SAL-0951 in the Treatment of Chemotherapy-induced Anemia in Patients With Non-myeloid Malignancies

Inclusion Criteria:

1. Subjects with body weight ≥40 kg at screening;

2. Subjects with histologically or cytologically confirmed diagnosis of non-myeloidmalignancy (non-curative), and planned to receive anti-tumor treatment (myelosuppressive chemotherapy) for at least 6 weeks simultaneously from the day ofthe first dose (Day 1);

3. Subjects with myelosuppressive chemotherapy-related anemia, defined as centrallaboratory Hb ≤100 g/L during the screening period, and documented decrease in Hblevel ≥10 g/L after the start of chemotherapy as judged by the investigator;

4. Subjects with ferritin ≥50 ng/mL and transferrin saturation (TSAT) ≥10% atscreening;

5. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score ≤1at screening;

6. Subjects with life expectancy ≥6 months as judged by the investigator on the date offirst dose;

7. All male subjects and female subjects of childbearing potential who agree to use amedically acceptable method of contraception from the day of signing the ICF until 90 days after last dose of investigational product (see section 4.3 for acceptablemethod of contraception);

8. Subjects voluntary to participate in the trial, having signed the ICF, able tounderstand the procedures and methods of this trial and willing to strictly followthe clinical trial protocol to complete the trial.

Exclusion Criteria:

1. Subjects with tumor who are receiving myelosuppressive chemotherapy and whoseexpected outcome is cured;

2. Subjects who receive hormonal agents, biologics, novel immunosuppressants (e.g.,PD-1 and PD-L1 immune checkpoint inhibitors) or targeted biologic therapy orradiation therapy alone to treat/control their tumors. However, if chemotherapy isused in combination with these drugs, subjects can be enrolled;

3. Subjects who have received blood transfusion therapy containing red blood cells orESAs (including but not limited to recombinant human erythropoietin, darbepoetinalfa, methoxy polyethylene glycol-epoetin beta/CERA, pegmolesatide) within 4 weeksbefore the first dose of investigational product;

4. Subjects with abnormal hepatic or renal function test results at screening asfollows:

• Patients with alanine transaminase (ALT) >3×upper limit of normal (ULN), oraspartate transaminase (AST) >3×ULN, or total bilirubin (TBL) >1.5×ULN are notallowed to be enrolled in the study (those with TBL ≤2×ULN can be included ifALT/AST is within the normal limit and the investigator believes that there isno safety concern)

• With estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 based onCKD-EPI 2009scr formula, as shown in Appendix 3.

5. Subjects with congestive heart failure (New York Heart Association [NYHA] Class IIIor greater), unstable angina, uncontrolled hypertension (defined as systolic bloodpressure >160 mmHg and/or diastolic blood pressure >100 mmHg despiteantihypertensive medication), or hypertensive crisis or hypertensive encephalopathy,or a history of significant valvular or endocardial disease that would put them atrisk for thromboembolism within 6 months prior to screening and/or within thescreening period;

6. Subjects with thromboembolic events (including but not limited to deep veinthrombosis [DVT], pulmonary embolism, myocardial infarction, stroke, transientischemic attack [TIA]) within 6 months prior to screening (excluding asymptomaticlacunar infarction);

7. Subjects with clinically significant anemia caused by other causes, such asmacrocytic anemia caused by vitamin B12 or folic acid deficiency, autoimmune anemia,hemolysis, genetic anemia such as sickle cell anemia or thalassemia, anemia causedby severe infection (such as active pulmonary tuberculosis, fungal infection, etc.)or existing active bleeding lesions (such as lung cancer-related hemoptysis,gastrointestinal tumor bleeding, gastrointestinal ulcer bleeding, etc.);

8. Subjects with active systemic infection requiring chronic antibiotic therapy;

9. Subjects with clinically significant or uncontrolled ongoing inflammatory/autoimmunedisease (e.g., systemic lupus erythematosus, rheumatoid arthritis, Crohn's disease,celiac disease, etc.);

10. Subjects with need for an ophthalmological procedure due to diabetic eye disease,diabetic macular edema or age-related macular degeneration, or subjects withproliferative choroidal or retinal lesions;

11. Subjects known to have significant gastrointestinal abnormalities, which wouldaffect drug intake, transport or absorption (such as inability to swallow, chronicdiarrhea, intestinal obstruction, etc.), or total gastrectomy;

12. Subjects known to have polycystic kidney disease;

13. Subjects known to have serious liver disease or active liver disease (exceptnon-alcoholic hepatic steatosis), including chronic hepatitis B (positive forhepatitis B surface antigen or hepatitis B core antibody, and HBV-DNA >20 IU/mL),chronic hepatitis C (positive for hepatitis C antibody, and HCV-RNA quantitativedetection higher than the upper limit of normal), autoimmune hepatitis, cirrhosis,or acute liver failure;

14. Subjects tested positive for human immunodeficiency virus (HIV) antibody;

15. Subjects with major surgery anticipated to occur during the trial;

16. Subjects with myeloid malignancies (such as chronic myeloid leukemia, etc.);

17. Subjects with primary or metastatic malignant tumors of the central nervous system;

18. Subjects with anticipated use of dapsone during the trial;

19. Subjects with hypersensitivity to HIF-PH inhibitors or any of the productcomponents;

20. Subjects with a history of drug or alcohol abuse in the past two years*;

*An average of 14 units of alcohol per week (1 unit ≈ 360 mL of beer, or 45 mL ofliquor, or 150 mL of wine) in 2 years before screening.

21. Subjects who have received another investigational product (or study drug), havereceived treatment with an investigational device (or study device), or haveparticipated in clinical research involving intervention (medical action beyond thescope of ordinary medical practice) and received treatment during the period within 8 weeks prior to the screening;

22. Subjects who have participated in clinical trials of HIF-PH inhibitor treatment (including enarodustat) within 4 weeks before screening and have receivedinvestigational product (active drug) treatment;

23. Subjects who are pregnant, lactating, or may be pregnant (the possibility ofpregnancy cannot be ruled out by the investigator based on the results of pregnancytest at screening visit);

24. Subjects who have taken traditional Chinese medicine, Chinese patent medicine,and/or herbal medicine for anemia within 2 weeks before the first dose ofinvestigational product;

25. Subjects with any other medical condition that, in the opinion of the investigator,could pose a safety risk to them in this trial, could confound efficacy or safetyassessment, or could interfere with their participation in the study.