In November, a number of pharmaceutical companies announced that related products won the first imitation!

【Pharmaceutical Network Enterprise News】The first generic drug, that is, the first generic drug
approved for marketing.
At present, under the background of encouraging innovation at the national level, leading pharmaceutical companies with high R&D levels are continuing to promote the work
of "preempting imitation" while actively deploying innovative drugs.
Recently, the website of the State Food and Drug Administration shows that Changfeng Pharmaceutical's nitrosestine fluticasone nasal spray (azelastine propionate nasal spray) has been approved for imitation of Class 3 production, becoming the first approved enterprise
for this product.
Fluticasone hydrochloride propionate nasal spray is a new structure of 2, 3 diazepine derivatives, is a potential long-acting anti-allergic compound, has the characteristics of H1 receptor antagonist, has antihistamine, anti-allergic effects, mainly used for the prevention and treatment of allergic rhinitis
.
It is understood that Changfeng Pharmaceutical is a comprehensive pharmaceutical enterprise committed to providing high-quality respiratory drugs to patients around the world, focusing on the development of products in the field of
respiratory therapy.
Up to now, Changfeng Pharmaceutical has approved 3 products, in addition to 4 inhalants under review under new classification, which are deemed to have been evaluated
after approval.
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 (eliglousstat capsules), which was 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 imigerase and verasidase α (verasidase α), both of which are imported products, of which the sales of imisidase in the first half of 2022 in China's public medical institutions terminal was close to 150 million yuan, an increase of 95.
22%
over the same period last year.
Compared with innovative drugs, because the first generic drug has the advantages of lower development difficulty, and after marketing, it can often quickly seize more markets, etc.
, it has become the focus of
more and more pharmaceutical companies' R&D layout.
Data show that as of October this year, more than 50 first generic drugs have been approved
in China.
Among them, Kelun Pharmaceutical's performance is very eye-catching
.
It is understood that this year, 16 generic drugs have been approved for marketing, and 7 varieties are the first generic + first evaluated in China, including brimonidine timolol eye drops, ceftriaxone sodium/sodium chloride injection for injection, tragliptin succinate tablets, gadolinol injection, sildenafil citrate oral collapse tablets, medium and long chain fat emulsion / amino acid (16) / glucose (36%) injection, medium and long chain fat emulsion / amino acid (16) / glucose (30%) injection, etc
。 In fact, the first generic drug has always been one of the key points of the R&D layout of domestic pharmaceutical companies, with the upgrading and development of China's pharmaceutical industry, the R&D strength of domestic pharmaceutical companies has gradually improved, and pharmaceutical companies are paying more and more attention to the first generic drug
.
The industry expects that in the future, under the background of the continuous advancement of policies such as volume procurement and medical insurance negotiation, as well as the increasing efforts of the state to encourage patent challenges, more new dosage forms and large-variety first generic drugs will become the focus of the layout of
pharmaceutical companies.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.