, /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") contiguous announced that the Chinese regulatory authorization National Medical Products Administration ("NMPA") has accepted Everest Medicines' (HKEX 1952.HK, "Everest") New Drug Application ("NDA") for Nefecon. The acceptance brings Nefecon, approved and marketed successful the U.S. nether the sanction TARPEYO® and successful the E.U. arsenic Kinpeygo®, an important measurement person to perchance becoming the first-ever approved therapeutic enactment indicated for superior IgAN attraction successful China.
In December 2020, the NMPA recommended Breakthrough Therapy Designation ("BTD") for Nefecon for the attraction of IgAN. Chronic kidney illness is 1 of the astir superior nationalist wellness problems successful China, wherever IgAN is estimated by Everest to impact astir 5 cardinal people.
"It is breathtaking that Everest's NDA has been accepted by the NMPA, providing a way guardant to code the precise important diligent colonisation suffering from IgAN successful China. We look guardant to continuing our collaboration arsenic we absorption connected bringing caller solutions to patients," said CEO Renée Aguiar-Lucander.
In June 2019, Calliditas entered into a licence statement with Everest to make and commercialize Nefecon successful Greater China and Singapore successful IgAN. This statement was extended to see South Korea successful March 2022.
For further information, delight contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com
The accusation was sent for publication, done the bureau of the interaction persons acceptable retired above, connected November 15, 2022 astatine 08:00 a.m. CET.
About Calliditas
Calliditas Therapeutics is simply a commercialized signifier biopharma institution based successful Stockholm, Sweden focused connected identifying, processing and commercializing caller treatments successful orphan indications, with an archetypal absorption connected renal and hepatic diseases with important unmet aesculapian needs. Calliditas' pb product, developed nether the sanction Nefecon, has been granted accelerated support by the FDA nether the commercialized sanction TARPEYO® and conditional selling authorization by the European Commission nether the commercialized sanction Kinpeygo®. Kinpeygo is being commercialized successful the European Union Member States by Calliditas' partner, STADA Arzneimittel AG. Additionally, Calliditas is conducting a Phase 2b/3 objective proceedings successful superior biliary cholangitis and a Phase 2 proof-of-concept proceedings successful caput and cervix crab with its NOX inhibitor merchandise candidate, setanaxib. Calliditas' communal shares are listed connected Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed connected the Nasdaq Global Select Market (ticker: CALT).
Forward-Looking Statements
This property merchandise contains forward-looking statements wrong the meaning of the Private Securities Litigation Reform Act of 1995, arsenic amended, including, without limitation, statements regarding prospective regulatory support and selling of Nefecon successful China, Calliditas' strategy, commercialization efforts, concern plans, regulatory submissions, objective improvement plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target," and akin expressions are intended to place forward-looking statements, though not each forward-looking statements incorporate these identifying words. Any forward-looking statements successful this property merchandise are based connected management's existent expectations and beliefs and are taxable to a fig of risks, uncertainties, and important factors that whitethorn origin existent events oregon results to disagree materially from those expressed oregon implied by immoderate forward-looking statements contained successful this property release, including, without limitation, immoderate related to Calliditas' business, operations, continued regulatory approvals for TARPEYO and Kinpeygo and further regulatory approvals for Nefecon, including successful China, marketplace acceptance thereof, objective trials, proviso chain, strategy, goals and anticipated timelines, contention from different biopharmaceutical companies, and different risks identified successful the conception entitled "Risk Factors" successful Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to spot undue reliance connected immoderate forward-looking statements, which talk lone arsenic of the day they are made. Calliditas disclaims immoderate work to publically update oregon revise immoderate specified statements to bespeak immoderate alteration successful expectations oregon successful events, conditions, oregon circumstances connected which immoderate specified statements whitethorn beryllium based, oregon that whitethorn impact the likelihood that existent results volition disagree from those acceptable distant successful the forward-looking statements. Any forward-looking statements contained successful this property merchandise correspond Calliditas' views lone arsenic of the day hereof and should not beryllium relied upon arsenic representing its views arsenic of immoderate consequent date.
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