Financial Performance - Revenue for the six months ended June 30, 2025, was RMB 53.2 million, a decrease of 12.5% from RMB 60.8 million for the same period in 2024[8]. - Loss for the period decreased significantly by 54.5% to RMB 76.4 million from RMB 167.0 million in the previous year[10]. - Adjusted loss for the period was RMB 72.9 million, a reduction of 52.2% from RMB 152.6 million in the same period last year[11]. - Total comprehensive loss for the period was RMB 87,994,000, compared to RMB 168,242,000 in 2024, marking a 47.8% decrease[123]. - The company reported a loss attributable to ordinary shareholders of RMB 76,378,000 for the six months ended June 30, 2025, a significant improvement from a loss of RMB 167,033,000 in the same period of 2024[157]. Income and Expenses - Other income and gains increased to RMB 38.1 million, up 39.5% from RMB 27.3 million in the prior year[9]. - R&D expenses decreased by 38.9% to RMB 79.9 million from RMB 130.8 million in the previous year[10]. - Sales and distribution expenses reduced by 33.9% to RMB 37.0 million compared to RMB 56.0 million in the same period last year[10]. - Administrative expenses fell by 32.8% to RMB 39.3 million from RMB 58.5 million in the prior year[10]. - The cost of goods sold for the six months ended June 30, 2025, was RMB 10,274 thousand, an increase from RMB 8,856 thousand in 2024, reflecting a rise of approximately 16%[143]. Product Development and Pipeline - The company’s product pipeline and business operations achieved significant progress during the reporting period[12]. - The commercialized asset includes ATG-022, a Claudin 18.2 antibody-drug conjugate, which is in clinical development[13]. - ATG-031 is currently undergoing a Phase I trial in the U.S. for advanced solid tumors[16]. - The company is developing multiple bispecific antibodies targeting various cancers, including ATG-201 for B-cell related autoimmune diseases and ATG-106 for ovarian and kidney cancers[27]. - The company has ongoing global clinical trials in collaboration with partners for its pipeline products[27]. Regulatory Approvals and Market Expansion - XPOVIO® (Selinexor) has been approved for inclusion in Taiwan's National Health Insurance as of March 1, 2025, for adult patients with relapsed/refractory multiple myeloma (rrMM) who have received at least two prior lines of therapy[14]. - The company has received NDA approvals for XPOVIO® in multiple regions including mainland China, Taiwan, Hong Kong, Macau, South Korea, Singapore, Malaysia, Thailand, Indonesia, and Australia[25]. - The company is focused on expanding its market presence in the Asia-Pacific region with its pipeline products[27]. - The company entered a commercialization agreement with Hansoh Pharmaceutical for the drug Xivivo® (Selinexor) in mainland China, with a potential upfront payment of up to RMB 200 million[33]. Corporate Governance and Leadership - The board of directors has committed to maintaining high standards of corporate governance to protect shareholder interests[89]. - The roles of the chairman and CEO are currently held by the same individual, Dr. Mei Jianming, which the board believes facilitates effective execution of strategic initiatives[89]. - The company has a strong leadership team, including CFO Long Zhen Guo, who has over 20 years of experience in investment banking and asset management[77]. - The management team is committed to strategic planning and market expansion to drive future growth[85]. - The company aims to leverage its experienced board and management team to navigate market challenges and capitalize on growth opportunities[85]. Shareholder Information and Equity Incentives - As of June 30, 2025, Dr. Jay Mei holds a total of 184,267,994 shares, representing approximately 27.12% of the company's equity[98]. - The total number of shares held by major shareholders includes 175,927,994 shares owned by JAY MEI 2025 GRAT, accounting for 25.89% of the equity[101]. - The company has various stock options and restricted share units granted to executives, which may influence future shareholdings[98]. - The company has granted a total of 42,814,766 stock options, with 2,048,000 options being canceled or expired during the reporting period[107]. - The company aims to retain and attract talent through the Restricted Share Unit Plan, which vests over a four-year period[170].
德琪医药(06996) - 2025 - 中期财报