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In recent years, with the continuous improvement of the innovation capability of the domestic pharmaceutical industry, many domestic pharmaceutical companies have begun to make more breakthroughs in products
.
It is worth noting that in this context, in order to gain more markets and serve more customers, a large number of domestic pharmaceutical companies have also begun to vigorously promote products to enter overseas and participate in international competition
.
Recently, Shijiazhuang Yiling Pharmaceutical has announced that it has received a notice from the U.
S.
Food and Drug Administration (hereinafter referred to as the FDA) that the company’s wholly-owned subsidiary Yiling Wanzhou International Pharmaceutical Co.
, Ltd.
declared to the U.
S.
FDA the ANDA product paroxetine tablets ( ANDA, the United States generic drug application, is approved by the U.
S.
FDA, which means that the applicant can produce and sell the product in the U.
S.
market) has been approved
.
On October 26, Lunan Pharmaceutical received an approval letter from the US FDA regarding the addition of the Shandong New Times Pharmaceuticals production site to the rosuvastatin calcium tablets ANDA (a brief application for new drugs), marking the ANDA rosuvastatin calcium produced by Lunan Pharmaceuticals The film can be sold in the US market
.
Data show that rosuvastatin calcium tablets are a selective hydroxymethylglutaryl-coenzyme A reductase inhibitor, which has the characteristics of potent hypolipidemic reduction, fast and safe
.
On October 8, BeiGene announced that its product Baiyueze® (Zebutinib) was approved in Australia for the treatment of adult patients with Fahrenheit's macroglobulinemia who had previously received at least one therapy, or as a first-line therapy It is used to treat patients who are not suitable for chemoimmunotherapy
.
In addition to being approved in Australia, in May of this year, the U.
S.
Food and Drug Administration (FDA) has also accepted Baiyueze® for the treatment of marginal zone lymphoma (MZL) adults who have previously received at least one CD20-directed therapy The patient’s New Indication Marketing Application (sNDA) and granted priority review qualifications
.
In addition, it has recently been approved by the Singapore Health Sciences Agency (HSA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one treatment in the past
.
On the whole, the global market has become the target of many domestic enterprises
.
The industry predicts that, based on the current industry trends, as China’s pharmaceutical industry continues to accelerate innovation, more and more companies will choose to “go out”
.
In fact, there are already a lot of domestically produced drugs that have been accepted by other countries and overseas pharmaceutical companies
.
According to incomplete statistics, there were a total of 100 license out transactions from 2007 to 2020, and a total of 67 transactions since 2020, surpassing the sum of previous years and accounting for 67% of the total in 13 years
.
Among them, as of August 31, 2021, the number of transactions is even closer to the total number of 2020
.
In this regard, the analysis believes that in recent years, a large number of domestic pharmaceutical companies have successively obtained approvals for their products overseas.
This is not only due to the increasing enthusiasm of Chinese pharmaceutical companies to tap foreign markets under the overseas strategy, but also the consistency evaluation and other medical reform policies for domestic innovation.
The influence of many factors such as the incentives of the drug market
.
With the acceleration of China's pharmaceutical industrialization transformation and the continuous advancement of technology, the industry predicts that in the future, more domestic generic drugs and innovative drugs will compete in the international market.
While gaining recognition in overseas markets, they will benefit more patients
.
.
It is worth noting that in this context, in order to gain more markets and serve more customers, a large number of domestic pharmaceutical companies have also begun to vigorously promote products to enter overseas and participate in international competition
.
Recently, Shijiazhuang Yiling Pharmaceutical has announced that it has received a notice from the U.
S.
Food and Drug Administration (hereinafter referred to as the FDA) that the company’s wholly-owned subsidiary Yiling Wanzhou International Pharmaceutical Co.
, Ltd.
declared to the U.
S.
FDA the ANDA product paroxetine tablets ( ANDA, the United States generic drug application, is approved by the U.
S.
FDA, which means that the applicant can produce and sell the product in the U.
S.
market) has been approved
.
On October 26, Lunan Pharmaceutical received an approval letter from the US FDA regarding the addition of the Shandong New Times Pharmaceuticals production site to the rosuvastatin calcium tablets ANDA (a brief application for new drugs), marking the ANDA rosuvastatin calcium produced by Lunan Pharmaceuticals The film can be sold in the US market
.
Data show that rosuvastatin calcium tablets are a selective hydroxymethylglutaryl-coenzyme A reductase inhibitor, which has the characteristics of potent hypolipidemic reduction, fast and safe
.
On October 8, BeiGene announced that its product Baiyueze® (Zebutinib) was approved in Australia for the treatment of adult patients with Fahrenheit's macroglobulinemia who had previously received at least one therapy, or as a first-line therapy It is used to treat patients who are not suitable for chemoimmunotherapy
.
In addition to being approved in Australia, in May of this year, the U.
S.
Food and Drug Administration (FDA) has also accepted Baiyueze® for the treatment of marginal zone lymphoma (MZL) adults who have previously received at least one CD20-directed therapy The patient’s New Indication Marketing Application (sNDA) and granted priority review qualifications
.
In addition, it has recently been approved by the Singapore Health Sciences Agency (HSA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one treatment in the past
.
On the whole, the global market has become the target of many domestic enterprises
.
The industry predicts that, based on the current industry trends, as China’s pharmaceutical industry continues to accelerate innovation, more and more companies will choose to “go out”
.
In fact, there are already a lot of domestically produced drugs that have been accepted by other countries and overseas pharmaceutical companies
.
According to incomplete statistics, there were a total of 100 license out transactions from 2007 to 2020, and a total of 67 transactions since 2020, surpassing the sum of previous years and accounting for 67% of the total in 13 years
.
Among them, as of August 31, 2021, the number of transactions is even closer to the total number of 2020
.
In this regard, the analysis believes that in recent years, a large number of domestic pharmaceutical companies have successively obtained approvals for their products overseas.
This is not only due to the increasing enthusiasm of Chinese pharmaceutical companies to tap foreign markets under the overseas strategy, but also the consistency evaluation and other medical reform policies for domestic innovation.
The influence of many factors such as the incentives of the drug market
.
With the acceleration of China's pharmaceutical industrialization transformation and the continuous advancement of technology, the industry predicts that in the future, more domestic generic drugs and innovative drugs will compete in the international market.
While gaining recognition in overseas markets, they will benefit more patients
.
