Updated regulatory plans for NEFECON in China
Calliditas Therapeutics (CALT) announced that its partner, Everest Medicines, intends to submit a New Drug Application (NDA) for NEFECON in China in the second half of 2022. Everest received Breakthrough Therapy Designation from China's drug evaluation authority in December 2020 and has completed the enrollment of 60 patients for the necessary data submission. This regulatory submission is expected to expedite approval for NEFECON, aimed at treating IgA nephropathy. The partnership has also expanded to include South Korea.
- Potential earlier approval of NEFECON in China could enhance market position.
- Breakthrough Therapy Designation received from Chinese regulatory authorities.
- Completion of enrollment for clinical data supports NDA submission.
- None.
STOCKHOLM, March 18, 2022 /PRNewswire/ -- 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 in 2H of 2022.
"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 Renée 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.
About Calliditas
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.
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
Everest Nefecon Timeline ENG |
View original content:https://www.prnewswire.com/news-releases/updated-regulatory-plans-for-nefecon-in-china-301505685.html
SOURCE Calliditas Therapeutics
FAQ
When does Calliditas Therapeutics plan to submit the NDA for NEFECON in China?
What is NEFECON used for?
What designation did NEFECON receive from Chinese authorities?
Which countries are included in Calliditas' partnership with Everest Medicines for NEFECON?
What is the significance of the Breakthrough Therapy Designation for NEFECON in China?
