Introduction to this report:

The HR of Ivorax vs K drug ITT population reached 0.51, and all subgroups benefited significantly; squamous cell carcinoma had excellent safety, breaking through the shackles of traditional anti-VEGF treatments; Summit added a first-line NSCLC clinical plan. Maintain an “Overweight” rating.

Key points of investment:

Maintain an “Overweight” rating. Evosi's clinical data is impressive. The company's core products are rapidly entering the harvest period, raising the 2024-2026 revenue forecast to 2.924/4.769/6.595 billion yuan (originally 2.907/4.697/6.457 billion yuan), maintaining the “gain” rating.

Evosil vs K achieved record results. The ITT population's HR reached 0.51, and all subgroups benefited significantly. The results of the Evosi Harmoni-2 study were published at WCLC. Among ITT people with PD-L1 TPS ≥ 1%, the MPFS of the Ivorsi group compared to the K drug group was 11.14 vs 5.82 months, and the HR reached 0.51 (49% reduction in the risk of disease progression/death in the Evosi group); compared with the K group, the Evarosi group also had higher ORR (50.0% vs. 38.5%) and DCR (89.9% vs. 70.5%), showing excellent overall efficacy. Furthermore, the Evosi group showed strong positive PFS in each subgroup analysis: PD-L1 TPS ≥ 50% HR = 0.46, PD-L1 TPS 1-49% HR = 0.54; squamous cell carcinoma HR = 0.48, non-squamous cell carcinoma HR = 0.51; HR in the with/without liver metastasis subgroup was 0.47/0.53, respectively; HR in the with/without liver metastasis subgroup was 0.55/0.53, respectively.

Squamous cell carcinoma patients have excellent safety, breaking through the barriers of traditional anti-VEGF therapy. The overall incidence of grade 3 TRAE between evosil and K drugs was comparable (22.2% vs 18.7%); among those, among squamous cell carcinoma patients with traditional anti-VEGF treatment (72.2% of squamous cell carcinoma patients were central, 10.0% had cavity/necrosis, and 6.7% had tumors surrounding important blood vessels), the risk of bleeding did not increase significantly. The incidence of VEGF-related grade 3 AEs was 10.2% vs 1.0%. The safety was excellent, breaking through the safety barriers brought about by traditional anti-VEGF treatments (such as The incidence of VEGF-related grade 3 AEs with K drug+lenvatinib in the LEAP-007 study was 57.9%), which is expected to translate into significant survival benefits.

A number of clinical trials have been promoted efficiently, and Summit added a first-line NSCLC clinical plan. Evosi 1L PD-L1 (+) NSCLC is already in the SNdA stage, and many subsequent phase III clinical trials are progressing one after another, including 1L squamous NSCLC (combination chemotherapy), 1L biliary tract cancer, 1L esophageal squamous cell cancer, 1L pancreatic cancer, etc., and partner Summit led the development of 2 global multi-center phase III clinical trials, namely evosil+ chemotherapy for EGFR-TKI treatment progress; According to this data disclosure, Summit also announced plans to launch a 1L global phase III clinical trial of NSCLC with high PD-L1 expression (TPS > 50%) and K drugs at 25H1.

Risk factors: the risk of uncertainty in the development of new drugs; the risk that commercialization progress falls short of expectations.