Qilu leads the mouth dissolving film, CSPC attacks micelles, Hengrui attacks liposomes... Improved new drugs explode the trillion-dollar market

The editor said: Recently, there have been many surprises in the research and development of new domestic chemical drug improvement drugs.

Source: Minet original

Recently, there have been many surprises in the research and development of new improved domestic chemical drugs.

19 new improved chemical drugs are on the stage, and Qilu dominates the field of mouth dissolving film

Improved new drugs are improvements to already marketed drugs, emphasizing "superiority" and having the advantages of high success rate, high return, low risk, and long life cycle, and have become a mainstream on the difficult road of new drug research and development

After the reform of China's drug registration classification, more and more companies have participated in the R&D and production of improved new drugs.

Table 1: Class 2 new chemical drugs approved since 2020 (excluding new indications)

Note: *For inclusion in priority review

Five of them were included in the priority review, among which risperidone microspheres for injection (II) are of obvious therapeutic advantages, overseas collinearity, major special varieties, chloral hydrate/syrup combined packaging, entecavir granules for children's medicine, and rice hydrochloride.

From the perspective of improvement, levoornidazole tablets, levornidazole sodium chloride injection, levornidazole dispersible tablets, levoornidazole capsules, and levofolic acid for injection are structural modifications, which improve the efficacy and security

In terms of dosage form improvement, since 2010, Chinese pharmaceutical companies have preferred to change ordinary tablets to capsules, dispersible tablets, and sustained-release tablets, mostly for the sake of change, without considering its clinical value; from the situation in recent years , Improved new drugs with high technology or high patent barriers such as oral dissolving membranes, liposomes, and microspheres have become a hot market

Qilu has already held 3 mouth-dissolving films, which have attracted much attention from the market

Figure 1: The sales scale of the three major varieties in 2020 (unit: 100 million yuan)

Source: Minet.

The liposome leader, CSPC, won the company's second liposome preparation in 2022

Luye's risperidone microspheres (II) for injection is the first microsphere preparation approved by the company, and also the first microsphere preparation in the domestic nervous system drug field.

The first micellar preparation in China was awarded to Shanghai Yizhong Pharmaceutical.

Figure 2: The main products of Shanghai Yizhong Pharmaceutical in 2021 (unit: yuan)

Source: Company Annual Report

Kelun, Renfu, Livzon.

As the heat wave of domestic chemical drug improvement and new drug research and development continues, five major categories will usher in multiple products on the market, involving domestic star pharmaceutical companies such as Kelun, Renfu, and Livzon

Table 2: Class 2 new chemical drugs reported for production and under review since 2019 (excluding new indications)

Note: *For inclusion in priority review

Anti-tumor and immunomodulatory agents are about to receive 3 new improved drugs.

The field of nervous system drugs will usher in 8 new improved drugs.
The first domestic competition for aripiprazole oral dissolving film falls between Qilu and Lipin Pharmaceutical (Xiamen) | Xiamen Lizhuo Pharmaceutical, Aripiprazole 2020 The annual terminal sales of public medical institutions in China exceed 1 billion yuan; Edaravone sublingual tablets have been included in the priority review, and sublingual tablets have the advantages of not being restricted by medical conditions and patient compliance.
Edaravone 2020 The annual terminal sales in public medical institutions in China also exceed 1 billion yuan; isoflurane injection is the first improved new drug reported by Yichang Renfu Pharmaceutical in the past ten years.
If the product is successfully approved, it will become the company's new improved drug.
A new breakthrough in the field
.

The field of genitourinary system and sex hormone drugs will usher in two kinds of oral dissolving films.
Sildenafil and tadalafil have become the major varieties of ED drugs.
At present, sildenafil citrate oral dissolving film is only one of the Lun reported that the tadalafil mouth-dissolving film is expected to usher in the second domestic company
.

In the past ten years, more than 200 improved new drugs have been approved for clinical use, and Hengrui and Nanjing Ruckus sprinted for production

Table 3: Some improved new drugs (excluding new indications) that have been approved for clinical trials since 2012 and have entered Phase II or above clinical trials

Source: Minet China Drug Clinical Trials Publicity Library

According to the data from Minet.
com, in the past ten years, more than 200 new improved chemical drugs have been approved for clinical use (statistics by product name + company name), and half of them have carried out clinical work so far
.

At present, Hengrui's ivabradine bisulfate sustained-release tablet is the fastest in research and development.
The phase III clinical trial of this new drug for moderate to severe chronic heart failure combined with left ventricular systolic dysfunction has been completed
.
At present, ivabradine in the domestic market is only available in ordinary tablets.
Servier’s original research drug has been approved for import, and 3 domestic pharmaceutical companies have obtained production approvals.
No sustained-release tablets are currently on the market.
, The sales of the original research drug of ivabradine hydrochloride tablets exceeded 100 million yuan
.

Nanjing Rucko Pharma's dexlansoprazole for injection has also completed Phase III clinical trials for upper gastrointestinal bleeding caused by peptic ulcer.
The category 2 clinical application of one company has been approved, and Nanjing Ruckus has the fastest progress
.
Lansoprazole is a large product with a terminal value of over 3 billion yuan in Chinese public medical institutions.
In recent years, its sales have declined.
Improved new drugs have improved efficacy and safety, and the market potential can be expected after listing
.

At present, there are 5 new improved drugs in Phase III clinical trials.
Xinlitai's Allisartan Medoxomil and Amlodipine Tablets and Allisartan Medoxomil and Indapamide Sustained-Release Tablets are compound preparations, and the indications are all essential hypertension
.
In recent years, the sales of compound preparations in the field of chronic diseases have grown rapidly.
Under the pressure of centralized procurement, improved new drugs are expected to break through the shackles and open up new horizons
.

Hengrui has also been actively deploying liposome preparations in recent years.
In 2021, the company submitted a 3-type generic listing application for bupivacaine liposome injection, which is expected to be the company's first product approved in this field.
Irinotecan hydrochloride liposome injection is expected to become the company's second liposome preparation
.
Irinotecan liposome injection is a hot product.
So far, 6 companies have been approved for clinical use, and Hengrui has the fastest progress.
In 2020, the sales of irinotecan in China's public medical institutions will exceed 1 billion yuan
.

Epilogue

At present, the pressure of normalization of centralized procurement on generic drugs is self-evident, and improved new drugs have become a mainstream on the road of innovative drug research and development
.
Compared with generic drugs, improved new drugs have lower investment costs and risks in research and development, higher technical or patent barriers, longer life cycles, and higher returns; for patients, improved new drugs can help improve drug effects and reduce The frequency of medication, enhancing compliance, reducing side effects, and improving safety are undoubtedly the preferred options for drug renewal iterations
.

Source: Mi Intranet database, announcements of listed companies, etc.

The clinical data statistics are as of April 18.
If there are any omissions, please correct me!