Overall, the company's recently disclosed CM310 moderate to severe atopic dermatitis data and CMG901's updated stage 1b gastric cancer data are consistent with previous historical data trends, are in line with expectations, and are steady, moderate and positive. Reiterates the “Buy” rating and target price of HK$58.
CM310 (IL-4Rα) 52-week atopic dermatitis efficacy data still maintained a better trend than Dupixent, in line with expectations; 52-week drug resistance currently appears to be lower than Dupixent, which is surprising: at week 52, the (CM310) group (dose: 300mg Q2W) EASI-75 compliance rate was 92.5%, the IGA score was 0/1, and the target rate was 67.3%, and the EASI-90 compliance rate was 77.1%, daily PP- The average weekly NRS score was ≥4 points lower than the baseline, and the compliance rate was 67.3% (N=476; 238 people in the test group and control group, respectively). Compared with Dupixent's 52-week efficacy data (global SOLO-CONTINUE test EASI-75 compliance rate was 71.6%; Korean real-world study EASI-75 compliance rate: 90.2%, EASI-90 compliance rate: 53.7%, PP-NRS: 65.6%), CM310 efficacy data maintained a slightly superior advantage over 52 weeks, in line with the previous 16-week data trend and our expectations. Serious adverse reactions (Serious AE) were 5.1%, and severe TEAE (severe TEAE) occurred during severe treatment (Severe TEAE) was 2.9%. Since TEAE discontinuation accounts for 2.5%, there are no new safety signals compared to the previously published 16-week data. We noticed that after 52 weeks of treatment, approximately 1.6% (4/238) developed treatment-induced anti-drug antibodies (ADA) in the CM310 group, but no neutralizing antibodies were detected.
Compared to Dupixent's 52-week 300mg Q2W global trial, 6% of patients developed ADA (of which 2% were persistent ADA) and 2% of patients developed neutralizing antibodies. It appears that patients with atopic dermatitis showed surprisingly lower resistance to CM310, which may help CM310 prolong its use in the real world.
CMG901 (CLDN18.2 ADC) 2+ gastric cancer indication disclosure updated phase 1b data, stable, moderate and positive, with the best potential in its class: Recently, Connoya announced the updated CMG901 phase I 2L+ gastric cancer data at the ASCO conference. As of February 24, 2024, in 89 evaluable GC/GEJC patients with high expression of CLDN18.2 in 89 evaluable GC/GEJC patients with high expression of CLDN18.2 (dose: 2.2/2.6/3.0 mg/kg, the previous median treatment line was 2 lines. High expression of CLDN18.2 is defined as CLDN18.2 staining intensity ≥2+ in 20% tumor cells). The overall confirmed ORR was 35%, and the confirmed DCR was 70%, of which the confirmed ORR in the 2.2 mg/kg dose group was 48%; in all 93 cases, 18.2 high-expression GC/GEJC mPFs were 4.8 m, and MOs was 11.8 m. Compared with the previously announced first-phase dose extension data (n = 89, ORR = 33%, DCR= 70%, of which ORR = 42% in the 2.2 mg/kg dose group; n = 93, mPFS 4.76m), the overall ORR and 2.2 mg/kg dose group ORR announced this time were further improved, and mPFS also improved slightly. In terms of 2L+GC/GEJC indications, CMG901 published first-phase efficacy data with the largest sample size among similar CLDN18.2 ADC drugs and showed best-in-class ORR in the 2.2 mg/kg dose group (other published CLDN18.2 ADC ORRs were between 30-47%, and sample sizes ranged from single digits to 30+ patients). In terms of safety, the proportion of grade 3 or above AEs and severe TRAE is similar to the previously disclosed data.
The main catalysts in 2024 include: 1) CM310: approved for adult atopic dermatitis (expected by the end of the year), application for chronic sinusitis with nasal polyps (expected mid-2024); 2) Other important data readouts: CM326 (TSLP) phase 1b/2a rhinitis data published, CM313 (CD38) phase 1b SLE data reading (expected 2H24), and CM336 (BcMaxCD3) phase 1 data reading.
Reiterating our “Buy” rating and target price of HK$58.
Investment risk: Commercialization falls short of expectations, development delays, or clinical trial data falls short of expectations.