Exclusive Interview with HopeGene Bio: Leveraging 7 Years of CGT Expertise to Power CDMO Growth, Securing Nearly RMB 100 Million in Orders Within a Year of Launch

After working at Imunopharm for approximately seven years, Dr. Lu Xin’an shifted to the CGT CDMO sector and established CYGENTA earlier this year.

Although CYGENTA has been established for less than a year, it is one of the earliest teams in China to engage in the R&D of novel CAR-T therapies. Its senior executives hail from global leading pharmaceutical companies such as Novartis and Sanofi. The company has built a one-stop CGT CDMO platform covering three major processes—plasmid, viral vector, and cell manufacturing—and providing full-lifecycle services including process development, quality studies, regulatory affairs, and non-clinical and clinical support. It has also established an upstream and downstream supplier network for the entire lifecycle of CGT products.

Recently, VCBeat New Medicine conducted an exclusive interview with Dr. Lu Xin’an, offering his perspective on the pain points in the CGT industry and the considerations behind his career pivot.

Since the FDA and EMA approved the first CGT drug (the oncolytic virus product Imlygic) for market launch in 2015, substantial capital has flowed into the CGT sector, positioning the CGT industry as the golden track for the next decade.

2015 also marked a turning point for China’s cell and gene therapy (CGT) industry, transitioning from a phase of unregulated growth to one of standardized development. After 2015, the government successively introduced relevant policies to strongly support the development of the CGT sector.

Dr. Lu seized a critical window of opportunity in the CGT industry. In 2015, the year he graduated from Tsinghua University, he co-founded Imunopharm, dedicated to treating malignant tumors using innovative CGT technologies.After nearly eight years of development, ImmuneOnco has obtained three clinical trial approvals from the National Medical Products Administration (NMPA) and secured Beijing’s first Drug Manufacturing License for gene and cell therapy products.

CGT drug development has never been an easy endeavor. As a relatively new sector, the field demands cutting-edge technologies and personnel at the forefront of the industry. High technical barriers, substantial R&D costs, a relative scarcity of specialized talent, and limited indications that complicate patient recruitment for clinical trials are among the multiple factors that make CGT drug development significantly more costly and challenging than traditional pharmaceutical development.

Dr. Lu stated, “As a biotech company, YiMiao ShenZhou now has a workforce of nearly 300 employees, yet it can only advance a few CGT product pipelines simultaneously.”Even leading domestic CGT companies such as ImmuOnco are acutely aware of the challenges inherent in CGT drug development. Currently, the majority of CGT companies in China are startups, commonly grappling with multifaceted pressures related to technology, capital, and human resources, which makes their progress arduous. Without leveraging outsourcing services, it would be extremely difficult for these companies to advance their operations.。

The advancement of the industry is inseparable from corporate efforts. “We aim to help pharmaceutical companies better conduct CGT drug R&D and encourage more companies to participate in the industry.” Therefore, ImmuneOnco spun off its CGT CDMO business and began establishing its CDMO service system one year in advance. Finally, in January 2022, Dr. Lu spearheaded the founding of CYGENTA.

CYGENTA Logo

The company’s name embodies the spirit of “Brimming with Hope, United in Purpose.” Dr. Lu explained, “The CGT industry is future-oriented and capable of addressing unmet clinical needs in advanced-stage cancers and rare diseases, thus brimming with hope. Meanwhile, the CGT sector requires the joint participation of physicians, pharmaceutical companies, CDMOs, and upstream and downstream partners. Only by staying united and collaborating closely can we overcome diseases.”

The research, development, and manufacturing of CGT therapies primarily encompass three stages: plasmid production, viral vector production (delivery system), and cell preparation. Among these, plasmid and viral vector production are relatively standardized, whereas the cell therapy manufacturing process involves steps such as cell culture, activation, transduction, purification, and enrichment. This necessitates the use of automated equipment, resulting in higher upfront capital expenditures for enterprises.

Dr. Lu stated that multinational and domestic CGT CDMO companies generally focus on plasmids and viruses as their primary service offerings, while cell-based service capabilities urgently need to be addressed.andCYGENTA has completed the entire journey of CGT drug development from 0 to 1.In addition to quality and cost advantages in plasmid and viral vector products, the process also features robust cell-based service capabilities., capable of providing gene and cell therapy companies with services including technical development, manufacturing, quality control, and regulatory registration for products such as plasmids, vectors, and cells.

Beyond the differentiation in products and services, CYGENTA has also adopted a markedly different approach to its regional layout. Dr. Lu explained: “Most domestic CGT CDMO companies are concentrated in the Yangtze River Delta region, with very few located in northern China. CDMOs like ours, capable of providing end-to-end services for plasmids, viruses, and cells—from Investigator-Initiated Trials (IIT) to commercialization—are even more scarce..” Located in the Daxing Biomedical Industry Base in Beijing, CYGENTA started in northern China and has been expanding across China and globally by leveraging Beijing’s educational and medical resources.

Leveraging its professional expertise and services, CYGENTA signed a cooperation agreement with Qinghui Liannuo within less than four months of its establishment. It has since partnered with numerous companies, including Jingda Biotech, Fuyuan Biotech, and Aiwan Biotech. Collaborations cover products such as CAR-NK cells, γδ T cells, and exosomes, as well as services including manufacturing (early-stage development and commercialization) and regulatory registration. Dr. Lu stated, “Including the orders recently signed, our total order value for this year has exceeded 100 million yuan.。”

“Our existing production capacity is insufficient to accommodate new orders,” said Lu Xin’an. To expand production capacity, meet market demand, and scale up its team, CYGENTA plans to complete two rounds of financing within this year. The company has already closed its angel round and is currently preparing for its Series A financing round.

Due to the complex manufacturing processes, stringent quality control requirements, and strict regulatory oversight associated with cell and gene therapy (CGT) drugs, there is a heavy reliance on imported high-quality reagents, consumables, advanced equipment, and instruments during production, resulting in a very low rate of domestic localization.

"The absence of domestically produced products is currently a major pain point facing the development of China's CGT industry,"Dr. Lu stated that establishing a robust domestic ecosystem is a crucial step toward achieving import substitution with domestically produced alternatives.Therefore, CYGENTA has proactively begun to build its upstream and downstream supplier network for the entire drug lifecycle, solidifying the foundation for its “one-stop” service.

“Although we currently collaborate with both domestic and international enterprises, we prefer to partner with local companies when their capabilities are comparable,” said Dr. Lu. He noted that building the ecosystem for China’s cell and gene therapy (CGT) industry requires not only efforts from enterprises but also, more critically, national-level macro-strategic integration of industry resources. By launching state-sponsored projects, resources across multiple disciplines—including chemistry, materials science, polymer science, and pharmaceutics—can be consolidated to create Chinese intellectual property (IP), achieve import substitution with domestically produced alternatives, and reduce drug costs.

As a novel therapeutic modality, cell and gene therapy (CGT) drugs have a short development history and lack standardized technical pathways. Consequently, there is substantial room for innovation and discussion in areas such as regulatory guidelines, drug evaluation criteria, clinical trial implementation, and commercialization. “Only when the innovative CGT model is successfully implemented can the industry truly take off,” Dr. Lu candidly stated, acknowledging that the CGT sector still faces significant challenges.

“It is precisely because development is challenging that CYGENTA is even more committed to contributing to the industry. ‘In the future, CYGENTA aims to help its collaborative clients advance their products into clinical trials and ultimately to market as soon as possible,’ Dr. Lu added. He expressed his hope that CYGENTA can support the growth of more cell and gene therapy (CGT) drug developers, helping establish CGT as an innovative and accessible treatment modality following small-molecule and large-molecule therapies.”