[Kim Jinsoo, Edaily Reporter] HLB Pharma, an affiliate of HLB Group, announced today that it has begun conceptual design work to produce its targeted anti-cancer drug, rivoceranib, at its Hyangnam facility in South Korea. The move marks a strategic shift toward in-house manufacturing and aims to reduce potential supply chain risks stemming from U.S.-China geopolitical tensions.
 | | HLB Pharma Hyangnam site. (NAVER MAP) |
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The company has recently closed all existing pharmaceutical production at the Hyangnam site, which previously manufactured injectable and liquid formulations. These products will now be produced at HLB’s Namyangju facility. The Hyangnam plant will be fully repurposed for rivoceranib production.
Currently, rivoceranib is produced by Hengrui Pharma in China. With the new initiative, HLB is advancing plans for independent production. The project is in the conceptual design phase, which includes overall site layout planning, process flow and equipment design, and the drafting of preliminary construction budgets and timelines.
“Design work is underway for our domestic rivoceranib production facility, and we are targeting a groundbreaking within this year,” an HLB official said.
Building a pharmaceutical facility that meets U.S. FDA Good Manufacturing Practice (GMP) standards can take several years. Celltrion and Samsung Biologics required approximately six and four years, respectively, for similar projects.
Strengthening Global Supply Chain and Regulatory ReadinessHLB anticipates that local production of rivoceranib will enhance manufacturing capacity and reduce exposure to global supply chain vulnerabilities. While the new facility will not impact the current FDA review process for the rivoceranib-camrelizumab combination therapy for hepatocellular carcinoma (HCC), it is expected to support future regulatory and commercial strategies in the U.S. and other key markets.
The company is currently pursuing FDA approval for a combination therapy of rivoceranib with camrelizumab, Hengrui’s immunotherapy agent. While rivoceranib has passed regulatory review, camrelizumab received additional minor comments from the FDA, delaying approval. Industry analysts have raised concerns that U.S.-China political tensions may be contributing to regulatory hurdles.
Despite Chairman Jin Yang-gon publicly stating that international politics have not affected the review process, investors continue to urge the company to diversify its manufacturing base.
“Hengrui has over a decade of experience producing rivoceranib and will remain our manufacturer for the time being,” the HLB official added. “However, once the domestic facility is operational, we expect to supply non-China markets using locally produced volumes.”
HLB is also preparing for expanded clinical use of rivoceranib. Its U.S. subsidiary, Elevar Therapeutics, completed a Phase 2 trial for peritoneal cancer in 2023. While the program is currently on hold, it remains a viable alternative should the HCC indication face setbacks. In such a case, domestic production could support a separate regulatory submission.
If the HCC combination therapy receives FDA approval, rivoceranib could be listed in the National Comprehensive Cancer Network (NCCN) guidelines based on its previously demonstrated efficacy in other indications, such as peritoneal cancer. This would further increase global demand, which the company aims to meet through its South Korean manufacturing capacity.
“The plant is still in the design stage and must undergo FDA inspections and other regulatory processes. Therefore, the timeline for commercial production remains uncertain,” the official said.
