Event
On March 18, 2022, the company issued an annual performance announcement that the company's revenue in 2021 was nearly 28.77 million yuan, in line with expectations; at the same time, the company's official website issued performance guidelines predicting a revenue target of 180 million to 200 million yuan in 2022, better than expected.
Comment
Selineso (Sivio) has been approved in China, Australia, South Korea and Singapore, marking the company's entry into a new channel for commercial growth. (1) Sivio is the world's first approved nuclear output inhibitor (SINE) targeting XPO1 targets, which induces apoptosis by promoting the accumulation of tumor inhibitory proteins in the nucleus. (2) Sivio's conditional approval is based on the results of the global phase II STORM test and the phase II MARCH test conducted in China. According to the STORM results, 25.3% of the 83 subjects who were refractory to bortezomib, kafizomib, lenalidomide, pomalidomide and darituyou monoclonal antibody still had ORR. MARCH showed that the ORR of all patients was 29.3%. ORR 25% of refractory patients with at least one protease inhibitor, one immunomodulator and one anti-CD38 monoclonal antibody.
(3) this is a product introduced by the company from Karyopharm Therapeutics (approved in the European Union in January 2021), and the company has commercial rights and 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. The domestic NDA for these two indications will be approved more than expected in 2021. (4) according to the company's website, the drug will be approved for market in Hong Kong and Taiwan in 2022.
The first of its kind in the world has been approved, which is the verification of international vision and rapid transformation strength. (1) Sivio is the first FDA-approved XPO1 targeting inhibitor for the treatment of multiple myeloma and diffuse large B-cell lymphoma. At present, four treatment schemes have been included in the guidelines of the Chinese Society of Clinical Oncology (CSCO): including the approved Sd (Serinesol, Dexamethasone) regimen for the treatment of myeloma, and the SVd (Serinesol, Bortezomib and Dexamethasone) regimen for second-line treatment. The second-line multiple myeloma study (BENCH) is under way in China. (2) at present, a total of 22 clinical trials have been approved in China, Australia and the United States for many of the company's cross-regional clinical trials, and these projects involve a number of global equity assets independently developed by the company. it is a more important point for the company in the future.
Profit forecast and valuation
We raise our profit forecast and expect the company's annual revenue to be about 1.8 million yuan in 2022-23-24, 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.