Nugget domestic high-end complex preparation industry

High-end complex preparation series two: the high threshold and high return of high-end complex preparations have been fully elaborated in series one, looking back at the development of this track in China, many leaders

1 High-end complex preparations, the next stop of differentiated development

Compared with ordinary preparations, high-end complex preparations are a more complex and advanced drug-carrying system, mainly including liposomes, microspheres, microcrystalline/nanocrystalline, micelles, etc.

At present, the European and American markets are the largest proportion of high-end complex preparation industry, due to the rising incidence of chronic diseases and the intensification of population aging, the Asian market will become the fastest growing region

Figure 1.

2 Based overseas, look at domestic development opportunities

According to incomplete statistics, more than 34 high-end complex preparations (including different dosage forms of the same drug molecule) have been approved for listing overseas, covering 32 effective drug molecules, of which liposomes, microspheres, microcrystalline/nanocrystals are important components of high-end complex preparations, and micellars are only in some regions with fewer

Domestic high-end complex preparations, a total of 8 products (6 drug molecules) have been approved for listing: liposome polyxorubicin, amphotericin B, paclitaxel, mitoxanthraquinone; The microspheres have leuprolide and risperidone, the nanoparticle varieties have albumin-bound paclitaxel, and the micellar has paclitaxel

Figure 2.

According to the Kaisi database, the hospital-side sales of domestic liposomes and microspheres increased from 6.

Figure 3.

Referring to the number of high-end complex preparation varieties that have been approved for listing overseas, the number of domestic listed varieties is currently small; And in the foreign market performance of better products, a number of products are not listed in the country, or the domestic competitive landscape is good still has a large incremental market

The main players of the domestic high-end complex preparation track are: Green Leaf, Stone Medicine, Kelun, Lizhu, Qilu, Shengzhao, Changzhou Jinyuan and so on

Figure 4.

The development of high-end complex preparations in China is mainly divided into two paths

As long as it can solve the clinical problem, then this product will definitely sell well, but do not ignore it, if the process development process of the early technical difficulty is more difficult and needs to be made equivalent, the cost, time and risk are postponed in the clinical stage, and the difference between the clinical value and the original research is not particularly obvious, in fact, the future sales height is difficult to reach the level of the original research.

At the same time, we note that a number of clinical application products accepted by CDE, or products registered for clinical trials on chinadrugtrials, have entered a "no progress" state (marked in red, no trials have been carried out after clinical approval, or clinical studies have not been promoted for a long time), which further proves that the development of high-end complex preparations is not easy
.

4 High-end preparation track, how to choose the target?

According to the collation of CDE acceptance documents, it is found that the current domestic development of high-end complex preparations follows the development trend of overseas development, and the products are concentrated in the development
of mature varieties verified by overseas markets.
Domestic research and development of mature large varieties such as paclitaxel (albumin-bound) suspension injection, doxorubicin liposome market competition is fierce, so when selecting companies or investment targets, we should pay attention to the company's product competition pattern
.

Figure 5.
Classification of high-end complex preparations CDE by generic name acceptance and declaration (source: CDE, public information, Fruitful Venture Capital collation)

We also emphasize the focus on the variety and quantity of the company's pipeline coverage, the current domestic high-end complex preparation industry market has not been fully opened, the company's pipeline variety of future sustained, stable profitability certainty is higher
.
The high-end complex preparation industry is more industrial, and the industry entry barrier lies in the complex production and manufacturing process of products, and the
requirements for processes and equipment are very high, and it takes a long time to invest in equipment and production capacity construction.
The more complete coverage of varieties under research indicates that the company's capacity construction and industrialization capabilities are stronger, and when the future market competition is gradually upgraded, relying on the cost advantages brought by industrialization and the iterative development of new products can make the company go further
in the competition.

epilogue

As we mentioned in the whole article, from the layout of high-end complex preparations at home and abroad, there is a huge gap in China, which also means huge opportunities
.
At the same time, in recent years, the development enthusiasm of high-end complex preparations has gradually risen, from which we have also seen a lot of enterprises that layout this track, in view of the fact that this track has a strong industrial manufacturing attributes, enterprises that can go to the clinical stage, most of them spend a lot of time to solve the problem of industrial production before the clinic, and establish high barriers, which are actually the first echelon
of China's high-end complex preparation industry 。 At present, there are only 3 domestic enterprises whose pipelines cover three major categories of liposomes, microspheres, microcrystalline/nanocrystalline products, namely Qilu, Green Leaf and Shengzhao, and they will also become an important part of
China's high-end complex preparation industry.