IR News 2026

Kyoto, Japan, October 29, 2026 – Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; Headquarters, Kyoto; President, Toru Nakai) today announced that it entered into an exclusive sublicense agreement with Tanabe Pharma Corporation (Tanabe Pharma; Headquarters, Osaka; Representative Director, CEO, Akihisa Harada) on October 22 for the exclusive rights to commercialize loncastuximab tesirine-lpyl (MT-2111) in Japan for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).

MT-2111 is a first-in-class CD19-directed antibody drug conjugate (ADC) developed by ADC Therapeutics SA (ADCT). In April 2021, the Product received accelerated approval from the U.S. Food and Drug Administration (FDA) as monotherapy for adult patients with r/r DLBCL after two or more lines of systemic therapy.

In January 2022, Tanabe Pharma entered into a license agreement with ADCT for the development and commercialization of MT-2111 in Japan. Based on the results from the MT-2111-A-101 study in Japanese patients with r/r DLBCL and studies conducted outside Japan, Tanabe Pharma filed a marketing authorization application in Japan on October 29, 2026, for MT-2111 to treat r/r DLBCL after two or more lines of systemic therapy. 

Tanabe Pharma will remain responsible for ongoing development activities and for obtaining regulatory approval in Japan under the current application.

Nippon Shinyaku is committed to developing agents for the treatment of intractable and rare diseases, with a view to deliver new treatment options to patients with B-cell lymphoma as soon as possible.

 

ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA® is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA® (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA®. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA® at www.ZYNLONTA.com. 

ZYNLONTA® is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy. 

MT-2111-A-101, a Phase 1/2, multi-center, open-label, single-arm study consists of a Phase 1 and a Phase 2 part.

The Phase 1 part investigated the safety, tolerability, and pharmacokinetics of MT-2111 monotherapy in patients with r/r DLBCL. The Phase 2 part evaluated the efficacy, safety and pharmacokinetics of MT-2111 monotherapy in r/r DLBCL patients. The primary endpoint of the Phase 2 part is ORR (Overall Response Rate) by independent review committee. The key secondary endpoints include CRR (Complete Response Rate), DOR (Duration of Response), PFS (Progression Free Survival), etc. The Phase 2 part enrolled total 43 Japanese patients.

Based on Nippon Shinyaku’s business philosophy, “Helping people lead healthier, happier lives,” we aim to be an organization trusted by the community through creating unique medicines that will bring hope to patients and families suffering from illness. Please visit our website (https://www.nippon-shinyaku.co.jp/english/) for products or detailed information.

About Tanabe Pharma 

Tanabe Pharma Corporation is a Japan-focused, innovation-driven pharmaceutical company guided by its mission, "Creating hope for all facing illness." Founded in 1678, the company is one of Japan's oldest pharmaceutical companies and is committed to addressing unmet medical needs through R&D, business development, and strategic partnerships with the aim of improving the lives of patients.

For more information, visit https://www.tanabe-pharma.com/en/

ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), transforming treatment for patients through our focused portfolio with ZYNLONTA® (loncastuximab tesirine-lpyl).

ADC Therapeutics' CD19-directed ADC ZYNLONTA® received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA® is also in development in combination with other agents and in earlier lines of therapy. 

Headquartered in Lausanne (Biopôle), Switzerland, with operations in London and New Jersey, ADC Therapeutics is focused on driving innovation in ADC development with specialized capabilities from clinical to manufacturing and commercialization. Learn more at adctherapeutics.com and follow us on LinkedIn.