On the morning of April 6, Kaifa pharmaceutical, a Hong Kong listed company, announced the key data results of phase III global multicenter clinical trial of prochloramide in the treatment of mild and moderate non hospitalized covid-19 patients.
According to the announcement issued by Kaifa pharmaceutical, prochloramide can effectively reduce the hospitalization / mortality of covid-19 patients, especially for all patients taking medicine for more than 7 days, and the corresponding protection rate is 100%. Prochloramide significantly reduced hospitalization / mortality in subjects with high risk factors, especially in the middle and high age group. Prochloramide can significantly and continuously reduce covid-19 viral load and improve covid-19 related symptoms. 99% of the subjects of the phase III global multicenter clinical trial are from the United States. The inclusion does not exclude the vaccination of the subjects, nor does it require the subjects to have risk factors.
Dr. Tong Youzhi, founder, chairman and CEO of pioneer pharmaceutical, said that the company will actively promote the application for EUA license for emergency use of prochloramide to national drug regulatory authorities in China, the United States and other countries and regions.
Affected by this news, the share price of Kaifa pharmaceutical soared by more than 200% in early trading today, and then fell back. As of the closing on April 6, the closing price of Kaifa pharmaceutical was HK $28.85/share, an increase of 106%.
pioneering pharmaceutical industry staged a “reversal”
According to the announcement issued by Kaifa pharmaceutical, the results of this trial show that the overall tolerance of prochloramide in the treatment of mild and moderate covid-19 subjects is good, safe and controllable.
According to the introduction of pioneer pharmaceutical, the clinical trial is a double-blind, placebo-controlled, randomized (1:1), global multi center registered clinical trial. The world’s first subject was enrolled on April 24, 2021, 733 subjects were enrolled on December 24, 2021 (727 from the United States and the rest from other countries), and the last subject’s last visit was completed on February 3, 2022. The subjects were given oral prochloramide 200mg once a day + standard treatment or placebo + standard treatment. The treatment cycle was 14 days. The subjects enrolled in the clinical trial have covid-19 symptoms for no more than five days for the first time, regardless of whether there are risk factors, and the subjects who have been vaccinated with covid-19 vaccine are not excluded.
It is worth mentioning that just over three months ago, Kaifa pharmaceutical’s share price fell sharply due to a less than expected clinical phase III report. On December 27, 2021, Kaifa pharmaceutical announced the progress of phase III clinical trial of prochloramide in the treatment of non hospitalized covid-19 patients with mild and moderate diseases (nct04870606). According to the interim analysis data of 348 patients with covid-19, it did not reach statistical significance due to the small number of events. Affected by this, on December 28, Kaifa pharmaceutical’s share price plunged at the opening, once falling by more than 80%.
In response to this matter, Tong Youzhi, founder, chairman and CEO of Kaifeng Pharmaceutical, previously explained to the reporter of Securities Daily that the clinical trial of prochloramide developed by the company is aimed at the whole population. Due to the large-scale vaccination of covid-19 vaccine in the United States, the number of severe patients in the placebo control group decreased and the number of hospitalized patients was too small, so the numerical probability did not increase statistically.
Li Yifeng, chief researcher of Guangzhou pebble investment pharmaceutical industry, told reporters that whether the product can be approved for listing depends on whether the FDA can accept the clinical data of developing the pharmaceutical industry.
For the interpretation of clinical data and listing progress of prochloramide, the reporter asked relevant people of Kaifa pharmaceutical about this matter, but as of press time, no reply has been received.
domestic covid-19 oral drug development acceleration
With the repeated covid-19 epidemic in China, the research and development of covid-19 oral therapeutic drugs is of great significance.
On February 11, the State Drug Administration approved the import registration of the combined packaging of nevitavir tablets / ritonavir tablets (i.e. paxlovid) of Pfizer covid-19 virus treatment drug conditionally in accordance with the special drug approval procedure. At present, the drug has been temporarily included in the payment scope of China’s medical insurance.
According to media reports, since the first batch of Pfizer covid-19 oral drug paxlovid arrived in China, it has been distributed and distributed to at least 8 provinces, regions and municipalities directly under the central government, including Jilin, Shanghai, Guangdong, Fujian, Jiangxi, Shandong, Zhejiang and Guangxi. At the same time, the external selling price of paxlovid has also been disclosed, which is 2300 yuan / box.
Bao Jingang, a researcher of Rongzhi investment under private placement paipai.com, told the Securities Daily that China plans to reserve 100000 boxes of Pfizer’s paxlovid, with high pricing and limited supply. Therefore, the main supply of covid-19 specific drugs in the future still depends on domestic production.
At present, many enterprises in China have deployed domestic covid-19 therapeutic drugs independently developed.
In March 2nd, Henan Normal University released the official transcript of China’s science and technology administrative micro blog. Professor Chang Junbiao, the 1.1 class of anti HIV innovative medicine Azvudine (FNC), was the third phase clinical trial of New Coronavirus pneumonia in China.
On March 16, Shanghai Junshi Biosciences Co.Ltd(688180) announced that vv116, an oral nucleoside anti sars-cov-2 drug developed by juntuo biology, a holding subsidiary of the company, and Suzhou Wangshan wangshui biomedical Co., Ltd., had launched a phase III clinical study and completed the enrollment and administration of the first patient.
