The countdown to the listing of the world's first national class II new drug penciclovir


Release time:

2012-08-29

News from our newspaper On December 3, the long-awaited approval for the production of penciclovir for injection was finally delivered to Jianfeng Pharmaceutical, and the countdown to the production and listing of this product officially began. A few days ago, the reporter interviewed Zhang Chunliang, executive deputy general manager of Jianfeng Pharmaceutical, and asked him to answer questions about Penciclovir for Jianfeng Injection.
Reporter: The banner of Jianfeng Pharmaceutical's penciclovir listing promotion is "the world's first listing". What kind of concept is this?
Zhang Chunliang: At present, penciclovir products on the pharmaceutical market at home and abroad have only one dosage form of topical cream. The project of Penciclovir for Injection of Jianfeng Pharmaceutical Co., Ltd. was established in 1999, officially started development in 2000, obtained clinical approval in 2001, completed phase III clinical trials in early 2006, and has been approved for listing for more than eight years, with a total investment of more than 1000 million yuan in research and development. At present, the penciclovir injection developed by some pharmaceutical companies in Europe and the United States is in the third clinical stage, so Jianfeng Pharmaceutical is the first company in the world to market and sell penciclovir for injection.
Reporter: what is the indication of penciclovir, curative effect?
Zhang Chunliang: Penciclovir is a specific drug for the treatment of herpes. It is the active metabolite of famciclovir, an antiviral drug widely used in the market at present. Famciclovir first metabolizes into penciclovir after entering the human body, which in turn inhibits and treats the virus. Moreover, penciclovir has high selectivity and does not affect the physiological activity of normal cells. Penciclovir enters virus-infected cells and is transformed into penciclovir triphosphate, which exerts an antiviral effect by inhibiting viral DNA replication. For uninfected cells, penciclovir remains unchanged and spreads out of the cells without affecting the physiological activity of normal cells.
Because penciclovir is the active metabolite of famciclovir in the human body, in addition to being suitable for patients with severe herpes zoster, penciclovir, like famciclovir, can be widely used in the treatment of viral infections such as herpes zoster and primary genital herpes.
In more than four years of clinical trials of Penciclovir for injection by Jianfeng Pharmaceutical, the first affiliated Hospital of Peking University, the second affiliated Hospital of Sun Yat-sen University, the Institute of Dermatology of Chinese Academy of Medical Sciences, Jiangsu Provincial People's Hospital and other authoritative diagnosis and treatment institutions confirmed by the State Food and Drug Administration on more than 700 patients, compared with acyclovir, Penciclovir for injection for herpes zoster treatment, early inhibition, blisters and pain relief is better than acyclovir, acyclovir, less time to start scabbing. And acyclovir three times a day, 0.5 grams each time, penciclovir only two times a day, each bottle (0.25 grams), medication dosage, medication frequency significantly reduced. Compared with the previous skin absorption of penciclovir topical cream, injection significantly faster onset. Therefore, on December 10, the "Pharmaceutical Economic News" in the second page of the eye-catching position with the title "New Star" at the Pharmaceutical Fair ", reported on the listing of drugs such as Jianfeng Pharmaceutical for injection penciclovir, calling it the" nemesis of herpes ". Professional media such as the "Pharmaceutical Procurement News" published on December 15 also publicized the information on the launch of the product.
Reporter: What are the market advantages of penciclovir for injection?
Zhang Chunliang: In addition to the advantages of clinical efficacy, Jianfeng Pharmaceutical Injection Penciclovir also has the advantages of dosage form and research and development protection. Since the oral bioavailability of penciclovir is only 20%, it is not suitable for development into oral dosage forms, so injection is the best choice. Although another enterprise in China is also developing penciclovir for injection, it is still in the review stage of the review center of the State Food and Drug Administration. It is estimated that its products will take at least half a year to go on the market. Penciclovir for injection is a national Class II new drug and enjoys a 4-year monitoring period. After the monitoring period expires, even if the follow-up manufacturers immediately follow up the research and development of imitation, it will not enter the market until 2013. Therefore, penciclovir for injection has broad market prospects.
In addition, due to the rectification of the pharmaceutical industry, there has been no new drug approval in China in recent years. As a new national class II new drug, penciclovir for injection has been widely concerned by the industry. At the 58th Pharmaceutical Fair held in Kunming from December 6th to 8th, many pharmaceutical sales companies and agents came to consult and asked to represent this product, including many large sales companies with strong strength. At present, we have reached a preliminary cooperation intention with some enterprises.
Reporter: What is the current preparation for the production of penciclovir for injection?
Zhang Chunliang: Since it was learned in early September that penciclovir for injection was approved by the State Food and Drug Administration for production, the pharmaceutical company has actively prepared for production, conducted quality audits and purchases of raw and auxiliary material manufacturers, and conducted a product test in October., Some minor modifications have been made to the production line, and there are no problems in the production process. At present, the product packaging has been designed. On December 16, the first batch of raw materials have arrived at Jiangnan Factory and are expected to be put into production by the end of the month. According to the relevant regulations, the first three batches of products should be sent to the provincial drug inspection institute for inspection. If there is no quality problem, large-scale production can be carried out. If all goes well, the product is expected to be put on the market by the end of January next year.
Reporter: What kind of sales plan has the pharmaceutical company formulated for penciclovir for injection?
Zhang Chunliang: After receiving the production approval, on December 10, the pharmaceutical company organized a coordination meeting attended by the heads of relevant product departments and enterprises, and further implemented the specific work related to the production and marketing of penciclovir for injection and product promotion. Hainan Jianfeng and Pharmaceutical Sales Company will be responsible for the sales of penciclovir for injection. Only regional agents will be set up in developed coastal provinces. Provincial agents can be considered in underdeveloped areas such as the central and western regions and the northeast. When selecting agents, the work of entering provincial medical insurance for products must be considered. Hainan Jianfeng has asked all sales regions to do a good job in bidding and market follow-up work for penciclovir for injection in a timely manner, reasonably lay out the market network and implement customers. Pharmaceutical companies will attract investment nationwide through the "Pharmaceutical Economic News", and professional newspapers such as the "Pharmaceutical Economic News" and "Chinese Journal of Pharmacy" will publish relevant introduction articles in the near future to carry out strong product promotion. At present, pharmaceutical companies are also organizing and planning large-scale academic activities attended by dermatological directors of major hospitals and directors of dermatological Junior College hospitals across the country, and key provinces will also hold listing promotion meetings. Promote product sales with advertising and academic promotion.
In 2008, 800000 penciclovir for injection are planned to be sold. This product will be a new bright spot in addition to spike pharmaceutical injection with cefmenoxime hydrochloride