Rhegen Bio Secures RMB 100 Million Pre-B Financing Round; Chairman Dr. Hu Yong Highlights mRNA Platform Innovation and Global Ambitions

VCBeat has learned that Shenzhen RHGEN Biotechnology Co., Ltd. (“RHGEN”) has completed a Pre-B financing round worth hundreds of millions of yuan. The round was led by existing shareholder Shenzhen Qianhai Richsource Investment Management Co., Ltd., with all other existing shareholders, including HongShan, continuing to participate in the follow-on investment.This marks RHGEN’s second fundraising round amid the current capital winter. Reportedly, the proceeds from this round will be primarily used to advance clinical trials of the company’s pipeline candidates and to support industrialization efforts.

RHGEN is a biotechnology company with globally leading mRNA technology. Headquartered in Shenzhen, the company has established R&D, production, and clinical registration centers in Wuhan and Shanghai, and is one of the few national high-tech enterprises specializing in mRNA. With independent global intellectual property rights for core mRNA technologies, RHGEN has evolved over several years into a vertically integrated drug development enterprise characterized by technological innovation and self-controllability. It is capable of designing and developing competitive mRNA vaccines and therapeutic drugs based on clinical and druggability requirements.

Over the past two years, mRNA technology has gained widespread recognition due to its application in COVID-19 vaccines, leading to a surge of mRNA startups in China. Among these companies, RHGEN (Shenzhen Ruiji Biotechnology Co., Ltd.) has achieved rapid growth and established a unique, fully integrated industrial chain layout. It is one of the few companies globally that holds independent intellectual property rights for comprehensive mRNA-related technologies. Its developed product, RH109, is the world’s first lyophilized mRNA vaccine against SARS-CoV-2 (Omicron variant) and has received clinical trial approvals in multiple regions both domestically and internationally. Furthermore, research data related to RH109 have been officially published in the journal Cell Discovery (Impact Factor: 38).

How Did This Young Biotech Company Achieve Rapid Growth? Recently, VCBeat New Medicine spoke with Dr. Hu Yong, Chairman of RHGEN.

Dr. Hu Yong, Chairman of RHGEN, first encountered mRNA in 2012. At that time, he had just earned his Ph.D. from the College of Life Sciences at Wuhan University and went to Harvard University in the United States to conduct postdoctoral research. In the laboratory of Martin Yarmush, a member of the U.S. National Academy of Engineering and a renowned expert in translational medicine, he began developing mRNA-based therapeutic drugs and researching the underlying technologies.

In 2019, Hu Yong, already a Principal Investigator (PI) and doctoral supervisor at the Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, decided to embark on an entrepreneurial venture. At that time, the COVID-19 pandemic had not yet swept across the globe, and mRNA technology was still an emerging field worldwide, with relatively low levels of maturity in both China and the United States.

The concept of mRNA has been around for a long time. However, prior to the pandemic, mRNA technology failed to attract significant attention due to its insufficient stability and high costs. The COVID-19 pandemic greatly accelerated the industrialization of the mRNA sector. In other words, before the pandemic, the mRNA field abroad was also confined to the stages of research and development and clinical trials, resulting in a relatively small gap between domestic and international capabilities. After the pathway for mRNA vaccine industrialization was successfully established internationally in 2020, Chinese companies flourished and continuously increased their investments.

“From a broader perspective, in several other Chinese industries, ranging from mobile internet to new energy vehicles, domestic companies have generally established themselves in the local market and cultivated a cohort of corresponding enterprises for nearly every sector where the U.S. has a presence. In the biopharmaceutical sector, there is not yet a generational gap between China and abroad in mRNA technology; rather, it remains in a catch-up phase. If companies can achieve independent control over foundational technologies, I believe that domestic mRNA firms will inevitably emerge and participate in international competition,” said Hu Yong.

Since its inception, RHGEN has been developing dozens of pipelines across three major R&D areas, covering infectious disease vaccines, tumor immunotherapy, and protein replacement therapy. Notably, since June 2022, RH109, the world’s first freeze-dried COVID-19 mRNA vaccine (Omicron variant) led by RHGEN, has received clinical trial approvals in the Philippines, New Zealand, and Hong Kong, China. Shortly thereafter, this vaccine was selected for specialized clinical studies in China.

RH109 utilizes RHGEN’s proprietary lyophilized LNP technology to effectively preserve the physicochemical properties and biological activity of mRNA, enabling long-term storage at 2–8°C. This addresses the industry-wide challenges of poor stability and difficulties in storage and transportation that have previously plagued mRNA vaccines.

This product marks the first milestone in RHGEN’s development strategy. By late 2021, as the Omicron variant had already begun to spread widely in Europe and the United States, the company decided to suspend its clinical trial application for an mRNA vaccine targeting the Delta variant and instead focus on developing a new vaccine against the Omicron variant. The development of lyophilized mRNA vaccines is technically challenging and time-consuming, requiring substantial scientific expertise and R&D investment. Leveraging RHGEN’s platform capabilities and manufacturing infrastructure established at its inception, the company rapidly achieved iterative updates of its COVID-19 mRNA vaccine.

However, the decisive factor in the mRNA sector does not lie in COVID-19 vaccines.

Compared with other technology platforms, mRNA vaccines feature a short R&D cycle and the advantage of rapidly responding to viral mutations. With the progression of the COVID-19 pandemic, the international development of combination vaccines against pan-respiratory viruses, including SARS-CoV-2, influenza, and respiratory syncytial virus (RSV), has become a new direction in mRNA vaccine development. Foreign industry giants such as Moderna and BioNTech have taken the lead in laying out their pipelines for combination vaccines targeting respiratory viruses.

“The WTO has conditionally waived intellectual property rights for COVID-19 mRNA vaccines in the coming years, allowing companies to develop COVID-19 vaccine products by following established international pathways, regardless of whether they possess underlying mRNA technology,” said Dr. Hu Yong. “However, for product pipelines beyond COVID-19—whether infectious disease vaccines, tumor immunotherapies, or protein replacement therapies—patent issues are inevitably involved. Patents are a critical factor in the industrialization of mRNA technology. Globally, mRNA-related patents have shown a continuous upward trend alongside industry development. In 2022, prominent companies such as Alnylam, Moderna, and Pfizer/BioNTech initiated patent litigations centered on mRNA technology patents. This signals that Chinese mRNA enterprises must directly address patent challenges during their industrialization process. As innovative drug R&D companies, it is essential to build their own patent portfolios in the future to better compete in the global market during international expansion.”

Underlying mRNA technologies are critical to drug development. After decades of advancement, Western countries have established substantial patent barriers in this field. RHGEN has accumulated over 130 patents, covering various foundational technology areas in mRNA drug R&D. The company’s R&D platform simultaneously supports product development across infectious disease vaccines, cancer immunotherapy, and protein replacement therapies.

The outstanding performance of mRNA vaccines during the pandemic has attracted significant capital attention, while also driving growth in financing across the broader niche sector. In 2021, there were 29 investment and financing events in China’s nucleic acid drug field. Amid the chilly biotech landscape, mRNA can be described as a “hotbed” of activity.

In China, mRNA companies were once “ubiquitous.” In contrast, RHGEN chose a growth path aligned with its own development strategy: pursuing vertical integration in technology to advance its product pipeline independently, and adopting a “small steps, fast pace” approach to financing tailored to its developmental needs, thereby ensuring the company’s healthy and orderly growth.

The research, development, and manufacturing processes for mRNA-based therapeutics are relatively complex, exhibiting the characteristics of typical complex engineering systems. While mRNA companies often seek to rapidly advance to Investigational New Drug (IND) applications and expedite market entry, frequently opting for outsourcing or partial outsourcing of related activities, collaboration with CROs and CDMOs has become a common model in the industry. However, RHGEN prefers to keep more critical operations in-house.

“Many of RHGEN’s technology platforms are independently developed,” introduced Dr. Hu Yong. “For instance, regarding the core upstream raw and auxiliary materials for mRNA, RHGEN has not only resolved intellectual property issues related to these materials but also achieved self-sufficiency to meet its own corporate needs.”

The most valuable segment of the mRNA vaccine industry chain lies in core raw and auxiliary materials, such as enzymes and non-natural nucleosides. It is estimated that 1 billion doses of mRNA vaccines can drive nearly RMB 10 billion in demand for these core materials. Raw and auxiliary materials account for more than 50% of the total production cost of vaccines. Within China’s domestic mRNA industry chain, many companies have only recently achieved mature industrialization in specific segments. In other production and preparation stages, most are either still in the phase of overcoming technical challenges or remain heavily reliant on imports.

Dr. Hu Yong pointed out that the company established the development philosophy of “beginning with the end in mind” from its inception: “RHGEN aims to build a vertically integrated drug R&D system, which covers not only delivery systems but also molecular design, sequence algorithms, modification strategies, and synthesis processes—all of which we have strategically laid out.”

“We can establish a closed-loop technology system internally. Meanwhile, for platform-based enterprises, building in-house teams also enables effective cost control. In the future, competitive advantage in the market will depend on value creation through mature commercialized products, which invariably relies on foundational technological innovation. This is RHGEN’s perspective,” said Hu Yong.

According to Dr. Hu Yong, RHGEN has established capabilities spanning from drug target discovery to clinical research. In 2022, RHGEN was recognized as a National High-Tech Enterprise. The company’s next stage of development aims to build relevant industrialization capabilities while advancing the clinical research of multiple pipeline candidates.

As a next-generation biotech company, RHGEN will continue to strengthen its strategic layout both domestically and internationally, attract top talent from home and abroad, and advance industrial collaborations, with the aim of becoming an innovative drug R&D enterprise with global competitiveness.