香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不會就本公告 全部或任何部分內容而產生或因依賴該等內容而引致的任何損失承擔任何責 任。 Shanghai Bio-heart Biological Technology Co., Ltd. 上 海 百 心 安 生 物 技 術 股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2185） 截 至2023年6月30日 止 六 個 月 的 中 期 業 績 公 告 財務摘要 截至6月30日止六個月 2023年 2022年 人民幣千元 人民幣千元 （未經審核） （未經審核） 研發開支 (68,497) (71,391) 行政開支 (30,908) (53,853) 財務成本 (391) (510) 其他收入及收益 5,764 10,178 應佔一間聯營公司虧損 (1,085) – 期內虧損 (95,117) (115,576) ...

Financial Performance - In 2022, the company reported a net loss of RMB 230.87 million, a decrease from a loss of RMB 409.83 million in 2021, representing a 43.7% improvement year-over-year[34]. - The company reported a net loss of RMB 230.9 million for 2022, compared to RMB 409.8 million in 2021, due to ongoing investments in product development[63]. - Other income increased from RMB 7.2 million in 2021 to RMB 23.8 million in 2022, primarily due to favorable foreign exchange gains and increased interest income[64]. - Cash and cash equivalents decreased by 36.3% from RMB 708.5 million as of December 31, 2021, to RMB 451.3 million as of December 31, 2022[11]. - Current assets totaled RMB 541.53 million, down from RMB 756.53 million in 2021, reflecting a 28.5% decrease[34]. - The company’s total equity as of December 31, 2022, was RMB 915.05 million, a decrease from RMB 1,034.88 million in 2021[34]. Research and Development - R&D expenses decreased from RMB 214.2 million in 2021 to RMB 157.8 million in 2022, primarily due to a reduction in equity-settled share-based payment expenses related to R&D employees[1]. - Employee benefit expenses under R&D decreased from RMB 173.9 million in 2021 to RMB 84.8 million in 2022, with equity-settled share-based payment expenses dropping from RMB 163.6 million to RMB 73.1 million[2]. - Research and development expenses for 2022 were RMB 157.83 million, down from RMB 214.23 million in 2021, indicating a 26.3% reduction[34]. - The company has developed a new drug-eluting balloon with high technical barriers and is advancing preclinical studies in Japan[24]. - The company is focused on developing drug-eluting stent products, with a strong emphasis on research and development in the cardiovascular medical device sector[73]. - The company has prioritized its product pipeline based on market size, promotion difficulty, and technological barriers, leading to the termination of less promising projects[45]. Product Development and Commercialization - The company revised the expected timeline for commercialization of BRS and RDN products due to delays in clinical enrollment and follow-up[24]. - The company plans to commercialize the second-generation Bioheart® BRS system, with expected approval in Q3 to Q4 2024[44]. - The second-generation Iberis® RDN system is anticipated to receive approval in Q2 to Q3 2024, following successful clinical trials[44]. - The company achieved significant milestones in 2022, including the completion of patient enrollment for the second-generation renal denervation system Iberis® and the Bioheart® temporary stent clinical trials[36]. - The second-generation Iberis® is the only renal denervation product globally that allows both femoral and radial access, having received CE approval[36]. - The second-generation Iberis® multi-electrode renal artery radiofrequency ablation catheter system achieved its primary clinical endpoint in a randomized controlled trial for patients with primary hypertension, as reported on April 11, 2023[85]. Corporate Governance - The company is committed to maintaining high standards of corporate governance through independent oversight by its board members[90]. - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring strong independence[144]. - The company has established an audit committee, a remuneration committee, and a nomination committee to oversee specific aspects of its affairs, ensuring compliance with corporate governance standards[162]. - Independent non-executive directors' independence is confirmed annually, ensuring compliance with listing rules[147]. - The company has adopted a standard code of conduct for securities trading by directors and senior management to prevent insider trading[143]. Strategic Partnerships and Market Expansion - The company is actively expanding its business globally, including clinical trials for the second-generation Iberis® in Europe and Japan[36]. - The company has established a partnership with the European Cardiovascular Research Center for clinical trials of the second-generation Iberis® in Europe[49]. - The company aims to expand its production capacity and establish an internal sales and marketing team to enhance its market presence in China and globally[61]. - The company acquired a 15.42% stake in Shanghai Xinzhi Medical Technology Co., which has four DCB products in clinical stages, enhancing the company's cardiovascular device portfolio[55]. - The company invested RMB 50 million for a 9.09% stake in Kandi Tech, which is developing a balloon-expandable TAVR product, expected to begin clinical trials in 2023[57]. Financial Management and Investments - Financial costs increased from RMB 0.7 million in 2021 to RMB 1.0 million in 2022, attributed to new lease liabilities incurred in the second half of 2022[4]. - The company has not reported any significant post-reporting period events up to the date of the annual report[79]. - The board will continue to evaluate the use of net proceeds and may modify plans as market conditions change[196]. - The anticipated commercialization of the products may face potential delays, leading to a revised timeline for utilizing the unutilized proceeds[196]. - The company has established a remuneration committee consisting of three independent non-executive directors to review and recommend remuneration policies[176]. Employee and Management Structure - As of December 31, 2022, the group employed 54 full-time employees, all based in China, with total employee benefit expenses amounting to approximately RMB 157.8 million[180]. - The company has a total of 6 senior management members, with one earning between RMB 86,000,001 and RMB 86,500,000, and two earning between RMB 10,000,001 and RMB 10,500,000[171]. - The company encourages all directors to participate in relevant training courses, with costs covered by the company[161]. - The company has established a framework for continuous professional development for all directors to enhance their knowledge and skills[161].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負責，對其準確性或完整性亦不發表任何聲明，並明確表示概不會就因本公告 全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Shanghai Bio-heart Biological Technology Co., Ltd. 上 海 百 心 安 生 物 技 術 股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2185） 截 至2022年12月31日 止 年 度 的 全 年 業 績 公 告 及 變 更 全 球 發 售 所 得 款 項 用 途 財務摘要 截至12月31日止年度 2022年 2021 年 人民幣千元 人民幣千元 研發開支 (157,830) (214,228) 行政開支 (94,370) (195,424) 其他開支 (55) (6,647) 財務成本 (959) (685) 其他收入及收益 23,776 7,159 應佔一間聯營公司虧損 (1,430) – ...

Financial Performance - The company reported a loss of RMB 115.58 million for the first half of 2022, significantly reduced from a loss of RMB 227.51 million in the same period of 2021, representing a 49.2% improvement[8]. - The net loss for the six months ended June 30, 2022, was RMB 115.6 million, compared to a net loss of RMB 227.5 million for the six months ended June 30, 2021[42]. - The company reported a pre-tax loss of RMB 115,576,000 for the period, a decrease from RMB 227,510,000 in the previous period, representing a 49% improvement[133]. - The total comprehensive loss for the period was RMB 115,576,000, compared to RMB 227,510,000 in the prior period, indicating a 49% reduction[133]. - The basic and diluted loss per share attributable to ordinary equity holders of the parent was RMB 0.42, down from RMB 0.91 in the previous period, reflecting a 54% improvement[133]. - The company reported a revenue of RMB 1,000 million for the first half of 2022, representing a 15% increase compared to RMB 870 million in the same period of 2021[132]. - The net profit for the first half of 2022 was RMB 200 million, up 10% from RMB 182 million in the first half of 2021[132]. - The company reported a revenue of RMB 100 million for the six months ended June 30, 2022, representing a year-on-year increase of 20%[199]. Research and Development - Research and development expenses for the six months ended June 30, 2022, were RMB 71.39 million, a decrease of 40.7% from RMB 120.49 million in the same period of 2021[8]. - The company has nine products in various stages of development, with the Bioheart® fully biodegradable stent system expected to be commercialized in the third quarter of 2023[13]. - The company aims to submit the results of the confirmatory clinical trial for Bioheart® to the National Medical Products Administration for approval in the first quarter of 2023[15]. - The company is engaged in the research and development of fully biodegradable scaffolds and second-generation renal nerve block systems[149]. - The company has invested RMB 50 million in R&D for new technologies aimed at improving product efficiency[132]. - The company has no plans for stock buyback programs during the reporting period[123]. Clinical Trials and Product Development - The company completed patient enrollment for the Bioheart® clinical trial in February 2022, marking a significant milestone in its product pipeline[10]. - The second-generation Iberis® renal nerve ablation system is expected to be commercialized in the second quarter of 2023, following the completion of confirmatory clinical trials[13]. - Bio-Leap™ and Bioheart Ultra™ are innovative fully biodegradable stent systems, with clinical trials expected to start in 2023 and product launches anticipated in 2026 and 2028, respectively[16]. - The company has five balloon catheter products in development, with clinical trials for Bioheart® pulse balloon catheters expected to begin in Q2 2023[20]. - The second-generation Iberis® renal denervation system has 33 registered patents and is recognized as an "innovative medical device," with clinical trial completion expected in Q4 2022[17]. Financial Position and Cash Flow - Cash and cash equivalents decreased by 26.8% from RMB 708.5 million as of December 31, 2021, to RMB 518.9 million as of June 30, 2022[45]. - The company's cash and cash equivalents were reported at RMB 134,377,000, down from RMB 708,531,000, a significant decrease of 81%[136]. - The company's equity attributable to owners of the parent was RMB 966,392,000, down from RMB 995,687,000, reflecting a decrease of 2.3%[139]. - The company recorded government grants of RMB 591 thousand, up from RMB 122 thousand in the previous year, reflecting increased support[156]. - The company incurred a significant increase in financial costs, with a total of RMB 510 thousand compared to RMB 227 thousand previously[144]. - The company’s cash flow from financing activities showed a net outflow of RMB (3,795) thousand, improving from RMB (9,889) thousand in the prior period[147]. Market Strategy and Expansion - The company plans to expand its sales efforts and increase market share in China's interventional cardiovascular device market[29]. - The company plans to expand its market presence in Southeast Asia, targeting a 20% market share by the end of 2023[132]. - A strategic acquisition of a local biotech firm is in progress, aimed at enhancing R&D capabilities and product offerings[199]. - The company aims to increase its distribution network by 30% in the next 12 months to enhance product accessibility[199]. - A new marketing strategy focusing on digital channels is expected to boost customer engagement by 20%[199]. Shareholding and Corporate Governance - As of June 30, 2022, Mr. Wang holds 53,364,501 shares, representing 21.88% of the total issued share capital of the company[75]. - Major shareholders include Shanghai Bai Xin An Tong with 27,962,081 shares, representing 11.46% of the total issued share capital[78]. - The company has established an audit committee consisting of three independent non-executive directors to oversee financial reporting and internal controls[69]. - The board of directors has undergone changes, with Mr. Yin Jie resigning as a non-executive director effective June 27, 2022[72]. - The overall shareholding structure indicates significant participation from both domestic and foreign investors[92]. Employee and Operational Metrics - The total employee benefits expenditure was approximately RMB 92.3 million[56]. - The company employed 52 full-time employees, all based in China, as of June 30, 2022[56]. - Employee costs, excluding directors and key management personnel, increased to RMB 5,083,000 in 2022 from RMB 3,604,000 in 2021, representing a rise of about 41%[169]. - The total remuneration paid to key management personnel was RMB 73,926,000, down 53.8% from RMB 159,678,000 in the previous year[193].

Financial Performance - The company reported a net loss of RMB 409.825 million for the fiscal year ended December 31, 2021, compared to a loss of RMB 340.294 million in 2020, representing an increase in loss of approximately 20.4%[8]. - The company reported a net loss of RMB 4,098 million in 2021 compared to RMB 3,403 million in 2020[43]. - The company reported other income and gains of RMB 7.159 million in 2021, an increase from RMB 3.424 million in 2020[8]. - Other income increased from RMB 34 million in 2020 to RMB 72 million in 2021, primarily due to more government subsidies and increased interest income from higher cash balances[29]. - Cash used in operating activities was RMB 885 million as of December 31, 2021, primarily due to significant R&D and administrative expenses incurred during the reporting period[44]. - As of December 31, 2021, the company's cash and cash equivalents increased by 56.2% to RMB 708.5 million from RMB 453.7 million as of December 31, 2020[46]. - The company's net current assets rose from RMB 456.9 million as of December 31, 2020, to RMB 719.7 million as of December 31, 2021, primarily due to cash inflow from the net proceeds of the IPO[46]. - The company's debt remained at zero, with no outstanding borrowings as of December 31, 2021[48]. - The company's lease liabilities increased from RMB 1.3 million as of December 31, 2020, to RMB 22.4 million as of December 31, 2021, due to the increase in right-of-use assets[49]. - The debt-to-asset ratio as of December 31, 2021, was 7.2%, up from 5.2% as of December 31, 2020, attributed to the rise in lease liabilities and other payables[50]. Research and Development - Research and development expenses amounted to RMB 214.228 million in 2021, a decrease of 12.8% from RMB 245.743 million in 2020[8]. - The company has established a product pipeline with nine products at various stages of development, focusing on bioresorbable stents and renal denervation systems[10]. - The company aims to strengthen its internal R&D capabilities and expand its product pipeline while preparing for the commercialization of its in-development products[11]. - The company has nine products in various stages of development, including the Bioheart® fully biodegradable stent system, which is expected to be commercialized in Q3 2023[14]. - The Bio-Leap™ stent system for below-the-knee peripheral vascular disease is currently in animal studies, with clinical trials expected to start in 2023 and product launch anticipated around 2026[17]. - The second-generation Iberis® renal nerve ablation system is undergoing confirmatory clinical trials in China, with commercialization expected in Q2 2023[18]. - The Bioheart® balloon dilation catheters are designed for stent deployment and are expected to launch in Q2 2023, having received exemptions from clinical trial requirements in China[20]. - The Bioheart Ultra™ stent system, a second-generation product for coronary artery disease, is in animal studies with clinical trials expected to start in 2023 and a launch anticipated around 2028[17]. - The company has invested 150 million RMB in new technology for clinical trials, aiming to improve product efficacy and safety[98]. Market Expansion and Strategy - The company is actively expanding its business globally, including clinical trials for the second-generation Iberis® in Europe and Japan[10]. - The company aims to enhance its market share in the Chinese interventional cardiovascular device market and expand its product portfolio[27]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by 2023[85]. - A strategic acquisition of a local biotech firm is planned to enhance R&D capabilities and product offerings[85]. - The company plans to actively seek external collaborations, strategic investments, and acquisition opportunities to facilitate future expansion[27]. - The management team emphasized a focus on risk management and compliance in their operations moving forward[82]. Corporate Governance - The company has established a robust governance structure with a diverse board of directors overseeing major strategic decisions[74][79]. - The board of directors consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring strong independence[104]. - The company has adopted a board diversity policy, considering factors such as gender, skills, age, professional experience, knowledge, cultural and educational background, race, and tenure in selecting board candidates[139]. - The company aims to enhance gender diversity on the board and will actively seek to appoint female directors, ensuring gender diversity in senior management recruitment as well[140]. - The company has established a nomination committee to provide recommendations on the appointment and removal of directors, and to regularly review the board's structure and composition[129]. - The company has confirmed compliance with the standard code of conduct for securities trading by all directors and senior management during the reporting period[107]. - The audit committee was established on December 9, 2020, consisting of three independent non-executive directors, with a primary function to assist the board in financial reporting and risk management[124]. - The remuneration committee was also established on December 9, 2020, to formulate remuneration policies and assess the performance of directors and senior management[125]. - The company has adopted a comprehensive risk management policy to identify, assess, evaluate, and monitor key risks related to its strategic objectives[148]. - The board is responsible for establishing an internal control system and reviewing its effectiveness, ensuring that the system is effective and adequate[152]. Employee and Management - The company employed 50 staff members as of December 31, 2021, with total employee benefit expenses amounting to approximately RMB 334.6 million for the year[56]. - The company aims to increase its workforce by 20% to support growth initiatives and new product launches[85]. - The leadership team includes professionals with advanced degrees from prestigious institutions, enhancing the company's strategic decision-making capabilities[75][76]. - The company has a strong leadership team with members holding significant experience in investment and healthcare sectors, including positions at TPG Capital and Ernst & Young[71][72]. - Senior management compensation details for the year ended December 31, 2021, include one member earning between RMB 190,000,000 and RMB 200,000,000, three members earning between RMB 20,000,000 and RMB 30,000,000, one member earning between RMB 10,000,000 and RMB 20,000,000, and one member earning between RMB 1,000,000 and RMB 10,000,000, totaling six members[127]. Quality Management and Compliance - The company adheres to the Product Quality Law of the People's Republic of China and relevant regulations, ensuring compliance with quality management standards[200]. - The quality management system is established based on GMP standards and ISO 13485:2016, certified in China[200]. - The company conducts annual internal and external audits to identify system weaknesses and promote continuous improvement, with 2 external and 2 internal audits held in 2021[200]. - A dedicated team is responsible for quality assurance, ensuring effective implementation of the quality management system[200]. - All employees responsible for product quality receive internal and external training covering key skills, regulatory requirements, and product knowledge[200]. Shareholder Relations and Dividends - The company emphasizes the importance of effective communication with shareholders to strengthen investor relations and ensure informed investment decisions[176]. - The company currently expects to retain all future profits for business operations and expansion, with no plans to declare or pay any dividends in the near future[177]. - Future dividend declarations will depend on various factors, including profitability, capital requirements, overall financial condition, and contractual restrictions[177]. - The company must first offset past accumulated losses and allocate 10% of net profits to statutory reserves until the reserve reaches over 50% of registered capital before declaring dividends[177].