Report from the "clean" zone of JSC "Biochemist" on the production of "Areplivir" — in the Capital With

In 70 percent of patients taking Areplivir, the absence of the virus is recorded on the fourth day.

June 26, 2020 The Russian Ministry of Health has approved Areplivir for the treatment of coronavirus infection. The developer, Promomed, has received a registration certificate for its release at its own production site, JSC Biochemik. According to experts, this event will make it possible to change the course of the epidemic and create reliable protection against the threat of the predicted "second wave" of covid.

"C" visited the "clean zone" of production, and saw with her own eyes how the "killer" of the coronavirus was born. The tour began with the traditional attire in protective suits. Jackets, trousers, hats, shoe covers, respirators, gloves — the entrance to the "clean zone" of Areplivir production is not much different from the entrance to the "red zone" of the hospital. The production facilities here resemble the secret laboratories of the future — narrow corridors where you can only walk two at a time, matte-white walls and ceilings, and a bright blue self-leveling floor. There are small windows made of special glass and closed doors along the walls. We go through the first door and find ourselves in a room where four people are cramped. "The tablet mass comes here through the hopper and is pressed. Each tablet, with a diameter of 11 mm, weighs 435 micrograms. The operator controls the appearance, weight, and transmits the tablets received to the quality control department," the attendant tells us. There is a bitter suspension in the air that penetrates through a regular respirator. However, the employee of this workshop is not in danger — he is wearing a dust mask with filter cans on the sides. The next step is to apply the shell to the finished tablet. The process takes place in the same small room. There are two main equipment here: a reactor in which a film-forming solution is prepared, and a centrifuge, where the tablet mass is wrapped in a finished shell. The air here is sweet, although the film itself has no taste. "The average volume of one industrial batch is 60 kg (about 4 thousand) tablets and 150 liters of film coating. But we can produce several such batches per day," says the attendant.

The next stage is to "seal" the tablets into 10 blisters, which then fall into the hands of the packers. Within 8.5 hours, they put the blisters and instructions for the drug in blue-and-white boxes with the image of the coronavirus. By the way, the packaging design was developed by Biochemist specialists. There's a whole department here for that. Returning from the "clean zone", in one window we notice a strange action — the "rods" of a mini-press unknown to us rise and fall into flasks with a bright blue liquid. It's a magical sight. "This is the production of capsules for medicines," they explain to us, but the magic does not disappear from this.

The production tour ends with a video conference with Dmitry Zemskov, Executive director of Biochemik, who spoke in detail about the serial launch of a new coronavirus drug. According to him, on June 23, the registration certificate for Areplivir was received and the first batch of 10 thousand packages will go to consumers this Saturday, June 27. "So Biochemist is fully ready for large—scale production of the drug — the company is capable of producing up to one million packages per month, which will cover all the needs of Russian medical institutions," Zemskov assured.

"At the moment, Areplivir is at the stage of completing clinical trials, in which 210 patients with confirmed coronavirus infection who are undergoing treatment in medical institutions in Saransk, Moscow, and St. Petersburg voluntarily participate. The results of the third phase of clinical trials of the drug "Areplivir" demonstrated its effectiveness in excess of 90%. It has been confirmed that the duration of the disease with the use of Areplivir is reduced from nine to four days compared with the control group of patients. In the biological samples of 70 percent of patients taking Areplivir, the absence of the virus was detected on the fourth day. These are excellent results!" added the Executive Director of Biochemistry. According to Dmitry Zemskov, despite the short duration of clinical trials, Areplivir has shown high efficacy even without complex therapy, including antibiotics. Doctors recommend prescribing Areplivir to patients with moderate to mild covid in the first 48 hours of treatment.

"At the same time, clinical studies have not revealed previously unreported side effects of the drug. All these indicators make it possible to call Areplivir a "drug of hope and salvation," Zemskov is sure. The drug is based on the active substance Favipiravir, which blocks the reproduction of the virus in the human cell and thereby prevents the spread of infection in the body. Its formula was developed by the Japanese twenty years ago. Russian specialists have not only restored the favipiravir molecule, but also improved it. "This is not only a Japanese development, but also our technology, which was forged 24 hours a day. The resulting molecule will become a platform for the creation of various antiviral drugs," Dmitry Zemskov assured. At the same time, he added that their "firstborn" Areplivir will be available only for medical institutions, it will not be available for free sale through pharmacies.

"We already have applications from Moscow and the Moscow region, as well as hospitals in Mordovia. So help in the fight against coronaviruses for our patients is already very close," Zemskov said.