Event: The company released its 2023 annual report. In 2023, revenue reached 1.08 billion yuan (+40.3%). The company increased investment in R&D, and R&D expenses in 2023 were 1.31 billion yuan (+33%).
Core products continue to be released, and both free immunity and oncology have been admitted to more than 600 hospitals. The dosage of tetacipr and verdicitumab will continue in 2023. After inclusion in medical insurance, the volume exchange rate was obvious. As of December 31, 2023, the autoimmunity commercialization team has more than 750 people and has been admitted to more than 800 hospitals. The oncology commercial team consists of nearly 600 people and has been admitted to more than 650 hospitals.
Many indications of titacipr continue to advance and gradually enter the harvest period. Titacipr completed the enrollment of patients with severe myasthenia gravis in China, and the US obtained an IND application from the FDA in January 2023. The Chinese Phase III clinical study of Sjogren's syndrome completed enrolling the first patient in April 2023. The domestic phase III clinical trial protocol for immunoglobulin A nephropathy (IgAN) was approved by the CDE in September 2022, and the first patient enrollment was completed in the second quarter of 2023. The company is conducting a phase III international multicenter clinical study of titacipr for the treatment of SLE in the US, and the first patient was enrolled in June 2022.
Verdicitumab continues to explore indications such as UC, GC, BC, and gynecologic tumors. The recruitment of patients with verdicitumab as a key phase II clinical trial in the US to treat patients with HER2-expressing UC after first-line chemotherapy failure is ongoing. CDE approved the phase II/III clinical trial IND for first-line HER2-expressing patients with locally advanced or metastatic GC in combination with treprilimumab and chemotherapy or treprilizumab and hercetin. The trial completed its first patient enrollment in the third quarter of 2023. A phase II clinical trial for new adjuvant treatment of HER2-positive BC with or without pertuzumab was approved.
A phase II clinical trial with treprilizumab or letrozole neoadjuvant treatment for HR-positive and HER2-low BC expression was approved in March 2023. A phase II clinical study on recurrent or metastatic cervical cancer with recurrent or metastatic cervical cancer treated with PD-1/PD-L1 treated with PD-1/PD-L1 that failed at least the first-line platinum-containing standard treatment was officially approved by the CDE.
Profit forecast: With the continued release of tetracip and verdicitumab, we expect the company's revenue in 2024-2026 to be 16.7 billion yuan, 23.4, and 4.16 billion yuan, respectively.
Risk warning: R&D progress falls short of expectations, commercialization of core varieties falls short of expectations, policy risks.