Medical network - July 11 "left LAmbreTM closure system is one of the first China's independent brands left closure products, had been on the market in Europe, currently in communication with the FDA for the first round." On the 15th international BBS af, health science and technology first, chief technology officer de-yuan zhang to 21st century business herald reporters.
Industry media according to the epidemiological study, the incidence of atrial fibrillation is about 1% to 2% of the total population, China has an estimated 10 million people, atrial fibrillation on average every three with one suffered a stroke in patients with atrial fibrillation, and cause of stroke in patients with nonvalvular atrial fibrillation thromboembolism over 90% comes from the left.
"It was a completely independent intellectual property products, represents China's high-tech medical equipment product development progress. Left LAmbreTM closure approved listing, is also in the field of high-end medical equipment in China has gradually break the import an important manifestation of monopoly." Ecg physiological and pacemaker branch of Chinese medical association, director of the committee, director of the wuhan university people's hospital of cardiology yellow anew to the reporter pointed out that the 21st century economy.
Before 2000, China does not have the ability to production defect closure of congenital heart disease, 100% need to import, a small closure cost up to 40000 above, the Chinese enterprises to implement domestic, sharply lower prices, coupled with national health supplements, greatly reduces the burden of patients. The de-yuan zhang said that if the Chinese enterprises to gain a foothold in the international competition, must be continuous innovation in technology breakthrough.
The first left closure system is approved
In this device in the study of Chinese clinical PI (principal investigator) from the new point of view, huang left LAmbreTM closure system is safe and effective, simple and easy to use, greatly shorten the doctor's learning curve. "We planted in 157 patients, the clinical research results the success rate is 98.5%, and China is 99% (two cases of midway stop treatment hence also which belong to the case for failure)."
De-yuan zhang, left LAmbreTM closure has seven countries in Europe, 35 hospitals, into the group of more than 400 patients, has been in communication with the FDA for the first round.
It is understood that LAmbre? Left before closure system run by the state food and drug administration into the innovation of medical apparatus and instruments for examination and approval of special channel, for priority review and registration procedures, and by the state administration of food and drug supervision and administration of medical devices technical review center will provide guidance to deep discuss technical problems, give priority to technical review and administrative examination and approval of product.
Recently, total bureau of national food and drug supervision and administration of medical device registration division Gao Guobiao, deputy director of the 21st century economy at an industry conference reporter pointed out that the medical device industry is one of the fastest growth in more than a decade, the proportion in clinical applications and contribution rates also increased significantly, and medical equipment in our country new law system has been basically formed, has more than 40 form a complete set of regulatory documents, and more than 200 technical review guidelines, etc.
At present, countries have stepped up to the innovation of scientific research equipment products such as support, opened up a limited approved, including future health science and technology first, and more research and development of enterprises will directly benefit.
Health science and technology will be in excess of 20% of the revenue proportion first money into research and development. Health science and technology first, chief financial officer jian-xiong liu pointed out that only the high spending on research and development to ensure the company a long time in the future, the product has certain leading, sustainable development of the company, you can get more powerful guarantee.
At this stage to health science and technology have 15 products pre-study, 15 products in ongoing clinical research, seven products, 1-2 marketed products per year on average. Health pre-study, products are in development to walk in the forefront of the industry innovation, with global initiative or fill the blank of the Chinese research and market position.
High-end medical equipment domestic alternative
Was founded in 1999 the first national health technology aiming at localization of closure of congenital heart disease, in 2001, is China's first independent research and development success breakthrough foreign monopoly closure of congenital heart disease in the factory.
In 2003, the first national health technology successfully copied out of the second generation of drug-loading Johnson stents, but for the patent protection consciousness of science and technology, health science and technology first choice on the basis of the stent, began to develop independent intellectual property rights of the third generation of biodegradable stents. Is also for this reason, health science and technology in the first two generation of drug stent market does not account for position, on the contrary, two other domestic enterprises with forced listed profitable.
De-yuan zhang to 21st century business herald reporters that this is related to the growing history of health science and technology first. Health science and technology in the first launched in 2001, the first product, with American firms engage in a lawsuit, until 2008 won patent lawsuit.
"Litigation" thing has been accompanied by the growth of science and technology, first in the results of science and technology, news about "litigation". As in the Indian market, it is with a us medical device companies have been in the lawsuit, but because they are not, so could not be solved.
"The us company more than half of India's market share is replaced by us, but in China, the company's market share is most is replaced by us." De-yuan zhang told reporter in the 21st century economy, health science and technology of earlier every six r&d engineers were equipped with an intellectual property analyst, and in Europe and the United States patent consultants have special intellectual property rights.
China's early research and development enterprise suffer more in the protection of intellectual property rights, and the actual operation, in accordance with the rule for a research and development enterprises is none. "Late product finalize the design, research and development, application and so on each place will involve intellectual property patent problems." De-yuan zhang pointed out.
In de-yuan zhang's view, small companies with big companies equal communication is an important aspect of the Angle of the patent. "First of all have their own patents, with this ability, you can patent cross with big companies. So we went to see what the competitors' products have defects, think about how to improve its product defects, the big company first application for a patent for these products may improve the direction of the future. If the future really want to improve will fall to our patent definition."
The above approach commonly used is actually a lot of large companies, including a lawsuit, apply rival defect improvement patents. Patent or a small company in the future, the intellectual property an important opportunity, won the corner overtaking is domestic instead of imported high-end medical equipment in the future an important link in.
Over the years, more than 80% market share of high-end medical equipment by the monopoly of transnational corporations, some of the more advanced areas, even 100% was monopolized by the multinational companies, such as had congenital heart defect closure, one important reason is that a lot of China did not grasp the core technology, there is no corresponding intellectual property rights. |
