In May, Elevar and Hengrui Pharma submitted an NDA and BLA for the combination of rivoceranib and camrelizumab as a first-line therapy for uHCC, with FDA PDUFA dates in May 2024
FORT LEE, NJ and PRINCETON, NJ, USA I October 17, 2023 I Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma), one of China’s largest pharmaceutical companies, today announced a global licensing agreement that grants Elevar rights to commercialize and develop Hengrui Pharma’s anti-PD-1 antibody camrelizumab in combination with rivoceranib for unresectable hepatocellular carcinoma (uHCC) worldwide, excluding Greater China Region and Korea.
Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales. The total estimated 10-year payout could be up to $1 billion.
In May 2023, a new drug application (NDA) for rivoceranib and a biologics license application (BLA) for camrelizumab were submitted to the U.S. Food and Drug Administration (FDA) for the combination of rivoceranib and camrelizumab as a first-line therapy for uHCC. The FDA accepted the submissions, assigning Prescription Drug User Fee Act (PDUFA) target action dates in May 2024.
Rivoceranib is developed by Hengrui Pharma in China. In January 2023, the combination was approved in China as a first-line treatment for uHCC. Elevar maintains development rights to rivoceranib outside of China and Korea.
“This agreement will boost our companies’ shared focus on advancing the standard of care in uHCC, as having both camrelizumab and rivoceranib under one portfolio will significantly streamline commercialization,” said Saeho Chong, Elevar chief executive officer. “In our investigational Phase 3 CARES-310 study, the combination was shown to provide the highest reported median overall survival of any currently available uHCC treatment. Elevar’s alliance with Hengrui Pharma is a catalyst for our world-class team as we focus on bringing life-changing products to cancer patients.”
Each year, liver cancer is the cause of more than 830,000 deaths worldwide1. HCC is the most common type of liver cancer and typically has a poor prognosis with a lack of treatment options.
With 14 research and development centers built around the world and several subsidiaries established in the U.S., EU, Australia and Japan, Hengrui Pharma is globally focused on innovation and open collaboration. The company has 13 in-house-developed innovative products and two in-licensed innovative products marketed in China, more than 80 proprietary innovative candidates in the R&D stage and nearly 20 under clinical development worldwide.
Hengrui has also demonstrated a clear commitment to HCC patients globally, as its initial efforts in China led to the 2020 approval of rivoceranib, under the name Aitan®, as a single agent for a second-line treatment for advanced HCC.
Elevar and Hengrui Pharma first shared results for the CARES-310 study in September 2022 at the annual Congress of the European Society for Medical Oncology (ESMO). The results were also published in The Lancet on July 24, 2023. Camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and increased overall response rate versus sorafenib, a standard first-line treatment for uHCC.
About Hepatocellular Carcinoma (HCC)
HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.
About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1). Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Currently, more than 10 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer) and treatment settings.
Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, nasopharyngeal carcinoma in the first-line setting, and uHCC in combination with rivoceranib as a first-line treatment. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.
About Rivoceranib
Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression.
Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib was the first TKI approved in gastric cancer in China (2014). It is also approved in China as a single agent for a second-line treatment for advanced HCC (2020) and in combination with camrelizumab for a first-line treatment for uHCC (2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.).
Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan®.
About Elevar Therapeutics
Elevar Therapeutics, Inc. is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidate is rivoceranib. Additional information is available at ElevarTherapeutics.com.
About Hengrui Pharma
Hengrui Pharma is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma ranked 24th among the top 1,000 global pharma companies in 2021. Hengrui Pharma has been on the Pharma Exec’s annual listing of the top 50 global pharmaceutical companies for the fifth consecutive year.
1https://www.cancer.net/cancer-types/liver-cancer/statistics
SOURCE: Elevar Therapeutics
Post Views: 328
In May, Elevar and Hengrui Pharma submitted an NDA and BLA for the combination of rivoceranib and camrelizumab as a first-line therapy for uHCC, with FDA PDUFA dates in May 2024
FORT LEE, NJ and PRINCETON, NJ, USA I October 17, 2023 I Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma), one of China’s largest pharmaceutical companies, today announced a global licensing agreement that grants Elevar rights to commercialize and develop Hengrui Pharma’s anti-PD-1 antibody camrelizumab in combination with rivoceranib for unresectable hepatocellular carcinoma (uHCC) worldwide, excluding Greater China Region and Korea.
Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales. The total estimated 10-year payout could be up to $1 billion.
In May 2023, a new drug application (NDA) for rivoceranib and a biologics license application (BLA) for camrelizumab were submitted to the U.S. Food and Drug Administration (FDA) for the combination of rivoceranib and camrelizumab as a first-line therapy for uHCC. The FDA accepted the submissions, assigning Prescription Drug User Fee Act (PDUFA) target action dates in May 2024.
Rivoceranib is developed by Hengrui Pharma in China. In January 2023, the combination was approved in China as a first-line treatment for uHCC. Elevar maintains development rights to rivoceranib outside of China and Korea.
“This agreement will boost our companies’ shared focus on advancing the standard of care in uHCC, as having both camrelizumab and rivoceranib under one portfolio will significantly streamline commercialization,” said Saeho Chong, Elevar chief executive officer. “In our investigational Phase 3 CARES-310 study, the combination was shown to provide the highest reported median overall survival of any currently available uHCC treatment. Elevar’s alliance with Hengrui Pharma is a catalyst for our world-class team as we focus on bringing life-changing products to cancer patients.”
Each year, liver cancer is the cause of more than 830,000 deaths worldwide1. HCC is the most common type of liver cancer and typically has a poor prognosis with a lack of treatment options.
With 14 research and development centers built around the world and several subsidiaries established in the U.S., EU, Australia and Japan, Hengrui Pharma is globally focused on innovation and open collaboration. The company has 13 in-house-developed innovative products and two in-licensed innovative products marketed in China, more than 80 proprietary innovative candidates in the R&D stage and nearly 20 under clinical development worldwide.
Hengrui has also demonstrated a clear commitment to HCC patients globally, as its initial efforts in China led to the 2020 approval of rivoceranib, under the name Aitan®, as a single agent for a second-line treatment for advanced HCC.
Elevar and Hengrui Pharma first shared results for the CARES-310 study in September 2022 at the annual Congress of the European Society for Medical Oncology (ESMO). The results were also published in The Lancet on July 24, 2023. Camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and increased overall response rate versus sorafenib, a standard first-line treatment for uHCC.
About Hepatocellular Carcinoma (HCC)
HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.
About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1). Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Currently, more than 10 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer) and treatment settings.
Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, nasopharyngeal carcinoma in the first-line setting, and uHCC in combination with rivoceranib as a first-line treatment. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.
About Rivoceranib
Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression.
Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib was the first TKI approved in gastric cancer in China (2014). It is also approved in China as a single agent for a second-line treatment for advanced HCC (2020) and in combination with camrelizumab for a first-line treatment for uHCC (2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.).
Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan®.
About Elevar Therapeutics
Elevar Therapeutics, Inc. is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidate is rivoceranib. Additional information is available at ElevarTherapeutics.com.
About Hengrui Pharma
Hengrui Pharma is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma ranked 24th among the top 1,000 global pharma companies in 2021. Hengrui Pharma has been on the Pharma Exec’s annual listing of the top 50 global pharmaceutical companies for the fifth consecutive year.
1https://www.cancer.net/cancer-types/liver-cancer/statistics
SOURCE: Elevar Therapeutics
Post Views: 328
