High-end preparations are "increasing in value"! Qilu, Livzon, Beite...Lead the 6 golden tracks

With the normalization of centralized procurement, the competitive pressure of ordinary preparations has increased, and high-end preparations with high technology and high barriers can be regarded as an innovative "shortcut"
.

Compared with ordinary generic drugs, high-end formulations have high R&D process and market entry barriers, and fewer competing products; compared with innovative drugs, high-end formulations have a shorter R&D cycle, which can effectively save R&D costs and reduce R&D risks

Two liposome preparations exceed 2 billion, with CSPC and Luye leading the way

Two liposome preparations exceed 2 billion, with CSPC and Luye leading the way

Liposome preparations approved in China

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

Liposome preparations are micro-vesicles formed by encapsulating drugs in lipid bilayers.
They have the characteristics of strong targeting, high safety, good slow-release effect, and high biocompatibility.
They are considered to be One of the most promising injection dosage forms at present
.

At present, a variety of liposome preparations have been approved for marketing in China.
Doxorubicin Hydrochloride Liposome Injection and Paclitaxel Liposome for Injection will be used in urban public hospitals, county-level public hospitals, urban community centers and township health centers in China in 2020.
The terminal sales of the hospital (referred to as China's public medical institutions) have exceeded 2 billion yuan, of which paclitaxel liposomes for injection are Luye Pharma’s exclusive products (including exclusive formulations, the same below)
.

Domestic liposome preparations under development

Source: China Drug Clinical Trial Publicity Library of Meinenet

Domestic research and development of liposome preparations is relatively hot, including bupivacaine liposome injection, amphotericin B liposome for injection, mitoxantrone hydrochloride liposome injection, and irinotecan hydrochloride liposome Injection, alprostadil liposome for injection, docetaxel liposome for injection, doxorubicin hydrochloride liposome injection, etc.
Among them, irinotecan hydrochloride liposome injection is highly competitive, Hengrui, Six companies including CSPC and Luye competed for the first in the country
.

In terms of the status of enterprise declarations, CSPC leads the way.
One product has been approved, two have been submitted for production, and four have been approved for clinical trials or are undergoing clinical trials; Luye Pharma also has one product approved and five products have been approved.
Approved for clinical trials or are in clinical development
.

3 domestic microsphere preparations were approved, with Livzon and Luye leading the way

3 domestic microsphere preparations were approved, with Livzon and Luye leading the way

Some domestic approved microsphere preparations

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

Microspheres are tiny spherical entities with a particle size of about 1-250 microns that are dispersed and embedded in a polymer matrix through microencapsulation technology
.

The microsphere preparation can not only prolong the action time of the drug, improve the drug effect, but also greatly reduce the number of times the patient is administered, and improve the convenience and compliance of the patient's medication

Among the domestically marketed microsphere preparations, the sales of leuprorelin acetate sustained-release microspheres for injection and leuprolide acetate microspheres for injection in China's public medical institutions in 2020 will each exceed 1 billion yuan
.

Domestic microsphere preparations under development

Source: China Drug Clinical Trial Publicity Library of Meinenet

The microsphere preparation market has a bright future, which has attracted many companies to deploy
.

At present, the microsphere preparations declared by domestic enterprises mainly include rotigotine sustained-release microspheres for injection, triptorelin acetate microspheres for injection, goserelin acetate sustained-release microspheres for injection, and triptore acetate acetate for injection parylene sustained release microspheres, injectable octreotide acetate microspheres, injectable Alarelin release microspheres and the like

The main applicant companies include Luye, Livzon, Changchun Jinsai, Qilu, Anhui Fengyuan Pharmaceutical, etc.
Among them, Livzon and Luye are the leaders.
Both companies have 1 product approved, and 5 have been approved for clinical trials or are in clinical trials.

.

Domestic substitution of inhalants is underway, with Healthyuan and Chengdu Beite leading the way

Domestic substitution of inhalants is underway, with Healthyuan and Chengdu Beite leading the way

Inhalants have obvious clinical advantages
.

Compared with oral agents, inhalants can directly reach the absorption or action site, with quick onset and avoid the liver first-pass effect; compared with intramuscular injection, intravenous drip, etc.

In 2020, China's public medical institutions will terminal over 1 billion inhalants

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

Compared with other high-end preparations, the domestic market for inhalants is relatively mature.
In recent years, as more and more domestic inhalants have been approved for marketing, the market share of imported inhalants has gradually been eroded
.

The sales of five inhalants in China's public medical institutions will exceed 1 billion yuan in 2020, and Hengrui will dominate the market for sevoflurane for inhalation

At present, more than 100 domestic inhalants (counted by the name of the drug + the name of the declared company) have been reported for production under the new registration classification.
From the perspective of the competition of varieties, ambroxol hydrochloride inhalation solution, compound ipratropium bromide inhalation solution, isopropyl The competition for tropium bromide inhalation solution, salbutamol sulfate solution for inhalation, and terbutaline sulfate inhalation solution for nebulization is fierce.
Among them, nearly 20 companies have applied for new classification of ambroxol hydrochloride inhalation solution, and 2 companies have successfully obtained Batch production is regarded as over-rated
.

Judging from the status of the company’s declarations, Joincare, Sichuan Prime (subsidiary of Chengdu Beite), Zhengda Tianqing Pharmaceutical, Hebei Renheyikang, Changfeng Pharmaceutical, Hengrui and other companies involved a large number of products, of which Health Yuan and Sichuan Prime have reported production of 10 or more inhalants
.

3 oral membrane preparations were approved, Qilu and Hengrui led the way

3 oral membrane preparations were approved, Qilu and Hengrui led the way

Oral fast-dissolving film preparation refers to a film-like preparation made by processing medicines and suitable film-forming materials for oral or mucosal use.
It has convenient administration, accurate dosage, stable quality, convenient carrying, and is suitable for children, the elderly, and emergency use.
Advantages
.

At present, 3 types of oral dissolving membranes have been approved for marketing in China, namely Qilu's Olanzapine Oral Dissolving Membrane and Montelukast Sodium Oral Dissolving Membrane, and Hausen's Olanzapine Oral Dissolving Membrane.

Domestic oral membrane preparations under development

Source: China Drug Clinical Trial Publicity Library of Meinenet

The oral dissolving film preparations currently registered in China include memantine hydrochloride oral dissolving film, ondansetron oral dissolving film, tadalafil oral dissolving film, aripiprazole oral dissolving film, and donepezil hydrochloride oral dissolving film, etc.
tadalafil orally disintegrating film more intense competition; indications involved include erectile dysfunction, Alzheimer's disease, schizophrenia and so on
.

The main application companies include Qilu, Hengrui, Lipin Pharmaceutical, Kelun Pharmaceutical, etc.
Qilu 2 products have been approved, 3 products have been submitted for production, and 3 products have been approved for clinical use; Hengrui has no products approved for the time being , But one product has been submitted for production, one product has completed the BE test, and two products have been approved for clinical use
.

Micellar preparations are widely used in anti-tumor drugs, and the development of these two products is hot

Micellar preparations are widely used in anti-tumor drugs, and the development of these two products is hot

Micellar preparations have the advantages of solubilizing poorly soluble drugs, improving bioavailability, targeting, EPR effect, etc.
, and are widely used in anti-tumor drugs
.

At present, no micellar preparations have been approved in China, but there are already many companies

Domestic micellar preparations under development

Source: China Drug Clinical Trial Publicity Library of Meinenet

At present, there are not many types of micellar preparations registered and declared in China.
There are many companies applying for paclitaxel polymer micelles for injection and docetaxel polymer micelles for injection.
Both paclitaxel and docetaxel belong to taxane antibiotics.
For oncology drugs, its early marketed preparations need to be solubilized with surfactants, and there are serious adverse reactions.
The development of new pharmaceutical preparations such as liposomes, micelles, albumin-binding, and nanoparticles can solve this problem
.

The domestic nano preparation market is blank, and the research and development progress is relatively slow

The domestic nano preparation market is blank, and the research and development progress is relatively slow

Nanoparticles are solid drug-carrying colloidal particles with natural or synthetic polymer materials as carriers, with a general particle size of 10-1000nm
.

Nanoparticles have passive targeting to liver, spleen, bone marrow and other parts, can be used as a carrier of anticancer drugs, and can also improve the therapeutic effect of antibiotics and antiviral drugs

Domestic nano-formulations under development

Source: China Drug Clinical Trial Publicity Library of Meinenet

At present, there are not many types of nano preparations under research in China, mainly including fenofibrate tablets, docetaxel nanoparticles for injection, amphotericin B composite phospholipid nanoliposomes for injection, and irinotecan hydrochloride nanogel for injection beam, like paclitaxel injection nanoparticles
.

Source: Mi Nei Net Database