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Trevena (NASDAQ: TRVN) Partner Receives Approval for OLINVYK in China

Trevena, Inc. (NASDAQ: TRVN) is engaged as a biopharmaceutical company, which is focused on the research, development and commercialization of innovative medicines to treat central nervous system (CNS) disorders. Shares of the biopharma company are skyrocketing 365% through late trading on Monday, May 8, 2023. Over the past three months, Trevena has seen average daily volume of 104,060 shares. However, volume of 82.99 million shares or dollar volume of around $224.9 million, has already exchanged hands through late trading.

Shares of Trevena are surging after the company announced that its partner Jiangsu Nhwa received approval from China’s National Medical Products Administration (NMPA) for OLINVYK, a novel medication for acute pain management in adults requiring intravenous opioid analgesics when alternative treatments are inadequate. This approval follows the NMPA’s acceptance of the New Drug Application (NDA) in January 2022 and is based on the results of two bridging trials in China, which confirmed OLINVYK’s safety, tolerability, and pharmacokinetic profile. Jiangsu Nhwa, which has an exclusive license agreement for OLINVYK’s development and commercialization in China, will now work to launch and fully commercialize the product.

Upon approval, Trevena is set to receive a $3 million milestone payment from Jiangsu Nhwa and could receive $15 million upon the first commercial sale of OLINVYK in China, as part of its non-dilutive royalty-based financing with an affiliate of R-Bridge Healthcare Fund. Additionally, Trevena may receive another $10 million upon achieving a commercial or financing milestone. OLINVYK, which contains the Schedule II controlled substance oliceridine, was approved by the FDA in August 2020 and is available in various dosages for adult patients.

“We are very pleased to see our partners, Jiangsu Nhwa, achieve this important milestone which will allow Chinese patients to benefit from OLINVYK,” said Carrie Bourdow, President and CEO of Trevena. “We have worked closely with our partners during their submission process, and look to our continued collaboration as they move forward with launch and full commercialization of OLINVYK in China.”

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