On 30 July 2024 (USA time), Kindos Pharmaceutical Co., Ltd., NKF's subsidiary, receives the first round of one-time approval from the U.S. Food and Drug Administration (FDA) for its self-developed Ropivacaine Hydrochloride Injection, which is permitted to be marketed and sold.

Ropivacaine Hydrochloride Injection, as the first-line local anaesthesia drug, is used for surgical anaesthesia and acute pain control with low toxicity and long duration of action. At the same time, the product has the dual role of anaesthesia and analgesia, and is widely used in surgical regional block and epidural anaesthesia and epidural post-operative or labour analgesia, with high clinical application value. Data shows that its U.S. market size 2023 is nearly USD 68 million.

In mid-July this year, FDA conducts a nearly 10-day pre-approval on-site inspection on Kindos Pharmaceutical for Ropivacaine Hydrochloride Injection ANDA application. This approval sets a new record for the ANDA with most specifications in Kindos. Up to now, more than a quarter of FDA-approved molecules of Kindos have received marketing approval in the first round of review, far exceeding the industry average.

This once again fully demonstrates Kindos team the professional and efficient R&D capability, the international first-class cGMP manufacturing capability and the precise and rigorous pharmaceutical registration capability. Kindos will continue to uphold the work philosophy of "doing right at once", and will continue to promote high-quality of products and services to a new level with a scientific and rigorous attitude and a compliant and efficient system.