MedLeader Biopharma Files IPO Prospectus: A Full-Service CRO Accelerating Frontier Vaccine Development from Preclinical to Clinical Stages
“The Trend of Innovative Drug R&D in China” shows that in 2017, the number of initial Investigational New Drug (IND) applications for innovative drugs reached 194, with 164 successfully approved. Compared with 2016, the number of initial IND applications for new drugs in 2017 increased by 78%, among which chemical drugs and therapeutic biological products increased by 60% and 159%, respectively.
The growing enthusiasm for new drug development has led to an increase in the number of Investigational New Drug (IND) applications, accompanied by accelerated improvements in drug regulation and review standards, as well as the initiation of consistency evaluations (bioequivalence, BE) for generic chemical drugs starting in 2016.
Rising quality standards and the drive for cost reduction and efficiency gains have fueled growing demand for outsourcing services among pharmaceutical companies. The high-tech, high-risk, capital-intensive, and lengthy nature of new drug development has encouraged more contract research organizations (CROs) to participate in the R&D process, making CROs increasingly favored by both the market and investors.
However, at that time, the regional distribution of domestic pharmaceutical CRO manufacturers was relatively concentrated, primarily in the Pearl River Delta and Yangtze River Delta regions, with relatively fewer enterprises in other areas such as Southwest China. How to leverage the advantages of Southwest China to provide R&D capabilities equivalent to those in coastal regions, thereby offering “faster” and “more cost-effective” R&D services for drug commercialization, was an urgent issue to be addressed. In this context, Chongqing Meilaide Biomedical Co., Ltd. (hereinafter referred to as “Meilaide”) was established.
Meilaide is a comprehensive contract research organization (CRO) dedicated to providing end-to-end CRO services, from GLP to GCP, for drug development institutions and enterprises., with services spanning various sectors including chemical drugs, preventive and therapeutic biologics, medical devices, and IVD, covering multiple therapeutic areas such as anti-infectives, endocrinology, oncology, and the nervous system.
The company aims to assist pharmaceutical enterprises in shortening R&D cycles, reducing R&D costs, and enhancing productivity and efficiency by providing one-stop CRO services that include preclinical research and clinical services, ultimately bringing safe and effective products to market.
Dr. Liu Yan, General Manager of Meilaide, discovered during her many years of new drug research that while the southwest region places significant emphasis on and encourages pharmaceutical R&D, there is a scarcity of companies providing CRO services. As a result, biopharmaceutical enterprises are sometimes compelled to engage CRO firms in coastal regions for preclinical and clinical trials, which undoubtedly increases their R&D costs.
Therefore, based on market research and analysis, Dr. Liu Yan decided to establish a CRO service enterprise in Chongqing capable of covering both preclinical and clinical stages, providing more efficient and cost-effective drug development CRO services to pharmaceutical companies in China and around the world.
Thus, Meilaide was established in 2017 with just over ten employees and single-digit contract orders. At that time, Dr. Liu Yan met Director Li Rongcheng, who had extensive experience in vaccine development and formerly served as the Director of the Clinical Research Center at the Guangxi Center for Disease Control and Prevention. Dr. Liu’s vision gained Director Li’s endorsement, and he was successfully invited to serve as Meilaide’s Chief Scientist.
In 2019, the company entered a fast track of development. 6300m2The laboratory’s central testing facility was put into operation, and a subsidiary was established in New York State, USA. In 2020, offices were opened in Nanning, Chengdu, Changsha, Kunming, and Guangzhou to facilitate the conduct of regional clinical trials. In the same year, clinical trial sites were established in Ecuador, Indonesia, Laos, Pakistan, and other countries to carry out vaccine clinical trials.
In 2021, the Drug Safety Evaluation Research Center, which had been under preparation for three years, was officially completed and put into operation. The center is certified with ABSL-2 (Animal Biosafety Level 2 Laboratory) status and obtained its Good Laboratory Practice (GLP) certification in 2022. With this milestone, Chongqing Meilaide Biomedical Co., Ltd. has essentially established the framework for its preclinical and clinical research CRO services.
As of the end of 2023, Meilaide has built an interdisciplinary team comprising more than 500 professionals in biomedical fields such as pharmacy, medicine, chemistry, biology, and statistics, with over 17% of its employees having more than ten years of experience in drug research and development.
To better serve sponsors and ensure high-quality research outcomes and successful project implementation, Meilaide has successively established various business departments, including the Clinical Department, Medical Department, Bioanalysis Center, Pharmaceutical Research Center, Drug Safety and Evaluation Research Center, Project Management Department, Pharmacovigilance Department, and Regulatory Affairs Department.
Since its establishment, Chongqing Meilaide Biomedical Co., Ltd. has built four comprehensive platforms: a pharmaceutical research platform, a drug safety evaluation research center, a clinical medicine platform, and a biotechnology platform. It has also established a CRO service chain targeting IND (Investigational New Drug) and NDA (New Drug Application) submissions. Currently, Meilaide provides one-stop services for drug development, ranging from hit-to-lead optimization to post-marketing studies. These services include pharmaceutical research, preclinical research, clinical research, medical affairs, regulatory submission, laboratory services, and pharmacovigilance.
In pharmaceutical research, Meilaide provides services for small-molecule and large-molecule drugs, including process development, quality studies, CMC regulatory submissions, formulation research, as well as laboratory-scale, pilot-scale, and commercial manufacturing scale-up. Therapeutic areas covered in R&D include oncology, neuroscience, anti-infectives, cardiovascular, gastrointestinal, ophthalmology, endocrinology, and immunology.
In terms of laboratory services, Meilaide’s laboratory holds dual P2 (BSL-2 and ABSL-2) certifications, enabling it to conduct pharmacodynamics studies, toxicity studies, viral titer and potency assays, and other tests within its P2 laboratories. Laboratory services also include in vitro and in vivo ADME studies, immunological assays, genetic analysis, biomarker testing, and analytical method development and validation.
In terms of non-clinical safety evaluation services, Meilaide Drug Safety Evaluation Research Center boasts an animal facility spanning over 5,000 square meters, housing experimental animals such as non-human primates, rodents (rats, mice, guinea pigs, cotton rats), dogs, rabbits, sheep, pigs, and ferrets. The company provides both GLP and non-GLP safety evaluation services, including toxicology studies, immunogenicity and immunotoxicity testing, clinical laboratory analyses, pharmacokinetic studies, pharmacodynamic studies, and drug screening.
Among these, nearly half of Chongqing Meilaide Biomedical Co., Ltd.’s projects are dedicated to vaccine R&D. The company offers comprehensive services covering all stages of vaccine development, including vaccine design, adjuvant selection, analytical method development and validation, preclinical evaluation, medical affairs, clinical operations, pharmacovigilance, and regulatory affairs.
Chongqing Meilaide Biomedical Co., Ltd. is involved in all current hot vaccine pipeline categories, such as RSV (Respiratory Syncytial Virus) vaccines, VZV (Varicella-Zoster Virus) vaccines, multivalent influenza vaccines, HPV (Human Papillomavirus) vaccines, and rabies vaccines. Furthermore, Chongqing Meilaide possesses a variety of vaccine manufacturing technologies, including inactivated vaccines, live-attenuated vaccines, modified viral/bacterial vector vaccines, mRNA/DNA vaccines, recombinant vaccines, bacterial lipopolysaccharide vaccines, virus-like particle (VLP) vaccines, and toxoid vaccines.
Meilaide’s one-stop vaccine R&D platform is consistently centered on services for IND and NDA submissions, extending beyond the scope of the NMPA, EMA, and FDA. From project initiation, Meilaide provides sponsors with regulatory pathway planning and proceeds to deliver a comprehensive suite of subsequent R&D services.
In May 2023, the successive market launches of RSV vaccines from GlaxoSmithKline (GSK) and Pfizer broke the market void in the RSV vaccine sector, giving other companies in this field a “glimmer of hope for success.”
According to data released by Frost & Sullivan, the global market size for RSV drugs is projected to grow from $1.8 billion in 2020 to $12.8 billion in 2030. The broad development prospects have attracted numerous companies to enter the field; according to incomplete statistics, there are currently more than 70 RSV vaccine pipelines under development worldwide. Among these, overseas multinational corporations (MNCs) are making faster progress, with most having entered or completed Phase III clinical trials.
The domestic RSV vaccine market in China is also a blue ocean yet to be tapped. According to data from Frost & Sullivan, the incidence of acute lower respiratory tract infections caused by RSV infection in China is approximately 31.0‰. With the accelerating pace of population aging, the potential target population is projected to reach 29.68 million by 2030, and the domestic RSV drug market is expected to grow from USD 5.2 million in 2020 to USD 1.5 billion in 2030.
Currently, multiple companies in China have entered this sector and are accelerating the advancement of their development pipelines. However, numerous challenges persist in RSV vaccine research and clinical trial design, such as the instability of the RSV surface F protein, the need to formulate distinct development strategies for different populations, and the lack of robust animal models and serological markers.
In this context, Meilaide has strategically positioned itself to provide one-stop CRO services centered on RSV vaccine development. Dr. Wang Tao, Deputy General Manager, stated, “With the rising number of patients with respiratory infectious diseases and an accelerating aging population, demand for vaccines continues to grow, attracting numerous companies to enter the vaccine sector. Among these, the RSV vaccine segment has garnered particular market attention. Therefore, we have prioritized our layout of CRO services in the vaccine field.”
To address R&D challenges, Meilaide leverages its one-stop vaccine development platform to provide enterprises with comprehensive services covering the entire vaccine research and development lifecycle. Notably, the company offers specialized one-stop services for RSV vaccines, encompassing four major categories: true virus neutralizing antibody assays, viral load testing, conjugate antibody detection, and cell subset analysis alongside cytokine level measurements.
Currently, Meilaide has successfully assisted sponsors in achieving key milestones in RSV vaccine development. Furthermore, Meilaide continues to monitor advancements in RSV vaccine research, continuously optimizing study protocol design and analytical method development, thereby accelerating the market launch of domestically produced RSV vaccines.
Currently, Meilaide is advancing a new total of 26,000 m2construction of the test site, including the Phase I Center for the Domestication and Breeding of Experimental Monkeys, 7,000 m2Pilot-scale Base and a Total of 3,000 m²2Animal Imaging Center and Animal Model Center. Leveraging full-chain CRO service capabilities, we will further expand the scope of our business services on this foundation.
According to the “Industry Research Report on the Pharmaceutical R&D Outsourcing Services Market” published by Frost & Sullivan, the market size of China’s pharmaceutical CRO industry grew from RMB 36.49 billion in 2018 to RMB 81.37 billion in 2022, representing a compound annual growth rate (CAGR) of 22.2%, and is projected to reach RMB 275.77 billion by 2030. Among these trends, the one-stop CRO service model has gradually become mainstream. This model requires products to interface with only one CRO service provider throughout the entire R&D process, thereby improving efficiency and reducing the time required for products to move from R&D to commercialization.
“Meilaide is continuously advancing the construction of new platforms and testing facilities. Upon completion and commissioning, the company’s comprehensive service capabilities will be further enhanced, enabling it to provide more extensive and effective CRO services to a broader range of enterprises and research institutions.” Discussing the company’s future development, Dr. Wang Tao, Deputy General Manager, stated. We look forward to Meilaide’s continued innovation in R&D platform technologies, delivering more efficient and comprehensive services to the healthcare industry, ultimately benefiting more patients.