In 2022, the "close relatives" of Class 1 innovative drugs will accelerate the launch of the outbreak

In recent years, with the introduction of a series of domestic policies to encourage pharmaceutical innovation, the launch of Class 1 innovative drugs of chemical drugs has accelerated
.
According to industry statistics, in 2021, a total of 13 new improved chemical drugs will be launched in China, and in 2022, 4 products have been approved for marketing since the beginning of the year, and new improved chemical drugs are accelerating
.
From the perspective of new improved chemical drugs (excluding new indications) approved from 2020 to the present, there are a total of levoornidazole tablets from Shenghe Pharmaceuticals, olanzapine oral dissolving film from Hansoh, and montelukast from Qilu Pharmaceuticals.
19 products such as sodium dissolving film, paclitaxel polymer micelles for injection from Shanghai Yizhong and pregabalin sustained-release tablets from Hengrui were launched
.
In terms of therapeutic areas (categories), these 19 drugs are mainly concentrated in the fields of anti-tumor and immunomodulatory agents, systemic anti-infective drugs, and nervous system drugs
.
Among the 19 drugs, 5 drugs were included in the priority review, and the green channel was opened for listing, namely, Luye Pharma's risperidone microspheres for injection (II), Tefeng Pharma's chloral hydrate/syrup combination packaging, Shanghai Huizhou Pharmaceutical Co.
, Ltd.
Lun's levofolic acid for injection, entecavir granules from Warner Bros.
, and mitoxantrone hydrochloride liposome injection from CSPC Zhongnuo Pharmaceutical
.
Among them, Luye Pharma's Risperidone Microspheres (II) for injection is a product with obvious therapeutic advantages, overseas collinearity, and major special projects.
Tefeng Pharma's chloral hydrate/syrup combination packaging and Warner Pharma's Entecavir granules are both For children's medicine, the mitoxantrone hydrochloride liposome injection of Zhongnuo Pharmaceutical Co.
, Ltd.
of CSPC is a breakthrough treatment drug
.
From the perspective of manufacturers, Qilu Pharma's number of approvals is outstanding.
A total of 3 new improved chemical drugs have been launched, namely montelukast sodium oral dissolving film, olanzapine oral dissolving film, and tadalafil oral dissolving film
.
Among them, montelukast sodium oral dissolving film and tadalafil oral dissolving film are currently exclusive varieties.
The company is actively researching and developing in the field of oral dissolving film products.
In addition to these three listed products, the company also submitted a memantine hydrochloride oral The marketing application of the film-dissolving and aripiprazole oral-dissolving film, the relevant acceptance number is under review and approval
.
The company stated that it is in an advantageous position in terms of the number of declarations and listings of oral dissolving film preparations in China
.
Since 2022, the research and development boom of new chemical drug improvement drugs has continued to rise, and the number of applications has increased significantly
.
Judging from the application of improved new chemical drugs, according to industry statistics, 35 new improved chemical drugs of Category 2 (according to the acceptance number) were added in March alone, including 33 IND applications and 2 NDA applications, involving a total of 26 species
.
From January to March 2022, CDE has accepted a total of 83 chemical drug improved new drug applications
.
According to the situation of the products under review, it is expected that several products will soon be launched in the fields of anti-tumor and immunomodulators, and nervous system drugs
.
In the field of anti-tumor and immunomodulatory agents, three improved new drugs are expected to be launched, namely Luye's Goserelin Acetate Sustained-Release Microspheres for Injection, Livzon Group's Tritorelin Acetate Microspheres for Injection, Na Pharma's sodium levofolinate for injection
.
Among them, Luye's Goserelin Acetate Sustained-Release Microspheres for Injection is the company's second microspheres to be produced, and it is expected to achieve the world's first market launch.
In institutional terminals, the sales volume of goserelin exceeds 3 billion yuan; Livzon's microspheres of triptorelin acetate for injection are also expected to become the company's second approved microsphere preparations.
The terminal of medical institutions also exceeds 1 billion yuan
.
The field of nervous system drugs will usher in 8 new improved drugs, including aripiprazole oral dissolving films, edaravone sublingual tablets and other large varieties exceeding 1 billion yuan
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.