Introduction to this report:
According to the 24-week data of the core product obutinib MS, the safety data is good, and it is expected to become a BIC product. The product pipeline continues to be enriched and clinical progress is smooth. It is expected to lead to the company's second growth curve and maintain its holdings and ratings.
Summary:
Maintain the “increase in holdings” rating. The company announced 223H1 revenue of 378 million yuan, up 53.5% year on year; of these, obutinib revenue was 321 million yuan (of which Q2 was 170 million yuan), up 47.81% year on year; net loss was 206 million yuan, a year-on-year decrease of 119 million yuan. R&D expenses amounted to 358 million yuan, up 30.93% year on year; management expenses amounted to 191 million yuan, up 2.77% year on year. Cash and equivalent goods on hand were 8.740 billion yuan. The increase over last year was mainly due to the listing of funds raised on the Science and Technology Innovation Board. Considering the potential restrictions on the admission of obutinib to the hospital in the second half of the year, the 23-25 revenue forecast was lowered to $838, 12.24, and $1,899 million (originally $983, 1,620, and $2,276 million). Using the absolute valuation method, the target price was lowered to HK$9.66 (-4.84) to maintain the rating for increasing holdings.
The core product obutinib MS has excellent clinical data and is actively expanding the indications. The global 24-week data for phase II of obutinib for MS treatment reached the main end point, significantly reducing disease progression in MS patients and showing an improvement trend in dose dependency. All three dose groups achieved new lesion control after 4 weeks of treatment, and the effects continued for 24 weeks. Compared with the placebo group (50 mg obutinib once a day after week 12), 80mg QD reduced Gd+T1 by 92.3% at 24 weeks, making it a potential BIC variant for treating MS. r/r MZL was approved for marketing, becoming the first and only BTK inhibitor with MZL indications in China; r/r MCL Singapore approved for listing; r/r MCL US has completed enrollment and is expected to submit an NDA in mid-2024; phase III of 1L CLL/SLL has been completed and is expected to be submitted to the NDA in 2024Q2; 1L DLBCL-MCD phase III clinical registration has been successfully carried out; ITP phase II clinical PoC has been completed and phase III trials have begun; SLE IIa clinical trials have begun in the field of self-exemption The data is positive, IIb accelerated enrollment, and results are expected in mid-2024.
The product pipeline continues to be enriched, and clinical progress is smooth. Tafasitamab was approved for sale in Hong Kong and imported for clinical use in Hainan and the Greater Bay Area. Tafasitamab+LEN treatment r/rdlBCl has completed patient enrollment. It is expected that 2024Q2 will be submitted to BLA, and 2025H1 will be approved for marketing.
ICP-332 (TYK2) treatment-specific dermatitis phase II is in progress, and data is expected to be read out by the end of 2023; ICP-488 (TYK2) phase I is complete, PoC is expected to be completed in 2023Q4, and phase II is being initiated; ICP-723 (Pan-TRK) registration is in progress, and NDA is expected to be submitted in 2024; and ICP-192 (Pan-FGFR) cholangiocarcinoma clinical trials are progressing smoothly.
Catalyst: Sales volume exceeded expectations, R&D progress exceeded expectations.
Risk warning: commercialization capabilities fall short of expectations; R&D falls short of expectations; risk of policy changes.