Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark significant steps in advancing the company’s pipeline in oncology and pain management.
Irinotecan Liposome Injection for Advanced Colorectal Cancer (CRC)
The irinotecan liposome injection will enter a randomized, double-blind, parallel controlled, multi-center Phase II/III study in combination with oxaliplatin, 5-fluorouracil, calcium folinate, and bevacizumab for first-line advanced colorectal cancer (CRC). Irinotecan, a semisynthetic derivative of camptothecin, works by binding to Topoisomerase I and inducing reversible single strand breaks in DNA, thereby preventing the reconnection of broken single chains. The drug, originally developed by Merrimack Pharmaceuticals, has been approved for marketing in various regions including the US, Europe, South Korea, Singapore, and Japan since 2015. In China, it obtained market approval in April 2022, filed by Servier. Hengrui Pharmaceuticals’ irinotecan liposome injection is awaiting regulatory decision in China for the treatment of unresectable locally advanced or metastatic pancreatic cancer that has failed previous gemcitabine-based chemotherapy combined with fluorouracil and calcium folinate.
Bupivacaine Liposome Injection for Regional Analgesia and Postoperative Pain
Meanwhile, the bupivacaine liposome injection will be assessed in regional analgesia after adult paravertebral nerve block surgery and postoperative pain after laparoscopic colorectal surgery with plane block of transverse abdominal muscle. Bupivacaine, an amide local anesthetic, is widely used in local anesthesia and postoperative analgesia. The liposome formulation, originated by US firm Pacira and marketed in the US since 2011 under the trade name Exparel, is commercially available in the US and Europe. Hengrui’s generic version was approved in China in November 2022 for use in postoperative local analgesia in patients aged 12 years and above with single dose infiltration, and postoperative regional analgesia in adults with intramuscular sulcus brachial plexus block.-Fineline Info & Tech
