Investigational Drug Information for MB-102

What is the development status for investigational drug MB-102?

MB-102 is an investigational drug.

There have been 6 clinical trials for MB-102. The most recent clinical trial was a Phase 3 trial, which was initiated on March 1^st 2023.

The most common disease conditions in clinical trials are Renal Insufficiency, Kidney Diseases, and Acute Kidney Injury. The leading clinical trial sponsors are MediBeacon, Mustang Bio, and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

There are sixty-one US patents protecting this investigational drug.

Summary for MB-102

US Patents	61
International Patents	0
US Patent Applications	125
WIPO Patent Applications	47
Japanese Patent Applications	4
Clinical Trial Progress	Phase 3 (2023-03-01)
Vendors	13

Recent Clinical Trials for MB-102

Title	Sponsor	Phase
A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants	MediBeacon	Phase 3
A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.	Phase 3
Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring	MediBeacon	Phase 3

See all MB-102 clinical trials

Clinical Trial Summary for MB-102

Top disease conditions for MB-102

Top clinical trial sponsors for MB-102

See all MB-102 clinical trials

US Patents for MB-102

Drugname	Patent Number	Patent Title	Patent Assignee	Estimated Expiration
MB-102		Compositions and methods for assessing gut function	Medibeacon Inc
MB-102		Compositions and methods for assessing eye vasculature	Medibeacon Inc
MB-102		Two piece sensor assembly and method of use	Medibeacon Inc
MB-102		Compositions and methods for assessing gut function	Medibeacon Inc
MB-102		Compositions and methods for assessing gut function	Medibeacon Inc
MB-102		3′3′-cyclic dinucleotides	Institute of Organic Chemistry and Biochemistry of ASCR vvi

MB-102 Development Update and Market Projection

Last updated: September 8, 2026

MB-102 is publicly associated with Mustang Bio’s investigational CD20-directed chimeric antigen receptor T-cell, or CAR-T, program for relapsed or refractory B-cell malignancies. The program has not reached FDA approval, commercial launch, or established revenue generation. Mustang Bio’s current strategic focus has shifted toward other assets, particularly MB-101, MB-105, and MB-106, leaving MB-102 with limited visible development momentum. [1][2]

The commercial opportunity remains substantial because CD20-positive non-Hodgkin lymphoma is a large treatment market, but MB-102 would face intense competition from approved CD19 CAR-T products, bispecific antibodies, antibody-drug conjugates, autologous CD20 CAR-T programs, and established anti-CD20 antibodies.

What is MB-102 and which company developed it?

MB-102 is an autologous CAR-T candidate designed to recognize CD20, a validated antigen expressed on many B-cell malignancies. The program was developed by Mustang Bio, a subsidiary of Fortress Biotech, in connection with its broader cellular-therapy portfolio. [1]

Attribute	MB-102
Developer	Mustang Bio, Inc.
Parent company	Fortress Biotech, Inc.
Modality	Autologous CAR-T cell therapy
Target	CD20
Primary disease area	B-cell non-Hodgkin lymphoma and related B-cell malignancies
FDA status	Investigational; no approval identified
Commercial status	Not marketed
Orange Book status	No listing expected because MB-102 is not an approved small-molecule drug
Biosimilar pathway	Not applicable in the conventional sense; competition would arise from competing biologics and cell therapies
Public commercial revenue	None identified

CD20 is a clinically validated target. Rituximab and obinutuzumab have established the target in B-cell lymphoma and leukemia, while CD20-directed CAR-T programs seek to provide deeper or more durable cellular killing.

What is the current development status of MB-102?

MB-102 has not emerged as one of Mustang Bio’s lead clinical assets in recent public corporate disclosures. Mustang’s more visible CAR-T programs have included MB-101, an IL13Rα2-directed therapy for glioblastoma, MB-105, a PSMA-directed therapy for prostate cancer, and MB-106, a CD20-directed program associated with Fred Hutchinson Cancer Center. [1][2]

The distinction between MB-102 and MB-106 is commercially important. Both are associated with CD20-directed CAR-T development, but they represent separate Mustang programs and development relationships. MB-106 has had greater public visibility in clinical development and corporate communications.

Development timeline

Period	Development event
2017-2019	Mustang Bio disclosed a CD20-directed CAR-T program identified as MB-102 in its development portfolio.
2019-2021	The program remained part of Mustang’s broader early-stage cellular-therapy pipeline, with limited publicly disclosed clinical differentiation.
2022-2023	Mustang concentrated investor and development communications on selected lead programs, including MB-101, MB-105, and MB-106.
2024 onward	MB-102 was not prominent in the company’s leading publicly discussed pipeline assets.

The available record does not support treating MB-102 as a late-stage clinical program. There is no public basis for projecting an imminent biologics license application, priority review, or commercial launch.

When could MB-102 lose exclusivity?

MB-102 has no established regulatory exclusivity date because the product has not received FDA approval. If approved as a biologic, the product could receive 12 years of reference-product exclusivity under the Public Health Service Act, subject to statutory limitations and the date of any eventual approval. [3]

Patent expiry would depend on the specific patent family, earliest effective nonprovisional filing date, patent-term adjustment, patent-term extension, terminal disclaimers, and continuation practice. No reliable commercial forecast should use a single patent-expiry date without a verified patent-family analysis.

The relevant regulatory exclusivity framework would be:

Exclusivity type	Potential treatment
Biologic reference-product exclusivity	Generally 12 years from FDA licensure
Orphan-drug exclusivity	Seven years if orphan designation and approval requirements are met
Pediatric exclusivity	Six additional months if statutory requirements are satisfied
Patent protection	Usually based on 20 years from the earliest effective nonprovisional filing date, subject to adjustments
Orange Book listing	Not applicable to an unapproved cell therapy
Purple Book reference	Potentially relevant after biologic approval

What patents protect MB-102?

Publicly available business disclosures do not establish a complete, verified patent estate for MB-102. The likely protection categories are:

1. CAR construct design, including the binding domain and intracellular signaling domains.
2. Nucleic acids and vectors used to introduce the CAR into T cells.
3. Manufacturing methods for cell activation, transduction, expansion, and cryopreservation.
4. Patient-treatment methods for CD20-positive malignancies.
5. Combination treatment with lymphodepletion, antibodies, checkpoint inhibitors, or other immunotherapies.
6. Product specifications, release testing, and potency assays.

CAR-T patent strength depends on claim scope and freedom-to-operate risk. A broad CD20-targeting claim may face validity and written-description challenges because CD20 CAR constructs are widely disclosed. Manufacturing claims can provide more durable protection if they cover a specific process that improves transduction, persistence, yield, or product consistency.

How strong is the MB-102 patent estate?

MB-102’s patent estate cannot be rated as strong based on public information alone. The commercial position appears weaker than that of a program with:

• A disclosed issued patent family covering the exact CAR construct.
• Confirmed ownership or exclusive licensing rights.
• Composition-of-matter claims extending beyond the basic CD20 target.
• Validated manufacturing claims.
• Issued patents in the United States, Europe, Japan, and China.
• Patent-term protection aligned with a realistic launch date.

The most significant legal risk is crowded prior art around CD20 CAR-T design. The strongest defensible position would likely come from specific construct architecture, manufacturing controls, or clinical-use claims rather than generic claims to CD20 CAR-T cells.

What is the FDA and Orange Book status of MB-102?

MB-102 has no FDA approval and no commercial labeling. It therefore has no approved indication, no FDA-recognized launch date, and no Orange Book patent listings.

Orange Book litigation and Paragraph IV challenges generally apply to approved small-molecule drugs listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. An investigational CAR-T product such as MB-102 would instead face later competition through biologics regulation, patent litigation, competing cell therapies, and potentially biosimilar or interchangeable-product pathways if the product ultimately receives approval. [4]

A future MB-102 approval would likely require:

• An investigational new drug application.
• A registrational clinical program in relapsed or refractory CD20-positive disease.
• Chemistry, manufacturing, and controls validation.
• Demonstration of product consistency across manufacturing sites.
• Long-term follow-up for delayed adverse events.
• A biologics license application under section 351(a) of the Public Health Service Act.

Which companies are challenging the MB-102 market?

MB-102 would compete against approved products and late-stage development programs rather than generic tablets. The main competitive groups are:

Competitive group	Representative products or companies	Competitive advantage
CD19 CAR-T	Yescarta, Kymriah, Tecartus, Breyanzi	Established efficacy, manufacturing experience, regulatory approvals
CD20 antibodies	Rituxan, Ruxience, Truxima, Riabni, Gazyva	Lower administration complexity and broad physician familiarity
Bispecific antibodies	Lunsumio, Columvi, Epkinly	Off-the-shelf treatment and repeat dosing
CD20 CAR-T programs	Mustang Bio and other academic or industry programs	Target validation and possible antigen-specific differentiation
Next-generation CAR-T	Allogeneic, armored, dual-target, and memory-enriched programs	Potentially lower cost, faster treatment, or improved persistence
Antibody-drug conjugates	Polivy and future agents	Established or emerging use in aggressive B-cell lymphoma

MB-102 would need to demonstrate a meaningful benefit over CD19 CAR-T and bispecific antibodies. A CD20 target alone would not provide sufficient differentiation.

What generic entry risks exist for MB-102?

Traditional generic entry risk is low because MB-102 is a cell therapy rather than a conventional small-molecule drug. The primary risks are:

• Competing CD20 CAR-T products.
• CD19 CAR-T products expanding into the same treatment lines.
• Bispecific antibodies replacing or delaying CAR-T treatment.
• Improved anti-CD20 antibody regimens.
• Allogeneic CAR-T products with shorter manufacturing times.
• Patent challenges against construct or manufacturing claims.
• Hospital reluctance caused by complex logistics and treatment-center requirements.

The largest commercial threat is substitution by off-the-shelf bispecific antibodies. These products can avoid individualized manufacturing and may be administered through a more familiar treatment pathway.

What market could MB-102 address?

The addressable market is the population with relapsed or refractory CD20-positive B-cell lymphoma, particularly diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and related non-Hodgkin lymphoma subtypes.

The commercial opportunity should be modeled as a treatment-center-limited market rather than the entire CD20-positive patient population. Manufacturing capacity, referral patterns, reimbursement, performance status, prior CAR-T exposure, and line-of-therapy requirements would limit actual uptake.

Scenario-based market projection

Scenario	Annual treated patients	Estimated net price per patient	Potential annual revenue
Low adoption	500	$250,000	$125 million
Base adoption	1,500	$300,000	$450 million
High adoption	3,000	$350,000	$1.05 billion

These figures represent commercial scenarios, not a company guidance forecast. They assume regulatory approval, adequate manufacturing capacity, payer coverage, and clinical differentiation. The low scenario reflects narrow use after multiple prior therapies. The high scenario requires strong durability data, manageable toxicity, and broader use across CD20-positive lymphoma.

A realistic risk-adjusted value would be materially lower while MB-102 remains an early or inactive program. For an early-stage autologous CAR-T asset with uncertain clinical activity and no visible late-stage regulatory path, a commercial probability of success would generally be far below that of an approved or registrational-stage product.

How does MB-102 compare with MB-106?

MB-106 appears to have greater public development visibility than MB-102. Both programs involve CD20-directed CAR-T development, but their clinical positioning and development relationships differ.

Metric	MB-102	MB-106
Target	CD20	CD20
Modality	Autologous CAR-T	Autologous CAR-T
Public development visibility	Limited	Higher
Current lead-program status	Unclear or deprioritized	More prominent in public disclosures
Differentiation challenge	High	High
Commercial readiness	Pre-commercial	Pre-commercial
Principal risk	Program prioritization and competitive crowding	Clinical, manufacturing, and financing execution

MB-106 is the more relevant internal comparator when evaluating Mustang Bio’s CD20 strategy. MB-102 would require a clearly superior construct, manufacturing advantage, licensing position, or clinical profile to justify renewed investment.

What licensing and transaction risks affect MB-102?

Mustang Bio’s cell-therapy programs have relied on academic and institutional relationships. For MB-102, the key diligence issues are:

• Ownership of the CAR sequence and vector technology.
• Field-of-use restrictions.
• Sublicensing rights.
• Milestone and royalty obligations.
• Rights to improvements and manufacturing processes.
• Termination provisions.
• Patent-prosecution control.
• Rights to clinical data generated by academic collaborators.

A program can have scientific value but limited transaction value if the company lacks exclusive worldwide rights or must pay substantial royalties. No major commercial licensing transaction establishing a validated value for MB-102 has been publicly identified.

What generic launch scenarios exist for MB-102?

If MB-102 were revived and approved, the most likely launch paths would be:

Narrow launch

Approval in heavily pretreated CD20-positive lymphoma, with use at a limited number of authorized treatment centers. This would reduce manufacturing risk but produce modest revenue.

Competitive launch

Approval supported by response-rate and durability data sufficient to compete with CD19 CAR-T and bispecific antibodies. This scenario could support several hundred million dollars in annual sales but would require strong reimbursement and manufacturing performance.

Platform expansion

Initial approval followed by development in earlier lines of therapy, combination regimens, or additional CD20-positive malignancies. This is the only scenario likely to support billion-dollar annual sales, but it would also require additional trials and manufacturing scale.

Key Takeaways

• MB-102 is associated with Mustang Bio’s investigational CD20-directed CAR-T program.
• The product has no FDA approval, commercial sales, Orange Book listing, or established exclusivity date.
• Public development visibility is limited compared with Mustang’s MB-101, MB-105, and MB-106 programs.
• The main market opportunity is relapsed or refractory CD20-positive B-cell lymphoma.
• Competition from CD19 CAR-T products and bispecific antibodies is the central commercial risk.
• A plausible annual sales range, if successfully revived and approved, is approximately $125 million to $1.05 billion depending on adoption and pricing.
• Patent value will depend on construct-specific and manufacturing claims, not merely broad CD20 CAR-T coverage.
• MB-102 currently represents an early-stage, high-risk optionality asset rather than a near-term commercial product.

FAQs

Is MB-102 approved by the FDA?

No. MB-102 has no identified FDA approval or commercial indication.

Is MB-102 a biosimilar to rituximab?

No. MB-102 is an autologous CD20-directed CAR-T cell therapy, while rituximab is an anti-CD20 monoclonal antibody.

Does MB-102 have an Orange Book patent listing?

No. An investigational CAR-T therapy would not normally have an Orange Book listing before FDA approval.

Could MB-102 compete with Yescarta or Breyanzi?

Yes. If approved for overlapping B-cell lymphoma indications, MB-102 would compete with CD19-directed CAR-T products such as Yescarta and Breyanzi, as well as bispecific antibodies.

What is the most important value driver for MB-102?

The decisive value driver would be evidence that CD20 targeting provides superior durability, safety, manufacturing reliability, or treatment access compared with approved CD19 CAR-T therapies and off-the-shelf bispecific antibodies.

References

1. Mustang Bio, Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission. https://www.sec.gov/edgar/browse/?CIK=1556266

2. Fortress Biotech, Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission. https://www.sec.gov/edgar/browse/?CIK=1429260

3. U.S. Food and Drug Administration. (2024). Reference product exclusivity for biological products filed under the Public Health Service Act. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/reference-product-exclusivity-biological-products

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book