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On April 1, the NMPA issued a new batch of drug notifications to be received.
The marketing applications of 6 products of 5 pharmaceutical companies were not approved, including Pantoprazole Sodium for Injection of Pusheng Pharmaceuticals and 2 products of Nanyue Biotechnology.
Hepatitis B human immunoglobulin and Sanofi Pasteur's inactivated polio vaccine, many of which are remarkable varieties on the market
.
Pantoprazole sodium for injection, such as pantoprazole sodium for injection, this product is a selective long-acting proton pump inhibitor, mainly used for intravenous drip treatment of peptic ulcer bleeding, non-steroidal anti-inflammatory drugs The occurrence of acute gastric mucosal injury and ulcer bleeding under stress, after general anesthesia or major surgery, and prevention of gastric acid reflux combined with aspiration pneumonia in debilitated coma patients
.
According to the data of Minet.
com, the total market sales of pantoprazole sodium for injection in domestic pharmaceutical medical and retail terminals in 2020 will be about 4.
343 billion yuan
.
According to the data query of the State Food and Drug Administration, there are currently 156 approval numbers for pantoprazole sodium for injection in China
.
In addition, according to the catalogue of varieties accepted by the State Food and Drug Administration, a total of 7 pharmaceutical companies of pantoprazole sodium for injection are listed, including Sialon Pharmaceuticals, Xuansheng Pharmaceuticals, Dingxin Pharmaceuticals, Kangyuan Pharmaceuticals, Livzon Group,
etc.
It is reported that after successfully developing the generic drug of pantoprazole sodium for injection, Puli Pharma has successively submitted registration applications in many countries, and has successively obtained marketing approvals in the Netherlands, Germany, Australia and Canada
.
Recently, the company also received marketing authorization from the Medicines and Health Products Regulatory Agency (MHRA) in the United Kingdom
.
Octreotide acetate Octreotide acetate is a tetradeceptide human somatostatin analog.
Its pharmacological action is similar to that of somatostatin.
It can inhibit the pathological secretion of growth hormone (GH) and gastroenteropancreatic (GEP) endocrine system peptides.
It is clinically suitable for Emergency treatment of esophageal-gastric varices bleeding caused by liver cirrhosis, relief of symptoms and signs related to gastroenteropancreatic endocrine tumors, prevention of postoperative complications of pancreas,
etc.
According to the data query of the State Food and Drug Administration, there are currently 25 approval numbers for octreotide acetate injection in China, involving pharmaceutical companies such as Renfu Pharmaceutical and Sinopharm Yixin
.
According to data from Minet.
com, the sales volume of this product in public medical institutions in China will exceed 2 billion yuan in 2020, of which Novartis will account for more than 60% of the market share.
.
Sun Pharmaceutical Industries Ltd and Northrop Grumman's Octreotide Acetate Injection have not been approved for this marketing application
.
There are also many pharmaceutical companies applying for listing of this variety.
For example, in early March, Huiyu Pharmaceutical, which has attracted much attention, replied to investors on the interactive platform that Octreotide Acetate Injection was the company’s initiative to withdraw its domestic registration application, and the product has been registered and reviewed in the UK.
It is expected to be approved around April this year, and the company plans to re-submit the domestic registration application in the next few months
.
Hepatitis B human immunoglobulin is another example of hepatitis B human immunoglobulin, which is a concentrated passive immune preparation to prevent the negative value of hepatitis B virus invasion.
It allows the body to passively receive exogenous antibodies and can quickly obtain passive protection Immunity, can take effect quickly, neutralize and clear the free hepatitis B virus in the serum, and avoid the localized infection of hepatitis B virus
.
China is a big country with hepatitis B, with nearly 900,000 cases in 2020, and patients have a large clinical demand for hepatitis B human immunoglobulin
.
In 2020, the number of batches of hepatitis B human immunoglobulin issued is about 1.
5 million bottles, a year-on-year increase of 0.
7%
.
According to the data query of the State Food and Drug Administration, there are currently 63 approval numbers in China, involving a large number of pharmaceutical companies such as Sinopharm, Boya Bio, and Rongsheng Pharmaceutical
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
The marketing applications of 6 products of 5 pharmaceutical companies were not approved, including Pantoprazole Sodium for Injection of Pusheng Pharmaceuticals and 2 products of Nanyue Biotechnology.
Hepatitis B human immunoglobulin and Sanofi Pasteur's inactivated polio vaccine, many of which are remarkable varieties on the market
.
Pantoprazole sodium for injection, such as pantoprazole sodium for injection, this product is a selective long-acting proton pump inhibitor, mainly used for intravenous drip treatment of peptic ulcer bleeding, non-steroidal anti-inflammatory drugs The occurrence of acute gastric mucosal injury and ulcer bleeding under stress, after general anesthesia or major surgery, and prevention of gastric acid reflux combined with aspiration pneumonia in debilitated coma patients
.
According to the data of Minet.
com, the total market sales of pantoprazole sodium for injection in domestic pharmaceutical medical and retail terminals in 2020 will be about 4.
343 billion yuan
.
According to the data query of the State Food and Drug Administration, there are currently 156 approval numbers for pantoprazole sodium for injection in China
.
In addition, according to the catalogue of varieties accepted by the State Food and Drug Administration, a total of 7 pharmaceutical companies of pantoprazole sodium for injection are listed, including Sialon Pharmaceuticals, Xuansheng Pharmaceuticals, Dingxin Pharmaceuticals, Kangyuan Pharmaceuticals, Livzon Group,
etc.
It is reported that after successfully developing the generic drug of pantoprazole sodium for injection, Puli Pharma has successively submitted registration applications in many countries, and has successively obtained marketing approvals in the Netherlands, Germany, Australia and Canada
.
Recently, the company also received marketing authorization from the Medicines and Health Products Regulatory Agency (MHRA) in the United Kingdom
.
Octreotide acetate Octreotide acetate is a tetradeceptide human somatostatin analog.
Its pharmacological action is similar to that of somatostatin.
It can inhibit the pathological secretion of growth hormone (GH) and gastroenteropancreatic (GEP) endocrine system peptides.
It is clinically suitable for Emergency treatment of esophageal-gastric varices bleeding caused by liver cirrhosis, relief of symptoms and signs related to gastroenteropancreatic endocrine tumors, prevention of postoperative complications of pancreas,
etc.
According to the data query of the State Food and Drug Administration, there are currently 25 approval numbers for octreotide acetate injection in China, involving pharmaceutical companies such as Renfu Pharmaceutical and Sinopharm Yixin
.
According to data from Minet.
com, the sales volume of this product in public medical institutions in China will exceed 2 billion yuan in 2020, of which Novartis will account for more than 60% of the market share.
.
Sun Pharmaceutical Industries Ltd and Northrop Grumman's Octreotide Acetate Injection have not been approved for this marketing application
.
There are also many pharmaceutical companies applying for listing of this variety.
For example, in early March, Huiyu Pharmaceutical, which has attracted much attention, replied to investors on the interactive platform that Octreotide Acetate Injection was the company’s initiative to withdraw its domestic registration application, and the product has been registered and reviewed in the UK.
It is expected to be approved around April this year, and the company plans to re-submit the domestic registration application in the next few months
.
Hepatitis B human immunoglobulin is another example of hepatitis B human immunoglobulin, which is a concentrated passive immune preparation to prevent the negative value of hepatitis B virus invasion.
It allows the body to passively receive exogenous antibodies and can quickly obtain passive protection Immunity, can take effect quickly, neutralize and clear the free hepatitis B virus in the serum, and avoid the localized infection of hepatitis B virus
.
China is a big country with hepatitis B, with nearly 900,000 cases in 2020, and patients have a large clinical demand for hepatitis B human immunoglobulin
.
In 2020, the number of batches of hepatitis B human immunoglobulin issued is about 1.
5 million bottles, a year-on-year increase of 0.
7%
.
According to the data query of the State Food and Drug Administration, there are currently 63 approval numbers in China, involving a large number of pharmaceutical companies such as Sinopharm, Boya Bio, and Rongsheng Pharmaceutical
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
