Financial Performance - Total revenue for the six months ended June 30, 2021, was RMB 18.1 million, a decrease of RMB 1.3 million from RMB 19.4 million for the same period in 2020[7]. - The loss for the period was RMB 233.0 million, a reduction of RMB 304.7 million from RMB 537.7 million in the prior year[10]. - Adjusted loss for the period, excluding certain expenses, was RMB 209.9 million, an increase of RMB 73.4 million from RMB 136.5 million in the prior year[13]. - The company reported a pre-tax loss of RMB 2,329.95 million for the six months ended June 30, 2021, compared to a loss of RMB 5,377.47 million for the same period in 2020, indicating a significant reduction in losses[59]. - The total loss for the period was RMB 2,329.95 million for the six months ended June 30, 2021, compared to RMB 5,377.47 million for the same period in 2020, indicating improved financial performance[59]. - The company reported a net loss of RMB 232,995 thousand for the six months ended June 30, 2021, compared to a net loss of RMB 537,747 thousand for the same period in 2020, representing a 56.7% improvement in losses year-over-year[168]. Research and Development - R&D expenses decreased to RMB 135.3 million for the six months ended June 30, 2021, down RMB 34.6 million from RMB 169.9 million in the prior year[7]. - The company plans to continue focusing on R&D and expanding its clinical trials to enhance its product pipeline[7]. - The company has made steady progress in its preclinical pipeline, including assets such as ATG-101 (PD-L1/4-1BB bispecific antibody) and ATG-037 (CD73 inhibitor)[25]. - The company has a pipeline of 13 oncology drug assets, with 5 having Asia-Pacific rights and 8 having global rights[31]. - The company is advancing several preclinical candidates, including ATG-018 (ATR inhibitor) and ATG-012 (KRAS inhibitor), with IND applications planned for early 2022[46]. Clinical Trials and Approvals - The company received IND approval from the National Medical Products Administration (NMPA) for the global Phase II/III study of Selinexor (ATG-010) in combination with Rituximab, Gemcitabine, Dexamethasone, and Cisplatin for treating relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) on January 25, 2021[15]. - The NMPA accepted the New Drug Application (NDA) for ATG-010 for treating relapsed/refractory multiple myeloma (rrMM) on January 28, 2021, and granted priority review on February 24, 2021[15]. - The company announced a total response rate (ORR) of 26.7% in the Phase II MARCH trial for Selinexor combined with low-dose Dexamethasone in Chinese patients with rrMM, with an ORR of 33.3% in patients previously treated with three drug classes[17]. - The NMPA accepted an IND application for a Phase II study to evaluate the safety and efficacy of Selinexor in treating patients with myelofibrosis on July 6, 2021[20]. - The company submitted an NDA to the Taiwan Food and Drug Administration (TFDA) for Selinexor for three indications on July 14, 2021, marking the sixth NDA submission for ATG-010 in various regions[20]. Financial Position - As of June 30, 2021, the company's cash and bank balances were RMB 2,806.5 million, down from RMB 3,109.8 million as of December 31, 2020, primarily due to R&D costs and administrative expenses[72]. - Current assets totaled RMB 2,876.2 million, with current liabilities of RMB 122.2 million, resulting in a current ratio of 2,352.8% as of June 30, 2021, up from 2,077.0% at the end of 2020[77]. - The company's debt-to-asset ratio was 4.4% as of June 30, 2021, a slight decrease from 4.9% at the end of 2020[78]. - The company reported a foreign exchange gain of RMB 5,310 thousand in other comprehensive income for the first half of 2021[171]. - The company’s total equity attributable to owners increased to RMB 6,385,298,000 as of June 30, 2021, from RMB 6,383,316,000 at the beginning of the year[176]. Management and Governance - Dr. Kevin Patrick Lynch appointed as Chief Medical Officer in April 2021, with nearly 30 years of R&D experience in the pharmaceutical industry[89]. - Mr. Long Zhen Guo appointed as Chief Financial Officer in June 2020, with over 16 years of experience in investment banking and asset management[90]. - The company is focused on overall medical development and strategic planning under the leadership of its executive team[89]. - The board includes members with diverse expertise in finance, investment, and pharmaceutical development, enhancing the company's strategic direction[93]. - The company aims to leverage its leadership's extensive experience to drive growth and innovation in the healthcare sector[94]. Shareholder Information - As of June 30, 2021, the company’s board members and executives hold a total of 179,927,994 shares, representing approximately 26.81% of the total shares outstanding[119]. - The major shareholder, JAY MEI 2020 GRAT, holds 175,927,994 shares, accounting for 26.21% of the total shares[128]. - Boyu Capital Group Holdings Ltd. owns 73,789,650 shares, which is 10.99% of the total shares[128]. - The company has a total of 4,000,000 stock options granted to Dr. Mei Jianming, subject to vesting conditions[123]. - The company’s major shareholders include several investment firms, indicating a diversified ownership structure[128]. Use of Proceeds - The net proceeds from the IPO and the exercise of the over-allotment option amounted to approximately RMB 2,274.70 million[115]. - 41% of the net proceeds is allocated for ongoing and planned clinical trials and milestone payments for two core products, with RMB 62.37 million utilized as of June 30, 2021[116]. - 25% of the net proceeds is designated for ongoing and planned clinical trials and milestone payments for four other clinical-stage candidates, with RMB 33.46 million utilized[116]. - The total unutilized net proceeds as of June 30, 2021, amounted to RMB 1,907.12 million[116]. - The company plans to utilize the remaining proceeds in accordance with the business needs and future developments[115].
德琪医药-B(06996) - 2021 - 中期财报