The company introduced HNC042 for injection, a class 1 new anti-influenza drug

2020-05-19 15:16:00
        According to the contract, ZBD Pharmaceutical has the exclusive rights to develop, register, manufacture and commercialize the products in mainland China. If Henuokang realizes the transfer of international rights and interests, ZBD Pharmaceutical Company will enjoy a 15% share of international rights and interests. 
 
   Announcement shows that treasured island pharmaceutical industry the introduction of the anti-flu drug HNC042 as neuraminidase inhibitors, is used for the prevention and treatment of influenza virus infection 1 kind of innovative medicine, especially for need to be hospitalized intravenous therapy of patients with severe influenza has obvious therapeutic effect, to the wild type and mutant resistant (H274Y) of the influenza virus neuraminidase all showed high inhibitory activity. 
 
   Influenza virus caused by the epidemic wide, infectious strong, high incidence of disease, the economic loss caused every year in the first infectious diseases. The World Health Organization (WHO) estimates that seasonal influenza causes 3 to 5 million severe cases and 290,000 to 650,000 deaths worldwide every year, making it the most dangerous respiratory virus to human health. In recent years, the overall incidence of influenza in China has been rising rapidly. According to the Chinese Bureau of Disease Control and Prevention, the number of cases of influenza in China reached 986,543 in January 2020, with 108 deaths.With people's attention to the prevention and treatment of influenza, the market of anti-influenza virus drugs has maintained a rapid growth trend.
 
   At present, the three types of anti-influenza virus drugs on the market can be divided into three types according to their different mechanisms of action. The first type is M2 channel blockers, the second type is neuraminidase inhibitors, and the third type is RDRPs inhibitors. Currently, oseltamivir and zanamivir and palmer peramivir on behalf of neuraminidase inhibitors are the mainstream variety in the influenza virus infection, the flu diagnosis and treatment schemes (2019 edition) "mainly recommended against influenza virus neuraminidase inhibitors include drugs oseltamivir and zanamivir and palmer peramivir, occupied the most market share.The main therapeutic field of HNC042 project is anti-influenza virus, which is a systemic antiviral drug. The reference drug is the first new anti-influenza drug in China, peramivir sodium chloride injection (hereinafter referred to as "peramivir"), and it is the only injection of neuraminidase inhibitor on the market in China.Different from oral neuraminidase inhibitors, peramivir is adapted for the treatment of critically ill patients with influenza and other neuraminidase inhibitors who do not respond well. Peramivir was listed in 2013, and the market size has been growing rapidly in recent years. From 2017 to 2019, the operating revenue of Peramivir was RMB 70 million, RMB 152 million and RMB 520 million respectively, with a five-year compound growth rate of 186%, of which the sales of Peramivir accounted for about 51% in 2019.

                                                     珍宝岛药业再添重磅品种 引入抗流感1类新药注射用HNC042

  HNC042 against a variety of in vitro antiviral activity is superior to the same target compounds and oseltamivir, especially for the department he WeiNai medicine strain has a strong inhibitory effect, the body for PR8 influenza a (H1N1) virus infection in mice death has the good protection, as well as the resistance type H274Y - PR8 influenza virus infection in mice with strong antiviral efficacy, effect is better than that of peramivir.

   It is understood that the HNC042 project for injection has been completed in the United States phase I clinical trial, the results show good safety and tolerability, PK is linear, supporting the launch of the Ⅱ phase I clinical trial. In October 2018, the new product has obtained the domestic clinical approval and is about to start the domestic clinical trial. Compared with the similar innovative drug projects of other domestic research and development units, the new product has made rapid progress.
 
   On May 14, the State Food and Drug Administration (SFDA) issued the Announcement on the Conformity Evaluation of the Quality and Efficacy of Generic Chemical Injections, which officially launched the consistency evaluation of chemical drug injections. The move will have an impact on the generic drug market of chemical drug injections.In this situation, HNC042 will have independent pricing power as a class 1 new drug injectable variety after listing, which will highlight its advantages.ZBD Pharmaceutical said that the introduction of this innovative drug has enriched the company's differentiated layout of chemical drug preparations, and will further expand the antiviral drug product pipeline of ZBD Pharmaceutical, and form strategic matching and resource sharing with the company's existing oral varieties of traditional Chinese medicine for clearing heat and detoxification.
 
   In recent years, ZBD Pharmaceutical has transformed and innovated. Based on the promotion of traditional Chinese medicine, ZBD Pharmaceutical has developed high-end chemical generic drugs and innovative drugs in the medium term, and long-term layout of biological drugs. Combined with high quality research and development resources at home and abroad, the company adopts the "introduction of cooperation + independent research and development" two-wheel drive research and development mode. According to the 2019 annual report of ZBD Pharmaceutical, the company's 2019 annual revenue of chemical preparations increased by 32.83% compared with the same period last year, and sales has the advantages of synergy and late-comer scale.At the beginning of 2020, the company became the exclusive distributor of Datoromycin for injection (500mg) from India BE Company in mainland China. This product enriches the existing anti-infection product pipeline of ZBD and opens the first step of the licens-in mode of ZBD, which is expected to BE launched next year.Sandoz, a global generics giant owned by Novartis, has been granted the U.S. dealership for the product, indicating that the market for the product is competitive.
 
   At the same time, ZBD Pharmaceutical selects and reserves high-end generic drugs and innovative drugs with certain research and development difficulties for the domestic market according to the domestic clinical needs, new disease targets and new technological progress. Among them, there are 3 innovative drugs in research and chemical drugs, 42 generic drugs in chemical drugs, and 2 consistency evaluation varieties have been approved for production. The introduction of class 1 new drug for injection HNC042 will further promote the company's research and development strategy to develop in depth.