Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 72,016 thousand, an increase of 33.4% compared to RMB 53,956 thousand for the same period in 2022[2] - The loss for the period was RMB (218,694) thousand, compared to RMB (144,451) thousand in the same period last year, reflecting a year-over-year increase in loss of 51.5%[2] - The adjusted loss for the period, excluding foreign exchange gains, was RMB (281,690) thousand, compared to RMB (270,659) thousand in the previous year, indicating a slight increase in adjusted loss[2] - Loss for the period increased from RMB 1,445 million for the six months ended June 30, 2022, to RMB 2,187 million for the six months ended June 30, 2023, an increase of RMB 742 million[12] - The company reported a loss attributable to ordinary shareholders of RMB 218.694 million for the six months ended June 30, 2023, compared to a loss of RMB 144.451 million for the same period in 2022[146] - The company reported a total comprehensive loss of RMB 57,549 thousand for the six months ended June 30, 2023, compared to RMB 49,365 thousand in the same period of 2022, indicating a 16.5% increase in losses[101] Research and Development - Research and development costs increased to RMB (226,093) thousand, up 26.0% from RMB (179,407) thousand in the prior year[2] - R&D expenses increased from RMB 1,794 million for the six months ended June 30, 2022, to RMB 2,261 million for the six months ended June 30, 2023, primarily due to increased licensing fees and R&D personnel costs by RMB 467 million[12] - The company is conducting multiple Phase I trials for new assets, including ATG-017, ATG-101, and ATG-037, targeting various cancers[5][7] - The company received IND approval from the FDA for ATG-031 to initiate a Phase I trial for treating advanced solid tumors or B-NHL patients in May 2023[5] - The company has initiated a Phase I trial for ATG-022 (Claudin 18.2 antibody-drug conjugate) and has observed partial responses prior to the predicted effective dose range[72] - The company is conducting a Phase I trial of ATG-037 (CD73 inhibitor) in combination with pembrolizumab, with 13 patients currently enrolled in the combination therapy[74] Product Pipeline and Approvals - The company submitted a New Drug Application (NDA) for XPOVIO® (Selinexor) in Indonesia in May 2023 for the treatment of relapsed/refractory multiple myeloma and relapsed/refractory diffuse large B-cell lymphoma[3] - The company has received NDA approvals for XPOVIO® (Selinexor) in mainland China, South Korea, Singapore, Australia, Taiwan, and Hong Kong[21] - XPOVIO® (Selinexor) received NDA approval for the treatment of relapsed/refractory multiple myeloma in July 2023, and a supplemental NDA was submitted for its use in combination with bortezomib and dexamethasone[33] - The company has secured exclusive global rights for the development and commercialization of ATG-017, a mTORC1/2 inhibitor, from AstraZeneca[32] - The company announced significant progress in its product pipeline and operations during the reporting period, including the latest results of the I/II phase TORCH-2 study presented at ASCO 2023[14] Financial Position and Assets - Current assets decreased to RMB 1,445,151 thousand as of June 30, 2023, down from RMB 1,896,080 thousand at the end of 2022, reflecting a decline of 23.7%[80] - The total equity attributable to owners of the parent company was RMB 1,466,336 thousand as of June 30, 2023, down from RMB 1,713,322 thousand at the end of 2022, representing a decrease of 14.4%[81] - The company's net assets decreased to RMB 1,466,336,000 from RMB 1,713,322,000 at the end of 2022[113] - As of June 30, 2023, the company's cash and bank balance was RMB 1,322.4 million, down from RMB 1,789.6 million as of December 31, 2022, mainly due to operating expenses and milestone payments[183] Strategic Partnerships and Collaborations - The company has partnered with Karyopharm for the commercialization of XPOVIO® in multiple regions, enhancing its market presence[34] - The company entered into an exclusive collaboration agreement with Jiangsu Hengrui Medicine Co., Ltd. for the commercialization of XPOVIO® in mainland China, with potential upfront payments of up to RMB 200 million[71] - The company is actively expanding its product pipeline and exploring new therapeutic areas through strategic partnerships and collaborations[31] Clinical Trials and Results - The open-label Phase II study of Eltanexor (ATG-016) for high-risk myelodysplastic syndromes is currently ongoing in mainland China[15] - The objective response rate (ORR) for the combination therapy of ATG-008 (onatasertib) and pembrolizumab in recurrent/metastatic cervical cancer patients was 52.4%, based on early data from 21 patients[38] - In the TORCH-2 study, the ORR for PD-L1 positive subjects was 77.8% (7 out of 9 patients) and the median progression-free survival (PFS) for all treated patients was 5.5 months[38] - The ORR for ATG-008 monotherapy in the open-label Phase II TORCH trial for HBV+ unresectable HCC patients was 16.7%, with a median duration of response (DOR) of 4.3 months[38] Governance and Compliance - The audit committee consists of three independent non-executive directors, ensuring compliance with listing rules[196] - The independent auditor, Ernst & Young, conducted a review of the interim financial information for the six months ending June 30, 2023[197] - The company plans to continue reviewing its corporate governance practices, including the separation of the roles of Chairman and CEO[189]
德琪医药-B(06996) - 2023 - 中期业绩