Recently, Nanjing RegeneCore Biotech Co., Ltd. issued a recruitment notice for patients with moderate to severe asthma, drawing widespread attention. It turns out that RC1416 injection—China's first domestically developed autoimmune bispecific nanobody drug independently researched by RegeneCore—is currently undergoing clinical trials at dozens of renowned hospitals nationwide. Demonstrating significant advantages in efficacy, safety, and druggability, this bispecific antibody therapy holds promise as a breakthrough treatment for patients suffering from moderate to severe asthma.

While YOUNGY GROUP is widely recognized for its achievements in the new energy sector, the conglomerate has quietly positioned itself as a pioneer in the emerging blue ocean of life sciences. Nanjing RegeneCore, a subsidiary under YOUNGY GROUP, stands as a leading innovative high-tech enterprise in China's nanobody pharmaceuticals field. Since its establishment, the company has dedicated itself to R&D of nanobody-based biologic drugs, embodying Chairman Lv Xiangyang's corporate philosophy: Technological innovation is the core engine driving enterprise growth.

YOUNGY GROUP: Pioneering the Blue Ocean and Leading the Charge in Biomedical Innovation

In 1989, Belgian scientists serendipitously discovered a novel antibody in the blood of camelidae, ushering in a new era of antibody research. This antibody, now known as the nanobody, is the smallest antibody obtainable through genetic engineering, measuring just nanometers in length. Compared to conventional antibodies, nanobodies possess distinct advantages due to their minute size. In clinical diagnostics and therapeutics, nanobody drugs can rapidly capture viral antigens and efficiently block pathogen transmission. For currently incurable autoimmune diseases such as psoriasis, lupus erythematosus, and rheumatoid arthritis, nanobody therapeutics are expected to demonstrate even greater efficacy. In oncology, nanobody drugs are also considered "high-potential candidates" due to their enhanced permeability into tumor tissues.

From the perspective of the pharmaceutical industry, the global market size of antibodies reached 236.86 billion US dollars last year. When it comes to the bispecific antibody field, the current market size exceeds 11 billion US dollars, and it is expected to exceed 190 billion US dollars by 2033. Although the market size of nanobodies is currently only several billion US dollars, because nanobodies and bispecific antibodies have strong complementary advantages, bispecific nanobodies have become a research hotspot. With the increasing global demand for innovative drugs, bispecific nanobodies, as a new form of antibody drugs, have great market potential.

Driven by the mission of benefiting human health and recognizing the promising market prospects, Chairman Lv Xiangyang, with his unique entrepreneurial vision and foresight, established Nanjing RegeneCore Biotech Co., Ltd. in 2017. This marked the beginning of a technological innovation journey beyond traditional industries. Despite China's relatively late start compared to international counterparts, RegeneCore is among the first domestic R&D institutions in the nanobody field, achieving an early lead and continuous innovation. As a pioneer, RegeneCore not only enjoys first-mover advantages but also has sufficient time for independent innovation, building momentum for future breakthroughs.

　　RegeneCore is located at the foot of Longwang Mountain in the Nanjing Jiangbei New Area Biomedical Valley, a national-level development zone.

Wang Yang, General Manager of Nanjing RegeneCore, stated that the global research and development of bispecific nanobody drugs is still in its early stages. Many multinational pharmaceutical companies are utilizing nanobody technology as one of their drug development platforms, with only four nanobody-based drugs currently approved for market globally. In the long run, nanobodies are increasingly favored by the new drug R&D industry due to their unique advantages. Previously, major international pharmaceutical giants have expressed strong interest in the nanobodies developed by RegeneCore and proposed acquisitions.

At present, the global market for nanobody drugs continues to expand, with projections indicating sustained high growth in the coming years. This trend will provide RegeneCore with ample room for development and significant market opportunities.

Connecting to Rich Harvests: Two Nanobodies Approved for Clinical Trials in China and the US Within Two Years

In 2018, the world's first nanobody drug, Caplacizumab, was approved for marketing in the European Union, and at that time, nanobody innovation enterprises, including Nanjing RegeneCore, were also seeking breakthroughs in this field. Time will prove that RegeneCore's forward-looking layout and direction were correct, and all we need to do is wait patiently for the flowers to bloom. From its establishment in 2017 to 2023, it has been just six short years, but Chairman Lv Xiangyang's foresight has already borne fruit, and RegeneCore is ushering in a harvest season in the bioscience and biotechnology sector.

On March 27, 2023, RegeneCore received a clinical trial notification from the National Medical Products Administration (NMPA) for its self-developed recombinant anti-human IL-4Ra and IL-5 single-domain antibody injection (RC1416 Injection), intended for additional maintenance therapy in moderate-to-severe asthma. This marks the first clinical trial authorization for a domestic autoimmune bispecific nanobody drug. The RegeneCore research team conducted antibody screening, combination, evaluation, and re-screening through a drug development process involving camel immunization, antibody screening, antibody modification, and antibody combination, ultimately obtaining an anti-IL-4R/IL-5 bispecific antibody with excellent pharmacodynamics, safety, and druggability. In the treatment of asthma patients, drugs targeting two or more sites simultaneously may achieve better therapeutic effects compared to single-target drugs. Therefore, the RegeneCore team designed a bispecific antibody targeting both IL-4R and IL-5. The dual targets of IL-4Rα and IL-5 are also internationally pioneering and belong to Class 1 innovative drugs. In April of the same year, RC1416 Injection received clinical trial application approval from the U.S. Food and Drug Administration (FDA), marking the synchronization of the product's clinical development strategy domestically and internationally. Currently, this antibody has entered Phase II clinical trials, prompting the announcement at the beginning of this article recruiting patients with moderate-to-severe asthma.

Nanjing RegeneCore's advanced laboratory.

The research and development efficiency of RegeneCore is astonishing. In July of this year, RegeneCore's second self-developed nanobody drug, the RT2831 project, officially received approval for its Investigational New Drug (IND) application in the United States. This marks another significant breakthrough by the RegeneCore team in the field of cancer treatment, following their achievements in autoimmune diseases. The RT2831 project is a bispecific nanobody drug targeting specific antigens on the surface of malignant hematological tumor cells, which has demonstrated excellent safety and efficacy in preclinical studies. In September of the same year, the RT2831 project received approval from the National Medical Products Administration of China to conduct clinical trial research.

The Secret Behind: Group Support, Long-term Accumulation, and a Focus on Innovation

Why is RegeneCore's research and development so efficient? What does RegeneCore rely on to tackle cutting-edge biotechnology topics and fill domestic and international gaps? What is the secret behind it?

Wang Yang stated that competition in the field of new drug research and development is fierce, and every stage of development is thrilling. Each enterprise has its own focus and areas of expertise due to different directions. The rapid development of RegeneCore is mainly attributed to the strong strength of the YOUNGY GROUP. It is thanks to the continuous strong support from Chairman Lv Xiangyang and the Group that RegeneCore has been able to progress step by step until today. The Group has provided strong support to RegeneCore, ranging from research and development investment to operational management. Chairman Lv Xiangyang has shown great care, providing meticulous guidance and full support at every important stage and juncture of RegeneCore's development. Especially regarding RegeneCore's development direction and strategy, Chairman Lv Xiangyang has pointed out the right path for the company with his extraordinary vision and outstanding leadership.

　　Chairman Lv Xiangyang inspecting RegeneCore and posing for a group photo.

Talent is the most valuable asset of any enterprise. The rapid development of RegeneCore is also inseparable from a team with high scientific research capabilities, strong combat effectiveness, and excellent work ethics. RegeneCore boasts an international scientific advisory team and a high-level research and development team, with Professor Xie Wei, a Changjiang Scholar from the Ministry of Education, serving as the company's consulting scientist. The team is comprised of 70% master's and doctoral researchers. Wang Yang noted that the members of the RegeneCore team are highly cohesive, united in their research and development efforts, and have formed a "project-priority" work style.

RegeneCore's accumulation in the field of nanobody technology and its years of focus and continuous innovation are the key to the company's success. Currently, the company possesses more than 100 nanobody libraries targeting various drug targets and has obtained or applied for over 70 invention patents in areas such as nanobody-targeted drug research and development, nanobody-based companion diagnostics, nanobody-mediated cellular therapy, and nanobody-enhanced drug delivery.

With the strong support of YOUNGY GROUP, RegeneCore has built a robust nanobody technology system through continuous independent research and development. It has established five core technology platforms, including a nanobody screening technology platform, a nanobody optimization technology platform, and a druggability assessment technology platform, laying a solid foundation for the research and development of innovative nanobody drugs and consolidating its own "moat" for development. After years of dedicated research, Nanjing RegeneCore is now focusing on three major disease areas: autoimmune diseases, cancer, and neurological diseases. It has developed a series of innovative nanobody drugs with independent intellectual property rights and established a competitive product pipeline with significant advantages.

Wang Yang stated that RegeneCore is still an early-stage biotech company and a new drug research and development company that has just entered the clinical development stage, with a long way to go in the future. Currently, RegeneCore is mainly focused on nanobody technology and new drug development. It has also established the Thoth Institutes for Health Research to explore cutting-edge and original new drug target discovery and disruptive technology development. In the future, RegeneCore will actively explore new technologies and therapies in the field of life and health, forming a unique drug pipeline based on nanobody technology and continuously launching high-quality innovative drugs with independent intellectual property rights to maintain human health and strive to become one of the leaders in the global medical technology field.

Innovation is the primary driving force for development. The achievements of RegeneCore not only represent YOUNGY GROUP's deep layout in the field of life sciences but also serve as the best interpretation of Chairman Lv Xiangyang's philosophy of scientific and technological innovation. In the future, YOUNGY GROUP will continue to use innovation as its sail and industry as its rudder, leading the trend of the times, climbing the peaks of life sciences, and writing a legendary chapter of scientific and technological innovation in the new era.

This article is reprinted from the official website of YOUNGY GROUP, original link: http://www.youngy.com.cn/article/1792.html