At present, the situation of national epidemic prevention and control is grim and complex, and there are good news in the field of domestic covid-19 specific drugs.
In the morning of April 6, Kaifa Pharmaceutical (09939. HK) disclosed the key data and results of its covid-19 oral drug prochloramide in the phase III global multicenter clinical trial (nct04870606) for the treatment of mild to moderate non hospitalized covid-19 patients.
The results of clinical trials showed that prochloramide was well tolerated, safe and controllable in the treatment of mild to moderate covid-19 subjects. During the whole trial, the incidence of adverse events was 7.9% in the control group and 9.6% in the prochloramide group, most of which were mild. The most common adverse event was vertigo (1.1% in the control group and prochloramide group), and the incidence of any other adverse events was less than 1%. There were no serious adverse events in the study.
In the capital market, Kaifa pharmaceutical rose sharply at the opening and closed at HK $28.85 per share, up 106.37%. In addition, just the trading day before the announcement (April 4), Kaifa pharmaceutical closed with an increase of 36.79%.
Phase III data disclosure: it can effectively reduce the hospitalization or mortality of mild and moderate diseases
It is understood that prochloramide, as a degradation agent of ACE2 (angiotensin converting enzyme 2) and TMPRSS2 (transmembrane protease serine 2), can be used in the clinical treatment of covid-19.
It is worth noting that the clinical trial progress of prochloramide is not smooth sailing. Kaifa pharmaceutical disclosed on December 27 last year that the interim analysis of the above phase III clinical trial did not reach statistical significance. The company immediately said that it would apply to various regulatory agencies, including FDA, to modify the clinical trial scheme, and planned to continue to recruit covid-19 patients.
Now, four months later, the key data results released this time have reversed prochloramide. For the reasons for the reversal of the results, insiders of Kaifa pharmaceutical replied to reporters that the interim analysis results released at that time were blind. Now the whole clinical trial has been blinded and more data have been displayed.
In the trial group, the death rate of patients who were treated with Prozac was more than 690 (P 0.02), especially in the control group, the death rate of patients who were treated with Prozac was more than 690 (P 0.02).
Prochloramide significantly reduced hospitalization / mortality in subjects with high risk factors, especially in the middle and high age group. For subjects older than 60 years old and with at least one underlying disease (such as obesity, diabetes, hypertension, etc.), puke luramine significantly reduced hospitalization / mortality (P 0.02), with a corresponding protective rate of 100% and no hospitalization or death.
Kaifa also said that compared with the control group, the treatment group of prochloramide could significantly and continuously reduce the covid-19 viral load from the 3rd day to the 28th day of Administration (the 3rd and 28th days, P 0.01). In terms of symptom improvement, prochloramide group can better improve some related symptoms of covid-19 pneumonia, such as fever, shortness of breath and cough, and the improvement is better than that of the control group until at least the 28th day.
Tong Youzhi, chairman and CEO of Kaifa pharmaceutical, also commented on the clinical trial results disclosed this time, and said that it would actively promote the application for emergency medication EUA license from the national drug regulatory authorities of China, the United States and other countries and regions.
We have reached strategic cooperation agreements with many companies on prochloramide
Pioneer pharmaceutical released its annual performance report for 2021 on March 25. According to the annual report, during the reporting period, the income of Kaifa pharmaceutical was 34.23 million yuan, which came from the down payment of external authorization for covid-19 indications of prochloramide.
As of December 31, 2021, the company's R & D cost increased from RMB 329 million in the previous year to RMB 768 million, a year-on-year increase of 133.5%. The increase in R & D expenditure was mainly due to the three phase III global multicenter clinical trials of prochloramide in the treatment of covid-19 led by the company during the reporting period. In terms of product development, the diversified product pipeline of small molecule innovative drugs, biological innovative drugs and combination therapy of the company is "multi pronged". It has seven new drug projects under clinical research in China, the United States and other countries, as well as a number of preclinical projects. Prochloramide is in the core position in the R & D pipeline of developing the pharmaceutical industry, and it is also one of the products with the fastest progress in clinical trials.
In terms of commercial cooperation, the pharmaceutical industry has reached strategic cooperation with Huayi Taikang, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , etana on prochloramide.
On April 12, 2021, a strategic cooperation agreement was reached with Huayi Taikang on expanding the production capacity of prochloramine.
On July 15, 2021, a cooperation agreement was reached with Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry on the commercialization of prochloramide treatment covid-19 in India and 28 African countries. The two sides cooperated with each other and jointly promoted the application, promotion and sales of emergency use authorization (EUA) for prochloramide covid-19 indications. According to the terms of the agreement, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) industry will obtain the exclusive registration and commercial sales rights of prochloramide in the cooperation area, and pay no more than 560 million yuan for the development of pharmaceutical industry, including down payment, development milestone of about 110 million yuan and commercialization milestone of no more than 450 million yuan. In addition, Kaifa pharmaceutical will charge no less than 50% of the total profit as the sales commission based on the future net sales of prochloramide in the cooperation area.
On August 25, 2021, the company and etana reached a cooperation agreement on the commercialization of prochloramide treatment covid-19 in Indonesia. According to the agreement, Kaifa pharmaceutical will receive the down payment and milestone payment from etana. In addition, it will also obtain the economic benefits related to the listing and sales of prochloramide in Indonesia.
As of December 31, 2021, the cash, cash equivalents and time deposits of Kaifa pharmaceutical were RMB 1.055 billion, including the bank financing used of RMB 155 million. In addition, as of December 31, 2021, the unused bank financing of the company was 150 million yuan.
