Event: the company released its semi-annual report of 2023, with an operating income of 5 million yuan (+ 180.1%) and a net profit of-90 million yuan in the first half of 2023. In the second quarter of 2023, the operating income was 5 million yuan (+ 180.2%) and the net profit returned to the mother was-50 million yuan.
The first patient enrolled in the critical Ⅱ phase of SY3505 was completed in June 2023. SY-3505 entered the clinical phase Ⅱ study in July 2022, received feedback from CDE conditional approval of listing qualifications in March 2023, launched a key registration phase Ⅱ clinical trial, and successfully enrolled the first subject in June. The summary of SY-3505 clinical Ⅰ / Ⅱ phase study was presented at the 2023 ASCO conference.
The critical Ⅱ phase of SY5007 completed the first patient enrollment in February 2023, and the Ⅲ phase officially started in July. As of February 3, 2023, a total of 60 subjects were enrolled in the phase Ⅰ study of SY-5007, including RET-positive non-small cell lung cancer, thyroid cancer and other solid tumors. The summary of the phase Ⅰ study was published at the ASCO conference in 2023. The first participant in the critical phase Ⅱ study was completed in February 2023.
At the same time, the SY-5007 confirmatory phase Ⅲ clinic has also been officially launched in July 2023 by the group leader unit Shanghai Lung Hospital.
The second generation of ALK SY-707 has launched Pre-NDA communication with CDE. The confirmatory clinical trial of SY-707 Ⅲ reached the predetermined mid-term analysis node in the program. The mid-term analysis showed that the PFS assessed by IRC in ALK-positive NSCLC patients was significantly better than that of the control drug clozotinib and was safe. The company has carried out Pre-NDA communication with CDE. In addition, the Ⅰ b / Ⅱ phase of SY-707 combined with triplizumab and gemcitabine in the treatment of advanced pancreatic cancer is currently in the dose climbing phase.
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, 3 in key Ⅱ / Ⅲ phase, 3 in Ⅱ phase and 10 in Ⅰ phase. It contains not only popular mature targets, such as ALK inhibitors and BTK inhibitors, but also nova targets, such as "unlimited cancer species" target FGFR4 inhibitor SY-4798, pan-tumor target WEE1 inhibitor SY-4835.
Profit forecast and investment advice. It is estimated that the operating income of the company from 2023 to 2025 is about 0.06,1 and 230 million yuan respectively. Considering that the first drug holding has strong early research strength and continuous improvement in clinical capacity, the first new drug SY-707 will submit an application for listing soon, and SY-3505 and SY-5007 will be ready to maintain a "buy" rating.
Risk tips: research and development or review and approval progress is not as expected risk, market competition aggravating risk, pharmaceutical industry policy risk and so on.