The two-pronged approach of "rights introduction + independent research and development" from a global perspective is a must for fast-break innovative drugs Blue Ocean. (1) at present, the global biological innovation market is large and the competition is increasingly fierce. In addition to the innovation at the international level, rapid transformation and commercialization are also necessary to win. International cooperation is also indispensable. (2) ATG-017, developed by the company, is a selective oral inhibitor of extracellular signal-regulated kinase 1 and 2 (ERK1/2), and Drug O is the first PD-1 monoclonal antibody approved to market in the world. ATG-017 is currently in an open, multicenter, phase 1, phase 2 dose exploration trial called ERASER for patients with mutations in the RAS-MAPK pathway, and drug O is its first combination. (3) in addition, Onatasertib, introduced in cooperation with the company, is a new second-generation mTOR inhibitor, which can inhibit both mTORC1 and mTORC2, which is expected to improve the efficacy and reduce side effects; the ORR of its combination with PD-L1 in the treatment of advanced solid tumor is 30%.
Selinexor has been approved in the European Union and South Korea, and a listing in China is imminent. (1) Selinexor is the first approved nuclear output inhibitor (SINE) for XPO1 target in the world, which induces apoptosis by promoting the accumulation of tumor inhibitory proteins in the nucleus. (2) this is a product introduced by the company from KaryopharmTherapeutics (approved in the European Union in January 2021), and the company has commercial interests in the Asia-Pacific region. The drug was approved in South Korea in July 2021 for the treatment of multiple myeloma and diffuse large B-cell lymphoma. Domestic NDA for these two indications was accepted by NMPA in January 2021 and is expected to be approved for listing in 2022. This is the first SINE drug in China. Four treatments containing this drug have been included in the latest version of CSCO guidelines, and more indications are expected to be expanded in the future.
The layout of R & D pipeline is rich, covering a variety of large and small molecular drugs. The company focuses on global competitive differentiation targets and currently has 15 assets and 10 global interests, among which Selinexor, Verdinexor and Eltanexor form a rich SINE drug research and development pipeline.
Profit forecast and valuation
We maintain our profit forecast and estimate that the company's revenue in 2021-2023 will be about 0.280.59 billion yuan, maintaining a "buy" rating.
Risk hint
Risks such as the lack of expectations in the process of R & D and commercialization, the change of core personnel, and the price reduction of health insurance negotiations.