Guangzhou Fermion Technology Co., Ltd. and Simcere Pharmaceutical Group Limited have announced an exclusive licensing and collaboration agreement to develop FZ002-037, a clinical-stage pain treatment targeting the somatostatin receptor 4 (SSTR4). This partnership aims to address the significant unmet need for effective and safer pain therapies in Greater China.
FZ002-037, developed by Fermion, is a highly selective oral small-molecule SSTR4 agonist. Preclinical studies suggest that the drug provides primarily peripheral analgesia, potentially avoiding the central side effects and addiction risks associated with traditional opioid pain medications. This makes it a promising candidate for patients requiring long-term pain management.
Clinical Development and Potential Applications
FZ002-037 has completed Phase I clinical trials in China, demonstrating a favorable safety profile. Phase II studies are set to begin soon, focusing on diabetic peripheral neuropathy. The drug's potential applications extend to various chronic and acute pain conditions, offering a non-opioid alternative for a wide range of patients.
According to Fermion, FZ002-037 exhibits excellent selectivity, with a double-digit pM EC50, and has shown strong efficacy in multiple chronic and acute pain models. Phase I studies revealed no reported CNS or gastrointestinal adverse events, along with a pharmacokinetic profile suggesting potential for once-daily dosing.
Strategic Partnership and Future Plans
Under the agreement, Simcere will gain exclusive rights to develop and commercialize FZ002-037 in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan. Fermion will receive an upfront payment, milestone payments, and tiered royalties based on future sales.
Dr. Deco Deng, Founder of Fermion, expressed enthusiasm for the partnership, stating, "As the first domestically developed and the world's second high-selectivity SSTR4 agonist to enter the clinical stage, FZ002-037 holds great promise. By leveraging Simcere's strong development and commercialization capabilities, we are confident in accelerating its progress to provide better treatment options for patients suffering from pain."
Zhou Gaobo, Chief Investment Officer of Simcere, highlighted the importance of addressing pain management, noting, "Pain significantly affects patients' quality of life and remains a major unmet clinical need. Addressing these 'clinical pain points' has always been a core mission for Simcere. We look forward to collaborating with innovative partners like Fermion to deliver more effective and safer pain therapies to patients as quickly as possible."
