A few days ago, Roche Pharmaceuticals announced that it has cooperated with China's Hangzhou Geli Bio to develop a new drug Danoprevir for the treatment of hepatitis C. This has also become the first test water for Roche to develop, produce and sell new drugs in cooperation with Chinese pharmaceutical companies.
In the most critical registration link for new drug development, Swiss Roche Pharmaceuticals is beginning to "overtake in corners".
This means that in the Chinese market, this cooperation model will become a new business model launched by Roche and will gradually expand to other areas and local companies in terms of coverage.
According to the cooperation agreement announced by both parties, during the cooperation between the two parties, Geli Bio will fund and be responsible for the development, registration and production of Danoprevir in Mainland China and Hong Kong, Macao and Taiwan; Roche will pay Geli Bio for drug development and Commercial mileage.
As the cooperation agreement extends to the sales link after the drug is marketed, Geli Biology will also receive a commission fee for drug sales, but the parties have not further disclosed the specific method and proportion of this share.
"At present, both parties have formulated a detailed R & D plan and timetable, and are also in close communication with the China Food and Drug Administration, hoping to promote the drug as soon as possible." Wu Jinzi, President and CEO of Goli Biotechnology (Hangzhou) Co., Ltd. revealed At present, it is preparing to declare the domestic clinical approval, and the drug has successfully completed the second phase clinical trials in Europe and the United States.
As the relevant Chinese authorities tighten the drug registration window, the average speed of new drugs being marketed in China is much slower than the international market. The time spent in the registration process has become the most critical indicator of drug market competition except for the product itself.
In this regard, Luke Miels also said: "Danoprevir is a domestic company that declares a new drug by Geli Bio, which can not only develop the drug according to the characteristics of the Asian population, but also accelerate the speed of approval of the new drug. market."
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