HLB·Jiangsu "FDA, facility issues not related to efficacy"

Received a CRL for Rivoceranib plus camrelizumab…issue was found during the monitoring of the pant

Not related to clinical results…will retry for approval after seeking cooperation and supplementation

(from the left) Chief Technology Officer (CTO) Han Yong-hae of HLB Group, Vice President Frank Jiang of Jiangsu Hengrui Pharmaceuticals, CEO Jung Se-ho of Elevar Therapeutics, and Vice President Jang Sung-hoon of Elevar Therapeutics.

"It appears that there are no issues related to the efficacy of Rivoceranib plus camrelizumab therapy.

 

However, we were pointed out of the manufacturing facility during the monitoring of Jiangsu Hengrui Pharmaceuticals.

 

We do not need an additional clinical trial.

 

By closely cooperating with the U.S.

 

FDA, we will introduce a novel drug to patients with liver cancer." HLB group and Jiangsu Hengrui Pharmaceuticals hosted a press conference on May 23rd at Sofitel Ambassador Seoul Hotel and stated this regarding the FDA’s rejection of approval for their novel candidate drug, Rivoceranib plus camrelizumab, for the treatment of liver cancer.

 

The press conference was attended by Chief Technology Officer (CTO) Han Yong-hae of HLB Group, Vice President Frank Jiang of Jiangsu Hengrui Pharmaceuticals, CEO Jung Se-ho of Elevar Therapeutics, and Vice President Jang Sung-hoon of Elevar Therapeutics.

 

HLB announced on the 17th that they received a complete response letter (CRL) request from the U.S.

 

FDA regarding the application for Rivoceranib plus camrelizumab combination therapy as the first-line treatment for liver cancer.

 

The main reason for receiving the CRL was reported to be issues raised during the Bioresearch Monitoring (BIMO) inspection, which aimed to verify the manufacturing facility and key clinical sites for camrelizumab initially.

 

Jiangsu Hengrui Pharmaceuticals explained that it was due to facility issues.

 

“This case of FDA’s rejection of approval was due to the facility issue,” Vice President Frank Jiang of Jiangsu Hengrui Pharmaceuticals said.

 

“We expect to confirm the details at a future meeting.

 

We will closely cooperate with the FDA and HLB.“ CTO Han Yong-hae of HLB Group said, “During the FDA inspection, some issues were raised regarding the manufacturing facility of camrelizumab, but Jiangsu Hengrui Pharmaceuticals diligently addressed the supplementation." He further mentioned, "Disparities between the examiner and examinee may exist.

 

The FDA made no comments regarding efficacy and safety, and no additional clinical trials are needed.“ HLB and Jiangsu Hengrui Pharmaceuticals have been developing Rivoceranib plus camrelizumab combination therapy as a treatment for liver cancer and gastric cancer.

 

Rivoceranib is an oral anticancer drug that selectively inhibits vascular endothelial growth factor receptor-2 (VEGFR2), which is involved in angiogenesis.

 

Jiangsu Hengrui Pharmaceuticals’ camrelizumab inhibits PD-1 protein expressed on the surface of immune cells (T cells), preventing the binding to PD-L1 receptors on cancer cell surfaces, thereby activating immune cells.

 

The CARES-310 Phase 3 clinical trials showed improved efficacy of Rivoceranib plus camrelizumab combination therapy compared to Bayer’s Nexabar, which is used as a standard therapy for liver cancer.

 

In clinical trials, Rivoceranib plus camrelizumab recorded a median overall survival (OS) of 22.1 months, demonstrating an improvement compared to Nexabar’s 15.4 months.

 

This result was more extended than the OS of 19.2 months recorded by Roche’s combination therapy of Tecentriq, an immunotherapy for cancer, plus Avastin, a targeted anticancer agent, for the first-line therapy of liver cancer.

 

Furthermore, it is also extended than the OS of 16.4 months of AstraZeneca’s Imfinzi plus Imjudo combination therapy.

 

These drugs were compared with Nexabar alone.

 

However, the talks caution against comparing research results on the same basis.

 

In the CARES-310 study, 83% of the patients were Asians, whereas in the IMbrave150 study of Tecentriq plus Avastin combination therapy, the proportion of Asians was 40%.

 

The FDA has requested additional data for novel drug clinical trials focusing on specific races or countries.

 

CTO Han Yong-hae of HLB Group said, "While there may be differences in efficacy between races in other cancer types, race is not a significant factor in first-line treatment for liver cancer," and added, "Updated results will be available at the American Society of Clinical Oncology (ASCO) meeting starting on the 31st of this month.

 

I believe that with additional data, the combination therapy of Rivoceranib plus camrelizumab will receive more positive evaluation."