China's Biotech Milestone: Fucaso’s Approval Signals a New Global Era

HONG KONG – November 27, 2025

In a landmark decision that reverberates from Shanghai to global pharmaceutical boardrooms, IASO Bio’s advanced cell therapy, Fucaso (Equecabtagene Autoleucel), has secured marketing approval from the Hong Kong Department of Health. While the approval provides a desperately needed new option for patients with relapsed or refractory multiple myeloma, its true significance extends far beyond the clinic. This event marks a pivotal moment for China's biopharmaceutical industry, validating its innovation pipeline and manufacturing prowess on the world stage.

The approval of Fucaso is the first for a CAR-T therapy developed in Mainland China to be granted in Hong Kong. More critically, it is the first China-developed Advanced Therapy Medicinal Product (ATMP) to achieve recognition under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) for Good Manufacturing Practice (GMP). This dual achievement is not just a win for IASO Bio; it’s a powerful signal that China’s biotech sector is graduating from a regional player to a globally competitive force, capable of meeting the most stringent international quality standards.

The 'Made in China' Seal of Global Quality

For years, the global pharmaceutical industry has watched China’s rapid ascent in drug discovery. Now, the focus is shifting to manufacturing quality—the bedrock of global commercialization. IASO Bio’s PIC/S GMP recognition, granted after a rigorous inspection by Hong Kong’s Department of Health, is a game-changer in this regard.

PIC/S is an international instrument of cooperation between regulatory authorities in the field of GMP. Its membership includes over 50 authorities, including the U.S. FDA and Japan's PMDA, making its standards a de facto global benchmark. Achieving this recognition means IASO Bio's "Manufactured in Nanjing, Supplied Globally" model is not just a corporate slogan but a validated operational reality. It streamlines the path for Fucaso’s entry into other PIC/S member countries, potentially reducing redundant inspections and accelerating market access. For investors and potential partners, this certification de-risks the manufacturing and supply chain, a common point of concern for cross-border collaborations.

This milestone effectively challenges outdated perceptions of Chinese manufacturing and sets a new precedent. It demonstrates that Chinese biopharma companies can build and operate facilities that are not only innovative but also compliant with the highest international quality systems, a crucial factor for building trust with regulators, physicians, and patients worldwide.

Hong Kong's '1+' Pathway: A New Gateway for Innovation

The strategic brilliance of Fucaso’s approval is also a story about regulatory innovation. The therapy was approved under Hong Kong's "1+" mechanism, a forward-thinking policy designed to transform the city into a premier hub for health and medical innovation. Introduced in late 2023, the pathway allows for drug registration based on prior approval from just one reference regulatory authority—in this case, Mainland China's NMPA—supplemented by local clinical evidence.

This streamlined process, which can slash approval times from two years to as little as seven months, positions Hong Kong as a crucial "super-connector." It creates an efficient bridge for cutting-edge therapies developed in Mainland China to gain a foothold in an internationally respected market, one that operates under a different regulatory and legal framework. For companies like IASO Bio, it offers a strategic launchpad for global expansion. For Hong Kong, it cements its role as a vital gateway, attracting R&D investment and clinical trial activity while providing its residents with early access to life-saving treatments.

Ms. Jinhua Zhang, Founder, Chairperson, and CEO of IASO Bio, commented on the process: "This approval in Hong Kong represents an important milestone in our global strategy. We appreciate the rigorous and efficient review conducted by the Hong Kong Department of Health as well as the clarity of the '1+' pathway."

Redefining Hope for Multiple Myeloma Patients

Behind the regulatory and industrial milestones lies a story of profound clinical impact. Fucaso is a CAR-T therapy, a revolutionary approach where a patient's own T-cells are genetically engineered to recognize and destroy cancer cells. It targets the B-cell maturation antigen (BCMA), a protein highly expressed on multiple myeloma cells. For patients who have relapsed after multiple lines of treatment—including proteasome inhibitors and immunomodulatory agents—options are limited and prognoses are often grim.

The approval was based on the impressive results from the FUMANBA-1 registrational study. The data revealed that Fucaso induces deep and durable responses. Across the study, the therapy achieved an overall response rate (ORR) of 96%. Even more striking was the rate of complete response (CR) or stringent complete response (sCR), which reached 88.4% in patients who had not previously received a CAR-T therapy, with a median progression-free survival of nearly 36 months. Furthermore, 95% of all patients achieved minimal residual disease (MRD) negativity, a key indicator of deep remission.

What sets Fucaso apart in a competitive field—which includes globally recognized therapies like Abecma and Carvykti—is its fully human design. This structure is believed to reduce immunogenicity, the risk of the patient's body rejecting the modified cells. Lower immunogenicity may allow the CAR-T cells to persist longer in the body, potentially leading to more sustained anti-tumor activity and a favorable long-term safety profile. The FUMANBA-1 study supported this, showing a low incidence of severe side effects like cytokine release syndrome (CRS) and neurotoxicity, which were overwhelmingly low-grade and manageable.

From Regulatory Approval to Patient Access

With the BLA approved, the critical next step is ensuring broad patient access. Fucaso was previously available in Hong Kong on a limited basis through a Named Patient Programme. The full commercial approval now opens the door for wider, more structured access within the city’s advanced healthcare system.

The key will be Fucaso’s inclusion in the Hong Kong Hospital Authority (HA) Drug Formulary, which governs which medicines are available in the public system that serves the vast majority of the population. The HA has already shown a willingness to embrace the '1+' pathway, having incorporated several drugs approved under the mechanism into its formulary. Inclusion would signify a commitment to making this high-cost, high-impact therapy accessible, shifting the financial burden from individual patients to the public health system.

This approval in Hong Kong is a key step in IASO Bio's global ambitions, which include ongoing BLA reviews in Singapore and Saudi Arabia and clinical development in Japan. The successful navigation of Hong Kong’s regulatory and quality assurance systems provides a robust and validated playbook for expansion, proving that breakthrough therapies from China are ready to meet global standards and address unmet medical needs across the world.