Biopharmaceutical company Trevena announced that its partner, Jiangsu Nhwa, has received approval from China’s National Medical Products Administration (NMPA) for Olinvyk (oliceridine).

Olinvyk is an opioid agonist indicated to manage pain severe enough to require an intravenous opioid analgesic in adult patients whose alternative treatments are inadequate.

It comprises oliceridine, a Schedule II controlled opioid that has high potential for abuse, just as other opioids also do.

Trevena president and CEO Carrie Bourdow stated: “We are very pleased to see our partners, Jiangsu Nhwa, achieve this important milestone which will allow Chinese patients to benefit from Olinvyk.

“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 commercialisation of Olinvyk in China.”

The regulatory agency in China accepted the new drug application (NDA) for Olinvyk in January 2022.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Approval is based on data obtained from two bridging trials conducted in China, as well as on US clinical data.

The findings from the bridging trials showed that Olinvyk’s tolerability, safety and pharmacokinetic profile in Chinese patients were consistent with those observed in other Olinvyk clinical trials.

Jiangsu Nhwa now has rights to develop and commercialise Olinvyk in China under an exclusive licence agreement.

Trevena will receive a $3m milestone payment from Jiangsu Nhwa and is also eligible to receive an additional $15m on the first commercial sales of Olinvyk in China, based on ex-US royalty-based financing with the R-Bridge Healthcare Fund.