Shanghai – November 03, 2026 -- IASO Bio's FUCASO, the first BCMA-targeted CAR-T therapy approved in Singapore, will be covered under the country's Cancer Drug List (CDL) from December 1, 2026. The coverage follows the product's commercial launch in Singapore on November 3 with local partner Pills and Pokes.

Singapore's HSA approved FUCASO in June 2026 for late-line multiple myeloma

The Health Sciences Authority cleared FUCASO for adults with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least three prior lines of therapy. Those lines must include at least one proteasome inhibitor and one immunomodulatory agent. IASO Bio describes the product as the world's first fully human BCMA-targeted CAR-T therapy.

First commercial patient achieved complete response two months after approval

Parkway Cancer Centre in Singapore completed the first commercial infusion two months after approval. The patient, an adult with R/R MM who had received four prior lines of therapy, has achieved complete response.

The case tested the full cross-border chain: patient screening and leukapheresis in Singapore, cold-chain transport, manufacturing and release at IASO Bio's China facility, and cold-chain return for infusion. IASO Bio says the model is now validated commercially and can be replicated in other markets. Pills and Pokes, a specialty pharmaceutical importer and distributor, handles importation, supply and marketing locally.

Singapore's Agency for Care Effectiveness cleared FUCASO for CDL inclusion from December 1

After evaluation by the Agency for Care Effectiveness under the Ministry of Health, FUCASO was added to the CDL. From December 1, eligible patients can claim treatment costs through a financing network of public and commercial funds, which IASO Bio says will significantly reduce out-of-pocket burden. The company is treating the listing as a template for reimbursement bids in other overseas markets.

Pivotal study shows 98.9% overall response rate in first-time CAR-T recipients

In the registrational FUMANBA-1 study, patients receiving CAR-T for the first time showed the following results:

• Overall response rate: 98.9%
• Stringent complete response/complete response rate: 88.4%
• Median progression-free survival: 35.9 months
• Grade 3 or higher cytokine release syndrome: 0.9%

No Grade 3 or higher ICANS, parkinsonism-like manifestations or second primary malignancies were reported.

A retrospective study of 281 R/R MM patients, presented at the 2026 International Myeloma Society Annual Meeting, reported a 95.9% overall response rate and a 77.2% sCR/CR rate. The 12-month progression-free survival rate was 71.5%.

IASO Bio targets Southeast Asia's 600 million people from a Singapore base

The company cites Singapore's hematology-oncology expertise, cell therapy infrastructure and regional patient inflows as the basis for using it as an anchor market. It says HSA decisions carry significant influence across the region, and that CAR-T remains largely inaccessible in most Southeast Asian markets. Treatment in Singapore, it argues, cuts the time and cost of care compared with travel to Europe or the United States.

Zhang Hua, IASO Bio's Chief Business Officer, called the event the "full commercial take-off" of FUCASO in the region. Gail Chang, CEO of Pills and Pokes, said Singapore is the product's first market outside Greater China.