The company's recent situation
On December 17, 2023, the company announced that the phase II clinical study of the TYK2 inhibitor ICP-332 for the treatment of moderate to severe atopic dermatitis (AD) had reached a major end point.
reviews
The TYK2 inhibitor ICP-332 published positive data on phase II AD treatment for 4 weeks. It is recommended to focus on clinical development and long-term follow-up data for subsequent registration. The phase II clinical trial was a randomized, double-blind, placebo-controlled trial. A total of 75 AD patients were treated for 4 weeks. The percentage change in EASI scores of patients in the 80mg dose group and 120mg dose group once a day from baseline was 78.2% and 72.5%, respectively, and the placebo group was 16.7%, with statistical differences (P<0.0001). EASI-75 was 64%/64% in the 80 mg and 120 mg dose groups, respectively, and 8% in the placebo group (P<0.0001). The safety of all dosage groups was good. We believe that the four-week data released for ICP-332 is not head-to-head. Compared with JAK inhibitors, the effects are faster and there is more potential for score improvement, but the different doses have not shown any differences in the short term, and long-term efficacy and safety still need to register clinical data. Nuochengjianhua is currently actively preparing for the launch of the ICP-332 phase III registered clinical trial and is planning to begin in 2024.
1Q-3Q23 obutinib sales were affected by policy and sales team adjustments, and the volume was slightly lower than expected, focusing on the pace of new indications for hematoma in 24 years. Obutinib's 1Q/2Q/3Q23 sales were 1.51/1.69/159 million yuan, respectively. 3Q fell 6.1% month-on-month, and 1-3Q increased 21.7% year-on-year. The volume was slightly lower than expected due to policy and sales team adjustments. We expect sales in 2024 to increase slightly year-on-year. Based on competitive zebutinib sales data, we believe that approval of the domestic BTK inhibitor 1L CLL/SLL indication and entry into medical insurance is expected to bring about a significant increase. The company expects obutinib to submit an NDA for 1L CLL/SLL domestically in 2024, and submit a listing application for r/r MCL to the US in mid-2024.
Focus on the readout of multiple catalytic data in 2024. In October '23, the phase III registered clinical trial of obutinib for primary immune thrombocytopenia completed the administration of the first patient in China. Based on the positive results of the phase IIa clinical trial for systemic lupus erythematosus, the company has initiated a phase IIb clinical trial in China. It is expected that the clinical plan will be communicated with the CDE for registration after a mid-term analysis by the end of 2024. A mid-term global multi-center phase II clinical analysis of obutinib for multiple sclerosis showed that all treatment groups had reached the main end point and were communicating with the FDA to lift the clinical suspension. The company anticipates that the phase II clinical trial of the TYK2 inhibitor ICP-488 for psoriasis will read psoriatic phase I data in 1H24.
Profit forecasting and valuation
Since obutinib was affected by sales team adjustments and the volume was slightly lower than expected, we lowered our 23/24 revenue forecast by 8%/10% to 758/1,025 million yuan. Due to the company's good cost control, we raised our net profit forecast for 23/24 from -760/-649 million yuan to -7.13/-622 million yuan. Adopting the DCF valuation method, it maintained an outperforming industry rating and maintained the target prices for A shares/H shares at RMB 12.58 and HK$13.52.
risks
Clinical progress or data falls short of expectations; product sales fall short of expectations; increased competition; policy risk.