Reistone Biopharma Secures Nearly $100 Million Series A Financing to Advance Four Phase III Clinical Programs

VCBeat News learned that on May 9, 2022, RemeGen Co., Ltd. (“RemeGen”) announced the completion of its nearly $100 million Series A financing round. The round was co-led by Huagai Capital’s healthcare fund and the Capital Health Industry Fund managed by Huagai Capital, with participation from Yunion Healthcare Ventures, Zhangjiang Haoheng, Zero2IPO Industrial Investment, and Hanne Capital. The proceeds from this financing will be used to advance RemeGen’s research and global clinical development of innovative drugs in the field of autoimmune and inflammatory diseases.

RuiShi Biopharma is dedicated to the development and commercialization of innovative drugs worldwide, emphasizing differentiation and uniqueness in its clinical product pipeline and clinical R&D. The company is committed to developing affordable innovative therapies for patients globally. Co-founded in early 2018 with a $100 million investment from Hengrui Medicine, RuiShi Biopharma has maintained a strategic focus on being rooted in China while embracing a global perspective. Since its establishment, the company has attracted top industry talent, deepening its expertise in novel drug discovery for immune-mediated inflammatory diseases, with a particular focus on autoimmune disorders affecting the digestive system, skin, and nervous system. Its global multi-center clinical trials and new drug development efforts are advancing in tandem. All four of the company’s investigational drugs are classified as Class I new drugs by the National Medical Products Administration (NMPA). Multiple clinical trials are currently underway, with four having advanced to Phase III. Additionally, several self-developed molecules have entered the preclinical research stage.

This marks RStone Biotherapeutics’ first external financing round, signifying that the company, together with its investors, is steering RStone toward independent market-oriented operations and ushering in a new era of rapid growth. Against the backdrop of significant volatility in the capital markets and intensifying competition within the pharmaceutical industry, this financing underscores investor recognition of RStone Biotherapeutics’ strategic layout and product advantages. Leveraging this opportunity, RStone Biotherapeutics will accelerate global clinical trials of its pipeline products while increasing investment in early-stage novel drug development, thereby facilitating the research, development, and multi-party collaborations for high-potential Best-in-class and First-in-class candidates.

Autoimmune diseases affect approximately 5%–8% of the global population, causing significant suffering for patients and representing a major global socioeconomic challenge. Autoimmune diseases already constitute the second-largest pharmaceutical market worldwide, after oncology; however, there is a substantial gap between China and the rest of the world in the development of drugs and diagnostics for autoimmune diseases. It is widely acknowledged by experts and scholars that diagnosis rates are low and that there is a shortage of both medical resources and medications. Due to the long-term impact on quality of life, patients with autoimmune diseases urgently need non-hormonal alternative therapies, which serves as the driving force behind RemeGen’s dedication to this field.

SHR0302, the flagship core product of Ruisi Biopharmaceuticals, is a next-generation highly selective and potent JAK1 inhibitor currently undergoing clinical trials in both oral and topical formulations to meet the diverse needs of patients with autoimmune diseases requiring long-term medication. Compared with pan-JAK inhibitors, SHR0302 offers higher selectivity and an improved safety profile relative to JAK2/3 inhibition; compared with biologics, it provides a more convenient and accessible oral or topical option for chronic disease patients on long-term therapy.

In January 2021, SHR0302 tablets were granted Breakthrough Therapy designation by the National Medical Products Administration (NMPA) for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older. Phase II clinical trials of SHR0302 tablets for three indications—atopic dermatitis, ulcerative colitis, and alopecia areata—have all met their clinical endpoints, and Phase III clinical trials are currently being fully conducted. Additionally, SHR0302 topical ointment, an innovative formulation for mild-to-moderate atopic dermatitis, has also entered Phase III clinical trials.

Another key product, SHR1459, is a novel, orally bioavailable, and potent BTK inhibitor with higher selectivity compared to similar drugs; as a specific BTK inhibitor, it has best-in-class potential. The company is currently conducting multiple Phase II clinical trials of SHR1459 for immune-inflammatory conditions.

In addition, RS1805 tablets, a gut-selective RORγt inhibitor, are the only investigational drug globally targeting this pathway for inflammatory bowel disease that has entered Phase II clinical trials.

Raistone Biologics’ new drug R&D laboratory was officially launched in August 2021. The company has established an international core team with extensive experience in innovative drug development, focusing on immunology and pursuing innovation through both independent R&D and external collaborations. Its early-stage R&D pipeline is strategically aligned with key mechanisms and pathways in autoimmune diseases, actively advancing more than a dozen immunoinflammatory small-molecule and antibody projects with the potential to be “best-in-class” or “first-in-class” globally. Several internally developed molecules have already entered the preclinical research stage.

The Company will continue to leverage its integrated R&D and clinical advantages in the field of autoimmune diseases, striving to become a globally leading biopharmaceutical company with a highly differentiated product pipeline, and to develop better, more numerous, and affordable innovative medicines for patients worldwide.

Sun Piaoyang, Chairman of Hengrui Medicine and Chairman of Ruisi Biopharma“He hengrui has always adhered to its mission, continuously developing more new and high-quality medicines through innovations in products, technologies, and business models to benefit patients. The external financing of Ruisi Biotech represents a beneficial exploration by Hengrui in terms of model innovation. Ruisi Biotech is an outstanding representative of the enterprises invested and incubated by Hengrui, and its management team is highly capable with strong execution. We hope that the Ruisi team will remain true to its original aspirations, forge ahead, and contribute to the cause of human health.”

Dr. Min Wang, CEO and Co-Founder of RStone BiotherapeuticsHe stated, “We are deeply honored to have received recognition and support from renowned investment institutions such as Huagai Capital in this round of financing. This marks Ruishi Biologics’ first external fundraising effort and represents a significant milestone in the company’s development. Since its inception in early 2018, Ruishi Biologics has remained focused on the field of autoimmune and inflammatory diseases. Over the past four years, we have progressed steadily, achieving substantial advances in multiple clinical indications for our product pipeline. Moving forward, we will work hand in hand with our investors to accelerate the R&D and commercialization of innovative immunology therapies through independent research and development as well as external collaborations, thereby benefiting patients and giving back to society. With a global perspective, we aim to establish Ruishi Biologics as a leading enterprise in China’s autoimmune treatment sector and strive to improve the health of patients worldwide.”

Xu Xiaolin, Chairman and Founding Partner of Huagai Capitalstated: “Raistone Biopharma is a leader in the research and development of novel therapeutics for autoimmune and inflammatory diseases in China, boasting a leading product pipeline and rapid growth, with distinct advantages in both clinical development and commercialization. As a professional investment institution deeply rooted in the healthcare industry, Huagai Capital looks forward to creating strategic synergies with Raistone Biopharma to advance its R&D of new drugs for autoimmune and inflammatory diseases, thereby benefiting a broad patient population.”

Zeng Zhiqiang, Managing Partner of Huagai Medical Fundstated, “First, congratulations to Ruisi Biopharma on successfully completing its financing against the current market trend. We are pleased to lead this round of financing and have full confidence in the company. We hope that this investment will support the company’s growth into a globally competitive innovative drug developer.” Zhu Jingyang, Deputy Investment Director at Huagai Medical Fund, stated, “There is a significant unmet clinical need for autoimmune and inflammatory diseases both in China and globally. Huagai Capital is optimistic about the founding team’s long-term expertise in this field and believes that Ruisi Biopharma will accelerate the clinical development and commercialization of its product pipeline in the future.”

Huagai Capital, established in 2012, is a private equity investment firm co-founded by professionals from renowned domestic and international investment institutions. With the vision of “becoming the most trusted capital partner for entrepreneurs and investors,” the company focuses on private equity investments in the healthcare and technology sectors, committed to fostering the growth of small and medium-sized enterprises into industry leaders. Currently, the firm manages approximately RMB 20 billion in assets, with 22 of its portfolio companies successfully listed.

The Capital Health Industry Fund is an equity investment fund with an expected fundraising scale of approximately RMB 3 billion. Its cornerstone investors include Heyin Investment, Yizhuang State-owned Capital Operation Co., Ltd., JD.com Group, Qi-An-Xin Technology, Joinn Laboratories, Beilu Pharmaceutical, and other listed companies in the medical industry as well as professional institutions. Huagai Capital serves as the fund manager. Rooted in Beijing and extending its reach across China, the Capital Health Industry Fund seeks healthcare enterprises with sustained innovation capabilities, focusing on investment opportunities in “Specialized, Refined, Differential, and Innovative” (SRDI) enterprises. It will engage in PIPE investments, mergers and acquisitions for industrial chain integration, incubation and spin-offs of innovative technologies for listed companies, thereby building a competitive ecosystem of leading medical innovation enterprises centered around listed companies.

Yunion Healthcare Ventures was established in early 2019, with its cornerstone investors hailing from leading pharmaceutical companies in the industry. Research-driven, the fund deeply explores global investment opportunities in cutting-edge innovative drugs, medical technologies, and devices. It co-incubates companies alongside top scientists, physicians, and clinical translation teams to address the challenge of achieving original innovation from 0 to 1.

Zhangjiang Haoheng is an equity investment management company initiated and established by Zhangjiang High-Tech (600895.SH) in 2019. With a Phase I fund size of RMB 2 billion, it focuses on technological innovation enterprises in fields such as integrated circuits, biopharmaceuticals and medical devices, next-generation information technology, and intelligent manufacturing. Rooted in the core industries of Zhangjiang Science City, the company concentrates on “hard tech” sectors and leverages capital to support technological innovation. Meanwhile, by drawing on Zhangjiang High-Tech’s rich industrial ecosystem and integrating various innovation elements and resources, it provides diversified support and services to enterprises, including spatial products, talent acquisition, and policy assistance.

Zero2IPO Industrial Investment, established in 2012 and affiliated with the Zero2IPO Group, specializes in providing strategic industrial layout and medium-to-long-term asset management and investment services to listed companies, family enterprises, and local governments.

Leveraging Zero2IPO Group’s in-depth understanding of China’s private equity industry and its comprehensive suite of services—including research, conferences, consulting, and investment—Zero2IPO Industrial Investment employs an active management approach to unlock enterprise and market value through direct investments and strategic allocations to top-tier sub-funds, thereby realizing the philosophy of value investing.

Zero2IPO Industrial Investment has established strategic industrial funds in collaboration with multiple listed companies, such as Pien Tze Huang, Lingnan Landscape, and Yaoji Technology. It also manages dozens of family funds and nearly ten local industrial funds. Currently, the assets under management (AUM) of Zero2IPO Industrial Investment exceed RMB 20 billion. More than just a financial investor, Zero2IPO Industrial Investment leverages its industrial resources to assist enterprises with strategic planning and resource integration, accelerating their growth while driving local industrial development. This approach creates a win-win scenario for listed companies, portfolio companies, funds, and local governments.

Hanne Capital was established in early 2017 as a specialized private equity fund focused on early- and growth-stage investments in the healthcare sector within Greater China. The founding partners have served for many years as core executives at industry-leading private equity funds or renowned multinational pharmaceutical and medical device companies, achieving milestone accomplishments in the field. The investment team comprises professionals with extensive investment experience and keen business acumen. We uphold high standards of professional ethics and a strong commitment to professionalism.