At the 2025 ASCO Meeting, Innovent gave multiple oral presentations on IBI363, a first-in-class PD-1/IL-2α BsAb, showcasing Phase I/II clinical data across three initial indications - NSCLC, CRC, and melanoma - with a focus on IO-resistant and immune-cold tumours.
　　Given the positive results, we raised our revenue forecasts to incorporate IBI363’s expected contribution alongside other core assets. Maintain BUY.
　　Key Factors for Rating
Significant overall survival benefit in 3L+ CRC. In a cohort of 68 advanced colorectal cancer (CRC) patients treated with IBI363 (0.1-3 mg/kg), the median overall survival (mOS) reached 16.1 months, markedly longer than the 6.4-9.3 months typically observed with standard care. Both subgroups - with and without liver metastases - showed encouraging outcomes, reporting mOS of 14.4 months and 17.0 months, respectively. In a subset of 22 patients treated at 1 mg/kg every two weeks (Q2W), the confirmed objective response rate (cORR) was 13.6%. Separately, among 73 patients receiving IBI363 combined with bevacizumab (0.6-3 mg/kg), the cORR was 15.1%, with a median progression-free survival (mPFS) of 4.7 months. OS data remained immature (median follow-up: 9.4 months). Notably, patients without liver metastases achieved an ORR of 31.3% and mPFS of 7.4 months. The safety profile was manageable: Grade ≥3 treatment-related adverse events (TRAEs) occurred in 27.9% of monotherapy patients and 35.6% of those on combination therapy.
Durable disease control in 2L+ acral and mucosal melanoma. In a cohort of 31 patients receiving IBI363 monotherapy (1 mg/kg Q2W), the cORR was 23.3% and disease control rate (DCR) reached 76.7%. Median PFS was 5.7 months, outperforming historical benchmarks (<3 months) seen with prior PD- 1 monoclonal antibodies, and mOS was 14.8 months. Grade ≥3 TRAEs occurred in just over 29% of patients, with treatment discontinuation due to TRAEs limited to one case (3.2%), reflecting a favourable safety profile in this challenging patient population.
Encouraging PFS in IO-resistant NSCLC. Among 136 patients treated (0.6- 3.0 mg/kg), the 3 mg/kg sqNSCLC cohort (n=67) demonstrated an mPFS of 9.3 months. OS data remained immature (median follow-up: 12 months), but results compared favourably with emerging therapies such as ADCs and other BsAbs.
　　Efficacy signals were also observed in PD-L1 TPS <1% low-expressing sqNSCLC, as well as in smoking-associated adenocarcinoma NSCLC. The safety profile remained acceptable, with Grade ≥3 TRAEs in 43% of patients, treatment discontinuation in 7%, and only one TRAE-related death (0.7%) reported.
　　Advancing to Phase III for broader validation. The U.S. FDA has granted Fast Track Designation, and China’s NMPA has granted Breakthrough Therapy Designation for IBI363 in indications including advanced sqNSCLC and melanoma. Innovent plans to launch two Phase III trials in 2H25: IBI363 monotherapy in IO-resistant sqNSCLC, and IBI363 plus bevacizumab in 3L microsatellite stable (MSS) CRC. Additionally, a head-to-head Phase II pivotal trial is underway comparing IBI363 to Keytruda in first-line acral/mucosal melanoma - marking a critical step toward global registration and commercialisation.
　　Key Risks for Rating
　　1) Delay or failure on clinical development of key assets; 2) breakdown of key partnerships; 3) slower-than-expected product launch or sales ramp-up.
　　Valuation
Following positive ASCO data, we revised our revenue projections upward to reflect expected contributions from IBI363 and other core assets. We estimate Innovent’s revenues at RMB11.4bn/14.2bn/17.9bn, respectively for 2025E/26E/27E.
We also raised terminal growth rate from 3.5% to 4.0%, while maintaining WACC at 11.1%. Our 10-year DCF model derived a new TP of HK$82. We forecast peak sales of RMB40.3bn for Innovent, implying a current Price-to-Peak Sales multiple of 2.8x. Maintain BUY.