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Financial Services Association, August 14 (Reporter Lu Afeng) “It's a bit incredible, but it's more driven by investor sentiment.” Today, after seeing that Guangshengtang (300436.SZ) recorded two 20CM rises and falls within three trading days, an industry expert told the Financial Federation reporter. This evening, Hiroshengdang also announced abnormal fluctuations in stock trading, in an attempt to get investors' emotions back to their senses.

From August 12 to 14, Guangshengtang achieved two 20CM rises and stops in three days. After today's market, Hiroshengdang hurriedly came out to put out the fire: “The company's stock price has continued to rise sharply in the short term, but there have been no major changes in the company's fundamentals. There may be irrational hype, etc., and there may be a risk that the stock price will fall back after a sharp rise.”

In addition to emphasizing the uncertainty of innovative drug research and development, Guangshengtang also stated that the company's operating performance continued to lose money in the last three years and the first phase: the company was in a state of loss from 2021 to the first quarter of 2024, and net profit attributable to shareholders of listed companies was -0.035 billion yuan, -0.127 billion yuan, -0.349 billion yuan, and -0.015 billion yuan, respectively.

The industry generally believes that the reason that drove Guangshengtang's three-day 20CM rise and fall was an announcement issued on August 12 regarding the company's Phase II clinical trial study of an innovative hepatitis B drug.

Guangshengtang revealed in an announcement on the 12th that GST-HG141, an innovative drug for hepatitis B treatment, has completed phase II clinical trials for chronic hepatitis B hypoviraemia. The research results show that GST-HG141 has good safety and pharmacodynamic properties for hypoviraemia patients. The positive results obtained in the phase II clinical trial support GST-HG141 to continue to carry out phase III confirmatory clinical trials. Relevant research data will also be submitted to CDE for clinical communication in the near future.

An industry insider told the Financial Federation reporter that revealing the ignorance of the phase II clinical trial does not mean that the drug can be successfully developed; it is only a phased achievement. Guangshengtang's market these days is more of a result of investor sentiment catalyzing. “As for the real value of this drug, it remains to be seen.”

“In addition to investor sentiment, the positive results achieved by GST-HG141 in the phase II clinical trial may indeed be the result of the rise and fall of the stock price.” Dr. Cao Bo of Innovative Medicine explained to the Financial Federation reporter that the results of phase II clinical trials of the drug showed that different doses of GST-HG141 can significantly inhibit HBV DNA, and after 24 weeks of combined nucleoside analogue treatment, the proportion of HBV DNA in the high and low dose groups below the lower test limit reached 81.5% and 84.0%, respectively. This effect far exceeds the effect of nucleoside analog monotherapy. These positive data support the continuation of GST-HG141 in phase III confirmatory clinical trials.

According to Guangshengtang's 2023 financial report, GST-HG141 is a core protein inhibitor that can effectively reduce HBV cccDNA. It is the world's first in class MOA type II core protein inhibitor. It is a key part of the clinical treatment of hepatitis B. It specifically targets viral targets, has little risk of effects on host targets, and is highly safe. Currently, there are no such targeted drugs on the market worldwide.

Guangshengtang has an extensive layout in hepatitis B treatment drugs. In addition to GST-HG141, the company has also deployed first-generation and second-generation HBsAg inhibitors GST-HG131 and GST-HG121. Among them, GST-HG131 is the first hepatitis B surface antigen (HBsAg) inhibitor approved for clinical use in China, and its clinical progress is in sync with GST-HG141 described above. Currently, phase IIa clinical trials are being actively carried out.

Also, according to public information, Assembly Bioscience's ABI-H0731, ABI-H2158, and ABI-H3733 have the same global target path as GST-HG14. In 2020, BeiGene (688235.SH) obtained China's rights (including Hong Kong, Macao and Taiwan regions) from the three members of Assembly Bioscience with a “40 million dollar down payment+up to 0.5 billion US dollars+share”.

According to media reports, the development of the above three pipelines introduced by BeiGene was terminated for various reasons. A Financial Services Association reporter inquired about BeiGe Shenzhou's 2023 financial report and found no progress in research on these three pipelines.

Also, according to data from Pharmaceutical Rongyun, a reporting unit including Assembly BioScience's ABI-H0731 tablets for evaluating a randomized, phase IIa, multicenter, open study phase II clinical trial in patients with chronic hepatitis B was voluntarily terminated; a reporting unit including Assembly BioScience's evaluation of the ABI-H2158 regimen to treat chronic hepatitis B infection was also actively terminated, but in healthy people Phase I clinical trials are ongoing to evaluate the safety, tolerability, and pharmacokinetics and pharmacodynamics of ABI-H2158 in patients with chronic hepatitis B infection; ABI-H3733 has not registered clinical trial information in China.