality, knowledge, and skills[144]. - The company has a large sales and distribution network in mainland China, consisting of approximately 2,724 sales and marketing personnel, 1,146 distributors, and 2,061 third-party promoters[47]. - The company recognizes the benefits of a diverse board and has adopted a policy to promote diversity among board members[156]. Challenges and Risks - The company faces intense competition in the biotechnology and pharmaceutical industry, which may hinder its ability to compete effectively with existing and future competitors[76]. - The government’s centralized procurement policies may lead to significant price reductions for products, potentially affecting revenue and profit levels negatively[77]. - The approval process for new drugs by the National Medical Products Administration can take several years and may involve high costs and uncertainties[78]. - The management team acknowledges the risks associated with corruption and improper promotion of products, which could damage the company's reputation and lead to regulatory investigations[79]. - The company may lose market share and face adverse impacts on revenue and profitability if it fails to win bids in provincial tendering processes for selling products to hospitals[77]. Corporate Social Responsibility - The group made donations of approximately RMB 21.6 million to various medical charity projects during the reporting period[141]. - The group has established detailed internal rules regarding environmental protection and complies with national emission standards[143]. - The company maintains long-term relationships with major distributors based on qualifications, reputation, market coverage, and sales experience[145]. - The company emphasizes long-term financial performance as a governance goal, focusing on innovation in core therapeutic areas[174]. - The company is committed to maintaining high standards of corporate governance, adhering to the corporate governance code as per the Hong Kong Stock Exchange regulations[153].
三生制药(01530) - 2023 - 年度财报