金年会|金年会·jinnian(金字招牌)诚信至上

        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

        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