Investment Rating - The report suggests a positive investment outlook for the company, indicating that it is significantly undervalued with a market capitalization of only HKD 1.5 billion [6]. Core Insights - The company has achieved excellent results in innovative drug development, with a strong cash reserve of RMB 2.275 billion, sufficient to support research and development until 2028 [6]. - In 2023, the company reported a revenue increase of 4.6% to RMB 56.6 million, with a substantial reduction in losses from RMB 315 million in 2022 to RMB 145 million in 2023, primarily driven by increased sales from the Ritonavir product [6]. - The company is focused on key pipeline developments, including six Phase II or III clinical trials across various disease areas such as acne, hepatitis B, NASH, and glioblastoma [6]. Revenue and Loss Analysis - The 2023 revenue of RMB 56.6 million reflects a 4.6% increase, attributed to higher product sales, improved inventory management leading to lower sales costs, and increased other income from bank interest and equity gains from Sagimet Biosciences' IPO [6]. - The significant narrowing of losses is a positive indicator of the company's financial health and operational efficiency [6]. Clinical Pipeline Progress - The ASC40 product for acne treatment has shown promising Phase II clinical trial results, with a 53.1% reduction in total lesions at the 25 mg dose and a 61.3% reduction at the 50 mg dose, demonstrating statistical significance and good safety [6]. - The company is actively pursuing international business development projects, particularly for the ASC40 acne project, which has a vast market potential [6]. Strategic Focus - The company is a research-driven biotech firm, making significant progress in the development of ASC40 for acne, NASH, and glioblastoma, while also advancing global collaborations [6]. - The report emphasizes the company's commitment to investor returns, having repurchased and canceled HKD 130 million worth of shares, indicating a focus on enhancing shareholder value [6].

Financial Performance - Gross profit for the year ended December 31, 2023, was approximately RMB 26.0 million, compared to a gross loss of RMB 24.7 million in 2022, driven by improved cost control and a revenue increase of approximately RMB 2.5 million, or 4.6% [30]. - Total revenue increased by 4.6% from approximately RMB 541 million in 2022 to approximately RMB 566 million in 2023, primarily due to an increase in revenue from Ritonavir products of approximately RMB 494 million, offset by a decrease in promotional service revenue of approximately RMB 404 million [43]. - The group’s revenue increased by 4.6% from approximately RMB 541 million for the year ended December 31, 2022, to approximately RMB 566 million for the year ended December 31, 2023 [61]. - Other income and gains increased by 64.8% from approximately RMB 112.0 million in 2022 to about RMB 184.7 million in 2023, largely due to gains from an IPO and increased bank interest income [32]. - The company reported a pre-tax loss of approximately RMB 144.7 million in 2023, a significant improvement from a loss of approximately RMB 314.8 million in 2022 [59]. - The annual loss reduced from RMB 3,148 million for the year ended December 31, 2022, to RMB 1,447 million for the year ended December 31, 2023 [84]. Research and Development - The company's R&D costs for the year ended December 31, 2023, totaled approximately RMB 216.8 million, a decrease from RMB 267.1 million in 2022, primarily due to reduced clinical expenses [20]. - R&D costs decreased by 18.8% from approximately RMB 671 million in 2022 to approximately RMB 668 million in 2023, attributed to improved efficiency in clinical and preclinical projects and reduced depreciation and amortization costs [45]. - The company has established 12 key clinical stage assets focusing on viral diseases, NASH, and tumors, with strategic goals for 2024 including completing patient enrollment for ASC41 in NASH Phase II trials and initiating discussions with the National Medical Products Administration for ASC40 registration trials [41]. - ASC40 for moderate to severe acne has entered Phase III clinical trials, with 480 subjects randomized to receive either ASC40 or a placebo for 12 weeks [51]. - ASC61, an oral PD-L1 small molecule inhibitor, is currently undergoing Phase I clinical trials in the U.S. for advanced solid tumors, with a focus on determining the recommended dose for Phase II trials [49]. - The group achieved six IND approvals from the FDA and/or national drug regulatory authorities, supporting four candidates in ongoing Phase II or III clinical trials [62]. Expenses and Cost Management - Administrative expenses rose by 228.5% to approximately RMB 115.6 million in 2023, primarily due to increased consulting fees and employee-related costs [35]. - Sales and distribution expenses decreased by 97.7% to approximately RMB 0.4 million in 2023, attributed to the cessation of promotional activities for a specific product [34]. - The total administrative expenses composition showed that agency and consulting fees accounted for 54.0% of the total in 2023, compared to only 11.7% in 2022 [37]. - Other expenses significantly decreased by 96.4% from approximately RMB 59.8 million for the year ended December 31, 2022, to approximately RMB 2.1 million for the year ended December 31, 2023, primarily due to a reduction in impairment of other intangible assets [152]. Cash Flow and Liquidity - Cash and cash equivalents, along with time deposits, amounted to approximately RMB 2,274.6 million, expected to support R&D activities and operations until 2028 [55]. - The net cash flow used in operating activities for the year ended December 31, 2023, was approximately RMB 144.2 million, mainly due to an operating loss of approximately RMB 258.2 million before changes in working capital [165]. - The company reported a net cash flow used in financing activities of approximately RMB 81.5 million for the year ended December 31, 2023, primarily due to share repurchases during the reporting period [167]. - The company’s cash and cash equivalents decreased from RMB 2,470.834 million as of December 31, 2022, to RMB 2,274.574 million as of December 31, 2023 [180]. Clinical Trials and Product Development - The company anticipates completing patient enrollment for the Phase III clinical trial of ASC40 for acne in 2024 [27]. - The group completed the enrollment of 120 patients in the Phase III registration trial of ASC40 for rGBM treatment, which may allow for a mid-term analysis [85]. - The ongoing phase II study of ASC22 for HIV-1 is evaluating safety and efficacy with a treatment period of 12 weeks [98]. - The ASC40 clinical trial for NASH is a 52-week study involving 168 patients with confirmed fibrosis, aiming to submit phase 2b data to the FDA in 2024 [104]. - ASC10, an oral prodrug, has shown effective inhibition of respiratory syncytial virus with an EC50 of 0.51 to 0.6 µM in preclinical studies [118]. Market and Strategic Outlook - The global RSV drug market is projected to grow at a compound annual growth rate (CAGR) of 14.9%, reaching $4.2 billion by 2027 [95]. - The company aims to enhance global competitiveness by accelerating the development of first-in-class or best-in-class drug candidates [41]. - The company is actively seeking opportunities for out-licensing several clinical assets [40]. - The company is exploring further clinical development opportunities for ASC22 in combination with other therapies for chronic hepatitis B functional cure [116].

Financial Performance - Total revenue increased by 21.7% to approximately RMB 46.5 million for the six months ended June 30, 2023, compared to RMB 38.2 million for the same period in 2022[16]. - Gross profit rose by 58.5% to RMB 38.6 million, up from RMB 24.4 million year-on-year[13]. - Other income and gains increased by 56.9% to RMB 75.0 million, compared to RMB 47.8 million in the previous year[16]. - The company reported a pre-tax loss of RMB 16.6 million, significantly reduced from RMB 88.0 million in the previous year, reflecting an 81.2% improvement[13]. - The net loss margin improved to (35.6%) from (230.3%) year-on-year[13]. - The total comprehensive income for the period was RMB 37,253,000, compared to a loss of RMB 18,781,000 in the previous year[118]. - The company reported a loss attributable to equity holders of RMB 16,559,000 for the six months ended June 30, 2023, compared to a loss of RMB 87,998,000 in the same period of 2022, showing an improvement in financial performance[164]. Research and Development - The company achieved five IND approvals from the US FDA and China's National Medical Products Administration during the reporting period[17]. - The company plans to initiate a Phase III clinical trial for ASC40, a treatment for acne, in the second half of 2023[36]. - ASC42, a new selective non-steroidal FXR agonist, is undergoing a Phase II study with 98 patients, targeting those who are intolerant or unresponsive to UDCA[38]. - The ASC40 clinical trial for rGBM has enrolled 108 patients out of a planned 180, with an objective response rate of 56% reported in previous studies[181]. - ASC43F has shown good safety and tolerability in Phase I clinical trials, with significant reductions in LDL-C and triglycerides in overweight and obese subjects[177]. - The company plans to complete the enrollment of approximately 120 rGBM patients for interim analysis by the third quarter of 2023[182]. - ASC61 is currently undergoing Phase I clinical trials for advanced solid tumors, with a focus on determining the recommended dose for Phase II trials[183]. - The company has optimized its resources to focus on 12 clinical-stage assets, most of which have the potential to be first-in-class or best-in-class products[196]. Cash and Liquidity - Cash and bank balances as of June 30, 2023, were approximately RMB 2,512.9 million, sufficient to support R&D activities and operations until 2027[16]. - Cash and cash equivalents, along with time deposits with maturities over three months, totaled RMB 2,512.9 million as of June 30, 2023, compared to RMB 2,470.8 million at the end of 2022[20]. - The total cash and cash equivalents increased to RMB 469.69 million as of June 30, 2023, from RMB 1,103.02 million at the end of June 30, 2022[31]. - The company reported a net cash flow from investing activities of RMB 141,685,000, a significant recovery from a net outflow of RMB 571,882,000 in the same period of 2022[136]. - The company’s total cash and cash equivalents at the end of the period stood at RMB 469,694,000, down from RMB 1,103,020,000 in the previous year[136]. Assets and Liabilities - As of June 30, 2023, the total assets of the company amounted to RMB 691,000, a decrease from RMB 6,267,000 as of December 31, 2022[40]. - Total liabilities decreased from RMB 108,189,000 to RMB 83,267,000, a reduction of about 23.1%[126]. - The company reported no borrowings as of June 30, 2023[41]. - The debt-to-asset ratio improved to 3.4% as of June 30, 2023, down from 4.4% as of December 31, 2022[46][47]. - Trade payables increased to RMB 6,953 million as of June 30, 2023, compared to RMB 3,135 million as of December 31, 2022, reflecting a significant growth[24]. - Other payables decreased to approximately RMB 40.4 million as of June 30, 2023, from approximately RMB 42.7 million as of December 31, 2022, indicating stability in liabilities[26]. Shareholder Information - As of June 30, 2023, the total number of shares issued by the company is 1,087,134,000[95]. - Dr. Wu holds 514,393,664 shares, representing 47.32% of the company's equity[81]. - Mrs. Wu holds 82,827,414 shares, representing 7.62% of the company's equity[81]. - Major shareholders include C-Bridge Capital GP, Ltd. and TF Capital, Ltd., each holding 64,154,727 shares, representing 5.90%[87]. - The company repurchased a total of 5,705,000 shares at a total cost of HKD 10,913,340 in June 2023[72]. - The company repurchased an additional 8,690,000 shares at a total cost of HKD 18,261,340 in July 2023[72]. Corporate Governance - The company maintained compliance with all applicable corporate governance codes during the reporting period[70]. - The company has adopted a written guideline for securities trading that meets or exceeds the standards of the code[71]. - The company did not grant any stock options to any directors during the reporting period[59]. - The company’s board believes that having the same person serve as both chairman and CEO enhances efficiency in leading and managing the company[70].

欢迎各位投资者来到2023年中期录演季上市公司录演现场本次录演由智通财经与第一上海联合主办录演即将开始请各位投资者将手机调至静音下面有请哥里之耀进行录演及投资者交流时长40分钟有请哥里之耀谢谢智通财经和第一上海的组织 22%主要的收入贡献是立陶纳为我们从2022年的下半年陆续跟国内的几家大的做新冠口服药的公司都签订了相关的合同所以还是抓住这样一次性的机会但是因为新冠疫情已经过去所以我们不会对于新冠的业务或者它的收入有非常高的期望 上半年还有接近4000多万的理财的收益利息所以资金这块的公司在18A的这些公司当中看起来还是非常的充裕与此同时我们上半年也做了一些优化把之前的一些管线做了缩减目前就主力聚焦在刚刚提到的这些项目上上半年我们的研发费用是9200万全年预计可能也就是2亿多一点 我们在五月份也公布了桌窗的二期数据其实整个今年上半年公司的管线的进展还是非常的顺利与此同时我们也是从6月20号开始进行实时回购从6月15号以来到现在我们已经累计回购了接近4000万港币这也是在所有的18A公司当中为数不多的 重点推进的几个项目首先第一个是我们看一下在Nash领域Nash这块在国内来看颗粒是绝对的做得比较好的公司我们从 ...

Financial Performance - Total revenue for the six months ended June 30, 2023, was RMB 46,506 thousand, representing a 21.7% increase from RMB 38,218 thousand in the same period of 2022[2] - Gross profit for the same period was RMB 38,620 thousand, reflecting a significant increase of 58.5% compared to RMB 24,367 thousand in 2022[2] - The company reported a pre-tax loss of RMB (16,559) thousand, an improvement of 81.2% from a loss of RMB (87,998) thousand in the previous year[2] - The net loss attributable to equity holders was RMB (16,559) thousand, with a net loss margin of (35.6%), compared to (230.3%) in the prior year[2] - For the six months ended June 30, 2023, the total loss was RMB 16.6 million, a significant improvement compared to a loss of RMB 88.0 million for the same period in 2022[98] - The company reported a loss attributable to equity holders of the parent of RMB (16,559) thousand for the six months ended June 30, 2023, an improvement from a loss of RMB (87,998) thousand in the same period of 2022[189] Research and Development - ASC22, an immunotherapy for chronic hepatitis B, is in a Phase IIb clinical trial with results expected in Q3 2023[6] - The company has received five IND approvals from the US FDA and China's National Medical Products Administration, demonstrating strong R&D efficiency[4] - ASC40, a selective FASN inhibitor, showed an objective response rate of 56% in a Phase II study for rGBM patients[22] - The company has decided to terminate the development of ASC09, an HIV protease inhibitor, due to loss of competitive advantage[25] - The company initiated a Phase II clinical trial for ASC41 in NASH patients, enrolling approximately 180 patients with a treatment period of 52 weeks[42] - The company announced positive interim data from a Phase IIb clinical trial of ASC40 for treating moderate to severe NASH patients, showing statistically significant improvements in multiple key disease markers after 26 weeks of treatment[41] - The company plans to start a Phase III clinical trial for ASC40 in acne treatment in the second half of 2023, following positive Phase II results[47] - The company has established 12 key clinical stage assets focused on viral diseases, non-alcoholic fatty liver disease/PBC, and oncology[52] Cash Flow and Liquidity - The company reported a net cash outflow from operating activities of approximately RMB 68.0 million for the six months ended June 30, 2023, mainly due to an operating loss of approximately RMB 65.3 million before changes in working capital[63] - The company reported a net cash inflow from investing activities of approximately RMB 141.7 million for the six months ended June 30, 2023, primarily due to the redemption of fixed deposits[64] - The cash flow from operating activities showed a net outflow of RMB 67,959 thousand for the six months ended June 30, 2023, an improvement from a net outflow of RMB 99,707 thousand for the same period in 2022[148] - Cash flow from investing activities resulted in a net inflow of RMB 141,685 thousand for the six months ended June 30, 2023, compared to a net outflow of RMB 571,882 thousand in the previous year[149] - The company had cash and cash equivalents of RMB 469,694,000 as of June 30, 2023, up from RMB 403,768,000 at the end of 2022[124] - The company's current ratio increased from 23.5 as of December 31, 2022, to 30.8 as of June 30, 2023, while the quick ratio rose from 23.3 to 30.5, mainly due to a reduction in current liabilities[89] Expenses and Cost Management - The company's sales and distribution expenses decreased by 92.9% from approximately RMB 10.5 million for the six months ended June 30, 2022, to approximately RMB 0.7 million for the six months ended June 30, 2023, due to the termination of promotional services for a product in mainland China[33] - The company's cost of sales decreased by 43.1% from approximately RMB 13.9 million for the six months ended June 30, 2022, to approximately RMB 7.9 million for the six months ended June 30, 2023, primarily due to the cessation of promotional services[52] - Research and development costs decreased to RMB 92,258,000 from RMB 118,814,000, indicating a reduction of approximately 22.3%[120] - The total employee cost for the six months ended June 30, 2023, was approximately RMB 55.3 million, compared to RMB 48.8 million for the same period in 2022, reflecting an increase of 13.0%[94] - The company’s other expenses decreased by 75.0% from approximately RMB 2.0 million for the six months ended June 30, 2022, to approximately RMB 0.5 million for the same period in 2023, primarily due to reduced donations[153] Assets and Liabilities - The company's total non-current assets decreased to RMB 93,803,000 from RMB 112,316,000, a decline of about 16.5%[124] - The asset-liability ratio as of June 30, 2023, was 3.4%, down from 4.4% as of December 31, 2022, indicating a stronger financial position[115] - Non-current liabilities decreased to RMB 7,520 thousand as of June 30, 2023, down from RMB 8,967 thousand as of December 31, 2022, indicating a reduction of 16.1%[144] - Trade payables increased significantly to RMB 6,953 thousand as of June 30, 2023, compared to RMB 3,135 thousand as of December 31, 2022, reflecting a growth of 122.5%[141] - Trade receivables decreased significantly from approximately RMB 238.78 million as of December 31, 2022, to approximately RMB 56.35 million as of June 30, 2023[158] Corporate Governance and Compliance - The audit committee, composed of three independent non-executive directors, reviewed the interim results and found them compliant with applicable accounting standards and regulations[197] - The company is committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[192] - The company did not incur any income tax expenses for the periods ended June 30, 2023, and June 30, 2022, due to the absence of taxable income[186] Shareholder Activities - The company repurchased shares amounting to RMB 10,043 thousand during the six months ended June 30, 2023[149] - The company repurchased 5,705,000 shares in June 2023 at a total cost of HKD 10,913,340, with a highest price of HKD 2.03 and a lowest price of HKD 1.77[195] - The company also repurchased 8,690,000 shares in July 2023 at a total cost of HKD 18,261,340, with a highest price of HKD 2.28 and a lowest price of HKD 1.89[195] - No dividends were recommended for the six months ended June 30, 2023, consistent with the same period in 2022[187]

Financial Performance - Total revenue decreased by 29.6% from approximately RMB 769 million in 2021 to approximately RMB 541 million in 2022, primarily due to the termination of promotional services for Roche's product in China[22] - Gross loss for 2022 was approximately RMB 24.7 million, down from a gross profit of approximately RMB 39.2 million in 2021, mainly due to inventory impairment related to chronic hepatitis C products[24] - The net loss margin for 2022 was (11.9)%, compared to (55.3)% in 2021[21] - The company reported a loss increase from RMB 199.0 million for the year ended December 31, 2021, to RMB 314.8 million for the year ended December 31, 2022, primarily due to inventory impairment related to chronic hepatitis C products[63] - Other income and gains increased by 70.0% from approximately RMB 65.9 million in 2021 to approximately RMB 112.0 million in 2022, driven by foreign exchange gains of approximately RMB 60.2 million and bank interest income rising by 96.2% to approximately RMB 44.2 million[192] - The gross margin for 2022 was 44.1%, compared to 61.0% in 2021, after adjusting for the impact of inventory impairment[191] Research and Development - R&D expenses increased by 25.2% from approximately RMB 213.3 million in 2021 to approximately RMB 267.1 million in 2022, driven by multiple candidate drugs advancing to Phase II or III clinical trials[23] - The company plans to accelerate clinical trials for multiple candidate drugs in 2023, including ASC40 for acne and ASC22 for chronic hepatitis B functional cure[20] - ASC40 (denifanstat) showed positive interim results in a Phase IIb clinical trial for NASH patients, with top-line biopsy results expected in Q4 2023[26] - The company received 13 IND approvals from the US FDA and/or China's National Medical Products Administration, advancing two new drug candidates to Phase II and supporting six candidates in ongoing clinical development for Phase II or III[37] - The company has established a broad asset pipeline focusing on viral diseases, non-alcoholic fatty liver disease/PBC, and oncology[46] - The company announced positive Phase I clinical results for the broad-spectrum antiviral prodrug ASC10 and received FDA approval to conduct Phase IIa clinical trials for ASC10 treating RSV infections, expected to complete in Q4 2023[48] - The company has successfully advanced the registration pathway for ASC22 with the Chinese National Medical Products Administration[73] - The company has three commercially available products and twenty-three strong candidates in its research pipeline, focusing on areas such as NASH/PBC, viral diseases, and tumors[83] Business Development - The company has entered into commercial supply agreements for Ritonavir tablets with Pfizer China, highlighting its strong business development capabilities[17] - The company signed commercialization supply agreements for Ritonavir with domestic and multinational pharmaceutical companies, which are expected to significantly contribute to total revenue in 2023[69] - The company aims to maximize the value of its pipeline assets through continued exploration of collaboration opportunities with domestic and international companies[20] - The company is cautious about the sustainability of revenue from Ritonavir due to uncertainties regarding the demand for COVID-19 treatment drugs in mainland China[69] Financial Position - The total assets for the company as of December 31, 2022, were approximately RMB 2.657 billion, with total liabilities of approximately RMB 117 million[21] - As of December 31, 2022, the company's cash and cash equivalents amounted to approximately RMB 2,470.8 million, expected to support R&D activities and operations until 2027[45] Employee and Corporate Governance - The company had a total of 278 employees as of December 31, 2022[131] - The company reported no incidents of employee deaths or work-related injuries during the year, indicating successful health and safety measures[136] - The company is committed to enhancing employee health and safety through various training programs and emergency preparedness drills[109] - The company emphasizes employee welfare, providing benefits that exceed the minimum legal standards, including paid annual leave and various types of leave[139] - The company has a zero-tolerance policy for child labor and forced labor, ensuring compliance with employment laws[132] - The company has established a recruitment management system to ensure effective hiring aligned with business development strategies[132] Environmental and Social Responsibility - The company emphasizes energy conservation and environmental protection as part of its corporate social responsibility initiatives[79] - The company is committed to reducing carbon emissions during operations and has implemented measures to monitor and improve environmental practices[169] - The company has established an Environmental, Social, and Governance (ESG) committee to oversee the implementation of sustainability policies and environmental measures[168] - The company generated a total of 108.10 tons of hazardous waste, with a hazardous waste intensity of 0.48 tons per employee[181] - The company has saved approximately 298,454 sheets of paper this year, equivalent to about 3.2 trees, by promoting eco-friendly office practices[177] Quality Management - The company adheres to international standards for production quality and management systems, ensuring compliance with GMP regulations[90] - The company has implemented a comprehensive quality management system to ensure compliance with Chinese Good Manufacturing Practices for pharmaceutical products[119] - The company has established a safety signal management SOP to handle safety signals from various sources, prioritizing public health impacts[95] - The company has developed standard operating procedures for managing adverse events during clinical trials, ensuring safety and compliance[96] Market Insights - The global respiratory syncytial virus (RSV) drug market is projected to grow at a compound annual growth rate (CAGR) of 14.9% from 2022 to 2027, reaching an estimated revenue of $4.2 billion by 2027[163] - Approximately 58,000 children under the age of 5 are hospitalized annually in the U.S. due to RSV, with an estimated 14,000 deaths among adults aged 65 and older each year[163]

那么临床前实验证明对呼吸道荷包病毒有非常好的临床前的疗效 安全性也非常好 剂量也确定了所以我们希望在今年底跟大家分享我们RAC的数据那讲完我们产品的这个 那除了研发可能推进呢我们去年开始全球布局商务拓展希望能跟不同的公司合作我们的项目出海license up我们目标是license up所以呢我们也这个引进了前第一三共北美总裁兼首席执行官江格鲁担任公司的首席商务官那去年我们做成功的一个 收入下降了30%那么研发费我们不说了全年净亏损的是3.1人民币和2020年相比好像增加实际上没增加为什么因为这个全年这个净亏损3.1包括了饼干相关产品的成货 未来5年尤其刚才我说的保证我们未来5年可以做first in car做创新不做me too不做me battle要的这个重要的限定支持好那给大家更新一下利通阿维的情况啊这个到今天为止利通阿维就说基于不可撤销的订单的利通阿维的预售款 一些工作 我们也非常高兴得到很多相关部门的认可作为香港发展公司也是我们的责任要做一个可持续发展的生物科技公司与此同时的话我们也获得一些奖项 比如说,2022年我们获得了浙江省2020年度科技进步历史奖也入选了中国小分子创新的Top 30这样的l ...

Financial Performance - The company's gross loss decreased from approximately RMB 39.2 million for the year ended December 31, 2021, to a gross loss of approximately RMB 24.7 million for the year ended December 31, 2022, primarily due to inventory impairment related to chronic hepatitis C products[3]. - The company reported a net loss of RMB 314.8 million for the year ended December 31, 2022, compared to a net loss of RMB 199 million for the year ended December 31, 2021, with the increase attributed to inventory and intangible asset impairments related to chronic hepatitis C products[51]. - The company's total revenue decreased by 29.6% from approximately RMB 769 million for the year ended December 31, 2021, to approximately RMB 541 million for the year ended December 31, 2022, primarily due to the termination of promotional services for Palvico® to Roche Pharmaceuticals in China[42]. - The company reported a net loss margin of (582.1)% for the year ended December 31, 2022, compared to (258.9)% for the previous year, highlighting deteriorating profitability[40]. - The gross profit for 2022 was approximately RMB 23.9 million, with a gross margin of 44.1%, down from 61.0% in 2021[102]. - The total comprehensive loss for the year was RMB 193.3 million, compared to RMB 231.0 million in the previous year[193]. Research and Development - Research and development expenses increased by 25.2% from approximately RMB 213.3 million for the year ended December 31, 2021, to approximately RMB 267.1 million for the year ended December 31, 2022, driven by continued investment in antiviral candidates for COVID-19 and chronic hepatitis B functional cure[9]. - The total research and development costs for viral diseases amounted to approximately RMB 144.8 million for the year ended December 31, 2022, compared to RMB 67.3 million for the year ended December 31, 2021[12]. - The company achieved 13 IND approvals from the National Medical Products Administration of China and the FDA, advancing 2 new candidate drugs into Phase II and supporting 6 candidates in ongoing Phase II or III clinical development[43]. - The company is expanding its clinical pipeline with a focus on innovative therapies for chronic hepatitis and viral infections[1]. - The ASC22 clinical trial for chronic hepatitis B patients is based on a randomized, single-blind, multi-center design with 75 patients[81]. - The ASC40 (denifanstat) Phase IIb clinical trial for NASH patients showed statistically significant improvement in multiple key disease markers after 26 weeks of treatment[85]. Financial Position - The company's total assets decreased from approximately RMB 21.0 million as of December 31, 2021, to approximately RMB 18.3 million as of December 31, 2022[22]. - Cash and cash equivalents increased significantly from approximately RMB 768.1 million in 2021 to approximately RMB 2,067.1 million in 2022, reflecting improved liquidity[26]. - The company has approximately RMB 2,470.8 million in cash and cash equivalents as of December 31, 2022, sufficient to support R&D activities and operations until 2027[70]. - The company had no debt as of December 31, 2022, indicating a strong balance sheet position[154]. - The total current assets decreased from RMB 2,631.6 million in 2021 to RMB 2,544.7 million in 2022[194]. - The company's total liabilities included other payables amounting to RMB 101.05 million, an increase from RMB 86.76 million as of December 31, 2021[144]. Operational Efficiency - The company's administrative expenses rose by 17.5% from approximately RMB 29.9 million for the year ended December 31, 2021, to approximately RMB 35.2 million for the year ended December 31, 2022[6]. - Sales and distribution expenses decreased by 18.6% from approximately RMB 20.9 million for the year ended December 31, 2021, to approximately RMB 17.0 million for the year ended December 31, 2022[5]. - Other expenses significantly increased by 172.7% from approximately RMB 21.9 million for the year ended December 31, 2021, to approximately RMB 59.8 million for the year ended December 31, 2022, mainly due to increased impairment of other intangible assets[13]. - The company's financing costs were approximately RMB 0.2 million for the year ended December 31, 2022, up from RMB 0.1 million in the previous year, reflecting increased lease liabilities[32]. Market and Product Development - The company has signed commercialization supply agreements for Ritonavir with domestic and multinational pharmaceutical companies, which are expected to significantly contribute to total revenue in 2023[60]. - The ASC10 has received FDA approval to conduct a Phase IIa clinical trial for RSV infection, with completion expected in Q4 2023 in either the US or China[63][64]. - The company has expanded its production capacity for ritonavir oral tablets to approximately 530 million tablets per year[80]. - The company has obtained exclusive rights for ASC40 and ASC60 in the Greater China region from Sagimet Biosciences[57]. - The company plans to accelerate the clinical trials for multiple products, including ASC22 for chronic hepatitis B and ASC40 for acne, with Phase II or III trials expected to commence[125]. Employee and Organizational Structure - The total number of employees as of December 31, 2022, was 278, with 60% in R&D and 19% in operations[161]. - The company had 278 employees as of December 31, 2022, with over 76% holding a bachelor's degree or higher[187]. - Total employee cost for 2022 was approximately RMB 127.0 million, up from RMB 110.6 million in 2021[187]. Risks and Challenges - The company faced foreign exchange risks primarily from USD, with no currency hedging transactions in place during the reporting period[160]. - The company reported a foreign exchange risk due to fluctuations in the exchange rates affecting its financial condition and operating performance[185].

Revenue and Sales Performance - Total revenue increased by 4.6% to approximately RMB 38.2 million for the six months ended June 30, 2022, compared to RMB 36.5 million for the same period in 2021[10]. - Product sales surged by 1,374.6% to RMB 5.2 million, while promotional service revenue decreased by 4.3% to RMB 32.998 million[8]. - Revenue for the six months ended June 30, 2022, was RMB 38,218,000, an increase from RMB 36,549,000 in the same period of 2021, representing a growth of approximately 4.6%[190]. - Revenue from external customers in mainland China for the six months ended June 30, 2022, was RMB 38,218,000, compared to RMB 34,842,000 in the same period of 2021, marking an increase of approximately 9.5%[190]. - Product revenue from collaborations for the six months ended June 30, 2022, was RMB 5,220,000, compared to RMB 354,000 in the same period of 2021, showing a significant increase[193]. Financial Performance - The net loss for the period was RMB 87.998 million, a 20.6% improvement compared to RMB 110.828 million in the previous year[8]. - The basic and diluted loss per share for the period was (8.10) cents, compared to (10.09) cents in the previous year[8]. - The company reported a loss before tax of RMB 87,998,000, an improvement from a loss of RMB 110,828,000 in the same period last year[169]. - The total comprehensive loss for the period was RMB 18,781,000, significantly lower than the comprehensive loss of RMB 124,868,000 in the same period last year, marking a substantial improvement[170]. - The company reported a loss of RMB 87,998,000 for the six months ended June 30, 2022, an improvement from a loss of RMB 110,828,000 in the same period of 2021, representing a reduction of approximately 20.5%[170]. Research and Development - Research and development expenses rose by 60.5% to approximately RMB 118.8 million, reflecting the company's commitment to ongoing investment in R&D[10]. - Research and development expenses increased to RMB 118,814,000 for the six months ended June 30, 2022, compared to RMB 74,026,000 in the prior year, indicating a growth of approximately 60.5%[200]. - The company achieved seven IND approvals from the National Medical Products Administration of China and the FDA during the reporting period[10]. - ASC22 has received IND approvals from both the FDA and China's NMPA for chronic hepatitis B and HIV-1 functional cure indications[13]. - The company is advancing its pipeline with a focus on innovative therapies for viral diseases and oncology[15]. Clinical Trials and Approvals - The company reported a 42.9% functional cure rate in chronic hepatitis B patients during the IIb clinical trial of ASC22 at the EASL 2022 International Liver Congress[12]. - ASC42 for PBC has completed the first patient dosing in China for its Phase II clinical trial and received FDA approval for DDI studies[13]. - The company is advancing ASC22 into Phase III trials with the National Medical Products Administration, focusing on patients with baseline HBsAg ≤ 100 IU/mL[33]. - ASC40 has initiated the first patient dosing in a Phase III clinical trial for recurrent Glioblastoma Multiforme (rGBM), with an objective response rate of 65% reported in previous Phase II studies[51]. - The Phase III clinical trial for ASC42 is planned to commence in the US and EU following the completion of the Phase II trial in China[49]. Cash and Liquidity - The cash and cash equivalents as of June 30, 2022, were approximately RMB 2,483.7 million, sufficient to support R&D activities for the next five years[10]. - Cash and cash equivalents at the end of the period were RMB 1,103,020 thousand, down from RMB 1,772,023 thousand at the end of the previous year[177]. - The total cash and cash equivalents at the end of the period was RMB 1,103.02 million as of June 30, 2022, down from RMB 1,727.41 million at the beginning of the period[109]. - The company’s cash and cash equivalents decreased by RMB (691,305) thousand during the period, compared to a decrease of RMB (425,148) thousand in the previous year[177]. - The company had no borrowings and unutilized bank financing amounted to RMB 30.0 million[119]. Operational Efficiency - Administrative expenses decreased by 18.6% from approximately RMB 22.1 million to approximately RMB 18.0 million, attributed to improved operational efficiency[81]. - The sales cost decreased by 64.6% from approximately RMB 391 million to approximately RMB 139 million, mainly due to inventory impairment provisions in the previous period[69]. - The company has established a strong commercial presence in the hepatitis field, covering approximately 874 hospitals and pharmacies in China as of June 30, 2022[61]. - The company is actively exploring partnerships with international pharmaceutical companies to maximize the value of its proprietary pipeline assets, including Ritonavir and ASC10[65]. - The company has appointed John P. Gargiulo as Chief Business Officer to enhance business development capabilities and accelerate growth through the launch of multiple commercial products in the next three years[65]. Shareholder Information - As of June 30, 2022, Dr. Wu held 597,221,078 shares, representing approximately 54.94% of the company's equity[145]. - The company had significant shareholders, including JJW12 Limited, which held 552,393,664 shares, accounting for 50.81% of the equity[149]. - The board of directors did not recommend any dividend for the six months ended June 30, 2022, consistent with the previous year[198]. - The company confirmed that all directors complied with the securities trading standards throughout the reporting period[138]. - The company maintained compliance with corporate governance codes to enhance shareholder value and transparency[137].

Drug Development and Clinical Trials - The company is focusing on maximizing revenue from Ritonavir, Newlita®, and Danoprevir, while enhancing competitiveness in viral disease treatment through clinical development of ASC22 and two COVID-19 oral candidates, ASC10 and ASC11 [14]. - The company has advanced one candidate drug into Phase III clinical trials and another into Phase IIb trials, along with four candidates entering Phase II trials [11]. - ASC10 and ASC11 are oral candidates targeting COVID-19, with ASC10 showing excellent in vitro antiviral activity against various SARS-CoV-2 variants, including Omicron [12]. - ASC22, a subcutaneous PD-L1 antibody for chronic hepatitis B functional cure, is the fastest progressing candidate in global clinical development [12]. - The company aims to accelerate Phase II and III clinical trials for ASC40 (rGBM), ASC42 (PBC), and ASC40 (acne) in 2022 [14]. - The company advanced multiple drug candidates into various phases of clinical trials, including one candidate into Phase III and several into Phase II [23]. - ASC40, an oral FASN inhibitor, showed a 50% response rate in reducing liver fat (≥30% reduction) in a Phase II clinical trial with approximately 330 patients, and the trial is expected to complete mid-term results in 2022 [58]. - The Phase III clinical trial for ASC40 in combination with bevacizumab for recurrent glioblastoma (rGBM) has enrolled its first patient, with an objective response rate of 65% reported in previous Phase II trials [69]. - ASC42's Phase II/III clinical trial for primary biliary cholangitis (PBC) has been approved, with plans to enroll 100 patients who are insufficiently responsive or intolerant to UDCA [65]. - The company plans to submit IND applications for ASC10 in China and the US in the first half of 2022, ahead of previous expectations [50]. - Clinical trials for ASC10 targeting COVID-19 are expected to commence in 2022 [51]. - ASC11 is a candidate drug for COVID-19 targeting the protease (3CLpro) with a differentiated chemical structure compared to FDA-approved Nirmatrelvir, and clinical trial IND submissions are planned for late 2022 in China and the US [53]. Financial Performance - The company's annual loss decreased by 4.9% to approximately RMB 199.0 million for the year ending December 31, 2021, compared to RMB 209.2 million for the previous year [14]. - Total revenue increased by 119.6% from approximately RMB 350 million in 2020 to approximately RMB 769 million in 2021 [21]. - Gross profit turned from a loss of approximately RMB 235 million in 2020 to a gross profit of approximately RMB 392 million in 2021, representing an increase of about 266.7% [21]. - R&D expenses rose by 95.5% from approximately RMB 1,091 million in 2020 to approximately RMB 2,133 million in 2021, primarily due to ongoing investments in antiviral candidates for COVID-19 and chronic hepatitis B [21]. - Net loss decreased by 4.9% from approximately RMB 2,092 million in 2020 to approximately RMB 1,990 million in 2021 [21]. - Cash and cash equivalents as of December 31, 2021, were approximately RMB 2,495.5 million [22]. - Revenue from the promotion of the drug Pairohxin® increased by 9.8% to approximately RMB 70.9 million for the year ending December 31, 2021, up from RMB 64.6 million in the previous year [45]. - Other income and gains decreased by 26.7% from approximately RMB 89.9 million to approximately RMB 65.9 million, primarily due to a reduction in government grants [94]. - The company recorded financing costs of approximately RMB 0.1 million for the year ended December 31, 2021, slightly down from RMB 0.135 million in 2020 [110]. Market and Product Approvals - The company received approval for Ritonavir oral tablets in September 2021, becoming the only approved product in China for this antiviral agent, with an annual production capacity expanded to approximately 530 million tablets to meet growing demand [10]. - The company received marketing approval for Ritonavir tablets (100 mg) from the National Medical Products Administration [23]. - The company submitted marketing authorization applications for Ritonavir tablets in 12 European countries [23]. - The oral direct-acting antiviral treatment for chronic hepatitis C was included in the National Reimbursement Drug List [23]. - The all-oral direct-acting hepatitis C treatment regimen has shown a 99% cure rate in genotype 1 non-cirrhotic chronic hepatitis C patients during clinical trials [38]. - The company’s hepatitis C treatment regimen has been included in the National Medical Insurance Drug List in China [38]. - The company aims to become the global commercial supplier of Ritonavir oral tablets, having received approval for its product in China in September 2021 [36]. - The company has submitted marketing authorization applications for Ritonavir to 12 European countries, including Germany, France, and the UK [36]. Research and Development Focus - The company is committed to addressing clinical needs in viral diseases, non-alcoholic fatty liver disease, and oncology through innovative drug development [10]. - The company plans to focus on three therapeutic areas in 2022: viral diseases, non-alcoholic fatty liver disease/PBC, and tumors [81]. - The company is leveraging the synergistic effects of its three drug candidates targeting different but complementary pathways for treating liver diseases [62]. - The company has a pipeline of products targeting various cancers, including ASC40 for recurrent glioblastoma and drug-resistant breast cancer [28]. - The company has secured exclusive licensing rights for ASC40 and ASC60 in the Greater China region from Sagimet Biosciences [30]. Corporate Governance and Management - The company has a strong emphasis on corporate governance, with a dedicated company secretary and compliance with professional standards [178]. - The board of directors includes independent non-executive directors with extensive experience in clinical medicine and finance, enhancing governance and oversight [172][173]. - The company has appointed a chief scientist with over 20 years of experience in pharmaceutical research, previously leading global teams at Novartis [176]. - The management team is actively involved in the development of multiple drug candidates, indicating ongoing investment in R&D [163]. - The company has established compliance procedures to ensure adherence to applicable laws and regulations, with no significant adverse events reported during the fiscal year ending December 31, 2021 [183]. Employee and Operational Insights - The total employee cost for the year ended December 31, 2021, was approximately RMB 110.6 million, up from RMB 94.1 million for the year ended December 31, 2020 [158]. - The company had a total of 266 employees as of December 31, 2021, with 44% in R&D, 26% in commercialization, and 10% in production [158]. - Over 64% of the employees hold a bachelor's degree or higher, reflecting a highly educated workforce [157]. - The company has implemented various employee incentive plans, including restricted stock units and stock option plans [160]. - The company is committed to providing statutory benefits to employees, including pension insurance and medical insurance, in compliance with local laws [184]. - The company has not encountered any significant labor disputes or difficulties in recruiting employees during its operations [185]. Risk Management and Compliance - The company emphasizes the importance of risk management in its operations, with management assisting the board in evaluating significant risks [189]. - The company actively seeks strategic alliances and licensing arrangements for the development and commercialization of several investigational drugs, which involves inherent risks [188]. - The company recognizes the importance of maintaining strong relationships with stakeholders, including employees and medical experts, to achieve sustainable development [185]. - The company has a limited number of distributors contributing to sales, selected based on qualifications, reputation, market coverage, and sales experience [186]. - The company did not enter into any currency hedging transactions during the reporting period, indicating a strategy to minimize foreign exchange risk through close monitoring [156].