LSK BioPharma and Jiangsu Hengrui Medicine Announce Global Clinical Collaboration

LSK BioPharma, a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd., one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, today announced that the companies have entered into a global clinical collaboration in patients with advanced hepatocellular carcinoma (HCC), evaluating the safety and efficacy of LSKB's rivoceranib, also known as apatinib or Aitan® (brand name) in China, a selective and potent VEGFR-2 inhibitor, in combination with Hengrui's camrelizumab (SHR-1210), a humanized anti-PD-1 monoclonal antibody currently under NDA review in China for classic Hodgkin's Lymphoma (cHL).

Under the terms of the clinical collaboration agreement, Hengrui will be responsible for administering the clinical trial with all study costs outside of China shared equally among both parties. LSKB will retain full commercial rights for rivoceranib outside of China and Hengrui will retain full commercial rights for camrelizumab worldwide.

"At diagnosis, hepatocellular carcinoma typically has a dismal prognosis due to a lack of treatment options and the ineffectiveness of standard systemic therapies," said Dr. Sung Chul Kim, LSKB's President, "we are enthusiastic to work with Hengrui for the potential to help more patients by combining rivoceranib with camrelizumab."

"We are pursuing camrelizumab in about 20 clinical trials in China. There is ample scientific evidence and preliminary clinical data supporting the synergistic effects of camrelizumab when used in combination with apatinib (rivoceranib)," said Dr. Lianshan Zhang, President of Global R&D of Hengrui. "We look forward to partnering with LSKB to build upon the existing preclinical and clinical data and further explore this combination therapy for patients with hepatocellular carcinoma, an area of high unmet medical needs."

"As one of the leading biopharmaceutical companies in China, we are committed to developing innovative medicines to address the urgent clinical needs. Through years of effort, Hengrui has built a robust oncology pipeline, which holds significant potential to benefit cancer patients. We are excited about this collaboration to accelerate the delivery of effective and durable treatment options for patients around the world," said Dr. Piaoyang Sun, Chairman of Hengrui.

Currently, Hengrui is conducting an open-label, single arm multicenter phase 2 study (NCT03463876) to evaluate the efficacy and safety of the combination of camrelizumab and apatinib in patients with advanced HCC in China, where Hengrui has received approval of apatinib monotherapy for advanced gastric cancer. At ASCO 2018, it was reported that the objective response rate (ORR) and disease control rate (DCR) were 50.0% and 85.7%, respectively, among 14 evaluated advanced HCC patients treated by camrelizumab in combination with apatinib in an open-label, phase 1 study in China (Xu et al., NCT02942329). In addition, camrelizumab and apatinib combination therapy is also being evaluated by Hengrui for multiple indications including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC) in China.

It is hypothesized that the combination of rivoceranib and camrelizumab may enhance the immune system, aiding the fight against cancer. In addition to the known anti-angiogenic effects of rivoceranib, it may also enhance camrelizumab's anti-tumor activity by normalizing tumor vasculature and reversing the tumor suppressive immune microenvironment.

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