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Stockholm, Sweden

Key Takeaway: Updated regulatory plans for NEFECON Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that partner Everest Medicines (HKEX 1952.HK) plans to submit an NDA for NEFECON in China in the second half of 2022. Everest received Breakt

Full Press Release Details

Updated regulatory plans for NEFECON
Calliditas Therapeutics AB (Nasdaq:
CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that partner Everest Medicines (HKEX 1952.HK) plans to submit
an NDA for NEFECON in China in the second half of 2022.
Everest received Breakthrough Therapy
Designation (BTD) from the China Center for Drug Evaluation, National Medical Products Administration (CDE,NMPA) in December, 2020 and
have completed enrollment of the 60 Chinese patients required to complement the submission of the global data set from the NefIgArd trial.
Everest plans to conduct an interim analysis of the Chinese patients and this is expected to lead to a regulatory submission in China
"We are excited about the possibility
of a significantly earlier potential approval in China, and are happy to support our partner Everest in their endeavors to bring the
first approved medicine for IgA nephropathy to Chinese patients," said CEO Ren e Aguiar-Lucander.
As previously reported, in 2019 Calliditas
entered into a license agreement to develop and commercialize NEFECON in Greater China and Singapore for the chronic autoimmune kidney
disease IgA Nephropathy (IgAN). In March 2022, Calliditas expanded this partnership to include South Korea.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com
The information was sent for publication,
through the agency of the contact persons set out above, on March 18, 2022 at 8:00 a.m. CET.
Calliditas Therapeutics
is a commercial stage biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments
in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead
product, TARPEYOTM (budesonide) delayed release capsules has been approved by the FDA and is the subject of a marketing authorization
application (MAA) with the European Medicines Agency (EMA). Additionally, Calliditas is conducting a pivotal clinical trial with its
NOX inhibitor product candidate setanaxib in primary biliary cholangitis and is initiating a head and neck cancer Phase 2 trial with
setanaxib. Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed
on the Nasdaq Global Select Market (ticker: CALT).
Forward-Looking Statements
This press release contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including,
without limitation, statements regarding Calliditas' strategy, commercialization efforts, business plans, regulatory
submissions, clinical development plans and focus. The words "may," "will," "could,"
"would," "should," "expect," "plan," "anticipate," "intend,"
"believe," "estimate," "predict," "project," "potential,"
"continue," "target," and similar expressions are intended to identify forward-looking statements, although
not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based
on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors
that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements
contained in this press release, including, without limitation, any related to Calliditas' business, operations, continued FDA
approval for TARPEYO, market acceptance of TARPEYO, clinical trials, supply chain, strategy, goals and anticipated timelines,
competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" in
Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on
any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly
update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any
such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the
forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas' views only as
of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Last updated: Mar 18, 2022