On March 25, March 25, 2006, BI (boehringer ingelheim) announced that afatinib had officially landed in China. On March 24, astrazeneca's oce for announced in China approved by the public, both are beholden to priority review policy and blockbuster lung cancer targeted drugs into China market. Since the adjustment of the examination and approval system of pharmaceutical industry in China, the new drug approved in foreign countries has been significantly accelerated in the domestic market. Do you know what the foreign blockbuster drugs that can stir up the market for lung cancer in China? Let's analyze it together. 

 

The market for lung cancer is huge and multinational drug companies are laying out their plans 

 

Lung cancer in China is the first place in row of mortality and morbidity of malignant tumor diseases, according to relevant data to predict, the scale of the lung cancer treatment in China market in 2017 will be the super billions. At present, the domestic anti-lung cancer drug market has become blue sea, and the enterprises have been laid out. Multinational drug companies are also trying to get a piece of China's huge market for lung cancer. 

 

 

 

Steady growth, and ecktini's sales hit a billion 

 

Ek for from beida pharmaceutical research and development, is China's first with independent intellectual property rights of small molecules targeting anticancer drugs, on June 7, 2011, listed on the CFDA granted, commodity called kaimei (Conmana). Ek for is a kind of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR - TKI), applicable to the epidermal growth factor receptor (EGFR) with a sensitive gene mutation of locally advanced or metastatic non-small-cell lung cancer (NSCLC) first-line treatment. 

 

In May 2016, beida pharmaceutical industry to participate in the national drug price negotiation and reach an agreement, the commitment on the premise of health-care cohesion, kay beauty of sales price by 54%, achieve the goal of price for quantity. Compared to sales in 2016 reached 2016 box, 427700 boxes of rose by 31.46% in 2015, sales reached 1.035 billion yuan, increased by 13.36% compared with 2015, 913 million yuan, to be a leader in domestic lung cancer targeted drugs market. 

 

 

 

Six foreign blockbuster cancer targeted drugs have been launched in China, and the competition is intensifying 

 

1 gifetini 

 

Gefitinib was developed by astrazeneca and was approved by the FDA on May 5, 2003, and was approved by the CFDA in December 2004, with the product known as Iressa. (for he was the first epidermal growth factor receptor (EGFR) tyrosine kinase selective inhibitors, suitable for single drug treatment of platinum and west he match chemotherapy failure of locally advanced or metastatic non-small-cell lung cancer (NSCLC). 

 

The Chinese structure patent expired on April 23, 2016, and in January the CFDA approved a listing of geimoninib products made by qilu pharmaceuticals. Global sales are expected to fall to about $340m by 2022 due to a drop in global sales due to the expiry of the patent. Sales in China were also down in 2016, with sales of about $116 million, down 16% from a year earlier. 

 

 

 

 

erlotini 

 

For it's by genentech (roche subsidiary) and Ann, to develop, on November 18, 2004 by the FDA approal, listed on the CFDA granted in April 2006, commodity called Tarceva (Tarceva). Erlotini is the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which is used to treat metastatic non-small-cell lung cancer. 

 

It for, in the structure of China's patent protection has expired in March 28, 2016, domestic currently is no listing of its generic, but rossing pharmaceutical, simcere 79 companies in the layout, in the near future can see domestic first appeared in imitation of a drug. 

 

 

 

 

ositiinib 

 

For Mr Bush was developed by astrazeneca targeted cancer drugs, on November 13, 2015, the United States listed on the FDA approval, on March 22, 2017, won the CFDA public approval, hit a 2007 annual registration classification after the implementation of imported drugs on the market in China the speed record. For Mr Bush, is a kind of epidermal growth factor receptor (EGFR) inhibitor, belongs to the third generation of EGFR inhibitor, is approved to treat EGFR mutations - T790 positive non-small cell lung cancer, commodity called Teresa (Tagrisso). 

 

For Mr Bush, a year after the listed to obtain good results of the global sales of $423 million, listed on China's "fast" is also CDE full affirmation of its product strength, global sales peak is expected the next five years to $3 billion, lung cancer in the market in China will also be for ek's powerful competitors. 

 

 

 

arafinib 

 

The company was approved by the F.D.A. on July 12, 2013, and was approved by the F.D.A. on Feb. 21, 2017, with the product named Gilotrif. Afafinib is the world's first publicly traded tyrosine kinase (TKI) receptor inhibitor of the ErbB family, which is used for first-line treatment of metastatic non-small-cell lung cancer (NSCLC). Compared with the first-generation egfr-tkis, which is currently listed in China, there is a clear clinical advantage, which is believed to be a good performance in China's lung cancer market. 

 

 

 

 

5 azotini 

 

It was approved by the FDA on August 26, 2011, and was approved by the CFDA on September 18, 2014. The product is known as Xalkori. The first ALK kinase inhibitor was used to treat ALK positive localized or metastatic non-small cell lung cancer. Global sales have been growing steadily, with sales of $561 million in 2016 and a projected peak of $800 million in the next five years. 

 

 

 

 

6 bevacizumab 

 

Beacizumab bead sheet resistance by genentech (roche's subsidiary) research and development, approved by FDA on February 26, 2004, 2010 on February 26, getting listed on the CFDA approval, commodity called bevacizumab (Avastin). Beacizumab bead sheet resistance is a humanized monoclonal antibody IgG1 type, can be combined with vascular endothelial growth factor (VEGF) and specificity, which block VEGF and its receptors in endothelial cell surface (Flt 1 and KDR), with inhibition of tumor angiogenesis. At present, the indications for the drug approval has metastatic colorectal cancer, non-small cell lung cancer, cervical cancer, ovarian cancer and metastatic breast cancer and glioblastoma, in China is mainly used for metastatic colorectal cancer and the treatment of non-small cell lung cancer. 

 

Bevacizumab had a global sales of $67.83 billion in 2016, with sales of 360m yuan in domestic sample hospitals and a steady increase in sales. 

 

The target drug for foreign lung cancer in phase iii clinical trials 

 

Nivolumab 

 

Worth of single resistance (Nivolumab) by ono pharmaceutical and bristol-myers squibb, joint research and development, on July 4, 2014, approved by the Japanese PMDA, December 22, 2014, the FDA approval, on June 19, 2015, approved by European medicine EMA on the market. 

 

At present, the drug is in phase iii clinical phase in China, the indications of clinical trial are non-small cell lung cancer and advanced hepatocellular carcinoma, which is expected to be approved in 2018. Worth of single resistance as the world's first listed drugs of PD - 1, because of its good curative effect and a wide range of indications, post-marketing quickly occupy the market, annual sales of $2015 and $982 million, 2016 sales of $37.74, is expected to peak sales could reach $8.8 billion over the next five years. 

 

Pembrolizumab 

 

Pembrolizumab (Pembrolizumab) was developed by Merck and is the first u.s.-listed pd-1 inhibitor to be listed in the United States on October 28, 2014. Keytruda, in contrast to Opdivo, leads a first-line treatment for pd-1 in non-small-cell lung cancer. 

 

Currently the drug in China in the third phase of clinical stage, clinical trials of indications for non-small cell lung cancer, esophageal cancer, gastric cancer and hepatocellular carcinoma (HCC), is expected in 2019. The company has $566 million in sales in 2015 and $14.2 billion in 2016, with a projected peak of $6.5 billion over the next five years. 

 

 

 

Alectinib 

 

Alectinib, developed by Chinese and foreign pharmaceuticals (roche), was approved by the Japanese PMDA on July 4, 2014, and was approved by the FDA on December 11, 2015, with the name Alecensa. Elle, for he is a selective anaplastic lymphoma kinase (ALK) inhibitor, can inhibit tumor cell proliferation, inducing cell death, the drug approved for use in anaplastic lymphoma kinase (ALK) positive for the treatment of non-small cell lung cancer. 

 

At present, the drug is in phase iii clinical phase in China, the trial registration time is October 26, 2015, and if all goes well, it is expected to be listed in China in 2018. Sales of the company are $184m in 2016, with a projected peak of $900m over the next five years. 

 

Foreign lung cancer targeted drugs in the clinical stage of verification 

 

Color red for his (Ceritinib) prepared by r&d, on April 29, 2014, was approved by FDA, on May 6, 2015 won European approval EMA, March 28, 2016, won the Japan PMDA approved, called Zykadia goods. Zolatinib is a variant lymphoma kinase (ALK) inhibitor, which is applied to the treatment of non-small-cell lung cancer patients who are not resistant to the ALK positive and metastatic disease of ketazolinib. 

 

The drug was approved for clinical approval on October 22, 2013, and clinical trials were conducted on 13 March 2017. Its global sales of $0.91 billion in 2016 are expected to peak at $250m over the next five years. 

 

 

 conclusion 

 

With the gradual reform of the examination and approval system of drug examination and approval, the speed of foreign drugs in our country has been promoted. The rapid listing of alafinib and ositini also offers new hope for lung cancer patients in China, as well as increased competition for the lung cancer drug market. In the face of the impact of the blockbuster drug abroad, domestic enterprises how to face, for ek, can continue to maintain its leadership in lung cancer targeted drugs market, let's wait and see.