Carcell Biopharma Files IPO Prospectus to Accelerate CGT Platform Development with Dual Technology Platforms

Following small-molecule drugs and antibody-based therapeutics, cell and gene therapy (CGT) has brought new hope to medicine.

According to Frost & Sullivan, the global CGT market is projected to reach $30.54 billion in 2025, with a compound annual growth rate (CAGR) of 71% from 2020 to 2025. The Chinese CGT market is expected to maintain rapid growth, reaching an overall market size of $2.59 billion in 2025, with a CAGR of 276% from 2020 to 2025.

According to Nature, as of April 2021, there were 1,358 active clinical trials in the global cell and gene therapy (CGT) R&D pipeline, representing a substantial 43% increase from the end of 2020. As disclosed in the prospectus of Obio Technology, total financing in the CGT sector grew from approximately USD 7.5 billion in 2017 to USD 19.9 billion in 2020.

The advent of new technologies is poised to unravel more mysteries in human health development, yet the process of advancement requires continuous optimization.Currently, the most significant pain points in the CGT industry are manufacturing processes, costs, and the treatment of solid tumors.

VCBeat (hereinafter referred to as “VB”), as an observer of the healthcare industry, is highly interested in the current status and future development of the CGT sector.Driven by this curiosity, VCBeat had the privilege of interviewing Lin Xiangqian, Chairman and Global Chief Executive Officer (CEO) of Carcell Biopharma (“Carcell”), and Wu Lanlin, CEO of Carcell China.

Lin Xiangqian, Global CEO of KemixinIn addition to serving as Chairman of Kemeixin, he is the founder of EVX Ventures (formerly ESCO Ventures X), the incubator of Kemeixin, and the Chairman and CEO of the ESCO Group.

EVX Ventures is a global venture capital firm dedicated to creating, incubating, and investing in early-stage biotechnology companies. EVX Ventures focuses on building disruptive biomedical technology platforms and developing novel therapeutic modalities, investing in technological innovations worldwide to redefine the future of treatment.

In terms of commercialization and strategic development, Lin Xiangqian demonstrates exceptional business acumen. During his youth, he began participating in the commercial operations and strategic transformation of ESCO Group, assisting its evolution from a local small and medium-sized enterprise in Singapore into a global life sciences group, thereby increasing the company’s value by more than 300-fold. Today, ESCO Group’s products are sold in over 100 countries, with business operations spanning the United States, Europe, and China.

To propel Asian technology onto the global stage, Lin Xiangqian founded EVX Ventures in 2018.EVX Ventures leverages Singapore’s strategic advantages as a global hub and innovation center to build an international talent team and deploy its biopharma investment strategy on a global scale. Lin Xiangqian has driven the secondary strategic transformation of ESCO Group through an “incubation + investment” model. He has also used this approach to incubate and establish multiple companies in the biosciences sector, serving as the founder of several startups.

Currently, the projects incubated by EVX Ventures include Carcell Biopharma, Cargene, Carmine Therapeutics, Nuevocor, and PairX Bio, spanning multiple fields such as cell and gene therapy, oligonucleotide drugs, and tumor immunotherapy.

Wu Lanlin, China CEO of Kemixin, with over 20 years of experience in the pharmaceutical and healthcare industry. Possessing both clinical expertise as a physician and academic backgrounds in MBA and EMBA, he/she has previously held marketing positions at Xi’an Janssen, Baxter, and Merck & Co., overseeing brand management for multiple product portfolios including urology, anti-infectives, oncology pain management, orthopedics, and parenteral nutrition.

Furthermore, Wu Lanlin previously served as Assistant President of Sanpower Group, where he was responsible for strategic management in the biomedical sector. Since 2018, as CEO of Dendreon China, he has overseen the launch in China of Provenge, the world’s first cellular immunotherapy drug for solid tumors. His responsibilities have included comprehensive oversight of the construction of the first cell manufacturing facility, technology transfer, Investigational New Drug (IND) application, and clinical trial implementation.Possesses extensive leadership experience in strategy, technology, business, and operations.

In addition to the two core members mentioned above, other key team members also possess extensive industry experience in pharmaceutical investment, business operations, scientific research translation, CMC establishment, drug R&D, and regulatory submissions. Overall, Kemexin is a specialized, diversified, and multidisciplinary team.

Currently, Kemexin is headquartered in Shanghai. Leveraging the fertile ground of China’s biopharmaceutical sector and connecting with EVX Ventures in Singapore—a global gateway—Kemexin can accelerate its drug R&D and corporate operations in China, the United States, and Singapore through resource integration.

VB：As an emerging industry in development, the CGT sector still faces certain pain points, such as high costs, manufacturing processes, and the need for breakthroughs in the field of solid tumors. From an industry perspective, how will Kemeixin address these challenges?

Lin Xiangqian:This issue aligns precisely with the current strategic layout of Kemeixin’s technology platform.Currently, Kemeixin operates two primary technology platforms. One is an engineered red blood cell platform for immunomodulation, which facilitates the development of allogeneic cell therapy products and addresses the cost challenges associated with autologous cell therapies. Furthermore, leveraging this platform, we have actively established a product pipeline targeting solid tumors. The other platform is a non-viral gene delivery technology based on lipid nanoparticles (LNPs), which effectively overcomes the cost and technical limitations associated with adeno-associated virus (AAV) vectors.

Wu Lanlin:Overall, it is widely recognized that currently approved CAR-T products represent only version 1.0 within the cell and gene therapy (CGT) field, due to their high individualized costs and complex manufacturing processes. Therefore, significant technical breakthroughs remain to be achieved in current cell therapies, both in terms of cost control and the establishment of chemistry, manufacturing, and controls (CMC).

Technologically, Kemeixin leverages its engineered red blood cell technology platform and proprietary covalent linking technology to load various targets, enabling the development of products for different diseases. Its non-viral vector gene delivery technology platform elegantly circumvents challenges associated with AAV vectors, such as the inability to administer repeated doses and high production costs, thereby achieving a technological iteration over AAV vectors.

For the industry as a whole, with the successive introduction of policies such as the 2017 “Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial),” regulatory oversight of cell therapy in China has become increasingly clear. Risk control policies are being rapidly issued and iterated, covering stages from preclinical trials to subsequent clinical trials and post-market product management. As a globalized company, Kemengxin will swiftly integrate the most advanced regulatory frameworks from various countries and promote technological iteration within the industry through academic exchanges and other interactions, thereby accelerating the resolution of key industry pain points.

VB：Kemeixin was founded leveraging EVX Ventures’ extensive expertise in incubating international biopharmaceutical platform companies. As the two of you represent the incubator and the incubated enterprise, respectively, please share your perspectives on how EVX Ventures has supported the company’s development in various aspects.

Lin Xiangqian:From the perspective of EVX Ventures, “CAR-X” is one of our key incubated projects. As the founder of EVX Ventures, I was personally involved in the establishment of Comagen and in building its early-stage team.

Modeled after Flagship, the renowned incubator that has nurtured numerous Boston-based star companies, we are also committed to building an Asian, Chinese version of Flagship.To address the localized context in China, we need to implement suitable models. EVX Ventures leverages innovative platform-based technologies and a diversified platform model to develop novel drugs. Since its inception, all projects incubated by us have featured strong Chinese characteristics.

Wu Lanlin:From the perspective of portfolio companies, the strongest impression EVX Ventures leaves us with is one of profound reassurance. We have observed that many invested enterprises, lacking concrete operational experience in their early stages, often proceed by trial and error, which can lead to detours and unnecessary losses.

As a key incubation project of EVX Ventures, the “CAR-X” series marks the third company to be incubated.Although Kemexin, as a startup team, cannot be comprehensive in every aspect during its entrepreneurial journey,However, through internal resource integration within EVX Ventures, we are able to engage in learning and exchanges with two other “CAR-X” companies. Therefore, compared with other startups, Kemeixin has a more solid foundation and can draw on a wealth of successful experience.

VB：With the support of EVX Ventures, Kemeixin has achieved steady growth. To date, Kemeixin has established a “diversified platform” along with two technical platforms centered on engineered red blood cells for immunomodulation and non-viral vector gene delivery based on lipid nanoparticles. Please provide a brief overview of Kemeixin’s current platform model and technical platforms.

Wu Lanlin:The so-called diversified platform means that while Kemingxin’s scientists focus on pipeline development, other teams are dedicated to introducing new technologies and patents. We have also established teams to cover CMC establishment, production scale-up, talent development, regulatory submissions, and clinical development.

From the perspective of pharmaceutical company development, our process from “0” to “1” is robust. Furthermore, our pipeline portfolio is diversified.

Comedigen’s current two technology platforms are the engineered red blood cell platform for immune modulation and the non-viral vector gene delivery platform based on lipid nanoparticles.

First is the engineered red blood cell technology platform. Our initial R&D concept stemmed from the role of red blood cells in transporting oxygen within the bloodstream. We reasoned that if they can carry oxygen, they might also be capable of carrying many other substances. Moreover, red blood cells possess a mesh-like structure, which helps prevent deformation of the loaded therapeutic agents, thereby preserving their original properties. Additionally, due to this mesh-like architecture, various molecular structures can be loaded onto the “mesh pores” of red blood cells, offering high versatility and utility.

Rubius Therapeutics in the United States developed first-generation engineered red blood cells and identified certain limitations. For instance, as these cells are derived from stem cells, their source is restricted, resulting in high costs and prolonged manufacturing cycles. Furthermore, there remain numerous technical challenges in the production process that require optimization.

Building on the first-generation engineered red blood cells, Kemixin has developed the second-generation engineered red blood cells.

The cells used in second-generation engineered red blood cells are derived from healthy donors. Using a proprietary process developed by Kemeixin, patented enzymes are covalently linked to the cell membrane surface, followed by conjugation with various active agents, including proteins, peptides, antigens, and cytokines, thereby achieving drug delivery through systemic circulation.

Furthermore, given the abundant presence of red blood cells in the human body, they can theoretically be effectively utilized for the treatment of solid tumors. On the other hand, since the lifespan of red blood cells is 120 days, conjugating an effective protein to them would essentially create a long-acting protein therapeutic.

Currently, following process improvements by Kemoxin, the second-generation engineered red blood cells have achieved effective control over production cycles, costs, and other key parameters.

Next is the non-viral vector gene delivery technology platform based on lipid nanoparticles (LNPs). From an overall development perspective, as a transformative new technology, cell and gene therapy (CGT) faces certain challenges in the discovery of novel targets and their effective application.Optimizations in delivery systems could bring greater innovative and practical value to CGT technologies.

Comedixin is also actively positioning itself in this area. Since adeno-associated virus (AAV) vector delivery technology does not allow for repeated dosing and has limitations in scalable manufacturing and cost control, Comedixin employs lipid nanoparticle (LNP) delivery technology to overcome the constraints associated with AAV vector delivery.

Furthermore, the outbreak of the COVID-19 pandemic has led many vaccines to adopt lipid nanoparticles (LNPs) as a delivery technology, thereby accelerating the development of mRNA therapeutics. If nucleic acid-based drugs are the high-speed train of the next era of medicine, then LNP delivery technology is the locomotive driving this rapid advancement.

Kemexin’s LNP technology stems from the experience accumulated by companies previously incubated by EVX Ventures in the field of DNA-based therapeutics, soIn its future strategic layout for nucleic acid-based therapeutics, Kemeixin will prioritize the research and development of DNA drugs.

VB：What new strategic initiatives and future prospects can we anticipate, inspired by Kemexin’s platform model and technology?

Lin Xiangqian:We are eager to overcome the current bottlenecks in cell therapy for solid tumors and allogeneic cell therapy.Breakthroughs in next-generation cell and gene therapy (CGT) technologies are poised to emerge alongside advances in non-viral vector development, opening up vast and promising application landscapes. Nevertheless, developing new drugs and achieving technological iterations is no easy feat. We aim to collaborate with scientists and entrepreneurs across the industry to jointly drive sector-wide progress.

We aim to establish China as the hub of our accelerator, integrating resources from China with EVX Ventures’ global network to expedite the development of new drugs for patients worldwide.

VB：What is the current status of Kemexin’s project portfolio, partnerships, and other developmental initiatives?

Wu Lanlin:Kemexin leverages EVX Ventures to integrate resources and development advantages across different countries, demonstrating strong capabilities in driving translational efforts.Our current focus is primarily on the oncology sector, with two pipelines having already identified their respective first indications.

As Kemexin builds its foundation through fundamental technological accumulation and innovation, we prioritize not only speed but also the acquisition of numerous patents and the integration of emerging technologies. Currently, Kemexin has established collaborative partnerships with several overseas universities to accelerate technology development.

VB：In the CGT industry, upstream raw materials are a critical component in addressing cost issues and ensuring stable manufacturing processes for subsequent product development. As a global enterprise integrating laboratory, biopharmaceutical, and IVF equipment manufacturing, how does Mr. Lin Xiangqian, Chairman of ESCO, contribute to the development of Kemexin?

Lin Xiangqian:Currently, ESCO also has R&D and production centers in China. Therefore, as a startup, Kemeixin indeed possesses certain advantages in resource availability and cost efficiency for raw materials compared to other startups.To steer the CGT industry toward positive development in terms of materials and costs, we must integrate the upstream and downstream segments of the industrial chain. By leveraging continuous user feedback and our ongoing optimization efforts, we can achieve a mutually reinforcing cycle of improvement.

VB：What are the competitive advantages of Comagen as a startup? What is its most pressing need at present?

Wu Lanlin:As a diversified platform enterprise, Kemeixin leverages its “diversified platform” model as a key advantage, further strengthened by the rapid translation capabilities backed by EVX Ventures. Additionally, Kemeixin’s core founding team is diverse, with each member bringing successful experience in their respective fields, and many of the key personnel are seasoned entrepreneurs rather than first-time founders.

Under this premise, Kemexin believes thatOne success can replicate another.

Of course, as a startup, Kemeixin has needs in areas such as financing, team building, and industry networking. We also welcome institutions and talent to join Kemeixin in advancing the development of the CGT industry. Furthermore, as the company grows, its needs naturally evolve at each stage; for instance, the founding stage requires capital and talent, while the registration phase necessitates assistance from CRO companies. These are all inevitable steps for an entrepreneurial team.

VB：Finally, let’s discuss Kemeixin’s short-term goals and long-term vision.

Wu Lanlin:In the short term, as an experienced integrated team leveraging a diversified CGT industrial translation platform, Kemeixin aims to file its first Investigational New Drug (IND) application at the fastest possible pace. This milestone will demonstrate to investors and industry peers our determination to drive industrial translation and address key challenges within the sector.

In terms of long-term development, we aim to steadily and systematically launch a series of products through two core technology platforms, addressing specific diseases and benefiting particular patient populations. Meanwhile, we also hope to contribute more to industrial development by promoting scientific regulatory practices in the industry and tackling common challenges encountered in large-scale manufacturing.

We are not just a company; we are an integral part of society. Kemeixin is committed to fulfilling its corporate social responsibilities and jointly leading the development of the CGT industry.