Event: according to the company's semi-annual report of 2023, the revenue in the first half of 2023 reached 140 million yuan (+ 49%), and the revenue of Orebatini was 110 million yuan (+ 37%), of which sales in the second quarter increased by 153% compared with the same period last year, and the number of boxes increased by 560%.
The dose of Orebatinib is obvious, and the heavy indication is just around the corner. Orebatinib is the first third-generation BCR-ABL inhibitor on the market in China, and it is also the only therapeutic drug for CML with T315I mutation. Indications for chronic CML patients resistant to tyrosine kinase inhibitors (TKI) were submitted to the market in July 2022 and nearly approved. In addition to CML, the indication of Orebatinib in the treatment of Ph+ ALL is in the clinical Ⅲ stage, and it is expected to become the first TKI drug used in the first-line treatment of Ph+ ALL in China.
The internationalization process of APG-2575 is accelerated, and indications such as WM and GIST are explored. APG-2575 is the second Bcl-2 inhibitor in the world and the first in China to see a clear curative effect and enter a critical clinical stage of registration. In August 2023, FDA granted permission to launch a globally registered phase Ⅲ clinical trial for previously treated CLL/SLL patients, accelerating the internationalization process. In addition, the company disclosed the trial data of APG-2575 for WM and GIST at the annual meetings of ASCO and AACR, constantly exploring new indications.
The pipeline continues to advance, showing the potential of FIC and BIC. APG-115 was unveiled at the ASCO conference, which combined with K drug showed therapeutic potential in tumor immune drug resistant melanoma patients. APG-2449 also shows therapeutic potential in the treatment of NSCLC resistant to second-generation ALK inhibitors. We believe that a number of drugs show the potential of FIC and BIC, which is expected to continue to enrich the company's clinical pipeline.
Profit forecast and rating. We expect the company's operating income from 2023 to 2025 to be 4.3,7.1 and 1.31 billion yuan respectively. Yasheng pharmaceutical research and development strength is strong, the pipeline continues to land, maintaining the "buy" rating.
Risk hints: research and development is less than expected risk, commercialization is less than expected risk, market competition aggravates risk, drug price reduction risk.