HLB’s shot at FDA approval just took another hit. The agency has again rejected the company’s liver cancer drug, CAM-RIVO—a combination of PD-1 inhibitor camrelizumab and VEGFR inhibitor rivoceranib—citing unresolved manufacturing lapses at Jiangsu Hengrui's plant in Lianyungang, China.
This is the second time the FDA has issued a complete response letter (CRL) over chemistry, manufacturing, and control deficiencies tied to camrelizumab’s production.
HLB Chairman Jin Yang-gon speaks in a YouTube broadcast early Friday, confirming the FDA’s rejection of CAM-RIVO and outlining plans to address Hengrui’s manufacturing issues.
HLB Chairman Jin Yang-gon speaks in a YouTube broadcast early Friday, confirming the FDA’s rejection of CAM-RIVO and outlining plans to address Hengrui’s manufacturing issues.
HLB Chairman Jin Yang-gon, in a 3 a.m. YouTube video on Friday, said the rejection came despite both HLB and Hengrui being confident they had addressed the FDA’s concerns.
“We spent the last ten months working nonstop, convinced we had done enough,” he said. “Now, I have to deliver disappointing news again.”
The CRL does not specify the exact deficiencies, Jin added, but Hengrui will work with the FDA to clarify what needs to be corrected. HLB plans to submit the CRL to the Korea Exchange for transparency, though confidentiality agreements prevent the company from disclosing the full document.
The rejection follows an FDA inspection of Hengrui’s facility in January, where inspectors found contamination risks, sloppy cleaning, and missing records—just one piece of a broader compliance mess—before being stalled near a waste bin, where they caught an employee dumping documents under watchful eyes.
Meanwhile, Bristol Myers Squibb (BMS)'s Opdivo-Yervoy combo is advancing just as HLB’s timeline slips. The therapy won European approval this month and is now on track for an FDA decision by April 21.
Head-to-head, CAM-RIVO isn’t far behind. The combo showed a median overall survival (OS) of 22.1 months, compared to Opdivo-Yervoy’s 23.7 months. CAM-RIVO also has a slightly better hazard ratio (HR) of 0.62 versus 0.66 against sorafenib.
HLB shares dropped 7.65 percent Thursday, closing at 66,400 won, as investors braced for the FDA’s decision. The company has been signaling a potential pivot to other indications, including adenoid cystic carcinoma (ACC) and bile duct cancer.
In a phase 2 trial for ACC, rivoceranib showed a 15.1 percent overall response rate (ORR) with tumor shrinkage in 85 percent of patients, though not all met the RECIST criteria for response.
Kim Ji-hye jkim404@docdocdoc.co.kr
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FutureChem is pushing ahead with its prostate cancer radiopharmaceutical FC705, moving the candidate into a phase 3 trial in Korea to assess its potential in metastatic castration-resistant prostate cancer (mCRPC).
FutureChem’s phase 3 trial of FC705 aims to bring a homegrown PSMA-targeted radiopharmaceutical to Korean patients who currently rely on imports. (Credit: FutureChem)
FutureChem’s phase 3 trial of FC705 aims to bring a homegrown PSMA-targeted radiopharmaceutical to Korean patients who currently rely on imports. (Credit: FutureChem)
The study, set to enroll 94 patients, will be conducted at eight hospitals in the Seoul metropolitan area, including Seoul St. Mary’s Hospital. FutureChem is testing FC705 in combination with standard therapy, comparing its efficacy and safety to standard treatment alone. Key endpoints include radiographic progression-free survival (rPFS), objective response rate (ORR), and disease control rate (DCR).
FC705 targets prostate-specific membrane antigen (PSMA) and carries the radioisotope lutetium-177 (177Lu). The drug is designed to extend circulation time in the bloodstream through an albumin binder, potentially enhancing its therapeutic impact.
With radioligand therapy gaining momentum globally, FutureChem is positioning FC705 as a domestic alternative in Korea, where patients have largely relied on imported treatments. To strengthen its case, the company is tweaking its dosing regimen for phase 3, shifting from six doses to four doses of 100 millicuries every eight weeks, a move driven by positive phase 2 results.
That trial saw 60 percent of patients achieve a PSA response—defined as a 50 percent or greater drop in prostate-specific antigen (PSA) levels—even after progressing on second-generation hormonal therapy and taxane-based chemotherapy. Three patients achieved complete PSA clearance
Unlike previous radioligand therapies, FutureChem said FC705 will incorporate PSMA PET/CT imaging as a composite efficacy assessment tool, a first for prostate cancer radiopharmaceuticals. The company says it will release interim data as soon as possible, focusing on rPFS and other key efficacy markers.
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Kim Ji-hye jkim404@docdocdoc.co.kr
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