Ten Leading Organizations Unite to Advance CGT Industry Upgrade Tour – Shanghai Stop

▲ Liu Xiao | Vice President of Business and Marketing, Xingcheng Biotechnology

Deputy Director of the MAH Special Committee, China Pharmaceutical Enterprise Management Association

Mr. Wu Bo, Co-CEO and Chief Strategy Officer of Xingbei GroupDelivering the opening remarks for the event, Mr. Wu reviewed the development of the biopharmaceutical industry in recent years. He noted that the advancement of the cell and gene therapy (CGT) sector has brought new hope to patients suffering from various major diseases, and he expressed his earnest expectation that the industry will achieve substantial growth through the concerted efforts of all elites present. Meanwhile, as the operator of the Life Science Park, Xingbei·Free Trade Zone No. 1 is committed to creating a high-quality R&D and operational environment for researchers and doing its utmost to contribute to industrial upgrading in the life sciences field.

▲ Wu Bo | Co-CEO and Chief Strategy Officer of Xingbei Group

Liu Dong, Editor-in-Chief of VCBeatDelivering remarks on behalf of the organizer, Liu Dong, a media professional with over a decade of experience in the biopharmaceutical industry, affirmed the value of this event. He stated that VCBeat will continue to aim at building a similar ecosystem, striving to help outstanding companies gain access to valuable resources. Meanwhile, he expressed his hope that companies would utilize this platform to articulate their needs and convey their intentions, ultimately facilitating connections and fostering in-depth collaboration.

▲ Liu Dong | Editor-in-Chief, VCBeat

Legend CapitalVice President of Investment, Wang Haotian

Key Takeaways: The pharmaceutical industry has entered the era of molecular biology. China is experiencing robust growth in the field of cell and gene therapy (CGT), with a relatively small gap compared to overseas markets in terms of clinical pipelines. Currently, China holds a comparative advantage in the overall cost of drug development. With increasingly mature infrastructure and technology platforms, as well as a growing concentration of talent, innovative biomedical products in China are poised to compete on par with those in other developed countries at the New Drug Application (NDA) stage. After a prolonged period of exploration and accumulation, domestic innovative drugs are transitioning from a "follow-on" strategy to genuine innovation. Continuous advancements in CGT manufacturing processes, gradual improvements in regulatory frameworks, and the increasing volume of business development (BD) transactions—with Chinese deals gaining prominence—all signal a promising future.

▲ Wang Haotian | Vice President of Investment, Legend Capital

Wang Xin, Chief Strategy Officer (CSO) of Borui Ce Biotechnology

▲ Wang Xin | Chief Strategy Officer (CSO), BioRayce

Austar Group: Jin Lei, Expert in Cell Therapy Solutions

Key Takeaways: In the consideration of risk factors for the production of cell therapy products, Advanced Therapy Medicinal Products (ATMPs) are considered to have a high level of risk, based on the fact that most involve typical aseptic processing. The complexity of ATMPs arises from varying risk levels due to the nature and characteristics of starting materials and the complexity of manufacturing processes, which further complicates risk management. Furthermore, maintaining chain of identity is crucial for ensuring patient traceability and preventing mix-ups of materials from different patients.

Closed Processing Technologies and Strategies: Use closed equipment, containers, or bags to contain cells, in-process products, culture media, or buffers whenever possible; utilize gravity, pressure, or small pumps to add or remove liquids through single-use tubing; employ manifolds connected to sampling containers for sampling; apply various aseptic connection and disconnection methods throughout the process. When a process step cannot be fully closed, environmental isolation devices (such as isolators or Rapid Access Barrier Systems) can be used to isolate the product from personnel interaction and the external environment. This strategy reduces the area requiring higher classification levels and lowers the risk of introducing external contamination. Austar Life Sciences Technology Co., Ltd. helps biopharmaceutical companies establish comprehensive quality systems and provides services such as engineering consulting, equipment validation consulting, compliance gap analysis, and mock audits.

▲ Jin Lei | Cell Therapy Solutions Expert, Austar Group

Li Junhui, Vice President of Science and Technology Production at Xingcheng Biotechnology

Key Takeaways: Strategies for Developing Virus Packaging Media: First, establish a model medium; then implement a customized medium replacement strategy; subsequently adjust the customized medium formulation (via Design of Experiments [DOE] optimization, based on metabolism, AAV packaging titer, and empty capsid rate); and finally confirm the medium formulation. Key Considerations for Developing Import-Substitute Media: Supplier’s large-scale production capacity, regulatory compliance of manufacturing, batch-to-batch consistency, and availability of alternative suppliers. In plasmid production, lysis is the most critical step. A robust lysis process offers significant advantages, including markedly improved yield, substantially reduced generation of process-related impurities, and significantly lowered product-related impurities. Hangzhou Xingcheng Biotechnology Co., Ltd. provides fully customizable end-to-end process development and GMP manufacturing services, offering comprehensive solutions for the production of plasmids, mRNA, adeno-associated viruses (AAV), and lentiviruses, along with analytical method development and testing, quality systems, and management frameworks for intellectual property and trade secrets.

▲ Li Junhui | Vice President of Science, Technology and Production, Xingcheng Biotechnology

Liu Jing, Deputy General Manager of the Safety Assessment Center (Southern Beijing), Saifu Pharmaceutical

▲ Liu Jing | Deputy General Manager, Safety Assessment Center (Southern Beijing), Saifu Pharmaceutical

Yeasen R&D Scientist Teng Yigang

Key Takeaways: Currently, most cell and gene therapy (CGT) treatments are in early stages, with over 70% of CGT pipelines in the preclinical phase, and fewer projects having entered late-stage clinical trials or regulatory filing stages. The CGT field as a whole is still in its nascent stage, but future pipeline momentum is strong. From a financing perspective, areas based on AAV delivery vectors have received more attention. The four commonly used viral vectors each have their own advantages and disadvantages, making them suitable for different scenarios. AAV and LV are new-generation vectors for gene and cell therapy, respectively, offering weaker immunogenicity and the ability to penetrate the nuclear membrane compared to previous generations such as ADV and RV. LV has stronger tropism, can infect non-dividing cells, and is safer than RV; AAV has an extremely broad host range, enables long-term gene expression with durable therapeutic effects, and exhibits very low immunogenicity and hepatotoxicity, although it has limited packaging capacity and a longer time from infection to expression. Yeasen possesses both independent core technology R&D capabilities and large-scale production capacity, with thousands of core products covering multiple series including molecular cloning, qPCR, NGS, in vitro transcription, antibodies, protein purification and analysis, cell culture, transfection and analysis, and reporter gene detection, which are widely applied in life science research, diagnostic testing, biopharmaceuticals, and other fields.

▲Teng Yigang | R&D Scientist, Yeasen

During the final open-mic discussion session,Liu Xinxing, CEO of Dingxin Gene; Tang Chenxiang, COO of Huanma Bio; Chen Lijuan, COO of Yuesai Bio; Gu Long, Partner at Anjie Shize Law Firm; and the moderator, Dr. Liu Xiao, Vice President of Business and Marketing and Deputy Director of the MAH Special Committee of the China Pharmaceutical Enterprise Management AssociationSharing on the topic of “Leveraging CMC Synergy to Help Innovative Enterprises Achieve a Robust, Rapid, and Cost-Effective Transition from IIT/IND to BLA”

Regarding CMC-related issues,Mr. Liu Xinxing, Dingxin Gene“It is believed that CMC considerations should be initiated as early as possible. The development of CDMOs over the past 3–5 years, including lessons learned from pitfalls encountered, are all advantageous factors that help address CMC challenges. The exploration of any new project and new collaboration must center on ultimate value; based on this premise, core product requirements should be considered to seek further cooperation.”Mr. Tang Chenxiang, General Manager of Huanma BiotechHe stated, “For circular RNA, the CDMO sector is still in its early stages, with few companies capable of providing such services. This is a common challenge shared by any emerging industry. From our own perspective, the most distinctive feature of Huanma Bio is its circularization capability, with manufacturing processes serving as our core competitiveness. Our intrinsic drive to excel in Chemistry, Manufacturing, and Controls (CMC) during our self-built facility development has motivated us, and we will continue to optimize our processes and platform technologies.”

Regarding recommendations for the development of domestic suppliers,Ms. Chen Lijuan, General Manager of Yuesai BiotechIt was stated that supply chain enterprises could consider moving beyond the existing business model of “lending demos for short-term cost recovery,” as this approach hinders the long-term and rapid process development efforts of R&D-focused companies, particularly for novel therapies such as induced pluripotent stem (iPS) cell-based treatments. It is hoped that domestic alternative suppliers will jointly develop R&D-grade essential materials and processes, innovate collaboration models, accelerate the adoption of domestically produced alternatives to reduce costs, and achieve a win-win outcome. Meanwhile,AnJie & Broad, Lawyer Gu LongFrom a legal perspective, the following recommendations are proposed for the long-term development of biotech enterprises. First, the expectations for license-out deals among domestic biotech companies are not fully aligned with existing overseas valuation models, necessitating more extensive value alignment in the early stages. Second, companies may adopt commissioned R&D or collaborative R&D models based on technology platforms to share risks and costs. Finally, for two enterprises to establish a successful partnership, both parties must possess strong and complementary technical or resource advantages; furthermore, it is crucial to build trust grounded in a comprehensive legal framework.

In addition, as the moderator ofDr. Xiao Liu, Hangzhou Xingcheng Biotechnology Co., Ltd.When discussing collaborations in drug delivery, it is proposed to evaluate from a goal-oriented perspective. The enterprise’s objective is to develop a marketable drug, which requires resolving delivery challenges. Priority must be given to ensuring safety; next, efficacy should be considered, as it constitutes the essence of a pharmaceutical product. Accessibility should be addressed only after safety and efficacy are guaranteed. Here, accessibility refers not only to affordability but also to technological feasibility. Regarding preferences for collaborating with domestic and international suppliers, it is advisable to adopt an end-to-end approach. Supply chain security and stability are critical to ensuring the safety and viability of pharmaceutical products. It is essential to avoid situations where product supply is interrupted midway through production, particularly during the regulatory submission period. This poses a significant challenge for companies providing domestic alternatives.

▲ Panel Session (from right to left): Liu Xiao, Liu Xinxing, Tang Chenxiang, Chen Lijuan, Gu Long

▲ Group Photo of Guests