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- 2025-12-22 13:08:39
- Company
- Biosimilars to Prolia compete for the market worth KRW 170B
- by Whang, byung-woo Apr 10, 2025 05:57am
- As biosimilars have been introduced following the patent expiration of the osteoporosis treatment, 'Prolia (denosumab),' competition in the market is expected to heat up. As biosimilars from Celltrion and Samsung Bioepis, distributed by Daewoong and Hanmi, respectively, become distributed, the original drug producer, Chong Kun Dang, and the biosimilar companies are expected to engage in active marketing activities. Product photo of ProliaAmgen’s original drug, Prolia, generates exceptional sales in the domestic osteoporosis treatment market. Last year, Prolia's reimbursement criteria were expanded. Reimbursement has been expanded allowing even borderline patients who reached the treatment target defined by the T‑score for osteoporosis, thereby extending its influence. After surpassing KRW 100 billion in sales with KRW 115.7 billion in 2022, Prolia's sales continued to grow, reaching KRW 151.1 billion in 2023 and KRW 174.9 billion in 2024. However, following the expiration of domestic patents last March, biosimilars have been introduced, inevitably impacting Prolia's sales. The first to enter the market was Celltrion's Stoboclo, which captured the 'first mover' position by receiving marketing approval from the MFDS in November last year—the first biosimilar to denosumab to be approved. 4-year Sales Trend for Prolia (unit: KRW 100 million, source: IQVIA) Stoboclo, which was launched last month on the 19th, features an improved syringe design compared to the original drug, enhancing convenience and safety for healthcare providers. The syringe is designed so that the needle is automatically concealed after injection, allowing for single-handed handling, and minimizing needle-related injury risks. Subsequently, on the 4th, Samsung Bioepis' Prolia biosimilar, Obodence, received domestic marketing approval. Although the reimbursement price for Obodence has not yet been set, it is expected to be launched on the market by the end of this year after completing the reimbursement listing process with the Ministry of Health and Welfare (MOHW). Stoboclo, already available in the market, is expected to capture market share based on the price competitiveness of biosimilars. As of April 1, Prolia's reimbursement price was adjusted from KRW 154,700 to KRW 123,760. In contrast, Stoboclo's reimbursement price is KRW 111,384, approximately KRW 10,000 lower than the original product's price. Although Samsung Bioepis' pricing strategy is difficult to predict, several opinions suggest it will be set at the same level as Stoboclo. However, unlike overseas markets, where biosimilars have strong price competitiveness, the domestic market relies more on sales capabilities, which is likely to drive market competition. We must wait and see, but according to the Health Insurance Review and Assessment Service (HIRA) announcement, by March 18, 2026, the price difference between the original drug, Prolia, and its biosimilar, Stoboclo, will be eliminated. In other words, this implies that the price competitiveness of biosimilars will be lost. Currently, the market is dominated by major domestic pharmaceutical companies with strong sales capabilities, such as Amgen-Chong Kun Dang, Celltrion-Daewoong, Samsung Bioepis-Hanmi Pharmaceuticals. It is anticipated that competition among biosimilars will be influenced by whether they pass the Drug Committee (DC) reviews at hospitals. Based on other biosimilar cases, hospitals tend not to secure two biosimilars, so the extent of a company's network of prescribing hospitals could determine its success. From this perspective, it appears that Stoboclo, which was the first to enter the market, may initially have a competitive edge; however, given that osteoporosis treatments are prescribed not only in university hospitals but also in primary clinics, it remains to be seen what strategies each company will deploy. In Amgen's case, its original product, containing the active ingredient denosumab, is expected to solidify its market position by emphasizing its authenticity and strengthening its partnership with Chong Kun Dang. According to pharmaceutical industry sources, Amgen is actively working to expand its partnership with Chong Kun Dang, especially in university hospitals, to further reinforce its sales capabilities. Prolia's long-term efficacy and safety data, accumulated over many years, may also serve as a strong competitive advantage. Prolia's long-term benefits were demonstrated in two studies, FREEDOM (from August 1, 2004, to June 17, 2008) and FREEDOM Extension (from August 7, 2007, to July 19, 2015).
- Company
- Yuhan "Immunotherapy candidate, Phase 1/2 IND approved"
- by Kim, Jin-Gu Apr 10, 2025 05:57am
- Yuhan announced on April 7 that it received approval from the Ministry of Food and Drug Safety (MFDS) for its investigational new drug (IND) application to initiate Phase ½ trial of 'YH32364,' a novel immunotherapy for cancer under development. According to Yuhan, YH32364 is a bispecific antibody that simultaneously targets epidermal growth factor (EGFR) and 4-1BB. While YH32364 binds to EGFR expressed on cancer cell surfaces and blocks growth signaling, it also stimulates 4-1BB signaling and activates immune cells, thereby maximizing anticancer effects. In a preclinical efficacy trial, YH32364 showed stronger superior effects in EGFR-expressing tumors compared to cetuximab. It was demonstrated that the candidate drug retained long-term anti-tumor effects through immunological memory. Furthermore, it was confirmed that YH32364 activated 4-1BB signaling in EGFR-expressing tumors, leading to the recruitment of tumor-infiltrating immune cells and altering the tumor microenvironment. This trial is a Phase ½ trial involving human study participants for the first time. It will assess the safety·tolerability·pharmacokinetics·antitumor activity of YH32364 in patients with locally advanced or metastatic solid tumors that overexpress the epidermal growth factor receptor (EGFR). EGFR overexpression in various solid cancers has been mainly targeted for cancer treatment. The currently developed monoclonal antibody (mAB) applies to metastatic colorectal cancer and head and neck squamous cell carcinoma (HNSCC). The candidate has shown specific efficacy and it has been reported that unmet needs for effective treatments are high. Yuhan stated that YH32364 works by activating immune cells through EGFR-specific 4-1BB signaling in tumors. The company hopes YH32364 will be more effective in a wide variety of EGFR-expressing solid cancers than anti-EGFR mAb. Yeol-Hong Kim, Head-R&D at Yuhan, said, "After several years of focusing on discovering·optimizing leading product, as well as preclinical development, the Yuhan R&D center successfully entered clinical development stage," adding, "YH32364 is a significant achievement as it is a bispecific antibody, combining solid cancer target EGFR and 4-1BB that strengthens immune responses in tumor microenvironment. Yuhan plans to recruit study participants soon." YH32364 a novel immunotherapy for cancer pipeline that Yuhan signed technology transfer with ABL Bio in 2018. 4-1BB (CD137 or TNFRSF9) is a member of the TNF receptor family. It is expressed in many cells, including activated T-cells, Natural Killer cells (NK cells), and dendritic cells (DC). 4-1BB plays a crucial role in retaining effective T-cell immune response and forming immunological memory.
- Opinion
- [Reporter's View] Korean R&BD system and strategies
- by Whang, byung-woo Apr 10, 2025 05:57am
- “It is not easy for a new drug to succeed just with good technology. It is only a real success when the drug reaches the market.” This is what an executive of a global pharmaceutical trading company said to the reporter recently. The tides are changing in the pharmaceutical and biopharmaceutical industry. The focus is shifting from R&D (Research & Development) to R&BD (Research & Business Development). In other words, business-related strategies such as technology transfer, joint development, and investment attraction have become as important as R&D. The reality of the industrial ecosystem is behind this. South Korea is still choosing a growth strategy centered on technology exports rather than innovative new drugs. Although the number of pipelines is increasing, due to the nature of drug development that is accompanied by high cost and long-term battles, companies are focusing on technology transfer based on early-stage - such as Phase I and II - clinical results rather than the final approval, in order to achieve results. In fact, it takes a long time for a single candidate substance to reach global clinical trials, approval, and market entry. There is also a view that this is an unavoidable strategy in the domestic environment, where the pharmaceutical and bio-pharmaceutical ecosystem is relatively small, in terms of market size and investment conditions. At the global level, there is a growing recognition that it is difficult to survive without commercialization in mind from the early stages of R&D. R&BD, which adds business to R&D, has been spreading in line with this trend. Although Business Development (BD) was an existing job category, there is an overall shift beyond a simple change in terminology, and the occupation now entails roles in setting research direction, investment structure, and organizational operation methods. A typical example of such change is reflected in the recent activities of the Korea Drug Development Fund (KDDF). The KDDF has recently put its R&BD strategy at the forefront when selecting support projects. It comprehensively evaluates not only scientific feasibility but also the possibility of technology transfer, marketability, and global partnership plans. Whereas in the past the focus was on “good research,” now the emphasis is on “technologies with commercial potential.” To this end, KDDF is currently preparing a multi-layered support system for strengthening R&BD, including consulting, collaboration programs with global pharmaceutical companies, and VC networking. There are also cases where KDDF has arranged global partnering meetings for participating companies, which have led to positive trends in early-stage technology transfer. They are sharing 'how to speak in business language, not technology'. At the event, Yeong-Min Park, head of the KDDF, emphasized that “a sophisticated commercialization strategy is needed from the early stages for successful new drug development.” Ultimately, the key now lies in how to define the destination of research and development. Paper? Patent? Clinical trial? Now the destination is 'market'. The industry believes that no matter how excellent the technology is, it is useless if it is not connected to the market. Many pharmaceutical companies are reorganizing their structures by establishing new R&BD organizations or including BD personnel in their R&D departments. New drug development is both a science and a business. And it is the role of R&BD to create the intersection of the two. The capabilities of business developers are becoming as important as those of researchers. This is because, although there are many technologies, there are few success stories. Now is the time to ask what value the technology has in the market rather than the R&D results. Ultimately, the task of the pharmaceutical and biopharmaceutical industry is to nurture people who can bring the technology to the market.
- Company
- Dupixent aims to meet unmet needs in COPD
- by Whang, byung-woo Apr 10, 2025 05:56am
- Dupixent (dupilumab), which is leading the atopic dermatitis market, is seeking to enter the market as Korea's first chronic obstructive pulmonary disease (COPD) targeted biologic drug. The company wants to open a new paradigm in the treatment of COPD, which has a high unmet need, based on Dupixent’s mechanism that targets interleukin (IL)-4 and IL-13. Professor Chin Kook Rhee, Department of Respiratory Medicine at Seoul St. Mary Sanofi held a meeting on the 9th to highlight the expansion of Dupixent's COPD indication and announce its future plans. COPD patients experience a decline in their quality of life due to dyspnea, fatigue, and acute exacerbations, and in severe cases, it can even lead to death. However, even with the existing inhaler-based triple therapy, about 50% of patients still experience severe exacerbations, indicating an unmet need. “COPD is a chronic condition that requires systemic corticosteroid drugs or antibiotic treatment due to repeated acute exacerbations, which significantly increases the health and economic burden,” said Professor Chin Kook Rhee of the Department of Respiratory Medicine at Seoul St. Mary's Hospital, presented at the event. ”Once an acute exacerbation occurs, the risk of future acute exacerbations and cardiovascular disease increases. In addition to the burden of treatment, the condition also brings a high social and economic burden, including nursing care costs, which are estimated to cost around KRW 1.4214 trillion per year. Rhee added, “Many patients with COPD whose acute exacerbations are not sufficiently controlled, as well as COPD patients with elevated blood eosinophil levels due to type 2 inflammation are at high risk of experiencing an acute exacerbation or rehospitalization.” He added, “The mortality rate within 3.6 years after the first severe acute exacerbation is about 50%, so preventing acute exacerbations is one main goal of COPD treatment.” In this context, Dupixent's expanded indication for COPD is attracting attention as it is expected to benefit patients whose acute exacerbations are not sufficiently controlled. Dupixent has been approved by the Ministry of Food and Drug Safety for additional maintenance treatment of adults with COPD whose blood eosinophil count is elevated and not adequately controlled with standard inhaler therapy. This approval was granted following two Phase III clinical studies that showed a reduction in the annual exacerbation rate of COPD and significant improvements in lung function and patient quality of life. According to the Phase III BOREAS and NOTUS studies, which became the basis for the indication expansions, the annual moderate-to-severe exacerbation rates at week 52 of Dupixent’s administration were 0.78 and 0.86, respectively, 30% and 34% lower than the placebo group’s 1.1 and 1.3, meeting the primary efficacy endpoint. Pic of DupixentImprovement in lung function was observed as early as the second week of Dupixent treatment and was maintained until the 52nd week. In the BOREAS and NOTUS clinical studies, the forced expiratory volume in one second (FEV1) before the use of bronchodilators was 160 mL and 139 mL at Week 12 of Dupixent administration, compared to 77 mL and 57 mL in the placebo group, and significant improvement was confirmed at Week 52, at 153 mL and 115 mL compared to the 70 mL and 54 mL. in the placebo group. “Dupixent selectively inhibits the signaling of IL-4 and IL-13, which can promote the activation and transport of type 2 inflammatory cells, including eosinophils,” said Rhee. ”Domestic and international guidelines also additionally recommend Dupixent.” He went on to say, “It is unusual for a Korean treatment guideline to recommend a drug before it is approved in Korea; this shows the high expectations and social demand for innovative new drugs in COPD and the dire unmet need. It is also necessary to strengthen treatment access so that more COPD patients can benefit from the clinical benefits of Dupixent.” However, with separate treatments currently being provided for low-risk and high-risk groups, and a three-drug therapy being reimbursed for the high-risk group, Dupixent is likely to be positioned as the last treatment option. “We welcome the introduction of a new treatment in an area where there was no choice when exacerbations continued after using the three-drug therapy, as Dupixent has proven to be beneficial even in this case,” said Rhee. ”Considering the situation of asthma, there is a possibility that Dupixent’s position may change in the long run and become an earlier line option to prevent exacerbations in COPD as well.” For Sanofi, Dupixent’s entry into the reimbursement system is likely to be a major task in order to expand its market influence in Korea. A Sanofi official added, “Sanofi also has much vision and a sense of mission for the early diagnosis and early treatment of COPD and will strive to improve access to our drugs.”
- Policy
- Cost of cell&gene therapies for clinical patients set
- by Lee, Jeong-Hwan Apr 10, 2025 05:56am
- The government has set out to create standards for the 'cost of clinical trial drugs' to be used as an indicator when giving patients expensive cell and gene therapy drugs at the clinical trial stage. This is to rationally calculate the cost that patients must pay when they are administered investigational drugs for therapeutic purposes. The government plans to look at the cost calculation methods for investigational drugs that are in operation overseas, such as in the US and Europe, and analyze the current state of the system in Korea to create cost standards for each detailed item of investigational drugs. On the 8th, the Korea Institute of Drug Safety & Risk Management announced that it would begin research on establishing a standard for the cost of investigational drugs. The current Pharmaceutical Affairs Act stipulates that drugs in the clinical trial stage can be used for therapeutic purposes. The problem is that there is no reasonable standard for pricing drugs that must be charged to patients, as the manufacturing costs of cell therapies and gene therapies are often high. This is because there are various detailed items that are included when calculating the cost according to the characteristics of each drug, such as cell therapy and gene therapy. The cost of investigational drugs is the price minus the cost of facility and environmental management and research and development and refers to the cost directly incurred in the manufacture of investigational drugs used for individual patients. The KIDS will investigate the cost calculation methods for investigational drugs that are being used in overseas countries such as the US and Europe to establish the cost calculation standards for patient claims for investigational drugs, and examine the cost calculation details when claiming the cost of investigational drugs for therapeutic use in domestic clinical trials. The cost calculation method will also be analyzed by comparing the cases when importing investigational drugs and domestic contract manufacturing drugs. KIDS will also seek to discover the specific cost calculation items used for cell therapies and radiopharmaceuticals that take into account their characteristics, such as the manufacturing process of pharmaceuticals. Based on this, KIDS plans to prepare a detailed cost standard for each item used to calculate the price of investigational drugs. KIDS explained, “We will study whether detailed items such as raw material costs, material costs, labor costs, manufacturing expenses, and quality inspection costs should be included in the cost calculation of manufactured drugs. We will consider the purpose of the cost stipulated in the Prime Minister's Decree on the Pharmaceutical Affairs Act & Regulation on Safety of Drugs.” It added, “We will also look at the details of the raw material costs, such as whether the raw material is autologous or allogeneic, the type of source, such as blood, cord blood, skin, or adipose tissue, and the method of collection, such as surgery or blood collection. The goal is to establish standards that can be used by suppliers of investigational drugs when calculating costs.”
- Company
- Novartis, PNH drug 'Fabhalta' enters drug pricing nego.
- by Eo, Yun-Ho Apr 10, 2025 05:56am
- Product photo of Fabhalta The new oral drug 'Fabhalta' has entered the last phase of receiving approval for insurance reimbursement. According to industry sources, Novartis Korea’s ’Fabhalta (iptacopan),’ a treatment for paroxysmal nocturnal hemoglobinuria (PNH), is under negotiations for drug pricing. Consequently, attention is gaining to whether another treatment option for PNH would emerge. PNH is a rare disease estimated to occur in approximately 1.5 individuals per 1 million globally. Until now, the treatment for PNH has relied on C5 inhibitors. In 2010, ’Soliris (eculizumab)’ was first approved in South Korea, and 'Ultomiris (ravulizumab)' has been used for PNH treatment since its approval in 2022. Both treatment options are C5 inhibitors. C5 inhibitors inhibit C5, the terminal component within the complement system's alternative pathway involved in the body's immune response, and are administered via intravenous injection. In April last year, the subcutaneous injection product 'Empaveli (pegcetacoplan),' which works by binding to C3 and C3b to inhibit the complement cascade, was approved. The oral drug Fabhalta, which operates by inhibiting factor B, was introduced in August. Due to the mechanistic limitations of C5 inhibitors, there are still unmet needs for patients with PNH. 'Extravascular hemolysis (EVH)' PNH arises from a genetic deficiency in red blood cells and leads to both intravascular hemolysis (IVH) and extravascular hemolysis (EVH). Such hemolysis subsequently triggers thrombosis and bone marrow failure, thereby endangering life. Therefore, controlling hemolysis is critical for treating PNH. However, the current standard treatment for PNH, a C5 inhibitor, effectively manages IVH but is inherently limited in its mechanism to control EVH. This is why there is significant interest in the reimbursement status of the factor B inhibitor, Fabhalta. Factor B is located higher in the alternative pathway than C5, C3, and C3b, and by inhibiting it, one can comprehensively regulate both IVH and EVH. In fact, the efficacy of Fabhalta has been demonstrated in patients with no prior treatment experience. According to the APPOINT-PNH study, conducted in treatment-naïve PNH patients, 19 out of 33 patients achieved a hemoglobin level of at least 12 g/dL without the need for red blood cell transfusions. Furthermore, 92% of the patients showed a clinically significant increase in hemoglobin of at least 2 g/dL, and 63% maintained a hemoglobin level of 12 g/dL or higher without transfusions. During the 24‑week study period, hemoglobin levels continued to rise steadily, reaching normalized levels by week 20 and remaining at that level through week 24. Additionally, 98% of the patients overcame transfusion dependency. Professor Junho Jang, Department of Hematology at Samsung Medical Center, said, "When a C5 inhibitor first emerged, experts stated that the PNH treatment paradigm has shifted. However, C5 inhibitors are still limited in managing EVH." "Fabhalta is a new drug that is likely to bring a paradigm shift for PNH treatment. This drug is involved in regulating factor B located in the upper alternative pathway, thus inhibiting factor B. It can comprehensively control both IVH and EVH. A favorable result has been demonstrated through clinical trials," Professor Jang emphasized.
- Company
- Will Leqvio not be reimbursed for ASCVD in Korea?
- by Eo, Yun-Ho Apr 09, 2025 05:56am
- The reimbursement of the twice-yearly dyslipidemia drug ‘Leqvio’ for ASCVD became unclear in Korea. According to Dailpharm coverage, the siRNA drug, Leqvio (inclisiran), from Novartis Korea failed to set reimbursement standards at the Drug Reimbursement Evaluation Subcommittee meeting of the Health Insurance Review and Assessment Service in February as a treatment for the “reduction of cardiovascular events in patients with atherosclerotic cardiovascular disease(ASCVD).” However, at the meeting, the indication for “heterozygous familial and familial, or mixed dyslipidemia” passed review, and the Drug Reimbursement Evaluation Committee conditionally approved the indication for reimbursement earlier this month. This is because the target patients are very few. The government may have decided that it would not be a problem to delay reimbursement for Leqvio because a competitor of the same therapeutic class, Amgen Korea's 'Repatha (evolocumab)', is already listed for reimbursement. However, it is worth considering the fact that Leqvio is administered directly by healthcare professionals at hospitals twice a year. Not only is the number of doses reduced, but the advantage is that the injection is administered by medical staff at the hospital rather than by the patient. In fact, 78.4% of the target patient population, including patients with atherosclerotic cardiovascular disease (ASCVD) who have been administered Leqvio for up to 6.8 years or more, have reached the target LDL-C level. In a real-world study in the United States, the group with high medication adherence (fully adherent) among patients with ASCVD, including myocardial infarction, had a 27% lower risk of major adverse cardiovascular events (MACE) compared to the low-adherence group. In addition, it was found that patients with ASCVD who were highly compliant with their medication had lower annual medical costs than those with low compliance, which reduced the risk of recurrent cardiovascular disease and the economic burden of ASCVD patients. In other words, the convenience of taking the drug provided by Leqvio has clear therapeutic benefits. The market for statins and ezetimibe combination drugs alone is worth KRW 1 trillion, and if we add the funds spent on statins and PCSK9 inhibitors, the funds spent on lowering LDL-C alone are estimated to be between KRW 1.5 trillion to KRW 2 trillion. However, the LDL-C target achievement rate for ASCVD patients in Korea is only 24%. “In the case of high-risk patients, medication adherence is especially important for lipid-lowering treatment. In reality, medication adherence to current treatment options is low, and only 3 out of 10 patients still achieve the target LDL-C level. This is proof that new treatment options are urgently needed for lipid-lowering therapy,” said Jon Suh, Secretary of the Insurance Committee of the Korean Society of Cardiology and a member of the Insurance Committee of the Korean Society of Cardiology.
- Company
- Doctors long for a new treatment option for liver cancer
- by Moon, sung-ho Apr 09, 2025 05:56am
- Progressive hepatocellular carcinoma, or liver cancer, is a disease with only a few effective treatment options in the clinical setting. Recently, the emergence of various first-line treatment options such as targeted anticancer drugs and immuno-oncology drugs, has raised expectations for improved treatment outcomes. However, treatment options for liver cancer are still in high demand in the clinical setting due to low treatment response rates, the lack of biomarkers for treatment selection, and the lack of second-line treatment options. # Among these, the domestic pharmaceutical and bio industry is attracting attention, with Korean companies making a bid into the global big pharma-led drug market with their development of new drugs. According to the medical community on the 7th, the treatment options that are used as a standard therapy in the first-line treatment of liver cancer are the Tecentriq (atezolizumab) and Avastin (bevacizumab) combination therapy. According to the “Guidelines for the Treatment of Hepatocellular Carcinoma” revised by the Korean Liver Cancer Association and the National Cancer Center in 2022, if a liver cancer patient is not indicated for surgery or local treatment as first-line systemic therapy, the Tecentriq and Avastin combination or Imfinzi (durvalumab) and Imjudo (tremelimumab) is recommended as the first choice. Professor Hong-Jae Jeon of the CHA Bundang Medical Center (Hematolo-oncology), explained, “Liver cancer is the sixth most common cancer worldwide and the second leading cause of cancer deaths in Korea, and various treatment options have emerged to improve its prognosis. However, there is still a high unmet need in terms of long-term survival. As the development of therapeutic agents continues with the aim of improving the treatment outcomes of liver cancer, immune-oncology drugs have recently emerged as an innovative first-line treatment option for liver cancer.’ However, the standard therapy currently available for practical use in clinical practice is limited to the Tecentiq+Avastin combination. Previously, there were treatments such as Nexavar (sorafenib) and Lenvima (lenvatinib), but in the course of developing treatments, the Tecqntriq+Avastin combination has recently been used as a standard therapy. In the case of the Imfinzi+Imjudo combination, which has improved the risk of bleeding, a typical side effect of existing treatments, the combination has been approved by the Ministry of Food and Drug Safety in Korea but is not reimbursed by the National Health Insurance, so it can only be used as a non-reimbursed drug. AstraZeneca, Imfinzi’s developer, pushed for reimbursement and passed the threshold of the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service in November last year, but the application is still in the pharmacoeconomic evaluation stage of the subcommittee under the Drug Reimbursement Evaluation Committee. Imjudo, which is used in combination with Imfinzi, is administered only once, but the patient must pay KRW 10 million for the single shot, so it is essential for the company to apply for the combination’s reimbursement due to poor patient access in terms of finances. As a result, although there are currently 4 liver cancer treatment options approved in Korea, the first-line treatment option is limited to the Tecentriq+Avastin combination. The problem is that the reimbursement of even this combination is at risk of being cut back in the field. In fact, major medical associations have prepared and submitted a proposal to the Health Insurance Review and Assessment Service to improve reimbursement standards for liver cancer treatments, led by the Tecentiq+Avastin combination, in the second half of last year. This is believed to be a measure to reduce the frequency of reimbursement price cuts due to increased claims for this treatment option. Professor Hyun Yang of Eunpyeong St. Mary's Hospital (Department of Gastroenterology) recently gave a presentation on the topic at the Korean Liver Cancer Association. He said, “There is a gap between the actual reality and the application of reimbursement for systemic treatment of hepatocellular carcinoma. There is ambiguity in the reimbursement criteria for the Tecentriq+Avastin combination therapy, which states 'local treatment is not possible,’ and there is a gap between the indication for the Phase III clinical trial of the Imfinzi+Imjudo combination therapy as well as the combination therapy in question.” Soon Sun Kim, Insurance Director of the Korean Liver Cancer Association (Department of Gastroenterology, Ajou University Hospital), said, “We submitted expert consensus opinions to HIRA on the reimbursement application of systemic liver cancer treatment for hepatocellular carcinoma. We presented the opinion paper to improve the ambiguity of the reimbursement criteria for the use of such treatments.” The lack of treatment options for liver cancer in clinical settings has created an unmet demand, and the domestic pharmaceutical and biotechnology industries, which have identified the marketability in the field, are busy developing new drugs. A typical example is HLB's rivoceranib. HLB Life Science acquired the development rights to rivoceranib from Bukwang Pharm in 2018 for KRW 40 billion. Since then, HLB has been developing a combination therapy of lenvatinib and camrelizumab for liver cancer with Jiangsu Hengrui Pharmaceuticals Company, Camrelizumab, which was developed by Jiangsu Hengrui Pharmaceuticals Company, is an immuno-oncology drug that inhibits the PD-1 protein expressed on the surface of immune cells (T cells), preventing them from binding to the PD-L1 receptor on the surface of cancer cells and activating immune cells. According to the results of the Phase III CARES-310 study, which was unveiled at the 2022 European Society for Medical Oncology (ESMO) by HLB and Jiangsu Hengrui Pharmaceuticals, the combination of rivoceranib and camrelizumab recorded a median overall survival (OS) of 22.1 months, an improvement over Nexavar’s 15.4 months. However, the FDA approval was again denied last month, following the one in May last year. As with the previous time, the issue this time is also related to the Chemistry, Manufacturing, and Control (CMC) of camrelizumab by Jiangsu Hengrui Pharmaceuticals. However, HLB has expressed its intention to reapply for FDA approval, so there is still a possibility of approval. The progress of Yuhan Corporation's subsidiary, ImmuneOncia, a biotech company specializing in immuno-oncology drugs, is also noteworthy. The company's pipeline has recently attracted increased attention after passing the preliminary screening for the KOSDAQ listing. In particular, there is a lot of interest in 'IMC-002’ in the company's pipeline of monoclonal antibodies targeting the CD47 factor. MC-002 is an immune checkpoint inhibitor for macrophages that blocks the “don't eat me” signal between CD47 on cancer cells and SIRPα on macrophages, helping macrophages attack cancer cells (phagocytosis). In Phase Ia clinical trial on solid tumors, it has been attracting attention as a CD47 immuno-oncology drug candidate that global big pharma has given up on because it minimizes binding to normal cells such as red blood cells and is highly safe. Based on this, ImmuneOncia also signed a technology export contract for IMC-002 to China with 3D Medicines for KRW 540 billion in 2021. The results of the Phase Ib clinical trial of IMC-002 will be presented at the American Society of Clinical Oncology (ASCO 2025) congress scheduled to be held in May. ImmuneOncia plans to develop IMC-002 as a second-line treatment option for liver cancer, which has a high unmet clinical need. “The biggest feature is that it binds strongly to cancer cells while minimizing binding to normal cells, such as red blood cells,” said Heung Tae Kim, CEO of ImmuneOncia (Oncology specialist). ”This is why global pharmaceutical companies have been held back. Existing candidate substances had a strong tendency to bind with red blood cells, causing side effects such as anemia and thrombocytopenia, but IMC-002 has solved the safety issues and is expected to be highly effective,” he explained. Kim added, ”In addition to the safety data, we will present efficacy data on our candidate at ASCO 2025. While our competitors have been developing treatments for blood cancers, we are currently conducting clinical trials for liver cancer among solid cancers. In the case of liver cancer, there are first-line treatment options regarded as standard of care, but there are virtually no therapies available as a second-line treatment. We are working to provide next-generation options in this market.”
- Company
- Trials for bispecific antibodies in cancer immunotherapy
- by Son, Hyung Min Apr 09, 2025 05:56am
- Yuhan, Hanmi Pharmaceuticals, and other domestic pharmaceutical and biotech companies have entered Phase 1 clinical trials of bispecific immuno-oncology drugs, delving into new drug development. Bispecific antibodies are drugs that can simultaneously bind to two different antigens or two distinct antigen-binding sites on the same antigen. Multispecific antibodies that target biomarkers simultaneously have the advantage of crossing the blood-brain barrier (BBB) by binding to receptors on its surface. In particular, passage through the BBB is necessary for anticancer drugs to enhance drug permeability. Recently, an increasing number of companies have been developing multispecific antibodies by combining antibodies that bind to antigens regulating immune cell activation with those that bind to tumor-specific antigens. Yuhan·Hami enter phase 1 trials #iAccording to industry sources, on the 9th, Yuhan received IND approval from the Ministry of Food and Drug Safety (MFDS) for its bispecific antibody immuno-oncology candidate 'YH32364.' Introduced initially to Yuhan in 2018 from ABL Bio, YH32364 is now entering its first clinical study in humans. This trial will assess the safety, tolerability, pharmacokinetics, and antitumor activity of YH32364 in patients with locally advanced or metastatic solid tumors that overexpress the epidermal growth factor receptor (EGFR). YH32364 is designed as a bispecific antibody that simultaneously targets EGFR and 4-1BB. EGFR is a well-known biomarker expressed in major solid tumors, including non–small cell lung cancer (NSCLC) and colorectal cancer. By simultaneously targeting EGFR and T-cell activating 4-1BB, Yuhan aims to maximize the antitumor effect of this immuno-oncology candidate. Hanmi Pharmaceuticals, in collaboration with Beijing Hanmi Pharmaceuticals, is currently conducting a Phase 1 clinical trial of the immuno-oncology candidate 'BH3120,' which targets both 4‑1BB and PD‑L1. Cetuximab is an anticancer drug that targets the EGFR receptor and is used in the treatment of various cancers, including colorectal cancer, head and neck cancer, and lung cancer. Yuhan expects YH32364, which activates immune cells through 4‑1BB action dependent on the tumor’s EGFR expression, will be effective against a broader range of EGFR‑expressing solid tumors than conventional anti‑EGFR monoclonal antibodies. Hanmi Pharmaceuticals, in collaboration with Beijing Hanmi Pharmaceuticals, is currently conducting a Phase 1 clinical trial of the immuno-oncology candidate 'BH3120,' which targets both 4‑1BB and PD‑L1. Hanmi Pharmaceuticals’ proprietary platform technology Pentambody was used in developing BH3120. Pentambody is a next‑generation dual antibody platform technology that activates immune cells while attacking only the target cancer cells. Because BH3120 activates 4‑1BB only in immune cells surrounding PD‑L1‑expressing tumor cells, it minimizes the toxic side effects of 4‑1BB and achieves long‑term anticancer effects that prevent recurrence. In clinical trials, BH3120 demonstrated decoupling effects of immune activation between the tumor microenvironment and normal tissues, confirming its safety. Hanmi Pharmaceuticals and Beijing Hanmi Pharmaceuticals also explore combining BH3120 with additional anticancer agents. Active R&D for bispecific immune-oncology agents Korean biotech industry also focuses on bispecific antibody immune-oncology agents. In addition to ABL Bio's YH32364 (ABL Bio candidate ABL104) transferred to Yuhan, it also has ABL501, which targets PD‑L1 and LAG‑3, and ABL503, which targets PD‑L1 and 4‑1BB. ABL501 is a bispecific antibody designed to improve the low response rates of conventional immuno-oncology agents and treat patients with resistance by targeting two different immune checkpoint proteins, PD‑L1 and LAG‑3. This candidate blocks the binding of LAG3-MHCII and PD‑1-PD‑L1, thereby preventing T cells from being inactivated by tumors. ABL501 mechanism of action (Source=ABL Bio). In preclinical studies, ABL501 demonstrated tumor-killing effects in NSCLC patient's tumor cells and in patients' peripheral blood organoids, compared to the conventional Tisentric agent. Currently, ABL501 monotherapy is being studied in a dose-escalation Phase I trial as a monotherapy. This clinical study is funded by the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare (MOHW) under the National New Drug Development Support Project. ABL Bio is also conducting a Phase 1 trial of ABL503. Clinical data showed that the administration of ABL503 has demonstrated antitumor efficacy and confirmed its safety profile. Notably, among the patients who achieved a complete response (CR) or partial response (PR), some had previously shown resistance to or experienced recurrence after treatment with immunotherapies targeting PD‑L1. Among 26 patients exposed to the effective dose, responses were observed in 7 patients. The results showed that there was one CR and six PR. Regarding safety, after administration of ABL503, some toxicities inherent to PD‑L1 and 4‑1BB targeted anticancer agents were observed; however, these were manageable with steroid treatment or temporary treatment interruption. Tium Bio has confirmed the efficacy of the bispecific inhibitor TU2218 in preclinical studies. TU2218 concurrently blocks transforming growth factor (TGF‑β) pathways, which is known to interfere with immuno-oncology activity and vascular endothelial growth factor (VEGF). The process maximizes the efficacy of immuno-oncology agents. In a breast cancer mouse model, TU2218, in combination with an anti‑PD‑1 agent, improved tumor growth inhibition compared to conventional chemotherapy. In a colorectal cancer model, the potential of a triple combination therapy was demonstrated. In a colorectal cancer model, the potential of a triple combination therapy was demonstrated. The combination of TU2218, an anti‑PD‑1 agent, and an anti‑CTLA‑4 agent exhibited superior tumor growth inhibition compared to the control group receiving a placebo plus an anti‑PD‑1 agent and an anti‑CTLA‑4 agent. The triple combination therapy containing TU2218 achieved an 84% tumor growth inhibition rate, compared to 70% in the control group. Additionally, TU2218, in combination with an anti‑PD‑1 agent and Renbatinib, achieved a 99% tumor growth inhibition rate. IMC-201, developed by ImmuneOncia, is a bispecific antibody independently created using CD47 and PD‑L1. In preclinical studies, IMC-201 strongly bound to solid and hematologic cancer cells expressing CD47/PD‑L1, while selectively acting only on the cancer cells even under conditions where red blood cells and cancer cells were co‑cultured. Furthermore, it exhibited higher macrophage-mediated phagocytosis compared to the parental antibody, IMC-002. In particular, in a mouse tumor model of triple‑negative breast cancer, IMC-201 demonstrated more potent tumor inhibition than the combination of the parental antibodies IMC-002 and IMC-001. ImmuneOncia is also developing the immuno‑oncology candidate IMC-002. IMC-002 is designed to block CD47 on cancer cells and inhibit macrophage signaling. In a study where IMC-002 was administered to 12 patients, no drug toxicity was observed at any dose level. Among these 12 patients, 6 achieved stable disease (SD). The company plans to determine the recommended Phase 2 dose based on the clinical findings from the Phase 1b study.
- Company
- Samsung Bioepis launches Epysqli in the US
- by Whang, byung-woo Apr 09, 2025 05:56am
- Pic of Epysqli Samsung Bioepis (CEO Kyung-ah Kim) announced on the 8th that it has launched Epysqli (project name SB12, ingredient name eculizumab), a treatment for rare diseases, in the US through its marketing partner, Teva. Epysqli is a biosimilar version of Soliris. Soliris is a treatment for rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) developed by Alexion in the United States. Soliris is a representative ultra-high-priced biopharmaceutical with a large unmet need in the medical field, and the annual treatment cost for PNH in the United States amounts to USD 520,000 (about KRW 760 million). Last year, global sales amounted to approximately KRW 3.8 trillion (USD 2.588 billion), of which approximately KRW 2.2 trillion (USD 1.523 billion) was from sales in the United States. Epysqli was launched at a 30% discounted price to the wholesale acquisition cost (WAC) of the original drug, Soliris, and is expected to save treatment costs in the United States. “The launch of Epysqli is expected to play an important role in expanding treatment options for patients suffering from rare diseases in the United States,” said Linda Y. MacDonald, Vice President and Head of the Global Commercial Division at Samsung Bioepis. ”We will continue to work towards establishing a sustainable healthcare system by providing affordable biopharmaceuticals with proven quality, safety, and efficacy.” Thomas Rainey, Senior Vice President of US Biosimilars at Teva, said, “Access to medicines is very limited for patients with rare diseases. Through the launch of Epysqli, we plan to expand access to treatment for patients with rare diseases while expanding our biosimilar portfolio.” Meanwhile, Samsung Bioepis signed a commercialization partnership agreement with Teva in January to enter the US market and is supplying Epysqli to medical sites through a direct sales system in Europe and South Korea. In Europe, it was launched in July 2023 and has achieved the top market share in the biosimilar market in Germany and Italy, and secured contracts with the largest procurement group in France (UniHA) and the Dutch government. In Korea, it launched the product in April last year at about half the price of the original drug and is working to increase patient access to ultra-high priced biopharmaceuticals and contribute to saving national finances.
