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].

Financial Performance - Total revenue increased by 14.8% to approximately RMB 36.5 million for the six months ended June 30, 2021, compared to RMB 31.8 million for the same period in 2020[12]. - The loss for the period increased by 115.3% from approximately RMB 515 million in the first half of 2020 to approximately RMB 1,108 million in the first half of 2021, mainly due to increased R&D expenses[31]. - The company reported a net cash outflow from financing activities of RMB 1,206 thousand for the six months ended June 30, 2021, compared to RMB 21,670 thousand for the same period in 2020[106]. - The company reported a significant increase in sales and distribution expenses, totaling RMB 9,487,000, compared to RMB 17,773,000 in the previous year[167]. - The company incurred a loss before tax of RMB 110,828,000 for the six months ended June 30, 2021, compared to a loss of RMB 51,465,000 for the same period in 2020, representing an increase in losses of approximately 115%[167]. Research and Development - R&D expenses rose by 43.1% to approximately RMB 74.0 million, primarily due to increased clinical development costs for NASH, HBV, and oncology candidates[12]. - The company aims to address unmet medical needs in NASH, oncology, and viral diseases, positioning itself as an innovative biopharmaceutical company[11]. - ASC40, a leading NASH candidate, completed enrollment in a randomized, double-blind, placebo-controlled Phase IIb clinical trial with approximately 330 patients[13]. - ASC42, another NASH candidate, completed a Phase I clinical trial in 64 healthy subjects, achieving favorable topline data[13]. - The company is developing a fixed-dose combination formulation ASC43F targeting two pathways (THRβ and FXR), which is set to enter clinical trials[15]. Clinical Trials and Approvals - The company has five clinical trial applications approved by China's NMPA and one by the FDA, accelerating the clinical trial processes for multiple candidates[13]. - ASC40 has been approved for a Phase III clinical trial for the treatment of rGBM patients[42]. - ASC22, a PD-L1 antibody, completed enrollment of 149 chronic hepatitis B patients in a Phase IIb clinical trial with positive interim results[20]. - The ASC40 NASH IIb clinical trial (FASCINATE-2) has enrolled approximately 330 patients with moderate to severe fibrosis (F2-F3) to evaluate the efficacy of TVB-2640 (ASC40) over a 52-week treatment period[32][33]. - The company has initiated a Phase II clinical trial for FXR agonist ASC42 for chronic hepatitis B after completing a bridging trial in China[20]. Financial Position and Cash Flow - Cash and cash equivalents amounted to approximately RMB 2,577.8 million as of June 30, 2021[13]. - The company's cash flow from operating activities showed a net outflow of RMB 85,824 thousand for the first half of 2021, compared to an outflow of RMB 17,936 thousand in the same period of 2020[173]. - The total cash and cash equivalents amounted to RMB 2,577,848 thousand, a decrease of 5.0% from RMB 2,714,011 thousand as of December 31, 2020[94]. - The company's equity attributable to owners of the parent decreased from RMB 2,981,650 thousand at the end of 2020 to RMB 2,860,283 thousand, a decline of approximately 4%[170]. - The company recognized a foreign exchange loss of RMB 14,040 thousand during the period, compared to a gain of RMB 31,606 thousand in the previous year[171]. Inventory and Receivables - Inventory decreased by 36.9% to approximately RMB 37.2 million as of June 30, 2021, down from approximately RMB 58.9 million as of December 31, 2020[84]. - Trade receivables increased to approximately RMB 47.1 million as of June 30, 2021, from approximately RMB 26.6 million as of December 31, 2020[85]. - The group reported a significant inventory impairment of RMB 23,036,000, compared to RMB 6,639,000 in the prior year[188]. - Trade receivables amounted to RMB 47,070,000, an increase from RMB 26,629,000 at the end of 2020[194]. Corporate Governance - The company maintained compliance with corporate governance codes to protect shareholder interests and enhance corporate value[136]. - The chairman and CEO positions are held by the same individual, Dr. Wu, which the board believes enhances efficiency in management[136]. - The company has adopted written guidelines for securities trading by directors, ensuring compliance throughout the reporting period[137]. - No changes in the board of directors' information were reported since June 2021[139]. - The company did not recommend any interim dividend for the six months ended June 30, 2021[158].

Pipeline Development - The company made significant progress in its pipeline for non-alcoholic fatty liver disease, with three innovative therapies targeting complementary pathways (FASN, THR-β, and FXR) and three corresponding combination therapies[13]. - Two clinical trial applications (ASC41 and ASC42) received approval from the FDA, and one (ASC41) was approved by the NMPA in China, with two fast track designations granted by the FDA for ASC42 and ASC40[13]. - The company completed four Phase I/Ib clinical trials (three for ASC41 and one for ASC40) and one Phase II clinical trial (ASC40) in 2020[13]. - The company has completed four Phase I/Ib clinical trials and one Phase II clinical trial for its NASH product pipeline[24]. - ASC40 and ASC42 have received FDA Fast Track designation, indicating significant progress in the NASH pipeline[24]. - The company has initiated a multi-dose Phase IIb clinical study for ASC22 in chronic hepatitis B patients[28]. - The company has a comprehensive pipeline targeting NASH, oncology, and chronic hepatitis B, with multiple candidates in various stages of clinical trials[24][28]. - The company has initiated the development of fixed-dose combination formulations (FDC) for three different combination therapies targeting specific disease pathways[49]. Clinical Trial Results - In oncology, the company focused on lipid metabolism and immune regulation, with a unique competitive advantage in oral FASN inhibitors and oral PD-L1 small molecule inhibitors[13]. - The Phase II trial data for ASC40 (TVB-2640) combined with bevacizumab showed an overall response rate (ORR) of 65%, with a complete response (CR) of 20% and a partial response (PR) of 45%[15]. - The six-month progression-free survival rate (PFS6) for the combination therapy was 47%, significantly improved compared to historical data of 16% for bevacizumab monotherapy (P=0.01)[15]. - The total response rate (ORR) for ASC40 (TVB-2640) combined with Bevacizumab in a Phase II trial for high-grade glioma patients was 65%, with a complete response (CR) of 20% and a partial response (PR) of 45%[52]. - The 6-month progression-free survival rate (PFS6) for ASC40 (TVB-2640) combined with Bevacizumab was 47%, significantly improved compared to historical data of 16% for Bevacizumab monotherapy (P=0.01)[52]. - ASC40, a novel fatty acid synthase inhibitor, showed a 50% to 61% response rate in reducing liver fat content in a global Phase II clinical trial involving 129 NASH patients[40]. - In the Chinese cohort of the ASC40 trial, liver fat content decreased by 28.2% compared to 11.1% in the placebo group, with ALT levels dropping by 29.8%[41]. - ASC41 demonstrated a significant reduction in LDL-C and triglycerides in a Phase I trial, with triglycerides decreasing by 39% in the 1mg dose group compared to baseline[44]. Financial Performance - The financial summary for the last five fiscal years is included, highlighting the company's performance and asset-liability overview[17]. - Total revenue for the year increased by 35.6% to approximately RMB 64.6 million from RMB 47.6 million in the previous year[28]. - The company reported a net loss of RMB 209.241 million, with a net loss margin of (597.8%) for the year[1]. - The revenue from the promotion of the drug Palrohin® for chronic hepatitis increased by 35.6%, from approximately RMB 476 million for the year ended December 31, 2019, to approximately RMB 646 million for the year ended December 31, 2020[55]. - The total revenue decreased by 79.8% from approximately RMB 173.4 million for the year ended December 31, 2019, to approximately RMB 35.0 million for the year ended December 31, 2020[67]. - R&D expenses decreased by 13.5% from approximately RMB 126.0 million for the year ended December 31, 2019, to approximately RMB 109.1 million for the year ended December 31, 2020[66]. - The gross profit decreased by 118.9% from approximately RMB 124.3 million for the year ended December 31, 2019, to approximately RMB (23.5) million for the year ended December 31, 2020[73]. - Other income and gains decreased by 29.0% from approximately RMB 126.6 million for the year ended December 31, 2019, to approximately RMB 89.9 million for the year ended December 31, 2020[74]. - The group reported a loss for the year ended December 31, 2020, with financial details available in the consolidated financial statements on pages 103 to 174[200]. - The board does not recommend the payment of any final dividend for the year ended December 31, 2020[200]. Management and Governance - The company has a strong management team, with Dr. Wu's spouse, Ms. He, serving as Vice President since January 2014, overseeing daily operations[147]. - Independent non-executive directors, including Dr. Wei and Mr. Gu, provide oversight and independent judgment to the board, ensuring corporate governance[149]. - The company has established a diverse board with members having extensive experience in clinical medicine and finance, enhancing strategic decision-making[149]. - The company is focused on expanding its pipeline of innovative drugs, leveraging the expertise of its leadership team in the pharmaceutical industry[145]. - The management team is committed to maintaining high standards of operational oversight, particularly in human resources and general affairs[147]. - The company has established compliance procedures to ensure adherence to applicable laws and regulations, with no significant violations reported during the year ended December 31, 2020[163]. Market and Competition - The financial outlook heavily relies on the successful sales of its antiviral drugs, Gonowei® (Danoprevir) and Xinlilai® (Ravidasvir)[169]. - The company faces intense competition in the antiviral drug market, which may impact its financial performance[169]. - The company has established long-term relationships with a limited number of distributors based on their qualifications and market coverage[167]. - The group reported that sales to its top five customers accounted for 100% of total revenue for the year ended December 31, 2020, compared to 80.5% for the year ended December 31, 2019[196]. - The largest customer contributed 96.9% of total revenue for the year ended December 31, 2020, up from 27.5% in the previous year[196]. - The top five suppliers accounted for 64.6% of total procurement for the year ended December 31, 2020, compared to 61.0% for the year ended December 31, 2019[197]. - The largest supplier represented 26.5% of total procurement for the year ended December 31, 2020, an increase from 23.8% in the previous year[197]. Compliance and Risk Management - The company has implemented measures to ensure compliance with environmental, health, and safety laws and regulations[162]. - The company has a risk management framework in place to address operational, financial, and regulatory risks[170]. - The company has received annual independence confirmations from its independent non-executive directors, ensuring compliance with listing rules[175]. - The controlling shareholder confirmed compliance with the non-competition commitment during the reporting period, with no new business opportunities reported[180]. - No significant transactions or contracts involving directors or their associates were reported during the reporting period[182]. - There were no related party transactions or continuing related party transactions that required disclosure under the listing rules during the reporting period[184]. - The group did not enter into any management contracts with individuals or entities to manage or handle any significant part of its business during the reporting period[198]. Employee Relations - The company has not encountered any significant labor disputes and maintains a good relationship with its employees[166]. - Employee salaries and benefits accounted for 51.2% of total administrative expenses in 2020, down from 49.9% in 2019[80]. - The total employee cost for the year ended December 31, 2020, was RMB 941 million, down from RMB 1,151 million in 2019[141]. Environmental and Community Engagement - The company has established detailed internal rules regarding environmental protection and complies with national emission standards[162]. - The company is committed to maintaining good relationships with surrounding communities and ensuring compliance with applicable environmental regulations[162]. - The company emphasizes the importance of maintaining good relationships with stakeholders, including employees and medical experts, to achieve sustainable development[166].

Financial Performance - Total revenue for the first half of 2020 was RMB 31.8 million, a decrease of 57.8% compared to RMB 75.4 million in the same period of 2019[8] - Product sales generated RMB 1.1 million, a significant decline of 98.1% from RMB 55.4 million in the first half of 2019[8] - Promotion service revenue increased by 53.5% to RMB 30.8 million, up from RMB 20.0 million in the same period last year[8] - The company reported a pre-tax loss of RMB 51.5 million, compared to a loss of RMB 47.2 million in the first half of 2019, representing a 9.0% increase in loss[8] - The net loss margin was 161.7% for the first half of 2020, compared to 62.6% in the same period of 2019[8] - Gross profit fell by 62.3% from approximately RMB 55.7 million in the first half of 2019 to approximately RMB 21.0 million in the first half of 2020, primarily due to a decline in sales of Gonowei® (Danoprevir)[42] - The company reported a basic and diluted loss per share of RMB 4.94, compared to RMB 4.47 in the same period last year[125] - The total comprehensive loss for the period was RMB 19,859,000, significantly improved from a loss of RMB 43,536,000 in the previous year[127] Research and Development - The company completed a Phase II clinical trial for a novel FASN inhibitor for treating NASH, achieving a response rate of 61% in the 50mg group[13] - The IND application for ASC22, a subcutaneous PD-L1 antibody, was approved, and the first patient was dosed in a Phase IIa clinical trial for hepatitis B[13] - ASC41, an oral selective THR-ß agonist for treating NASH, received IND approval on May 13, 2020[13] - The company is developing multiple products for chronic hepatitis B and C, with several candidates in various clinical trial phases[19][20] - The clinical trial for ASC09F (ASC09/Litonavir combination) is ongoing, with internal development for global markets[16] - The company has established a leading pipeline for NASH treatment, including three candidate drugs: ASC40, ASC41, and ASC42, targeting different mechanisms[24] - ASC40, a novel oral FASN inhibitor in Phase II clinical trials, showed a 61% response rate in reducing liver fat content in the 50mg group[25] - ASC41, a high-selectivity THR-ß agonist, demonstrated a maximum reduction of 45% in NAS scores and 25% in liver fibrosis scores in mouse models[26] - ASC22, a PD-L1 antibody for hepatitis B treatment, is in Phase II clinical trials and is the only subcutaneously administered PD-L1 antibody with stability at room temperature[29] - ASC09F, a protease inhibitor for HIV-1, has a high genetic barrier to resistance and has completed Phase I and IIa clinical trials, showing effective antiviral activity[34] Market and Product Development - The company has commercialized three drugs, including the first self-developed direct antiviral drug for hepatitis C in China[10] - The company anticipates increased competitiveness in its HCV business following the recent approval of its first all-oral hepatitis C treatment regimen[11] - The promotion revenue of Palosyn® reached RMB 30.8 million, representing a 53.5% increase compared to the same period in 2019[20] - Gonowei® (Danosvir) sales amounted to RMB 1.1 million, primarily due to the shift towards all-oral treatment regimens for hepatitis C[20] - The new drug application for Lavidawe (NS5A inhibitor) has been approved, with a 12-week treatment regimen showing a cure rate (SVR12) of up to 99%[21] - The company is focusing on expanding its market presence and enhancing competitiveness in the hepatitis C treatment sector[21] - The company has established a commercialization team of approximately 135 members, covering around 1,000 hospitals and pharmacies in strategic regions of China[22] - The company has signed 19 distribution agreements to enhance its market reach through distributors[22] - The company anticipates significant growth in Palosyn® promotion revenue due to its potential for clinical cure in specific hepatitis B patients[20] Financial Position and Cash Flow - The company's cash and cash equivalents totaled approximately RMB 1,943.662 million as of June 30, 2020, compared to RMB 1,102.956 million as of June 30, 2019, indicating a significant increase[74] - The net cash used in operating activities was RMB (17.936) million for the six months ended June 30, 2020, compared to RMB (64.434) million for the same period in 2019[74] - The net cash flow used in investment activities for the six months ended June 30, 2020, was approximately RMB 362.6 million, mainly attributed to an increase in time deposits with original maturities over three months of approximately RMB 359.1 million[77] - The company reported a net loss of RMB 51,465 thousand for the six months ended June 30, 2020, compared to a net loss of RMB 47,232 thousand for the same period in 2019, indicating an increase in loss of approximately 4.9%[132] - The total liabilities as of June 30, 2020, were RMB 3,388,573 thousand, a decrease from RMB 3,427,412 thousand as of January 1, 2019, indicating a reduction of approximately 1.1%[131] - The company’s total cash and cash equivalents as of June 30, 2020, were RMB 2,996,911 thousand, slightly up from RMB 2,989,164 thousand as of December 31, 2019[161] Corporate Governance and Shareholder Information - The company maintained a high level of corporate governance to protect shareholder interests and enhance corporate value[97] - The company confirmed compliance with all applicable code provisions of the corporate governance code during the reporting period[98] - As of the report date, Dr. Wu held 597,221,078 shares, representing approximately 53.98% of the company's equity[101] - The company’s major shareholders include JJW11 Limited with 64,945,019 shares (5.87%) and CBC Investment Twelve Limited with 50,729,518 shares (4.59%) as of the report date[106] - The company has adopted a written code of conduct for securities trading that meets or exceeds the standards of the code of conduct[100] - Dr. Ji-Rong Ji resigned as an independent non-executive director effective June 30, 2020[99] Future Outlook - Future outlook remains cautious due to market conditions influenced by the COVID-19 pandemic, with a focus on maintaining liquidity and managing operational costs[167] - The company continues to explore market expansion opportunities, particularly in the Greater China region, to enhance its competitive position[167] - The company expects revenue guidance for the next quarter to be between RMB 800 million and RMB 1 billion, reflecting a potential growth of 15% to 25%[172] - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share within the next two years[172] - A new product launch is scheduled for Q3 2020, anticipated to generate an additional RMB 200 million in revenue[172] - The company is exploring strategic acquisitions to enhance its product portfolio, with a budget of up to RMB 500 million allocated for this purpose[172] - The company aims to reduce operational costs by 15% over the next year through efficiency improvements[172]