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- 2026-05-05 11:26:34
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- Saxenda and Qsymia take up 57% of the obesity market share
- by Chon, Seung-Hyun Feb 28, 2024 10:35am
- Last year, Korea’s obesity drug market size reached its largest size in history. It broke the record in 2019, and since then, the market size expanded for five consecutive years. Saxenda and Qsymia account for 60 % of the total market share. Meanwhile, sales of previous obesity drugs, such as psychotropic drugs, are declining, further polarizing the market. As blockbuster drugs gaining popularity overseas are nearing launch in Korea, the dynamics of the Korean obesity drug market are expected to change in the future. The market for obesity drugs was 178 billion won last year, up 1.3% from the previous year, according to a pharmaceutical market research company IQVIA on the 29th. The market for obesity drugs reached 134.1 billion won in 2019, hitting a new record in ten years, and changed its record for four consecutive years. The market has been growing rapidly every year, with an increase of 83.9% over five years since it made 96.8 billion won in 2018. Annual obesity market size (left) and market share percentages of Saxenda and Qsymia in Korea (right) (Unit: 100 million won, Source: IQVIA). The introduction of Saxenda and Qsymia recently has expanded the market for obesity drugs. Last year, Saxenda recorded sales of 66.8 billion won, marking a 13.4% increase compared to the previous year, achieving a new record for two consecutive years. After recording sales of 42.6 billion won in 2019, Saxenda slowed in sales in 2020 and 2021, with 36.8 billion won and 36.2 billion won, respectively. It is analyzed that due to limited outdoor activities during the initial spread of Covid-19, the interest in obesity drugs may have decreased. However, it has been noted that the demand for Saxenda rose as many people gained weight due to reduced outdoor activities during the Covid-19 pandemic since 2020, and as outdoor activities resumed, the demand for Saxenda continued to increase. In comparison to the sales in 2020, Saxenda's sales in 2022 increased by 84.4% over the course of two years. Saxenda, launched in Korea in 2018, is the first glucagon-like peptide-1 (GLP-1) agonist medication for obesity. It contains the same ingredient as Victoza (ingredient: liraglutide), which is prescribed to patients with type 2 diabetes, but with different methods of administration and dosages. Saxenda became the top-selling drug in the market after recording sales of 42.6 billion won in 2019, just after its launch, and maintained the place for five consecutive years. The mechanism of action of Saxenda was designed similarly to the body’s GLP-1, leading to the suppression of appetite and weight loss. It gained popularity with the perception that it is relatively safer than existing weight-loss drugs. According to estimates, Saxenda took up a 37.5% market share of the obesity market last year. While Saxenda’s market share grew significantly from 7.8% in 2018 to 31.8% in 2019, it slowed down in 2020 and 2021, holding 25.8% and 25.2%, respectively. However, in 2022, Saxenda’s market share increased to over 30% and continued to grow last year. Alvogen Korea’s Qsymia has been gaining popularity recently. Qsymia reached sales of 35.5 billion won last year, an increase of 18.0 % compared to the previous year. In two years since 2021, when it made 26.2 billion won, the sales expanded by 35.4%. Qsymia, a combination drug of “phentermine’ and ‘topiramate,’ was launched in late 2019. Alvogen Korea acquired the sales rights for Qsymia in Korea from Vivus of the United States in 2017. Alvogen initiated domestic marketing through a joint sales agreement with Chong Kun Dang. Despite oral administration, Qsymia has a relatively small amount of psychotropic drug ingredients, and it has the advantage that it can be prescribed for an extended period. Alvogen Korea's extensive sales networks in the domestic obesity market, gained from its previous experience selling Furing and Furimin, synergized with Chong Kun Dang's business power to penetrate the market with Qsymia rapidly. Last year, Qsymia's market share in the obesity treatment market increased by 2.8% compared to the previous year, reaching 19.9%. The combined market share of Saxenda and Qsymia accounted for 57.5% of the total obesity market last year. The market share of Saxenda and Qsymia increased by 16.0% over two years, from 41.5% in 2020, significantly enhancing their market influence. In contrast, existing obesity drugs, excluding Saxenda and Qsymia, showed weakness overall. Sales of obesity drugs, excluding Saxenda and Qsymia, decreased by 12.7% to 757 billion won compared to the previous year. Daewoong Pharmaceutical's Dietamin saw a decrease in sales to 7 billion won last year, down 11.5% from the previous year. Huons' Hutermin recorded sales of 4.3 billion won, a 10.7% decrease from the prior year. The market share of existing obesity treatments, excluding Saxenda and Qsymia, was 68.2% in 2019 but decreased to 42.5% last year. The industry anticipates that the emergence of overseas validated blockbuster treatments for obesity would bring significant changes in market dynamics. Last April, the Ministry of Food and Drug Safety (MFDS) approved Novo Nordisk's Wegovy. Wegovy is a GLP-1 agonist in the same class as Saxenda. Novo Nordisk improved upon Saxenda, administered once daily, by making Wegovy a once-weekly injection. Since its release in the U.S. market, Wegovy's demand has surged to the point of shortages, with even Ozempic, a diabetes treatment with the same ingredient and usage, experiencing stockouts due to its high popularity. Eli Lilly's Mounjaro received approval from the MFDS in June last year. Mounjaro is a next-generation GLP-1 agonist that activates GLP-1 and GIP receptors with a once-weekly dose. It was approved as a treatment for type 2 diabetes and is expected to secure indications for obesity treatment in the future. Since its approval in the United States last year, Mounjaro generated sales of 2 trillion won in the first half of this year. With Mounjaro's approval as an obesity treatment, it is expected to bring significant changes in the obesity drug market alongside Wegovy.
- Company
- KRPIA appoints Sanofi CEO Kay Bae as new chair
- by Feb 28, 2024 05:50am
- Kay Bae (Bae Kyung-eun) appointed as the new chair of KRPIA The Korean Research-based Pharmaceutical Industry Association (KRPIA) announced on the 23rd that it has appointed Kay Bae (Bae Kyung-eun), Country Lead of Sanofi-Aventis Korea, as the 15th chair of KRPIA. Bae served on the KRPIA board of directors in September 2013, and she has been a member of the vice-chair body, contributing to the growth of KRPIA. Bae graduated from the College of Pharmacy at Seoul National University and received a master’s degree in global management from Aalto University School of Business. Bae gained diverse experiences in the field, including positions as Global Head of Business Units, Head of Anticancer Drugs and Prescription Medicines, and CEO at global pharmaceutical companies since 1994. For over ten years, Bae served as the head of Sanofi-Aventis Korea, where she is currently the CEO. She led the unification of independent business units, Sanofi Pasteur, a subsidiary dedicated to producing vaccines, and Sanofi Genzyme, a part of the Specialty Care franchise, into a single brand. Before becoming CEO of Sanfofi-Aventis Korea and Genzyme Korea, Bae worked at Novartis Korea and Novartis Unites States. Since September 2022, Bae has been serving as the chairperson of the Healthcare Committee at the European Chamber of Commerce in Korea (ECCK). Bae is known for having a profound understanding of the pharmaceutical industry and the Korean systems and policies while demonstrating strong leadership skills. “We will strive to provide rapid and broadened treatment benefits of innovative new drugs to patients in Korea amid the rapidly evolving healthcare and medical industry,” Bae said. “To promote innovative development in the domestic pharmaceutical and biotechnology industry, we plan to collaborate with other domestic companies by strengthening our open innovation platform,” Bae added. The KRPIA has announced the appointment of new vice-chairs along with a new chairperson. KRPIA’s vice-chairs are △Jae (Byungjae) Yoo of Novartis Korea, △Hye Young Lee of BMS Pharmaceutical Korea, and △Dong-Wook Oh of Pfizer Korea. A new board of directors was elected through a voting process in mid-January last year: △Maurizio Borgatta of GSK Korea △Jaeyeon Choi of Gilead Sciences Korea, △Christoph Hamann of Merck Korea, △Ji-young Sohn of Moderna Korea, △JinA Lee of Bayer Korea, △Sang Kyung Noh of Amgen Korea, △Junil Kim of Astellas Pharma Korea, △Soyoung Kang of AbbVie Korea, and △Albert Kim of MSD Korea.
- Policy
- Patients bear 100% of Imfinzi cost for biliary tract cancer
- by Lee, Tak-Sun Feb 28, 2024 05:50am
- Reimbursement standards have been prepared for the use of combination therapy in biliary tract cancer in Korea. However, in consideration of health insurance finances, patients are required to the full cost of the high-priced immuno-oncology drugs. The Health Insurance Review and Assessment Service recently added the combination of immuno-oncology Imfinzi (durvalumab) with gemcitabine and cisplatin to the biliary tract cancer reimbursement standards after an opinion survey on the amendment to the notification on medicines prescribed and administered to cancer patients. This is the first time an immuno-oncology drug regimen has been added for biliary tract cancer. HIRA said that the cost of the Imfinzi+gemcitabine+cisplatin combination is too high relative to its clinical benefit to cover the entire regimen, therefore patients will need to bear a 100% copayment rate for Imfinzi and a 5% copayment rate for the other drugs, gemcitabine + cisplatin. In terms of eligibility, reimbursement standards are limited to histologically confirmed adenocarcinoma and exclude ampulla of Vater cancer. Currently, the drug price (upper limit) of Imfinzi is set at KRW 3,347,202 per vial (10 ml). The use of immuno-oncology drugs, which attack cancer cells by activating the body's immune system, is being applied to various cancer types. In Korea, it is being used in lung, head and neck, stomach, breast, and cervical cancers, and the use has now been extended to biliary tract cancer. In addition, the immuno-oncology drug Keytruda applied for reimbursement extensions to 13 cancer indications last year. Meanwhile, in the amendment to reimbursement standards for anticancer drugs, the use of FOLFIRINOX (oxaliplatin+irinotecan+leucovorin+5-FU) therapy (neoadjuvant chemotherapy) was newly added for pancreatic cancer and capecitabine monotherapy (adjuvant therapy) for biliary tract cancer. In addition, the phrase that restricts the use of enzalutamide (Xtandi soft capsules)+ADT and abiraterone acetate (Zytiga)+ADT regimens for prostate cancer has been removed. In acute myeloid leukemia, reimbursement for Xostapa is now approved without limiting the duration of treatment, regardless of their eligibility for hematopoietic stem cell transplantation As a result of the negotiations with the NHIS, the expected claims amount for Xostapa was set at KRW 124.1 billion, and an additional KRW 83.8 billion was with the reimbursement extension. However, the actual financial expenditure is expected to be less than this when considering the risk-sharing agreement. Xostapa agreed to a drug price of KRW 190,704, a 6.2% reduction from the current upper limit, starting in March.
- Company
- Immuno-oncology market triples in 4 years
- by Son, Hyung-Min Feb 28, 2024 05:50am
- Sales in the immuno-oncology market surpassed KRW 700 billion last year, driven by the surge in sales of Keytruda and Opdivo. The market has more than tripled in size over the past 4 years. Keytruda and Opdivo together accounted for 72.4% of the market and generated more than KRW 500 billion in sales. The market’s prospects are also bright with major immuno-oncology drugs showing additional efficacy in various solid tumors. According to the market research institution IQVIA on the 27th, the total immuno-oncology treatment market has recorded KRW 730.8 billion in the past year, a 46.6% increase from the KRW 498.3 billion in the previous year. Sales have been growing steeply in the immuno-oncology market. The market, which was worth KRW 200 billion in 2019, reached KRW 700 billion last year after recording KRW 407 billion in 2021 and KRW 498.3 billion in 2022. Immuno-Oncology Drug Market Size (Unit: KRW 100 million) Immuno-oncology drugs target PD-1/PD-L1 biomarkers that are expressed in major solid tumors. This is why the drugs have expanded their indications to several solid tumors, and sales are surging. In addition to their better effect, immuno-oncology drugs are also known to have fewer side effects than first-generation cytotoxic anti-cancer drugs and second-generation targeted anticancer drugs. Since the immuno-oncology drugs work by strengthening the body's immune system, side effects such as hair loss, vomiting, nausea, diarrhea, and bone marrow suppression are relatively mild. Keytruda, which owns 26 indications, approaches KRW 400 billion in sales...Opdivo’s sales surpass the KRW 100 billion mark #EB The market leader is MSD's Keytruda. Keytruda generated KRW 398.7 billion in sales last year, up 66.4% YoY. It occupied 54.6% of the market. Keytruda is approved for 26 approved indications in Korea, owning the most amount of indications among all cancer drugs. However, only 4 of the cancers are reimbursable: lung cancer, Hodgkin's lymphoma, urothelial carcinoma, and melanoma. MSD is seeking reimbursement for a variety of other solid tumors, including triple-negative breast and head and neck cancer. Keytruda's sales may surge further if its reimbursement is further extended. In second place was Opdivo. Opdivo generated KRW 130.4 billion in sales last year, up 18.7% from KRW 109.8 billion in 2022. After hovering in the KRW 60 billion range from 2019 to 2020, the company surpassed the KRW 100 billion mark in 2022 after reaching KRW 85 billion in 2019. Together, Keytruda and Opdivo generated KRW 529.1 billion in sales last year, accounting for 72.4% of the market. Opdivo is a PD-1 class immuno-oncology drug co-developed by BMS and Japan's Ono Pharmaceutical. It has 22 approved indications in Korea, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Both companies have been steadily expanding the number of their solid tumor indication since their approval. In addition to extending Opdivo’s reimbursement coverage, BMS and Ono plan to develop a subcutaneous (SC) formulation to expand options for the patients. Opdivo's major patents are set to expire in 2028. BMS confirmed that Opdivo’s subcutaneous (SC) formulation was non-inferior to the intravenous (IV) formulation in a Phase III clinical trial conducted to confirm the efficacy of the SC formulation. The safety results were also comparable in both arms. The SC formulation can be administered in less than 5 minutes, compared to the 1 hour required for the existing IV formulation. BMS is preparing to apply for approval of its SC formulation with regulatory authorities around the world. Tecentriq and Imfinzi gains ground in intractable cancers Roche's Tecentriq and AstraZeneca's Imfinzi also showed marked sales growth. Roche Tecentriq generated KRW 97.3 billion in sales last year, up 18.9% YoY. After posting KRW 37 billion in 2020 and doubling its sales in 2021, Tecentriq’s sales have been on a steady rise. Roche has been rapidly expanding Tecentriq’s indication by actively accepting the government’s requests. Tysentriq gained coverage for lung cancer within a year of approval and expanded coverage in 2019 by removing the PD-L1 expression limit. Roche plans to expand Tecentriq’s indications through combined use with targeted cancer drugs. Tecentriq, in combination with Avastin, became the first immuno-oncology drug to be reimbursed for the first-line treatment of liver cancer. Roche is also conducting combination trials with NT-I7, an anti-interleukin (IL)-7 inhibitor developed by a Korean biotech NeoImmuneTech, in lung and skin cancers. AstraZeneca's Imfinzi posted sales of KRW 82.7 billion last year, up 57.8% from KRW 52.4 billion in 2022. After generating KRW 3.4 billion in sales in 2019, Imfinzi’s sales surged 624% to KRW 24.6 billion the following year. With sales exceeding KRW 80 billion last year, Imfinzi ranked fourth in the immuno-oncology market. Imfinzi’s strength is that it is the first immuno-oncology drug to show efficacy in biliary tract cancer. In 2022, AstraZeneca received approval for the Imfinzi+gemcitabine+cisplatin combination in Korea. This approval established the Imfinzi combination as the new standard of care in biliary tract cancer for 12 years. AstraZeneca is currently in the process of extending Imfinzi’s reimbursement to its biliary tract cancer indication. BMS plans to extend indications for the Yervoy+Opdivo combo...Bavencio’s sales increase with reimbursement in urothelial cancer BMS On the other hand, Yerovy’s sales growth was not as dramatic. Sales of Yervoy, which is the only immuno-oncology drug to target CTLA-4, grew only 12.6% last year, generating sales of KRW 16 billion. In 2021, Yervoy received approval for use in combination with Opdivo in 2021. However, the maximum dosing interval was set at 2 years, meaning that even if it works, patients will not be eligible for additional reimbursement afterward. BMS plans to explore multiple uses for the Yervoy and Opdivo combination. The company is currently exploring the combination of metastatic colorectal cancer, squamous cell carcinoma, and head and neck cancer. Merck's Bavencio generated KRW 5.7 billion in sales last year. Sales of Bavencio grew with its reimbursement approval in metastatic urothelial cancer. Bavencio, which was approved in Korea in 2019, secured reimbursement as a first-line maintenance therapy for urothelial cancer in 2023. The variable is Padcev. Padcev, which is an antibody-drug conjugate (ADC) cancer drug developed by Astellas and Seegen, has confirmed efficacy results as a first-line treatment in urothelial cancer. Based on the results of the study, the company is accelerating its efforts to receive approval as a first-line treatment in urothelial cancer This could have implications for Bavencio, as it is being used as a maintenance therapy in the first-line setting.
- Company
- Will the first oHCM drug Camzyos be reimbursed in Korea?
- by Eo, Yun-Ho Feb 28, 2024 05:50am
- The industry’s eyes are focused on the reimbursement review progress of Camzyos, the first treatment for obstructive hypertrophic cardiomyopathy. Dailypharm’s coverage found that the pharmacoeconomic evaluations for Camzyos(mavacamten), BMS Pharmaceutical Korea's new drug for obstructive hypertrophic cardiomyopathy (oHCM), is now complete and that it will be submitted for review by the Health Insurance Review and Assessment Service's Pharmacoeconomic Evaluation Subcommittee next month (March). Being the first treatment option in its field, many challenges are expected in its reimbursement approval process. However, as the government has shown a willingness to improve the valuation process for new drugs, including providing preferential treatment for innovative new drugs, it remains to be seen whether this will positively impact Camzyos’s reimbursement process. Camzyos is the first and only cardiac myosin inhibitor that specifically targets excess cross-bridge formation of myosin and actin proteins, the main cause of oHCM. It improves left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin, relaxing the overcontracted heart muscle. Due to the lack of a cure, oHC has long been managed with off-label drug use. The European Society of Cardiology (ESC) revised its HCM guidelines for the first time in 9 years with the introduction of Camzyos. Before then, HCM guidelines have been based on small observational data reported from individual institutions, retrospective analyses, or expert consensus opinions. Therefore, Camzyos was a game-changer in the field. After demonstrating its significant effect in two large-scale Phase III randomized controlled trials (RCTs), Camzyos was recommended at the highest evidence level, A, for the first time among treatment options in the ESC guidelines. The American College of Cardiology (ACC) and American Heart Association (AHA) are also currently preparing to update their guidelines. Based on the Phase III trial data, Camzyos received a breakthrough therapy designation (BTD) and was approved by the US FDA. Based on these factors, Camzyos appears to meet the criteria for an innovative new drug announced by the government last year, where: ▲ there is no substitute or therapeutically equivalent product or treatment; ▲ has shown clinically meaningful improvement, such as a significant prolongation of survival period; ▲has received the Ministry of Food and Drug Safety’s GIFT (Global Innovative products on Fast Track) designation, US FDA’s Breakthrough Therapy Designation (BTD), and was approved through the European EMA’s Priority Medicines scheme (PRIME). With reimbursement for the breast cancer drug Enhertu (trastuzumab deruxtecan) recently making progress by passing an unusual ICER threshold, attention is focused on whether Camzyos can follow suit. In the Phase III EXPLORER-HCM trial, which served as the basis for Camzyos’s approval, Camzyos achieved and improved the primary composite endpoint of the proportion of patients with decreased symptom burden (by NYHA class) and functional capacity (peak oxygen consumption, pVO2) by more than 2 times compared with placebo. In particular, 20% of the patients who received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement. Also, the dynamic left ventricular outflow tract obstruction was reduced by over 4 times with the use of Camzyos. 7 out of 10 patients treated with Camzyos improved to the extent that they would not consider surgery, and showed consistent benefits over 30 weeks.
- Company
- Samsung Bioepis confirms efficacy of its Eylea biosimilar
- by Nho, Byung Chul Feb 27, 2024 05:45am
- Samsung Bioepis (CEO Hansung Ko) announced today that the company had presented the follow-up results from its Phase III clinical trial on SB15 (Korean brand name: Afilivu/Eylea biosimilar/Aflibercept) at the Annual Asia-Pacific Academy of Ophthalmology (APAO) Congress that was held in Indonesia from the 22nd to the 25th this month, SB15 is a biosimilar of Eylea, the eye diseases treatment for diseases such as macular degeneration that was developed by the U.S. company Regeneron in the U.S. It works by binding to the vascular endothelial growth factor (VEGF) and inhibiting the formation of new blood vessels. Macular degeneration is an ocular disease caused by aging and inflammation of the retinal macula, the nerve tissue in the center of the retina of the eye. In severe cases, it can cause blindness, resulting in high patient costs due to continuous treatment. In the abstract presented at the congress, Samsung Bioepis disclosed the results of a subgroup analysis of 103 patients (82 patients in Korea and 21 in Japan) with neovascular age-related macular degeneration (nAMD) in Asia who participated in a Phase III clinical trial for SB15. The company conducted a global Phase III clinical trial on SB15 from June 2020 to March 2022, recruiting 449 patients from 10 countries across Asia, Europe, and the U.S. The data from the Asian region was selected for the follow-up analysis. In the Asian subgroup analysis, the efficacy, safety, and immunogenicity, including best corrected visual acuity (BCVA), of patients randomized at Week 0 to receive SB15 through Week 56 (SB15 arm, 52 patients) versus the original drug product (original drug product arm, 24 patients) versus patients randomized at Week 0 to first use the original drug product then switch to SB15 from Week 32 (switch arm, 26 patients) were analyzed. Results showed that the patients' best-corrected visual acuity improved similarly in all 3 arms at Week 56 compared to Week 0: 8.3 letters in the SB15 arm, 7.0 letters in the original drug’s arm, and 6.8 letters in the switching arm. The type and frequency of adverse events were also comparable in the SB15, original, and switching arms, with no new safety signals identified in any of the 3 arms and no detection of anti-drug antibodies, an indication of the drug's immunogenicity. Hejin Kim, Vice President of the Medical Team at Samsung Bioepis, said, “We were able to reaffirm the efficacy of SB15 through the Asian subgroup analysis. The drug demonstrated bioequivalence to the original drug in the Asian subgroup just as it had in the global clinical trial.” Samsung Bioepis currently owns a total of 11 biosimilar products in its pipelines, and SB15 is the second ophthalmic treatment developed by the company after SB11 (Amelivu in Korea, Byooviz in the U.S. and Europe, and Lucentis biosimilar/ ranibizumab). Samsung Bioepis plans to work with Samil Pharm on the sales of SB15 and SB11 in Korea to boost the development and sales synergies of both companies. The 2 companies launched SB11 in January 2023, and in February this year, they signed an additional sales agreement for SB15, establishing a cooperation system for the 2 ophthalmic drugs.
- Policy
- AbbVie Korea will discontinue supply of Kaletra
- by Lee, Tak-Sun Feb 27, 2024 05:45am
- The HIV drug Kaletra, which was used as a first-line antiviral treatment during the COVID-19 outbreak, will be withdrawn from the domestic market. The decline in domestic demand is cited as the reason. On the 23rd, AbbVie Korea reported to the Ministry of Food and Drug Safety that will stop supplying Kaletra Tab(lopinavir + ritonavir) in Korea. The company explained, "In light of the decrease in demand for Kaletra and the fact that improved substitute options are well in supply, we plan to discontinue its supply." The company added that the impact on patients is expected to be minimal as improved alternatives are already well-established in the market. In consideration of the available improved alternatives to Kaletra, AbbVie said it will work to ensure that patient care is not disrupted through notifications and guidance to long-term care organizations and their patients. With the notification, Kaletra will be available only until October of this year. Kaletra was used as an antiviral drug during the first outbreak of the COVID-19 virus in February 2020. However, in August of that year, the National Medical Center’s Central Clinical Committee for New Infectious Diseases removed Kaletra from recommendations in the clinical practice guideline for the antiviral treatment of COVID-19. Instead, remdesivir was added in its place. The reasoning was that Kaletra seemed to have no or limited effect against COVID-19. At the time, the committee explained, "HIV-protease inhibitors, including Kaletra, are not generally recommended for COVID-19 and may be considered cautiously in very limited circumstances, such as in clinical studies.” Kaletra gave up the rights to its patent in early 2020, allowing generics to be developed around the world, but no generic versions have been released in South Korea since. Currently, Pfizer's Paxlovid and MSD's Lagevrio are the only officially authorized COVID-19 treatments in Korea.
- Company
- K-biopharma starts trials with bispecific antibodies
- by Son, Hyung-Min Feb 27, 2024 05:45am
- Major global pharmaceutical companies have accomplished successful marketing of bispecific antibodies. Now, the Korean biopharmaceutical industry is also joining this challenge. Current bispecific antibodies include Roche’s Lunsumio and Columvi, Abbvie’s Epkinly, and Janssen’s Tecvayli. Korean companies are planning to evaluate the possibility of developing bispecific antibodies in an area of immunotherapy. According to industry sources on the 26th, Hanmi Pharm, ABL Bio, and ImmuneOncia joined the race to develop bispecific antibodies. Bispecific antibodies are known to have clinical advantages as they have additional specific antigen-binding sites compared to monoclonal antibodies. Korean biopharmaceutical companies have started developing anticancer therapy with bispecific antibodies. Hanmi Pharm’s immunotherapy candidate product BH3120 has recently entered Phase 1 clinical trials. BH3120 simultaneously targets 4-1BB and PD-L1. PD-L1 is a target that immunotherapies, such as Keytruda and Opdivo, have demonstrated effectiveness. Hanmi plans to expand the antibody’s efficacy by also targeting 4-1BB protein. Hanmi’s bispecific antibody platform technology, Pentambody, was applied to developing BH3120. Pentambody is a next generation bispecific antibody platform technology that stimulates immune cells while attacking target cancer cells simultaneously. BH3120 is designed to activate 4-1BB specifically in the immune cells near PD-L1-expressing cancer cells. This design minimizes toxicity while demonstrating anti-cancer efficacy in preventing late recurrence. ABL Bio has the most bispecific antibodies of any pharmaceutical companies in Korea. ABL Bio has more than seven pipelines including ABL001(VEGFxDLL4), ABL111(Claudin18.2x4-1BB), and ABL503(PD-L1x4-1BB). ABL Bio is also developing ABL001 jointly with Handok. Handok has entered into a licensing agreement with ABL Bio, securing the rights of the drug in Korea and the company has been focusing on biliary tract cancer since February 2021 and conducting Korean Phase 2 clinical trial of ABL001(HDB001A). Handok’s Korean Phase 2 clinical trial, which enrolled patients with biliary tract cancer, demonstrated drug’s efficacy. Therefore, Handok has established a foundation for expanding into multinational clinical studies. In the clinical trial, ABL001 was administered in combination with Paclitaxel to patients who had received their first or second systemic anticancer therapies. The combination therapy demonstrated an objective response rate (ORR) of 37.5%. The median overall survival (OS) was reported to be 12.5 months, with an estimated median duration of response rate (DOR) of 9.4 months. The company is planning to enter later stage clinical trials. ABL Bio announced the interim analysis of Phase 3 for ABL111 last year. The company aims to secure indications for solid cancer by simultaneously targeting Claudin18.2 and 4-1BB. ABL111 did not show any serious adeverse reactions of greater than level4, with an index of 4-1BB-specific toxicity side-effects, according to the company. Additionally, ABL503 is a cancer immunotherapy that simultaneously targets PD-1 and 4-1BB, similar to Hanmi’s BH3120. According to the Phase 1 clinical trial result, one instance of complete response (CR) and three instances of partial remission (PR) were confirmed in ovarian cancer patients administered with ABL503. The Phase 1 clinical trial of ABL503 is currently being conducted at six institutions in the United States and three institutions domestically, focusing on dose escalation and expansion parts. Once the optimal dosage is determined, the plan involves identifying the most suitable target among solid tumors. ImmuneOncia’s IMC-201 is an independently developed bispecific antibody utilizing CD47 and PD-L1. In the preclinical study, IMC-201 binds strongly to solid cancer cells or blood cancer cells expressing CD47/PD-L1 and selectively binds to cancer cells even when cancer cells and red blood cells are co-cultured. In addition, IMC-201 exhibited higher macrophage-dependent phagocytosis than monoclonal antibody IMC-002. Particularly in a mouse tumor model of triple-negative breast cancer, IMC-201 showed more substantial tumor suppression than the combination of monoclonal antibodies IMC-002 and IMC-001. ImmuneOncia is developing cancer immunotherapy candidate IMC-002. IMC-002 blocks the signal between CD47 on cancer cells and macrophages. The result of IMC-002 administration to 12 patients demonstrated no drug toxicity in each dose. 6 out of 12 patients showed stable disease (SD). The company will determine the recommended dose based on Phase 1 clinical study results.
- Policy
- Expedited domestic supply of suspended essential medicines
- by Lee, Hye-Kyung Feb 27, 2024 05:45am
- The timelines for domestic distribution of supply-disrupted essential medicines will likely be shortened to two months from four months starting this year. The Korea Orphan & Essential Drug Center (KOEDC) announced on the 27th their plans to ensure a stable supply through monitoring the supply and demand of orphan drugs and essential medicines in Korea and overseas, according to its ‘2024 Business plan.’ If supply monitoring indicates medical needs and urgency of medicines, the center will shorten the timelines for domestic supply through a preliminary survey of overseas medicines for expedited supply. Previously, the Ministry of Food and Drug Safety (MFDS) was responsible for confirming the expedited supply of essential drugs that had been suspended, and the center handled business related to imports and distribution. The plan for expedited supply of suspended essential drugs: the center will be responsible for implementing preliminary measures of expedited supply, such as independently conducting surveys of overseas medicines and domestic demands. Then, the MFDS will undertake administrative management of the expedited supply. From now on, the center will conduct preliminary measures of expedited supply, such as independently conducting surveys of overseas medicines and domestic demands. Then, the MFDS will undertake administrative management of the expedited supply. Furthermore, the center aims to strengthen the domestic self-sufficiency of suspended essential medicines by expanding consignment manufacturing (a new item per year). If a stable supply of the previously ordered items is achieved, the production will be transferred to private companies. The center will diversify their sources for purchasing (manufacturer, overseas wholesale business) drugs, especially for orphan drugs, to improve the system of imports and distribution of orphan drugs and essential medicines that are not available domestically. Furthermore, the center plans to shorten import timelines and reduce drug prices by discussing estimated demands with a distributor beforehand and obtaining three months of stock. Besides these plans, the center will strengthen its supportive measures. This includes improving the environment related to safe use of medicines and reducing patients’ financial burden by adjusting drug prices. The center will continue to offer support related to regular surveys of overseas medicines and adjustment of drug prices by reducing importing costs, tariff refunds via tariff and tax exemption, low-income funding projects for purchasing medicines (90 million won), and patient support (free supply) programs. “KOEDC will continue to survey and provide information related to the development of orphan drugs and put our efforts into providing patients with medicines that are necessary but unavailable domestically,” KOEDC President Jinseok Kim stated
- Company
- Reimbursement for novel CMV drug Livtencity imminent in KOR
- by Eo, Yun-Ho Feb 27, 2024 05:45am
- The novel cytomegalovirus drug Livtencity will soon receive reimbursement in Korea. According to industry sources, Takeda Pharmaceutical Company of Korea recently completed drug pricing negotiations with the National Health Insurance Service for its cytomegalovirus (CMV) drug Livtencity (maribavir). The drug is expected to be approved in April if no issues arise. When reimbursed, the drug will provide a new treatment option for patients who are resistant to existing drugs. The company submitted an application for Livtencity’s reimbursement in Q3 last year, and the agenda the passed Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in December of the same year. Cytomegalovirus (CMV) is a type of herpes virus that's extremely common worldwide. Over 60% of all adults are infected with CMV within their lifetime and typically develops in patients who use immunosuppressants after hematopoietic stem cell transplantation (HSCT). Around 30-70% of HSCT patients experience CMV viremia. In HSCT patients, CMV causes multisystemic diseases such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis. Among these, pneumonia’s mortality rate is near 60%. Because CMV in immunocompromised patients is fatal, patients had generally received preemptive treatment mainly with ganciclovir, valganciclovir, foscarnet, and cidofovir, and hospitalization had been essential. Additionally, because these drugs have similar mechanisms of action if resistance to one drug develops, it is highly likely that the patient will not respond to other treatments as well. However, the introduction of Livtencity will bring hope to these patients. Livtencity has almost no side effects compared to existing drugs and can become an alternative if patients develop resistance to the existing drugs. Livtencity’s antiviral activity inhibits CMV multiplication and migration through a differentiated multi-modal mechanism of action that inhibits the protein kinase of the HCMV enzyme UL97. It not only inhibits DNA from coming out of cells, but also interferes with viral DNA replication, encapsidation, and nuclear egress. Meanwhile, Livtencity was first approved in November 2021 by the US FDA as the first treatment for patients with post-transplant CMV infection/disease and was approved in Korea in December 2022.
