Grand Life Sciences and Cali Biosciences Announce Strategic Collaboration for CPL-01 Commercialization
Grand Life Sciences and Cali Biosciences Announce Strategic Collaboration for CPL-01 CommercializationPotentially Pioneering a New Era in Peri-Operative Pain Management
Accelerating Commercialization of CPL-01 in China
Beijing and San Diego, December 2, 2024 Grand Life Sciences Group Co., Ltd. (“Grand Life Sciences”), an integrated pharmaceutical company with full value chain capacities and a global vision, and Cali Biosciences Co., Ltd. (“Cali Biosciences”),a biopharmaceutical company focused on the research and development of innovative drugs in the peri-operative field, are pleased to announce that they have entered into an exclusive market promotion agreement for Grand Life Sciences to commercialize CPL-01, a sustained-release injectable formulation of ropivacaine, in mainland China and the Hong Kong and Macao Special Administrative Regions.
Under the agreement, Grand Life Sciences is obligated to make up-front and milestone payments to Cali Biosciences. Cali Biosciences will, in turn, pay Grand Life Sciences promotion service fees.
Potentially Setting New Standards in Pain Management with Unique Clinical Benefits
Ropivacaine is a member of the amide class of local anesthetics indicated for the production of local or regional anesthesia for surgery and acute pain management. However, traditional Ropivacaine hydrochloride injections have a limited duration of action, necessitating frequent dosing or catheter-based deliveries for long-term pain management. Currently, there are no approved long-acting ropivacaine formulations available globally.
CPL-01, developed using Cali Biosciences’ proprietary PG-Depot technology platform, represents a significant advancement in peri-operative pain management. CPL-01 enhances the duration of analgesic effects and is able to slowly release ropivacaine in a consistent and predictable manner for up to 72 hours with a single administration, providing effective management of peri-operative pain. Unlike traditional ropivacaine hydrochloride injections, which CPL-01 offers a more convenient and patient-friendly solution without the need for an analgesic pump. Cali Biosciences’ Phase 2b clinical trial data have demonstrated that CPL-01 reduces postoperative pain intensity scores and decreases the reliance on opiate analgesics compared to placebo, while exhibiting a positive safety profile.
Cali Biosciences initiated the Phase 3 clinical trials of CPL-01 for open inguinal herniorrhaphy and bunionectomy in the United States in April 2023 and May 2023, respectively. Cali Biosciences also submitted the protocols of Phase 3 clinical trial to the NMPA in China in March 2023, based on the results derived from our clinical trials conducted in the United States.
Expanding Demand for Effective Peri-Operative Analgesics
Factors including rising life expectancy, advancements in medical diagnostic technologies and improved treatment capacities have led to an increasing volume of surgical procedures. Consequently, the global demand for peri-operative pain management drugs will continue to rise.
The increasing number of surgeries combined with the high incidence of postoperative pain underscores the significant need for effective peri-operative analgesic solutions. CPL-01 with its unique clinical benefits is well-positioned to meet this growing market demand.
Leveraging Combined Strengths for Market Success
Grand Life Sciences and Cali Biosciences are combining their strengths to maximize the market potential of CPL-01. With Grand Life Sciences’ extensive distribution network and expertise in the Chinese pharmaceutical market, coupled with Cali Biosciences’ innovative drug development capabilities, the collaboration aims to accelerate the commercialization of CPL-01 in China.
This exclusive commercialization partnership with Cali Biosciences for CPL-01 will further enrich Grand Life Sciences’ pain management product pipeline. The collaboration is expected to create synergistic effects with the existing products, aiding in the development of a high-value product portfolio addressing unmet medical needs. Leveraging its established marketing network and mature commercialization operations, Grand Life Sciences is poised to accelerate the market expansion and clinical adoption of CPL-01, bringing the benefits of this innovative therapy to a broader patient population.
Executive Commentaries
Mr. Zenghui Feng, the chairman of the board of directors of Grand Life Sciences, commented, “Pain management is one of key focuses for Grand Life Sciences. Our collaboration with Cali Biosciences will enhance our anesthesia and pain management pipeline and strengthen our leadership in the peri-operative pain management area. Through innovative drugs like CPL-01, we will better address medical needs and expand treatment options for post-operative pain management, benefiting a wide range of patients”. Mr. Zhiming Wang, Executive President and General Manager of Marketing Center of Grand Life Sciences, further observed, “This cooperation with Cali Biosciences is a strategic alliance for both parties. CPL-01 is the first long-acting local analgesic product introduced by Grand Life Sciences. We hope that with our joint efforts, the latest product can truly reach every clinical doctor and help patients alleviate their pain”.
Mr. Dibang Lin, the co-founder and chairman of the board of directors of Cali Biosciences, commented, “We are thrilled to partner with Grand Life Sciences for the commercialization of CPL-01 in China. Grand Life Sciences is a leading pharmaceutical company in the anesthesia and pain management area, and we are confident that this collaboration will unlock significant market potential for CPL-01.” Mr. PJ Chen, the chief executive officer of Cali Biosciences, further remarked, “This partnership leverages the strengths of both companies to accelerate the commercialization of CPL-01 in China, potentially providing an unique treatment option for patients with post-operative pain. In addition, we are also committed to making CPL-01 available to patients outside of China as a medical choice.”
About CPL-01
CPL-01 is a sustained-release injectable formulation of ropivacaine hydrochloride. Ropivacaine is a member of the amide class of local anesthetics indicated for the production of local or regional anesthesia for surgery and acute pain management. Ropivacaine hydrochloride injection is approved for local or regional anesthesia for surgery and for acute pain management. However, because of the short duration of effect of the traditional ropivacaine hydrochloride injection, infusion by catheter is required if protracted local analgesia is needed for post-operative pain management. Cali Biosciences has applied PG-Depot, a versatile drug delivery platform, in developing CPL-01 to prolong the duration of local site analgesic effect after a single local administration.
About Cali Biosciences
Cali Biosciences Co., Ltd. was established in the Cayman Islands in 2021. Cali Biosciences US, LLC was established in San Diego in 2016, and later Cali Biosciences built its global headquarters in Shenzhen. Cali Biosciences is a biotechnology company dedicated to the research and development of pain management drug candidates based on its drug delivery platforms and other patented technologies, with a view to extending the coverage to manufacturing and commercialization of the pharmaceutical products it develops. The product pipeline of Cali Biosciences currently focuses on non-opioid post-operative pain management including analgesia, anesthesia, sedation, and control of inflammation. Cali Biosciences is committed to responding to unmet medical needs and serving patients and medical professionals around the world.