Sedana Medical enters China – signs with Chinese distributor

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced a 10-year exclusive distribution agreement with the Chinese distributor Kyuan Xinhai Medical, a subsidiary of partly state-owned Shanghai Pharma, the second largest life science company in China. Kyuan will immediately commence the fast-track registration of AnaConDa in China and estimates approval will be obtained in less than two years. The Chinese market potential for sedation in intensive care is estimated to be five to six million ventilation days annually.

Kyuan is making a major investment in this cooperation which includes substantial costs for the registration work and the launch of the product. Kyuan have committed to an initial frame order of SEK 16 million which will be placed immediately after the registration is obtained.

Kyuan’s intention is to apply for approval of AnaConDa using the fast-track approval route and estimates that the registration will be completed in less than two years. In parallel, Sedana Medical and Kyuan will also together investigate the requirements to register the anaesthetic IsoConDa (isoflurane). Sedana Medical estimates that the Chinese market potential for sedation in intensive care is five to six million ventilation days annually.

“We could not have found a better partner for our Chinese registration and launch. The distribution agreement with Kyuan gives us a strong position in a key market.” said Christer Ahlberg, CEO of Sedana Medical.

“We are happy to take on this commitment with Sedana Medical as we see how beneficial the therapy can be for patients in China. We look forward to registering the AnaConDa technology as soon as possible.” said General Manager Mr. Chu Chenxi at Kyuan.

As a result of the large potential in China and the rest of Asia, Sedana Medical now estimates that the total market potential in inhaled sedation in intensive care is SEK 20-30 billion annually compared to previous estimate of SEK 10-20 billion.

About Kyuan and Shanghai Pharma

Shanghai Pharmaceuticals Holding Co. Ltd. (“Shanghai Pharma”) is partly state owned and engaged in research and development, manufacturing, distribution and retailing of pharmaceutical products. The company was founded in 1994 and is headquartered in Shanghai, China and the stock is dual listed on the Shanghai Stock Exchange and the Hong Kong Stock Exchange.

Kyuan Xinhai (Beijing) Medical Products Trade Ltd. (“Kyuan”), the largest company within Shanghai Pharma, is a distributor for several large Western pharmaceutical and medical device companies.

About Sedana Medical’s market
Sedana Medical's market consists primarily of sedation of mechanically ventilated intensive care patients. The market for sedation of mechanically ventilated intensive care patients today consists of established drugs that are administered intravenously. There are several challenges for both patients and care givers with today's intravenous treatment that are largely solved by inhaled sedation. Today, it is estimated that between seven and eight million patients are sedated due to mechanical ventilation in intensive care globally, evenly distributed between the US, Europe and Asia. These patients are sedated on average three to four days. Sedana Medical estimates the annual total market potential for inhaled sedation in intensive care to SEK 20-30 billion.

For additional information, please contact:
Christer Ahlberg, CEO, Sedana Medical AB
Mobile: +46 70 675 33 30
E-mail: christer.ahlberg@sedanamedical.com 

Sedana Medical is listed on Nasdaq First North in Stockholm.
The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, certifiedadviser@penser.se. 

This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above, on June 3, 2019 at 8:30 a.m. (CET).

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Sedana Medical AB (publ) has developed and sells the medical device AnaConDa, for the administration of volatile anaesthetics to mechanically ventilated patients. A major clinical registration study is currently ongoing to obtain market approval in Europe for inhalation sedation in intensive care units with the pharmaceutical IsoConDa® (isoflurane).

Sedana Medical has direct sales in the Nordic countries, Germany, France, Great Britain and Spain as well as external distributors in the rest of Europe, Canada, Australia, Japan and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.