company status

December 17, 2023, the company announced that TYK2 inhibitor ICP-332 treatment of moderate to severe atopic dermatitis (AD) phase II clinical study reached the primary endpoint.

comments

TYK2 inhibitors ICP-332 the release of phase II 4-week treatment of AD positive data, it is recommended to pay attention to the follow-up registration clinical development and long-term follow-up data. The phase II clinical trial is a randomized, double-blind, placebo-controlled trial. A total of 75 AD patients received 4 weeks of treatment. The percentage change of EASI score from baseline in the 80mg dose group and 120mg dose group was 78.2 and 72.5, respectively, and that in the placebo group was 16.7, with statistical difference (P<0.0001). EASI-75 was 64%/64% in the 80mg and 120mg dose groups, respectively, and 8% in the placebo group (P<0.0001). The safety of each dose group was good. We believe that ICP-332 the 4-week data released this time are not head-to-head compared with JAK inhibitors, the effect is faster and the score improvement is more promising, but different doses have not shown any difference in the short term, and long-term efficacy and safety still need to register clinical data. Nuocheng Jianhua is currently actively preparing to ICP-332 the development of Phase III registered clinical trials and plans to start in 2024.

1Q-3Q23 Obitinib sales by the policy and sales team to adjust the impact of the release slightly lower than expected, focus on blood tumor 24 years of new indications listed to declare the rhythm. Obutinib 1Q/2Q/3Q23 sales were 1.51/1.69/0.159 billion yuan, 3Q down 6.1 percent month-on-month, 1-3Q up 21.7 percent year-on-year, slightly lower than expected due to policy and sales team adjustments, we expect sales to increase slightly year-on-year in 2024. Based on the sales data of the competition, we believe that the domestic BTK inhibitor 1L CLL/SLL indication approval and entry into health insurance is expected to bring a large increase. The company expects orbitinib to submit NDA of 1L CLL/SLL in China in 2024 and r/r MCL to the United States in mid -2024.

focus on 2024 a number of catalytic data readout. In October 23, the Phase III registration of Obutinib for the treatment of primary immune thrombocytopenia was completed 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 and expects to communicate with CDE on the registration clinical protocol after interim analysis by the end of 2024. The global multi-center phase II interim clinical analysis of orbitinib for multiple sclerosis showed that all treatment groups met the primary endpoint and the clinical suspension is being lifted in communication with the FDA. The Company expects Phase II clinical trials of TYK2 inhibitor ICP-488 for psoriasis to be read out in 1H24.

earnings forecast and valuation

as the volume of orbitinib was slightly lower than expected due to the adjustment of sales team, we lowered our 23/24 revenue forecast by 8%/10% to 7.58/1.025 billion RMB due to good cost control of the company, as a result, we raised our net profit forecast for 23/24 from -7.60/-0.649 billion RMB to -7.13/-0.622 billion RMB. Adopt DCF valuation method, maintain OUTPERFORM sector rating and maintain A- share/H-share target price of Rmb12.58 and HK $13.52.

risk

clinical progress or data less than expected; product sales less than expected; increased competition; policy risk.