- Trial Phase
- Approved
- Time to Market
- Already approved. First approved by FDA in March 2016 (US) and by NMPA in December 2018 (China). Commercial launch in China was August 2019.
- Why 3/10
- Evomela is already FDA- and NMPA-approved and on the market, with no pending PDUFA or pivotal readout. The next dated binary for this drug would be any sales recovery milestone under the revised China license (settled June 2026), but there is no hard catalyst date. Per the rubric, an approved marketed drug with no imminent regulatory binary scores 3-5, and the score is set at 3 because the asset is in secular decline amid generic competition and the company is distressed.
Evomela is a declining revenue product for a company that was delisted from Nasdaq and has warned of going-concern risk. The stock (now OTC: CASIF) has lost most of its value. CASI is pivoting to its pipeline asset CID-103 (anti-CD38 antibody), but Evomela remains the only commercialized product. The June 2026 settlement with Acrotech preserved the China license but added minimum purchase commitments — watch for CASI's ability to meet those given generic pressure.
Price Chart
Executive Summary
Evomela (melphalan for injection) is CASI Pharmaceuticals' only commercialized product, approved in the US since 2016 and in China since 2018. It is a reformulated version of the decades-old chemotherapy melphalan, used as a conditioning agent before stem cell transplants in multiple myeloma. CASI holds exclusive rights to commercialize Evomela in Greater China under a license originally granted by Spectrum Pharmaceuticals (later assigned to Acrotech Biopharma). The drug faces severe headwinds: a domestic generic melphalan competitor in China has eroded sales, driving revenue from $28.5M (2024) to $20.7M (2025). A license-termination dispute with Acrotech was settled in June 2026, preserving CASI's rights but adding minimum purchase commitments. CASI was delisted from Nasdaq in February 2026 (now OTC: CASIF) and has warned of substantial doubt about its ability to continue as a going concern.
How It Works
Evomela is an intravenous chemotherapy drug (melphalan, an alkylating agent) that works by damaging cancer cells' DNA, preventing them from dividing. It is used at high doses as a conditioning treatment before a stem cell transplant in patients with multiple myeloma. Its key differentiating feature vs. older melphalan formulations is that it uses Captisol technology instead of propylene glycol, giving it longer stability once mixed — which allows longer infusion times and more flexible administration.
Trial Status
Approved by FDA (2016) based on a Phase 2b bioequivalence study vs. Alkeran. Approved by China's NMPA (2018). Commercialized in China since August 2019. No further pivotal trials pending for this formulation.
The Two-Sided Case
Upcoming Catalysts
- Progress on CID-103 (anti-CD38 antibody) pipeline — CASI's key strategic pivot — including any FDA clinical hold resolution or Phase 2 data
- Ability to meet minimum Evomela purchase commitments under the revised Acrotech license agreement
- Any further acquisition proposal for CASI's China business (Dr. Wei-Wu He made an offer in June 2024)
- Quarterly revenue reports tracking Evomela's sales trajectory vs. generic competition
Source Filing
The SecBot filing or press-release report that triggered this drug report:
CASI Pharmaceuticals, Inc. 6-K CASIF ·Originating report