Hepatitis B Drug Candidate STSG-0002 Discontinued in Clinical Trials, R&D Investment of RMB 150 Million Written Off

　　【Pharmaceutical Network Product Information】The development of innovative drugs is characterized by high investment and high risk, and many new drugs encounter "failure" during clinical trials. According to statistics, as of December 21, 2023, the total number of trials registered on the National Medical Products Administration's Drug Clinical Trial Registration and Information Disclosure Platform was 22,895, of which 626 trials were voluntarily terminated, accounting for approximately 2.73% of the total number of trials.
 

Recently, a new drug has been terminated in its clinical trial. On December 11, Staidson announced that the STSG-0002 injection, developed by the company and its wholly-owned subsidiary SoloBio, was in the Ib/II phase. Recently, based on the preliminary research results obtained from the clinical trials of this drug, and after comprehensive evaluation of various factors such as subsequent development investment, SoloBio decided to terminate the clinical trial and subsequent development of the STSG-0002 injection in order to allocate R&D resources reasonably and focus on advantageous projects in the R&D pipeline.
 

It is reported that STSG-0002 injection, a Class I therapeutic biologic product with independent intellectual property rights in China, is intended for the clinical trial indication of chronic hepatitis B. STSG-0002 injection is a liver-targeting replication-defective recombinant adeno-associated virus carrying shRNA expression cassettes targeting the P and X regions of the HBV genome.
 

On September 19, 2019, the product received the "Clinical Trial Notification" issued by the National Medical Products Administration. In March 2022, the company submitted a communication exchange application to the CDE and received a response from the CDE in June of the same year, agreeing to add clinical trials in the population of chronic hepatitis B patients based on existing clinical research to explore the efficacy and safety of this product. In February this year, the Phase Ib/II clinical trial information of the gene drug "STSG-0002 Injection" for the treatment of hepatitis B virus infection-related diseases was disclosed on the Drug Clinical Trial Registration and Information Disclosure Platform of the Center for Drug Evaluation of the National Medical Products Administration, and in May, the first subject dosing of the Phase Ib/II clinical trial was completed.
 

However, due to the preliminary efficacy data observed not meeting expectations, and the limited benefit for subsequent subjects continuing with the trial drug, in order to reduce subject risk, SoloBio and the principal investigator jointly decided to terminate the relevant clinical trials of this project.
 

After the clinical trial is terminated, the trial will stop enrolling new participants. Subjects already enrolled will continue to be followed up according to the clinical trial protocol, including long-term follow-up, and the rights of the enrolled subjects will be fully protected.
 

As of the date of this announcement, the R&D investment in STSG-0002 injection has totaled approximately 150 million yuan (unaudited). With the termination of the drug's clinical trials, this signifies that the 150 million yuan R&D investment has gone down the drain.
 

However, Staidson stated that the termination of the drug's clinical trial would not have a significant adverse impact on the company's recent performance. The company also expressed its commitment to pharmaceutical research and development while strictly controlling R&D costs.
 

Public information shows that Staidson is a pharmaceutical enterprise mainly engaged in the research and development, production, and sales of biological products. The company's marketed products include innovative biologics and specialty chemical drugs, covering numerous therapeutic areas such as the nervous system and intestinal system, and have formed a certain product influence in relevant application fields.
 

Although some of the company's products have "failed," recent progress has been made with other products. For example, on December 19, Staidson announced that the BDB-001 injection project had been included in the CDE’s Breakthrough Therapy designation list. On December 11, the company announced the first patient dosing in the Ib/II phase clinical trial of the STSA-1002 injection (for Acute Respiratory Distress Syndrome), and on the same day, the company released a Phase II clinical study summary report for STSP-0601 injection for on-demand treatment of bleeding in patients with Hemophilia A or B without inhibitors.
 

The third quarter report of 2023 shows that the company's main business revenue was 274 million yuan, a year-on-year decrease of 28.33%; the net profit attributable to the parent company was -185 million yuan, a year-on-year decrease of 19.43%.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.