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In the past 2022, the financing of innovative pharmaceutical companies did not continue the boom of previous years, but came to a trough
.
According to the statistics of R&D customers, compared with 2021, the number of financing obtained by biopharmaceutical development companies and the total amount of financing disclosed have declined
.
The decline in total financing was particularly severe, from US$14.
5 billion in 2021 to US$
8.
1 billion last year.
5 billion in 2021 to US$8.
1 billion last year
However, in the sluggish funding market, cell and gene therapy (Cell and Gene
Therapy) has attracted the attention of many investors, with the amount of financing remaining the same as last year and a significant increase
in the number of financing transactions.
Cell and gene therapy as a new generation of treatments has brought great promise to patients and has also become the darling of
the global investment community.
According to CrunchbaseNews, from 2007 to 2016, a total of $2.
3 billion of global money poured into private companies in the space, with Chinese and South Korean companies accounting for about
15 percent.
Driven by the international industrial situation and a number of favorable domestic policies, the domestic cell and gene therapy industry has developed
rapidly since 2019.
According to ASGCT (American Society of Gene
+Cell
Therapy, American Society for Gene and Cell Therapy), by the end of 2020, China had carried out more than 300 clinical trials of cell and gene therapy, second only to more than 650 in the United States, and was one of
the most active countries in the world.
In 2021, the approval of two CAR-T products, Yikaida ® and Pinoda ®, has accelerated the boom in investment in the industry
.
Chase with the trend or be cautious and bullish?
Chase with the trend or be cautious and bullish?When asked how to view the current cell and gene therapy financing boom, Pan Xiaogang, executive director of AstraZeneca China's strategic cooperation and business development department and head of innovative medicine investment at AstraZeneca CICC Medical Industry Fund, admitted in an interview with R&D customers that this wave of financing fever does have a certain degree of chasing the trend, which is related
to the fact that there are fewer people engaged in the industry in China, and relatively speaking, there are more capital sides.
But as an emerging industry, from a global perspective, cell and gene therapy is also a hot
spot for financing.
Founded in 2015, Xingze Capital has invested in a number of cell and gene therapy companies
in recent years, such as Tianze Yuntai, Naiji Pharmaceutical, Youkadi, Shabble Biotechnology, Qi Heshengke and Microlight Gene.
Ding Wei, its executive director, told R&D that Apricot Capital has always been optimistic about this emerging field and has made it a focus because cell and gene therapy represent the frontier trend
of innovative drugs and biotechnology.
Ding Wei further explained that cutting-edge technology is the real driving force of clinical application innovation, and he believes that cell and gene therapy must be one of the most active innovation opportunities in the future, and technological progress will bring new hope for curing diseases, so it is reasonable for this field to become a hot spot for investment
.
After combing through cell and gene therapy financing in the past two years, developers found that although the number of cell and gene therapy financing transactions has increased considerably, financing is mainly concentrated in the early stage of financing, especially the pre-A round and series A
.
This trend is particularly pronounced in 2022, with Pre-A and Series A funding accounting for 54%
of all funding in this area that year.
The amount of a single financing transaction is also not high, and the vast majority of it is in the range
of tens of millions to 100 million yuan.
In 2021 and 2022, there were only 3 and 2 single financings exceeding US$100 million, respectively
.
Compared with the sharp increase in the number of overall financing transactions, the early financing rounds and not high investment amount also indicate that the investment community is relatively cautious and optimistic about
cell and gene therapy financing.
Who is the next CAR-T?
Who is the next CAR-T?The number of approved cell and gene therapy products is still limited
compared to many product candidates.
According to ASGCT, as of the end of October 2022, a total of 3,649 cell and gene therapy products under development worldwide are in the preclinical to marketing application stage, but only 22 gene therapy products (including gene-modified cell therapy products) have been approved, and the vast majority of them are CAR-T, viral vectors and oncolytic virus products
.
In addition, 55 non-genetically modified cell products have been approved for marketing
.
The successful launch of a series of CAR-T cell products has also stimulated the company's enthusiasm
for research and development.
Among the cell and gene therapy products currently in the research stage, CAR-T cell products occupy a considerable proportion and have also attracted a lot of investment
.
However, in addition, some companies trying to update the technology, especially iPSC (induced pluripotent stem cell) therapy and gene editing, have received more attention
from investors in China.
The number of iPSC companies financing in 2022 increased significantly compared to the previous year
.
Of course, these newer technologies are still far from clinical application and cannot be realized
in the short term.
So, which type of product is more likely to become the next large-scale cell and gene therapy product after CAR-T?
Pan Xiaogang put forward his own views
on this.
His AstraZeneca CICC Medical Industry Fund invested in TCR-T cell therapy company Tiankeya last year
TCR-T developer: Tiankeya, which transforms T cells into drug-carrying platforms) and base editing company sprout genes
.
He said that in addition to the more mature and industrialized CAR-T cell products, other new cell and gene therapy technologies, such as TCR-T, iPSC and gene editing, still have various limitations in science and many problems to be solved
.
There may be a single product that makes a breakthrough in a certain disease, but as a whole, it will take a long time for the next more mature product like CAR-T to land
.
The challenge of return on investment
The challenge of return on investmentCell and gene therapy products are fundamentally different from
traditional medicines.
At present, the approved CAT-T treatment products are personalized products that require self-infusion, which are difficult to mass production, high production costs, high product pricing, affecting product accessibility, and limited sales
.
According to the prospectus of Hengrun Dasheng, the two CAR-T products currently listed in China, Yikaida and Pinoda ® ®, are priced at 1.
2 million yuan and 1.
29 million yuan respectively
.
Among them, Tenoda ® is the only listed product of JW Therapeutics, with sales of only 5 million US dollars in the whole year of 2021 and 9 million US
dollars in the first half of 2022.
The current situation raises questions: Will investing in cell and gene therapy companies pay off? In response to this question, both investors interviewed said that they are optimistic about the possibility
of lower prices and improved accessibility of products in this field in the future.
In the view of Ding Wei of Xingze Capital, any new technology and new product will be more difficult in the initial stage of application, which is a necessary stage, and the monoclonal antibodies that are now widely used have also undergone such a process
.
As an investor, he is confident in the prospects of cell and gene therapy, and believes that with the accumulation and evolution of technology, there will be breakthroughs
in commercialization.
On the other hand, Ding Wei pays attention to the team
with excellent production process capabilities.
He said that the production process is the key to cell and gene therapy products, and by continuously optimizing the production process, the production cost of such products can be reduced, thereby reducing the cost of
treatment.
Pan Xiaogang considers this challenge
from another perspective.
He believes that the two CAR-T products that have been listed in China are imported from abroad, so the price is higher, and with the approval of products independently developed by domestic enterprises, the pricing is expected to be greatly reduced
.
On the other hand, Huimin Insurance in some regions has also included cell therapy in the scope of reimbursement, and some regions have also given better medical cost protection measures for rare diseases, which will also help reduce the patient's out-of-pocket part and improve the accessibility of cell and gene therapy
.