Financial Performance - For the six months ended June 30, 2023, the company's revenue was approximately RMB 261.2 million, an increase of about RMB 40.5 million or 18.4% compared to RMB 220.7 million for the same period in 2022, primarily driven by the continued sales growth of BA1101 in China[2]. - Gross profit for the six months ended June 30, 2023, was approximately RMB 158.2 million, a decrease of about RMB 10.9 million or 7.4% compared to RMB 147.3 million for the same period in 2022[2]. - The company reported a loss before tax of RMB 119.3 million for the six months ended June 30, 2023, compared to a loss of RMB 153.3 million for the same period in 2022[5]. - Basic and diluted loss per share for the period was RMB 0.23, compared to RMB 0.31 for the same period in 2022[5]. - The company reported a basic loss per share of RMB 0.51, calculated based on a weighted average of 509,278,094 shares issued during the period[23]. - The company reported a loss of RMB 119.5 million for the six months ended June 30, 2023, compared to a loss of RMB 153.3 million for the same period in 2022[74]. Cost and Expenses - The cost of sales for the same period was RMB 103.0 million, accounting for approximately 39.4% of total revenue, up from 33.3% in the same period of 2022, due to a decrease in production volume leading to higher unit manufacturing costs[2]. - Selling and distribution expenses were approximately RMB 117.1 million, an increase of RMB 16.3 million or 16.2% compared to RMB 100.8 million for the same period in 2022, consistent with revenue growth[3]. - Research and development expenses were approximately RMB 126.0 million, a decrease of about RMB 43.1 million compared to RMB 169.1 million for the same period in 2022, mainly due to the advancement of a research project to Phase III clinical trials[3]. - Administrative expenses significantly decreased from RMB 37.6 million for the six months ended June 30, 2022, to RMB 26.6 million for the same period in 2023, primarily due to the absence of listing-related expenses[69]. - Other income and gains decreased to RMB 1.7 million, down approximately RMB 11.8 million or 87.4% from RMB 13.5 million in the prior year, mainly due to a reduction in government grants[68]. Assets and Liabilities - Total non-current assets as of June 30, 2023, were RMB 1,475.1 million, an increase from RMB 1,355.9 million as of December 31, 2022[6]. - Current assets totaled RMB 668.1 million as of June 30, 2023, down from RMB 846.7 million as of December 31, 2022[6]. - The company's net assets were RMB 1,309.5 million as of June 30, 2023, compared to RMB 1,418.4 million as of December 31, 2022[7]. - The total non-current liabilities increased by RMB 239 thousand due to the recognition of deferred tax liabilities related to leasing transactions[12]. - The total equity decreased by RMB 239 thousand as a result of the cumulative losses recognized in the financial statements[13]. - As of June 30, 2023, the group's debt-to-equity ratio increased from 20.7% as of December 31, 2022, to 21.9% as of June 30, 2023, primarily due to a decrease in reserves during the period[77]. Research and Development - As of June 30, 2023, the R&D team consists of 285 experienced members, and the company has obtained 7 new patents globally[38]. - The company continues to focus on R&D capabilities and industry influence, with significant advancements in its innovative product pipeline[38]. - The company aims to enhance its innovative antibody pipeline by focusing on the development of novel antibody drugs that address unmet medical needs, particularly in oncology[61]. - The company is committed to maintaining high standards in clinical research and regulatory compliance to ensure successful product launches[42]. - The company plans to invest in manufacturing equipment to expand production capacity, including two production lines with three 2,000-liter single-use bioreactors each[63]. Market and Product Development - Two products, Boanuo® and Boanubei®, have successfully launched in mainland China, with Boanuo® gaining two new indications included in the updated National Medical Insurance Catalog[37]. - The company has a balanced product pipeline, including two commercialized products and seven innovative research antibodies, targeting major therapeutic areas with substantial unmet market demand[40]. - The company is actively pursuing international market expansion, with applications for product approvals in Brazil and other regions[42]. - The company anticipates launching four candidate products (BA1102, BA5101, BA9101, and BA1104) in the Chinese market within the next three years, with three products (博优诺®, BA6101, and BA1102) expected to launch internationally[61]. - The collaboration with Eucan Vision for BA9101 aims to accelerate clinical trials and commercialization in China[44]. Corporate Governance and Compliance - The company has adhered to all applicable corporate governance codes during the reporting period, with one exception regarding the separation of roles between the Chairman and CEO[89]. - The company maintains high standards of corporate governance to protect shareholder interests and enhance corporate value[88]. - The independent auditor has reviewed the unaudited interim financial statements for the six months ending June 30, 2023[92].

Product Development and Commercialization - Shandong Boan Biotechnology has successfully commercialized two products: BA1101, a biosimilar to Bevacizumab, and BA6101, the world's first biosimilar to Denosumab[4]. - The company has 11 candidate drugs nearing commercialization, including BA1102 and BA9101, which are in the late stages of clinical trials[4]. - The company plans to submit multiple Biologics License Applications (BLA) for its candidate drugs in the next two years[4]. - BA1102 and BA6101 are also in preparation for clinical trials overseas, indicating the company's international expansion efforts[4]. - The company aims to accelerate the market entry of its drugs through a diversified commercialization strategy, including domestic and international markets[7]. - The company has formed strategic partnerships with companies like AstraZeneca and Zhengda Pharmaceutical to enhance product commercialization[7]. - The company has a robust product pipeline with two commercialized products, seven innovative antibodies, and four biosimilar candidates[21]. - BA1102, a biosimilar drug, has completed Phase III clinical trials and is currently under BLA submission in China[22]. - The company is actively pursuing business collaborations to expand its market presence and enhance its innovative product offerings[20]. - The company is focusing on expanding its market presence in Europe and the US for its biosimilar products, aiming for global sales[28]. Financial Performance - The company's revenue for the year ended December 31, 2022, reached approximately RMB 516.0 million, a significant increase of 225.1% compared to RMB 158.7 million for the year ended December 31, 2021[10]. - Gross profit for the same period was approximately RMB 354.2 million, representing a year-on-year increase of 232.6%[12]. - The company recorded a net loss of RMB 331.7 million for the year ended December 31, 2022, compared to a net loss of RMB 240.5 million in 2020[15]. - The company's total equity decreased to RMB 1,418,377,000 from RMB 1,551,687,000, reflecting a decline in shareholder value[179]. - The company reported a total revenue of RMB 515,960,000 for 2022, a significant increase of 225.5% compared to RMB 158,704,000 in 2021[177]. - The net loss attributable to the owners of the parent company was RMB 331,749,000, compared to a loss of RMB 225,417,000 in 2021, indicating a worsening financial performance[177]. Research and Development - Research and development expenses totaled approximately RMB 400.3 million, up by RMB 168.7 million from RMB 231.6 million in 2021, driven by increased investment in R&D projects[14]. - The company has expanded its R&D team to 285 members and secured 21 new patents globally as of December 31, 2022[23]. - The company’s ongoing research and development efforts are aimed at enhancing its product pipeline across various therapeutic areas, including oncology and autoimmune diseases[28]. - The company has established a comprehensive biopharmaceutical platform that integrates R&D, production, and commercialization, enhancing operational efficiency[6]. Market Strategy and Distribution - Shandong Boan Biotechnology's distribution network covers over 1,000 hospitals nationwide, demonstrating its strong commercialization capabilities[7]. - The company anticipates 2023 to be a year of significant revenue growth from commercialized products and accelerated innovation pipeline development[20]. - The company has made significant progress in obtaining medical insurance access for its products, which is expected to drive sustained sales growth[22]. - The company has established a customer complaint handling mechanism to enhance service quality[98]. Corporate Governance and Management - The company has a board composed of experienced members, including the CEO and R&D President, with over 24 years of experience in the pharmaceutical industry[68][69]. - The company has adopted a set of corporate governance standards that meet or exceed the standard code[5]. - The board consists of nine members, including two executive directors, three non-executive directors, and three independent non-executive directors[130]. - The company has established five board committees: Audit Committee, Remuneration Committee, Nomination Committee, Strategic Committee, and Environmental, Social and Governance Committee[129]. - The company emphasizes the importance of diverse experiences and skills among board members for effective governance[132]. Financial Management and Risk Assessment - The company has implemented risk management procedures to minimize financial risks, including interest rate, foreign exchange, credit, and liquidity risks[96]. - The company has established a framework for investment risk assessment to balance various investment risks and returns[94]. - The company has established clear responsibilities and powers within its organizational structure to ensure effective risk management and internal controls[154]. - The company has a policy for reviewing and monitoring compliance with legal and regulatory requirements[142]. Environmental and Social Responsibility - The company is committed to environmental sustainability and adheres to relevant environmental laws and regulations in China[97]. - The company encourages green practices and promotes environmental awareness among employees[97]. - The Environmental, Social, and Governance (ESG) Committee was established on March 27, 2023, to manage ESG-related risks and opportunities[152]. Employee and Shareholder Relations - The company employed a total of 745 employees as of December 31, 2022, up from 572 employees as of December 31, 2021, with employee costs amounting to RMB 121.4 million in 2022[65]. - The company has a commitment to independent oversight, as evidenced by the diverse backgrounds of its board members in various sectors[82]. - The company has established a shareholder communication policy to facilitate ongoing dialogue and information sharing with investors[159].

Financial Performance - For the year ended December 31, 2022, the company's revenue was approximately RMB 516.0 million, an increase of about RMB 357.3 million or 225.1% compared to RMB 158.7 million for the year ended December 31, 2021[2]. - Gross profit for the year ended December 31, 2022, was approximately RMB 354.2 million, representing a year-on-year increase of about RMB 247.7 million or 232.6%[3]. - The company reported a pre-tax loss of RMB 331.7 million for the year ended December 31, 2022, compared to a loss of RMB 225.4 million for the year ended December 31, 2021[4]. - The company reported a net loss of RMB 331.7 million for the year ended December 31, 2022, compared to a loss of RMB 225.4 million in 2021[79]. - The effective tax rate for the company was reduced to 15% in 2022 from 25% in 2021 due to its recognition as a high-tech enterprise[28]. Expenses - The cost of sales increased from RMB 52.2 million for the year ended December 31, 2021, to approximately RMB 161.7 million for the year ended December 31, 2022, accounting for about 31.3% of total revenue in 2022 (2021: 32.9%) due to increased production volume[2]. - Research and development expenses for the year ended December 31, 2022, amounted to approximately RMB 400.3 million, an increase of about RMB 168.7 million compared to RMB 231.6 million for the year ended December 31, 2021, primarily due to increased investment in R&D projects[4]. - Selling and distribution expenses rose to RMB 214.1 million for the year ended December 31, 2022, an increase of RMB 54.0 million or 296.5% compared to RMB 160.1 million for the year ended December 31, 2021[3]. - Administrative expenses increased significantly from RMB 42.2 million in 2021 to RMB 82.3 million in 2022, primarily due to global sales listing expenses rising from RMB 2.4 million to RMB 43.1 million[74]. - Financing costs rose to RMB 13.4 million in 2022, up from RMB 11.6 million in 2021, representing a 15.5% increase due to higher bank loan levels[78]. Assets and Liabilities - Total non-current assets as of December 31, 2022, were approximately RMB 1,355.9 million, an increase from RMB 1,166.8 million as of December 31, 2021[6]. - Current assets decreased to RMB 846.7 million as of December 31, 2022, from RMB 939.9 million as of December 31, 2021[6]. - The company's total liabilities increased to RMB 471.7 million as of December 31, 2022, compared to RMB 260.5 million as of December 31, 2021[6]. - Net assets decreased to RMB 1,418.4 million as of December 31, 2022, from RMB 1,551.7 million as of December 31, 2021[7]. - Total equity as of December 31, 2022, was CNY 1,418,377, a decrease from CNY 1,551,687 in the previous year, representing a decline of approximately 8.6%[8]. Revenue Sources - Total revenue from customer contracts for 2022 was RMB 515,960,000, a significant increase from RMB 158,704,000 in 2021, representing a growth of approximately 225%[19]. - Major customer A contributed RMB 191,396,000 to the revenue in 2022, up from RMB 48,291,000 in 2021, indicating a growth of 296%[18]. - All external revenue for the year was generated from customers in mainland China, indicating a focused market strategy[20]. Research and Development - The company has developed a diverse and risk-balanced product pipeline, including two commercialized products, seven innovative antibodies, and four candidate biosimilars, focusing on major therapeutic areas such as oncology, metabolism, autoimmune diseases, and ophthalmology[45]. - As of December 31, 2022, the R&D team comprised 285 experienced members, contributing to the filing of 21 new patents and the publication of 7 research papers[44]. - The company has established a mature proprietary R&D platform focused on antibody discovery and drug development, with teams in Yantai, Nanjing, and Boston[57]. Product Development and Commercialization - The company has successfully launched two products, BA1101 and BA6101, in mainland China[43]. - The commercialized product, Boyounuo® (Bevacizumab injection), received approval from the National Medical Products Administration (NMPA) in April 2021 and has expanded its indications to include multiple cancers, enhancing its market accessibility[47]. - Boyoubai® (Duzhong antibody injection), the first biosimilar of Prolia®, was approved in November 2022 for treating postmenopausal women at high risk of fractures, significantly reducing fracture risks in this population[48]. - BA1102 received acceptance for the biopharmaceutical license application in China in March 2023, with ongoing R&D in Europe and the US, aiming for global market sales[49]. Market Strategy and Future Outlook - The company emphasizes the unmet market demand in China and abroad for its therapeutic areas, which could drive future growth[45]. - The company plans to enhance its commercialization capabilities by expanding sales and marketing teams to cover more target hospitals, aiming to increase the market share of its product 博優諾®[64]. - The company seeks to explore collaborations with renowned international partners to enhance its overseas influence and expand geographical coverage for its candidate drugs[68].