[Edaily Reporter KIM JI-WAN ] SamilPharmaceutical(000520)With “Lorecivivint,” a new drug for osteoarthritis for which BioSplice holds exclusive domestic distribution rights, entering the regulatory review process in the UK following its submission in the U.S., its entry into the Korean market—valued at up to 8 trillion won—is drawing near.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced on the 8th (local time) that it had determined the marketing authorization application for Lorecivivint submitted by BioSplice to be complete and valid, and had commenced the formal review process.

Previously, SamilPharmaceutical signed an agreement with BioSplice in 2021, securing the rights for the domestic development, approval, and exclusive commercialization of Loresibivint. The total contract value amounts to up to $10 million (11.3 billion won), including an upfront payment and milestones for clinical trials, approval, and sales. Under the agreement, SamilPharmaceutical will pay BioSplice double-digit royalties on product sales.

Following the U.S., the U.K. Begins Approval Review… Strong Contender to Be the World’s First DMOAD

Under the MHRA’s national review process for new drugs, the goal is to reach a conclusion within the 150-day actual review period if key issues are resolved during a single round of inquiries and supplementary submissions. If further review is required, the target is generally to reach a conclusion within 210 days. However, periods during which the “review clock is paused” due to the company’s submission of supplementary data are not included in this timeframe. Based on the review schedule released by the MHRA, a decision on whether Loersibivint will receive UK approval is likely to be announced as early as March or April of next year.

Following the UK, BioSplice plans to submit a marketing authorization application for Loresibivint to the EMA later this month. Previously, the company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) last January. This means that the approval process, which began in the U.S., is expanding to the UK and Europe in just over eight months.

Erich Horsley, CEO of BioSplice, stated, “After more than 10 years of clinical development and 11 clinical trials, Loresibivint is now undergoing formal review in the UK,” adding, “Patients with osteoarthritis have been waiting for decades for a meaningful new treatment option.” He went on to emphasize, “This review could be a crucial step toward significantly improving the quality of life and life expectancy of countless patients.”

Currently, there is no cure for osteoarthritis. The typical treatment pathway has been to “endure the pain with painkillers or injections until it becomes severe, at which point patients undergo joint replacement surgery.” While this can alleviate immediate pain, it has the limitation of failing to halt the progression of cartilage wear and joint degeneration itself.

In this context, Loresibivint aims to become the world’s first “disease-modifying osteoarthritis drug” (DMOAD). To date, no DMOAD has been approved by the U.S. Food and Drug Administration (FDA).

In the Phase 3 “OA-07” clinical trial of Roersivibint, the treatment group showed a 19.5% improvement in the WOMAC pain score at 6 months. The improvement in the placebo group was 5%. At the 12-month mark, the treatment group demonstrated significant improvements over the placebo group not only in pain but also in joint function.

The highlight is the X-ray findings. In the trial, the research team conducted long-term follow-up of the “medial joint space width” (mJSW), or the space between the knee bones. As osteoarthritis progresses and cartilage wears away, this space narrows. Results showed that the joint space increased in patients who received an annual dose of Loersibivint. Even in patients who had received a placebo during the first year and experienced a narrowing of the joint space, the joint space widened after receiving Loersibivint.

Kolon TissueGene, Inc.(950160)This stands in contrast to the results of the U.S. Phase 3 clinical trial “ACTiVION-II” for Biosplice’s osteoarthritis treatment “TG-C,” released last July, in which the drug failed to meet primary endpoints such as 12-month pain (VAS) and the WOMAC pain score.

In response, BioSplice emphasized, “The OA-07 study demonstrated structural benefits in the joints that are rarely observed in osteoarthritis research,” adding, “These results support the potential for Roersivibint to become the world’s first osteoarthritis treatment.”

The international academic journal *Nature Reviews Drug Discovery* also predicted this year that Loersibivint is a strong candidate for DMOAD approval.

Patient Groups: “We’ve Waited 30 Years—We Need Loresibivint”

With these impressive clinical results

,

patient groups are also raising their voices.

U.S. arthritis patient advocacy groups CreakyJoints and the Global Healthy Living Foundation (GHLF) have been consistently calling for the urgent introduction of Roersibivint.

Through their campaign, they stated, “We have suffered from osteoarthritis for far too long,” and urged patients to “take action” (ACT NOW). Specifically, they are encouraging patients to write letters directly to the U.S. Congress.

The reason patient advocacy groups have taken the lead is the long-standing lack of fundamental, long-term treatments. According to Creaky Joints, there are approximately 25 million people in the U.S. with knee osteoarthritis, and about 650,000 knee replacement surgeries are performed annually. Nevertheless, for decades, patients have been forced to rely on painkillers, injections, and physical therapy before ultimately opting for knee replacement surgery.

Louis Tharp, Executive Vice President of GHLF and Cricky Joints, emphasized, “Patients are waiting for a safe, innovative, and potentially disease-transforming treatment (Loresibivint).”

Domestic Patient Base Surpasses 3 Million… Value of SamilPharmaceutical’s Licensing Rights Comes into Focus

The value of the exclusive domestic licensing rights for Loresibivint secured by SamilPharmaceutical is also on the rise.

According to last year’s health insurance statistics from the National Health Insurance Service and the Health Insurance Review and Assessment Service, approximately 3.45 million patients in South Korea received treatment for knee osteoarthritis. Related medical expenses totaled 2.1738 trillion won, ranking among the top categories for domestic medical spending based on a single condition.

Loresibivint is primarily intended for patients with KL stages 2–3, who are experiencing progressive cartilage damage. The KL grading system categorizes knee osteoarthritis into four stages (0–4) based on the degree of progression. Generally, Stage 2 is considered clear-cut osteoarthritis; in Stage 3, joint space narrowing becomes pronounced; and Stage 4 represents a severe stage where the joint space is nearly lost, making patients candidates for joint replacement surgery.

The number of patients in Korea with KL stages 2–3 is estimated to be between 2 million and 2.7 million. Based on a simple calculation using an estimated treatment cost of approximately 3 million won per session, the preliminary domestic market size for Loresibivint soars to between 6 trillion and 8 trillion won. Based on this simple calculation, if SamilPharmaceutical secures a 1% market share in the domestic target market, annual sales would be approximately 60 to 80 billion won; at 3%, 180 to 240 billion won; and at 5%, 300 to 400 billion won. Last year, SamilPharmaceutical recorded sales of 210.3 billion won.

An industry insider analyzed, “Considering the size of the domestic market and global clinical trial results, the licensing rights secured by SamilPharmaceutical five years ago are increasingly likely to become a prime example of ‘low-cost first-mover advantage.’”

A SamilPharmaceutical official stated, “Loresibvin is not merely a new addition to our pipeline. If approval and commercialization proceed as planned, it is a core asset capable of transforming SamilPharmaceutical’s revenue structure and the company’s standing itself.” The official added, “In particular, given the absence of competing DMOADs in the domestic market, if approvals in major global markets materialize, the value of the domestic exclusive rights we proactively secured in 2021 could be significantly reevaluated.”

The spokesperson continued, “Following the U.S., the substantive review has begun in the UK, and a European marketing authorization application is also scheduled,” adding, “We will accelerate preparations for domestic approval and launch in line with the progress of global regulatory approvals.”