• K8·凯发(中国)天生赢家·一触即发

    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

    • 15

      In-House Innovative Products Launched

    • 2

      Partnered Innovative Product Launched

    • 90

      +

      In-House Innovative Pharmaceuticals under Clinical Development

    • 300

      +

      Ongoing Clinical Studies

    • ~

      20

      Ongoing International Clinical Studies

    *By July. 31, 2024

    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

    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

    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

    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

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