
mRNA Drug R&D and Manufacturing Company

Pharmaceutical R&D Developer
With its flexible modular design and adaptability to a variety of diseases,mRNA technology has rapidly expanded from the traditional vaccine track to multiple fields, including cancer therapy, metabolic diseases, and gene editing, with the global industry scale continuing to expand.Precedence Research predicts that the global mRNA therapeutics market size will reach $42.64 billion by 2034.
Yet beneath the industry’s fervor, structural weaknesses are becoming increasingly pronounced:Most domestic companies focus on following popular targets for development, with very few deeply cultivating core underlying technologies such as LNP vectors, original sequences, and mass production processes. Issues like homogenization of underlying technologies, patent restrictions, and insufficient process stability have long trapped the domestic mRNA sector in intense internal competition, making it difficult for companies to enter high-value therapeutic areas. The logic of industry competition is shifting from a mere comparison of pipeline quantities to a comprehensive contest of underlying technological strength and clinical implementation capabilities.
Against this backdrop, WestGene Biopharma (hereinafter referred to as “WestGene”), an innovative enterprise incubated through the commercialization of scientific and technological achievements from the State Key Laboratory of Biotherapy at West China Hospital, Sichuan University, has long been dedicated to the independent research and development of foundational nanodelivery technologies. By focusing on unmet critical clinical needs worldwide, the company has established a fully integrated, autonomous, and controllable mRNA technology platform, thereby carving out a distinct path of differentiated innovation.
Recently, two research achievements from West Gene were successfully selected for the 2026 ASCO Annual Meeting. Among them, the in vivo CAR-T therapy WGb-0301 was selected for a Rapid Oral presentation, and the study on the EBV-associated tumor therapeutic mRNA vaccine WGc-043 combined with PD-1 antibody for the treatment of lymphoma was selected for Poster presentation.
On June 9, one week later, West Gene entered into a collaboration with Cartesian Therapeutics, a pharmaceutical company listed on the Nasdaq. Under the agreement, Cartesian will advance the development of novel in vivo CAR-T therapies for autoimmune diseases based on West Gene’s proprietary tLNP delivery platform; West Gene will receive an upfront payment and is eligible for potential development and commercial milestone payments.
Two major achievements selected for ASCO, and a business development deal reached with Cartesian, a leading company in the mRNA CAR-T field. West Gene’s innovative strength and international influence in mRNA drugs, LNP delivery, and next-generation cell therapy are gradually being unleashed. VCBeat, as an observer of the medical industry,Exclusive Interview with Professor Song Xiangrong, Founder and General Manager of WestGene: An In-Depth Analysis of the Industrialization Challenges, Core Technological Breakthroughs, and Long-Term Strategic Layout of China’s mRNA Technology
Deeply Cultivating the Industry for Nearly 20 Years, Conquering Two Major “Chokehold” Challenges
With nearly two decades of dedicated expertise in pharmaceutics and the translational research of nanodelivery systems, Song Xiangrong has consistently focused on addressing the critical “last mile” challenges in new drug development. He specializes in core areas such as formulation optimization, innovative delivery routes, and scalable mass production, striving to bridge the gap between basic scientific research and clinical application.
In 2013, China’s mRNA industry was virtually nonexistent. Song Xiangrong’s team took the lead in initiating independent research and development of lipid nanoparticle (LNP) nanodelivery vectors. At that time, high-end pharmaceutical excipients and nanocarriers in China were largely dependent on imports, and a mature industrialization system had yet to be established. Moreover, the barriers to commercializing original nanocarriers were extremely high, with comprehensive safety evaluations and large-animal validation requiring substantial R&D investment.
Song Xiangrong recalled, “Our team developed a COVID-19 mRNA-LNP vaccine utilizing ionizable lipids with a novel structure; we invested over RMB 8 million solely in the safety evaluation of these ionizable lipids. The high R&D costs and stringent validation standards have caused most cutting-edge technologies from Chinese universities to stall at the preclinical stage, failing to achieve clinical translation.”
To obtain real-world human safety data for the team’s self-developed ionizable lipids and vaccines, Song Xiangrong voluntarily waived his right to receive the national inactivated vaccine during the COVID-19 pandemic and chose to become the first subject in the clinical trial.
She explained, “Once a commercially available inactivated vaccine is administered, the resulting immune response would interfere with the trial outcomes, making it impossible to accurately distinguish the true safety and tolerability of our proprietary vector. Therefore, I have reserved myself as the first subject in the clinical trial who has not previously received any COVID-19 vaccine.”
Song Xiangrong remarked with a smile, “I have a deep impression of testing the new carrier materials and vaccines I developed myself, and the vaccination outcomes were quite satisfactory.”
Beyond safety, the large-scale mass production of nano-formulations represents another core barrier constraining the development of such novel technologies.To address the shortcomings of traditional aluminum adjuvants, namely their low immunogenic efficiency and limited applicability, WestGene has developed a novel nano-adjuvant, WGa-01, which can increase antibody titers by 10- to 100-fold compared to traditional aluminum adjuvants. However, the unique microscopic properties of nanomaterials make process scale-up highly susceptible to parameter fluctuations and particle heterogeneity, posing significant challenges for mass production.
To bridge the industrialization chain,Song Xiangrong led a team to be stationed at the production frontline in the factory for over a month,Fine-tuning process parameters at each stage and addressing production challenges to ultimately achieve stable, large-scale manufacturing of nano-adjuvants.WestGene has accumulated rare industry capabilities for the industrialization and commercialization of nanomedicines.
Reflecting on these experiences, Song Xiangrong remarked, “Our entrepreneurial journey was driven by necessity. As nano-delivery and mRNA technologies belong to the frontier of innovation, few companies in China were previously willing to undertake the translation and commercialization of such technologies. It is not just our team; many domestic research teams possess highly valuable cutting-edge technologies, yet most are stalled at the preclinical stage due to bottlenecks in safety and toxicity assessments as well as process scale-up for manufacturing. These represent two core challenges in the fields of delivery technology and new drug development: safety evaluation and process scale-up.”
Leveraging Sichuan University and West China Hospital’s comprehensive entrepreneurship policies, clear technology ownership mechanisms, and capital market support for original innovation, Song Xiangrong and Academician Wei Yuquan co-founded WestGene in 2021. The company aims to translate its independently developed nanodelivery and mRNA technologies into clinical applications to benefit patients, systematically advancing the collaborative innovation driven by the deep integration of “academia, research, medicine, and industry.”
Building an Independent, End-to-End mRNA and LNP Platform to Break Overseas Patent Monopolies
The core competition in the global mRNA industry is, in essence, a contest of foundational technologies and patent systems. Leveraging long-term technological iteration, overseas giants have established formidable patent barriers around lipid nanoparticle (LNP) vectors and sequence modifications. Most domestic companies rely on mature overseas technological frameworks to build their pipelines, which not only poses patent risks but also limits technical performance within the confines of foreign systems, making it difficult to adapt to differentiated clinical scenarios.
In Song Xiangrong’s view, for domestically produced mRNA to break free from homogenized involution, merely competing on short-term pipeline layouts offers no core advantage. Long-term accumulation of foundational technologies and an autonomous, controllable technical system are the core barriers that enable enterprises to navigate industry cycles.
West Gene has established a domestically scarce platform for foundational mRNA technology and LNP-targeted delivery, with a cumulative portfolio of over 90 patents. Granted patents cover major global markets including China, the United States, Europe, and Japan. Professional FTO (Freedom to Operate) searches conducted by US law firms have verified that the technology is fully independent and controllable, fundamentally resolving patent risks for Chinese mRNA enterprises.
Among these, the clinically validated proprietary LNP delivery platform is the core lifeline of mRNA therapeutics and constitutes WestGene’s core competitive advantage in technological differentiation.West Gene has established a full-chain technology platform encompassing ionizable lipid design based on proprietary AI algorithms, mRNA sequence optimization, formulation processes, and GMP manufacturing. The company has obtained approvals for seven Phase I and II clinical trials from regulatory authorities including China’s Center for Drug Evaluation (CDE) and the U.S. Food and Drug Administration (FDA), accumulating data from hundreds of patients that demonstrate favorable safety and tolerability profiles.
Furthermore, West Gene possesses a clinically validated tLNP/in vivo CAR-T platform.Leveraging this tLNP platform, CAR-T cells can be generated directly in patients via intravenous injection of mRNA for the treatment of tumors and autoimmune diseases, thereby disrupting the complex traditional process of ex vivo CAR-T preparation. Currently, West Gene’s in vivo CAR-T pipelines targeting CD19, CD20, and BCMA have all entered clinical trials, and its in vivo dual-target CAR-T project against CD19/BCMA is also poised to enter the clinical stage.
Leveraging a robust underlying technology platform, West Gene has built a pipeline of more than 20 high-value product candidates, covering areas such as oncology,in vivo CAR-T, obesity, aging, autoimmune diseases, gene editing, and other fields.
In terms of production capacity layout, WestGene has established GMP-compliant manufacturing facilities, possessing integrated development and large-scale production capabilities ranging from targeted antibodies, plasmids, and mRNA bulk drug substances to LNP formulations, thereby meeting the demands of clinical research.
Multiple "World's First" Blockbuster Products Target Clinically Essential Therapeutic Areas
Currently, China’s mRNA sector is in a transitional phase from concentrated exploration to diversified development. Amid the dynamically evolving industry landscape, Song Xiangrong has consistently adhered to the core R&D principle that “technological boundaries determine pipeline strategy.” He notes, “Compared with the substantial financial strength and mature industrial accumulation of overseas giants, domestic innovative pharmaceutical companies lack advantages in direct competition. Only by leveraging proprietary foundational technologies, targeting unmet global clinical needs, and building pipelines with high barriers and high value can they achieve differentiated breakthroughs.”
Based on this approach, WestGene constructed“Short-term Monetization, Mid-term Breakthroughs, Long-term Exploration”three-tier pipeline matrix. Clear division of labor across stages with seamless integration, balancing short-term cash flow stability, mid-term clinical breakthroughs, and long-term technological iteration to build a sustainable path for innovative development.
West Gene focuses on short-term monetization of technologies and the commercialization of mature products to solidify its operational foundation.Leveraging its clinically validated technology platform, West Gene prioritizes the advancement of technologies and products that can be rapidly commercialized to generate revenue, thereby establishing a dual-track development model of “in-house pipeline + technology licensing” to provide stable cash flow support for corporate R&D.
Regarding mature products,Its independently developed novel nano-adjuvant, WGa-01, has received Emergency Use Authorization (EUA), enabling the product’s commercial launch and practical application.In terms of technology licensing,West Gene, leveraging its LNP platform, has successively secured business development (BD) partnerships with domestic and international enterprises such as BGI FireEye Engineering and Cartesian Therapeutics. These ongoing BD collaborations and product commercialization efforts provide a stable cash flow to support the company’s cutting-edge R&D.
At the midline level, West Gene focuses on several innovative pipelines to achieve differentiated clinical breakthroughs.Leveraging a fully self-developed, end-to-end technological foundation, the company is prioritizing the advancement of its core pipeline characterized by high barriers to entry and significant clinical value, aiming to achieve mid-stage clinical milestones and commercialization, thereby establishing it as the primary engine for corporate growth.
Among these, the core pipeline candidate WGc-043 is the world’s first mRNA therapeutic vaccine for EBV-associated tumors to have its Investigational New Drug (IND) application approved by both the Chinese and U.S. regulatory authorities.Providing a globally pioneering, precision immunotherapy regimen for patients with end-stage tumors associated with Epstein-Barr virus, such as nasopharyngeal carcinoma and NK/T-cell lymphoma.
Clinical data demonstrate that WGc-043 exhibits an excellent safety profile, with over two-thirds of patients developing EBV antigen-specific immune responses post-treatment, resulting in outstanding disease control. Compared to traditional cell therapies and targeted drugs, this vaccine offers additional advantages, including a shorter manufacturing cycle, scalability for mass production, convenient intramuscular administration, and a high safety margin. Currently, WGc-043 has been launched at the Boao Lecheng International Medical Tourism Pilot Zone in Hainan for real-world studies, paving the way for subsequent conditional approval and accelerated commercialization.
Another core pipeline candidate, WGc-0201, is the world’s first mRNA therapeutic vaccine developed for HBV.This pipeline targets key oncogenic factors of HBV, inducing a dual immune response against both the HBV virus itself and HBV-driven liver cancer, thereby disrupting immune escape in virus-driven tumors at their source. Currently, WGc-0201 has received clinical trial approvals in both China and the United States and is in global clinical development.
WGb-0301, an in vivo CAR-T pipeline prominently disclosed at this year’s ASCO Annual Meeting,This represents another tangible outcome of West Gene’s foundational technological prowess, addressing multiple industry shortcomings associated with traditional CAR-T therapies. According to the first-in-human study data disclosed at this year’s ASCO, WGb-0301 has demonstrated favorable safety profiles and preliminary signs of efficacy in patients with relapsed/refractory B-cell lymphoma:
All patients exhibited rapid induction of CAR expression within 4–6 hours post-administration, achieving profound B-cell depletion, with CAR positivity rates reaching up to 100%. One patient achieved complete remission (CR). Furthermore, up to 10 safe repeat administrations were successfully performed, setting a new global public record. The overall tolerability was favorable; all treatment-related adverse events were Grade 1–2, with no Grade 3 or higher severe adverse reactions reported.
Following the conclusion of the on-site reports at ASCO, multiple overseas companies immediately engaged WestGene in business development discussions. One week later, on June 9, Nasdaq-listed pharmaceutical company Cartesian Therapeutics announced a collaboration with WestGene.Under the agreement, Cartesian will advance the development of novel in vivo CAR-T therapies for autoimmune diseases based on West Gene’s proprietary tLNP delivery platform, and West Gene will receive an upfront payment as well as subsequent development and commercialization milestone payments.
In terms of long-term strategic layout, West Gene focuses on frontier blue-ocean sectors to continuously build up corporate innovation momentum.Leveraging the strong scalability of its underlying technology, West Gene has moved beyond the conventional tracks of oncology and hepatology to proactively enter blue-ocean fields such as obesity and aging, thereby avoiding homogeneous competition within the industry. Currently, its obesity pipeline has completed proof-of-concept studies in mice, with subsequent clinical development to be advanced through a co-development model. This strategy aims to continuously explore the expansion potential of its core technology, securing growth momentum for the company’s long-term development.
Dual-Engine Drive: Proprietary Pipeline and Platform Empowerment Accelerate Global Expansion
Looking ahead, Song Xiangrong believes that West Gene’s development vision extends beyond the launch and commercialization of multiple innovative drugs; it lies in the continuous iteration of core foundational technologies such as delivery systems, sequence design, and mass production, with the aim of refining a safe, efficient, scalable, and versatile domestically produced mRNA technology platform to support the high-quality development of the global mRNA industry.
Aligning with current industry development trends and corporate strategic objectives, West Gene has innovatively established a dual-track development model of “self-operated pipeline + platform empowerment.” Song Xiangrong likened this approach to JD.com’s business model, stating, “The operational logic of this model is very similar to JD.com’s development pattern.”
West Gene centers its self-operated business on its proprietary pipeline, continuously validating the safety, efficacy, and scalability of its platform technology through clinical data from first-in-class candidates such as EBV therapeutic cancer vaccines, HBV-related hepatocellular carcinoma therapeutic vaccines, and in vivo CAR-T therapies. Simultaneously, by opening its underlying technology platform for patent licensing and joint development, the company monetizes its technology to generate cash flow, which in turn fuels the R&D of its frontier pipeline, thereby establishing a sustainable industrial closed loop.
Building on this foundation, WestGene is steadily advancing its three core strategic initiatives at the current stage: strengthening its high-end talent pipeline by recruiting senior industry partners and professional operational experts to enhance the commercialization capabilities of its R&D and entrepreneurial teams; bolstering its financial reserves through specialized financing to ensure the clinical progression of core pipelines and continuous technological iteration; and accelerating its global industrial layout by leveraging business development (BD) transactions and risk-sharing joint development models to propel domestically developed original technologies and innovative pipelines into the international market.
From a decade of deep commitment to overcoming “chokehold” challenges in nanodelivery technologies and personally testing drugs to uphold the original mission of a pharmaceutical enterprise, to building a fully independent, end-to-end mRNA technology platform and developing multiple first-in-global pipelines, and finally to expanding overseas into international markets, WestGene’s growth trajectory is a true microcosm of China’s biopharmaceutical industry transitioning from “importation and imitation” to “independent innovation.”
Amid the mRNA industry wave, WestGene will continue to leverage its advantages in integrating medicine and research, focus on critical clinical needs, refine core technologies, and support the high-quality development of the global biopharmaceutical industry with hard-core domestic innovation, writing a new chapter in the global breakthrough of Chinese mRNA enterprises.