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Medical network, June 29, director of a research and development of listed companies to the 21st century economic report reporter pointed out that (" priority review) means that the two drug firms to enter the examination and approval of the green channel, both from the view of public information progress about, who the first listed as injection of paclitaxel (albumin), who will gain bigger market advantage.
On the evening of June 20, CDE, the national food and drug administration, published the list of the 20 approved applications for priority review procedures. The announcement said that "it is intended to include the use of paclitaxel (white protein binding) as a priority in line with" clinical urgency and market shortage ".
Among them, two enterprises of hengrui pharmaceutical and shi pharmaceutical group were given priority reviews with paclitaxel (white protein binding type). A listed corporate r&d director told reporter pointed out that the 21st century economy, which means that the two drug firms to enter the examination and approval of the green channel, both from the view of public information progress about, who the first listed as injecting paclitaxel (albumin), who will gain bigger market advantage.
Taxol is one of the most commonly used antitumor drugs in clinic, and there are 63 and four import batch number of taxol injection. Public data shows that China's key cities public hospital drug paclitaxel amount is about 1.4 billion yuan, and the overall size of the market has more than 2.5 billion yuan, the future hengrui, nolato, group drugs after entering the market, the market pattern of taxol would change.
Henrystone "put on the express"
Released on June 20th, CDE group of quasi 20 "priority review of applications for drug registration, involving shiyao group and hengrui pharmaceutical companies of albumin in combination with paclitaxel injection, are based on the proposed according to the 'urgent clinical needs, market shortage will be injected with paclitaxel (albumin combined type) into priority review."
"Priority review relevant matters is the CFDA (total bureau of national food and drug supervision and administration) on February 24, 2016 the administration about addressing drug registration for priority review backlog of examination and approval opinions", is to strengthen the drug registration management, speed up has clinical value for urgent clinical needs by new drugs and generic drugs research and development of the listed, solved the problem of drug registration application backlog, shiyao group, hengrui pharmaceutical r&d strength strong drug firms are expected to take on the express.
Released from CDE fitting into priority review, hengrui medicine taxol was incorporated into on October 28, 2016, issued a list of priority review, reason is "the first copy varieties" are given, while shiyao group appears in the March 3, 2017 announced the fourteenth batch of the list of the priority review, told them "urgent clinical needs, shortage of market, the first copy".
One industry insider who has studied pharmaceutical reviews has pointed out to 21st century economic reporter that if the same description, the shi pharmaceutical group paclitaxel, or compared to hengrui pharmaceuticals, will be listed earlier. However, the two reasons are "urgent clinical need, shortage of market and the first copy" in the list of the 20 approved drug registration applications.
MaiSiKang lai Shi Lichen founder in the 21st century economic report reporter interview analysis, according to the earlier enterprise generics market, the more advantage in pricing, and bidding, and listed means more spread out the market ahead of time, the market share may also be higher. "Once a company takes the lead, it is expected to quickly replace the expensive original research product with a low price, and it will be more advantageous in pricing policy than the subsequent follow-up."
Released on July 21, 2016 CFDA quasi priority review list "imitation" varieties, with 22 first medicine was incorporated into, and big variety first imitation drugs is the latest hot spots, priority review first imitation drugs to the drug companies greater market space for imagination.
It is understood that shiyao and hengrui were the first two companies to submit the application for the production of white protein paclitaxel, which was also a different way in the contest of the first imitation of albumin taxol. The medical cube data of the pharmaceutical industry analyzed its path, such as the new classification of the drug by the new classification of the drug. Hengrui before "imitation" reasons to obtain the priority review qualification (CYHS1300522), after the generics approved BE clinical, direct mail, country human medicinal center to apply for production (CYHS1790004), to narrow the gap in with the meaning of time as possible.
The market pattern has changed
Paclitaxel was first discovered in the 1960s and then appeared in the market in the form of injection. Taxol is one of the most commonly used antitumor drugs and is now a first-line medicine for breast and ovarian cancer treatment. At present, there are three kinds of taxol products in the domestic market, which are taxol injection, the injection of paclitaxol lipid and white protein with paclitaxol injection.
In 2016, Celgene's Abraxane (paclitaxel albumin combined) sales were close to $1 billion. Currently, there are only 1 Chinese paclitaxel liposomes, which were listed in 2003 by nanjing luye pharmaceutical, which is called "lipoplin".
Paclitaxel itself is difficult to dissolve in water, and in order to make an injection, the original medicine has to add the surfactant polyoxyethylene castor oil to the drug, but the solvent can cause a variety of adverse reactions. Force robot is on the basis of the original drug taxol liposome new dosage form of development, can solve the problem of taxol solubility, paclitaxel on the clinical application of popular, market share is also growing.
Albumin taxol by American Abraxis BioScience companies to develop, is a kind of brand-new preparation, paclitaxel combined with albumin in January 2005, approved by the FDA for breast cancer (trade name Abraxane), then approved treatment for lung cancer, and pancreatic cancer. In 2010, new key paid $2.9 billion for Abraxis, which won the company.
Our country approved the import of new base Abraxane in 2008. In 2015, Chinese market sales of taxol (white protein combined with white protein) were about $36.14 million, with global sales of us $973 million in 2016.
According to industry media reported that China's key cities public hospital drug paclitaxel amount is about 1.4 billion yuan, and the overall size of the market has more than 2.5 billion yuan, including domestic paclitaxel injection occupies 16.47% share of imports and paclitaxel injection (13.8%), and new type cif albumin in combination with paclitaxel is occupied 9% market share, nanjing green pharmaceutical has a 60% market share.
Albumin, however, there is no domestic domestic paclitaxel, according to medical rubik's cube, according to the current existing nine enterprises to carry out the relevant declaration, including hengrui hengrui, nolato, group, qilu pharmacy, the sea is pharmaceutical enterprises. To this end, who will win the white protein paclitaxel "the first copy" has received the attention of the industry.
"Paclitaxel injection has been proved in clinical efficacy, but also more and more widely used in the tumor treatment such as lung cancer, the future market will be bigger. If hengrui pharmaceutical or generic drugs listed shiyao group, is bound to break the existing pattern, market will expand with the dose, will further reduce the price." The r&d director told reporters in the 21st century economy.
It is worth noting that, according to the knowledge, the liluin of nanjing luye pharmaceutical entered the catalogue of the 2017 medical insurance negotiation of the ministry of human resources. Past health talks, said the director in the directory of drugs, is to obtain a bigger share of the market, what market structure change in the future, and perhaps to see how the drug firms to market layout. |
