Shionogi : FY2025 Supplement

FY2024

FY2025

Change

Change (％)

Comment

FY2025

forecast

Progress (％)

FY2026

forecast

Change

Revenue Cost of sales

438.3

(63.8)

499.7

(82.5)

61.4

18.6

14.0

29.2

Increasing/(decreasing) in Prescription drugs 24.7billion Overseas subsidiaries/Export 5.9billion Royalty income 33.9billion

500.0

(82.0)

99.9

100.5

700.0

(120.0)

200.3

37.5

Gross profit

374.4

417.2

42.8

11.4

418.0

99.8

580.0

162.8

SG&A expenses

(101.9)

(126.9)

25.0

24.6

Increase due to the launch expenses of new products in the U.S. and post-merger integration (PMI) activities related to business investments for future growth

(116.2)

109.2

(181.6)

54.7

R&D expenses

(108.6)

(122.8)

14.2

13.1

Increase due to the advancement of projects in the priority areas of infectious disease and QOL disease

(120.0)

102.4

(155.0)

32.2

Amortization of intangible assets associated with products

(4.2)

(6.1)

1.9

46.0

(3.8)

160.4

(58.4)

52.3

Other income Other expenses

0.5

(3.7)

47.2

(41.8)

46.6

38.1

-

-

Bargain purchase gain from the absorption-type split of the pharmaceutical business of JT

Increase in impairment losses

7.0

76.4

35.0

29.7

Operating profit

156.6

166.7

10.1

6.5

185.0

90.1

220.0

53.3

Finance income

53.2

80.8

27.6

51.9

47.0

153.6

-

(72.2)

Finance costs

(9.0)

(8.6)

(0.4)

(4.7)

Profit before tax

200.8

238.9

38.2

19.0

232.0

103.0

220.0

(18.9)

Income tax expense

(31.2)

(33.0)

1.8

5.7

Profit

169.5

205.9

36.4

21.5

Profit attributable to Owners of parent

Non-controlling interests

170.4

(0.9)

205.2

0.8

34.7

1.7

20.4

-

188.0

109.1

210.0

4.8

Profit

169.5

205.9

36.4

21.5

FY2024

FY2025

Operating profit

156.6

166.7

Other income

Other expenses

(0.2)

2.0

(46.4)

40.4

Core operating profit *1

158.4

160.8

Depreciation and amortization

20.9

27.0

EBITDA *2

179.3

187.7

FY2024

FY2025

Change

Change(％)

FY2025

forecast

Progress(％)

Prescription drugs

98.8

123.5

24.7

25.0

143.5

86.0

Acute Respiratory Virus Infection Treatment

51.8

33.8

(18.0)

(34.8)

56.0

60.3

QUVIVIQ

0.8

2.6

1.8

224.1

2.5

103.2

SYMPROIC

5.0

6.1

1.1

21.2

6.5

94.2

OXYCONTIN Franchise

4.3

4.4

0.2

4.6

5.3

83.7

Others

36.9

76.6

39.6

107.4

73.2

104.5

Overseas subsidiaries/Export

59.1

65.0

5.9

9.9

61.0

106.5

Shionogi Inc. (US)

23.4

28.7

5.4

22.9

27.2

105.8

Shionogi B.V. (EU)

16.8

20.8

3.9

23.4

19.3

107.8

Shionogi China

8.7

6.2

(2.5)

(28.3)

5.9

104.6

Others

10.2

9.2

(1.0)

(9.4)

8.6

107.2

Contract manufacturing

17.3

15.1

(2.2)

(12.7)

14.0

107.6

OTC and quasi-drugs

16.8

15.0

(1.8)

(10.5)

17.5

86.0

Royalty income

244.7

278.6

33.9

13.9

261.5

106.5

HIV Franchise

240.4

261.3

20.9

8.7

245.0

106.7

Others

4.3

17.3

13.0

304.9

16.5

104.7

Others

1.7

2.5

0.9

51.1

2.5

101.6

Total

438.3

499.7

61.4

14.0

500.0

99.9

FY2025

FY2026

forecast

Change

Prescription drugs

123.5

178.6

55.2

Acute Respiratory Virus Infection Drugs

33.8

41.6

7.8

QUVIVIQ

2.6

6.7

4.1

ZURZUVAE

0.5

4.0

3.5

RADICUT

-

7.0

7.0

SYMPROIC

6.1

6.4

0.3

OXYCONTIN Franchise

4.4

4.9

0.4

TORII Pharmaceutical-related products

40.5

77.6

37.0

Others

35.5

30.5

(5.0)

Overseas subsidiaries/Export

65.0

175.2

110.3

Shionogi Inc. (US)

28.7

138.7

110.0

Shionogi B.V. (EU)

20.8

22.6

1.8

Shionogi China

6.2

5.3

(1.0)

Others

9.2

8.7

(0.6)

Contract manufacturing

15.1

14.4

(0.6)

OTC and quasi-drugs

15.0

18.8

3.8

Royalty income

278.6

310.6

32.0

HIV Franchise

261.3

276.0

14.7

Others

17.3

34.6

17.3

Others

2.5

2.3

(0.2)

Total

499.7

700.0

200.3

FY2024

FY2025

1Q

2Q

3Q

4Q

1Q

Y on Y change (%)

2Q

Y on Y change (%)

3Q

Y on Y change (%)

4Q

Y on Y change (%)

Revenue

Cost of sales

97.6

(14.4)

116.4

(15.7)

119.6

(15.9)

104.7

(17.8)

99.8

(12.3)

2.2

(14.7)

113.2

(16.9)

(2.7)

7.9

147.7

(25.1)

23.5

57.8

139.0

(28.1)

32.8

58.0

Gross profit

83.1

100.7

103.7

86.9

87.5

5.2

96.2

(4.4)

122.6

18.2

110.9

27.6

SG&A expenses R&D expenses

Amortization of intangible assets associated with products

Other income Other expenses

(24.0)

(29.4)

(1.1)

0.1

(0.5)

(23.7)

(27.4)

(1.1)

0.4

(1.2)

(25.5)

(22.6)

(1.1)

0.0

(1.2)

(28.7)

(29.2)

(0.9)

0.0

(0.8)

(25.8)

(24.9)

(0.5)

0.1

(1.3)

7.4

(15.4)

(55.7)

11.3

132.6

(27.6)

(27.5)

(0.5)

0.4

(1.3)

16.3

0.6

(54.7)

(10.4)

13.9

(35.5)

(29.9)

(0.6)

20.4

(3.2)

39.4

32.0

(48.5)

-159.3

(38.0)

(40.5)

(4.6)

26.3

(36.0)

32.6

39.0

395.2

-

-

Operating profit

28.1

47.8

53.4

27.4

35.1

24.9

39.7

(16.9)

74.0

38.6

18.0

(34.3)

Finance income

Finance costs

11.3

(2.8)

13.9

(4.4)

10.2

(1.5)

21.0

(3.5)

13.6

(2.3)

20.5

(17.9)

14.2

(1.8)

2.1

(58.2)

20.5

(1.6)

101.7

8.3

32.5

(2.8)

54.7

(19.2)

Profit before tax

36.5

57.3

62.0

44.9

46.3

26.8

52.1

(9.2)

92.9

49.7

47.6

6.2

Income tax expense

(6.2)

(4.7)

(11.6)

(8.7)

(7.0)

12.3

(7.9)

66.0

(18.2)

57.2

0.1

(100.7)

Profit

30.3

52.6

50.5

36.2

39.3

29.8

44.2

(15.9)

74.7

48.0

47.7

31.8

Profit attributable to Owners of parent

Non-controlling intersts

30.6

(0.3)

52.5

0.1

50.7

(0.2)

36.6

(0.4)

39.4

(0.0)

28.5

(97.7)

44.2

0.0

(15.8)

(104.6)

74.7

0.0

47.4

(98.6)

46.9

0.8

28.1

(277.0)

Profit

30.3

52.6

50.5

36.2

39.3

29.8

44.2

(15.9)

74.7

48.0

47.7

31.8

FY2024

FY2025

1Q

2Q

3Q

4Q

1Q

Y on Y change (%)

2Q

Y on Y change (%)

3Q

Y on Y change (%)

4Q

Y on Y change (%)

Prescription drugs

15.4

32.3

31.2

19.8

14.1

(8.5)

22.7

(29.7)

49.9

59.7

36.8

85.5

Acute Respiratory Virus Infection Treatment

QUVIVIQ SYMPROIC

OXYCONTIN Franchise

Others

3.9

-

1.1

1.0

9.4

21.0

-

1.3

1.0

9.0

18.5

0.5

1.5

1.2

9.6

8.5

0.3

1.2

0.9

8.9

2.9

0.1

1.5

1.1

8.5

(25.8)

-35.3

8.3

(9.4)

5.8

0.3

1.5

1.2

14.0

(72.4)

-14.2

13.1

55.0

18.6

0.7

1.6

1.2

27.7

0.7

37.3

10.6

(0.1)

190.0

6.5

1.5

1.5

0.9

26.3

(23.2)

388.3

29.0

(2.2)

195.5

Overseas subsidiaries/Export

15.0

13.4

15.0

15.7

14.2

(4.9)

16.4

22.7

18.3

21.7

16.0

2.0

Shionogi Inc. (US) Shionogi B.V. (EU) Shionogi China

Others

6.0

4.0

2.3

2.7

5.2

4.3

1.9

1.9

6.3

4.6

2.1

2.1

5.9

3.9

2.4

3.5

6.2

4.7

1.5

1.8

3.7

17.4

(34.7)

(31.6)

7.4

5.1

1.5

2.4

40.9

19.2

(22.5)

25.9

8.5

5.8

1.5

2.5

35.7

24.6

(25.3)

19.9

6.7

5.1

1.7

2.5

12.9

32.8

(29.5)

(28.8)

Contract manufacturing OTC and quasi-drugs

Royalty income

3.6

2.4

61.0

4.2

5.7

60.5

2.9

4.5

65.3

6.6

4.1

57.9

4.5

2.4

63.9

24.1

0.1

4.7

2.7

5.4

65.4

(36.2)

(5.1)

8.1

3.1

3.8

72.0

5.8

(16.4)

10.3

4.8

3.4

77.3

(26.1)

(17.9)

33.6

HIV Franchise

Others

59.8

1.2

59.8

0.7

63.9

1.4

56.9

1.0

61.2

2.7

2.3

125.0

64.6

0.8

8.1

13.0

67.6

4.3

5.8

219.2

67.9

9.4

19.4

835.3

Others

0.2

0.4

0.6

0.6

0.6

282.1

0.6

66.5

0.7

10.9

0.7

16.4

Total

97.6

116.4

119.6

104.7

99.8

2.2

113.2

(2.7)

147.7

23.5

139.0

32.8

As of Mar. 31 2025

As of Mar. 31 2026

Y on Y change

Comment

Assets

Increase due to the absorption-type split of the pharmaceutical business of JT and the consolidation of Torii Pharmaceutical Co., Ltd.

Increase due to the consolidation of Torii Pharmaceutical Co., Ltd.

Increase due to the absorption-type split of the pharmaceutical business of JT and the consolidation of Torii Pharmaceutical Co., Ltd.

Increase due to ViiV becoming an equity-method affiliate Decrease due to ViiV becoming an equity-method affiliate

Non-current assets

Property, plant and equipment

115.4

156.5

41.1

Goodwill

15.7

35.1

19.3

Intangible assets

143.7

173.6

29.9

Right-of-use assets

19.4

22.8

3.4

Investment property

27.7

27.3

(0.4)

Investments accounted for using equity method

10.4

710.8

700.3

Other financial assets

299.8

107.5

(192.3)

Deferred tax assets

13.2

4.3

(8.9)

Other non-current assets

31.4

28.7

(2.8)

Total non-current assets

676.8

1,266.5

589.7

Current assets

Inventories

65.5

99.4

33.9

Increase due to the consolidation of Torii Pharmaceutical Co., Ltd.

Trade receivables

120.6

159.8

39.2

Increase due to the consolidation of Torii Pharmaceutical Co., Ltd.

Other financial assets

270.0

310.7

40.7

Increase in time deposits over 3 months

Other current assets

27.7

29.0

1.4

Cash and cash equivalents

374.8

711.4

336.6

Increase due to borrowing

Total current assets

858.5

1,310.3

451.8

Total assets

1,535.3

2,576.9

1,041.5

Equity and liabilities

Equity

Share capital

21.3

21.3

-

Capital surplus

17.8

17.8

(0.0)

Treasury shares

(65.9)

(65.2)

(0.7)

Retained earnings

1,115.7

1,492.7

377.0

Other components of equity

272.9

218.6

(54.3)

Decrease due to ViiV becoming an equity-method affiliate

Equity attributable to owners of parent

1,361.9

1,685.2

323.3

Non-controlling interests

0.6

1.0

0.4

Total equity

1,362.5

1,686.2

323.7

Liabilities

Non-current liabilities

Lease liabilities

18.4

18.9

0.5

Other financial liabilities

8.3

4.0

(4.3)

Retirement benefit liability

8.0

16.7

8.7

Deferred tax liabilities

4.4

17.5

13.1

Provisions

-

2.5

2.5

Other non-current liabilities

4.4

3.6

(0.7)

Total non-current liabilities

43.5

63.2

19.8

Current liabilities

Bonds and borrowings

-

660.0

660.0

Borrowing in connection with business acquisitions

Lease liabilities

3.5

5.5

2.0

Trade payables

13.6

22.1

8.6

Other financial liabilities

18.1

40.7

22.6

Increase in other payable

Income taxes payable

22.4

18.9

(3.5)

Other current liabilities

71.9

80.2

8.3

Total current liabilities

129.4

827.4

698.0

Total liabilities

172.9

890.7

717.8

Total equity and liabilities

1,535.3

2,576.9

1,041.5

FY2024

FY2025

Apr.-Jun.

Apr.-Sep.

Apr.-Dec.

Apr.-Mar.

Apr.-Jun.

Apr.-Sep.

Apr.-Dec.

Apr.-Mar.

STS2030 Revision Growth

Revenue

Billions of yen

97.6

214.0

333.6

438.3

99.8

213.0

360.7

499.7

Overseas sales CAGR *1

％

-

-

-

17.9

-

-

-

23.6

EBITDA

Billions of yen

33.1

86.7

146.4

179.3

40.6

85.8

147.8

187.7

STS2030 Revision Shareholder return

Basic earnings per share *2

yen

36.02

97.74

157.30

200.36

46.26

98.19

185.95

241.11

Diluted earnings per share *2

yen

36.01

97.70

157.25

200.29

46.25

98.16

185.91

241.04

Ratio of dividends to equity attributable to owners of parent (DOE)

％

-

-

-

4.0

-

-

-

4.0

Return on equity attributable to owners of parent (ROE)

％

2.4

6.6

10.4

13.1

2.9

6.0

11.0

13.5

Others

Ratio of profit before tax to total assets (ROA)

％

2.5

6.5

10.6

13.6

3.0

6.2

11.7

11.6

Ratio of operating profit to revenue

％

28.8

35.5

38.7

35.7

35.2

35.1

41.2

33.4

Ratio of equity attributable to owners of parent to total assets

％

87.9

88.7

88.7

88.7

89.6

88.6

87.6

65.4

Dividend payout ratio

％

-

-

-

30.6

-

-

-

29.4

FY2024

FY2025

As of

Jun. 30

SAs of ep. 30

As of Dec. 31

As of Mar. 31

As of Jun. 30

As of Sep. 30

As of Dec. 31

As of Mar. 31

Employees

Persons

5,001

4,990

4,944

4,955

5,039

5,613

6,205

6,223

FY2024

FY2025

Change

Change(％)

FY2025

forecast

Progress(％)

FY2026

forecast

Change

Investments in equipments

Depreciation and Amortization

12.3

20.9

18.3

27.0

6.0

6.0

48.7

28.8

23.3

20.3

78.4

132.9

39.4

80.4

21.1

53.5

Property, plant andequipment

11.7

13.5

1.8

14.9

Intangible assets

6.2

8.7

2.6

41.9

Right-of-use assets

2.7

4.3

1.6

60.4

Investment property

0.4

0.4

0.1

19.5

FY2024

FY2025

FY2026

forecast

CR

AR

CR

AR

AR

USD

149.53

152.62

159.90

150.67

153

GBP

193.76

194.73

211.05

201.86

205

EUR

162.05

163.88

183.44

174.65

184

Areas

Generic name/Code No. [Product name]

Mechanism of action (Administration)

Indication

Stage

Origin

Development

Infectious disease

Cefiderocol Tosilate Sulfate Hydrate

[US, Japan: Fetroja®] [EU:Fetcroja®]

Cell-wall synthesis inhibition

（injection）

Gram-negative infection

（pediatric）

Phase III

In-house

In-house

Gram-negative infection

Phase III

MAA submission: Australia

（Dec. 2024）

In-house

In-house

S-268019

[Japan:Covgoze®]

Vaccine (muscular injection)

Prevention of COVID-19

（Adolescent）

Phase II/III

In-house

In-house

Prevention of COVID-19

（Children）

Phase I/II/III

In-house

In-house

S-268024

Vaccine（muscular injection）

Prevention of COVID-19

NDA submission: Japan (Nov. 2025)

In-house

In-house

S-567123

Vaccine（muscular injection）

Prevention of COVID-19

PhaseⅠ

In-house

In-house

Ensitrelvir Fumaric Acid [Japan:Xocova®]

3CL protease inhibitor（oral）

Treatment of COVID-19

（12 years old and older）

Phase III

NDA submission:EU (Jun. 2025)

In-house

Japan, global, Taiwan:

In-house South Korea:

In-house

/Ildong Singapore:In-house

/Juniper

Treatment of COVID-19

（Children, 6 to 11 years）

NDA submission: Japan (Jun. 2025)

In-house

In-house

Post exposure prophylaxis of COVID-19

NDA submission: Japan

（Mar. 2025）, US（Jun. 2025）, EU（Jun. 2025）, Taiwan(oct. 2025)

In-house

In-house

Treatment of COVID-19

（Pediatric, 0 to 5 years）

Phase III

In-house

In-house

Olorofim

Dihydroorotate dehydrogenase（DHODH） inhibition（oral）

Invasive aspergillosis

Phase III

F2G (UK)

In-house/ F2G

Secutrelvir

3CL protease inhibitor（oral）

Treatment of COVID-19

Phase II

In-house

In-house

3CL protease inhibitor

（long-acting injection）

Pre exposure prophylaxis of COVID-19

Phase I

In-house

In-house

S-337395

RNA dependent RNA polymerase inhibitor（oral）

Treatment of RSV infection

Phase II

In-house/ UBE

In-house/ UBE

S-649228

Cell-wall synthesis inhibition

（injection）

Gram-negative infection

Phase I

In-house/ Qpex

In-house

QOL

Diseases

Naldemedine tosilate [Japan:Symproic®] [EU:Rizmoic®]

Peripheral opioid receptor antagonist

（oral, powder）

Opioid-induced constipation (pediatric)

Phase I/II

In-house

In-house

Peripheral opioid receptor antagonist

（oral）

Opioid-induced constipation

Phase III

NDA submission: China

（May. 2025）

In-house

In-house

Peripheral opioid receptor antagonist

（oral）

Parkinsonʼs disease with constipation

Phase II

In-house

In-house

Zatolmilast

PDE4D negative allosteric modulator（oral）

Fragile X syndrome

Phase II/III

Tetra

（USA）

In-house

Jordan syndrome

Phase II

Tetra

（USA）

In-house

Alzheimer's disease

Phase II

Tetra

（USA）

In-house

S-588410

Cancer peptide vaccine (injection)

Esophageal cancer

Phase II

OncoTherapy Science, Inc.(Japan)

In-house

Bladder cancer

Phase III

OncoTherapy Science, Inc.(Japan)

In-house

S-488210

Cancer peptide vaccine (injection)

Head and neck squamous cell carcinoma

Phase I/II

OncoTherapy Science, Inc.(Japan)

In-house

S-588210

Cancer peptide vaccine

（injection）

Solid tumor

Phase I

OncoTherapy Science, Inc.

（Japan）

In-house

SR-0379

Promote granulation formation (topical）

Cutaneous ulcer

（Pressure ulcer, Diabetic ulcer）

Phase III

FunPep

（Japan）

In-house/ FunPep

Redasemtide Trifluoroacetate

Mobilization of mesenchymal stem cells （MSCs）to peripheral blood（injection）

Stroke

Phase IIb

StemRIM

（Japan）

In-house

Epidermolysis bullosa

Phase II

StemRIM

（Japan）

In-house

Areas

Generic name/Code No. [Product name]

Mechanism of action (Administration)

Indication

Stage

Origin

Development

QOL

Diseases

S-531011

anti-CCR8 antibody

（injection）

Solid tumor

Phase Ib/II

In-house

In-house

S-740792

New mechanism of action

（oral）

Walking impairment associated with multiple sclerosis

Phase I

In-house

In-house

S-054501 [SASS-001] (S-600918 +

Concomitant drug X)

P2X3 receptor inhibitor

（oral）+Mechanism of Concomitant drug

Sleep Apnea with a Central Component

Phase II

S-600918:

In-house

Shionogi-Apnimed Sleep Science, LLC（USA）

S-606001

Glycogen synthase 1 (GYS1) inhibitor (oral)

Pompe disease

Phase II

Maze

（USA）

In-house

SDS-881

AI Programmed Medical Device for Conversational Cognitive Function Testing

Cognitive impairment in dementia

Phase III

FRONTEO

（Japan）

In-house

S-898270

Phosphodiesterase 4D

（PDE4D）Inhibitors

Alzheimer's Disease

Phase I

In-house

In-house

S-054502 [SASS-002]

(Sulthiame)

Carbonic anhydrase inhibitor

Sleep Apnea

Phase II

Desitin

Shionogi-Apnimed Sleep Science, LLC（USA）

Cantharidin [YCANTH®topical solution 0.71%］

Treatment for viral warts

（Topical）

Common warts

Phase Ⅲ

Verrica

（USA）

In-house

/Verrica

（USA）

TO-210

Peroxisome

proliferator-activated receptor γ（PPARγ）modulating agent（Topical）

Acne vulgaris

Phase III

Nogra

（Ireland）

In-house

TO-203

［MITICURE®House Dust Mite Sublingual Tablets］

Allergen Immunotherapy

（Sublingual tablet）

House dust mite inducedallergic asthma

Phase II/III

ALK

(Denmark)

In-house

TO-209

Allergen Immunotherapy

（Sublingual tablet）

Grass pollen-induced allergic rhinitis

Phase III

ALK

(Denmark)

In-house

Tapinarof

Aryl hydrocarbon receptor (AhR) modulating agent

（Topical）

Atopic dermatitis in pediatric patients

NDA submission: Japan

（Oct. 2025）

Dermavant (Switzerland)

In-house

Atopic dermatitis in infant patients

Phase III

Dermavant (Switzerland)

In-house

Delgocitinib

Janus kinase (JAK) inhibitor (Lotion Fomulation)

Atopic dermatitis

NDA submission: Japan (Feb. 2026)

In-house

In-house

Atopic dermatitis in pediatric patients

PhaseⅢ

In-house

In-house

S-051051 (JTE-051)

Tropomyosin Receptor Kinase A (TrkA)/Interleukin-2 inducible T-cell kinase (ITK) inhibitor (oral)

Interstitial cystitis/Bladder pain syndrome, Autoinflammatory/ Autoimmune diseases

Phase II

In-house

In-house

S-662662 (JTT-662)

Sodium-Glucose Co-transporter1 (SGLT1) inhibitor (oral)

Hypertrophic cardiomyopathy

Phase I

In-house

In-house

S-861861 (JTT-861)

Pyruvate dehydrogenase kinase (PDHK) inhibitor (oral)

Chronic heart failure

Phase II

In-house

In-house

S-064064 (JTC-064)

PDHK inhibitor (oral)

Neurodegenerative disease

Phase I

In-house

In-house

S-161161 (JTV-161)

Proto-oncogene serine/threonine-protein kinase1 (Pim-1) inhibitor (oral)

Pulmonary arterial hypertension

Phase I

In-house

In-house

S-162162 (JTE-162)

NLR family pyrin domain containing 3 (NLRP3) inhibitor (oral)

Autoinflammatory/ Autoimmune diseases

Phase I

In-house

In-house

S-261261 (JTV-261)

Phospholipase D1/2 (PLD1/2) inhibitor (oral)

Thrombosis

Phase I

In-house

In-house

S-262262 (JTC-262)

NLRP3 inhibitor (oral)

Neurodegenerative disease

Phase I

In-house

In-house

S-263263 (JTV-263)

Hematopoietic Prostaglandin D Synthase (H-PGDS) inhibitor (oral)

Peripheral artery disease

Phase I

In-house

In-house

S-461461（JTE-461）

Mas-related G protein-coupled receptor X2 (MRGPRX2) antagonist (oral)

Chronic spontaneous urticaria

Phase I

In-house

In-house

Generic name/Code No. [Product name]

Mechanism of action (Administration)

Indication

Stage

Origin

Development

S-723595 (TLC-3595)

Acetyl-CoA carboxylase 2 inhibitor（oral）

Type 2 diabetes

Phase IIa

In-house

OrsoBio, Inc.（USA）

S-365598

Integrase inhibitor

（ultra long-acting injection）

HIV infection

Phase IIb (Oral)

In-house

SHIONOGI-

ViiV Healthcare LLC

Delgocitinib

Janus kinase (JAK) inhibitor (Topical)

Chronic hand eczema

NDA submission: Mainland China (Sep. 2025)

In-house

LEO

Pharma (Denmark)

Chronic hand eczema in adolescents

MAV submission: EU (Nov. 2025)

In-house

LEO

Pharma (Denmark)

Palmoplantar pustulosis

Phase IIa

In-house

LEO

Pharma (Denmark)

Lichen sclerosus

Phase III

In-house

LEO

Pharma (Denmark)

JAK inhibitor (eye drop)

Ophthalmology disease

Phase II

In-house

ROHTO

(Japan）

Stage change

S-365598：Phase IIa → Phase IIb

Add

Naldemedine tosilate (Parkinsonʼs disease with constipation)：Phase II

Delgovitinib (Atopic dermatitis)：NDA submission: Japan

Delgocitinib (Atopic dermatitis in pediatric patients)：Phase III

Deleted

S-743229：Phase I

S-151128：Phase I

ADR-001: Phase I/II

S-222611 (Epertinib): Phase I/II

S-309309：Phase II

Resiniferatoxin：Phase III

Baloxavir marboxil (transmission): NDA submission: USA (Nov. 2024）