MabGen Therapeutics: An Antibody Drug Innovator Focused on Respiratory and Immune Diseases Submits IPO Prospectus

With nearly two decades of industry experience, Dr. Zhang Chenghai, founder of Maiji Biotechnology, has dedicated his career almost entirely to biopharmaceuticals, achieving significant results in the research and development of interferons, thymosins, glucocorticoids, and G protein-coupled receptors.

Around 2011, Dr. Zhang Chenghai participated in the establishment of a research platform for the structure and function of G protein-coupled receptors (GPCRs) at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. The crystal structure of the GPCR–arrestin complex, elucidated using this platform, was recognized as one of the Top Ten Scientific Advances of the Chinese Academy of Sciences in 2015. Prior to this, while serving as R&D Director at a pharmaceutical company in Shenzhen, he oversaw the pilot-scale process development for a gene-engineered thymosin project, which successfully advanced into clinical trials.

Subsequently, Dr. Zhang Chenghai joined Shanghai CP Guojian Pharmaceutical Co., Ltd., a domestic leader in monoclonal antibodies, as Deputy Director of the Research Institute. There, he established platforms for the construction of high-expression cell lines for monoclonal antibody drugs and for the development of innovative antibody therapeutics, and led the development and clinical trial applications of multiple monoclonal antibody biosimilars. Upon leaving in 2016 to found Maiji Biotechnology, he successfully developed several novel antibody molecular drugs, with innovative antibody candidates targeting PD-1, VEGF, and IL-17A advancing into clinical studies.

Dr. Zhang Chenghai told VCBeat that his experience during his doctoral studies at the Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, where he studied under Academician Hou Yunde, known as the “Father of Interferon in China,” and worked on the industrialization of biological macromolecules, made him place great emphasis on the value of translating scientific achievements into practical applications. “The key significance of scientific research lies in serving patients’ medical and health needs.” At Maiji Biotechnology, Dr. Zhang led his team from building an antibody drug screening platform, through stable cell line development and process optimization, to initiating clinical trials.

“Domestic pharmaceutical innovation is currently in an unprecedented period of opportunity, but a stable market landscape has yet to take shape; teams with different positioning can all find their own space for development,” stated Dr. Zhang Chenghai. In 2017 and 2018, Maiji Biotechnology successively secured angel-round investment from Huagai Capital and Series A funding from Zhangjiang Hi-Tech Investment and Guilin Sanjin Pharmaceutical Group, and has since initiated its Series B financing round.

In July this year, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) accepted Maiji Biotechnology’s Investigational New Drug (IND) application for MG-K10, a Class 1 humanized monoclonal antibody injection, and granted implicit approval to proceed with clinical trials. As an innovative biologic targeting respiratory and immune diseases, MG-K10 is Maiji Biotechnology’s first biologic drug candidate to enter clinical development. Dr. Zhang Chenghai expressed his hope that Maiji Biotechnology will leverage its proprietary TEADA antibody discovery platform to develop more innovative drugs that meet unmet clinical needs.

According to Dr. Zhang Chenghai, the company’s flagship product, MG010—the investigational drug aforementioned as having received clinical trial approval—is an innovative monoclonal antibody targeting IL-4Rα. Its first indication is moderate-to-severe asthma. “Currently, the efficacy of this target has been fully validated, and it holds substantial market potential in China once developed into a marketed drug.” Moving forward, Maiji Biotechnology will further develop MG010 for additional indications, including atopic dermatitis, COPD, and allergic rhinosinusitis.

IL-4Rα monoclonal antibodies bind to IL-4Rα, thereby simultaneously blocking the IL-4 and IL-13 signaling pathways, which are considered major drivers of allergic reactions such as asthma and atopic dermatitis. Globally, the only marketed or late-stage clinical drug targeting IL-4Rα is Dupilumab (generic name: Dupixent), co-developed by Sanofi and Regeneron, which serves as the benchmark comparator for MG010.

Dupilumab was approved by the FDA for market launch in March 2017, becoming the first biologic agent for the treatment of moderate-to-severe atopic dermatitis, and achieved sales of $247 million in its first year on the market. According to Sanofi’s financial report for the first quarter of 2020, Dupilumab has been approved for marketing in more than 40 countries and regions worldwide to date, generating over €2 billion in revenue for Sanofi within half a year, and has become a blockbuster drug in the field of allergy.

DupilumabSince its market launch, Sanofi and Regeneron have continued to expand the drug’s indications. In addition to atopic dermatitis, it has been approved for asthma and chronic rhinosinusitis with nasal polyps. Phase III clinical trials are underway for indications including bullous pemphigoid, allergic bronchopulmonary aspergillosis, urticaria, and chronic obstructive pulmonary disease (COPD), while Phase II clinical trials have commenced for pollen allergy and peanut allergy.Currently, Dupilumab has been launched in China, with its first indication being atopic dermatitis.

“MG010 has selected a first-line indication that is differentiated from Dupilumab.”Dr. Zhang Chenghai told VCBeat,In preliminary studies, MG010 demonstrated advantages including a stable manufacturing process, high antibody expression levels, and a long half-life. Data indicate that MG010 efficiently binds to IL-4Rα and blocks the biological functions of two inflammatory cytokines, IL-4 and IL-13.

Bronchial asthma, a chronic airway inflammation involving multiple cell types and cellular components, is listed by the World Health Organization as one of the four most intractable diseases. It ranks as the second leading cause of death and disability worldwide, surpassed only by cancer. Dr. Zhang Chenghai explained that the pathogenesis of asthma remains incompletely understood; currently, the well-established contributing factors primarily include immune-inflammatory responses, neural mechanisms, and airway hyperresponsiveness. “Although existing medications can alleviate symptoms to some extent, patients with moderate-to-severe asthma often lack effective therapeutic options. These patients account for the majority of clinical resource utilization in asthma care, representing an urgent unmet need in clinical practice.”

In China, the asthma patient population is large, and the incidence rate is high. In 2019, The Lancet published “Prevalence, risk factors, and management of asthma in China,” a study conducted by Academician Wang Chen’s team. The data showed that the prevalence of asthma among individuals aged 20 years and older in China was 4.2%, with a prevalence of 4.6% in males and 3.7% in females. The total number of patients reached 45.7 million (25.7 million males and 20.0 million females). Additionally, statistics indicate that there are approximately 10 million asthma patients under the age of 20 in China.

As challenging as the continuously expanding patient population is the low level of diagnosis and treatment for asthma patients in China, which has the highest asthma mortality rate worldwide. According to the 2018 epidemiological survey by the Chinese Asthma Alliance, only 28.8% of asthma patients were diagnosed, the national asthma control rate was 40.5%, and the complete control rate was merely 15.6%. In fact, asthma has become the second most common respiratory disease in China, with a mortality rate of 36.7 per 100,000 people—the highest globally.

“It is understood that in preclinical studies using asthma and delayed-type hypersensitivity models, MG010 demonstrated significant in vivo efficacy, while toxicology studies showed no obvious toxic side effects even at high doses. ‘The research on MG010 for the asthma indication is leading in China, which means there is huge market potential in a clinical setting where satisfactory treatment options are lacking,’ said Dr. Zhang Chenghai. ‘We expect to complete the Phase II clinical trial for the asthma indication in 2022, and after completing the Phase III clinical trial in 2024, we will apply for marketing approval.’”

When asked why his team did not pursue the more popular field of novel oncology drugs at the outset, but instead focused on R&D in respiratory and immunology, Dr. Zhang Chenghai responded: “There are already plenty of teams developing novel cancer therapies; adding one more would make little difference. In contrast, few teams are dedicated to novel respiratory and immunological drugs, so our absence could truly be felt.” This self-awareness likely stems from the team’s profound understanding of drug development in these areas, accumulated through years of deep engagement in biomedical R&D.

Currently, Maiji Biotechnology possesses a unique TEADA antibody discovery platform. According to reports, the TEADA antibody discovery platform features five major technical advantages: low cost, high throughput, high efficiency, high biological activity, and high druggability. Specifically, through optimized innovations in cutting-edge technologies, the TEADA platform has increased hybridoma screening throughput to more than 100 times that of industry peers. It also seamlessly integrates all stages of antibody discovery, significantly reducing the time required to identify candidate antibodies to approximately six months. Furthermore, for most projects, the TEADA platform is capable of identifying candidate antibodies with high affinity levels, thereby minimizing or eliminating the need for subsequent in vitro affinity maturation.

Meanwhile, Maiji Biotechnology has established a comprehensive druggability assessment platform that initiates a full-process evaluation of antibody druggability at a very early stage of drug development, ensuring that the selected candidate antibodies meet druggability requirements. “We set stringent criteria for activity and druggability from the outset and begin analyzing biological activity at an extremely early stage to ensure that candidate antibodies are selected through a rigorous process of choosing the best among the best,” explained Dr. Zhang Chenghai.

Leveraging the aforementioned technology platform, Maiji Biotechnology is efficiently building its R&D pipeline. In addition to MG010, its subsequent product candidates, MG012–MG014, are all focused on high-potential targets in the respiratory and immunology fields and are scheduled to sequentially submit Investigational New Drug (IND) applications and initiate clinical trials between 2020 and 2022. To ensure the high potential and low competitiveness of its follow-on products, Maiji Biotechnology typically selects targets that have only undergone preliminary validation abroad but have not yet been pursued by any domestic teams for further development.

This undoubtedly increases the risks associated with new drug development and poses a significant test to the team’s comprehensive capabilities. However, as Dr. Zhang Chenghai noted, in an innovative drug competitive landscape that is far from settled, various teams can find their appropriate niche. He envisions Maiji Biotech positioning itself as a platform-based novel drug company with long-term viability.