Medical network - on March 21, on March 17, national food drug safety administration issued "on the adjustment of imported drug registration management related matters decided (draft)" (hereinafter referred to as "draft"). Regulators simplifies the overseas unlisted new drugs into China a number of restrictions, which will greatly shorten the overseas listing process innovation medicine into China.
In this policy, a German multinational pharmaceutical giant boehringer ingelheim day announced that lung cancer drug resistance afar, will officially land China market. In an interview with time weekly reporters, chairman of the Chinese society of clinical oncology, director of the guangdong province people's hospital cancer center Wu Yilong view, the many indicators of anti-cancer drugs is better than similar products.
At present, the domestic small molecules targeting antineoplastic drugs for lung cancer treatment in the field of core products include the treatment of astrazeneca company, roche, it for and beida pharmaceutical (300558 SZ) for ek, such as a large market share by these products and generic drugs, on top of the now this pattern or will change.
Boehringer ingelheim Chinese vice President Stephen tulare, specialty products, said in an interview with time weekly reporter anti-cancer drugs at present a lot of changes in market, China's medical insurance directory now for the first time a lung cancer drugs: "we will try to see if it can go to the provincial health care directory, hope to be able to provide more patients as possible this kind of medicine."
Data show that at the end of 2015, China had nearly 4.3 million the number of cancer. The growing market of cancer drugs in China, its scale is close to one hundred billion yuan at present.
And lung cancer is the number one cause of mortality and morbidity in our country are malignant tumor diseases, according to the national cancer center in 2015 statistics, each year about 700000 new cases in China. While China against lung cancer drug market scale has more than 20 billion yuan.
A large number of anti-cancer drugs and related generic listing, could lead to drug firms have lower drug prices.
The market competition intensifies
On March 17, boehringer ingelheim in guangzhou announced that the first and the only listed the second generation and irreversible TKI class (tyrosine kinase inhibitor) o targeted drugs for will officially land China market.
In February, the method for, at the same time in the domestic approved two indications: for the epidermal growth factor receptor (EGFR) mutations positive first-line treatment in patients with lung cancer, as well as second-line treatment in patients with lung squamous carcinoma.
Wu Yilong said, at present the lung cancer treatment precision has entered the era, select targeted therapy drugs, depending on the type of gene mutation will greatly improve the effectiveness of treatment.
Method o time weekly reporter obtained the data shows, for he has a new mechanism of action, clinical evidence of its efficacy and safety is not only significantly superior to chemotherapy, and the only one line use can bring patients total survival improve the precision of targeted drugs.
"From the data we looking at now, Yi Rui sand and the side effects of the treatment () is lower than it, for there are some notice beautiful as female patients, we may choose the first generation will be better, but the curative effect of the second generation is very stable, so for some young people, especially in patients with life desire strong, can choose this one, with a number of options in the market." Wu Yilong said in an interview with time weekly reporter.
At present, the domestic market of lung cancer drug resistance has become a blue ocean, all the companies in the layout, trying to share, at the same time, a lot of drugs at home has a solid market channels and advantages, such as for ek, has entered the 26 provinces and autonomous regions of the country's health care payment directory.
In addition, ek for the treatment of the main competing goods, for it's patents in China has been in April 2016 respectively, due in March 2016, according to the CFDA public information display, as of August 31, 2016, there were 25 companies in the treatment for generic, 28 companies applying to it for generic.
How much time weekly reporter found, the domestic home the treatment pharmaceutical giant layout of generic drugs, such as baiyun mountain, hengrui pharmaceutical and north medicine; In addition, it for generic drugs have rossing pharmaceutical, simcere pharmaceutical companies, such as listing in the layout. These companies in terms of marketing channel resources and brand precipitation, continuous cultivation for many years.
February 18 this year, the first copy successfully by qilu pharmaceutical, domestic treatment of non-small cell lung cancer "blockbuster" the treatment line targeted drug (r) on the market.
The future may pose a threat to afar for Nepal, the face of market competition is fierce. Boehringer ingelheim specialty products business, vice President of China tulare did not respond time weekly reporter about the method for how to respond to these drugs, the future market competition.
Tulare told reporters, the time weekly boehringer ingelheim will think of some way to enter the provincial health insurance directory, before and into the health care, at his own expense channel must be able to provide to the patient.
Competition to promote the price
"If only one is not enough, must take drug prices down." Talk about problems at home against lung cancer drug prices, Wu Yilong tells time weekly newspaper reporters.
As the population ages, the rural population urbanization structural factors such as population and domestic environmental pollution caused by increasing incidence of lung cancer, lung cancer drugs in our country in 2015 the size of the market has reached 22.65 billion yuan, the average annual compound growth rate of 21.13% since 2010.
For lung cancer treatment to the current domestic small molecular targeted anti-tumor medicine field are mainly ek for the treatment, and it for 3 kinds of products.
According to the national drug safety administration institute of medicine economic south the antitumor drug market research analysis report, in 2010-2015, used for lung cancer in China market of small molecules targeting drug market capacity is 1.167 billion yuan and 1.228 billion yuan respectively, 1.167 billion yuan, 2.112 billion yuan, 2.797 billion yuan and 2.112 billion yuan.
Among them, there are three main kinds of products for ek, the treatment (kay beauty,), (Yi Rui sand), for it (tarceva) are applicable to the treatment received chemotherapy or not suitable for chemotherapy in locally advanced or metastatic non-small-cell lung cancer (NSCLC).
According to beida pharmaceutical industry after the prospectus disclosure, ek for terminal retail price of about 2708-3080 yuan/box (7 days), for it's terminal retail price is about 4200 yuan/box (7 days), and the treatment for terminal retail price of about 5000 yuan/box (10 days).
In the competitive market conditions, many pharmaceutical companies in order to protect themselves, and get the official "recognition", striving to have a bigger share of the market in the future, involved in the national health development planning commission.
Released on May 20, according to a 2016 national health development planning commission general office to release the results of our national drug price talks about notice (countries who do drug administration letter [2016] no. 515), in which the treatment for with ek are shortlisted for the first batch of national drug price negotiations, the future into national health insurance directory, ek on behalf of, the price is 1399 yuan/box (7 days), the treatment for, the price is 2358 yuan/box (10 days).
For, although it was not qualified for the national drug price negotiations, but in response to the above situation, Shanghai roche pharmaceuticals co., LTD. Has announced in August 2016, the initiative for this product on the basis of the terminal retail prices by 30%.
Close to boehringer ingelheim people, its not because it is the second generation of anti-cancer drugs, the price is very high, will give attention to both the Chinese market, work out a strategy suitable for the Chinese market.
"We would prefer to have the same drug market, so prices cheaper, the common people is the most to gain." Reporter Wu Yilong tell time weekly. |