Event: The company released its 2023 annual report and achieved revenue of 220 million yuan in 2023. The revenue mainly comes from product sales and cooperation milestone revenue, of which the company's product sales revenue was RMB 194 million.
New indications for olevatinib have been approved for marketing, and admission to hospitals has been increased. Orebatinib (Nellik) is the first third-generation BCR-ABL inhibitor to be marketed in China. On November 17, 2023, Nelick's new indications were approved for marketing to treat adult patients with chronic myeloid leukemia (CML) chronic phase (-CP) who are resistant and/or intolerant to first-generation and second-generation TKI drugs. The approval of the new indications has greatly expanded the applicable population of patients, brought new treatment options to drug-resistant patients, and is expected to further enhance Nellik? commercial performance. In 2023, the number of Nellick boxes sold increased 259% year on year, the number of admitted hospitals increased 567% year on year, and the total number of patients increased 123% year on year.
The internationalization process of APG-2575 has accelerated, and many indications have entered phase III clinical trials. APG-2575 is the second Bcl-2 inhibitor in the world and the first domestic Bcl-2 inhibitor that has seen clear efficacy and has entered the critical clinical phase of registration. In August 2023, APG-2575 was approved by the US FDA to conduct a globally registered phase III clinical study to treat previously treated patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), which is a major milestone in the APG-2575 internationalization process. APG-2575 was approved for clinical trials by CDE to conduct a globally registered phase III clinical study in combination with the Bruton tyrosine kinase (BTK) inhibitor acotinib compared with immunochemotherapy for first-line treatment of patients with CLL/SLL. In December, APG-2575 received CDE approval for a globally registered phase III clinical study for first-line treatment of newly diagnosed elderly or frail acute myeloid leukemia (AML) patients.
The pipeline continues to advance, demonstrating the potential of FIC and BIC. Two Nellick studies were selected for the 2023ASH oral report. Nellick significantly improved the clinical prognosis of CML patients and is expected to push Ph+ ALL treatment into the “chemotherapy-free” era. Furthermore, at ASCO 2023, Nelick had significant curative efficacy and good safety in TKI-resistant patients with succinate dehydrogenase (SDH) -deficient gastrointestinal stromal tumors (GIST). APG-2575 has shown strong efficacy and safety advantages in CLL, AML, and multiple myeloma (MM).
Profit forecast: Yasheng Pharmaceutical's R&D strength is strong, and the pipeline continues to be implemented. We expect the company's revenue in 2024-2026 to be 3.4, 6.2 and 1.18 billion yuan, respectively.
Risk warning: R&D falls short of expected risks, commercialization falls short of expected risks, market competition increases risks, and drug price reduction risks.