（2）IMM01 联合阿扎胞苷(AZA) 治疗初治的高风险的骨髓增生异常综合征(1L HR-MDS)IMM01 has entered phase III clinical phase, and the long-term sales peak is expected to reach 1.05 billion yuan
(1) IMM01 combined with tirelizumab for recurrent refractory classic Hodgkin lymphoma (R/R cL) after failure of previous PD-1 antibody treatment
In the phase II clinical trial of IMM01 combined with tiralizumab against r/rCHL after failure of previous PD-1 antibody treatment, the best overall response was 8 CR (24.2%), 14 PR (42.4%), and 9 SD (27.3%), with an ORR of 66.7% and a DCR of 93.9% in 33 evaluable patients as of June 30, 2024. IMM01 combined with tirelizumab showed relatively good anti-tumor efficacy in R/R ChL after PD-1 treatment.
(2) IMM01 combined with azacitidine (AZA) for primary treatment of high-risk myelodysplastic syndrome (1L HR-MDS)
In the phase II clinical study of IMM01 combined with azacitidine (AZA) for primary treatment of high-risk myelodysplastic syndrome (1L HR-MDS), as of June 30, 2024, the complete remission rate CR was 33.3%, the objective remission rate ORR was 64.7%, and the disease control rate DCR was 88.2%; among patients treated for 6 months or more, the complete remission rate ORR reached 89.7%, and the disease control rate DCR was 89.7%. At 100%, efficacy increases significantly as treatment time is extended.
(3) Treatment of chronic myelomonocytic leukemia (1LCMML) with IMM01 combined with azacitidine (AZA)
In the phase II clinical study of chronic granulocytic leukemia (1L CMML) treated with IMM01 plus azacitidine (AZA) as of June 30, 2024, the complete remission rate CR was 27.3%, the objective response rate ORR was 72.7%, and the disease control rate DCR was 86.4%; among patients treated for 6 months or more, the complete remission rate reached 46.2%, the objective remission rate ORR reached 84.6%, and the disease control rate DCR reached 100 %. The curative effect is further improved as treatment time is extended.
Currently, the three indications of R/R ChL, first-line high-risk MDS, and first-line CMML are all in phase III clinical research, with a risk adjustment factor of 0.9. We assume that the penetration rate will reach 25%/23%/25%, respectively. According to estimates, IMM01's long-term sales peak is expected to reach 1.05 billion yuan.
The clinical trials of the two bispecific antibodies are progressing steadily, and the long-term sales peak is expected to reach 3.17 billion yuan
(1) IMM0306 is undergoing phase ib/II clinical trials
In January 2023, the NMPA approved a phase IB/IIa clinical trial application for IMM0306 in combination with lenalidomide for front-line treatment of B-cell non-Hodgkin lymphoma (B-NHL). The first patient was administered in June 2023. As of June 30, 2024, of the 11 evaluable patients, ORR was 90.9% and CR was 27.3%.
Currently, R/R B-NHL indications are in phase IB/II clinical research, with a risk adjustment factor of 0.5. We assume that the penetration rate of 2L and 3L patients will reach 15%/10%, respectively. According to estimates, the long-term sales peak of IMM0306 is expected to reach 1.08 billion yuan.
(2) Significant progress has been made in BD for IMM2510
In August 2024, the company signed an authorization and cooperation agreement with SynbioTX for IMM2510 and IMM27M to collect initial payments of no more than $50 million and potential upcoming payments, as well as milestone payments of no more than $2.1 billion.
Currently, the three indications of NSCLC, TNBC, and R/R STS are still in early clinical research, with a risk adjustment factor of 0.5. We assume that the penetration rate will reach 3%/15%/15%, respectively. According to estimates, IMM2510's long-term sales peak is expected to reach 2.09 billion yuan.
Profit forecasting and valuation
We expect the company's revenue for 2024-2026 to be 0.157/0.151/0.139 billion yuan, respectively; net profit to mother of -0.232/-0.23/-0.458 billion yuan, respectively.
According to the DCF valuation model, based on a sustainable growth rate of 3.69% and WACC of 7.83%, it is estimated that the reasonable market value is 7.045 billion yuan. First coverage, giving a “buy” rating.
Risk warning
Innovative drug development falls short of expectations; new product release falls short of expected risks; risks brought about by adjustments in health insurance payment policies; geopolitical risks.