Recommended logic: (1) "2x3" ALK pipeline deep ploughing sequential treatment, the third generation ALK second phase clinical rapid progress, second / third line indications are expected to be qualified for conditional listing, sales peak is expected to exceed 1.4 billion yuan, the second generation ALK first / second line indications are expected to submit NDA; (2) SY-5007 has been qualified for conditional listing and is expected to become the first domestic RET inhibitor, and the peak sales are expected to be nearly 1.4 billion yuan. (3) it has excellent independent research and development ability, and a number of new drugs such as third-generation ALK, RET and so on have entered the first echelon of China.
SY-3505 is expected to become the first domestic third-generation ALK inhibitor, and SY-707 (second-generation ALK) NDA is just around the corner.
The third-generation ALK inhibitor SY-3505 is in the second clinical stage and is applying for conditional approval to be listed. It shows good anti-tumor effect on all kinds of ALK mutant tumor cells and has good blood-brain barrier properties, which provides the possibility for the follow-up expansion of brain tumor indications. It is expected to become the first domestic third-generation ALK inhibitor, with a domestic second-line sales peak of about 940 million yuan and a first-line sales peak of about 510 million yuan. DCF is valued at 2.96 billion yuan. The second generation ALK inhibitor SY-707 will be submitted to NDA soon. The clinical data have shown that the clinical results are not inferior to those of similar products, and the safety is better than that of similar products. It is estimated that the peak sales of first-and second-tier products in China are about 400 million yuan, and the valuation of DCF is 1.07 billion yuan.
SY-5007 has been conditionally approved for listing and is expected to become the first domestic selective RET inhibitor.
SY-5007 showed good pharmacological activity against tumor cells with different RET protein states, but had no inhibitory effect on RET negative cells, giving consideration to both activity and selectivity. Toxicological tests also showed excellent safety and toxicity / effectiveness windows. SY-5007 has been qualified for conditional listing approved by CDE for non-small cell lung cancer indications. Phase II key clinical trials for non-small cell lung cancer have been launched, and it is expected to become the first domestic selective RET inhibitor. Thyroid cancer indications have also entered the second phase of clinical practice. The peak domestic sales of lung cancer and thyroid cancer indications are 3.6 yuan and 1.04 billion yuan respectively, and the DCF valuation is 2.85 billion yuan.
Rich in the research pipeline to demonstrate excellent independent research and development capabilities, a number of new drugs into the first echelon of domestic. The company has obtained 17 clinical approvals of national class 1 innovative drugs, including 1 new drug on the market, 1 new drug completed clinical Ⅲ phase, 5 new drugs entered clinical Ⅱ phase, and 10 new drugs entered clinical phase I. It contains not only popular mature targets, such as ALK inhibitors and BTK inhibitors, but also nova targets, such as "unlimited cancer" target RET inhibitor SY-5007, pan-tumor target WEE1 inhibitor SY-4835.
Profit forecast and investment advice. It is estimated that the operating income of the company from 2022 to 2024 is about 0.02,0.96 and 150 million yuan respectively. Considering the strong early development strength and the continuous improvement of clinical capacity of the company, the first new drug SY-707 is about to submit an application for listing. SY-3505 and SY-5007 are ready to give the company 85 times PS in 2023, corresponding to the target price of about 55.15 yuan. For the first time, coverage gives a "buy" rating.
Risk tips: research and development is less than expected risk, market competition aggravates risk, pharmaceutical industry policy risk and so on.