On July 3, the medical network, with the speed of approval of drug review and approval, has seen several major new drug imports this year. Among them, the main products are: imported tumor glaxo's culture the azole slice, boehringer ingelheim's afar for, roche's d murphy, pills, astrazeneca's President for Nepal, bayer red GeFei pills; The products of hepatitis c include: bai-mei shi guibao's daravira tablet, asshuivir soft capsule; The products of diabetes include: dagleel, shagletin metformin. The anti-rheumatism products have Pfizer's tofti-cloth, etc.
The import a lot of new drug approval, will lead to cancer, hepatitis c, diabetes and high blood pressure in the areas of market pattern quietly - and the following main tumor field over the import of recently approved products to comb.
Prazolpani: global sales are soaring
Pazopanib, developed by glaxosmithkline, was approved by the FDA on October 19, 2009, with the name "Votrient". This product mainly applies to the treatment of advanced renal cell carcinoma and soft tissue sarcoma. Votrient is an oral drug that interferes with the formation of new blood vessels needed for solid tumor growth and survival.
According to the world's best-selling drug data, in 2011, the sales volume of prazolpani was us $155 million, 2015 sales volume was us $565 million, and sales in 2016 were us $729 million, up by 29.0% over the same period. From 2011 to 2016, the product is growing fast.
According to the data retrieval human medicinal center, glaxosmithkline's pei azole and slice has been obtained from the CFDA on February 21, 2017 approved, commodity called "d", is mainly used for advanced kidney cancer (aRCC) first-line therapy, dosage form of tablet, specifications for 200 mg, 400 mg. At present, there are six enterprises that are declaring peazoles in China, such as qilu pharmaceutical, jiangsu hausen pharma, zhengda tianqing pharmaceutical, jiangsu ossekang pharmaceutical, yangzijiang pharmaceutical co., etc.
Afatinib: fight for the lung cancer targeted drug
Afatinib, developed by German boehringer ingelheim, is a new generation of oral small-molecule tyrosine kinase inhibitors. This product has been on July 12, 2013 for the first time the FDA approval of registration, called "Gilotrif" goods, mainly used in the treatment of mutant non-small cell lung cancer and HER2 positive patients with advanced breast cancer, and on September 25, 2013 approved by the European commission (EC). Now for the United States and Europe have accepted afar, used in the treatment of disease progression after first-line chemotherapy of patients with adanced lung squamous cell carcinoma of the application for registration, has passed the FDA's orphan drug that intends to award for a rare disease specific status of the product.
The product is now available in more than 70 countries and is the fourth EGFR inhibitor approved by the F.D.A. after gifetini, erlotini and lapatinib. According to the world's best-selling drug data, in 2014, the sales volume was $115 million, with sales of $231 million in 2015 and $271 million in 2016. From 2014-2016 sales, the product has maintained a fast growth rate. The market has been doing well since the company went public, with global sales surpassing lapatinib in 2015.
According to the data of the search for the drug trial center, the beringer ingelenny company and tablets have been approved by the CFDA on February 21, 2017. The products are known as "jiteri". The product was also approved for two indications at the same time in China: first-line treatment for patients with mutational positive lung cancer (EGFR) and second-line treatment of lung squamous carcinoma patients. Dosage forms are tablets, with a specification of 230mg, 40mg and 50mg.
At present domestic is to declare the method for enterprise has 16, slice, respectively shiyao group in the pharmaceutical, jiangsu howson pharmaceutical, jiangxi qingfeng-xiangguang fracture pharmaceutical, qilu pharmaceutical, Yangtze river pharmaceutical co., jiangsu orsay kang pharmaceutical co., shandong new time pharmaceutical, rui Yang pharmaceutical, zhengda sunny pharmaceutical industry, etc. Lung cancer targeted drug market in China war had begun, the treatment in recent years on, the treatment for ek, and for the first time into the health care medicine directory, a growing number of lung cancer targeted drugs rapidly entered the Chinese market, drugs and gradually return to rational prices.
Ositinib: it's going to be a market shuffle for NSCLC
Mr Bush for his (Osimertinib) developed by astrazeneca PLC, on November 13, 2015, getting listed on the FDA's accelerated approval, commodity called "Tagrisso", is used for EGRR - T790M mutation positive metastatic non-small cell lung cancer (NSCLC) of the third generation of targeted drugs.
According to the world's best-selling drug data, ositiinib's sales in 2015 were us $0.19 billion, with sales of us $423 million in 2016. Ositinib has already been approved in the us, the European Union, Japan, Israel and South Korea and Bangladesh, and has shown strong momentum in its first year. Sales are expected to reach $3 billion a year, according to experts.
According to the data retrieval human medicinal center, astrazeneca company for Mr Bush, and the piece has been obtained from the CFDA on March 22, 2017 approved, commodity called "Teresa", mainly for the T790M EGFR mutations in non-small cell lung cancer. Dosage form is tablet, specification is 40mg, 80mg. The product is China's first third-generation lung cancer targeted drug.
According to statistics, about 85% of China's 730,000 new lung cancer patients per year are non-small-cell lung cancer, of which nearly 50% have EGFR T790M mutations. Is China's first big cancer, lung cancer has a great clinical demand, using the generation of the treatment, the second generation targeted drugs such as (Yi Rui sand), for it (tarceva), for ek (kay beauty), the method for kyrgyzstan (terry) patients after drug-resistant produce T790M mutation can be used for Mr Bush. The head-to-head confrontation will be inevitable in the coming years.
Public data shows, in September 2016, Mr Bush for was the CFDA on quick review channel, seven months after approved, compared to the United States listed approved in November 2015, China's listed four months time (just one year. The NSCLC market is changing, and ositinib's listing will bring the NSCLC market reshuffle.
Vimofenny: the global market drops slightly
D murphy (Vemurafenib) developed by roche, in August 2011 to get listed on the FDA's accelerated approval, commodity called "Zelboraf", mainly used in the treatment of melanoma, is the second after the United States approved Yervoy drugs used to treat melanoma. The product has been approved in 99 countries and territories, including the United States and the European Union. In the treatment of melanoma in roche global innovative drug pipeline, we also have MEK inhibitor Cobimetinib and pd-l1 monoclonal antibody Atezolizumab, and different innovative combinations of three drugs are applied to different types of melanoma.
According to the world's best-selling drug data, in 2015, sales were $218m, compared with $213m in 2016, down 2.2 per cent over the same period. From 2015-2016 sales, this product market has declined. Over the last two years, the main reason for the decline in sales of vimofeini is the competitive effect of Opdivo and Keytruda of Merck, which is a pd-1 antibody. In 2016, Opdivo and Keytruda had sales of $37.7 billion and $14.2 billion respectively.
According to the data retrieval human medicinal center, d, and not of Shanghai roche pharmaceuticals co., LTD has been obtained from the CFDA on March 10, 2017 approved, commodity called "Mr Bo fu", mainly used in the treatment of the CFDA approved test method of determining BRAFV600 mutation positive surgical resection or metastatic melanoma. Vimofeyne is the first highly selective BRAF inhibitor to be approved for listing in China. The dosage form is a tablet with a specification of 240mg. At present, no domestic enterprises have submitted to CFDA for the registration of vimofini tablets.
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