Domestic substitution of inhalation preparations is in full swing, and some core production equipment needs to be broken through

[ Market analysis of chemical machinery equipment network ] In recent years, respiratory diseases such as asthma, chronic obstructive pulmonary disease, and rhinitis have become common chronic diseases.
Among them, asthma has become the second largest respiratory disease in my country, and the population of asthma patients in China is huge.
Statistics show that in 2019, the prevalence of asthma among people aged 20 and over in my country was 4.
2%, and the total number of patients reached 45.
7 million.
In recent years, in the face of huge demand for medications for patients, the domestic replacement of inhaled preparations for the treatment of chronic respiratory diseases has been in full swing.

 

Domestic substitutes for inhalation preparations are in full swing
 

It is understood that inhaled preparations are currently recognized as standard drugs for the treatment of chronic respiratory diseases.
This is a special formulation that is administered through the lungs.
It can quickly enter the lungs through local administration to exert its efficacy and reduce The administered dose improves the efficacy of the drug.

 

In the domestic inhalation preparation market, 80% of the market share* is occupied by multinational pharmaceutical giants, among which AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline account for nearly 70% of the market.
In recent years, more and more domestic pharmaceutical companies are targeting the blue ocean of the inhalation preparation market and actively deploying them.
Domestically-made products have been approved for the market one after another, which has accelerated the domestic substitution process of inhalation preparations.
For example, on the evening of December 10, Joincare issued an announcement that the company’s self-developed product "Budesonide Suspension for Inhalation" received the "Drug Registration Certificate" approved and issued by the state*, and could be manufactured and sold.
The industry expects this The product is expected to become a blockbuster variety of nearly 2 billion yuan; on November 25, Yunnan Longhai Natural Plant Pharmaceutical Co.
, Ltd.
submitted the application for the expectorant "ambroxol hydrochloride inhalation solution" according to category 3 of chemical drug registration.
In the "approval" stage, it is also expected to be approved by the country* in the near future, becoming the first domestically approved ambroxol inhalation preparation.

 

　　In fact, the policy has also given relevant support.
For example, in August 2019, the National Center for Drug Evaluation (CDE) issued a document for the public solicitation of the "Guidelines for the Study of Generic Pharmaceutical and Human Bioequivalence of Oral Inhalation Preparations".
The guidelines are based on the particularity of oral inhalation preparations.
The method of conducting pharmacy and human bioequivalence studies during the development of generic drugs shows that the BE guidelines for inhaled preparations in China are close to the BE equivalence required by the US FDA.
The industry believes that the draft for consultation has more clearly defined the guidelines for bioequivalence of inhaled preparations, and that the review of inhaled preparations in my country is expected to be integrated and accelerate the process of domestic substitution of inhaled preparations in China.

 

　　Some core production equipment is in urgent need of breakthrough
 

　　It is worth mentioning that inhalation preparations belong to a combination of medicine and equipment and have high barriers.
For example, in the research and development stage, it is necessary to comprehensively consider aspects such as inhalation drug prescription, drug particle size and inhalation device design.
The approval stage needs to consider policies such as the consistency evaluation of inhalation preparations, and the production stage Factors such as the cost of industrialized equipment and micro-precision filling and assembly processes must also be considered.

 

　　Some analysts pointed out that the current domestic industrialization of inhaled preparations still has problems such as shortage of capital investment and insufficient overall production capacity.
It is understood that since the active ingredients of the medicinal solution cannot be sterilized at high temperature during the production process, it is necessary to use aseptic production equipment to achieve this requirement.
However, the cost of aseptic production equipment is generally relatively high.
If you want to achieve industrial production, The investment in the workshop is estimated to be more than 100 million yuan, which is a huge cost burden for most pharmaceutical companies.

 

　　In addition, the author has learned that part of the core production equipment of domestic inhalation preparation companies, such as dry powder powder quantitative packaging equipment, is still mainly dependent on imports, which greatly restricts production capacity expansion.
In the context of the continuous development of the domestic inhalation preparation industry, these core production equipment will play an important role.
Therefore, domestic equipment companies need to continue to make efforts, continue to strengthen R&D investment, improve filling accuracy and speed, etc.
, to create domestic cost-effective equipment , To meet the needs of pharmaceutical companies.

 

　　Original title: Domestic substitution of inhalation preparations is in full swing, but some core production equipment urgently needs breakthrough