CASI Pharmaceuticals (NASDAQ: CASI) denied renewal of China FOLOTYN license

Rhea-AI Filing Summary

CASI Pharmaceuticals, Inc. reported that China’s National Medical Products Administration formally rejected its renewal application for the Import Drug Registration License for FOLOTYN® in China. The company had already stopped selling FOLOTYN in China after the prior license expired, in line with applicable regulations, so sales had ceased before this formal rejection.

CASI describes itself as a clinical-stage biopharmaceutical company focused on developing CID-103 for patients with organ transplant rejection and autoimmune diseases. The company also notes that it is involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA® and CNCT-19, and directs readers to earlier SEC filings for more details.

Insights

Biopharma equity analyst

CASI loses Chinese FOLOTYN license; impact depends on prior sales scale.

CASI Pharmaceuticals confirms that its application to renew the Import Drug Registration License for FOLOTYN® in China has been formally rejected by the NMPA, following earlier correspondence indicating the renewal would not be granted. The company had already ceased FOLOTYN sales in China once the previous license expired, so commercial interruption preceded this notice.

The filing does not quantify FOLOTYN revenue contribution or how central it was to CASI’s business, making it hard to gauge financial impact from this event alone. CASI highlights its focus on developing CID-103 and notes ongoing disputes and legal proceedings related to EVOMELA® and CNCT-19, suggesting a portfolio in transition toward pipeline assets.

Future disclosures in periodic reports may provide more clarity on how the loss of FOLOTYN sales in China and the outcome of product-related legal proceedings affect overall revenue mix and strategy.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE
13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934

For the month of January, 2026

Commission File Number  001-41666

CASI PHARMACEUTICALS, INC.

(Translation of registrant’s name into English)

1701-1702, China Central Office Tower 1

No. 81 Jianguo Road, Chaoyang District

Beijing, 100025

People’s Republic of China

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F. 

Form 20-F  x Form 40-F  ¨

INCORPORATION BY REFERENCE

The information included in this Report on Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form F-3 (File No. 333-283998 and No. 333-281621) (including any prospectuses forming a part of such registration statement) and is to be a part thereof from the date on which this Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

CASI Pharmaceuticals Reports the Failure to Renew the Import Drug Registration License for FOLOTYN^® in China

CASI Pharmaceuticals, Inc. (NASDAQ: CASI, the “Company”), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today reported that, following prior correspondence from the Chinese Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) that the Company’s renewal application submitted in May 2025 for the Import Drug Registration License for FOLOTYN^® was not granted, the Company received a formal notice from the NMPA that the Company’s renewal application was not approved.

As previously reported, after the expiration of the current Import Drug Registration License for FOLOTYN^®, the Company ceased the sale of FOLOTYN^® in China pursuant to the relevant regulations and rules.

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. We caution readers not to place undue reliance on any forward-looking statements contained herein.

EVOMELA^® is proprietary to Acrotech Biopharma Inc. and its affiliates. FOLOTYN^® is proprietary to Acrotech Biopharma Inc and its affiliates. The Company is currently involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA^® and CNCT-19. Please refer to the Company’s earlier SEC filing for further information.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	CASI Pharmaceuticals, Inc.
	By:	/s/ David Cory
	Name:	David Cory
	Title:	CEO
Date: January 22, 2026

FAQ

What did CASI Pharmaceuticals (CASI) disclose about FOLOTYN in this 6-K filing?

CASI Pharmaceuticals disclosed that China’s National Medical Products Administration formally did not approve its renewal application for the Import Drug Registration License for FOLOTYN® in China. The company had already stopped selling FOLOTYN in China after the prior license expired under relevant regulations.

Is CASI Pharmaceuticals still selling FOLOTYN in China?

No. CASI Pharmaceuticals stated that after the expiration of the existing Import Drug Registration License for FOLOTYN®, it ceased sales of FOLOTYN in China in accordance with applicable regulations, and the renewal application has now been formally rejected.

What stage of development is CASI Pharmaceuticals (CASI) in, according to the filing?

CASI Pharmaceuticals describes itself as a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases.

Does CASI Pharmaceuticals mention other products besides FOLOTYN in this filing?

Yes. CASI references EVOMELA®, which is proprietary to Acrotech Biopharma Inc. and its affiliates, and CNCT-19. The company notes it is involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA and CNCT-19.

Are there any forward-looking statements in the CASI Pharmaceuticals 6-K?

Yes. The company includes a forward-looking statements section, explaining that statements about business outlook, strategic and operational plans, and expectations are subject to risks and uncertainties, and it refers readers to its SEC filings for further risk information.

Where can investors find more information on CASI Pharmaceuticals’ legal disputes mentioned in the filing?

CASI Pharmaceuticals notes that it is currently involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA® and CNCT-19, and directs readers to the company’s earlier SEC filings for further information.