Financial Performance - No revenue was generated for the six months ended June 30, 2021, and June 30, 2020 [12]. - Adjusted loss increased by RMB136.2 million or approximately 83.2% from RMB163.7 million for the six months ended June 30, 2020, to RMB299.9 million for the six months ended June 30, 2021 [12]. - The company has not generated any revenue from drug sales and has incurred operating losses each year since inception, with total comprehensive losses of RMB195.4 million and RMB325.8 million for the six months ended June 30, 2020, and 2021, respectively [96]. - The operating loss for the period was RMB 324,401,000, compared to an operating loss of RMB 193,462,000 for the same period in 2020, indicating a deterioration of 77.9% [168]. - The company reported a total comprehensive loss of RMB (325,821,000) for the period ended June 30, 2021, compared to a loss of RMB (195,447,000) for the same period in 2020, reflecting a worsening financial performance [176]. Research and Development - R&D costs increased by RMB133.8 million or 90.2% from RMB148.4 million for the six months ended June 30, 2020, to RMB282.2 million for the six months ended June 30, 2021 [12]. - Clinical research expenses accounted for RMB158.2 million or 56.1% of total R&D costs for the six months ended June 30, 2021, compared to RMB54.5 million or 36.7% for the same period in 2020 [109]. - The increase in R&D costs was mainly driven by the advancement of clinical trials for Proxalutamide for COVID-19 [114]. - The company has established an integrated R&D platform to support drug development from discovery to clinical trials [75]. - The company is employing PROTAC technology to develop compounds targeting AR and other unmet medical needs globally [78]. Clinical Trials and Product Development - Proxalutamide (GT0918) is being researched for COVID-19 treatment, showing positive effects on patients with mild to moderate symptoms [14]. - Two registered phase III MRCTs for Proxalutamide are being conducted for mild to moderate COVID-19 patients and one for inpatients in multiple regions including the United States and Europe [14]. - Pyrilutamide (KX-826) has met the primary endpoint in its phase II clinical trial for androgenetic alopecia in China, with plans to initiate phase III trials for males and phase II trials for females in Q4 2021 [19][20]. - ALK-1 (GT90001) is undergoing phase II clinical trials in Taiwan and the US for metastatic HCC, with potential for accelerated approval based on favorable data [22][25]. - Proxalutamide is in clinical trials for mCRPC and metastatic breast cancer, with patient enrollment completed on August 25, 2021 [29]. Financial Position and Cash Flow - Cash and cash equivalents increased by RMB167.3 million from RMB1,065.6 million as at 31 December 2020 to RMB1,232.9 million as at 30 June 2021, primarily attributable to net cash proceeds of approximately HK$1.16 billion received from the Subscription [129]. - The company reported net current assets of RMB 1,852.7 million as of June 30, 2021, indicating sufficient liquidity to meet financial obligations and fund R&D activities [166]. - The net cash used in operating activities was RMB431.8 million, compared to RMB162.2 million for the same period in 2020, representing a 166.5% increase [134][135]. - The company generated net cash from financing activities of RMB 842,207,000 for the six months ended June 30, 2021, compared to RMB 1,792,803,000 for the same period in 2020, showing a decline in financing inflows [178]. - The total assets of the company as of June 30, 2021, amounted to RMB 2,400,919,000, an increase from RMB 1,851,475,000 as of December 31, 2020, representing a growth of 29.6% [170]. Regulatory and Licensing - The company has received emergency use authorization (EUA) for Proxalutamide in Paraguay, marking it as the first of its kind globally, and has entered licensing agreements for commercialization in India, 28 African countries, and Indonesia [17][18]. - The company received FDA approval for the Phase III clinical trial of Proxalutamide for treating mild to moderate COVID-19 patients on March 5, 2021, and completed first patient enrollment in the U.S. by April 25, 2021 [41]. - The company announced a licensing agreement with Fosun Pharmaceutical for the commercialization of Proxalutamide in India and 28 African countries on July 14, 2021 [45]. Employee and Administrative Expenses - Administrative expenses increased by RMB4.6 million or 10.2% from RMB45.0 million for the six months ended June 30, 2020, to RMB49.6 million for the six months ended June 30, 2021 [12]. - Employee benefit expenses, including share-based compensation, accounted for RMB31.7 million or 63.9% of total administrative expenses for the six months ended June 30, 2021 [100]. - The increase in administrative expenses was mainly due to new recruitments and annual remuneration adjustments, as well as increased repair and maintenance expenses for self-owned properties [103]. - The company has established a sales and marketing team of 16 members as of June 30, 2021, to prepare for the commercialization of its core products [84]. Market Potential and Strategic Focus - The global patient population for COVID-19 exceeds 220 million, with prostate cancer being the fastest-growing cancer type from 2015 to 2019, and breast cancer being the most common among women in 2019 [23][26]. - The market for androgenetic alopecia includes over 133.7 million patients in China and 83.1 million in the US, highlighting significant commercial potential for the company's products [23][26]. - The drug candidate portfolio strategically targets COVID-19, major cancers, and other AR-related indications, reflecting a risk-balanced and diversified approach [25][28]. - The company is committed to developing its core products for various indications to address unmet clinical needs and contribute to global health [23][26].
开拓药业(09939) - 2021 - 中期财报