The World's First Biased μ-Opioid Receptor Agonist, Oliceridine Injection (TRV130), Approved in China, Bring a New Treatment Option to Chinese Patients with Acute Pain
8th May, 2023, Nhwa announced that National Medical Products Administration of China has approved oliceridine injection (8th May, 2023, Nhwa announced that National Medical Products Administration of China has approved oliceridine injection (hereinafter referred to as “TRV130”) for use in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
TRV130 is a first-in-class G-protein biased µ-opioid receptor agonist discovered and developed by Trevena, Inc., and its mechanism is based on the innovative achievement on 2012 Nobel Prize winning research in Chemistry. TRV130 (brand name in US: OLINVYK®) was previously approved by the Food and Drug Administration (FDA) for the same use. Pursuant to a License Agreement with Trevena, Inc., Nhwa holds the exclusive license for the development and commercialization of TRV130 in China.
The approval of TRV130 was based on results from two clinical trials in China and the bridge analysis with overseas clinical data. The data showed that TRV130's safety and pharmacokinetic profile in Chinese patients was consistent with global studies and had a similar analgesic effect to morphine with faster onset and lower incidence of adverse reactions, such as nausea and vomiting. The data supports TRV130's good benefit-risk ratio among Chinese patients.
“We are thrilled to receive approval for TRV130 in China. It is the first approved G-protein biased µ-opioid receptor agonist in the world and its innovative mechanism significantly reduced opioid-related side effects,” said Jiaquan Sun, President and CEO of Nhwa. “We look forward to working with healthcare providers and patients in China to bring this new treatment option to those in need.”
About Jiangsu Nhwa:
Jiangsu Nhwa Pharmaceutical Co., Ltd. (SZ002262), founded in 1978, is a leading CNS company in China. Over the past 40 years, Nhwa is exclusively dedicated to developing innovative and differentiated pipeline in the areas of anesthesia, analgesia, psychiatry and neurology via in-house R&D and global partnership.
As a fully integrated pharmaceutical company with more than 4000 employees, Nhwa has comprehensive capabilities in research, clinical development, manufacturing and commercialization of CNS drugs. In recent years, Nhwa has further strengthened its leadership in CNS field in China by providing the services of precision diagnosis of CNS disorders (Shanghai N-yuen Biotechnology Company), and investing the largest Chinese CNS internet health platform (Happy Mood).
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