On the evening of february 11th, berry announced that the company had successfully developed the technology and preparation technology of reedxivir raw materials, and had already produced reedxivir raw materials in mass production, reedxivir preparations are in the process of mass production. Affected by the news, on february 12, the opening of borui medicine was sealed in the trading board.
However, mr. boris said mr. redsievere eventually turned into a product and needed authorization from Gilead as a patentee. On february 12th shi lichen, head of beijing`s dingchen medical management advisory center, told economic in the 21st century that patent licensing or not the biggest issue in the current context was whether or not it ultimately depended on how the epidemic developed and on how regulators judged it. One core of chemical drugs is APIs, which, since Bori has been able to mass-produce, suggest that technical problems are small, in the context of the current epidemic, mandatory imitations can be made under the WTO principle, and the State may approve its listing on the basis of conditional listing. "
On the evening of february 11th, when news emerged of mr redsievert`s development, comments were mixed, with some saying it was a sign of the coming era of high imitation in china, others arguing that generics would help lower drug prices, and others questioning patent issues. In this regard, mr. stanley told the 21st century economics that one important value of generic drugs is to reduce the price of drugs, but that doesn`t mean that china is already entering the era of strong imitation, and there is still a big gap with foreign technology.
Jiang yangzhi, a capital partner at the german federation, also reported to the 21st-century economic journal that research and development of high-end generic drugs requires a certain strategy and cycle, with technical barriers and accumulated experience. "We remain wait-and-see under the condition that Glyde`s original drug is not yet available for large-scale clinical validation of the new coronavirus. "
Study first
Gerald`s redsievert has received widespread attention after successfully treating a new type of coronavirus pneumonia in the united states. With the support of the Ministry of Science and Technology, the National Health and Health Commission, the State Drug Administration and other departments, the antiviral drug Redsivir has completed the registration and approval of clinical trials, and the first batch of severe pneumonia patients with new coronavirus infection were given medication on February 6.
Given the urgency of the current situation, the owner of the Redsievert drug, Gilde Science of the United States, said it was taking various steps to speed up production and increase supply.
To better address drug-accessibility issues, mr. boris is also working on a generic version of reedxivir.
So far, the cost incurred by Bori in the development and production of the raw materials and preparations in Redsiev is expected to be about 5 million yuan, and the subsequent further expansion of production is expected to require an additional investment of about 10 million yuan. The R & D is independent of other existing businesses and the company`s other businesses are operating normally, Borey said.
It is understood that the imitation and preparation of reedxiwei raw materials after the production, through the drug clinical trials, drug approval and other links. At the same time, there are a number of uncertainties in the future, including whether redsievert eventually turned into a product into the market, and whether it can obtain the authorization of gillard as a patentee; and if the redsievere phase iii clinical trial is not over, redsievere`s imitation technology is of little value if the results are not satisfactory.
Another important aspect is closely related to the development of the epidemic. If the outbreak of a new type of coronavirus is quickly controlled and alleviated in the short term, the number of confirmed patients will continue to decline, and even if reedsivir is registered and approved for the treatment of a new type of coronavirus, it is not expected to be of great help to fight the epidemic.
Mr wang, secretary of medicine for mr borui, told the 21st-century economic journal that even if these factors lead to 15 million dollars worth of investment, he would not regret it. "In the face of the epidemic, we don`t want to wait and do research and development first. If we succeed, we won`t make a`national disaster`, we will provide the medicine to the country to treat more patients. "
After the outbreak began in late january, mr. borui began its research and development program, and in a short period of time developed and produced a generic version of reedxivir, and now produces preparations. "We can develop the production of APIs and have the capacity to produce preparations. "
Patents?
One important factor in the success of the generics market is the patent licensing of gillard. Glyde has now obtained patent approvals in major countries and regions such as the United States, China, the European Union, Japan and the Republic of Korea, according to a review by the Patenttcloud`s Duetcloud`s Due Intelligence, and its patent rights related to the compounds and methods of preparation are estimated to last up to 2031-2036.
In mr stanley`s view, patent licensing is not a major issue for boris. In the current epidemic situation, according to WTO-related principles Borui Pharmaceutical cannot be subject to patent-related mandatory imitation, although the original research drug phase 3 has not been completed, but if the epidemic prevention and control needs, the state can be conditional listing approval of its listing.
In addition to accepting China as a WTO member, another historic decision at the WTO`s fourth minister meeting in Doha in November 2001 was the Declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health. The Declaration made it clear that when developing countries were exposed to serious public health crises caused by AIDS, tuberculosis, malaria and other infectious diseases, member States could force imitations of medicines for the treatment of these diseases, and the Doha Declaration stated that the protection of intellectual property rights should not be an obstacle to access to "life-saving drugs ".
In fact, in the past, there have been cases in which multinational pharmaceutical companies authorized Chinese pharmaceutical companies when they had an infectious disease in China. In order to prevent and control the influenza pandemic, in December 2005, Roche authorized Shanghai Pharmaceutical Group to produce oseltamivir (Tamiflu); in March 2006, Roche Group also authorized Shenzhen Dongyangguang Industrial Development Co., Ltd. to produce oseltd. in China.
Moreover, in mr stanley`s view, high-quality generic drugs are one of the most important ways to promote drug accessibility, so many foreign companies are encouraged to develop and produce generic drugs.
It is understood that many generic pharmaceutical companies in the original patent period after the beginning of the start of research and development, clinical trials and so on.
Journallist, an industry veteran, told 21st-century economics that these were all international practice and did not violate patent law, in line with the "bolar exception" principle.
The "Bolar exception" principle is a patent infringement exemption principle that applies specifically to related fields such as pharmaceuticals and medical devices, named in the case of Roche v. Bolar patent infringement in the early 1980s. In practice, it is also referred to as the "clinical trial exception" principle or the "Bolar clause ". The basic meaning of this principle is that the conduct of patent-related acts in order to conduct clinical trials and registration of pharmaceuticals and medical devices is not considered as infringement of patent rights and shall be granted infringement exemptions.
Shi Lichen believes that enterprises actively do R & D investment, do clinical trials and so on, will be more conducive to the imitation of high-end drugs and so on, so that after the expiration of patent drugs the first to launch generic drugs, to help generic drugs to develop towards high quality.
According to the 21st-century economic report, journallist understands that there are many start-ups that are now following a combination of high imitation and innovation. In the industry`s view, over the years, especially in the last 10 years, with the growth of these enterprises, and the mastery of new technology, will play a great role in the development of Chinese generic drugs, innovative drugs, the future will change the pattern of the pharmaceutical industry.
