36Kr learned that the service provider focusing on cell gene therapy CDMO, Yuanjian Youke Biotechnology Co., Ltd. (hereinafter referred to as "Yuanjian Youke" or Forecyte Bio), has completed hundreds of millions of yuan A round of financing (the first round of financing), led by Xiangfeng Investment, with the participation of Boyuan Capital and Hongning Hengtai.
It is reported that this round of financing will be used for Yuanjian Youke to start the large-scale GMP production capacity construction in the Shanghai Pudong Free Trade Zone, including process development and large-scale GMP production of plasmids, viral vectors, and cell products, a total of 14 GMP production lines; in addition, it will also be used to start the GMP production of clinical-scale viral vectors and cell products in Maryland, USA, and accelerate the construction of CGT production capacity at home and abroad, so as to achieve "double declaration" to support clinical research in China and the US market.
Founded in July 2021, Yuanjian Youke is registered in Shanghai Pudong New Area Free Trade Zone and Xiamen, positioned as a cell gene therapy CDMO service provider, focusing on providing plasmids, viruses (adeno-related viruses, adenoviruses, lentiviruses, oncolytic viruses, retroviruses), cells (CAR-T, TCR-T, etc.), as well as providing services from process development, GMP production to IND/BLA declaration material preparation, and through process development and production workshops in Shanghai and Maryland, USA, To provide customers with integrated technology and production services.
According to He Yingke, co-founder and CEO of Yuanjian Youke, during the company's preparation for the GMP workshop, it has been able to provide customers with complete CDO (Contract Development Organization) related services; such projects can be transferred to the company's new production capacity in 2022, enter the CMO stage and GMP production. In addition, in addition to the above-mentioned plasmid, virus, and cell platforms, Yuanjian Youke is also building its own mRNA technology platform.
When talking about the original intention of entrepreneurship, He Yingke told 36Kr that since 2015, the relevant government departments in China have successively issued many policies that are conducive to the development of the biomedical industry, such as the CFDA's release of the "Consultation Draft for Consistency Evaluation", etc. At that time, the idea of entering the biomedical independent entrepreneurship was born, but the conscious experience was not enough, until the past two years to really implement the entrepreneurial idea; and the reason for locking the segment of cell gene therapy CDMO is the result of the favorable time and place.
First, as a new treatment method, cell therapy / gene therapy has brought revolutionary new treatment options to the medical field, coupled with the Chinese government's continuous strengthening of attention and support for the biomedical field, and the capital field of cell gene therapy technology, China's cell gene therapy has gradually become the focus of biomedicine.
Second, many policies are oriented: China is in great need of standardized and professional clinical service institutions, and cell gene therapy CDMO is still a huge blue ocean market. "Cell gene therapy, especially CDMO, is like the macromolecular drug industry in the 1980s and 1990s, which has just begun to develop and the technology is immature, there are no monopolies and bellwethers, and the technology is constantly updating, everyone has a chance, this is a very good track."
Third, I have also found a partner that is very complementary, experienced and suitable for the development needs of the industry.
According to He Yingke, the company's current featured products/services are mainly in three parts: plasmids, viruses and cells, which are not only related to the team's own experience accumulation, but also echo the current market demand.
She pointed out that taking plasmids as an example, the current market gap is very large, the popularity of new crown vaccine research and development has led to the development of mRNA drugs, domestic and foreign plasmid production capacity is far from enough, the overall supply is in short supply, even large multinational pharmaceutical companies are also lacking.
In addition, virus and cell products are also essential products for gene therapy and cell therapy companies, respectively, and the market demand is very large. Among them, the technical barriers to the production of adeno-associated virus (AAV), an important vector like gene therapy, are also very high. "Yuanjian Youke wants to differentiate itself in these 'harder' areas."
Image source: IC Photo
According to a previous analysis of 36 Kr
Unlike traditional drugs that can be quickly commercialized once they are listed, cell gene therapy is too special, and if pharmaceutical companies want to win, they must not only compete for the leading edge in drug research and development, but also try to solve the problems faced in all aspects of subsequent commercial production, which also brings explosive growth opportunities to the CDMO track.
One of the core logics is that the complexity of the production process determines its technical barriers, and pharmaceutical companies have a strong willingness to outsource, so the market for cell therapy CDMO is expected to grow rapidly in the future.
According to Frost & Sullivan's estimates, the global outsourcing market for gene cell therapy is expected to grow from $1.2 billion in 2017 to $3.6 billion in 2022, an average annual compound growth rate of 25%, much faster than the industry average. Taking the industry leader Longsha Group as an example, the company achieved a compound growth rate of 28% last year, which intuitively reflects the growth rate of the industry.
Among them, in addition to the materials & equipment required for production and preparation, scientific research reagent equipment and consumables, and comprehensive operating costs, the important ones also include related viral vectors - viral vectors that deliver genes are the key components of the final acquisition of CAR-T products, and the large-scale production of CAR-T can be said to be the large-scale production of viral vectors in a sense.
The formation of large-scale CDMO enterprises undoubtedly has more advantages, the core is to reduce costs through automated production, standardized manufacturing of lentivirals, plasmids and other ways.
At present, in addition to Yuanjian Youke, many companies have seen opportunities in the cdMO field, such as Jinsrui, Heyuan Biology, Paizhen Biology, etc. With the rise of these enterprises, biological cell therapy CDMO has also ushered in a new stage of development.
Core team information
CEO Ms. He Yingke has been with GSK for 20+ years, working in multiple departments and regions (US, China, and Japan) involved in every aspect of drug development. Her most recent role was to be responsible for the reconstruction of GSK's oncology division business in Japan and served as head of this area.
Dr. Zhang Shuyuan, CTO, has nearly 30 years of experience in the technology and management of gene and cell therapy process development and GMP production since the world's first gene therapy company. Throughout his careers with multiple biological and CDMO companies (including the predecessor of Lonza, the world's largest CDMO company), he has been exposed to almost all CMC-related processes and technologies, including plasmids, viral packaging (adeno-associated viruses, adenoviruses, lentiviruses, and oncolytic viruses), and cell therapy products. Most recently, he was Vice President of Process Development and Production at U.S. Cellular Gene Listed Company, where he had approved more than 10 INDs/CTAs and 1 BLA.
Dr. Yujian You, COO, has 14 years of business development and market sales experience in the life sciences field, including 8 years in Lonza responsible for North American market development, familiar with the CRO/CDMO business model. His most recent role was Vice President of Commerce at the leading CROs in China.
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