Financial Performance - Total revenue for the six months ended June 30, 2024, was zero, a decrease of 100% from RMB 46.5 million in the same period of 2023, primarily due to reduced market demand for Ritonavir products following effective control of COVID-19 in mainland China [3]. - The total revenue decreased by 59.7% to approximately RMB 49.0 million for the six months ended June 30, 2024, from approximately RMB 121.5 million in the same period of 2023 [5]. - Total revenue for the period was RMB 49,004,000, down from RMB 75,041,000 in the previous year, indicating a decline of about 34.7% [86]. - The company reported a total comprehensive loss of RMB 121,630,000 for the period, compared to a total comprehensive income of RMB 37,253,000 in the previous year [88]. - The company reported a loss attributable to ordinary equity shareholders of RMB 130,318,000 for the six months ended June 30, 2024, compared to a loss of RMB 16,559,000 for the same period in 2023 [111]. Research and Development - Research and development expenses increased by 43.5% to approximately RMB 132.4 million for the six months ended June 30, 2024, compared to RMB 92.3 million for the same period in 2023 [5]. - The company announced positive interim results from the Phase II clinical trial of ASC41 for treating NASH patients confirmed by liver biopsy [5]. - ASC40's Phase IIb FASCINATE-2 clinical trial for treating NASH also reported positive topline results, indicating progress in metabolic disease treatment [5]. - The company has made significant advancements in internal drug discovery for metabolic diseases during the reporting period [5]. - The company is focusing on ten key clinical stage assets targeting viral diseases, metabolic diseases, and tumors [25]. Cash and Liquidity - Cash and cash equivalents, along with other liquid assets, amounted to approximately RMB 2,117.2 million as of June 30, 2024, compared to RMB 2,516.4 million as of June 30, 2023, expected to support R&D activities until 2028 [5]. - As of June 30, 2024, the company had cash and cash equivalents of approximately RMB 2,117.2 million, sufficient to support R&D activities until 2028 [26]. - The company's cash and cash equivalents stood at RMB 342,994,000 as of June 30, 2024, compared to RMB 330,117,000 at the end of 2023, showing a slight increase of about 3.6% [89]. Clinical Trials and Product Development - ASC22 for chronic hepatitis B has shown a significant HBsAg decline with 21.1% (4 out of 19) of patients achieving HBsAg clearance after 24 weeks of treatment [12]. - ASC10, an oral prodrug for RSV, has demonstrated an EC50 of 0.51 to 0.6 µM against two clinical strains in vitro, indicating strong efficacy [13]. - ASC40, an oral small molecule targeting FASN for NASH, has received fast track designation from the US FDA [9]. - The Phase III trial for ASC40 in rGBM has completed patient enrollment, targeting approximately 180 patients for progression-free survival analysis [18]. - The company plans to submit Phase II data for ASC40 in 2024 and discuss registration trials with regulatory authorities [16]. Shareholder and Corporate Governance - The company’s chairman and CEO positions are held by the same individual, which the board believes enhances efficiency [65]. - The company confirmed compliance with corporate governance codes during the reporting period [65]. - The company did not recommend the payment of an interim dividend for the six months ending June 30, 2024 [79]. - The independent auditor, KPMG, reviewed the interim financial information and found it compliant with applicable accounting standards [78]. Employee and Management Costs - The total employee cost for the six months ended June 30, 2024, was approximately RMB 76.8 million, an increase from RMB 55.3 million for the same period in 2023, primarily due to payments made to R&D personnel [61]. - Total remuneration for key management personnel for the six months ended June 30, 2024, was RMB 44,544,000, significantly up from RMB 14,842,000 in the same period last year [130]. Legal and Regulatory Matters - The company has ongoing litigation with Viking Therapeutics regarding candidate drugs ASC41 and ASC43F, with no provisions made as of June 30, 2024 [128]. - The company incurred litigation expenses of RMB 20,459,000 for the six months ended June 30, 2024, compared to RMB 6,013,000 for the same period in 2023 [108]. Future Outlook and Strategy - The company plans to enhance its digital marketing strategies, aiming for a 20% increase in online engagement by the end of 2024 [135]. - The company is expanding its market presence in the Greater China region, targeting a market share increase of CC% by the end of 2024 [133]. - The company has established partnerships with leading research institutions to accelerate the development of its pipeline products [134].
歌礼制药-B(01672) - 2024 - 中期财报