every AI newsletter, on January 3, 2024, Guojin securities issued a research report commenting on junshi biology (688180).

On January 2, 2024, the Company announced that a new indication for peri-operative treatment of patients with non-small cell lung cancer (NSCLC) was approved in China, becoming the first domestic and second approved lung cancer peri-operative immunotherapy in the world.

There is a large unmet clinical need in the perioperative period of NSCLC. (1)20%-25% of NSCLC patients can be surgically resected when they are newly diagnosed, but even after radical surgery, 30%-55% of patients will relapse and die after surgery. At present, the clinical benefit of chemotherapy as preoperative neoadjuvant or postoperative adjuvant therapy is limited, and it can only improve the 5-year survival rate of patients by about 5%. Therefore, there is a huge unmet clinical need in the perioperative period of NSCLC. (2) The research data of teripril for this indication were released at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting: Compared with chemotherapy alone, teripril monoclonal antibody combined with chemotherapy for perioperative treatment of resectable stage III non-small cell lung cancer can significantly prolong the event-free survival time (mEFS) of patients (vs15.1 months has not been reached), and the risk of disease recurrence, progression or death of patients is reduced by 60%, the primary pathological response (MPR) and complete pathological response (pCR) rates were significantly better in the treprozumab group, 48.5 vs 8.4% and 24.8 vs 1.0%, respectively, and overall survival (OS) also showed a significant benefit trend. (3) On October 16, 2023, Mercadon announced FDA approval of Keytruda for the treatment of patients with resectable NSCLC, combined with chemotherapy as a neoadjuvant therapy, and then continued as a single drug as a postoperative adjuvant therapy, the drug became the world's first approved lung cancer perioperative immunotherapy. This time, Trepril followed, becoming my country's first and the world's second approved lung cancer perioperative immunotherapy. Its first "3+1+13" perioperative treatment model can better observe the benefits of long-term survival of patients.

six indications are included in health insurance, FDA approval, and a significant release of treilumab is expected. (1) In the first three quarters of 2023, the revenue of this product was 0.668 billion yuan, up 29.7 year on year. In the national health insurance negotiations in December 2023, three new indications were added to Treplimab, namely, combined cisplatin/gemcitabine in the first-line treatment of nasopharyngeal carcinoma, combined paclitaxel/cisplatin in the first-line treatment of esophageal squamous, combined pemetrexed/platinum in the first-line treatment of non-small cell lung cancer; in addition to the original second-line and above treatment of melanoma, second-line and above treatment of nasopharyngeal carcinoma, and three indications for the treatment of platinum-containing chemotherapy failure, including urothelial cancer that progressed within 12 months of neoadjuvant or adjuvant chemotherapy, six indications of the drug have been included in the medical insurance. (2) The drug was approved for listing in the United States in October 2023; in the European Union, the United Kingdom and Australia and other places to submit the listing, the overseas market volume can be expected.

we maintain our profit forecast and expect the company to earn 15/22/3.5 billion yuan in 2023/24/25, with a loss of 15/13/0.8 billion yuan respectively. Maintain a "buy" rating.

Risks such as the development and commercial promotion of new drugs falling short of expectations and increased market competition.

(Source: Huibo Investment Research)

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(edited by Zeng Jianhui)