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R&D Management

R&D Management


Hanmi Pharmaceutical R&D Vision

In December 2025, Hanmi Group's R&D Center, responsible for its future value, announced a strategy to lead a healthy aging era under the vision of ‘Shaping the Future of Aging’.
Hanmi Pharmaceutical is demonstrating its R&D capabilities through accelerating clinical development of innovative drug pipelines, securing First-in-Class drugs, and initiating numerous next-generation oncology projects based on new modalities. It is also excelling in academic achievements alongside clinical progress in key obesity/metabolic disease treatments.
Hanmi Pharmaceutical will make 2030 a period of new leaps forward, expanding beyond research into oncology, obesity, and metabolic diseases to anti-aging and reverse-aging research.

1. Global-level R&D Infrastructure and Technological Capabilities

Leading the next-generation drug paradigm by internalizing new technologies such as AI, BI/Omics

2. Metabolic to Longevity Leading the Anti-aging / Rejuvenation Field

Through the advancement of the H.O.P project, we will transform the next-generation obesity treatment market into an anti-aging/Longevity market.

Treatment for severe obesity
Highlighting the potential of triple-action agonists

Improving the quality of weight loss

Maximizing the potential of obesity treatments
Pivoting towards health promotion

Research on Global Top Tier triple-action agonists
(HM15275)

Development of new muscle-increasing drugs
combinable with existing GLP-1 drugs
(HM17321)

Utilizing common pathogenic mechanisms between obesity and aging, further elucidating anti-aging
effects (efpeglenatide, HM15275)

Hanmi Pharmaceutical's Aging Market Approach Strategy

3. Open Innovation Continuous creation of FIC innovative new drugs


R&D Investment

Hanmi Pharmaceutical is actively practicing R&D management to create 'global innovative new drugs'. Including investments in innovative drug research fields such as new drug development, biopharmaceuticals, and synthetic new drugs, as well as production facilities essential for product commercialization, its total R&D investment over the past decade amounts to KRW 2.9078 trillion. Hanmi Pharmaceutical will continue to make utmost efforts to realize a pharmaceutical powerhouse through sustained R&D investment.

2025 R&D Highlights

Hanmi Pharm Consolidated Basis

R&D Investment

KRW 229 billion

R&D and Facility Investment Over the Last 10 Years (2016~2025)

R&D Facility Investment

KRW 42.1 billion

R&D Investment Ratio to Sales

14.8%

KRW 2.9078 trillion

Hanmi Pharmaceutical's R&D Investment Amount Over the Last 10 Years

Hanmi Pharm (Consolidated Basis)
/ Unit: KRW 100M

Year

Sales

R&D Investment

R&D Commercialization
Facility Investment

R&D Investment Ratio to Sales(%)

2016

8,827

1,626

2,251

18.4

2017

9,166

1,706

2,289

18.6

2018

10,160

1,929

1,531

19.0

2019

11,136

2,098

1,509

18.8

2020

10,759

2,261

392

21.0

2021

12,032

1,615

281

13.4

2022

13,315

1,779

272

13.4

2023

14,909

2,050

302

13.8

2024

14,955

2,098

377

14.0

2025

15,475

2,290

421

14.8

R&D Investment Ratio to Sales in the Domestic Pharmaceutical Industry1)

Unit: %

Year

Hanmi Pharm
(Consolidated Basis)

Listed Companies

Pharmaceutical
Manufacturing Companies

Innovative
Pharmaceutical Companies

2016

18.4

8.9

6.0

11.7

2017

18.6

8.9

5.7

11.0

2018

19.0

11.2

6.4

11.5

2019

18.8

11.2

6.6

12.3

2020

21.0

12.3

6.5

14.2

2021

13.4

11.9

5.9

12.7

2022

13.4

12.7

6.3

13.2

2023

13.8

12.5

6.4

14.7

2024

14.0

12.0

5.2

13.4

1) Refer to Korea Pharmaceutical and Bio-Pharma Manufacturers Association Databook 2025

R&D Personnel

Hanmi Pharmaceutical operates 5 R&D centers in Korea, where 489 researchers are dedicated to R&D. Including the Beijing Hanmi Pharmaceutical research institute located in Beijing, the total number of researchers is 670, representing 17.3% of the total workforce.

2025 Hanmi Pharmaceutical R&D Personnel Status

Company

Department1)

Personnel (No.)

Total

Ph.D.

Master's

Bachelor's

Other

Hanmi Pharmaceutical

R&D Center

177

59

90

13

15

Seoul Research Center

139

14

56

66

3

Formulation Research Institute

58

5

38

13

2

Bio-Process Research Center

51

5

29

16

1

Sub-total

425

83

213

108

21

Beijing Hanmi Pharmaceutical

R&D Center

181

5

62

97

17

Hanmi Fine Chemical

R&D Center

64

3

44

15

2

Total

670

91

319

220

40

1) Indicates only research institutes or dedicated departments whose personnel expenses are reflected in R&D costs.

Annual Hanmi Pharmaceutical R&D Personnel Status2)

Category

Total Personnel (No.)

R&D Personnel (No.)

Ratio (%)

2018

3,981

599

15.0

2019

4,056

579

14.3

2020

3,805

538

14.1

2021

3,703

550

14.9

2022

3,774

584

15.5

2023

3,865

637

16.5

2024

3,962

676

17.1

2025

3,884

670

17.3

2) Personnel: Based on employees of Hanmi Pharmaceutical, Beijing Hanmi Pharmaceutical, and Hanmi Fine Chemical

R&D Network

Hanmi Pharmaceutical's R&D network is centered around the Hanmi Pharmaceutical R&D Center in Dongtan, Gyeonggi Province. It also includes the Seoul Research Center located at the Seoul headquarters, the Formulation Research Center affiliated with the Paltan Smart Plant, the Bio Process Research Center within the Pyeongtaek Bio Plant, and research institutes within its subsidiaries, Beijing Hanmi Pharmaceutical and Hanmi Fine Chemical. This network establishes an optimal research environment to facilitate rapid development and commercialization of substances in the research phase.


Core R&D Technologies

Based on advanced technology and research, Hanmi Pharmaceutical creates sustainable R&D and innovations unprecedented in the world. Currently, Hanmi Pharmaceutical possesses technologies such as long-acting biologics enabled by its LAPSCOVERY platform and bispecific antibody technologies. It is also focusing on developing improved and complex new drugs to enhance patients' quality of life. In the future, Hanmi Pharmaceutical will strive for sustainable development by discovering new modalities such as 'Antibody-Drug Conjugates (ADCs),' 'Cell and Gene Therapies,' 'mRNA-based Therapies,' and 'Targeted Protein Degraders.'

Long-acting
Biopharmaceuticals
Platform Technology

Protein/peptide drugs have a short half-life in the human body, leading to the inconvenience of frequent administration.
We are conducting research to improve efficacy and enhance patients' quality of life by utilizing various long-acting biopharmaceutical platform technologies tailored to the characteristics of new drugs.

Bispecific Antibody
Platform Technology

This bispecific antibody technology was independently developed by Beijing Hanmi Pharmaceutical, Hanmi Pharmaceutical's local subsidiary in China. It is a bispecific antibody platform technology where a single antibody can simultaneously bind to two different targets. This allows for simultaneous immuno-oncology and targeted oncology treatments. Notably, it boasts excellent immunogenicity and stability, along with high production efficiency, due to its structural similarity to natural immunoglobulin G (IgG).
Various bispecific antibody candidates are currently under development using PENTAMBODYTMtechnology.


Cancer Research

Many patients worldwide suffer from cancer, a leading cause of death.
We are making various attempts to overcome resistance to existing drugs and achieve the ultimate goal of conquering cancer. We are conducting research to enhance efficacy and expand indications through various combination therapies, including gene mutation-targeted cancer therapies, immuno-oncology drugs, and bispecific antibodies. Furthermore, within the accelerating trend of digital transformation, we are striving to build our pipeline through open innovation utilizing artificial intelligence.


IMD•New Formulation

Improved new drugs are medications that enhance safety, efficacy, and usefulness by addressing the drawbacks of already approved drugs.
Consequently, they are safer and more effective than existing products, offer greater convenience of administration, and by securing independent patent rights, they can increase competitiveness in the global market.




Key Research Areas

Obesity/Metabolism

Obesity is known to be a cause of major metabolic syndromes such as diabetes, hypertension, cardiovascular diseases, and fatty liver disease. The World Health Organization (WHO) defines obesity as the '21st-century epidemic' that modern society must address. Based on expertise and R&D capabilities in incretin science, we are conducting research to build a customized, full-cycle obesity management portfolio (H.O.P: Hanmi Obesity Pipeline) that encompasses differentiated obesity prevention, treatment, and high-quality weight management, utilizing peptides, proteins, formulation technology, and digital therapeutics.

Targeted + Immuno-oncology

Cancer is one of the most serious diseases affecting humanity and a major cause of death worldwide. Hanmi Pharmaceutical is dedicated to innovative new drug research to overcome resistance to existing drugs and achieve the ultimate goal of 'conquering cancer.' We are conducting research to enhance drug efficacy and expand indications through various combination therapies, including gene mutation-targeted cancer therapies, immuno-oncology drugs, and bispecific antibodies. Furthermore, in response to the accelerating era of digital transformation, we are actively promoting open innovation utilizing artificial intelligence to expand our pipeline.

Rare Diseases

Hanmi Pharmaceutical's management philosophy of 'Respect for Human Beings' and 'Value Creation' shines brightly, especially in the field of 'rare diseases,' among various new drug development areas. This also represents Hanmi Pharmaceutical's reason for existence: to contribute to a better life for humanity. In accordance with the management philosophy of its founder, the late Chairman Lim Sung Ki, who famously stated, "New drug development is social contribution," Hanmi Pharmaceutical is fully committed to developing innovative new drugs that can offer hope to patients worldwide suffering from rare diseases.


Pipeline



As of January 2026

Category

Preclinical

Phase 1

Phase 2

Phase 3/Approval

Obesity
/Metabolic

efpegerglucagon
+ efpeglenatide
LAPSGlucagon Combo

HM17321
LA-UCN2

HM15275
LA-GLP/GIP/GCG

efpeglenatide
LAPSExd4 analog




efocipegtrutide
LAPSTriple agonist





efpeglenatide
LAPSGLP/GCG agonist
MSD


Oncology

HM101207
SOS1

tuspetinib
MKI
Aptose

poseltinib
multi-TEC
NOBO Medicine

Rolontis®
eflapegrastim
Assertio Holdings


HM100714
sHER2

belvarafenib
pan-RAF
Genentech

tivumecirnon
CCR4
RAPT

Oraxol®
encequidar+paclitaxel
Health Hope Pharma



HM97662
EZH1/2

belvarafenib
pan-RAF
Roche

poziotinib
pan-HER
Assertio Holdings



BH2950
PD-1/HER2 BsAb
Innovent





Rolontis®
eflapegrastim
Assertio Holdings





BH3120
PD-L1/4-1BB BsAb





HM16390
LAPSIL-2 analog



Rare
Diseases

efocipegtrutide
LAPSTriple agonist

HM15421
LA-GLA
GC

efpegerglucagon
LAPSGlucagon analog





sonefpeglutide
LAPSGLP-2 analog





efpegsomatropin
LAPShGH


Other



Luminate®
risuteganib
Allegro, Heifei AffaMed

SYNOJOYNT®
sodium hyaluronate
Arthrex




Rare Disease Drug Designation Status

As of Dec. 2025

Largest Number of Orphan Drug Designations Among Korean Pharmaceutical Companies
(U.S. FDA, European EMA, Korean MFDS, etc.)

22 cases

Category

USA (FDA)

Europe (EMA)

Korea (MFDS)

Designations (Count)

10

8

4

Product Name

Indication

Designated Country

Designation Year

efocipegtrutide (LAPSTriple agonist)

Primary Biliary Cholangitis

USA (FDA)

2020

Primary Sclerosing Cholangitis

USA (FDA)

2020

Idiopathic Pulmonary Fibrosis

USA (FDA)

2021

Primary Sclerosing Cholangitis

Europe (EMA)

2021

Primary Biliary Cholangitis

Europe (EMA)

2022

Idiopathic Pulmonary Fibrosis

Europe (EMA)

2022

Oraxol®

Angiosarcoma

USA (FDA)

2018

Soft Tissue Sarcoma

Europe (EMA)

2019

sonefpeglutide (LAPSGLP-2 Analog)

Short Bowel Syndrome

USA (FDA)

2019

Europe (EMA)

2019

Korea (MFDS)

2019

Rare Pediatric Disease (RPD)

USA (FDA)

2020

tuspetinib (MKI)

Acute Myeloid Leukemia

USA (FDA)

2018

Korea (MFDS)

2019

efpegsomatropin (LAPShGH)

Growth Hormone Deficiency

Europe (EMA)

2018

efpegerglucagon (LAPSGlucagon analog)

Congenital Hyperinsulinism

USA (FDA)

2018

Europe (EMA)

2018

Korea (MFDS)

2019

Insulin Autoimmune Syndrome

Europe (EMA)

2020

Rare Pediatric Disease (RPD)

USA (FDA)

2020

LA-GLA (HM15421/GC1134A)

Fabry Disease

USA (FDA)

2024

Korea (MFDS)

2025



Securing and Strengthening Intellectual Property through R&D

The pharmaceutical industry is a national industry in South Korea that aims to contribute to the healthy lives of humanity. In particular, the status of pharmaceutical patent holdings serves as a quantitative measure and indicator, becoming another criterion for evaluating a company's R&D capabilities. Hanmi Pharmaceutical will continue its efforts to become a pharmaceutical powerhouse based on excellent intellectual property rights.

Hanmi Pharmaceutical Domestic and International Patent Application Status1) (As of Dec. 31, 2025)

Classification

Domestic

Overseas

Total

Registered Patents

267

2,397

2,664

Patent Pending

172

1,286

1,458

1) Based on Hanmi Pharmaceutical and Hanmi Science as applicants (Excluding PCT international applications, internal database records)

Domestic Pharmaceutical Patent Holdings Status (As of Dec. 31, 2025)

Classification

Hanmi Pharmaceutical

Company A

Company B

Company C

Company D

Registered Medicines

57

11

9

38

9

Registered Patents

48

12

8

23

6

Number of Domestic Patent applications2)3)

Year

Hanmi Pharmaceutical

Company A

Company B

Company C

Company D

2019

43

11

4

16

9

2020

39

13

11

36

15

2021

51

4

17

15

13

2022

25

12

3

26

20

2023

25

6

13

21

13

2024

23

7

3

11

14

Number of Overseas Patent applications2)3)4)

PCT4)

Hanmi Pharmaceutical

Company A

Company B

Company C

Company D

2019

19

10

8

24

8

2020

23

9

3

10

10

2021

37

4

9

20

7

2022

20

14

6

8

13

2023

15

4

7

16

17

2024

17

6

8

11

18

US

Hanmi Pharmaceutical

Company A

Company B

Company C

Company D

2019

20

10

3

14

10

2020

19

11

5

5

9

2021

44

7

7

14

5

2022

29

16

2

3

14

2023

28

5

1

7

6

2024

11

5

0

0

0

2) Domestic and international patent applications are published 1 year and 6 months after the filing date, thus the period from 2019 to 2024 was investigated.
3) Source: KIPRIS, Patent Search Database (WipsON)
4) PCT: Patent Cooperation Treaty



Contribution to the Fiscal Soundness of the National Health Insurance through Improved Combination New Drugs

The National Health Insurance, which underpins South Korea's healthcare policy and serves as a foundation for improving public health and quality of life, emphasizes the critical importance of securing its financial soundness. Hanmi Pharmaceutical, leveraging its global-standard R&D capabilities, contributes to the financial stability of the National Health Insurance by providing incrementally improved combination new drugs. Even when limited to six key products by 2025, it is estimated to have contributed to health insurance fiscal savings of up to KRW 94.3 billion.

Expected Effects of National Health Insurance Fiscal Soundness in 2025 (Top 6 Products)

Approx. KRW 94.3 billion

Cumulative Expected Effects Since the Launch of the Top 6 Products

Approx. KRW 625.1 billion

Product Name

Ingredient
Content

Proper Savings in 20251)

2025

Launch~2024

Jan~Aug

Sep-Dec2) 

Prescription Volume
(units)

Expected Fiscal
Improvement (KRW)

Prescription Volume (units)

Expected Fiscal Improvement (KRW)

Amosartan Tab.

5/50mg

68

77,048,857

5,239,322,288

847,988,467

88,027,701,496

5/100mg

347

27,892,551

9,678,715,034

444,517,532

163,787,576,313

Amosartan Q Tab.

5/50/5mg

212

3,414,746

723,926,158

18,203,766

4,000,953,165

5/50/10mg

210

2,597,510

545,477,157

15,554,802

3,396,383,881

5/50/20mg

210

405,859

85,230,428

2,737,290

599,563,623

5/100/5mg

521

1,398,577

728,658,601

7,300,958

3,901,816,221

5/100/10mg

519

1,423,692

738,896,034

9,381,835

5,009,583,754

5/100/20mg

519

321,614

166,917,884

2,371,945

1,267,152,793

Amosartan Plus Tab.

5/50/12.5mg

49

16,709,910

810,430,613

95,107,485

5,223,873,307

5/100/12.5mg

324

15,536,185

5,025,955,702

85,238,930

28,620,257,256

5/100/25mg

336

2,222,006

746,593,915

14,631,357

5,106,567,561

Amosartan XQ Tab.

5/50/2.5/10mg

245

2,538

620,614

New Launch in 2025

5/50/5/10mg

348

2,333,020

811,891,009

6,489,074

2,308,772,579

5/50/10/10mg

279

1,790,813

499,636,955

4,210,700

1,208,794,061

5/50/20/10mg

342

474,948

162,432,189

944,991

330,928,820

5/100/2.5/10mg

481

213

102,347

New Launch in 2025

5/100/5/10mg

635

1,008,096

640,140,916

2,717,844

1,756,842,159

5/100/10/10mg

566

1,073,242

607,454,847

2,819,779

1,628,331,535

5/100/20/10mg

629

295,967

186,163,513

696,233

447,118,146

Rosuzet Tab.

10/2.5mg

182

197

48,378,252

9,043,130,557

81,637,653

13,792,049,934

10/5mg

289

299

97,385,471

28,486,352,551

442,580,491

99,688,198,051

10/10mg

239

255

73,543,017

17,987,411,538

330,275,464

53,843,121,317

10/20mg

305

323

32,356,505

10,074,328,744

114,470,442

26,230,966,718

Rovelito Tab.

150/10mg

123

5,742,619

706,342,093

106,797,380

8,527,286,714

150/20mg

91

2,415,041

219,768,774

37,239,221

2,332,112,323

300/10mg

271

1,264,290

342,622,717

16,623,832

3,541,561,609

300/20mg

147

612,338

90,013,661

8,728,910

6,123,378,882

Total

417,647,877

94,348,536,839

2,699,266,379

530,700,892,218

Source: UBIST DATA
1) Justified Savings: Difference between prescription amount of Hanmi Pharmaceutical products and single-ingredient original drugs.
2) Price-reduced products in 2025: Rosuzet 10/2.5mg (KRW 727 → KRW 712, 2.1%), Rosuzet 10/5mg (KRW 789 → KRW 779, 1.3%)
Rosuzet 10/10mg (KRW 1,103 → KRW 1,087, 1.5%), Rosuzet 10/20mg (KRW 1,111 → KRW 1,093, 1.6%)

Limitations on Performance Indicator Disclosure
The quantitative indicators used in the report on contributions to the fiscal soundness of the National Health Insurance are compiled and structured by the company itself through media and various institutions, based on figures deemed suitable to visibly represent the diverse values that the company can create through R&D. “Contribution to the Fiscal Soundness of the National Health Insurance through Modified Complex New Drugs” The quantitative information presented in this section cannot be used for direct comparison of similar figures or performance with other companies or within other industries.