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It is reported that Guangshengtang announced in September that the company's innovative hepatitis B treatment drug GST-HG141 has completed the phase II clinical trial of hepatitis B low virology (LLV), and obtained the research summary report of the phase II clinical trial.

 

 

 

The research results show that GST-HG141 tablet has good safety and significant efficacy for patients with chronic hepatitis B hypoviremia, and its inhibitory effect on HBV DNA is better than the current clinical treatment recommended nucleoside (acid) analog single drug treatment control group. On the basis of nucleoside (acid) drug treatment, GST-HG141 tablet has confirmed its role in further inhibiting HBV DNA replication and potential depletion of cccDNA on the basis of nucleoside (acid) drug treatment in hepatitis B patients. The clinical research has achieved the expected goal, with excellent data.

 

 

 

Guangshengtang once said on the interactive platform that the company's innovative hepatitis B treatment drug GST-HG141 is an inhibitor of hepatitis B core protein, a new class of anti hepatitis B virus drugs with a new target, an important component of the company's "hepatitis B cure peak plan", and is committed to achieving the clinical cure of hepatitis B for the purpose of drug withdrawal.

 

 

 

Industry insiders point out that breakthrough treatment varieties refer to innovative drugs or improved new drugs used to prevent and treat diseases that seriously endanger life or seriously affect quality of life, and for which there are no effective prevention and treatment methods or sufficient evidence to show significant clinical advantages compared to existing treatment methods. Guangshengtang GST-HG141 tablets are included in the list of proposed breakthrough treatment varieties, and the review speed is expected to accelerate, the drug development process is expected to accelerate, and the unmet clinical needs of patients are solved.

 

 

 

According to the data, Guangshengtang's main business is the R&D, production and sales of nucleoside anti hepatitis B virus drugs, and its main products are anti hepatitis B virus drugs, liver protection drugs, digestive system drugs, respiratory system drugs, cardiovascular drugs, and medical inspection services. At the beginning of its establishment, Guangshengtang mainly focused on generic drugs. After going public, the company began to shift its focus to innovative drugs.

 

 

 

In recent years, with sustained high R&D investment and squeezed market space for traditional businesses, Guangshengtang's performance has been under severe pressure, and the company's attributable net profit has been at a loss for three consecutive years from 2021 to 2023. Financial data shows that from 2021 to 2023, Guangshengtang achieved operating revenues of approximately 370 million yuan, 386 million yuan, and 423 million yuan, respectively; The corresponding net profits attributable to the implementation are approximately -0.35 billion yuan, -127 million yuan, and -349 million yuan, respectively. In the first three quarters of this year, Guangshengtang's net profit decreased year-on-year. During the reporting period, Guangshengtang achieved a revenue of approximately 326 million yuan, a year-on-year increase of 16.67%; The corresponding net profit attributable to the implementation is approximately -0.71 billion yuan, a year-on-year increase of 63.93%.

 

 

 

It is reported that under pressure on performance, the controlling shareholder of Guangshengtang has recently introduced strategic investors through an agreement transfer. According to Guangshengtang's announcement on November 16, the company's controlling shareholder, Aohua Group, has transferred 8 million shares (5.02% of the company's total share capital) of the company's unlimited tradable shares to Yuanshan Fund through an agreement transfer. Regarding this transaction, Guangshengtang stated that the main purpose is to further optimize the company's shareholder structure and attract strategic investors who are optimistic about the company's long-term development.

 

 

 

According to the review, since December, in addition to GST-HG141 from Guangshengtang, multiple innovative drugs have been included in the list of proposed breakthrough treatment varieties for public announcement. On December 4th, SHR-A2102 for injection from Hengrui Pharmaceutical, Savotinib tablets from Huangyao Pharmaceutical, and HL-085 (Tolatinib) capsules from Kezhou Pharmaceutical were included in the list of proposed breakthrough treatment varieties for public announcement, with a deadline of December 11th. On December 3rd, the anti-CD19 single chain antibody chimeric antigen receptor T cell injection from Beijing Yongtai Ruike Biotechnology Co., Ltd., JL15003 injection from Jieke (Tianjin) Biopharmaceutical Co., Ltd., and GC101 adenovirus injection from Beijing Jinlan Gene Technology Co., Ltd. were included in the list of proposed breakthrough treatment varieties for public announcement. The deadline for public announcement is December 10th. On December 2nd, Xinda Biopharmaceutical (Suzhou) Co., Ltd. IBI354 was also included in the list of proposed breakthrough treatment varieties for public announcement, with a deadline of December 9th.