Camrelizumab(注射用卡瑞利珠单抗)

Introduction of Camrelizumab

Camrelizumab for Injection is a humanized IgG4-κ anti-PD-1 monoclonal antibody independently developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. As a Category 1 innovative biological product in China, it was approved for marketing by the NMPA on May 29, 2019, and is one of the first domestically developed PD-1 inhibitors approved in China.

Indications

1、Camrelizumab for Injection is indicated for the treatment of patients with relapsed or refractory classic Hodgkin's lymphoma who have received at least two lines of systemic chemotherapy.

This indication was conditionally approved based on the results of objective response rate and duration of response from a single-arm clinical trial. The full approval of this indication will depend on whether the planned confirmatory randomized controlled clinical trials can demonstrate the significant clinical benefit of camrelizumab treatment compared with standard therapy.

2、Camrelizumab for Injection is indicated for the treatment of patients with advanced hepatocellular carcinoma who have previously received sorafenib treatment and/or oxaliplatin-containing systemic chemotherapy.

This indication was conditionally approved based on the results of objective response rate and overall survival from a Phase II clinical trial. The full approval of this indication will depend on whether the planned confirmatory randomized controlled clinical trials can demonstrate the significant clinical benefit of camrelizumab treatment compared with standard therapy.

Overview

Dosage and Administration

Camrelizumab must be administered under the supervision of a physician experienced in malignant tumor treatment.

Recommended Dosage

Classic Hodgkin's Lymphoma: 200mg per administration, administered via intravenous injection, once every 2 weeks, until disease progression or unacceptable toxicity occurs.

Advanced Hepatocellular Carcinoma: 3mg/kg per administration, administered via intravenous injection, once every 3 weeks, until disease progression or unacceptable toxicity occurs.

Atypical responses may be observed (e.g., temporary tumor enlargement or the appearance of new small lesions within the first few months, followed by tumor regression). If a patient's clinical symptoms are stable or continuously alleviated, even in the presence of preliminary radiological evidence of disease progression, continuation of treatment with this product may be considered based on the evaluation of overall clinical benefit, until confirmed disease progression occurs.

Contraindications

This product is contraindicated in patients with known hypersensitivity to camrelizumab or any of its excipients.

Adverse Reactions

The most common adverse reactions of camrelizumab are: reactive capillary proliferative lesions, hypothyroidism, elevated aspartate aminotransferase, fatigue, elevated alanine aminotransferase, anemia, presence of proteinuria, fever and leukopenia. Most adverse reactions reported with monotherapy are Grade 1 or 2 in severity, and the most common Grade ≥3 adverse reactions are: anemia, hyponatremia, elevated gamma-glutamyl transferase, elevated aspartate aminotransferase, elevated conjugated bilirubin and elevated blood bilirubin.

Special Populations

Pregnancy and Lactation

Pregnancy

There are no data on the use of this product in pregnant women. Animal studies have demonstrated that PD-1 blocking antibodies have embryo-fetal toxicity. It is known that IgG can cross the placental barrier, and as an IgG4, this product may pass from the mother to the developing fetus. The use of this product during pregnancy is not recommended unless the clinical benefit outweighs the potential risk.

Lactation

It is currently unknown whether this product is excreted in human breast milk, as well as its effects on breastfed infants and breast milk production. Since human IgG is excreted in human breast milk, this product may pose potential risks to breastfed infants. Therefore, it is recommended that lactating women discontinue breastfeeding during the treatment with this product and for at least 2 months after the last dose.

Contraception

Women of childbearing potential should use effective contraceptive measures during the treatment with this product and for 2 months after the last dose.

Fertility

No studies have been conducted to evaluate the effects of camrelizumab on fertility in both sexes, so the impact of this product on male and female fertility is unknown.

Pediatric Use

The safety and efficacy of camrelizumab in pediatric and adolescent patients under 18 years of age have not been established.

Geriatric Use

Due to the limited number of geriatric patients enrolled in the current clinical trials, it is recommended that geriatric patients use this product with caution under the guidance of a physician. If use is necessary, no dosage adjustment is required.

For more detailed drug information, please consult the official package leaflet.

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