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- 2025-12-22 01:22:14
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- 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.
- Company
- ABL licenses out its tech to big pharmas worth ₩350B
- by Cha, Jihyun Apr 08, 2025 05:57am
- ABL Bio has signed a licensing-out agreement worth KRW 70 billion in advance payments (upfront). This is the company's 7th licensing-out agreement and its first platform deal. Including this contract, the cumulative technology fee ABL Bio earned through technology exports is close to KRW 350 billion. According to the Financial Supervisory Service on the 7th, ABL Bio signed a technology export contract with the multinational pharmaceutical company GlaxoSmithKline (GSK) on the 5th for the BBB shuttle platform ‘Grabbody-B' for the development of new treatments for degenerative brain diseases. This is the first time that ABL Bio has exported a platform, not a candidate substance. This contract aims to develop multi-targeted therapeutics using various modalities, including siRNA, ASOs, oligonucleotides or polynucleotides, and antibodies. Under the terms of the agreement, GSK will receive exclusive rights to develop and commercialize multiple new target candidates using ABL Bio’s GrabBody-B. ABL Bio will transfer its GrabBody-B-related technology and know-how to GSK, and GSK will be responsible for preclinical and clinical development, manufacturing, and commercialization. With this contract, ABL Bio will receive an advance payment (upfront) of EUR 38.5 million (approximately KRW 73.9 billion) and short-term milestones of EUR 38.6 million (approximately KRW 74.1 billion) with no obligation of return. ABL Bio will also receive up to EUR 2.063 billion (approximately KRW 3.9623 trillion) in development, licensing, and commercialization milestones for multiple programs. The total contract value, including the amount above, is EUR 2.1401 billion (approximately KRW 4.1104 trillion). In addition, ABL Bio will also be entitled to receive a royalty based on net sales. This is ABL Bio's 7th licensing-out agreement. Previously, in 2022, ABL Bio exported the dual antibody candidate 'ABL301' for the treatment of degenerative brain diseases to the multinational pharmaceutical company Sanofi. The contract is worth a total of USD 1.06 billion (about KRW 1.47 trillion), including an upfront payment of USD 75 million (about KRW 100 billion). In 2018, ABL Bio signed a licensing-out contract with Yuhan Corp for a total of KRW 59 billion for 2 candidate substances for an immuno-oncology drug based on bispecific antibodies. In the same year, it transferred the rights to 'ABL001', a candidate substance for the treatment of biliary tract cancer, to Compass Therapeutics in the United States. The contract size is worth USD 410 million in the anticancer field and USD 185 million in the eye disease field. ABL Bio has licensed out the ROR1-targeted ADC pipeline 'ABL202', which it jointly researched with LegoChem Biosciences in 2020, to CStone Pharmaceuticals in China. The total contract value was worth KRW 363.5 million, excluding sales royalties after commercialization, and all payments, including upfront, milestone, and royalty payments, are to be shared with LigaChem Biosciences in a certain ratio. In addition, ABL Bio signed licensing-out agreements with TSD Life Sciences and Handok in 2019 and 2020, respectively. However, the company did not disclose the specific contract amount, such as advance payments or milestones, for these contracts. The cumulative contract amounts and milestones received by ABL Bio through the licensing out agreements, including the advance payment for the GSK contract, totals at KRW 349.1 billion. This is the sum of the four technology export contracts that the company has disclosed the detailed terms, including contract amounts and milestones. To date, ABL Bio has received a cumulative USD 125 million in payments from Sanofi. It received USD 75 million in advance payments at the time of the 2022 contract and an additional USD 20 million in milestone payments in the same year. In January 2023, the company received a milestone payment of USD 25 million for the first dose administered in the Phase 1 clinical trial and received an additional USD 5 million in milestone payments for the transfer of manufacturing technology last year. In addition, ABL Bio received an advance payment of KRW 1.4 billion from Yuhan Corp. The advance payment received by ABL Bio from Compass Therapeutics was USD 11 million. With the inflow of revenue from technology exports, ABL Bio also succeeded in turning a profit in 2022, posting KRW 900 million in operating profit on a consolidated basis. However, the company returned to the red the following year due to increased research and development (R&D) expenses. Last year, ABL Bio posted KRW 33.4 billion in sales and KRW 59.4 billion in operating losses on a consolidated basis. Sang Hoon Lee, CEO of ABL Bio, said, “This contract reflects our strong commitment to innovatively advancing the development of treatments for degenerative brain diseases through our leadership in the BBB shuttle market and forging strategic partnerships with global big pharma companies like GSK.” Lee added, “This contract will be a great opportunity to further solidify ABL Bio's position in the degenerative brain disease treatment market through the commercialization of GrabBody-B and expand the scope of modality applicable to GrabBody-B.”
- Company
- ZP Therapeutics appoints Junghun Kim as new head
- by Eo, Yun-Ho Apr 08, 2025 05:57am
- Junghun Kim, General Manager of ZP Therapeutics The head of ZP Therapeutics has been replaced after about 3 months. According to industry sources, Zuellig Pharma Korea recently appointed Junghun Kim (50), former Country Manager of Takeda Pharmaceutical Malaysia and Singapore, as the new General Manager of its commercial division, ZP Therapeutics. Hyunjoo Lee (48), the former CEO who took office at the end of last year, recently moved to the position of head of the Oncology BU at AstraZeneca Korea after leaving the company. The new General Manager, Junghun Kim, has been in the pharmaceutical industry for about 20 years. Kim is a seasoned expert who has served various roles, including registration and approval (RA) work, sales branch manager, and marketing manager. Since joining Takeda Pharmaceutical Korea in 2015, Kim has served as the marketing manager and Franchise Head of the Internal Medicine division, which has GI and hematology products, and as the head of the Oncology Business Unit since 2019. He also served as the Country Manager of Takeda Malaysia and Singapore. Meanwhile, ZP Therapeutics Korea has established itself as a preferred commercial solution partner for pharmaceutical clients by providing integrated solutions that cover marketing, sales promotion, product launch, medical e-detailing, registration and approval, market access, digitalization, and data-driven sales excellence in line with the needs and changes in the pharmaceutical market. Currently, it licenses several specialty and generic drug brands and supports major pharmaceutical companies with its sales and marketing services.
- Opinion
- [Reporter's View] Why clinical outcomes require deliberation
- by Son, Hyung Min Apr 08, 2025 05:57am
- Even small differences in clinical outcomes can be highly meaningful. Especially for refractory diseases. Recent top‐line results from Compass Therapeutics’ Phase 2/3 COMPANION-002 trial for cholangiocarcinoma have sparked considerable debate within the industry. According to Compass Therapeutics, the treatment of bispecific antibody tovecimig in combination with the cytotoxic agent paclitaxel resulted in the objective response rate (ORR) of 17.1%, which is nearly three times higher than the 5.3% observed with paclitaxel monotherapy. However, some suggested that the 17.1% ORR is considerably lower than the 37.5% ORR recorded in a previous domestic Phase 2 study conducted by Handok. In a domestic Phase 2 trial, tovecimig+paclitaxel combination therapy had a 37.5% ORR. The latest clinical trial's ORR is less than half of the Phase 2 study. It is important to note that it is too early to make a definitive conclusion on the clinical trial outcomes. The patient populations differed significantly, 24 patients in the domestic Phase 2 trial versus 111 patients of varying races and ages in the global Phase 2/3 study. COMPANION-002 trial is still ongoing, and data on secondary endpoints such as progression-free survival (PFS), overall survival (OS), and duration of response (DOR) have yet to mature. Furthermore, the unique characteristics of cholangiocarcinoma must be taken into account. Although the overall patient numbers are relatively small, cholangiocarcinoma is notoriously difficult to diagnose early and is characterized by rapid metastasis and recurrence, leading to a 5-year relative survival rate of only 28.9% (2017–2021). In fact, seven out of ten cholangiocarcinoma patients eventually die. Another primary reason for the low survival rate is ineffective treatment options. In cases of locally advanced or metastatic cholangiocarcinoma where it is inoperable and first-line therapy has failed, there has been no approved targeted therapy available in Korea. Targeted drug studies have been challenging because of early diagnosis and a small population of patients. Although some targeted therapies for cholangiocarcinoma have shown less than a 1-month improvement in PFS compared to placebo, they have surpassed regulatory hurdles. FOLFOX-based regimens yield a median PFS of 4.0 months and an OS of 6.2 months. Some cancer types have many patients and easily detected in early phases. Clinical studies of those types rarely have data recording over ten digits of months of PFS and OS. However, in challenging fields such as cholangiocarcinoma and triple-negative breast cancer, where the development of targeted therapies is complex, even slight numerical differences can be highly significant. Therefore, it would be premature to draw definitive conclusions about Compass Therapeutics' cholangiocarcinoma treatment without waiting for the final data. As the pharmaceutical industry gradually overcomes long-standing challenges in developing effective therapies for cholangiocarcinoma, a range of new treatments is emerging. Recent developments include the addition of immunotherapies such as AstraZeneca's Imfinzi and MSD's Keytruda as first-line options, as well as the emergence of targeted therapies like Pemazyre and Tibsovo for second-line treatment, along with various agents including, tovecimig and rivoceranib. Experts emphasize that, given the scarcity of treatment alternatives for cholangiocarcinoma, even slight differences in efficacy relative to existing therapies can be significant. When interpreting clinical outcomes, it is essential to consider each cancer type's specific clinical context and biological characteristics. Ultimately, understanding the differences in clinical results between cancers with limited treatment options and those with a wide array of available therapies is critical for accurate data interpretation.
- Policy
- Health and Welfare Committee meeting may not be held in APR
- by Lee, Jeong-Hwan Apr 08, 2025 05:57am
- The Constitutional Court sentenced former President Suk Yeol Yoon to dismissal at 11:22 a.m. on the 4th, setting the stage for an early presidential election. The election date must be announced by Acting President Duck-Soo Han within 10 days of the president's impeachment. This means that the date of the early presidential election will be confirmed before the 14th of this month. The National Election Commission announced that it would begin accepting registrations for the 21st presidential election on the 4th, immediately after the Constitutional Court decided to cite the impeachment motion. The dismissal of the president has made it difficult for the National Assembly's standing committees to hold meetings. The secretaries of the ruling and opposition parties of the NA’s Health and Welfare Committee are likely not to hold a standing committee meeting in April. First, the National Election Commission announced the method of registering as a preliminary candidate, the campaigning method, and the taboo acts. A person who wants to become a preliminary candidate must submit to the National Election Commission documents certifying eligibility, such as a family relationship certificate, a document certifying criminal record, and a certificate of formal education, and pay a deposit of KRW 60 million (20% of the KRW 300 million deposit required of candidates). Assuming that all 60 days of the early presidential election period are used, the official candidate must register by the 10th to 11th of next month. The winner of the early presidential election will immediately begin his or her term without going through the Presidential Transition Committee. A prospective candidate may set up an ▲election office, ▲distribute campaign business cards, ▲create and send out promotional materials to no more than 10% of the total number of households in the country, ▲wear or carry a sash or sign, and ▲publish and sell (except through door-to-door sales) one copy of a prospective candidate's campaign pledge book in the usual way. Even if they are not a candidate or an election official, those who are allowed to campaign can do so at any time by sending text messages, posting on websites, or sending e-mails, and can campaign by phone or in person on days other than the election day. However, in order to conduct election campaigns by sending text messages through automatic mass communication or by entrusting an email transmission agency to send emails, one must register as a candidate or a candidate-to-be. Automatic mass communication is a method of sending messages to more than 20 recipients at the same time or to fewer than 20 recipients by automatically selecting recipients using a program. As the grounds for the presidential impeachment election confirmed, in accordance with Article 90 of the Public Official Election Act, it is not possible to install or post banners or other facilities that specify the name of a political party or the name, photo, or content that can be inferred from the name of a candidate (including a person who is seeking to be a candidate) to influence the election. The National Assembly is also likely to refrain from holding standing committee meetings this month. This is because the early presidential election has a greater weight than the holding of a standing committee meeting for the examination or processing of the bills under its jurisdiction. First of all, the Health and Welfare Committee is likely to not hold a Legislative Subcommittee and plenary session on its bills in April. An opposition member of the Health and Welfare Committee said, “With the early presidential election confirmed, there is a high probability that the bill review under the jurisdiction of the Health and Welfare Committee will be delayed. Although an agreement between the ruling and opposition party secretaries is necessary, I don't think the subcommittees on bills that were normally held during peacetime will be held.”
- Policy
- Pemzayre, high-priced drug post-management system candidate
- by Lee, Tak-Sun Apr 08, 2025 05:56am
- Handok 'Pemzayre Tab,' Handok's bile duct cancer (cholangiocarcinoma) treatment, is expected to be subjected to the post-management system for high-priced drugs. Pemzayre Tab is likely to be added to the reimbursement list in May. Consequently, a submission system for evaluating treatment outcomes as part of the post-management evaluation will be established. According to industry sources on the 7th, Pemzayre passed the Health Insurance Review and Assessment Service (HIRA's) Drug Reimbursement Evaluation Committee (DREC) in January. The company is negotiating with the National Health Insurance Service (NHIS) for drug pricing negotiations. Considering the 60-day drug pricing negotiations period, Pemzayre will likely to be added to the reimbursement list in May. This drug is the first targeted drug in South Korea with cholangiocarcinoma indication. Pemazyre is indicated for patients with locally advanced or metastatic who have FGFR2 gene fusions. Pemzayre has been in used the United States, Europe, and Japan. If it is reimbursed, this drug will be used in adult patients with locally advanced or metastatic cholangiocarcinoma who have FGFR2 gene fusions or rearrangements and have undergone one or more systemic therapy. Based on its anatomical origin, cholangiocarcinoma is classified into intrahepatic cholangiocarcinoma (iCCA), arising from bile ducts within the liver, and extrahepatic cholangiocarcinoma, developing from bile ducts outside the liver. Because this cancer is frequently diagnosed at an advanced stage with a poor prognosis, there is a critical unmet need for targeted therapies. FGFR2 fusion or rearrangements are known to be found in 10-16% of patients with iCCA. In recognition of this urgency, the Korean Ministry of Food and Drug Safety (MFDS) designated this as an orphan drug in November 2021. The MFDS granted marketing approval via expedited review in April 2023. Following approval, the drug quickly entered the reimbursement procedure. After successfully establishing reimbursement criteria in August last year and passing the DREC review in January this year, its chances of inclusion in the National Health Insurance system have markedly increased. However, pricing remains a significant issue. The product, which contains 14 tablets per package, has a supply cost of approximately US$19,000 per product. Given that the treatment course may extend for up to 42 days, its reimbursement could significantly burden health insurance expenditures. Accordingly, the government is expected to manage this drug under the "High-Priced Drugs Reimbursement Management Criteria." Currently, six drugs, Kymriah, Zolgensma, Spinraza, Yescarta, Luxturna, and Tecartus, are subject to these criteria. The criteria for high-priced drugs include ▲Newly listed with high prices and uncertain cost-effectiveness that require further verification ▲Incur substantial annual per capita expenditures, or generate annual health insurance claims that could severely impact the national health insurance budget ▲Expected to provide long-term benefits from a single administration, necessitating additional safety confirmation and long-term evaluation ▲Based on their impact on healthcare, deemed necessary for management. Once a drug is designated as a target under the high-priced drug post-management system, a post-administration response evaluation must be conducted, and the resulting data must be submitted. Based on this data, the HIRA will then perform performance evaluations and ongoing monitoring of treatment effectiveness. If a drug is under patient-based performance risk-sharing agreements, the NHIS will use it to calculate drug reimbursement amounts.
