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信达生物(01801.HK):创新管线进一步丰富 临床研发有序推进

Cinda Biotech (01801.HK): Innovative pipelines further enrich clinical research and development and advance in an orderly manner

安信證券 ·  Aug 28, 2022 00:00  · Researches

Event: on August 25, the company announced its results for the first half of 2022. During the reporting period, the company achieved a total revenue of 2.24 billion yuan, an increase of 15.3% over the same period last year, of which product revenue was 2.041 billion yuan, an increase of 10.0% over the same period last year.

The commercial pipeline is further enriched, and the upgrading of the management model is expected to increase sales output. In terms of commercial products that have been listed, seven of the company's products have been approved for listing, and during the reporting period, ramoximab was approved for first-line treatment of esophageal cancer and gastric cancer, and a number of new product indications were approved. In terms of commercial products that are about to be put on the market, the company currently has three varieties listed in NMPA, namely, RET inhibitors, PCSK9 monoclonal antibody IBI-306 and BCMA CAR-T IBI-326. The subsequent approval is expected to further enrich the company's commercial product pipeline. In addition, the company's commercialized business structure adjustment and upgrading will create a professional BU model, which is expected to further enhance sales output and support the long-term sustainable and healthy development of the business.

Four new molecules entered the clinical phase 3 / critical clinical research stage, and 20 new drug varieties entered the clinical study. At present, the company has a total of 34 innovative drug R & D pipeline products, in addition to the listed and NDA phase products, 4 new molecules have entered the clinical phase 3 / critical clinical research stage, and 20 new drug varieties have entered the clinical research. In terms of tumor pipeline, CTLA-4 monoclonal antibody, ROS1/NTRK inhibitor, PI3K δ inhibitor and CEACAM5 ADC entered the registration / key clinical study. In terms of non-tumor pipeline, the potential blockbuster GLP-1/GCCR dual-target agonist IBI-362 has read out the phase 2 clinical data of weight loss and diabetes, and is expected to enter the phase 3 clinical study of weight loss and diabetes indications from the end of 2022 to the beginning of 2023. In addition, IL-23p19 monoclonal antibody IBI-112 has also read the phase 2 clinical data of psoriasis. This product has the advantage of potential long-term efficacy and the convenience of prolonging the interval of administration, and is expected to enter the phase 3 clinical study of psoriasis in the second half of 2022.

Investment suggestion: we estimate that the company's income from 2022 to 2024 will be 4.888 billion yuan, 6.111 billion yuan and 8.333 billion yuan respectively, and the net profit will be-1.637 billion yuan,-841 million yuan and 471 million yuan respectively, and the corresponding EPS will be-1.12yuan,-0.57yuan and 0.32yuan respectively. Considering the potential of the company's listed / soon-to-be listed products and the rich clinical R & D pipeline, we believe that the company has a promising future and its investment rating is Buy-A.

Risk hints: the risk that the progress of clinical trials of innovative drugs is not as expected, the risk of failure of clinical trials, the risk of changes in medical policy, the risk that product sales are not as expected, and the risk of uncertainty in the development of the epidemic.

The translation is provided by third-party software.


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