Events:
The company announced that its holding subsidiary Fuhong Hanlin independently developed Hans-shaped (that is, Srulliumab injection) combined with carboplatin and etoposide for first-line treatment of extensive small cell lung cancer (ES-SCLC). The application for registration has been approved by the SDA.
Comments:
The first PD-1 monoclonal antibody to receive first-line treatment of small cell lung cancer has a remarkable effect: this approval makes the company's Srelli monoclonal antibody become the first PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer in the world, which opens a new era of immunotherapy for small cell lung cancer. We believe that the company will have obvious therapeutic advantages in this indication. Lung cancer is one of the most common malignant tumors in the world. According to GLOBOCAN data, there are 2.2 million new lung cancer cases and 1.8 million new lung cancer deaths in the world in 2020, ranking first in cancer deaths. Small cell lung cancer (SCLC), which accounts for about 15% of the total number of lung cancer, is the most aggressive subtype of lung cancer, with rapid clinical deterioration and poor overall prognosis. at present, the median OS (overall survival time) of the first-line treatment regimen is less than one year, and a number of PD-1 monoclonal antibody products have not made a breakthrough in the indications of small cell lung cancer. The median OS of the serrilizumab plus chemotherapy group was 15.8months, significantly longer than that of the control group, and the risk of death was reduced by 38%. The results showed that the combination of carboplatin and etoposide had significant benefits in patients with extensive small cell lung cancer who had not received previous treatment.
Multi-indication clinical and global multicenter clinical will broaden the market space: at present, the company's Srullizumab has been approved in three indications: microsatellite highly unstable (MSI-H) solid tumor, squamous non-small cell lung cancer (NSCLC) and extensive small cell lung cancer (ES-SCLC). At present, 10 combination therapies with Srulizumab as the core are in clinical practice, and applications for the domestic listing of esophageal squamous cell carcinoma (ESCC) have been submitted. We believe that with the approval of the new indications, the market space of the product will continue to be improved. In addition, the company has opened 128 trial centers in many countries around the world, of which 31.5% of the participants are white, and the company's clinical research results have been published in the Journal of the American Medical Association, one of the four top medical journals in the world. it has been recognized by the international academic community. The company has also launched a head-to-head bridging trial of Atenizumab for ES-SCLC in the United States and recently completed its first patient administration, and we believe that with its excellent efficacy, the company's products will also benefit in the European Union and the United States in the future.
Profit forecast: looking to the future, the company's innovative products have entered the harvest period one after another, the income structure will continue to be optimized, the international layout will also open up space for future growth, and the listing of COVID-19 bivalent vaccine in Hong Kong and Macao will also bring better profits. we are optimistic about the future development of the company. It is estimated that the company's net profit in 2022 and 2023 is 3.81 billion yuan and 4.84 billion yuan, YOY-19.6% and + 27.1% PE is 1.4yuan and 1.8yuan respectively, corresponding A-share PE is 25 / 20 times, H-share EPS is 16 / 13 times, A-share valuation is reasonable, H-share valuation is low, we continue to give Acord H-share "buy" investment rating.
Risk tips: vaccine approval and sales are not as expected, COVID-19 drug sales are not as expected, the progress of new product research and development is not as expected, the performance of mergers and acquisitions is not as expected, goodwill impairment risk