occurrences
On January 2, 2024, the company announced that a new indication of treipril (PD-1) monoclonal antibody for perioperative treatment of patients with non-small cell lung cancer (NSCLC) was approved in China, making it the first domestically produced perioperative immunotherapy for lung cancer to be approved in the world.
There was a large unmet clinical need during the NSCLC perioperative period, and treprilimab took the lead. (1) 20% to 25% of NSCLC patients can be surgically removed at the time of initial diagnosis, but even after undergoing radical surgery, 30% to 55% of patients will relapse and die after surgery. Currently, there are limited clinical benefits of chemotherapy as a new adjuvant before surgery or adjuvant treatment after surgery. It can only increase the 5-year survival rate of patients by about 5%, so there is a huge unmet clinical need during the perioperative period of NSCLC. (2) Research data on this indication of Trepri was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting:
Compared with simple chemotherapy, treprilizumab combined chemotherapy can significantly prolong the event-free survival (MEFs) of patients (not yet reached vs15.1 months) for resectable stage III non-small cell lung cancer, and the risk of disease recurrence, progression, or death was reduced by 60%. The primary pathologic remission (MPR) rate and complete pathological remission (PCR) rate of the treprilimumab group were significantly better, with 48.5% vs 8.4% and 24.8% vs 1.0%, respectively, and overall survival (OS) showed a clear trend of benefit. (3) On October 16, 2023, MSD announced that the FDA approved Keytruda for the treatment of resectable NSCLC patients, combined chemotherapy as a new adjuvant treatment, and then continued as a single drug as adjuvant treatment after surgery. The drug became the first approved perioperative immunotherapy for lung cancer in the world. This time, Trepril followed suit, and became the first perioperative immunotherapy for lung cancer approved in China and the second in the world to be approved. Its pioneering “3+1+13” perioperative treatment model can better observe patients' long-term survival benefits.
Six indications are covered by medical insurance, approved by the FDA, and large doses of treprimab can be expected. (1) In the first three quarters of 2023, the product's revenue was 668 million yuan, an increase of 29.7% over the previous year. In the national health insurance negotiations in December 2023, treprilizumab added three new indications, namely first-line treatment of nasopharyngeal cancer with cisplatin/gemcitabine, first-line treatment of esophageal scales with paclitaxel/cisplatin, first-line treatment of non-small cell lung cancer; plus the original second-line treatment of melanoma, second-line treatment of nasopharyngeal cancer, and treatment of urothelial cancer that has progressed within 12 months of new adjuvant or adjuvant chemotherapy. Currently, the drug has progressed within 12 months of new adjuvant or adjuvant chemotherapy. Six indications are covered by health insurance. (2) The drug was approved for marketing in the US in October 2023; it is being submitted for marketing in the European Union, the United Kingdom, Australia, etc., and can be expected to be released in overseas markets.
We maintain our profit forecast. We expect the company's revenue for 2023/24/25 to be 15/22/3.5 billion yuan, and losses to the mother will be 15/13/8 billion yuan, respectively. Maintain a “buy” rating.
Risk warning
Risks such as new drug development and commercial promotion falling short of expectations and increased market competition.