Gelonghui March 25 | Yiming Angko-B (01541.HK) announced annual results. The Group's loss during the year was reduced from RMB 402.9 million for the year ended December 31, 2022 to RMB 379.5 million for the year ended December 31, 2023. R&D expenses increased by 5.3% from RMB 277.3 million for the year ended 31 December 2022 to RMB 291.9 million for the year ended 31 December 2023, mainly due to (i) an increase of RMB 24.9 million in clinical trial expenses due to the progress of clinical drug candidates; and (ii) an increase of RMB 12.2 million in salary and related benefits due to the continuous expansion of the Group's clinical team in 2022, in line with the Group's continuous promotion and expansion of the drug pipeline R&D work; some of the pre-clinical and CMC expenses reduced people $13.7 million (offset by (i) reduced testing expenses for preparation of IND application submission for certain preclinical drug assets; and (ii) reduction of RMB 9.6 million in share-based payments (due to a decrease in the number of restricted shares already vested for the year ended 31 December 2023).
During the reporting period, drug pipeline development continued to be promoted rapidly, including the following milestones and achievements. Core product progress:
IMM01 (SIRPα-FC fusion protein)
• In January 2023, we obtained IND approval from the National Drug Administration for phase IB/IIa clinical trial to evaluate IMM01 in combination with bortezomib and dexamethasone in the treatment of multiple myeloma (MM).
• In June 2023, we completed patient recruitment for the phase II clinical trial of IMM01 combined with azacitidine as first-line treatment for high-risk myelodysplastic syndrome (MDS). As of December 31, 2023, among the 51 evaluable patients, the overall response rate (ORR) was 64.7% (33/51) and the complete remission rate (CRR) was 29.4% (15/51). Among patients treated for at least 4 months, ORR reached 85.3% (29/34) and CRR reached 44.1% (15/34). Among patients who have been treated for at least 6 months, ORR reached 89.3% (25/28) and CRR reached 53.6% (15/28), indicating that the efficacy continued to increase as the duration of treatment was prolonged.
• In March 2023, we completed patient recruitment for a phase II clinical trial of IMM01 combined with azacitidine as first-line treatment for chronic granulocytic monocytic leukemia (CMML). As of December 31, 2023, of the 22 evaluable patients, ORR was 72.7% (16/22) and CRR was 27.3% (6/22). Among patients treated for at least 4 months, ORR reached 87.5% (14/16) and CRR reached 37.5% (6/16). Among patients who have been treated for at least 6 months, ORR reached 84.6% (11/13) and CRR reached 46.2% (6/13), indicating that the efficacy continued to increase as the duration of treatment was prolonged.
• On January 19, 2023, we administered the first patient in the phase II clinical trial of patients with recurrent or refractory (R/R) classic Hodgkin lymphoma (cL) who relapsed or progressed after treatment with IMM01 and tirelizumab in combination with PD-1 inhibitors, and completed phase II recruitment in December 2023. As of March 1, 2024, of the 33 evaluable patients, 8 had achieved complete remission (CR) and 14 had partial remission (PR), ORR was 66.7%, and CRR was 24.2%. These results show encouraging anti-tumor efficacy, and are well tolerated and safe.
• In November 2023, the FDA granted IMM01 combined with azacitidine as an orphan drug for the treatment of CMML.