Tonghua Dongbao 2 insulin aspart injections were approved, one of which was the first imitation

【Pharmaceutical Network Enterprise News】The first generic drug, that is, the first generic drug
approved for marketing.
Because compared with innovative drugs, the first generic drug has the advantages of lower development difficulty and can often quickly seize more markets after marketing, which has become the focus of
more and more pharmaceutical companies' R&D layout.
On November 14, Tonghua Dongbao issued an announcement that it had recently received the "Drug Registration Certificate" of insulin aspart 50 injection and insulin aspart 30 injection approved and issued by the State Medical Products Administration
.
It is understood that insulin aspart is a rapid-acting insulin analogue, and its hypoglycemic effect is achieved by binding to insulin receptors on muscle and fat cells to promote the absorption and utilization of glucose by cells, while inhibiting the output of glucose in the liver
.
Data show that the sales of insulin aspart 50 injection in China's public medical institutions in the first half of 2022 have reached 152 million yuan, a year-on-year increase of 129.
52%.

The sales of insulin aspart 30 injection are also increasing year by year, and the total sales of China's public medical institutions and physical pharmacies have exceeded 632 million yuan in 2021, and the market prospect is very broad
.
At present, the domestic listed enterprises of insulin aspart 30 injection include Gan&Lee Pharmaceutical, Zhuhai Federal Pharmaceutical, and Yichang Dongguang Changjiang Pharmaceutical in addition to the original research manufacturers and Tonghua Dongbao
.
In terms of insulin aspart 50 injection, in addition to the original manufacturer, no other domestic company has obtained registration approval, so Tonghua Dongbao has become the first domestic enterprise
to obtain the registration approval of insulin aspart 50 injection.
With market and pricing advantages, in fact, the first generic drug has always been the focus of the R&D layout of
domestic pharmaceutical companies.
According to incomplete statistics, as of mid-October this year, more than 50 first generic drugs have been approved in China, involving 38 enterprises
.
Recently, in addition to Tonghua Dongbao, many pharmaceutical companies have announced that they have obtained and are about to obtain the first imitation
.
For example, on November 1, the website of the State Food and Drug Administration showed that Xiehe Pharmaceutical/Beijing Gloria Tiancheng Pharmaceutical was approved for production by imitating the 3 types of declared egasstat tartrate capsules (eliglustat capsules), which is the first imitation + the first domestic evaluation
.
According to public information, egasstat is a potent and highly specific ceramide analog inhibitor, which reduces the production of glucosylceramide by targeting glucosylceramide synthetase, and is a first-line oral drug for the rare disease Gaucher disease, and the original research has not been approved for import
.
At present, the domestic approved drugs for the same indication mainly include imigresidase and verasidase α (verasidase α), both of which are imported products, of which the sales of imilaterase in the first half of 2022 in China's public medical institutions terminal sales were close to 150 million yuan, an increase of 95.
22%
over the same period last year.
On October 29, CDE showed that the marketing application of olaparib tablets of Hangzhou Sino-American Huadong Pharmaceutical, a subsidiary of East China Pharmaceutical Group, was accepted
.
A week ago, Ouyi, a subsidiary of CSPC Pharmaceutical Group, also submitted a marketing application
for this variety.
It is reported that olaparib was originally developed by AstraZeneca and Merck-MSD, a PARP inhibitor, which was approved for marketing in the United States, the European Union and Israel in 2014, and is the world's first approved PARP inhibitor
.
At present, olaparib is the exclusive variety of AstraZeneca, although no other generic drugs have been approved for marketing in China, but a number of pharmaceutical companies have successively reported production into the market, in addition to the above two enterprises, including Qilu Pharmaceutical (the first to report production), Xuantai Pharmaceutical, Hunan Kelun, etc
.
have also been reviewed and approved.
.
.
.
.
.
.
In general, with the upgrading and development of China's pharmaceutical industry and the gradual improvement of the research and development strength of domestic pharmaceutical companies, pharmaceutical companies are paying more and more attention to the first generic drugs, and the results are also emerging
.
However, it is worth noting that as the first generic drug gradually becomes a must for pharmaceutical companies, the competition in related products is expected to intensify
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.