Kyowa Kirin Co., Ltd. TSE:4151
Kyowa Kirin : Appendix to the Consolidated Financial Summary (IFRS) Fiscal 2026 First Quarter
Source: MarketScreener
Kyowa Kirin Co., Ltd.
May 7, 2026
Appendix to the Consolidated Financial Summary (IFRS)
Fiscal 2026 First Quarter (January 1, 2026 - March 31, 2026)
These materials were made as a supplement to the Kessan Tanshin (Consolidated Financial Summary, IFRS), disclosed at the Tokyo Stock Exchange on May 7, 2026 for the first three months of Fiscal 2026, from January 1, 2026 to March 31, 2026.
This document is an English translation of the Japanese-language original
The statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons.
For the “FY 2026 forecasts” within these materials, revisions have been made to the forecasts announced on February 9, 2026
Figures presented in these materials have been rounded to the nearest tenth
Figures inside parenthesis presented in these materials indicate negative values.
Change amount in these materials presents change amount compared to the same period of the previous fiscal year.
Consolidated Financial Results
Trends in consolidated profit 1
Revenue by regional control function 2
Capital expenditures and intangible assets investment, 2
depreciation and amortization
Number of employees by regional control function 2
Consolidated Statement of Cash Flows 2
Status of Main Products
Revenue by Products 3
Revenue by Location 4
Collaboration Products 5
R&D Pipeline 6
The average exchange rates for each period were as follows:
Unit: Yen
FY 2025 results | FY 2026 results | FY2026 forecasts | ||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | Jan - Dec | |
USD | 154 | 150 | 149 | 150 | 155 | 150 |
GBP | 193 | 193 | 195 | 197 | 210 | 205 |
EUR | 161 | 162 | 165 | 168 | 183 | 180 |
Contact Kyowa Kirin Co., Ltd. Finance Department Tel +81 3 5205 7206
Consolidated Financial Results
Trends in consolidated profit
Unit: Billions of yenFY 2025 results
FY 2026 results
FY 2026
forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Change amount
Rate of change
Jan - Dec
Progress
Revenue
104.7
230.7
349.5
496.8
118.5
13.7
13%
520.0
23%
Cost of sales
(24.6)
(61.9)
(90.1)
(127.9)
(30.2)
(5.6)
23%
(132.0)
23%
Gross profit
80.1
168.8
259.4
368.9
88.2
8.1
10%
388.0
23%
Gross profit to revenue ratio
76.5%
73.2%
74.2%
74.2%
74.5%
-
-
74.6%
-
Selling, general and administrative expenses*2
(40.4)
(79.5)
(116.5)
(157.9)
(41.1)
(0.7)
2%
(163.0)
25%
Research and development expenses
(28.6)
(52.5)
(76.8)
(101.2)
(27.2)
1.4
(5)%
(95.0)
29%
R&D expense ratio
27.3%
22.8%
22.0%
20.4%
22.9%
-
-
18.3%
-
Core operating profit*1
11.2
36.8
66.1
109.8
20.0
8.8
78%
130.0
15%
Core operating profit ratio
10.7%
16.0%
18.9%
22.1%
16.9%
-
-
25.0%
-
Amortization (intangible assets)*2
(1.7)
(3.4)
(5.1)
(7.6)
(2.8)
(1.1)
64%
(11.0)
25%
Share of profit (loss) of investments accounted for using equity method
(0.9)
1.5
1.0
0.8
1.0
1.9
-
-
-
Other income
0.4
0.6
0.7
1.1
0.4
(0.0)
(3)%
Other expenses
(1.6)
(12.9)
(14.7)
(18.0)
(8.1)
(6.5)
410%
Finance income (costs)
0.4
(0.7)
(0.1)
1.1
3.4
3.0
691%
Profit before tax
7.9
22.0
47.9
87.2
13.9
6.1
77%
95.0
15%
Income tax expense
(1.7)
(5.7)
(15.3)
(20.2)
(1.9)
(0.2)
12%
(20.0)
9%
Ratio of income tax burden
21.5%
25.7%
32.0%
23.1%
13.6%
-
-
-
-
Profit
6.2
16.3
32.6
67.0
12.0
5.9
95%
75.0
16%
Profit to revenue ratio
5.9%
7.1%
9.3%
13.5%
10.2%
-
-
14.4%
-
FY 2028 forecasts
Early 20% range
ROE(%)
ROE(%) ※ Three-year average DOE(%)*3
7.7 - 8.2 -
8.3 - 7.7 - Mid 7% range
3.8 - 4.1 - Progressive payou of 4% or more
FY 2025 results
FY 2026 results
FY 2026 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Change amount
Rate of change
Jan - Dec
Progress
Core operating profit*1
11.2
36.8
66.1
109.8
20.0
8.8
78%
130.0
15%
Income tax expense
Ratio of income tax burden
(2.4)
21.5%
(9.5)
25.7%
(21.1)
32.0%
(25.4)
23.1%
(2.7)
13.6%
(0.3)
-
12%
-
(27.0)
-
10%
-
Core Profit*1
8.8
27.4
44.9
84.4
17.3
8.5
96%
103.0
17%
Core EPS (¥/share)*4
16.83 52.25 85.85 161.28 33.04 16.21 - 196.76 -
*1 We have adopted core indicators as performance metrics that offer better comparability with global pharma, reflecting group's sustainable profitability.
The core operating profit is calculated by deducting selling, general and administrative expenses (excl. amortization of intangible assets) and research and development expenses
from gross profit, and further excluding non-recurring items determined by the Company.
The core profit for the period is calculated by deducting income tax expense attributable to the relevant core operating profit from the core operating profit.
*2 Selling, general and administrative expenses do not include amortization of intangible assets (amortization of marketing rights).
*3 DOE is calculated by dividing the dividend amount by the beginning-of-period capital.
*4 The core EPS is calculated by dividing the core profit for the period by the weighted average number of shares outstanding during the period.
*5 For the actual results in 2025 and 2026 and the forecast for 2026, the Company did not exclude any items as non-recurring gains or losses, as determined by the Company.
Unit: Billions of yenFY 2025 results
FY 2026 results
Jan - Mar
Apr - Jun
Jul - Sep
Oct - Dec
Jan - Mar
Change amount
Rate of change
Revenue
104.7
125.9
118.8
147.4
118.5
13.7
13%
Cost of sales
(24.6)
(37.3)
(28.2)
(37.9)
(30.2)
(5.6)
23%
Gross profit
80.1
88.7
90.6
109.5
88.2
8.1
10%
Gross profit to revenue ratio
76.5%
70.4%
76.3%
74.3%
74.5%
-
-
Selling, general and administrative expenses
Research and development expenses
(40.4)
(28.6)
(39.1)
(23.9)
(37.0)
(24.3)
(41.4)
(24.3)
(41.1)
(27.2)
(0.7)
1.4
2%
(5)%
R&D expense ratio
27.3%
19.0%
20.5%
16.5%
22.9%
-
-
Core operating profit
11.2
25.6
29.2
43.8
20.0
8.8
78%
Core operating profit ratio
10.7%
20.3%
24.6%
29.7%
16.9%
-
-
Amortization (intangible assets)
(1.7)
(1.7)
(1.7)
(2.5)
(2.8)
(1.1)
64%
Share of profit (loss) of investments accounted for using equity method
(0.9)
2.5
(0.6)
(0.2)
1.0
1.9
-
Other income
0.4
0.2
0.2
0.3
0.4
(0.0)
(3)%
Other expenses
(1.6)
(11.3)
(1.9)
(3.3)
(8.1)
(6.5)
410%
Finance income (costs)
0.4
(1.2)
0.7
1.1
3.4
3.0
691%
Profit before tax
7.9
14.1
25.9
39.3
13.9
6.1
77%
Income tax expense
(1.7)
(4.0)
(9.7)
(4.9)
(1.9)
(0.2)
12%
Profit
6.2
10.2
16.3
34.4
12.0
5.9
95%
Profit to revenue ratio
5.9%
8.1%
13.7%
23.4%
10.2%
-
-
FY 2025 results
FY 2026 results
Jan - Mar
Apr - Jun
Jul - Sep
Oct - Dec
Jan - Mar
Change amount
Rate of change
Core operating profit
11.2
25.6
29.2
43.8
20.0
8.8
78%
Income tax expense
(2.4)
(7.1)
(11.6)
(4.3)
(2.7)
(0.3)
12%
Core Profit
8.8
18.5
17.6
39.5
17.3
8.5
96%
*The underlined portion indicates that the amount has been changed from the amount presented in "Appendix to the Consolidated Financial Summary (IFRS) Fiscal 2025" (announced on February 9, 2026)
- 1 -
Revenue by regional control function
Unit: Billions of yenFY 2025 results
FY 2026
results
FY 2026 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Change amount
Jan - Dec
Progress
Japan
27.2
58.4
89.7
122.5
26.2
(0.9)
111.5
24%
North America
35.5
88.4
129.9
192.5
36.2
0.7
211.0
17%
EMEA
19.7
37.0
62.4
83.7
23.1
3.4
78.5
29%
Others
22.3
46.9
67.5
98.1
32.9
10.6
119.0
28%
Total consolidated revenue
104.7
230.7
349.5
496.8
118.5
13.7
520.0
23%
Japan (location of customer)
28.3
63.1
96.0
128.8
27.7
(0.6)
120.0
23%
Overseas (location of customer)
76.4
167.6
253.4
368.0
90.8
14.4
400.0
23%
Overseas ratio
73%
73%
73%
74%
77%
-
77%
-
Revenue by regional control function is classified based on consolidated revenue from products of regional control functions in the One Kyowa Kirin (OKK) matrix global management structure, which combines a regional organization, a functional organization, and a product organization (product franchises).
EMEA consists of Europe, the Middle East, Africa, etc.
Others consists of revenue from technology out-licensing, revenue from APAC, hematopoietic stem cell gene therapy (revenue from Orchard Therapeutics), original equipment manufacturing, etc.
FY 2025 results
FY 2026
results
Jan - Mar
Apr - Jun
Jul - Sep
Oct - Dec
Jan - Mar
Change amount
Japan
27.2
31.2
31.3
32.8
26.2
(0.9)
North America
35.5
52.8
41.5
62.6
36.2
0.7
EMEA
19.7
17.3
25.3
21.3
23.1
3.4
Others
22.3
24.5
20.6
30.6
32.9
10.6
Total consolidated revenue
104.7
125.9
118.8
147.4
118.5
13.7
Capital expenditures and intangible assets investment, depreciation and amortization
Unit: Billions of yen
FY 2025 results
FY 2026 results
FY 2026
forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Jan - Dec
Capital expenditures (property, plant and equipment) *1
Intangible assets investment
8.2
1.3
14.9
9.9
22.9
21.3
35.8
48.1
8.6
2.2
33.9
18.3
Total
9.4
24.9
44.2
83.9
10.8
52.2
Depreciation (property, plant and equipment) Amortization (intangible assets)
Of which, sales right*2
3.8
2.3
1.7
7.6
4.7
3.4
11.7
7.1
5.1
15.8
10.4
7.6
4.2
3.4
2.8
16.8
15.0
11.0
Total
6.1
12.3
18.8
26.1
7.6
31.7
*1 Acquisitions of right-of-use assets are not included.
*2 Amortization of sales right is presented as amortization of intangible assets in the consolidated statement of profit or loss.
Number of employees by regional control function
FY 2025 results
FY 2026 results
As of
Mar 31
As of
Jun 30
As of
Sep 30
As of
Dec 31
As of
Mar 31
Change
amount
Japan
3,898
3,890
3,882
3,508
3,483
(415)
North America
709
678
699
706
740
31
EMEA
538
540
544
551
540
2
Others
375
381
387
397
402
27
Total
5,520
5,489
5,512
5,161
5,165
(355)
* Others consists of number of employees of APAC subsidiaries, Orchard Therapeutics, etc.
Consolidated Statement of Cash Flows Unit:Billionsofyen
FY 2025 results
FY 2026 results
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Change
amount
Cash flows from operating activities
7.4
39.8
69.6
96.6
56.3
48.9
Cash flows from investing activities
(21.5)
(34.7)
(41.6)
(89.2)
(8.6)
12.9
Cash flows from financing activities
(16.5)
(17.2)
(33.6)
(36.9)
(17.9)
(1.4)
Effect of exchange rate changes on cash and cash equivalents
0.3
2.0
1.2
3.5
0.9
0.6
Net increase (decrease) in cash and cash equivalents
(30.3)
(10.1)
(4.5)
(25.9)
30.8
61.1
Cash and cash equivalents at beginning of period
244.7
244.7
244.7
244.7
218.8
(25.9)
Cash and cash equivalents at end of period
214.4
234.6
240.2
218.8
249.5
35.2
- Revenue by Products Unit: Billions of yenUnit: Billions of yen
FY 2025 results
FY 2026 results
FY 2026 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Change amount
Jan - Dec
Progress
Products*1
91.8
205.2
310.1
438.4
93.6
1.9
445.1
21%
Crys vita
42.4
99.8
146.7
216.4
45.7
3.2
235.4
19%
Poteligeo
9.8
21.6
33.7
45.7
12.1
2.3
54.6
22%
Libmeldy/Lenmeldy
2.1
4.4
4.4
6.4
1.5
(0.6)
10.0
15%
Nourianz
2.0
4.6
6.9
9.5
1.9
(0.1)
7.4
25%
PHOZEVEL
1.5
3.7
5.9
8.2
1.9
0.4
11.6
17%
Duvroq
3.0
6.9
10.9
15.5
3.6
0.6
16.2
22%
Nesp
0.5
0.9
1.1
1.4
0.2
(0.3)
0.8
25%
Darbepoetin Alfa Injection Syringe [KKF]
2.3
4.9
7.6
10.4
2.2
(0.1)
9.2
24%
G-Las ta
4.3
9.1
13.7
18.2
3.5
(0.8)
16.2
22%
Romiplate
3.4
7.3
11.5
15.9
3.7
0.3
11.4
33%
Orkedia
2.4
5.4
8.2
11.3
2.4
0.0
11.6
21%
Rituximab BS [KHK]
1.5
3.2
5.0
6.9
1.5
(0.0)
5.7
27%
Nourias t
1.4
3.1
4.6
6.3
1.3
(0.1)
5.1
25%
HARUROPI
1.0
2.1
3.3
4.5
1.0
(0.0)
4.0
24%
Technology out-licensing*2
13.0
25.5
39.4
58.4
24.8
11.9
74.9
33%
Benralizumab royalty*3
7.4
15.7
25.4
38.1
8.6
1.2
Total
104.7
230.7
349.5
496.8
118.5
13.7
520.0
23%
FY 2025 results
FY 2026 results
Jan - Mar
Apr - Jun
Jul - Sep
Oct - Dec
Jan - Mar
Change
amount
Products*1
91.8
113.4
104.9
128.3
93.6
1.9
Crys vita
42.4
57.3
46.9
69.7
45.7
3.2
Poteligeo
9.8
11.8
12.1
12.0
12.1
2.3
Libmeldy/Lenmeldy
2.1
2.3
(0.0)
2.0
1.5
(0.6)
Nourianz
2.0
2.6
2.3
2.6
1.9
(0.1)
PHOZEVEL
1.5
2.1
2.2
2.3
1.9
0.4
Duvroq
3.0
3.8
4.1
4.6
3.6
0.6
Nesp
0.5
0.4
0.3
0.3
0.2
(0.3)
Darbepoetin Alfa Injection Syringe [KKF]
2.3
2.6
2.7
2.8
2.2
(0.1)
G-Las ta
4.3
4.8
4.6
4.5
3.5
(0.8)
Romiplate
3.4
3.9
4.2
4.4
3.7
0.3
Orkedia
2.4
2.9
2.9
3.1
2.4
0.0
Rituximab BS [KHK]
1.5
1.7
1.8
1.8
1.5
(0.0)
Nourias t
1.4
1.7
1.6
1.7
1.3
(0.1)
HARUROPI
1.0
1.2
1.1
1.3
1.0
(0.0)
Technology out-licensing*2
13.0
12.5
13.9
19.1
24.8
11.9
Benralizumab royalty*3
7.4
8.3
9.7
12.7
8.6
1.2
Total
104.7
125.9
118.8
147.4
118.5
13.7
*1 For revenue for Japan, the figures shown are those before the deduction of discounts and other items, and for revenue for overseas, the figures shown are those after the deduction of discounts and other items and include the impact of exchange rates.
*2 Revenue listed as “Technology out-licensing” represents the upfront income, milestone revenue and running royalty income that are obtained based on licensing agreements recognizing the granting to third parties the rights for development, manufacturing and sales of the Group’s pipeline compounds or the use of technology, etc.
*3 Benralizumab royalty only refers to the royalty on sales of Fasenra by AstraZeneca (including the Company’s own estimates).
- Revenue by location Unit: Billions of yenUnit: Billions of yen
Product name
FY 2025 results
FY 2026 results
FY 2026 forecasts
Jan - Mar
Jan - Jun
Jan - Sep
Jan - Dec
Jan - Mar
Change amount
Jan - Dec
Progress
Crysvita
42.4
99.8
146.7
216.4
45.7
3.2
235.4
19%
Japan
2.8
6.1
9.7
13.6
3.4
0.7
14.7
23%
North America
[Millions of USD]
24.1
157
64.0
430
92.0
620
141.8
946
23.5
151
(0.6)
(5)
220.7
19%
EMEA
[Millions of GBP]
14.8
77
28.0
145
42.4
219
57.5
293
17.9
85
3.1
8
Others
0.8
1.7
2.6
3.5
0.9
0.1
Poteligeo
9.8
21.6
33.7
45.7
12.1
2.3
54.6
22%
Japan
0.3
0.7
1.2
1.6
0.4
0.1
1.4
25%
North America
[Millions of USD]
6.9
45
16.0
107
25.1
169
33.9
227
8.9
57
2.0
13
40.9
273
22%
21%
EMEA
[Millions of GBP]
2.6
13
4.9
25
7.3
38
10.0
51
2.8
13
0.2
0
12.0
59
23%
23%
Others
0.0
0.1
0.1
0.2
0.0
(0.0)
0.2
9%
Libmeldy/Lenmeldy
2.1
4.4
4.4
6.4
1.5
(0.6)
10.0
15%
US
1.1
1.6
1.6
2.9
1.1
0.0
4.5
EMEA
1.0
2.8
2.8
3.5
0.4
(0.6)
5.5
Product name
FY 2025 results
FY 2026 results
Jan - Mar
Apr - Jun
Jul - Sep
Oct - Dec
Jan - Mar
Change
amount
Crysvita
42.4
57.3
46.9
69.7
45.7
3.2
Japan
2.8
3.3
3.6
3.9
3.4
0.7
North America
[Millions of USD]
24.1
157
39.9
273
28.0
191
49.8
325
23.5
151
(0.6)
(5)
EMEA
[Millions of GBP]
14.8
77
13.2
68
14.4
74
15.1
74
17.9
85
3.1
8
Others
0.8
1.0
0.9
0.9
0.9
0.1
Poteligeo
9.8
11.8
12.1
12.0
12.1
2.3
Japan
0.3
0.4
0.5
0.5
0.4
0.1
North America
[Millions of USD]
6.9
45
9.1
62
9.1
62
8.8
58
8.9
57
2.0
13
EMEA
[Millions of GBP]
2.6
13
2.3
12
2.5
13
2.7
13
2.8
13
0.2
0
Others
0.0
0.0
0.0
0.1
0.0
(0.0)
Libmeldy/Lenmeldy
2.1
2.3
(0.0)
2.0
1.5
(0.6)
US
1.1
0.5
(0.0)
1.3
1.1
0.0
EMEA
1.0
1.8
(0.0)
0.7
0.4
(0.6)
* The revenue, generated in various currencies inside each corporate region, is converted and aggregated in USD for North America and in GBP for EMEA.
- Status of Main Products
- Collaboration Product
- Revenue by Products Unit: Billions of yen
＜Accumulative＞ Unit: Billions of yen
Product name | FY2025 results | FY2026 results | |||||
Jan - Mar | Jan - Jun | Jan - Sep | Jan - Dec | Jan - Mar | Change amount | ||
KOMZIFTI | |||||||
Revenue*1 [Millions of USD] | - - | - - | - - | 0.3 2 | |||
Profit／Loss [Millions of USD] | (1.3) (8) | (3.1) (20) | (5.5) (37) | (8.2) (55) | (1.5) (9) | (0.2) (1) | |
Our group (50% share)*2 | |||||||
Revenue | - | - | - | - | - | - | |
Selling, general and administrative expenses | (0.6) | (1.5) | (2.8) | (4.1) | (0.7) | (0.1) | |
Core operating profit | (0.6) | (1.5) | (2.8) | (4.1) | (0.7) | (0.1) | |
Amortization (intangible assets) | - | - | - | (0.7) | (1.1) | (1.1) | |
Profit before tax | (0.6) | (1.5) | (2.8) | (4.8) | (1.8) | (1.2) | |
＜Quarterly＞ Unit: Billions of yen
Product name | FY2025 results | FY2026 results | |||||
Jan - Mar | Apr - Jun | Jul - Sep | Oct - Dec | Jan - Mar | Change amount | ||
KOMZIFTI | |||||||
Revenue*1 [Millions of USD] | - - | - - | - - | 0.3 2 | |||
Profit／Loss [Millions of USD] | (1.3) (8) | (1.8) (12) | (2.5) (17) | (2.7) (18) | (1.5) (9) | (0.2) (1) | |
Our group (50% share)*2 | |||||||
Revenue | - | - | - | - | - | - | |
Selling, general and administrative expenses | (0.6) | (0.9) | (1.2) | (1.3) | (0.7) | (0.1) | |
Core operating profit | (0.6) | (0.9) | (1.2) | (1.3) | (0.7) | (0.1) | |
Amortization (intangible assets) | - | - | - | (0.7) | (1.1) | (1.1) | |
Profit before tax | (0.6) | (0.9) | (1.2) | (2.1) | (1.8) | (1.2) | |
*1 Revenue is expected to be disclosed following Kura Oncology's earnings call.
*2 Under the strategic collaboration agreement with Kura Oncology, profits in the United States are been shared on a 50:50 basis.
The Group records the net profit or loss after profit sharing as revenue when it is positive and as selling, general and administrative expenses when it is negative. Furthermore, the calculation of profit share may utilize the estimates.
small molecule
antibody
HSC-GT
As of Mar 31, 2026
Code Name Generic Name Formulation | Mechanism of Action | Indication | Stage | [In-House or Licensed] Remarks | ||
PhI | PhII | PhIII | ||||
KK8123 Injection | Anti-FGF23 Fully Human Antibody | X-linked Hypophosphatemia | [In-House] Clinical study is being conducted in NA and EU as a global product | |||
KK8398 infigratinib Oral | FGFR3 Inhibitor | Achondroplasia | [QED Therapeutics] Clinical study is being conducted in JP | |||
Hypochondroplasia | Preparation underway for Ph Ⅲ clinical trial in JP | |||||
ziftomenib ※ Oral | Menin Inhibitor | Acute Lymphoblastic Leukemia（ALL） （Monotherapy） | [Kura Oncology] Clinical study is being conducted in NA and EU as a global product KMT2A-rearranged ALL KOMET-001 | |||
Acute Myeloid Leukemia (AML) （Monotherapy） | Clinical study is being conducted in NA and EU as a global product Non-NPM1-mutant AML/Non-KMT2A-rearranged AML KOMET-001 | |||||
Adult Relapsed or Refractory AML with a NPM1 Mutation Preparation underway for Ph Ⅱ clinical trial in JP | ||||||
Acute Myeloid Leukemia (AML) （Combination） | Clinical study is being conducted in NA as a global product NPM1-mutant AML/KMT2A-rearranged AML Combinations with venetoclax + azacitidine, and cytarabine + daunorubicin KOMET-007 | |||||
Clinical study is being conducted in NA as a global product FLT3/NPM1 co-mutated AML Combinations with cytarabine + daunorubicin, and quizartinib KOMET-007 | ||||||
Clinical study is being conducted in NA and EU as a global product NPM1-mutant AML/KMT2A-rearranged AML Combinations with gilteritinib, FLAG-IDA, LDAC KOMET-008 | ||||||
Clinical study is being conducted as a global product NPM1-mutant AML/KMT2A-rearranged AML Combinations with venetoclax + azacitidine, and cytarabine + daunorubicin KOMET-017 | ||||||
KK2845 | Anti-TIM-3 ADC | Acute Myeloid Leukemia （AML) | [In-House] Antibody-Drug Conjugate Clinical study is being conducted in JP as a global product | |||
OTL-203 | Hematopoietic Stem Cell (HSC) Gene Therapy | MPS-IH (Hurler Syndrome) | [In-House] Rare Pediatric Disease (RPD) and Fast Track designations (FDA) Priority Medicines (PRIME) designation (EMA) Area of clinical study: NA and EU | |||
OTL-201 | Hematopoietic Stem Cell (HSC) Gene Therapy | MPS-IIIA (Sanfilippo Syndrome type A) | PhⅠ/ PhⅡ | [In-House] Rare Pediatric Disease (RPD) designation (FDA) Preparation underway for registrational study (equivalent to PhⅢ study) | ||
KHK4951 tivozanib Ophthalmic | VEGF Receptor Tyrosine Kinase Inhibitor | Diabetic Macular Edema | [In-House] Clinical study is being conducted in JP, NA, Asia, and Oceania as a global product | |||
Neovascular Age-Related Macular Degeneration | Clinical study is being conducted in JP, NA, Asia, and Oceania as a global product | |||||
KK2260 Injection | EGFR-TfR1Bispecific Antibody | Advanced or Metastatic Solid Tumors | [In-House] REGULGENT Fully human antibody production technology Clinical study is being conducted in JP, and a clinical study is prepared under way for PhI in NA as a global product | |||
Code Name Generic Name Formulation | Mechanism of Action | Indication | Stage | [In-House or Licensed] Remarks | ||
PhI | PhII | PhIII | ||||
KK2269 Injection | EpCAM-CD40Bispecific Antibody | Advanced or Metastatic Solid Tumors | [In-House] REGULGENT Fully human antibody production technology Clinical study is being conducted in JP and NA as a global product | |||
KK4277 Injection | Anti-PTPRS Humanized Antibody | Systemic Lupus Erythematosus/Cutaneous Lupus Erythematosus | [SBI Biotech] POTELLIGENT Clinical study is being conducted in JP and Asia | |||
KK3910 Injection | Essential Hypertension | [In-House] Clinical study is being conducted in JP as a global product | ||||
OTL-200 atidarsagene autotemcel | Hematopoietic Stem Cell (HSC) Gene Therapy | Early-onset Metachromatic Leukodystrophy (MLD) | [In-House] Orphan Regenerative Medicine Product Designation in JP A Ph.3 clinical study in JP is under preparation Product Name in US: Lenmeldy Product Name in Europe: Libmeldy | |||
KK2223 | Cutaneous T cell lymphoma Peripheral T cell lymphoma | [In-House] Clinical study is prepared under way for PhⅠ | ||||
※ For detailed information on ziftomenib(Product Name in US: KOMZIFTI)'s development status, please refer to Kura Oncology's website. https://kuraoncology.com/
Note 1: Because the Company discontinued clinical trials of KHK4083/AMG 451 (rocatinlimab) for moderate to severe atopic dermatitis, prurigo nodularis, and moderate to severe asthma, the relevant development information has been removed from this table.
2: Our main progress from March 31, 2026 is as follows.
On April 24, 2026, it was announced that dosing of ziftomenib had commenced for the first patient in the Phase II trial in Japan targeting relapsed or refractory NPM1-
Major Applications and ApprovalsAs of Mar. 31, 2026
Code Name, Generic Name, Product Name | Indication | Application/Under Review | Countries/Regions Received Approval in 2026 |
OTL-200(atidarsagene autotemcel, Product name in Europe/US: Libmeldy/Lenmeldy） | Metachromatic Leukodystrophy（MLD） | filied in Japan | ー |