Yesterday (August 15th), the State Drug Administration officially approved Roche's new generation of ALK inhibitor An Shengsha (Chemical Common Name, Aletinib) import registration application for the treatment of anaplastic lymphoma kinase-positive Locally advanced or metastatic non-small cell lung cancer.
Lung cancer is the most common malignant tumor in China. The incidence rate and mortality rate are the first in malignant tumors, and it is the "first cancer killer" in China. 80%-85% of patients with lung cancer belong to non-small cell lung cancer. Among them, ALK-positive non-small cell lung cancer is a rare but very dangerous lung cancer subtype. The average age of patients is relatively low, and most patients have unsatisfactory response to chemotherapy drugs. And with high risk of recurrence, high incidence of brain metastases, poor prognosis and other issues.
According to the international clinical study ALEX results: compared with the existing standard treatment plan, Anshengsha used the first-line treatment of ALK-positive advanced non-small cell lung cancer with a median progression-free survival (PFS) time of 34.8 months. There are nearly three times the treatment plan, and the risk of brain metastasis can be reduced by 84%, and the risk of disease progression or death can be reduced by more than half.
"We are very much looking forward to this drug because a new generation of ALK inhibitors can extend the median progression-free survival (PFS) of ALK-positive advanced non-small cell lung cancer to 34.8 months, nearly three times the current treatment plan. Fang Jian, chief physician of the Department of Thoracic Oncology, Beijing Cancer Hospital, said.
It is precisely because of the practical clinical benefits brought to patients, whether in the clinical trial or the approval process of new drugs, Anshengsha has basically achieved simultaneous listing with Europe and the United States. In the past, imported anticancer drugs were approved for listing in China, generally compared with Europe and the United States. After the listing time was delayed by 5 to 6 years, An Shengsha was officially approved from entering the priority review process, and it took less than 5 months.
In recent years, the National Drug Administration has introduced a rapid approval channel for new drugs, and many drugs can qualify for faster time to market. This depends mainly on two points: First, the drugs that are urgently needed in clinical practice. Common and harmful to human health, but so far there is no good treatment, drugs that meet these conditions can be quickly approved; second, if a drug far exceeds the existing treatment, it can also get rapid approval.
"Aletinib is far more effective than the existing treatments, because it has been approved by crizotinib before, and the treatment of ALK positive is very good, allowing patients to obtain a total survival for several years. While alittinib is the second-generation drug, the ultra-long PFS has far exceeded the efficacy of crizotinib in compliance with the rapid approval conditions.†Fang Jian added, based on past experience, there are probably two or three new drugs. It takes only months to enter the market, depending on the progress of the company.
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The stainless steel mesh is made of metal wires such as 302, 304, 304L, 316, 316L, 310, 310s, etc. The surface is smooth, rust-free, corrosion-resistant, non-toxic, hygienic and environmentally friendly. Uses: hospitals, pasta, meat barbecue, life flower baskets, fruit basket series mainly stainless steel wire mesh, using electropolishing technology for surface treatment, the surface is bright as a mirror.
Stainless steel is heat resistant, acid resistant, corrosion resistant and wear resistant. Because of these characteristics, stainless steel mesh is widely used in mining, chemical, food, petroleum, pharmaceutical, etc., mainly for gas, liquid filtration and other media separation.
The stainless steel mesh is classified according to the varieties: stainless steel plain mesh, stainless steel twill mesh, stainless steel bamboo mesh, stainless steel mat mesh, contrast mesh, stainless steel paper net, etc.
The stainless steel mesh is made of metal wires such as 302, 304, 304L, 316, 316L, 310, 310s, etc. The surface is smooth, rust-free, corrosion-resistant, non-toxic, hygienic and environmentally friendly. Uses: hospitals, pasta, meat barbecue, life flower baskets, fruit basket series mainly stainless steel wire mesh, using electropolishing technology for surface treatment, the surface is bright as a mirror.
Stainless steel is heat resistant, acid resistant, corrosion resistant and wear resistant. Because of these characteristics, stainless steel mesh is widely used in mining, chemical, food, petroleum, pharmaceutical, etc., mainly for gas, liquid filtration and other media separation.
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