Incident: The company released its 2023 annual report. During the reporting period, it achieved operating income of 13.753 million yuan, R&D investment of 360 million yuan (+49.5%), monetary capital and transactional financial assets of about 2.33 billion yuan, and sufficient capital reserves.
The APL-1702 phase III clinical trial has reached the main research end point, and the NDA is imminent. APL-1702 () is a photodynamic therapy product that integrates medicine and equipment. The international multi-center phase III clinical trial of APL-1702 was successful. In terms of the main efficacy endpoints, the response rate of the APL-1702 treatment group increased by 89.4% (41.1% vs. 21.7%, p = 0.0001) compared to the placebo control group, showing significant efficacy. The company is actively preparing to submit a marketing application for APL-1702 to the Drug Evaluation Center of the China Drug Administration, and is actively preparing to discuss the Phase III clinical plan for marketing in the US market with the US FDA.
APL-1202 combined with tirelizumab as a new adjuvant treatment for MIBC obtained positive efficacy signals.
APL-1202 (Weiscike) is the world's first oral, reversible MetaP2 inhibitor to enter a critical/phase III clinical trial in the field of antitumor. The analysis results were positive during the phase II clinical trial of APL-1202 combined with tirelizumab as a new adjuvant treatment for muscle-invasive bladder cancer. The PCR rate increased significantly compared to the tirelizumab monotherapy group. APL-1202 combined with tirelizumab is expected to read the top-line data from the Phase II trial in the third quarter of 2024. At the same time, the company plans to conduct clinical research on APL-1202 combined immune checkpoint inhibitors in people with advanced bladder cancer in China.
Strengthen product collaboration in the urogenital field and establish a Women's Health Division to promote APL-1702 marketing. The company introduced prazopanib tablets (trade name: Dipate) and neratinib maleate tablets (trade name: Ourobi) to the urogenital field and breast cancer. Both drugs are oral tablets, easy to take, and are covered by medical insurance reimbursement. Depat and Oubi went on sale in October 2023 and December 2023, respectively, and achieved sales of 9.289,000 yuan by the end of the reporting period. The Women's Health Division was established to focus on marketing APL-1702 in the Chinese market and expanding the pipeline in the field of women's health to better meet the unmet clinical needs of women's health patients.
Profit forecast: With the launch and release of APL-1702, APL-1706, and generic drugs, we expect the company's revenue for 2024-2026 to be $2,370 million and $620 million, respectively.
Risk warning: R&D progress falls short of expectations, commercialization of core varieties falls short of expectations, policy risks.