Shutai Shen Announces Termination of RNAi-Based Hepatitis B Drug STSG-0002 Development Amid Stock Price Decline

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Innovation is not about wining and dining; the development of new drugs is a long-term endeavor with many uncertainties, and cutting losses in time can be a wise strategy.A few days ago, Fosun Honying terminated the Phase I clinical trial of ORIN1001. Coincidentally, recently, Staidson terminated the development of a new RNAi drug for hepatitis B.On the contrary, stop-loss also indicatesChina's new drug innovation warriors are venturing into uncharted territories, continuously exploring the vast ocean of source innovation, daring to try, daring to cut losses in time, and remaining honorable even in failure.

On December 11, Staidson (300204) announced that the companyStaidson's wholly-owned subsidiary, Beijing SoloBio Genetechnology Company Ltd., has developed the STSG-0002 injection, which is currently in the Ib/II phase. Recently, based on the preliminary research results obtained from clinical trials of the drug and after a comprehensive evaluation of various factors such as subsequent development investment, SoloBio decided to terminate the clinical trial and further development of the STSG-0002 injection in order to allocate R&D resources reasonably and focus on advantageous projects in the R&D pipeline.The total R&D investment for this new drug amounts to approximately 150 million yuan.

TodayStaidson (300204) stock price fell by 5.87%, with a current market value of approximately 5.2 billion yuan.In the first three quarters, the company achieved revenue of 270 million yuan, a year-on-year decrease of 28%. R&D expenses amounted to 250 million yuan, and the non-GAAP net profit was -188 million yuan, a year-on-year decrease of 18%.

The specific situation is as follows:

Staidson stated that, as of the date of this announcement, the R&D investment in STSG-0002 injection has totaled 150,430,000 yuan (unaudited).In accordance with relevant accounting standards and the company's accounting policies, the R&D investment for this new drug has been fully expensed and recorded in the corresponding accounting period's income statement, and will not have a significant adverse impact on the company's recent performance.

In addition to the termination of RNAi hepatitis B new drug development, the company has another piece of good news today.

On December 11, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Staidson and its subsidiariesDefengruiThe Class 1 new drug BDB-001 injection, filed by Staidson, is proposed to be included in the breakthrough therapy designation for the indication of:Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV). Public information shows that this is aC5a-Targeting Antibody, Defengrui &Germany InflaRx AchievesAuthorization and License Agreement, based on the latter's anti-C5a technology for the research, development, and commercialization of the product within China.

According toStaidson (300204) disclosed its 2023 mid-year report on August 29.The company focuses its key resources on advancing the following research projects to their milestone stages:

The company is committed to the research and development, production, and sales of therapeutic drugs for diseases with unmet clinical needs, mainly including protein-based drugs.Drugs (including therapeutic monoclonal antibody drugs), gene therapy/Cell therapy drugs, chemical drugs, and three major drug categories, treatThe therapeutic areas focus on infectious diseases, autoimmune system diseases, and neurological disorder treatments.

Source:Staidson Announcement