In the past six months, leveraging its professional clinical research service capabilities, Medkey Clinical has helped more than 30 innovative drugs and medical devices successfully obtain marketing approval from China’s National Medical Products Administration (NMPA). These products cover multiple core therapeutic areas including cardiovascular medicine, endocrinology, gastroenterology, dermatology, oncology, medical aesthetics, ophthalmology, neurology, etc. Partnering with a number of leading domestic and international pharmaceutical enterprises, Medkey Clinical has brought more high-quality treatment options to patients worldwide.
In the pharmaceutical field, Medkey Clinical has supported the successful market entry of multiple products with breakthrough value. An siRNA drug targeting APOC3 fills the gap in the treatment of specific rare diseases in China. Clinical data shows it reduces relevant patient indicators by 80% from baseline, with only four administrations required per year. A cAMP-biased GLP-1 receptor agonist has been approved for the first time globally, providing a new mechanism option for the treatment of type 2 diabetes. China’s first foam formulation for plaque psoriasis has been approved, enriching topical treatment solutions for skin diseases. In the field of oncology, a number of innovative drugs targeting HER2, CDK4/6 and other targets have received sequential approvals, providing new options for precision treatment of breast cancer patients.
In the medical device field, we have also achieved remarkable results. Multiple fillers and botulinum toxin products in the medical aesthetics field have been successfully approved, including China’s first pre-filled gel formulation, which further improves the ease of use of medical aesthetic products. Notably, a recombinant botulinum toxin type A injection project was exclusively executed by Medkey Clinical from Phase I to Phase III clinical trials. With full-process professional service capabilities, Medkey Clinical helped the product successfully complete clinical research and obtain marketing approval, demonstrating Medkey Clinical’s full-chain service strength in clinical research.
Up to now, Medkey Clinical has helped over 400 new drugs and medical devices obtain marketing approval. The successful approval of each product cannot be separated from the support of Medkey Clinical’s full-cycle clinical research services. Covering the entire cycle from early-phase clinical trials to late-phase clinical trials, coupled with the precise oversight of the project management team, Medkey Clinical ensures the efficient advancement of each project, thereby accelerating the progression of innovative discoveries from the laboratory to clinical practice.
As a key player in the global clinical research service field, Medkey Clinical will continue to focus on the needs of pharmaceutical and medical device innovation, rely on its professional service system, and join hands with global partners to accelerate the research and development and marketing of more innovative drugs and devices. We will empower the high-quality development of the global healthcare industry and contribute to the health and well-being of patients worldwide.
