Ten Organizations Collaborate to Advance CGT Industry Upgrade Initiative – Chengdu Tianfu International BioCity Hosts Ninth Stop of Park Tour Series

"Application of Yisheng Biotech's Novel PEI Transfection Reagent in Large-Scale AAV Production"

Key Insight: Cost reduction and efficiency enhancement are a major trend in the future development of CGT drugs

"Applications and Solutions of RNA in Cell Therapy"

Key Insight: RNA Stability Is Key to the Efficacy of Cell Therapy

"Application of New Technologies in the Research and Development of Gene and Cell Therapy"

Quote: Innovating Product Technology to Empower Scientific and Industrial Progress

CDMO services are not merely a simple manufacturing process; the development of a new drug requires numerous critical early-stage decisions. As the service provider, one must adopt a “drug developer” mindset, delivering “stable” and reliable services to clients. This involves helping clients make sound early-stage decisions, establishing a solid foundation for Chemistry, Manufacturing, and Controls (CMC), and ensuring consistent, high-quality outcomes that will ultimately yield successful results. Most importantly, it is about “Promise and deliver.” Service providers must stand in their clients’ shoes and spare no effort to help them avoid potential pitfalls.

Currently, the licensing costs for cell lines constitute a significant portion of expenses during the early development stage of biopharmaceutical companies. Furthermore, amidst declining drug prices, an increase in sales volume does not necessarily translate into higher profits. In this context, cost efficiency has become crucial for client companies. Kangsheng Biotechnology specializes in the research and manufacturing of cell lines and cell culture media, providing clients with critical raw materials and technical services. The cell lines offered by Kangsheng Biotechnology feature two key advantages: clear traceability and well-defined commercial licensing terms, which help enterprises reduce unnecessary costs. We aim to establish long-term partnerships with our clients to jointly promote the development of the industry.

GeneVector Biologics aims to provide Party A clients with comprehensive technical solutions spanning from CRO to CDMO, thereby meeting their more holistic needs. In response to the current surge in global expansion and business development (BD), GeneVector is also exploring new business avenues to offer clients services that are more reliable, cost-effective, and robust, including facilitating connections with overseas partners. Meanwhile, we seek to collaborate closely with Party A enterprises, fostering positive interactions to jointly accumulate greater expertise in late-stage new drug development services. Under this framework, GeneVector strives to deliver optimal solutions and premier services to each Party A client, truly empowering the transition of novel drugs from early-stage development through late-stage clinical trials and onto the global stage.

In recent years, many companies have pursued speed at the expense of early-stage product quality. Zuoxuanxing Biology aims to provide distinctive services to client enterprises and the industry as a whole, while identifying future customer needs to develop and deliver tailored solutions that truly address those needs—this is also our corporate development goal. Meanwhile, we seek to collaborate with more partners to establish domestic and international channels and jointly launch additional products and services, thereby helping client enterprises steadily advance their product development.

I believe that focusing on our core competencies can help cell and gene therapy (CGT) companies, as well as the entire industry, advance new drug development. Cutthroat competition has no bottom line; only when upstream enterprises stabilize and optimize their products and technologies can they drive progress in downstream processes and product development. Furthermore, clients and service providers should align their objectives and clarify quantifiable metrics for both parties. By meeting client needs and leveraging their feedback, service providers can continuously expand the boundaries of upstream product offerings, ultimately achieving a win-win outcome. As a supply chain enterprise, Zhisai Yuanji remains committed to controlling the development and supply of upstream raw materials and providing high-quality services to downstream clients, thereby better facilitating downstream R&D and ultimately achieving genuine domestic substitution of raw materials.

As the market returns to its fundamentals and the entrepreneurial landscape shifts, confidence is more valuable than gold, and hope will always remain. Today, companies that can secure financing and survive all possess distinct strengths; enterprises should maintain confidence in their development. However, early-stage companies cannot rely solely on fundraising to survive; they must devise strategies for sustainability, such as leveraging their core competencies to offer additional services or products, thereby generating internal revenue to navigate through difficult cycles. Cell and Gene Therapy (CGT) represents a key direction for future development. It is hoped that companies will remain committed to delivering high quality and superior service, providing novel solutions to the industry. I am confident that the CGT sector will ultimately achieve success.

AstraZeneca has been committed to advancing business development (BD) and global expansion initiatives. This November, AstraZeneca will participate in the 2024 Global MedBiotech Summit in Riyadh, Saudi Arabia, and has invited external partners to join, with gene therapy and cell therapy as key focus areas. As part of the side events associated with the summit, AstraZeneca will further organize local market exploration activities in Saudi Arabia, inviting Chinese enterprises to participate jointly in promoting regional innovation cooperation and coordinated innovative development.

In the first half of this year, the industry remained somewhat disappointed with the overall IPO environment, perceiving that both the A-share and Hong Kong stock markets were on a downward trend. However, data indicates that A-shares and Hong Kong stocks each demonstrated distinct advantages during this period. On one hand, companies listing on the A-share market achieved 100% oversubscription, with all these heavily oversubscribed deals exceeding 100 times subscription. On the other hand, regarding the number of new listings in the Hong Kong market, there were 13 IPOs in the first half of the year, raising a total of HK$5.9 billion, a 13% increase year-on-year. Among these, two were biotechnology companies without profits or revenue. Therefore, from the perspective of the overall environment and ecosystem for listings in Hong Kong, such enterprises are highly welcomed to go public.

I believe that now is a favorable time for certain companies to pursue financing in the Hong Kong stock market, driven by U.S. interest rate cuts, the return of international capital, and supportive policies both domestically and externally affecting Hong Kong-listed stocks. Meanwhile, we should not overlook the A-share market. For cell and gene therapy (CGT) companies, listing on the A-share market presents a significant challenge—namely, pre-IPO valuation. If these companies can secure investor favor before initiating their IPO process, their prospects for listing on the STAR Market look promising. As for Deloitte, we remain optimistic about the recovery of secondary market financing in the second half of the year for both the STAR Market and Chapter 18A of the Hong Kong Stock Exchange.

Judging from financing and investment data and market performance, the CGT industry is gradually recovering. Although there is still a certain “chill,” the development of CGT remains positive. Looking back at China’s economic development, it has become the world’s second-largest economy, with manufacturing undergoing earth-shaking changes. Therefore, we have every reason to believe that the future of China’s cell and gene therapy industry is bright.

With the continuous development of various novel drugs, multinational corporations (MNCs) and biotech companies are seeking more effective delivery tools. Lingtaike Bio is dedicated to the research and development of innovative lncRNA-based nucleic acid therapeutics. The company has established a nucleic acid drug stability platform and an extrahepatic targeted delivery platform, both with full independent intellectual property rights. We aim to empower enterprise growth through our globally leading lncRNA technology, helping companies overcome delivery challenges and accelerate the development of innovative therapies.

Currently, the prohibitively high costs of cell and gene therapies limit their widespread application and accessibility. Many patients cannot afford these expensive treatments, thereby losing access to effective therapeutic options. In the future, stakeholders across the entire industry chain, including R&D enterprises and hospitals, can collaborate to reduce the cost of cell and gene therapies. For instance, R&D companies could produce lentiviral or adeno-associated virus (AAV) vectors according to unified standards, which would then be handed over to hospitals and other institutions for cell culture. This approach would significantly cut costs and enable the development of truly patient-benefiting products.

YiMuFeng Bio is an innovative enterprise that leverages its immune cell therapy technology platform, combined with clinical innovation strategies, to develop novel therapeutics for solid tumors. Its independently developed autologous CAR-T cell injection product targeting CLDN18.2 is currently in Phase I clinical trials. The company is also engaged in business development (BD) negotiations with partners, including multinational corporations (MNCs). It is expected that by the end of this year, the completion of Phase I clinical trials will yield additional clinical data, thereby facilitating further advancement of collaborative partnerships.

In addition, we are exploring a wider range of collaborative models. For instance, we recently completed a license-out deal to advance regional partnerships. Through these regional collaborations, the company will also gain access to overseas human subject data. Meanwhile, the inclusion of such international data in business development (BD) transactions may further facilitate partnerships with multinational corporations (MNCs).

In business development (BD) transactions, multinational corporations (MNCs) tend to place greater emphasis on clinical data for candidate products targeting "fast-follow" indications. Given that most cell and gene therapy (CGT) companies are currently conducting investigator-initiated trials (IITs), IIT data alone has become insufficient to validate a company’s technological capabilities. MNCs now expect companies to provide Phase I, or even Phase II, clinical trial data to enhance credibility. Furthermore, when a company’s pipeline focuses on fast-follow indications, MNCs look for additional advantages and highlights to demonstrate how the product differentiates itself from competitors. In this context, the importance of “building a solid foundation and strengthening core competencies” is further underscored. Early-stage drug design and chemistry, manufacturing, and controls (CMC) process development are decisive factors influencing whether a company’s candidate product can successfully advance through development and achieve market approval.

For CGT companies, enhancing product accessibility is of paramount importance. Useano focuses on the research, development, and manufacturing of allogeneic universal CAR-T cell therapy drugs.

In terms of business development (BD), overseas clinical data serves as another critical asset for companies in BD transactions. In this regard, Ucella’s strategy involves importing umbilical cord blood hematopoietic stem cells for the research and development of cell therapy drugs. This approach eliminates the need to establish manufacturing facilities abroad for subsequent R&D activities, thereby reducing R&D and operational costs while achieving the goal of “domestic production with overseas clinical trials.”

Furthermore, although the CGT industry is currently recovering, companies must still make adequate preparations to weather the most challenging period. First, companies cannot rely solely on financing for survival; they need to explore diverse funding channels, such as government financial support and bond financing. In addition, companies should leverage their other “monetization capabilities,” such as utilizing their competitive advantages to develop new products or technologies, thereby cultivating a second growth curve.