Introduction to this report:
Tafasitamab's BLA application was accepted by the NMPA and included in priority approval. It has excellent efficacy data, good safety, BIC potential, is optimistic about future release, and maintains an “increase” rating.
Key points of investment:
Incident: The company announced that the BLA application for CD19 tafasitamab combined with lenalidomide for r/R DLBCL not suitable for autologous stem cell transplantation conditions was accepted by the NMPA and included in priority review. Previously, in 2021, the company signed a cooperation agreement with Inctye to obtain hematoma and solid tumor development rights in Greater China, which has been approved in Europe, the United States and Hong Kong, China.
DLBCL is the most common type of NHL. Globally, DLBCL accounts for 31% to 34% of NHL, and 46% of NHL in China. Currently, the MoS treatment for r/r DLBCL is 5-12 months, and Tafasitamab has excellent efficacy for 33.5 months, and the safety is good. We expect Tafasitamab's sales to peak at more than 1 billion yuan. It is expected that sales will continue after listing. We are optimistic that the company's cancer and self-immunity pipeline will continue to be realized, and maintain the “gain” rating.
The release of obutinib is expected to accelerate in 2024. Three indications of obutinib are covered by medical insurance, and as the only drug approved for the treatment of r/r MZL in China, it is included in the 2024CSCO lymphoma guideline's Level I recommendation plan for treating 2L MZL. With the inclusion of clinical guidelines and continuous doctor-patient education, it is expected that DOT treatment will be extended. The incidence of MZL in China is about 0.4/100,000, with 5,584 new cases per year. China's 1L CLL/SLL is expected to submit an NDA in 24Q3; the US r/r MCL is expected to submit an NDA in 24Q3; the combined ICP-248 treatment of 1L CLL/SLL is progressing, and it is expected that 25H1 will launch registered clinical trials. Domestic ITP phase III registered clinical trials are expected to submit an NDA within 2025; SLE IIb is expected to complete enrollment and mid-term data analysis before the end of the year, and the data is expected to be released in 25Q3. We expect that with the domestic release of obutinib MZL, CLL/SLL, and the launch of MCL in the US, the hematoma sector will rapidly expand. In 2023, sales of obutinib will reach 671 million yuan, and revenue is expected to increase by more than 30% in 2024.
The innovative pipeline is progressing smoothly, expanding self-immunity and solid tumor treatment. R&D is progressing smoothly: ① Tafasitamab China r/r DLBCL's BLA has been accepted and included in priority review. ② ICP332 (TYK2-JH1) has obtained PoC for treating atopic dermatitis. Phase III is expected to begin in 2024Q3; it is expected that China's vitiligo phase II will be initiated within the year; the US IND has been approved. ③ Phase II of ICP488 (TYK2-JH2) treatment for psoriasis is about to be completed. Phase II data will be read before the end of 2024. ④ The advanced solid tumor registration clinical trial of ICP-723 (NTRK) is progressing at an accelerated pace, and it is expected that an NDA will be submitted by the end of 2024. ⑤ ICP-189 (SHP2) combined with the third-generation EGFR inhibitor vormetinib to treat advanced solid tumors completed the first patient enrollment and is expected to receive PoC within 2024.
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.