High-end preparation technology has become an important breakthrough point in domestic pharmaceutical innovation, and 2 major "short boards" have yet to be filled

【Pharmaceutical Network Market Analysis】High-end preparation technology is the core technology of the development of improved new drugs, and compared with generic drugs, its technical threshold is higher and more growth; Compared with the original research, it has more advantages
in terms of clinical time, research and development difficulty, and research and development costs.

In recent years, due to the consistency evaluation, collection and other favorable policy support and capital increase, the development of domestic innovative drugs continues to heat up, high-end preparation technology has also been rapidly developed, the market has emerged Alipiprazole mouth lytic film, paclitaxel, leuprolide microspheres, salbutamol sulfate controlled-release tablets, ibuprofen suspension and many other high-end new preparation products
.

High-end preparation technology has become an important breakthrough point in domestic pharmaceutical innovation (Picture source: Pharmaceutical Network) Policies support the development of
high-end preparation technology.

As early as 2016, the "13th Five-Year Plan" included the development of high-end preparations into the national development plan; The subsequent promulgation of a new drug classification that includes innovative preparations in Class II innovative drugs; In January 2022, the Ministry of Industry and Information Technology and other nine departments jointly issued the "14th Five-Year Plan for the Development of the Pharmaceutical Industry", which clearly stated that it is necessary to strengthen the research of key core technologies, improve the level of industrialization technology, support enterprises to integrate scientific and technological resources, and implement the technical research project
of pharmaceutical industrialization.

For chemical drug technology, we will focus on complex preparation technologies with high selectivity, long-term sustained and controlled release, including injections such as microspheres, oral preparations such as slow controlled release and multi-particle systems, percutaneous, implanted, inhaled, oral lytic membrane delivery systems, and drug-device combination products
.

In view of biopharmaceutical technology, we
will focus on ultra-large-scale cell culture technology, new delivery methods of biological drugs and new delivery technologies.

At present, many domestic pharmaceutical companies, including Qilu Pharmaceutical and Ruihua Pharmaceutical, have continued to increase R&D investment in the field of new high-end preparations, and have gradually built a series of preparation research and development and production platforms, constantly breaking through the "card neck" technology and achieving rapid transformation
of scientific research results.

However, for a long time, there has been a situation of "heavy APIs and light preparations" in China, and the current domestic preparation industry is still in its infancy, including high-end preparation technologies and products such as oncology drugs, rare disease drugs, and children's drugs, most of which are still dependent on imports
.

With innovation becoming the main theme of the development of the pharmaceutical industry, and the increasing number of enterprises entering the field of preparation technology innovation, the industry believes that high-end preparation technology will be an important breakthrough point in China's pharmaceutical innovation, and it is also one of the
important directions for local pharmaceutical companies to participate in global innovation.

What needs to be seen is that the road to domestic development is long, and if you want to take this road steadily, you need to make up for some "short boards", including equipment, talents and other aspects
.

For example, in terms of high-end preparation equipment, at present, some pharmaceutical companies and scientific research institutes use mostly imported equipment, mostly imported from Japan, Europe and the United States, with high prices and high
maintenance costs.

The market share of domestic high-end preparation equipment is basically occupied by imported manufacturers, and the voice of domestic pharmaceutical machine enterprises is relatively small, so it is urgent to break the "bottleneck", move from low-end to high-end, and accelerate the process
of domestic substitution.

Since 2022, many domestic pharmaceutical companies are actively promoting high-end preparation industrialization projects
.

For example, on September 13, Shanghai Huiyong Pharmaceutical invested and built the "High-end Preparation Industrialization Base Project" announced the start of construction; On September 9, 2022, Saito Bio announced that the total amount of funds to be raised will not exceed 262 million yuan (including the number), and the net amount of funds raised after deducting the issuance fee will be used for high-end preparation industrialization projects
.

In this context, the industry expects that the upstream equipment industry will usher in new opportunities, and enterprises with strength may benefit
.

For example, Dongfulong is the general contractor service provider of the purification project of the Shanghai Huiyong Pharmaceutical High-end Preparation Industrialization Base Project that has recently started, and is also the core equipment supplier
of its cytotoxic filling production line, isolator and hormone filling production line and isolator injection workshop.

With the advancement of intelligent manufacturing, the high-end preparation industry also needs to be transformed and upgraded, which will bring opportunities and challenges
to the drug delivery machine industry.

In order to improve the level of automation, continuity, intelligence and digitalization in production, quality and operation, in recent years, many pharmaceutical companies such as Hongdou Group and Xinhua Pharmaceutical have been actively promoting the construction of "high-end preparation intelligent factories", using new technologies such as information technology and network technology to achieve production efficiency, quality and efficiency, energy conservation and environmental protection
.

The industry believes that automation, intelligence, greening, etc.
will become an important direction
for the development of high-end preparation equipment industry.

The shortage of talents is another major "roadblock"
for the development of the domestic high-end preparation industry.

On the one hand, it is impossible to attract talents, and on the other hand, it is to attract but cannot be
retained.

In this regard, the industry believes that pharmaceutical companies need to pay more attention to talents, and also need more policy-side support to ensure that there are enough talent resources to join the exploration and development of high-end preparations
.

Conclusion Frozen three feet, not a day's cold
.

Breaking through the "bottleneck" of domestic preparation technology development, but also need a lot of efforts, including policies, technology, talents, equipment and other factors are indispensable, I believe that with the continuous efforts of all parties, the future pharmaceutical companies can develop more people can afford to use high-quality, efficient, long-term, high compliance of good drugs, to promote the development of
the domestic high-end preparation industry.

Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.