Pipeline

R&D PIPELINE

We established a diversified and comprehensive R&D pipeline covering oncology, autoimmune diseases, pain management, cardiovascular diseases, metabolic diseases, infectious diseases, respiratory system diseases, hematological diseases, neurological diseases, ophthalmology, etc.

Major R&D Pipelines

  • 18

    New Molecular Entity drugs marketed in China

  • 4

    Other innovative drugs marketed in China

  • 90

    +

    In-House Innovative Pharmaceuticals under Clinical Development

  • ~

    400

    Ongoing Clinical Studies       

  • 20

    +

    Ongoing International Clinical Studies

*By January 6, 2025

Oncology
临床前
Phase I
Phase II

  • HRS-4357

    PSMA Nuclear Medicine

    Metastatic castration-resistant prostate cancer
    Single Agent

    Phase II

  • HRS-1167

    PARP1

    Recurrent ovarian cancer
    Combination Therapy (bevacizumab)

    Phase II

    Advanced prostate cancer
    Combination Therapy

    Phase II

    Advanced solid tumors
    Single Agent

    Phase I

  • SHR-4602

    HER2 ADC (Next-gen)

    HER2-expressing or -mutated advanced solid tumors
    Combination Therapy

    Phase II

    HER2-expressing or -mutated solid tumors
    Single Agent

    Phase I

  • SHR-1501

    IL-15

    Non-muscle invasive bladder cancer
    Combination Therapy (BCG bladder perfusion)

    Phase II

  • SHR-A1912

    CD79b ADC

    B-cell non-Hodgkin lymphoma
    Combination Therapy

    Phase II

    B-cell non-Hodgkin lymphoma
    Single Agent

    Phase I
    US

    B-cell lymphoma
    Single Agent

    Phase I

  • HRS2398

    ATR

    Advanced solid tumors
    Combination Therapy

    Phase II

  • HRS-8080

    SERD

    ER-positive, HER2-negative unresectable or metastatic breast cancer
    Combination Therapy (dalpiciclib)

    Phase II

    Advanced breast cancer
    Single Agent/Combination Therapy

    Phase I

  • HRS-4642

    KRAS G12D

    Advanced solid tumors with KRAS G12D mutations
    Combination Therapy

    Phase II

    Advanced solid tumors
    Single Agent

    Phase I

  • HRS-6209

    CDK4

    Advanced breast cancer
    Combination Therapy (HRS-8080/HRS-1358)

    Phase II

    Advanced solid tumors
    Single Agent

    Phase I

  • SHR-9839

    Advanced solid tumors
    Combination Therapy

    Phase II

    Advanced solid tumors
    Single Agent

    Phase I

  • HRS-2189

    KAT6

    Advanced breast cancer
    Combination Therapy

    Phase II

    Advanced malignant tumors
    Single Agent

    Phase I

  • HRS-5041

    AR-PROTAC

    Advanced prostate cancer
    Combination Therapy

    Phase II

    Metastatic castration-resistant prostate cancer
    Single Agent

    Phase I
    Australia, China

  • SHR-1826

    c-Met ADC

    Advanced solid tumors
    Combination Therapy

    Phase II

    Advanced malignant solid tumors
    Single Agent

    Phase I

Phase III

  • SHR-A2009

    HER3 ADC

    EGFR-mutated advanced or metastatic non-small cell lung cancer that has failed EGFR TK therapy
    Single Agent

    Phase III

    Advanced solid tumors
    Combination Therapy

    Phase II

    Advanced or metastatic solid tumors
    Single Agent

    Phase I

    Advanced solid tumors
    Single Agent

    Phase I
    Japan and Korea

  • SHR-A1921

    TROP2 ADC

    Platinum-sensitive recurrent epithelial ovarian cancer
    Single Agent or Combination Therapy with carboplatin

    Phase III

    Platinum-resistant recurrent epithelial ovarian cancer
    Single Agent

    Phase III

    Advanced solid tumors
    Single Agent

    Phase II
    US, Australia

    Advanced solid tumors
    Combination Therapy

    Phase II

  • SHR-A1904

    Claudin 18.2 ADC

    2nd-line CLDN18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma
    Single Agent

    Phase III

    CLDN18.2-positive advanced solid tumors
    Combination Therapy (adebrelimab)

    Phase III

    Advanced pancreatic cancer
    Single Agent

    Phase I

    Advanced solid tumors
    Single Agent

    Phase I
    US, Australia, China

  • SHR-A2102

    Nectin-4 ADC

    2nd/3rd-line locally advanced or metastatic urothelial carcinoma
    Single Agent

    Phase III

    Advanced solid tumors
    Single Agent

    Phase II
    US

    Advanced gynecologic malignancies
    Single Agent

    Phase II

    Locally advanced or metastatic non-small cell lung cancer
    Combination Therapy

    Phase II

    Advanced urothelial carcinoma
    Combination Therapy (adebrelimab)

    Phase II

    Locally advanced or metastatic esophageal cancer
    Combination Therapy (adebrelimab)

    Phase II

    Advanced solid tumors
    Single Agent

    Phase I

NDA/BLA Filed

  • SHR2554

    EZH2

    Relapsed and refractory peripheral T-cell lymphoma
    Single Agent

    NDA/BLA Filed

    T-cell lymphoma
    Combination Therapy

    Phase II

    Relapsed and refractory follicular lymphoma
    Single Agent

    Phase II

    Refractory/relapsed T-cell lymphoma
    Single Agent

    Phase I

  • SHR-1701

    PD-L1/TGF-β

    1st-line advanced or metastatic gastric cancer (GC) or gastroesophageal junction cancer
    Combination Therapy (chemotherapy)

    NDA/BLA Filed

    Advanced solid tumors
    Single Agent

    Phase I
    Australia

  • SHR-A1811

    HER2 ADC

    2nd-line and subsequent locally advanced or metastatic HER2-mutated adult non-small cell lung cancer
    Single Agent

    NDA/BLA Filed

    HER2-positive metastatic breast cancer
    Single Agent

    Phase III

    HER2-low recurrent/metastatic breast cancer
    Single Agent

    Phase III

    Adjuvant therapy for HER2-positive breast cancer
    Single Agent

    Phase III

    HER2-positive recurrent or metastatic breast cancer
    Combination Therapy

    Phase III

    3rd-line HER2-positive advanced colorectal cancer
    Single Agent

    Phase III

    1st-line treatment for HER2-mutated advanced or metastatic non-small cell lung cancer
    Single Agent

    Phase III

    Advanced solid tumors with HER2 expression
    Combination Therapy (fuzuloparib)

    Phase II

    HER2-low metastatic or unresectable breast cancer
    Combination Therapy

    Phase II

    HER2-expressing gynecological malignancies
    Single Agent

    Phase II

    HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma
    Combination Therapy (adebrelimab+chemotherapy)

    Phase II

    1st-line HER2 mutated, amplified, or overexpressed advanced non-small cell lung cancer
    Combination Therapy (pyrotinib/adebrelimab)

    Phase II

    Locally advanced unresectable or recurrent metastatic biliary tract cancer with HER2 expression/amplification
    Single Agent

    Phase II

    Gastric cancer or adenocarcinoma of the gastroesophageal junction and colorectal cancer
    Single Agent

    Phase I

    Advanced solid tumors
    Single Agent

    Phase I
    US, Australia, Asia Pacific (including China)

  • HR20013

    NK-1RA in combination with 5-HT3RA

    Prevention of highly emetogenic chemotherapy-induced nausea and vomiting
    Single Agent (FDC)

    NDA/BLA Filed

    Prevention of nausea and vomiting caused by antineoplastic drugs with moderate risk of vomiting
    Single Agent (FDC)

    Phase III

Marketed

  • Apatinib

    VEGFR

    HER2-negative metastatic breast cancer adult patients with germline BRCA mutations
    Combination Therapy (fuzuloparib)

    Marketed

    Advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma progressed or relapsed after at least 2Ls of systematic chemotherapy
    Single Agent

    Marketed

    Advanced hepatocellular carcinoma failed or intolerable after at least first-line systemic therapy
    Single Agent

    Marketed

    1st-line unresectable or metastatic hepatocellular carcinoma
    Combination Therapy (camrelizumab)

    Marketed

    1st-line unresectable or metastatic hepatocellular carcinoma
    Combination Therapy (camrelizumab)

    NDA/BLA Filed
    US, Europe, and Asia Pacific (including China)

    Unresectable hepatocellular carcinoma
    Combination Therapy (TACE+camrelizumab)

    Phase III

  • Pyrotinib

    HER1, HER2, and HER4

    Relapsed or metastatic advanced HER2-positive breast cancer patients without previous HER2 treatment
    Combination Therapy (trastuzumab+docetaxel)

    Marketed

    Relapsed or metastatic HER2-positive breast cancer with previous trastuzumab treatment
    Combination Therapy (capecitabine)

    Marketed

    Neoadjuvant treatment for early or locally advanced HER2-positive breast cancer
    Combination Therapy (trastuzumab+docetaxel)

    Marketed

    Extended adjuvant therapy for HER2-positive breast cancer
    Single Agent

    Phase III

    Advanced non-squamous non-small cell lung cancer with HER2 mutation
    Single Agent

    Phase III
    US, Europe, and Asia Pacific (including China)

  • Camrelizumab

    PD-1

    Relapsed and refractory classical Hodgkin lymphoma after at least two systematic therapies
    Single Agent

    Marketed

    Advanced hepatocellular carcinoma after sorafenib and/or lenvatinib and/or oxaliplatin-containing chemotherapy treatments
    Single Agent

    Marketed

    1st-line unresectable locally advanced or metastatic EGFR-mut negative ALK-negative NSCLC
    Combination Therapy (pemetrexed+carboplatin)

    Marketed

    Locally advanced or metastatic esophageal adenocarcinoma progressed after or intolerable to 1st-line treatment
    Single Agent

    Marketed

    Advanced nasopharyngeal carcinoma progressed after or intolerable to 2nd-line+ chemotherapy
    Single Agent

    Marketed

    1st-line locally relapsed or metastatic nasopharyngeal carcinoma
    Combination Therapy (cisplatin+gemcitabine)

    Marketed

    1st-line unresectable locally advanced/relapsed or metastatic esophageal squamous cell carcinoma
    Combination Therapy (cisplatin+paclitaxel)

    Marketed

    1st-line locally advanced/metastatic squamous non-small cell lung cancer
    Combination Therapy (carboplatin+paclitaxel)

    Marketed

    1st-line unresectable or metastatic hepatocellular carcinoma
    Combination Therapy (apatinib)

    Marketed

    Recurrent metastatic cervical cancer
    Combination Therapy (famitinib)

    NDA/BLA Filed

    1st-line advanced hepatocellular carcinoma
    Combination Therapy (apatinib)

    NDA/BLA Filed
    US, Europe, and Asia Pacific (including China)

    Relapsed and refractory classical Hodgkin lymphoma
    Single Agent

    Phase III

    Unresectable hepatocellular carcinoma
    Combination Therapy (TACE+apatinib)

    Phase III

    Unresectable locally advanced esophageal cancer
    Combination Therapy

    Phase III

    1st-line advanced cervical cancer
    Combination Therapy (famitinib)

    Phase III

  • fuzuloparib

    PARP1/2

    Maintenance therapy for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieve complete or partial remission with 1st-line platinum-based chemotherapy
    Single Agent

    Marketed

    Metastatic HER2-negative breast cancer with BRCA1/2 mutation
    Single Agent/Combination Therapy (apatinib)

    Marketed

    Recurrent platinum-sensitive gBRCA-mut ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma after 2nd-line+ chemotherapy
    Single Agent

    Marketed

    Maintenance therapy for platinum-sensitive recurrent epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma after platinum-containing chemotherapy
    Single Agent

    Marketed

    Metastatic castration-resistant prostate cancer
    Combination Therapy (abiraterone)

    Phase III
    US, Europe, and Asia Pacific (including China)

  • Dalpiciclib

    CDK4/6

    Relapsed or metastatic HR-positive HER2-negative breast cancer progressed after endocrine therapy
    Combination Therapy (fulvestrant)

    Marketed

    Initial endocrine therapy for locally advanced or metastatic HR-positive HER2-negative breast cancer
    Combination Therapy (aromatase inhibitor)

    Marketed

    Adjuvant therapy for HR-positive, HER2-negative breast cancer
    Combination Therapy

    Phase III

  • Rezvilutamide

    AR

    Metastatic hormone sensitive prostate cancer (mHSPC) with high tumor burden
    Single Agent

    Marketed

    Metastatic hormone-sensitive prostate cancer
    Single Agent

    Phase III
    Europe, China

  • Adebrelimab

    PD-L1

    1st-line extensive stage small cell lung cancer (ES-SCLC)
    Combination Therapy (carboplatin + etoposide)

    Marketed

    1st-line therapy for limited-stage small cell lung cancer
    Combination Therapy

    Phase III

    Perioperative treatment of resectable stage II or III non-small cell lung cancer
    Combination Therapy

    Phase III

    1st-line therapy for STK11/KEAP1/KRAS mutated advanced or metastatic non-squamous non-small cell lung cancer
    Combination Therapy (SHR-8068+platinum-containing doublet chemotherapy)

    Phase III

    Advanced hepatocellular carcinoma
    Combination Therapy (SHR-8068+bevacizumab)

    Phase III

    Advanced non-small cell lung cancer
    Combination Therapy (SHR-8068+platinum-containing chemotherapy)

    Phase II

    1st-line advanced biliary tract cancer
    Combination Therapy (SHR-8068+platinum-containing chemotherapy)

    Phase II

    Advanced gastric cancer and esophageal cancer
    Combination Therapy (SHR-8068+platinum-containing chemotherapy)

    Phase II

    Locally advanced cervical cancer
    Combination Therapy

    Phase II

  • Hetrombopag

    TPO-R

    Adult chronic primary immune thrombocytopenia who have not responded well to glucocorticoids, immunoglobulins, etc
    Single Agent

    Marketed

    Severe aplastic anemia who do not respond well to immunosuppressive therapy
    Single Agent

    Marketed

    Primary treatment of severe aplastic anemia
    Combination Therapy

    NDA/BLA Filed

    Chemotherapy-induced thrombocytopenia
    Single Agent

    Phase III
    US, Australia, Europe, and China

    Children with immune thrombocytopenia (ITP)
    Single Agent

    Phase III

    Chronic liver disease with thrombocytopenia with invasive procedures or surgeries
    Single Agent

    Phase III

    Primary treatment of non-severe aplastic anemia
    Combination therapy

    Phase II

  • Linperlisib

    PI3Kδ

    Refractory/relapsed follicular lymphoma in adult patients after 2nd-line+ systematic treatment
    Single Agent

    Marketed

  • Mecapegfilgrastim

    G-CSF

    Chemotherapy-induced neutropenia in adults with malignant cancers
    Single Agent

    Marketed

More
Metabolic And Cardiovascular Diseases
临床前
Phase I
Phase II

  • SHR-3167

    Diabetes mellitus
    Single Agent

    Phase II

  • SHR-2004

    FXI

    Prevention of venous thromboembolism after knee arthroplasty
    Single Agent

    Phase II

    Prevention of postoperative venous thromboembolism in patients undergoing ovarian cancer surgery
    Single Agent

    Phase II

    Prevent the risk of stroke or systemic embolism in patients with ventricular fibrillation
    Single Agent

    Phase I

  • HRS-1893

    Obstructive hypertrophic cardiomyopathy
    Single Agent

    Phase II

  • HRS-1780

    Mineralocorticoid receptors

    Chronic kidney disease
    Single Agent

    Phase II

Phase III

  • INS068

    Insulin

    Type 2 diabetes mellitus
    Single Agent

    Phase III

  • HR17031

    Insulin/GLP-1

    Type 2 diabetes mellitus
    Single Agent (FDC)

    Phase III

  • HRS-7535

    GLP-1 (oral)

    Type 2 diabetes mellitus
    Single Agent

    Phase III

    Overweight or obesity
    Single Agent

    Phase II

    Diabetic kidney disease
    Single Agent

    Phase II

  • HRS9531

    GLP-1/GIP

    Overweight or obesity
    Single Agent

    Phase III

    Type 2 diabetes mellitus
    Single Agent

    Phase III

    Obesity with heart failure
    Single Agent

    Phase II

    Obesity with obstructive sleep apnea
    Single Agent

    Phase II

    Obesity with polycystic ovary syndrome
    Single Agent

    Phase II

    Weight management and type 2 diabetes mellitus
    Single Agent (tablet)

    Phase I

  • SHR-1918

    ANGPTL3

    Homozygous familial hypercholesterolemia
    Single Agent

    Phase III

    Hyperlipidemia
    Single Agent

    Phase II

  • SHR4640

    URAT1

    Primary gout with hyperuricemia
    Single Agent

    Phase III

    Hyperuricemia in patients with gout
    Combination Therapy (febuxostat)

    Phase II

  • SHR6508

    CaSR

    Secondary hyperparathyroidism in patients on maintenance hemodialysis with chronic kidney disease
    Single Agent

    Phase III

NDA/BLA Filed
Marketed

  • Henagliflozin

    SGLT-2

    Type 2 diabetes mellitus
    Combination Therapy (metformin+retagliptin)

    Marketed

    Improve glycemic control in adults with type 2 diabetes mellitus
    Single Agent/Combination Therapy (metformin)

    Marketed

    Chronic kidney disease
    Single Agent

    Phase II

  • Retagliptin

    DPP-IV

    Type 2 diabetes mellitus
    Single Agent/Combination Therapy (metformin)

    Marketed

  • Recaticimab

    PCSK9

    Adults with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who are unable to achieve low-density lipoprotein cholesterol (LDL-C) goals despite moderate or higher doses of statins, or in combination with statins and other lipid-lowering therapies on the basis of dietary control; or as a single agent Adult patients with nonfamilial hypercholesterolemia and mixed dyslipidemia to reduce low-density lipoprotein cholesterol (
    Single Agent

    Marketed

More
Immunological And Respiratory Diseases
临床前
Phase I

  • HRS-7085

    Inflammatory bowel disease (healthy volunteers)
    Single Agent

    Phase I
    Australia

    Inflammatory bowel disease
    Single Agent

    Phase I

  • HRS-9821

    PDE3/4

    Chronic obstructive pulmonary disease (COPD)
    Single Agent

    Phase I

  • RSS0343

    Non-cystic fibrosis bronchiectasis
    Single Agent

    Phase I

  • SHR-4597

    Asthma
    Single Agent

    Phase I

  • HRS-9813

    Idiopathic pulmonary fibrosis
    Single Agent

    Phase I

  • RSS0393

    Psoriasis
    Single Agent

    Phase I

  • SHR-1139

    Psoriasis
    Single Agent

    Phase I

  • SHR-2173

    Systematic lupus erythematosis
    Single Agent

    Phase I

Phase II

  • SHR-1905

    TSLP

    Asthma
    Single Agent

    Phase II

    Chronic rhinosinusitis with nasal polyp (CRSwNP)
    Single Agent

    Phase II

    Chronic obstructive pulmonary disease
    Single Agent

    Phase I

    Asthma (healthy volunteers)
    Single Agent

    Phase I
    Australia

Phase III

  • SHR-1819

    IL-4Rα

    Atopic dermatitis
    Single Agent

    Phase III

    Prurigo nodularis
    Single Agent

    Phase III

    Chronic spontaneous urticaria
    Single Agent

    Phase II

    Atopic dermatitis in children/adolescents
    Single Agent

    Phase I

    Atopic dermatitis (healthy volunteers)
    Single Agent

    Phase I
    China, Australia

  • SHR-1703

    IL-5

    Eosinophilic asthma
    Single Agent

    Phase III

    Eosinophilic granulomatosis with polyangiitis
    Single Agent

    Phase III

  • HRS-5965

    Factor B

    Untreated paroxysmal nocturnal hemoglobinuria
    Single Agent

    Phase III

    Paroxysmal nocturnal hemoglobinuria treated with C5 antibody
    Single Agent

    Phase III

    IgA nephropathy
    Single Agent

    Phase II

NDA/BLA Filed

  • SHR0302

    JAK1

    Ankylosing spondylitis
    Single Agent

    NDA/BLA Filed

    Moderate-to-severe active rheumatoid arthritis
    Single Agent

    NDA/BLA Filed

    Moderate-to-severe atopic dermatitis
    Single Agent

    NDA/BLA Filed
    China, Canada

    Alopecia
    Single Agent

    NDA/BLA Filed

    Psoriatic arthritis
    Single Agent

    Phase III

    Active radiologically negative mid-axis spondyloarthritis
    Single Agent

    Phase III

    Mild-to-moderate atopic dermatitis
    Single Agent (ointment)

    Phase III

    Ulcerative colitis
    Single Agent

    Phase III
    US, Europe, China

    Vitiligo
    Single Agent (alkaline gel)

    Phase I

Marketed

  • Vunakizumab

    IL-17A

    Adults with moderate to severe plaque psoriasis who are receiving systemic therapy or phototherapy
    Single Agent

    Marketed

    Active ankylosing spondylitis in adults
    Single Agent

    NDA/BLA Filed

    Moderate-to-severe chronic plaque psoriasis in children and adolescents
    Single Agent

    Phase III

    Psoriatic arthritis
    Single Agent

    Phase III

  • Imrecoxib

    COX2

    Osteoarthritis-related pain
    Single Agent

    Marketed

More
Neuroscience
临床前
Phase I
Phase II

  • SHR-1707

    A-beta

    Alzheimer's disease
    Single Agent

    Phase II

    Alzheimer's disease
    Single Agent

    Phase I
    Australia

  • HRS8179

    SUR1

    Severe cerebral edema after massive ischemic stroke
    Single Agent

    Phase II

  • HRS-9231

    MRI of the brain and whole body
    Single Agent

    Phase II

    MRI testing
    Single Agent

    Phase I
    Australia

Phase III
NDA/BLA Filed
Marketed

  • Tegileridine fumarate

    MOR

    Post-operative analgesia for abdominal surgeries
    Single Agent

    Marketed

    Moderate to severe pain after orthopedic surgery
    Single Agent

    NDA/BLA Filed

  • Remimazolam

    GABAa

    Sedation and anesthesia in non-endotracheal intubation procedures/procedures, general anesthesia induction and maintenance
    Single Agent

    Marketed

    ICU sedation with mechanical ventilation
    Single Agent

    Phase III

More
Anti-infection
临床前
Phase I
Phase II
Phase III
NDA/BLA Filed
Marketed
More
Others
临床前
Phase I

  • HRS-2183

    Severe infections caused by gram-negative bacteria
    Single Agent

    Phase I

Phase II
Phase III
NDA/BLA Filed
Marketed
More