Kyowa Kirin : to Regain Control of Rocatinlimab Development and Commercialization Program

Published February 9, 2026 at 6:59 a.m. UTC

Source: MarketScreener

‌Kyowa Kirin to Regain Control of Rocatinlimab Development and Commercialization Program‌

February 2nd, 2026

Chairman and Chief Executive Officer (CEO) Masashi Miyamoto, Ph.D. President and Chief Operating Officer (COO) Abdul Mullick, Ph.D.

Managing Executive Officer, Chief Financial Officer (CFO) Motohiko Kawaguchi Managing Executive Officer, Chief Strategy Officer (CSO) Yasuo Fujii, MBA

‌Kyowa Kirin will continue to advance rocatinlimab development to create Life-changing value that makes people smile

Existing license and collaboration agreement will be terminated following Amgen's strategic
portfolio prioritization, and Kyowa Kirin will regain control of the global rocatinlimab program
Kyowa Kirin affirms commitment to developing rocatinlimab as a Life-changing differentiated asset with significant market potential
Regulatory submissions are planned for the first half of 2026
Amgen will provide transitional long-term manufacturing and supply of rocatinlimab to Kyowa Kirin
All eight Phase 3 studies (ROCKET Program) successfully met their primary and key secondary endpoints. Of note, rocatinlimab demonstrated a significant improvement in the co-primary

endpoint required for US regulatory submission, the revised Investigator's Global Assessment (rIGA) score of 0 or 1 (defined as achieving a vIGA-AD score of 0 [clear skin] or 1 [almost clear skin] with presence of only barely perceptible erythema) at week 24

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.

‌Rocatinlimab is a T-cell Rebalancing Therapy which directly targets a root cause of AD, activated pathogenic Effector and Memory T-cells

OX40

Ligand

OX40

(Receptor)

OX40

(Receptor)

OX40

(Receptor)

Antigen

Presenting Cell

Activated

T-cell

T-cell Rebalancing Approach

Novel upstream mechanism directly targeting pathogenic T cell: Inhibits and reduces OX40R+ T-cells that produce cytokines, one of the root causes of chronic inflammation

Cytokines

IL-4, IL-13, IL-31, TNFα, IL-

17, IL-5, IL-2, IL-22, IFNγ

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority. 2

‌At present, more than 10 assets related to OX40/OX40L are in clinical stage globally

OX40 signalling leads to the activation of downstream pathways that drive effector and memory T-cell differentiation, proliferation and survival1,2

Amlitelimab is an anti-OX40L therapy that

blocks the OX40 pathway by

binding to OX40L on APCs1,2

Amlitelimab1,2

…

APG9905

OX40

Ligand

OX40

(Receptor)

Rocatinlimab acts directly on pathogenic T cells by targeting OX40 receptor1,2

…

Rocatinlimab1,2IMG-0073STAR-03104

Antigen Presenting Cell (APC)

Activated T-cell

Note: AD, atopic dermatitis; APC, antigen-presenting cell; OX40R, OX40 receptor; OX40L, OX40 ligand.

1. Croft, et al. Am J Clin Dermatol 2024;25:447-461; 2. Le AM, et al. Pharmaceutics 2022;14:2753; 3. Shen Y, et al. Br J Dermatol 2024;191(Suppl 2); 4. Biris N, et al. Presented at EAACI 2024. Poster D1.343; 5. Wong M et al. RAD 2025., Kyowa Kirin internal search

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority. 3

‌Kyowa Kirin has absolute conviction in rocatinlimab's science and excited to advance Rocatinlimab program to the next chapter

Global Ph3 mono-therapy

data Published

Kyowa Kirin regain control of the global

program

Antagonist OX40 mAb

discovery project initiated based on proposal

from Dr. Croft at La Jolla Institute

(LJI)

2003

rocatinlimab precursor discovered

2003

Activity of rocatinlimab confirmed

2007

Pre-clinical studies initiated

2010

1st IND for rocatinlimab

2016

Partnership with Amgen Initiation of Ph3 AD ROCEKT

Program

Rocatinlimab was discovered and advanced by Kyowa Kirin

scientists, drawing on our deep expertise in immunology and

antibody engineering

2021

Global Ph2b data

Published

in the Lancet

2023

in the Lancet

2025

2026

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority. 4

‌Moderate-to-Severe Atopic Dermatitis (msAD) is a chronic, heterogeneous inflammatory skin disease that imposes a substantial burden on patients and caregivers

Many patients strive to find relief, and hope for new treatment options

Impact of Moderate-to-Severe AD:

Skin Symptoms

Excessively dry, itchy, and painful skin

Repeated scratching can lead to thickened, hardened skin and increased infection risk

Sleep Disruption

Chronic symptoms negatively impacts sleep in up to 80% of children and 90% of adults

Mental Health

Adults are twice as likely to experience depression and anxiety

Daily Life

Reduced productivity, limited social interactions and an overall

Despite existing therapies, many patients with moderate-to-severe AD continue to

experience inadequate disease control 1,2,3

1. Lio P, et al. J Drugs Dermatol. 2023;22:119-131. 2. Eichenfield LF, et al. SKIN J Cutaneous Med. 2024;8(6):s462. 3. Hongbo Y, et al. J Invest Dermatol. 2005;125:659-664.

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.

decrease in Quality of Life

‌Strictly Confidential

Current treatment options often fail to provide sufficient depth and durability of symptom improvement1-3

Due to the heterogeneous pathogenesis of AD, no one therapy shows consistent efficacy across diverse patient populations.
Only 10 - 15% of eligible patients are currently receiving biologic treatment4, indicating
considerable opportunity for growth in the msAD market.
More than 50% of patients receiving systemic therapies discontinue treatment within a year5.
Treatment goals have evolved from "short-term symptom control" to "long-term disease control",

There remains an urgent need for new therapies with novel mechanisms of action to expand

treatment options for patients with moderate-to-severe AD

1. Lio P, et al. J Drugs Dermatol. 2023;22:119-131. 2. Eichenfield LF, et al. SKIN J Cutaneous Med. 2024;8(6):s462. 3. Hongbo Y, et al. J Invest Dermatol. 2005;125:659-664. 4. IQVIA analysis: Closing in: Novel oral

immunotherapies are taking on the biologics [LINK], 5. Kyowa Kirin/Amgen internal data on file

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.

and ultimately toward "disease modification".

‌For patients with Atopic Dermatitis, Unmet Medical Needs (UMN) still exist

There remain significant unmet medical needs in AD. Few patients are able to continue existing advanced treatments over the long term. Patients are eagerly waiting for innovative new options.
I welcome new drug candidates with novel mechanism of actions that have the potential to deliver unique value that other therapies are not able to provide.

Professor Kenji Kabashima
Department of Dermatology,
Kyoto University Graduate School of Medicine
The following conflicts of interest (COI) should be disclosed in relation to this material.
7
COI Disclosure
Kenji Kabashima Department of Dermatology,
Kyoto University Graduate School of Medicine
Professor

Receives consulting fees from Kyowa Kirin Co., Ltd.

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.

‌Strong Growth Expected in the msAD Markets Driven by increasing penetration of biologics and the introduction of novel therapies

Atopic Dermatitis Market Outlook

Atopic Dermatitis

Market Overview

Estimated U.S. AD patient 12y+ population

>23 million

AT*-treated # of Patients in U.S**

800-850K

Biologic penetration in the U.S.

Projected sales

growth

15- 20%

Over 15%

400-450K

2030 and beyond

2026

6 therapies

launched to date

Dupixent Adbry Rinvoq Cibinqo

Nemluvio

Ebglyss

~75% anticipated increase in AT treated population from 6 to 10+ products launched based on similarities with psoriasis market

SOURCE: National Eczema Association; Asthma and Allergy Foundation of America; US Census Data; WHO, CDC, analyst research. FDA labels; corporate presentations; Clinicaltrials.gov; Allergy& Asthma Network; Datamonitor; Chan et al., J Am Acad Dermatol (2025); Hanifin et al., Dermatitis (2007); Silverberg et al., J Allergy Clin Immunol (2013); Datamonitor; Therapeutic Categories Outlook, TD Cowen (2024), Gorritz et al., J Derm Treat (2022); Heratizadeh et al., J Eur Acad Dermatol Venereol (2024); Lio et al., J Drugs Dermatol (2023); Fuxench et al., J Inv Dermatol(2019); Boytsov et al., J Derm Treat (2022); * Advanced Therapy, ** Based on L.E.K. epidemiology assessment

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority. 8

‌Rocatinlimab delivers progressive increases in the proportion of patients achieving deep responses through Week 52

2 4 8 12 16 20 24 28 32 36 40 44 48 52 2 4 8 12 16 20 24 28 32 36 40 44 48 52

Study week Study week

60.2

57.4

100 100

EASI-90

vIGA-0/1

Percentage of patients

ROCKET-ORBIT Topline: 52-week Open Label Adolescent Trial*

Safety results are consistent with

those observed in the ROCKET

24-week and 56-week adult trials.

The most frequent TEAE in ROCKET-

ORBIT were headache, pyrexia, apthous ulcer, upper respiratory tract infection, and nasopharyngitis.

Low discontinuation rate due to adverse events.

AD = atopic dermatitis; AU = aphthous ulcers; vIGA-AD = Validated Investigator's Global Assessment for Atopic Dermatitis; EASI = Eczema Area and Severity Index; TEAE = Treatment-Emergent Adverse Event

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.

*Data on file 9

‌A Robust Launch Readiness Upon Regulatory Approval

Kyowa Kirin has established operations in Japan, U.S., and Europe with proven track records

Japan: Strong track record in dermatology
U.S. and Europe: Excellent core teams across Sales, Marketing, Market Access, Medical, Patient

Support; proven success with Crysvita and Poteligeo

U.S. Dermatology Launch Preparation

Multi-year preparation for co-promotion with Amgen
Core functional teams already in place
Continued investment to ensure readiness for potential approval and launch

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.

Robust Manufacturing Capabilities Established

Combines Amgen's world-class manufacturing capability with Kyowa Kirin's global supply

infrastructure to ensure stable and reliable product supply

‌This transition will allow Kyowa Kirin to bring Rocatinlimab with the highest priority and urgency to patients around the world

Item	Original Agreement	After Original Agreement Termination
Market Authorization Holder	Amgen	Kyowa Kirin
Manufacturing	Amgen	Amgen will provide transitional long-term manufacturing and supply of rocatinlimab to Kyowa Kirin
Development	Led by Amgen	Led by Kyowa Kirin with certain transition services from Amgen
Commercialization	Japan: Kyowa Kirin US: Amgen (Kyowa Kirin co-promotion) Europe/Asia: Amgen (Kyowa Kirin retains co-promotion rights)	Japan & US: Kyowa Kirin Europe/Asia: Kyowa Kirin explores all options

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.

‌Impact on P&L: Short-term cost increase, but substantially beneficial over the mid to long term

Item	Original Agreement	After Original Agreement Termination
Revenue	Kyowa Kirin receives double-digit % royalty	Kyowa Kirin records sales revenue
COGS	-	Amgen supplies products at an agreed-upon price
SG&A Expenses	Shared equally by both companies	100% borne by Kyowa Kirin
R&D Expenses	Shared equally by both companies	100% borne by Kyowa Kirin Service fee payment to Amgen for transition support (FY2026-2027)

Profit Contribution Timing

2028

have not been evaluated by any health authority.

Future Prospects

Peak Sales Potential Over ¥200 billion

Rocatinlimab is currently under clinical investigation. Its efficacy and safety

‌Rocatinlimab: Pioneering a Novel Treatment Paradigm Through T-cell Rebalance

Directly targets a root cause of inflammation and chronicity to potentially achieve deeper and durable improvement
Potential to expand to other inflammatory diseases with significant unmet need

Moderate-to-Severe

Atopic Dermatitis

Patients

16 million

Existing Market Size

JPY 1 trillion~

Prurigo Nodularis

Patients

1 million

Existing Market Size

JPY 0.5-1 trillion

Moderate-to-Severe Asthma

Patients

13.5 million

Existing Market Size

JPY 1 trillion~

P3 Study (ROCKET

program) ongoing

P3 Study Enrollment Complete

P2 Study Enrollment Complete

Kyowa Kirin is fully committed to bringing rocatinlimab to patients worldwide with the highest priority and urgency

This is a catalyst for accelerated growth and the gateway to our next chapter

Rocatinlimab is currently under clinical investigation. Its efficacy and safety have not been evaluated by any health authority.

‌