日本語 
Curatis Holding AG has signed an exclusive licensing and development agreement with Japanese pharma company Neupharma for corticorelin, also known as C-PTBE-01. The research examines how to treat peritumoral brain edema which occurs in patients with brain tumors. The pharmaceutical industry of Japan ranks as the third largest market in the world after the United States and Europe which makes this partnership essential for introducing the drug to a major market.
Under the agreement, Neupharma gets the exclusive rights to develop and commercialize corticorelin in Japan. The company will also take charge of financing and running the pivotal clinical trial in the country that is required for regulatory approval. Curatis will receive upfront payments and milestone payments tied to regulatory and commercial progress. If all those targets are met, the payments can go up to CHF 83.5 million. On top of that, Curatis will receive royalties of up to 20 percent on sales in Japan.
The current plan is to introduce corticorelin in Japan first for children and adolescents. A meeting with Japan’s drug regulator PMDA is expected in the summer of 2026 to discuss the study required for registration. If things move as expected, the clinical trial in Japan should begin in 2027.
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The company is conducting work on its overall program while its current work continues. The company prepares for its essential Phase 3 study which will seek United States and European Union approval while it establishes international partnership talks.
Corticorelin is Curatis’ lead product candidate. It is being developed for peritumoral brain edema, often called PTBE. This condition appears alongside many primary and metastatic brain tumors. Metastases from lung cancer, breast cancer, melanoma, and colorectal cancer are common sources.
PTBE develops when fluid builds up around a brain tumor. That pressure interferes with brain function. Patients experience multiple symptoms including headaches and vomiting and neurological problems that include paralysis and speech disorders and vision issues and changes in mental state.
Right now the usual treatment relies on corticosteroids. They reduce swelling but the side effects can be serious. Patientswith this condition experience multiple health issues which include severe myopathy, problems with glucose metabolism, muscle wasting, abnormal weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension, and personality changes. The use of steroids produces interference with various cancer treatments which include chemotherapy and modern immunotherapy treatments that require proper T-cell function.
Corticorelin is a 41 amino acid endogenous polypeptide. Preclinical studies have shown it can help stabilize the blood brain barrier after it has been disrupted by a malignant tumor. Two clinical studies in PTBE patients have already suggested that corticorelin could significantly reduce the need for steroids and in some cases even replace them.
The patient numbers make the opportunity quite large. Around 60,000 patients in Japan and about 500,000 worldwide are estimated to be eligible for corticorelin treatment. The global market potential is expected to exceed USD 1 billion annually. Right now corticorelin is still an investigational drug and has not yet been approved for therapeutic use in the United States or outside it.
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