Sugemalimab, sold under the brand name Cejemly among others, is a

monoclonal antibody A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodie ...

used for the treatment of metastatic

non-small cell lung cancer Non-small-cell lung cancer (NSCLC), or non-small-cell lung carcinoma, is any type of epithelial lung cancer other than small-cell lung cancer (SCLC). NSCLC accounts for about 85% of all lung cancers. As a class, NSCLCs are relatively insensitiv ...

(NSCLC) in combination with chemotherapy. It is an antineoplastic monoclonal antibody that potentiates T-cell responses, including anti-tumor responses, through blockade of PD-1 binding to PD-L1 ligands. The most common side effects include anemia (low red blood cells), increased levels of

aminotransferase Transaminases or aminotransferases are enzymes that catalyze a transamination reaction between an amino acid and an α- keto acid. They are important in the synthesis of amino acids, which form proteins. Function and mechanism An amino acid c ...

s (liver enzymes),

rash A rash is a change of the skin that affects its color, appearance, or texture. A rash may be localized in one part of the body, or affect all the skin. Rashes may cause the skin to change color, itch, become warm, bumpy, chapped, dry, cracke ...

hyperlipidemia Hyperlipidemia is abnormally high levels of any or all lipids (e.g. fats, triglycerides, cholesterol, phospholipids) or lipoproteins in the blood. citing: and The term ''hyperlipidemia'' refers to the laboratory finding itself and is also use ...

(high blood fat levels),

hyperglycemia Hyperglycemia is a condition where unusually high amount of glucose is present in blood. It is defined as blood glucose level exceeding 6.9 mmol/L (125 mg/dL) after fasting for 8 hours or 10 mmol/L (180 mg/dL) 2 hours after eating. Blood gluc ...

(high blood glucose levels),

hyponatremia Hyponatremia or hyponatraemia is a low concentration of sodium in the Serum (blood), blood. It is generally defined as a sodium concentration of less than 135 mmol/L (135 mEq/L), with severe hyponatremia being below 120 mEq/L. Symp ...

(low blood levels of sodium),

hypokalemia Hypokalemia is a low level of potassium (K+) in the blood serum. Mild low potassium does not typically cause symptoms. Symptoms may include feeling tired, leg cramps, weakness, and constipation. Low potassium also increases the risk of an a ...

(low blood levels of potassium),

proteinuria Proteinuria is the presence of excess proteins in the urine. In healthy persons, urine contains very little protein, less than 150 mg/day; an excess is suggestive of illness. Excess protein in the urine often causes the urine to become fo ...

(protein in urine), abdominal (belly) pain,

tiredness Fatigue is a state of tiredness (which is not sleepiness), exhaustion or loss of energy. It is a symptom of any of various diseases; it is not a disease in itself. Fatigue (in the medical sense) is sometimes associated with medical conditions ...

arthralgia Arthralgia () literally means ' joint pain'. Specifically, arthralgia is a symptom of injury, infection, illness (in particular arthritis), or an allergic reaction to medication Medication (also called medicament, medicine, pharmaceuti ...

(joint pain),

hypoesthesia Hypoesthesia or numbness is a common side effect of various medical conditions that manifests as a reduced sense of touch or sensation, or a partial loss of sensitivity to sensory stimuli. In everyday speech this is generally referred to as nu ...

(reduced sensation to touch, pain and temperature),

hypothyroidism Hypothyroidism is an endocrine disease in which the thyroid gland does not produce enough thyroid hormones. It can cause a number of symptoms, such as cold intolerance, poor ability to tolerate cold, fatigue, extreme fatigue, muscle aches, co ...

(underactive thyroid gland) and

hypocalcemia Hypocalcemia is a medical condition characterized by low calcium levels in the blood serum. The normal range of blood calcium is typically between 2.1–2.6 mmol/L (8.8–10.7 mg/dL, 4.3–5.2 mEq/L), while levels less than 2.1 ...

(low blood levels of calcium). Sugemalimab was approved for medical use in China in December 2021, the European Union in July 2024, and the United Kingdom in October 2024.

Medical uses

Sugemalimab, in combination with platinum-based chemotherapy, is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the first-line treatment of adults with metastatic non-small cell lung cancer with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.

Mechanism of action

Sugemalimab is a fully human monoclonal antibody that targets the immunosuppressive ligand programmed cell death-1 ligand 1 (PD-L1; cluster of differentiation 274; CD274) and possesses immune checkpoint inhibitory and antineoplastic properties. When administered, sugemalimab binds specifically to PD-L1, blocking its interaction with its receptor, programmed cell death 1 (PD-1). This inhibition reverses T-cell inactivation induced by PD-1/PD-L1 signaling, enhancing the cytotoxic T-lymphocyte (CTL)-mediated immune response against tumor cells that express PD-L1. Many types of human cancer cells overexpress PD-L1, which, when bound to PD-1 on T-cells, suppresses the immune system and enables immune evasion. PD-1 itself is a transmembrane protein in the immunoglobulin superfamily expressed on activated T-cells, acting as a negative immune regulator that limits CD8-positive T-cell expansion and survival. The anti-PD-L1 monoclonal antibody CS1001, modeled after natural

immunoglobulin G4 Ig gamma-4 chain C region is a protein that in humans is encoded by the ''IGHG4'' gene. See also * Immunoglobulin heavy chain (IGH) * Immunoglobulin G Immunoglobulin G (IgG) is a type of antibody. Representing approximately 75% of serum antib ...

(IgG4), may reduce immunogenicity and other associated toxicities.

Society and culture

Legal status

In May 2024, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Cejemly, intended for the first-line treatment of metastatic non-small cell lung cancer in combination with chemotherapy. The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Sugemalimab was authorized for medical use in the European Union in July 2024. In October 2024, the UK's

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are accepta ...

approved sugemalimab as part of a first-line combination treatment for lung cancer. The approval was granted to CStone Pharmaceuticalsn under brand name Eqjubi. Approval was based on the findings from the multicenter, randomized, double-blind phase III GEMSTONE-302 trial (NCT03789604).

Names

Sugemalimab is the international nonproprietary name.

References

{{Authority control Cancer treatments Monoclonal antibodies for tumors Orphan drugs