Looking Beyond the Future

Looking Beyond the Future

At NZP, over 150 research and development projects are in progress, for example in-house therapeutic agents with entirely new mechanisms of action, novel drugs and medical devices being developed through industry-government-university cooperation, and AI-enabled health technologies. We carefully identify pursuits that would result in the most globally sought-after developments and that offer higher feasibility, so that we can proceed with such development projects smoothly. Meanwhile, Neurotropin®, an analgesic agent that has long underpinned NZP's business, is poised to make continued contributions to the world with indications it will reach a broader patient population. Going forward, we at NZP will keep challenging ourselves to open the door to a new dimension of healthcare.

Joint Development of Nerve Protective/Regenerating Patches

NZP teamed up with Osaka University Hospital and the National Institute for Materials Science (NIMS) for the joint development of HANZ Nerve Protective/Regenerating Patch, with NZP offering its advanced product development and technical expertise in functional materials,
Osaka University Hospital its treatment know-how, and NIMS its technical prowess in materials development and analysis. Made from biodegradable polycaprolactone and medicine known to have a nerve regenerating mechanism, HANZ Patch is a mesh sheet woven with nanofibers one-thousandth the size of a hair using the electrospinning method.
Wrapped directly around the damaged peripheral nerve, this flexible and biodegradable patch regionally continuously releases medicine to stimulate nerve regeneration and nerve function recovery.
When transplanted into a rat with a damaged sciatic nerve, it facilitated nerve regeneration and helped to recover the rat's motor and sensory functions.
Having arranged commercial production of this patch, NZP has begun exploratory clinical trials for its clinical application.
Once this becomes commercially available, HANZ Patch will be applicable to roughly 50,000 operations per year for patients needing surgery of peripheral nerves, including carpal tunnel release for patients with carpal tunnel syndrome (CTS), which afflicts several hundred thousand people in Japan every year.

Agreement on Joint Development and Marketing Rights of Bone Morphogenetic Protein Formulation

In September 2019, NZP reached an exclusive agreement with CG Bio Inc., a South Korean biomaterials company, on joint development and marketing rights in Japan of a bone morphogenetic protein-2 (BMP-2) formulation, NOVOSIS Putty, for the treatment of lumbar spine degeneration. When medication or other conservative medical treatments do not improve the symptoms of lumbar spine degeneration, spinal fusion surgery is the conventional option, in which autogenous bones from the pelvis or elsewhere are transplanted. As elderly people's bones take longer to heal, expectations are rising for bone regeneration in Japan, whose population is aging rapidly. We believe that this agreement will allow us to tap into our strengths in orthopedics to develop the BMP-2 formulation, a new treatment for lumbar spine degeneration applicable to difficult operations, and enhance the well-being of many patients with pain in their lower backs. Preparations are underway for a scheduled commencement of clinical trials in 2020 or thereafter.

Pain Diagnosis Support AI System

Since May 2017, NZP, Aichi Medical University, and FRONTEO Healthcare, Inc., a provider of information analysis solutions using AI for natural language analysis for medical professionals and long-term care providers, have engaged in joint research for the development and commercialization of a pain diagnosis support AI system. The project represents an attempt in a new business field, where AI is directed to learn treatment know-how gathered at Aichi Medical University Multidisciplinary Pain Center in order to support the diagnosis and treatment of chronic pain, in which psychosocial and other factors are intricately intertwined. The goal of this research is to develop a diagnosis support system that determines pain attributable to psychosocial factors, which is often hard to diagnose even by pain specialists, that provides a definite diagnosis to patients whose symptoms have or could become chronic in part because the cause of their pain has not been identified, and prompts a shift to the appropriate treatment for alleviating their pain. This system is being developed as a program medical device. Once it is on the market, we will promote its spread to clinics and hospitals throughout Japan. We also wish to reduce the burden of medical professionals and patients and increase efficiency in the medical economy by providing efficient and accurate treatment of the many patients who suffer chronic pain.

First-Class Marketing License for Medical Devices Obtained

On March 24, 2020, NZP received the first-class marketing license for medical devices, which allows us to make full-scale efforts to develop, manufacture, and market products in the medical devices category, including HANZ Nerve Protective/Regenerating Patch and the Pain Diagnosis Support AI System, which are under development. For the next step, we are striving to acquire ISO 13485 certification, the international standard specifying requirements for a quality management system focused on the medical devices industry. By modifying our quality management system (which was established based on the QMS Ministerial Ordinance set forth by the Ministry of Health, Labor and Welfare of Japan) to comply with ISO, the international standard, we are working to build a quality management system of a higher level. Nippon Zoki Pharmaceutical will remain committed to delivering useful products to those who need them in the fields of medical devices, as well as pharmaceutical products.