NEWS CENTER

Position:

Group Announcement

Media reports

Group News

Flu Season Is Here—Shisi Pharmaceutical’s Arbidol Joins the Main Force in Fighting the Flu

Category:

Group News

Time：2019-12-06

Recently, the Medical Administration Bureau of the National Health Commission issued the “Notice on Doing a Good Job in Influenza Treatment This Winter and Next Spring” (Guowei Ban Yi Han [2019] No. 819), along with the “Influenza Diagnosis and Treatment Protocol (2019 Edition)” as an attachment. Notably, in this new version of the influenza diagnosis and treatment protocol, the hemagglutinin inhibitor arbidol has been included in the list of antiviral drugs recommended for clinical use.

Flu Season Is Here—Shisi Pharmaceutical’s Arbidol Joins the Main Force in Fighting the Flu

The current situation of prevention and control is severe; antiviral drugs are the mainstay.

Influenza, or the flu, is an acute respiratory infectious disease caused by influenza viruses, and the entire population is generally susceptible. Because influenza viruses readily mutate and spread rapidly, they can cause seasonal epidemics every year. Although influenza is a self-limiting illness, it can be fatal in high-risk groups—including children, the elderly, and individuals with weakened immune systems or chronic underlying medical conditions. According to a report by the World Health Organization (WHO), each year during flu season, seasonal influenza epidemics worldwide result in 3 to 5 million severe cases and claim the lives of 290,000 to 650,000 people from influenza-related respiratory diseases.

China also bears a heavy burden from influenza. According to data from the Chinese Center for Disease Control and Prevention, in the first five months of 2019, the number of reported influenza cases had already reached 1.77 million—exceeding the total number of reported cases over the previous four years combined. Additionally, according to statistics from the National Health Commission, in northern and southern Chinese cities, the excess mortality rates from influenza-related respiratory and circulatory diseases averaged 12.4 per 100,000 people per year in the north and 8.8 per 100,000 people per year in the south.

In fact, getting vaccinated against influenza is the most effective way to prevent influenza and its serious complications. However, due to insufficient awareness among the general public and primary-care medical personnel regarding the dangers of influenza and the disease burden it imposes, China currently faces a low influenza vaccination rate—a situation that hinders the effective early identification and timely antiviral treatment of influenza. To reduce the disease burden of influenza, the National Health Commission has, over the past two years, continuously updated the influenza diagnosis and treatment guidelines, drawing on the latest domestic and international research findings as well as China’s previous experience in diagnosing and treating influenza. The aim is to further standardize and strengthen clinical management of influenza, thereby reducing the incidence of severe cases and lowering the mortality rate. Consequently, antiviral drugs remain the mainstay of frontline clinical efforts to combat influenza at this stage.

Currently, there are three types of antiviral drugs approved for the treatment of influenza in China: neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers. Abidor, recently included in the updated influenza diagnosis and treatment guidelines, is one of the hemagglutinin inhibitors. Developed by the former Soviet Union’s Research Center for Pharmaceutical Chemistry, Abidor was first launched in Russia in 1993 and is available in various dosage forms, including capsules, tablets, and oral suspensions. Its indications include the prevention and treatment of influenza A and B as well as other acute respiratory viral infections in children aged 2 years and older and adults; combination therapy for recurrent herpes infections; combined treatment of acute rotavirus gastroenteritis in children aged 2 years and older; and prevention of postoperative complications. After years of clinical verification, Abidor has proven to be effective in preventing and treating influenza with a favorable safety profile. It has thus become a recommended drug by the Russian Pharmacopoeia Commission for both elderly individuals and children as an essential therapeutic and preventive agent against influenza A and B viruses. Moreover, the Ministry of Health and Social Development of the Russian Federation has listed this drug as a prescription medication for free medical assistance provided by physicians and as an essential medicine for emergency medical services. In addition, Abidor is also designated as an important strategic reserve drug.

Shijiazhuang No.4 Pharmaceutical Co., Ltd. boasts a National Enterprise Technology Center and has established multiple drug innovation research centers in collaboration with renowned domestic universities and research institutions. It is one of the earliest pharmaceutical companies in China to engage in research and development of arbidol as an antiviral agent against influenza viruses. In 2004, Shijiazhuang No.4 Pharmaceutical was the first in China to obtain the production approval number for arbidol and launched the first generic version of the drug on the domestic market.

Unique pharmacological mechanism, unanimously recommended by consensus guidelines.

In terms of pharmacological action, arbidol specifically inhibits the fusion of viral envelopes with host cell membranes by activating 2,5-oligoadenylate synthetase, thereby blocking the first step of viral infection. Moreover, arbidol can also induce the body to produce endogenous interferon, which not only interferes with viral replication but also modulates the body’s immune functions, enhancing macrophage phagocytic activity and inducing activation of natural killer cells. Medical experts point out that arbidol’s advantage—its ability to combat influenza viruses through multiple synergistic mechanisms—is something that other anti-influenza drugs do not possess.

Studies have shown that Arbidol is currently the only drug with strong antiviral activity against all types of influenza viruses (A, B, and C). Among these, it exhibits the strongest efficacy against influenza A viruses (H1N1, H2N2, and H3N3), comparable to or even surpassing that of neuraminidase inhibitors such as oseltamivir and zanamivir. While effectively alleviating flu-like symptoms such as sore throat, muscle pain, and fatigue, Arbidol can also shorten the duration and course of illness, enhance viral clearance rates, and accelerate patient recovery.

For high-risk groups susceptible to influenza, arbidol can effectively shorten the duration of fever in patients and significantly reduce the incidence of other complications such as pneumonia. As a non-nucleoside broad-spectrum antiviral drug, arbidol not only inhibits influenza viruses but also exerts inhibitory effects on common respiratory pathogens including respiratory syncytial virus, rhinovirus, adenovirus, and coronavirus. Additionally, studies have shown that in patients with chronic obstructive pulmonary disease, prophylactic use of arbidol during seasons when influenza and acute respiratory viral infections are more prevalent can significantly reduce (by a factor of 2.6) the incidence of acute respiratory viral infections.

Thanks to its outstanding clinical data, arbidol has gained widespread recognition in the medical community. Even before being included in the new influenza diagnosis and treatment guidelines, arbidol had already been featured in the “Diagnosis and Treatment Protocol for Influenza A (H1N1) (2010),” issued by the former Ministry of Health. Moreover, both the Respiratory Disease Branch of the Chinese Medical Association and the Pediatric Branch of the Chinese Medical Association, in their jointly published “Chinese Expert Consensus on Antiviral Drug Therapy and Prevention for Influenza (2016),” as well as the Respiratory Physicians Branch of the Chinese Physicians Association in its 2016 “Expert Consensus on the Rational Use of Antiviral Drugs for the Treatment of Influenza,” have recommended arbidol as a commonly used antiviral drug for influenza.

Interestingly enough, Arbidol was also recommended in the “Interpretation of Clinical Pathways (2018 Edition)—Respiratory Diseases Volume: Interpretation of Community-Acquired Pneumonia Clinical Pathway,” and it has furthermore been included in the “Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (2019 Edition).” In August of this year, Arbidol was successfully added to the 2019 National Medical Insurance Catalogue as a Class B drug, authorized for use in antiviral treatment of influenza specifically for high-risk groups with severe influenza and patients suffering from severe illness.

Therapeutic effect For Wang, it's even more important to take economic considerations into account.

As the number of influenza cases increases year by year, so too do the medical treatment costs for influenza patients in healthcare institutions. A domestic study shows that the average cost per outpatient visit for influenza is 1,052 yuan, while the average cost per hospitalization reaches as high as 11,153 yuan. Among these, patients aged 60 and above have the highest average cost per treatment, at 18,818 yuan, placing a relatively heavy financial burden on influenza patients.

In parallel with the soaring cost of treatment, antiviral drugs have repeatedly set new records for market sales. According to data from MeneNet, sales of systemic antiviral drugs at the terminal level in China’s public medical institutions have risen steadily in recent years, reaching 19.089 billion yuan in 2018—a year-on-year increase of 9.01%. Among the top 20 best-selling drug varieties, anti-influenza viral agents rank prominently in terms of quantity. The enormous and unmet clinical demand has created a promising market outlook for anti-influenza viral agents. According to authoritative statistics, the annual compound growth rate of China’s major anti-influenza viral drugs has reached as high as 45.3%.

The above statistics also show that among the antiviral drugs currently in primary clinical use for influenza, oseltamivir overwhelmingly dominates, accounting for 87.3% of the market share. However, industry insiders point out that abidor, the “new star” in influenza treatment recently included in the influenza diagnosis and treatment guidelines, may shake up the existing competitive landscape in hospital settings, thanks to its inclusion in the new national medical insurance catalog.

A head-to-head study comparing arbidol and oseltamivir has shown that arbidol is equivalent to oseltamivir in terms of shortening the duration of illness and reducing the severity of symptoms. In terms of drug resistance, no resistant viral strains have yet been identified for arbidol, whereas oseltamivir has already seen the emergence of viral strains with high resistance to neuraminidase inhibitors. Moreover, in terms of mechanism of action, compared to arbidol—which both inhibits hemagglutinin and induces the body to produce endogenous interferon—oseltamivir, a neuraminidase inhibitor, has a somewhat more limited target. From an industry perspective, given their comparable efficacy, arbidol, which boasts a lower average daily treatment cost, is clearly more economically advantageous.

Currently, Abidol is manufactured by several domestic pharmaceutical companies. Among public medical institutions and urban retail pharmacies, only Shijiazhuang No.4 Pharmaceutical stands out as one of the top three in terms of brand competitiveness. Its exclusive product, Enoda® Abidol Hydrochloride Capsules, has been available on the Chinese market for many years and has won widespread acclaim from the market. In October 2019, Enoda® was awarded the title of “2019 China’s Most Innovative Pharmaceutical Formulation.” In November of the same year, Enoda® was also recognized—on the strength of its outstanding performance—as one of the “Landmark Achievements in China’s Pharmaceutical Technology Celebrating the 70th Anniversary of the Founding of the People’s Republic of China.”

(Originally published in the Pharmaceutical Economic Daily)

Keywords:

The Group’s 2020 Policy and Target Launch Conference Was Held.

Zhang Juhua, Secretary of the Gaocheng District Committee, visited the company for a research visit.

The Group’s 2020 Policy and Target Launch Conference Was Held.

Zhang Juhua, Secretary of the Gaocheng District Committee, visited the company for a research visit.