Incident: On January 2, the marketing application for a new indication for treating resectable stage IIIA-IIIB non-small cell lung cancer (NSCLC) was approved by the National Drug Administration (NMPA) independently developed by Junshi Biotech.
Comment:
This is the seventh indication for treprilimab approved in China. It is also the first perioperative treatment for lung cancer approved in China and the second in the world (after K drug).
1) Improving the long-term survival of stage III NSCLC patients in China is expected to greatly improve the level of NSCLC treatment in China and establish a new benchmark for perioperative treatment. Lung cancer is currently the malignant tumor with the second highest incidence rate and highest death rate in the world. NSCLC is the main subtype of lung cancer (85%). Some patients can be surgically removed (20-25%), but even with radical surgery, 30-55% of patients will relapse and die. Radical surgery combined with chemotherapy is one way to prevent disease recurrence, but the clinical benefits of chemotherapy as a new adjuvant before surgery or adjuvant treatment after surgery are limited, and can only increase the 5-year survival rate of patients by about 5%.
To address this clinical need, Junshi deployed treprilipril to treat NSCLC during the perioperative period using the “3+1+13” model: 3 (3 cycles of teripriprimab+neoadjuvant chemotherapy) +1 (1 cycle of treprilimumab plus chemotherapy adjuvant treatment) +13 (13 cycles of treprilizumab maintenance treatment).
Compared with chemotherapy alone, the “3+1+13” model of trepri significantly prolonged median EFS [immature vs. 15.1 months], reduced the risk of disease recurrence, progression, or death by 60%, and the primary pathologic remission (MPR) rate and complete pathological remission (PCR) rate increased 6-fold and 25-fold (48.5% vs. 8.4%, 24.8% vs. 1.0%), respectively. However, maintaining treatment with treprilizumab for 1 year after surgery can further eliminate minor residual lesions after surgery, so that patients who have not achieved pCR can also benefit from treatment. The EFS HR is 0.40, which is the most obvious study reported in perioperative immunotherapy.
Similar studies, KEYNOTE-671 and AEGEAN, are also explorations of perioperative immunotherapy. Although there is no direct comparison between different studies, the NEOTORCH data is difficult to conceal.
2) Trepril gradually opens up a new situation of treatment for large indications and promotes rapid sales growth. We calculated based on the number of new cases of NSCLC, perioperative treatment cycle, penetration rate, and tripley market share. It is estimated that in 2024, Trepley will treat NSCLC during surgery to reach 293 million yuan, with a peak sales value of 579 million yuan.
Profit forecast: We expect the company's 2023-2025 revenue to be 15.00, 25.00, and 4.250 billion yuan, respectively, with year-on-year growth rates of 3.20%, 66.67%, and 70.00%, respectively, and net profit to mother of -18.98, -7.59, and -046 billion yuan, respectively. The year-on-year growth rates are 20.53%, 60.01%, and 93.98%, corresponding to the current stock price PE, -21.88, -54.70, and -909.18 times, respectively, maintaining the “Highly Recommended” rating.
Risk warning: risk of clinical failure, risk of increased competition, risk of product sales falling short of expectations, policy risk.