Performance summary: In 2023, the company achieved operating income of 1,503 billion yuan (year-on-year increase of 3.38%), achieved net profit of 2.283 billion yuan (year-on-year decrease of 105 million yuan), and net profit of non-return to mother was 2.298 billion yuan (year-on-year decrease of 153 million yuan).
The first domestically produced PD-1 monoclonal antibody approved by the FDA. 3 new indications were included in medical insurance. In October 2023, treprilizumab combined with cisplatin/gemcitabine was approved by the FDA as first-line treatment for adult patients with metastatic or recurrent locally advanced nasopharyngeal cancer, and as a single agent to treat recurrent, unresectable, or metastatic nasopharyngeal cancer patients with recurrent, unresectable, or metastatic nasopharyngeal cancer during or after treatment with previous platinum-containing treatment. Treplimumab became the first PD-1 monoclonal antibody approved for nasopharyngeal cancer in the US. Thereafter, treprilimab became the world's first innovative Chinese biopharmaceutical to be selected as the preferred treatment plan in the NCCN guidelines for nasopharyngeal cancer. Starting in 2024, Tuoyi added 3 new indications to the new national health insurance catalogue. Currently, 6 indications have been included in the national health insurance catalogue. It is the only anti-PD-1 monoclonal antibody used to treat melanoma in the national health insurance catalogue.
BTLA monoclonal international multi-center phase III clinical trial commenced. In June 2023 and August 2023, the FDA and NMPA respectively agreed that the company will launch a randomized, double-blind, placebo-controlled, international multi-center phase III clinical trial for anti-BTLA, tifcemalimab combined with treprilimab as a consolidation treatment for patients who have not progressed after limited-stage small cell lung cancer radiotherapy. In December 2023, the company initiated a randomized, open, positive-controlled, multicenter phase III clinical trial of tifcemalimab combined with treprilimab for the treatment of CHL.
This study is another key registration study for tifcemalimab and the first phase III clinical trial of a BTLA target drug in hematologic oncology. In addition, a number of phase IB/II clinical trials with treprilizumab are being carried out simultaneously in China and the US, which is expected to increase patients' response to immunotherapy and expand the range of potential beneficiaries.
The R&D pipeline is progressing efficiently, and the momentum for subsequent growth is strong. There are more than 50 projects in the research pipeline, nearly 30 products under development, and more than 20 products in pre-clinical development. Of these, 3 products are being sold (Tuoyi, Junmaikang, Mindewei), 1 product has submitted an NDA (angorizimab), and 3 products are in phase III clinical (bevacizumab, IL-17A, and BTLA monoclonal antibodies). In the future, with the steady progress of clinical research on other products under development, the company's revenue is expected to gain momentum for continuous growth.
Profit forecast: Sales of treprilizumab have entered a positive cycle. The company continues to enrich its product pipeline through independent research and development and external cooperation to maintain a high growth rate of performance. The company's revenue growth in 2024-2026 is expected to be 21.5%, 63.2%, and 31.3%, respectively, and net profit losses to mother will be 19.1, 11.4, and 570 million yuan, respectively.
Risk warning: R&D progress in the research pipeline falls short of expectations; overseas listing progress or falls short of expectations; risk that future products will not be covered by health insurance.