The Medical Developments International Ltd (ASX: MVP) share price has been a strong performer on Thursday morning.
At the time of writing the healthcare company's shares are up 5% to $6.33.
Why is the Medical Developments International share price charging higher?
Investors have been buying the company's shares on Thursday after it provided an update on its key Penthrox product.
Penthrox is a fast onset, non-opioid analgesic indicated for pain relief by self-administration in patients with trauma and those requiring analgesia for surgical procedures. It has been around for decades in Australia and is better known by the public as the green whistle.
Over the last couple of years the company has successfully been expanding its presence globally, which leads us to today's announcement.
This morning Medical Developments International announced that the Chinese National Medical Product Administration (NMPA) has approved the opening of the company's Investigative New Drug (IND) application.
This application is a critical step to having Penthrox approved for sale in the massive China market.
According to the release, its submission in China is to have Penthrox approved for two separate indications – trauma pain and procedural pain.
What now?
Medical Developments International has commenced work to complete clinical bridging studies which are required in China for each indication. Management expects to complete them within 12 months. Furthermore, the company is undertaking a bridging Pharmacokinetic (PK) study.
These studies are designed to support the use of Penthrox in Chinese people and will be used as an adjunct to the global clinical data it has already submitted to the NMPA and other global authorities.
The company's chairman, David Williams, described the Chinese IND as a "red letter day" for Medical Developments International. This sentiment was echoed by its CEO, John Sharman.
He said: "The approval of the Penthrox IND by the Chinese authorities is a significant milestone for our company. The NMPA has accepted the safety and efficacy of the global clinical data. The clinical program we are undertaking in China comprises small studies designed to support the safety and efficacy of Penthrox in Chinese people."
"Our partner in China, Daiichi Sankyo, is Japan's biggest pharmaceutical company, which is expanding aggressively in China. The Chinese market has an unmet need for a strong non opioid analgesic like Penthrox and the ultimate approval by the NMPA of Penthrox will be very positive for MVP and Daiichi Sankyo," he added.
