The III phase clinical approval of APG-2575 global registration is a major milestone for the company. The company announced on August 7 that APG-2575 has been approved by FDA to launch a global multicenter registered phase III trial. The trial, which aims to evaluate the efficacy and safety of APG-2575 combined with BTK inhibitors in previously treated CLL/SLL patients, will be launched in the second half of this year. This event is a major milestone in the development of the company and a key step in the globalization of APG-2575.
The field of hematoma is widely distributed, and APG-2575 has the potential of BIC. APG-2575 is the first BCL-2 inhibitor in China and the second in the world to enter the registered clinical stage. Compared with venecola, the only BCL-2 inhibitor on the market, APG-2575 has significant safety advantages: APG-2575 can achieve daily dose increase compared with venecola's five-week dose increasing regimen; APG-2575 has a shorter exposure time in the circulatory system and a lower risk of TLS. The incidence of severe neutropenia is lower. At present, APG-2575 has carried out 19 clinical studies around the world, showing strong potential for monotherapy and combination therapy. In a global phase II study, APG-2575 was used to treat patients with R CLL/SLL. The ORR in monotherapy, combined rituximab and combined acatinib cohort was 67%, 79% and 98%, respectively. The ORR of 16 first-line patients treated with acartini was 100% (company announcement 20221213). Based on the therapeutic potential of APG-2575 in CLL/SLL patients, CDE has agreed to apply for listing on the basis of single-arm registration II data, and the study completed the first patient enrollment in March 2022 (Company announcement 20220315). In addition, CLL/SLL,APG-2575 is also developed for AML, MDS, MM, WM, etc., or has the potential for panhematological cancer therapy.
Profit forecast and investment advice. It is estimated that the company's revenue from 2023 to 2025 will be 430 Universe 7.42 billion Yuan. The company is deeply engaged in the field of apoptosis, and the approval of APG-2575 internationally registered clinic has improved its possibility of going out to sea, and globalization is expected. Using the DCF valuation method, the reasonable value of the company is HK $40.83 per share, which is given a "buy" rating.
Risk hint. The risk of R & D failure, sales below expectations, market competition exceeding expectations, and so on.