Recently, the National Medical Products Administration (NMPA) accepted the new indication marketing authorization applications for the innovative drugs Camrelizumab for Injection (AiRuiKa®) and Apatinib Mesylate (AiTan®) developed by Hengrui Medicine and its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. The indication is : Camrelizumab for Injection in combination with Apatinib Mesylate and transarterial chemoembolization (TACE) for the treatment of unresectable hepatocellular carcinoma .

Research on SHR-1210-III-336

This application for a new indication is based on a randomized, open-label, multicenter phase III clinical trial (SHR-1210-III-336) evaluating the efficacy and safety of camrelizumab and apatinib mesylate in combination with transarterial chemoembolization (TACE) versus TACE alone in patients with unresectable hepatocellular carcinoma. The study was led by Academician Jia Fan and Professor Shu-Kui Qin of Zhongshan Hospital affiliated with Fudan University, with participation from 34 centers nationwide, enrolling a total of 423 patients. The primary efficacy endpoint was progression-free survival (PFS) assessed by a blinded independent imaging review committee (BIRC); secondary efficacy endpoints included overall survival (OS), investigator-assessed PFS, BIRC- and investigator-assessed objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). Interim analysis results showed that, compared with TACE alone, the camrelizumab plus apatinib mesylate and TACE groups achieved a clinically significant improvement in BIRC-assessed PFS, and a trend toward OS benefit was observed. This combination therapy is expected to become a new clinical treatment option for patients with unresectable hepatocellular carcinoma .

Regarding unresectable hepatocellular carcinoma

Primary liver cancer is one of the most common malignant tumors worldwide, with hepatocellular carcinoma (HCC) accounting for 90% of its pathological types .² According to GLOBOCAN 2022 data, there are more than 860,000 new cases of liver cancer and more than 750,000 deaths worldwide each year, ranking third among the causes of cancer death globally .³ China is a high-incidence area for liver cancer, with 367,700 new cases and 316,500 deaths in 2022.⁴ Treatment of HCC requires different therapies depending on the disease stage. Transarterial ACE (TACE) is widely used in all stages of liver cancer in China and has become the standard treatment for patients with unresectable intermediate-stage liver cancer. However, repeated TACE treatments can cause liver function damage, which limits its clinical application, and some patients cannot benefit from it as a result. The efficacy of PD-1/PD-L1 antibody combined with anti-angiogenic targeted drugs has been validated in the first-line treatment of advanced hepatocellular carcinoma. This combination therapy can inhibit potential tumor immune escape and tumor angiogenesis induced by TACE, thus playing a synergistic role . The combination therapy of PD-1/PD-L1 antibody with anti-angiogenic targeted drugs and TACE is expected to improve the clinical benefit of patients with unresectable intermediate-stage hepatocellular carcinoma.

Regarding camrelizumab and apatinib mesylate

Camrelizumab for injection is a humanized PD-1 monoclonal antibody independently developed by the company . It can bind to the human PD-1 receptor and block the PD-1/PD-L1 pathway, restoring the body's anti-tumor immunity and thus forming the basis for cancer immunotherapy. Camrelizumab has a high affinity for PD-1 and has significantly prolonged overall survival by 6-8 years in various solid tumor treatment studies . Camrelizumab was approved for marketing in May 2019 and has been approved for multiple indications in China, covering lung cancer, liver cancer, esophageal cancer, nasopharyngeal carcinoma, and cervical cancer, making it a leading domestic PD-1 product in terms of the number of approved indications and tumor types covered.

Apatinib mesylate is a small-molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR) independently developed by the company , and was approved for marketing in October 2014. Currently, apatinib mesylate tablets have been approved for four indications in China: monotherapy for advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that has progressed or relapsed after at least two prior lines of systemic chemotherapy. Patients should be in good general condition at the time of treatment ; monotherapy for advanced hepatocellular carcinoma that has failed or is intolerant to at least one line of systemic therapy; in combination with injectable camrelizumab for first-line treatment of unresectable or metastatic hepatocellular carcinoma; and in combination with fluzoparib for adult patients with germline BRCA-mutated human epidermal growth factor receptor (HER2)-negative metastatic breast cancer who have received neoadjuvant, adjuvant, or metastatic chemotherapy. Hormone receptor (HR)-positive breast cancer patients must have previously received endocrine therapy or are considered unsuitable for endocrine therapy.