CFIC Introduction
The reporter learned from the interview that the "genotoxicity" and "reproductive toxicity" mentioned in the review report of Azivudine tablets have aroused concerns among some ordinary patients.
On July 29, Aoxiang Pharmaceutical continued to fall by the limit at the opening.
After the approval of Azivudine, the first domestically produced anti-COVID-19 oral drug, Aoxiang Pharmaceutical has recorded four consecutive daily limit drops.
However, despite the sharp retracement of the company's stock price, it has not stopped the company's shareholders from reducing their holdings.
On the evening of July 28, the company disclosed the progress announcement on the reduction of shares held by its controlling shareholders, directors, senior executives and shareholding platform.
On the same day, the company received a "Notice on Progress of Share Reduction" from Chairman and General Manager Zheng Zhiguo, Director Liu Bing, Director and Deputy General Manager Zhang Huadong, etc., who reduced their holdings of the company's shares by a total of approximately 480,000 shares. The shares held account for 0.125% of the company’s total shares. The time for this holding reduction plan has passed halfway. The company
also continues to stay in the popular stock bar of "Stock Bar" and is hotly discussed by investors.
Some investors also expressed dissatisfaction with this.
Aoxiang Pharmaceutical is a big bull stock this year. The early rise in stock price is related to the concept of new coronavirus drugs.
In January this year, it was reported online that Aoxiang Pharmaceutical would cooperate with Real Biotechnology to produce oral drugs for COVID-19.
html In May, Aoxiang Pharmaceutical officially announced that its wholly-owned subsidiary Qizheng Pharmaceutical had recently signed the "Entrusted Processing and Production Framework Agreement" and the "Drug Entrusted Production Quality Agreement" with Real Biotechnology for the processing and production of Azivudine tablets.On July 25, the State Food and Drug Administration conducted an emergency review and approval in accordance with the relevant provisions of the Drug Administration Law and in accordance with the special drug approval procedures, and conditionally approved the application for registration of additional indications for the treatment of new coronavirus pneumonia for Real Bio-Azivudine Tablets. This is the first domestically produced oral COVID-19 drug approved for marketing in China.
However, after that, Aoxiang Pharmaceutical was "voted with their feet" by investors and continued to fall by the limit. Even the company's shareholders and executives insisted on "escaping".
Compared with other "Azivdin concept stocks" horizontally, the stock price trend is not very optimistic.
The market is more concerned about the ability to deliver performance
The reporter learned from interviews that the "genotoxicity" and "reproductive toxicity" mentioned in the review report of Azivudine tablets have caused concerns among some ordinary patients.
In this regard, Cen Xiaobo, director of the National Chengdu New Drug Safety Evaluation Center, said in a recent interview with the media, “To talk about the safety of drugs from a professional perspective, we must combine the drug (safety) dose/administration route in the toxicity test and the clinical Comprehensive factors such as human drug exposure/drug concentration According to the analysis, it is not scientific enough to talk about the safety of drugs without these factors.”
According to reports, the dosages involved in the genotoxicity and reproductive toxicity in the Azivudine review report are safe for toxicity tests on animals. Dose and the therapeutic dose used in clinical humans are two different concepts. In the Ames trial of Azivudine tablets, the test concentration at a safe dose was nearly 100,000 times the blood concentration at the human clinical dose. In the CHL chromosome aberration test, the drug exposure at the safe dose in the reproductive toxicity test was more than 60 times the exposure at the clinical treatment dose, which is also a high treatment safety window. Cen Xiaobo pointed out that from a clinical perspective, Azivudine has a large safety window for genotoxicity and reproductive toxicity.
Some industry insiders also told reporters that "Azivudine tablets only 'improve clinical symptoms' but do not reduce 'all-cause mortality' and are not considered a specific drug." This has become one of the core views. In addition, multiple companies can produce Azivudine, and future demand will be affected by many factors such as the development of the epidemic and the effectiveness of this drug in actual use.
According to the key phase III registration clinical trial submitted by Real Biotech, the results showed that Azivudine has the activity of inhibiting the new coronavirus, and the virus clearance time is about 5 days; among the subjects whose clinical symptoms improved on the 7th day after the first dose, , the proportion in the Azivudine group was 40.43%, and the proportion in the placebo group was 10.87%.
The above-mentioned experts told reporters that if Azivudine can only shorten the time for the virus to turn negative, then even if the clinical trial is very strict, its importance will be greatly reduced. "The market demand (for Azfudine) is unclear, and the company's stock price has been pushed up significantly in the early stage, and it is normal for it to fall sharply now."
A staff member of the securities affairs department of an industrial chain pharmaceutical company told reporters that although domestic The launch of Azivudine, the first small molecule oral COVID-19 drug, is a milestone. However, taking into account the development and commercialization progress of COVID-19 drugs at home and abroad, the market’s focus has shifted from R&D progress expectations to performance fulfillment.
The facts confirm the above statement. Already investors are concerned about the "validity" of the company's previous agreement.
In response, the company responded that it was valid, but it did not sign a corresponding contract for specific cooperation.
Source of this article: Shanghai Securities News
Author: Zhang Xue Editor: Shao Ziyi Proofreader: Zhang Yu
Producer: Zhang Xi Picture editor: You Feifei Chief editor: Sun Fang
Coordinator: Pu Hongyi Producer: Lin Yanxing Issued by: Yu Yaqin
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