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

  • 13

    In-House Innovative Products Launched

  • 2

    Partnered Innovative Product Launched

  • 80

    +

    In-House Innovative Pharmaceuticals under Clinical Development

  • 260

    +

    Ongoing Clinical Studies

  • ~

    20

    Ongoing International Clinical Studies

*By Mar. 31, 2023

Oncology
临床前
Phase I
Phase II

  • SHR-A2009

    HER3 ADC

    Advanced solid tumors
    Combination Therapy (adebrelimab/aumolertinib)

    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

    Advanced solid tumors
    Combination Therapy (adebrelimab, or in combination with carboplatin/ cisplatin, or in combination with adebrelimab and carboplatin/cisplatin, or in combination with bevacizumab)

    Phase II

    Advanced solid tumors
    Single Agent

    Phase I
    US, Australia, China

  • SHR1459

    BTK

    Relapsed/refractory B-cell non-Hodgkin's lymphoma
    Combination Therapy (linperlisib)

    Phase II

    Neuromyelitis optica spectrum disorder
    Single Agent

    Phase II

    Primary membranous nephropathy
    Single Agent

    Phase II

  • SHR-8068

    CTLA-4

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

    Phase II

    Advanced HCC
    Combination Therapy (adebrelimab+bevacizumab)

    Phase II

  • SHR-1802

    LAG3

    Advanced solid tumors
    Combination Therapy (camrelizumab+famitinib)

    Phase II

    Advanced solid tumors
    Combination Therapy (adebrelimab)

    Phase II

    Advanced solid tumors
    Single Agent

    Phase I

Phase III

  • SHR-1701

    PD-L1/TGF-β

    Advanced or metastatic gastric cancer (GC) or gastroesophageal junction cancer
    Combination Therapy (chemotherapy)

    Phase III

    Perioperative treatment of resectable gastric cancer (GC) or gastroesophageal junction cancer
    Combination Therapy (tegafur+oxaliplatin)

    Phase III

    1st-line treatment for advanced cervical cancer
    Combination Therapy (chemotherapy±bevacizumab）

    Phase III

    Advanced solid tumors
    Combination Therapy (bevacizumab)

    Phase II

    Perioperative rectal cancer
    Combination Therapy (radiotherapy)

    Phase II

    Recurrent or advanced non-small cell lung cancer with EGFR mutation
    Combination Therapy (almonertinib)

    Phase II

    Inoperable stage III non-small cell lung cancer
    Combination Therapy (radiotherapy)

    Phase II

    HER2-positive advanced gastric cancer (GC) or adenocarcinoma of the gastroesophageal junction
    Combination Therapy (SHR-A1811)

    Phase II

    Advanced solid tumors
    Single Agent

    Phase I

    Recurrent or metastatic nasopharyngeal carcinoma
    Single Agent

    Phase I

    Solid tumors
    Single Agent

    Phase I
    Australia

  • Famitinib

    VEGFR, FGFR, c-kit, and other kinases

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

    Phase III

    1st-line PD-L1 positive non-small cell lung cancer
    Combination Therapy (camrelizumab)

    Phase III

    Advanced solid tumors
    Combination Therapy (camrelizumab+albumin-bound paclitaxel)

    Phase II

    Urologic and gynecologic tumors
    Combination Therapy (camrelizumab)

    Phase II

    Recurrent metastatic cervical cancer
    Combination Therapy (camrelizumab)

    Phase II

    Advanced solid tumors
    Combination Therapy (camrelizumab+SHR-1802)

    Phase II

  • SHR-A1811

    HER2 ADC

    HER2-positive metastatic breast cancer
    Single Agent

    Phase III

    HER2-low recurrent/metastatic breast cancer
    Single Agent

    Phase III

    HER2-positive unresectable or metastatic breast cancer
    Combination Therapy (pyrotinib/pertuzumab/adebrelimab/albumin-bound paclitaxel)

    Phase II

    Advanced solid tumors with HER2 expression
    Combination Therapy (fuzuloparib)

    Phase II

    Advanced non-small cell lung cancer with HER2 mutation, amplification, or overexpression
    Combination Therapy (pyrotinib/adebrelimab)

    Phase II

    HER2-positive advanced gastric cancer (GC) or adenocarcinoma of the gastroesophageal junction
    Combination Therapy (SHR-1701)

    Phase II

    HER2-low metastatic or unresectable breast cancer
    Combination Therapy (capecitabine)

    Phase II

    HER2-low advanced breast cancer
    Combination Therapy (dalpiciclib, fulvestrant, bevacizumab or letrozole/anastrozole)

    Phase II

    HER2-positive advanced solid tumors
    Combination Therapy (pyrotinib or bevacizumab, capecitabine and oxaliplatin or other standard treatment)

    Phase II

    HER2-expressing gynecological malignancies
    Single Agent

    Phase II

    Advanced NSCLC
    Single Agent

    Phase II

    Advanced solid tumors
    Single Agent

    Phase I

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

    Phase I

    Solid tumors
    Single Agent

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

  • HR20013

    NK-1RA in combination with 5-HT3RA

    Prevention of chemotherapy-induced nausea and vomiting
    Single Agent

    Phase III

NDA/BLA Filed
Marketed

  • Apatinib

    VEGFR

    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

    Adjuvant therapy for hepatocellular carcinoma (HCC) patients with high risk of recurrence after radical surgery or ablation
    Combination Therapy (camrelizumab)

    Phase III

    1st-line advanced or metastatic gastric cancer (GC) or gastroesophageal junction cancer
    Combination Therapy (oxaliplatin+capecitabine+camrelizumab)

    Phase III

    Unresectable HCC
    Combination Therapy (TACE+camrelizumab)

    Phase III

    Maintenance therapy for advanced ovarian cancer after platinum-containing therapy
    Single Agent/Combination Therapy (fuzuloparib)

    Phase III

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

    Phase III

    Metastatic castration-resistant prostate cancer
    Combination Therapy (fuzuloparib)

    Phase II

  • 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)

    Advanced non-small cell lung cancer with HER2 mutation, amplification, or overexpression
    Combination Therapy (SHR-A1811)

    Phase II

    Advanced HER2-positive unresectable or metastatic breast cancer
    Combination Therapy (SHR-A1811)

    Phase II

    Advanced HER2-positive solid tumors
    Combination Therapy (SHR-A1811 or bevacizumab, capecitabine and oxaliplatin, or other standard treatment)

    Phase II

  • 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 oxaliplatin-containing chemotherapy treatments
    Single Agent

    Marketed

    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

    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

    1st-line advanced or metastatic gastric cancer (GC) or gastroesophageal junction cancer
    Combination Therapy (oxaliplatin+capecitabine+apatinib)

    Phase III

    Adjuvant therapy for hepatocellular carcinoma (HCC) patients with high risk of recurrence after radical surgery or ablation
    Combination Therapy (apatinib)

    Phase III

    Unresectable HCC
    Combination Therapy (TACE+apatinib)

    Phase III

    Unresectable locally advanced esophageal cancer
    Combination Therapy (radiotherapy+chemotherapy)

    Phase III

    Neoadjuvant treatment for early or locally advanced triple-negative breast cancer
    Combination Therapy (albumin-bound paclitaxel)

    Phase III

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

    Phase III

    1st-line PD-L1 positive non-small cell lung cancer
    Combination Therapy (famitinib)

    Phase III

    Advanced solid tumors
    Combination Therapy (famitinib+albumin-bound paclitaxel)

    Phase II

    Urologic and gynecologic tumors
    Combination Therapy (famitinib)

    Phase II

    Recurrent metastatic cervical cancer
    Combination Therapy (famitinib)

    Phase II

    Advanced solid tumors
    Combination Therapy (famitinib+SHR-1802)

    Phase II

  • fuzuloparib

    PARP

    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)

    Maintenance therapy for advanced ovarian cancer after platinum-containing therapy
    Single Agent/Combination Therapy (apatinib)

    Phase III

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

    Phase III

    Metastatic castration-resistant prostate cancer
    Combination Therapy (apatinib)

    Phase II

    Advanced solid tumors with HER2 expression
    Combination Therapy (SHR-A1811)

    Phase II

    Neoadjuvant and adjuvant therapy for pancreatic cancer
    Combination Therapy (mFOLFIRINOX)

    Phase II

  • Dalpiciclib

    CDK4/6

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

    Marketed

    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 (endocrine therapy)

    Phase III

    Advanced HER2-low breast cancer
    Combination Therapy (SHR-A1811, fulvestrant, bevacizumab, or letrozole/anastrozole)

    Phase II

    Advanced breast cancer
    Combination Therapy (HRS-8807)

    Phase I

  • Rezvilutamide

    AR

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

    Marketed

    High-risk localised or locally advanced prostate cancer suitable for radical prostatectomy
    Combination Therapy (androgen deprivation therapy)

    Phase III

  • Adebrelimab

    PD-L1

    1st-line ES-SCLC
    Combination Therapy (carboplatin + etoposide)

    Marketed

    1st-line therapy for limited-stage small cell lung cancer
    Combination Therapy (concurrent chemoradiotherapy)

    Phase III

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

    Phase III

    Advanced non-small cell lung cancer with HER2 mutation, amplification, or overexpression
    Combination Therapy (SHR-A1811)

    Phase II

    HER2-positive unresectable or metastatic breast cancer
    Combination Therapy (SHR-A1811)

    Phase II

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

    Phase II

    Advanced HCC
    Combination Therapy (SHR-8068+bevacizumab)

    Phase II

    Advanced solid tumors
    Combination Therapy (SHR-1802)

    Phase II

    Advanced solid tumors
    Combination Therapy (SHR-A1921)

    Phase II

    Advanced solid tumors
    Combination Therapy (aumolertinib or SHR-A2009)

    Phase II

    Advanced malignant tumors
    Combination Therapy (SHR-2002)

    Phase I

  • Linperlisib

    PI3Kδ

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

    Marketed

    Relapsed/refractory B-cell non-Hodgkin's lymphoma
    Combination Therapy (SHR1459)

    Phase II

    Relapsed refractory inert non-Hodgkin's lymphoma
    Combination Therapy (rituximab)

    Phase II

  • Mecapegfilgrastim

    PEG rhG CSF

    Chemotherapy-induced neutropenia in adults with nonmyeloid malignant cancers
    Single Agent

    Marketed

More
Cardiovascular and Metabolism
临床前
Phase I
Phase II
Phase III
NDA/BLA Filed

  • HR20033

    SGLT2/Metformin

    Type 2 diabetes mellitus
    Single Agent (FDC)

    NDA/BLA Filed

  • HRX0701

    DPP-IV/Metformin

    Type 2 diabetes mellitus
    Single Agent (FDC)

    NDA/BLA Filed

  • SHR-1209

    PCSK9

    Primary hypercholesterolemia and mixed hyperlipidemia
    Single Agent

    NDA/BLA Filed

    Primary hypercholesterolemia and mixed hyperlipidemia with poor lipid control
    Combination Therapy (lipid-lowering drugs)

    NDA/BLA Filed

    Heterozygous familial hypercholesterolemia
    Single Agent

    NDA/BLA Filed

Marketed

  • Henagliflozin

    SGLT-2

    Type 2 diabetes mellitus
    Single Agent

    Marketed

    Type 2 diabetes mellitus
    Combination Therapy (metformin+retagliptin)

    Phase III

  • Retagliptin

    DPP-IV

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

    Marketed

    Type 2 diabetes mellitus
    Combination Therapy (metformin+henagliflozin)

    Phase III

More
Autoimmune Diseases
临床前
Phase I

  • HRS-7085

    Healthy volunteers
    Single Agent

    Phase I
    Australia

  • HRS-9821

    PDE3/4

    Chronic Obstructive Pulmonary Disease (COPD)
    Single Agent

    Phase I

  • RS1805

    RORγ

    Ulcerative colitis
    Single Agent

    Phase I

  • RS-2102

    Atopic dermatitis
    Single Agent

    Phase I

  • RSS0343

    Non-cystic fibrosis bronchiectasis
    Single Agent

    Phase I

  • SHR-1654

    Rheumatoid arthritis
    Single Agent

    Phase I

  • SHR-2001

    Systematic lupus erythematosis
    Single Agent

    Phase I

  • SHR-2106

    Prevention treatment for graft rejection after organ transplantation
    Single Agent

    Phase I

Phase II

  • SHR-1905

    Anti-TSLP

    Asthma
    Single Agent

    Phase II

    Chronic rhinosinusitis with nasal polyp (CRSwNP)
    Single Agent

    Phase II

    Healthy volunteers
    Single Agent

    Phase I
    Australia

  • SHR-2010

    MASP-2

    IgA nephropathy
    Single Agent

    Phase II

  • SHR-1819

    IL-4Rα

    Atopic dermatitis
    Single Agent

    Phase II

    Patients with moderate-to-severe chronic sinusitis with nasal polyps
    Single Agent

    Phase II

    Healthy volunteers
    Single Agent

    Phase I
    Australia

  • HRS-5965

    Factor B

    Indications related to complement-mediated hemolytic anemia
    Single Agent

    Phase II

    IgA nephropathy, idiopathic membranous nephropathy, C3 nephropathy and lupus nephritis
    Single Agent

    Phase I

Phase III
NDA/BLA Filed

  • SHR-1314

    IL-17A

    Moderate-to-severe plaque psoriasis
    Single Agent

    NDA/BLA Filed

    Ankylosing spondylitis
    Single Agent

    Phase III

    Psoriatic arthritis
    Single Agent

    Phase II

  • SHR0302

    JAK1

    Moderate-to-severe atopic dermatitis
    Single Agent

    NDA/BLA Filed

    Psoriatic arthritis
    Single Agent

    Phase III

    Ankylosing spondylitis
    Single Agent

    Phase III

    Rheumatoid arthritis
    Single Agent

    Phase III

    Active radiologically negative mid-axis spondyloarthritis
    Single Agent

    Phase III

    Alopecia
    Single Agent

    Phase III

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

    Phase III

    Ulcerative colitis
    Single Agent

    Phase III
    US, Europe, China

    Moderate-to-severe atopic dermatitis
    Single Agent

    Phase III
    Canada, China

    Graft-versus-host disease (GVHD)
    Single Agent (oral solution)

    Phase I

Marketed

  • Hetrombopag

    TPO-R

    Adult chronic primary immune thrombocytopenia after glucocortocoids or immunoglobulin treatment
    Single Agent

    Marketed

    Severe aplastic anemia after immunosuppressive therapy
    Single Agent

    Marketed

    Chemotherapy-induced thrombocytopenia
    Single Agent

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

    Primary treatment of severe aplastic anemia
    Combination Therapy (standard immunosuppressive therapy)

    Phase III

    Children with immune thrombocytopenia (ITP)
    Single Agent

    Phase III

    Primary treatment of non-severe aplastic anemia
    Combination therapy (cyclosporine)

    Phase II

More
Pain
临床前
Phase I
Phase II
Phase III
NDA/BLA Filed

  • SHR8554

    MOR

    Post-operative analgesia for abdominal surgeries
    Single Agent

    NDA/BLA Filed

    Moderate to severe pain after orthopedic surgery
    Single Agent

    Phase III

Marketed

  • Imrecoxib

    COX2

    Osteoarthritis-related pain
    Single Agent

    Marketed

  • Remimazolam

    GABA-A

    Colonoscopy sedation, bronchoscopy sedation, and general anethesia
    Single Agent

    Marketed

    ICU sedation with mechanical ventilation
    Single Agent

    Phase II

  • Dexmedetomidine hydrochloride nasal spray

    Pre-operative analgesia/anxiolytic for pediatric patients from age 2-6
    Single Agent

    Marketed

    Pre-operative analgesia/anxiolytic for adult patients
    Single Agent

    Marketed

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

  • Oteseconazole

    CYP51

    Severe vulvovaginal candidiasis
    Single Agent

    Marketed

    Recurrent vulvovaginal candidiasis
    Single Agent

    Phase III

More
Others
临床前
Phase I
Phase II
Phase III

  • HR19034 eye drops

    Atropine

    Slow down progression of myopia for pediatric patients
    Single Agent

    Phase III

  • SHR7280

    GnRH

    Uterine fibroids with heavy menstrual bleeding
    Single Agent

    Phase III

    Controlled ovarian hyperstimulation in assisted reproductive technology
    Single Agent

    Phase III

    Endometriosis
    Single Agent

    Phase II

NDA/BLA Filed
Marketed
More