Incidents:
The company announced that the National Drug Administration (NMPA) Drug Evaluation Center (CDE) has officially accepted a new drug marketing application (NDA) for tetuumab injection (recombinant anti-insulin-like growth factor 1 receptor antibody (IGF-1R antibody), R&D code: IBI311) for the treatment of thyroid eye disease (TED).
Comment:
The results of the phase 3 registered clinical study of tetuumab injection were positive. Detailed data will be published in academic journals.
The acceptance of this new drug application is based on the positive results of a phase 3 registered clinical study RESTORE-1 (ID: CTR20223 393) conducted among Chinese TED subjects. The study successfully reached the main study end point in February 2024. The study showed that the IBI311 group showed that improvements in eye prominence, degree of disease activity, and quality of life of the subjects were significantly superior to those in the placebo group. During the study and treatment, the overall safety of tetuumab was good, and no new safety signals were found. Detailed data plans for the RESTORE-1 study will be published at the 2024 academic conference and in academic journals.
Currently, domestic TED treatments are limited, and there are prospects for commercialization of tetuzumab.
As an autoimmune disease involving eye tissue, the estimated annual incidence of TED is 16/100,000 (women) and 2.9/100,000 (men), with a prevalence rate of 0.1-0.3%. Currently, for TED treatment, many overseas clinical treatment guidelines have included antibody biologics targeting IGF-1R in recommended treatment plans. In particular, for TEDs combined with prominent and prominent TEDs, antibody biologics targeting IGF-1R can be the first choice. Currently, there are limited treatment options for TED in China. As the first IGF-1R antibody drug to submit an NDA in China, IBI311 is expected to fill significant unmet clinical needs.
Profit forecast, valuation and rating: Maintain the forecast that the company's revenue for 2024-2025 will be 76.44/9.473 billion yuan, and an additional forecast of 2026 will be 11.455 billion yuan, an increase of 23.17%/23.93%/20.92% over the previous year.
Considering the increase in sales expenses of the new drug after the launch of the new drug and the continued increase in R&D investment, we lowered the net profit to the mother from 2024 to 2025 to -6.33/306 million yuan (the original forecast was 0.23/1,402 million yuan), and the additional forecast was 1.33 billion yuan for the company's net profit to the mother in 2026. According to the latest share capital estimate, EPS was -0.39/0.19/0.82 yuan. The sales performance of the company's core products is strong, and many major products have entered the advanced clinical stage. As a domestic star innovative pharmaceutical company, we are optimistic about the company's rich commercial product portfolio, providing complete comprehensive solutions for a wider and more segmented patient group, and maintaining a “buy” rating.
Risk warning: risk of R&D progress falling short of expectations; risk of sales falling short of expectations; risk of international cooperation falling short of expectations.