CASI Pharmaceuticals announced that the China National Medical Products Administration (NMPA) has approved a clinical trial application (CTA) for its anti‑CD38 monoclonal antibody CID‑103, allowing the company to launch a Phase 1/2 dose‑range and safety study in adults with chronic active renal allograft antibody‑mediated rejection (AMR). The approval, granted on January 15 2026, follows the company’s earlier FDA IND clearance for a similar U.S. study and marks the first regulatory milestone for CID‑103 in China.
CID‑103 targets a unique epitope on CD38 and is positioned as a potentially best‑in‑class therapy for organ transplant rejection, a field that currently has no approved treatments. By entering the Chinese market, CASI gains access to a large patient population and a streamlined regulatory pathway that could accelerate future approvals and broaden the drug’s global reach.
Financially, CASI remains under pressure. For the trailing twelve months, revenue totaled $26.85 million, a 3‑year decline of 5.7 %. Operating and net margins are negative at –162.19 % and –183.93 % respectively, and liquidity is constrained with a current ratio of 0.30 and a quick ratio of 0.24. The company recently secured a $20 million funding agreement with ETP Global III Fund LP to support CID‑103 development in China and has obtained a Nasdaq listing extension until February 17 2026 to meet compliance requirements.
Junping Chen, CASI’s China Chief Medical Officer, emphasized the unmet need: “Renal allograft AMR leads to transplant failure and often forces patients back onto dialysis. CID‑103 offers a novel mechanism that could change the treatment landscape.” CEO David Cory added, “The NMPA approval, coupled with our FDA IND, represents a critical step toward delivering a first‑in‑class therapy to patients worldwide.”
While the company’s stock has gained 20 % year‑to‑date, the approval does not immediately resolve its financial challenges. The regulatory milestone is a positive signal for future growth, but investors will continue to monitor CASI’s ability to translate clinical progress into commercial success and to maintain its liquidity position.
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