The indications for obutinib continue to expand, and it is expected that dosage will continue:
The company's first commercial product, Obutinib, was approved for marketing by the NMPA on December 25, 2020. The approved indications were R/R MCL and R/R CLL/SLL. In the first half of 2023, obutinib's revenue in the first half of 2023 was 321 million yuan, an increase of 47.97% over the 217 million yuan in the first half of 2022. The new indication r/r MZL was approved for listing, becoming the first and only BTK inhibitor approved for MZL in China; r/r MCL Singapore was approved for listing, r/ RMCl US registered clinical patients are expected to be enrolled. It is expected that NDA will be submitted in mid-2024, and patients who have completed the 1L CLL/SLL phase III clinical registration will be enrolled. It is expected that the NDA submitted in the second quarter of 2024 will expand as various indications expand, and the market space is expected to grow further. Obutinib showed a higher ORR compared to similar products in clinical trials for R/R MCL and R/R CLL/SLL. It has now been included in the national health insurance catalogue, and it is expected that market demand for obutinib will continue to grow as indications are approved and combined drug therapies such as antibody drugs are developed.
Rich product pipeline, excellent clinical trial data for core products
The company mainly focuses on the fields of hematoma, solid tumors and autoimmune diseases. Product types are small molecule inhibitors, monoclonal antibodies, and double antibodies. 1) The clinical results of obutinib in phase IIa of SLE were positive. The only BTK inhibitor showed efficacy in phase II SLE clinical trials, and phase LiB clinical enrollment was accelerated. Interim data is expected to be read by the end of 2024; 2) Phase I dose escalation clinical trials of BCL2 inhibitors in r/rcll/SLL, r/rMCL and other NHL patients are ongoing; excellent data have been shown: 2 cases of CR in 3 patients can be assessed, and UMM has been achieved. As the number of cases further accumulates, the product's The excellent efficacy will be further recognized, the product is powerful, and the combination with obutinib has great potential in the international market. 3) Tafasitamab has completed the enrollment of patients registered for DLBCL treatment in mainland China. It is expected that an NDA will be submitted in the second quarter of 2024 and approved for listing in the first half of 2025. 4) ICP-B02 is potentially the best-in-class CD3 x CD20 double antibody. Dose increments have been completed for all intravenous administration cohorts, and dose increases for the first subcutaneous injection cohort. Good efficacy was observed in both the IV and SC cohorts for patients with FL and DLBCL. NHL has great potential in multiple indications. 5) The phase III registered clinical trial of obutinib to treat primary immune thrombocytopenia (ITP) completed the first patient administration in China. Phase II clinical results: In the 50 mg oral dose group once a day, 40% of patients reached the main end point, and safety was good.
Coverage once again gives a buying rating, with a target price of HK$8.25
We expect the company's revenue for 2023-2025 to be 820, 1,270, and 1,820 million yuan. Net profit was -543, -322.5, and -81.8 million yuan, respectively, and cash on hand was 5.55 billion yuan. The company drives development through scientific innovation and has strong product strength.
The target price is HK$8.25, which has room for 35% increase from the current price, giving it a “buy” rating.