- LOGIN
- MemberShip
- 2025-12-23 21:05:24
- Company
- Erleada chases leader Xtandi in prostate cancer mkt
- by Kim, Jin-Gu Dec 06, 2023 06:00am
- Pic of Astella Astellas Pharm Korea ‘Xtandi (enzalutamide)’ took the lead among oral androgen receptor targeted agents (ARTAs) used to treat prostate cancer. In comparison to declining sales of Janssen's ‘Zytiga (Abiraterone),’ sales of Janssen's other prostate cancer drug ‘Erleada (Apalutamide)’ has been rapidly increasing since being released just 6 months ago, chasing Xtandi in the market. Xtandi's Q3 sales KRW 11.7 billion…top among ARTAs for prostate cancer The ARTA-type prostate cancer treatment, Xtandi, posted KRW 11.7 billion in sales in Q3. According to IQVIA, a pharmaceutical industry research institute, this represents a 53% increase from the KRW 7.6 billion it had raised in the same quarter last year. Xtandi is approved for ▲the treatment of asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), ▲mCRPC previously treated with docetaxel, ▲high-risk non-metastatic castration-resistant prostate cancer, and ▲hormone-sensitive metastatic prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). It was approved in Korea in June 2013 and received reimbursement in November following year. Recently, Xtandi's sales have increased sharply, especially since Q3 last year. Previously, its sales ranged around KRW 6 billion, but this significantly increased to KRW 7.6 billion in Q3 last year, then to KRW 8.7 billion in tQ4, KRW 10.5 billion in Q1 this year, and KRW 11 billion in Q2. The increase in sales last year is attributed to the expanded reimbursement. In August, selective reimbursement was granted for the use of ADT as combination therapy for patients with progressive prostate cancer accompanied by distant metastasis. Starting this November, reimbursement for ADTs were extended and is applied regardless of the use of other androgen-production-suppressing drugs. Despite a 3% reduction in the insurance price due to its increased usage, its increase in prescriptions is said to have offset this decrease. Quarterly sales of major ARTA prostate cancer treatments (Unit: KRW 100 mil, Data: IQVIA) Zytiga sales 'slow down'...Erleada sales reach KRW 4.8 billion in only half a year ' Zytiga, a previous competitor of Xtandi, has recently shown a decline in sales. Zytiga's sales in the last quarter were KRW 4.8 billion, a 14% decrease from KRW 5.6 billion of the previous year. Since 2021, Zytiga had closely chased Xtandi in terms of sales. In Q1 2021, sales of Xtandi and Zytiga were KRW 7.6 billion and KRW 2.9 billion, respectively, which is a 2.7 times difference. By Q1 2022, this gap narrowed to 1.2 times, with sales reaching KRW 6.4 billion for Xtandi and KRW 5.2 billion for Zytiga. The sales difference between the 2 drugs further decreased to less than KRW 1 billion in Q2 that year. However, Zytiga's sales have continued to remain in the range of KRW 5 billion since then. Meanwhile, Xtandi's sales increased rapidly. From Q2 his year, the sales difference between the two drugs doubled. Pic of JanssenJanssen's new ATRA-type prostate cancer treatment, Erleada, has rapidly increased its sales since its introduction. In December 2020, Erleada was approved as Janssen's third ATRA prostate cancer therapy. It was added to the reimbursement listing in April this year. Following the listing, Erleada generated sales of KRW 2.7 billion in the second quarter and increased to KRW 4.8 billion in the third quarter, marginally surpassing the sales of Zytiga. Therefore, Janssen plans to focus on Erleada as a latecomer follow-on drugs to Zytiga, aiming to challenge the market leader Xtandi. The market stirrer would be the change in the patient co-payment rates for Xtandi and Zytiga, and the generics development by domestic pharmaceutical companies. Last month, the co-payment rates for Xtandi and Zytiga were adjusted from 30% to 5%. This change occurred following the listing of Erleada, the third ARTA prostate cancer therapy, at a 5% co-payment rate. The maximum reimbursement amount (listed price) for Xtandi was adjusted in the process. Xtandi was registered as a subject to essential reimbursement through a risk-sharing agreement (RSA). With expanded reimbursement, the listed price per tablet was reduced from KRW 28,820 to KRW 14,170. This will be reflected after the fourth quarter of this year. The release of a Zytiga generic by a domestic pharmaceutical company is also anticipated to significantly influence the competitive ground. Hanmi Pharm launched Abiraterone, a generic of Zytiga, under reimbursement in October. As a result, the price of Zytiga was reduced by 30%, from KRW 16,780 to KRW 11,746 per tablet. This price reduction is expected to be reflected in sales after the fourth quarter of this year, potentially resulting steeper decline in Zytiga's sales.
- Company
- AbbVie Korea strengthens its autoimmune disease pipeline
- by Eo, Yun-Ho Dec 05, 2023 05:48am
- AbbVie Korea is actively working to advance its position in the field of autoimmune diseases. According to industry sources, AbbVie Korea successfully expanded the indications for its Interleukin-23(IL-23) inhibitor 'SKYRIZI (Risankizumab)’ and JAK inhibitor ‘RINVOQ (Upadacitinib).’ On November 15th, an indication was added for SKYRIZI to treat adult patients with moderately to severely active Crohn's disease who had responded inadequately or were intolerant to biologic therapy and/or existing therapies. The approval was based on a multicenter, randomized, double-blind, placebo-controlled Phase III trial that demonstrated the efficacy, safety, and tolerability of SKYRIZI in adult patients with moderate-to-severe active Crohn’s disease. In the ADVANCE and MOTIVATE induction trials, 1,419 patients were randomly assigned to receive 6000 mg intravenously, 1,200 mg intravenously, or placebo at week 0, week 4, and week 8. Clinical remissions and endoscopic responses were measured by stool frequency (SF) and abdominal pain score (APS) at 12 weeks. The FORTIFY trial evaluated 462 patients who showed clinical response to 12 weeks of intravenous induction therapy in the ADVANCE and MOTIVATE trials. Patients were randomly assigned to receive either subcutaneous risankizumab 180 mg, subcutaneous risankizumab 360 mg, or withdrawal from risankizumab to receive subcutaneous placebo every 8 weeks for up to 52 weeks. The primary endpoints were clinical remission and endoscopic response at week 52. SKYRIZI is currently approved and reimbursed in Korea to treat moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy and systemic therapy (including biologic treatment), as well as to treat active psoriatic arthritis in adults who are non-responsive to DMARDs (disease-modifying anti-rheumatic drug). As for RINVOQ, its reimbursement has been expanded to the treatment of severe active ankylosing spondylitis from December. Accordingly, patients with severe active ankylosing spondylitis who have stopped receiving treatment due to poor response to one or more types of tumor necrosis factor-alpha inhibitor (TNF-α inhibitor) or IL-17A inhibitor will be able to receive reimbursement for once daily treatment of 15mg of RINVOQ. The reimbursed price of RINVOQ is KRW 19,831 for once-daily dose of 15 mg, and patients covered by special exemption of calculations provisions only have to pay 10% of the drug price. RINVOQ proved efficacy in patients with severe active ankylosing spondylitis who were enrolled in the Phase 2/3 SELECT-AXIS1 and the Phase 3 SELECT-AXIS2 clinical trials. In both SELECT-AXIS 1 and 2 clinical studies, the ASAS40 (Assessment of Spondyloarthritis International Society response standard improvement of 40% or more) response rate for patients treated with RINVOQ 15 mg was 52.0% and 45.0%, respectively, at 14 weeks. This was significantly higher than that of the placebo group (26.0% and 18.0%, respectively.) In addition, the ASAS40 response was observed from Week 2 in SELECT-AXIS1 and from @eek 4 in SELECT-AXIS 2, confirming quicker effect of the drug. In the SELECT-AXIS 2 clinical trial, the average reduction in back pain in the Rinvoq 15mg treatment group was -3.00, which is a significant decrease compared to the placebo group (-1.47), and the intensity of morning stiffness also decreased by -3.08 compared to the baseline value compared to the placebo group (-1.67). Lee Sin Suk, Chairman of Korean College of Rheumatology, said, “RINVOQ has significantly improved the pain, inflammation, and joint damage in patients with severe active ankylosing spondylitis, and also helped improve the quality of life in patients as well as reaching treatment goals. The reimbursement expansion is likely to address the unmet need and alleviate the financial burden of patients who had been unable to receive benefits, and is expected to offer an effective oral treatment option for the patients."
- Company
- Companies in KOR and abroad compete in Eylea biosimilar mkt
- by Son, Hyung-Min Dec 05, 2023 05:48am
- Intense challenges are being made against Bayer's Eylea, the current leader in the macular degeneration market. Not only domestic biosimilar companies like Celltrion and Samsung Bioepis but also traditional pharmaceutical companies such as Sam Chun Dang Pharm have thrown down the gauntlet. Bayer and Regeneron, the original developers of Eylea, thus face fierce market competition not only with biosimilar developers but also with Roche's next-generation macular degeneration treatment, Vabysmo. According to industry sources on the 3rd, among domestic companies, Sam Chun Dang Pharm, Celltrion, Samsung Bioepis, and Alteogen are currently developing Eylea (aflibercept) biosimilars. All four companies have set their sights on the global market, preparing to receive approvals in the U.S. and Europe in addition to the Korean market. In the U.S., Celltrion, Amgen, and Sandoz are close to commercializing their biosimilars in the U.S. These companies have now completed global Phase III clinical trials and applied for marketing authorization in the U.S. and Europe. Eylea’s U.S. new drug exclusivity expires next May, and its European substance patent expires in November 2025. In Korea, Sam Chung Dang Pharm is nearing approval. The company applied for the marketing authorization of its Eylea biosimilar candidate ‘SCD411’ in two formulations - vial and prefilled syringe formulation – in Korea last month. Sam Chung Dang Pharm is the first company to apply for the approval of a prefilled syringe formulation of Eylea. The application was filed based on SCD411’s Phase III trial results. The trial, which had been conducted on 576 patients, demonstrated SCD411’s bioequivalence to Eylea. Based on the results, Sam Chung Dang Pharm is also preparing to apply for marketing approval of SCD411 in the United States and Europe as well. Eylea to inevitably compete with biosimilars and Vabysmo Pharmaceutical and bio companies in Korea and overseas have jumped into developing biosimilars due to the high marketability of Eylea. Eylea’s global sales were approximately USD 1.4 billion (KRW 1.9 trillion) in Q1 this year and USD 1.5 billion (KRW 2.373 trillion) in Q2 this year. Eylea had posted the highest sales in the domestic macular degeneration market. According to the pharmaceutical market research institution IQVIA, Eylea’s sales, which had been around KRW 46.8 billion in 2019, exceeded KRW 60 billion in 2020. Sales continued to grow, and Eylea posted KRW 80.4 billion in sales last year. However, sales generated by Eylea’s competitors last year, Novartis’ Lucentis (ranibizumab) and Beovu (brolucizumab) were only KRW 29.4 and KRW 14.5 billion, respectively. In addition to the challenges made by the biosimilar developers, Bayer’s Eylea is starting competition in earnest with Roche's macular degeneration drug Vabysmo (faricimab). Unlike existing VEGF inhibitors like Lucentis, and Eylea, the drug’s dual mechanism of action allows for it to also block the angiopoietin-2 (Ang-2) pathway to inhibit neovascularization. In particular, in clinical trials, Vabysmo improved visual acuity at a level non-inferior to that of Eylea, which is administered at 8-week intervals, when administered at intervals of up to 16 weeks. Vabysmo was granted reimbursement and released in earnest in October last month. Roche is also known to be planning to introduce a prefilled syringe formulation of Vabysmo next year.
- Company
- Celltrion applies for US approval of its Prolia biosimilar
- by Chon, Seung-Hyun Dec 04, 2023 05:13am
- Celltrion announced today that it has filed an application for the marketing authorization of its, ‘CT-P41,’ to the US Food and Drug Administration (FDA). CT-P41 is a biosimilar of ‘Prolia,’ a treatment for osteoporosis. Based on the results of a global Phase III clinical trial on CT-P41, Celltrion filed for marketing authorization of its substance for all of Prolia’s indications, including osteoporosis, bone loss, prevention of skeletal complications from multiple myeloma or solid cancer bone metastases, and giant cell tumor of bone. Prolia is a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that destroy the bone. The same active ingredient is also licensed under the brand name ‘Xgeva’ for the prevention and treatment of bone metastasis complications in cancer patients. Based on IQVIA, the drug generated USD 5.83 billion in sales last year (KRW 7.54 trillion), and its patent is set to expire in the U.S. and Europe in February 2025 and November 2025, respectively. In October, Celltrion conducted a global Phase III trial on 477 patients in postmenopausal women with osteoporosis in 4 countries including Poland and Estonia, to confirm the bioequivalence and pharmacodynamic similarity to the original drug. Celltrion has worked continuously with the FDA and the European Medicines Agency (EMA) throughout the development process to design a global development program that will enable CT-P41 to be approved simultaneously as a Prolia and Xgeva biosimilar, based on the results of the global Phase III study. The company explained that CT-P41 will be allowed to be prescribed interchangeably with the original product once it is approved in the U.S. because it will receive interchangeable biosimilar status. Following the U.S. approval, Celltrion plans to file for approval in other major global markets, including Europe. A Celltrion official said, "After confirming the bioequivalence and similarity of CT-P41 in the Phase III trial, we have submitted our application for its marketing authorization in the U.S. as an interchangeable biosimilar. will continue to work with regulatory authorities to complete the remaining approval processes."
- Company
- Pharma companies fiercely compete to develop ADC drugs
- by Son, Hyung-Min Dec 01, 2023 05:35am
- Competition among domestic pharmaceutical companies to secure new antibody-drug conjugate (ADC) technology has been intensifying in Korea. With ADC drugs recently demonstrating an effect on various cancer types, there is an analysis that the industry is making active measures to secure new ADC technologies. According to the pharmaceutical industry on the 29th, not only pharmaceutical companies such as Samjin Pharm and Chong Kun Dang, but also bio companies such as LegoChem Biosciences, ABL Bio, PinotBio, AIMed Bio, Celltrion, Samsung Biologics, and Lotte BioLogics have entered the ADC market. ADCs are drugs made by connecting antibodies that bind to specific target antigens on the surface of tumor cells to cytotoxic payloads with a linker. ADC has the advantage of increasing the treatment effect while minimizing side effects due to the target selectivity of the antibody and the apoptosis activity of the drug, which induces the drug to work selectively to target cancer cells. Domestic pharma and bio companies start developing ADC candidates through open innovation… is seeking promising ADC candidates The domestic pharmaceutical and bio industry joined in the ADC development game through open innovation. Accordingly, an overall platform technology has been implemented in all stages of development from early-stage candidate discovery to preclinical trials. To date, LegoChem Biosciences has successfully licensed-out 9 contracts in the field of ADC. Starting with technology transfer to China's Fosun Pharmaceutical Group in 2015, the company has licensed-out 5 pipeline platform technologies to Amgen in December last year. LegoChem Biosciences owns 2 proprietary platform technologies, ‘ConjuAll’ and ‘LegoChemistry.’ ABL Bio is developing ABL201, an ADC candidate targeting blood cancer, and ABL202, targeting solid cancer. ABL Bio also successfully licensed-out ABL201 to bio venture TSD Life Sciences. Also, ABL202 is being developed by incorporating LegoChem Biosciences linker technology. PinotBio is developing PINOT-ADC, which was developed by changing the chemical structure of camptothecin, a topoisomerase class anticancer drug. The candidate substance that linked PINOT-ADC to the HER2 targeting antibody was confirmed to have an anti-tumor effect in a preclinical mouse model. , Ahn-Gook Pharmaceutical, Celltrion, and Lotte Biologics, who eyed PinotBio’s technological capabilities, have made equity investments. AIMed Bio is developing its solid cancer-targeted ADC candidate, AMB302. AMB302 is a novel drug candidate targeting FGFR3 for glioblastoma and bladder cancer. Its first clinical trial is scheduled to begin next year. AIMed Bio received an equity investment from a Life Science Fund created by Samsung C&T, Samsung Biologics, and Samsung Bioepis last September. Samjin Pharm started ADC development in earnest after signing an agreement for joint R&D with an ADC specialist, Novelty Nobility. Under the agreement, the partners will be investigating the use of Samjin Pharm’s new payload with Novelty Nobility’s linker technology. The company is known to be developing differentiated payloads, unlike existing ADC new drug development companies. Chong Kun Dang will begin exploring candidate substances using the Dutch ADC company Synaffix’s ADC technology. Chong Kun Dang plans to secure the rights to use Synaffix’s 3 ADC platform technologies, GlycoConnect, HydraSpace, and an undisclosed linker-payload from the toxSYN platform, to develop ADC anticancer drugs. Samsung Biologics, Celltrion, and Lotte BioLogics are also expanding their ADC contract development and manufacturing (CDMO) business in addition to investing in new drug development companies. ADC development difficult…only around 10 candidates became commercialized Daiichi Sankyo and AstraZeneca’s ADC drug Enhertu Domestic pharmaceutical and bio companies are eager to develop ADC drugs because of the excellent effect demonstrated by ADC drugs developed to date. In particular, relatively recently released drugs are attracting attention as they have secured superior data over existing treatments for various cancer types. However, due to its difficulty in development, only a handful of drugs have been commercialized as of now. Since Pifzer’s Mylotarg (gemtuzumab ozogamicin) was released in early 2000s, Takeda’s Adcetris (Brentuximab vedotin), Roche’s Kadcyla (Trastuzumab emtansine), Pfizer’s Besponsa(Inotuzumab ozogamicin), and Roche’s Polivy (Polatuzumab vedotin-piiq) were successfully commercialized. Recently, Astellas’ Padcev (enfortumab vedotin), Gilead’s Trodelvy (sacituzumab govitecan), and Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) were also released into the market. The relatively recently released drugs have been demonstrating their efficacy in areas with a high unmet need or where existing treatments were ineffective, and have been scoring various therapeutic indications like immune-oncology drugs. In the case of Enhertu, it is currently approved as a treatment for HER2-positive breast cancer and gastric cancer in Korea but has also shown effectiveness in areas that lack treatment options, such as triple-negative breast cancer and non-small-cell lung cancer. Trodelvy is also looking to secure various indications. Currently, it has been approved as a treatment for triple-negative breast cancer in Korea, but its efficacy and safety are also evaluated for HR+/HER2- breast cancer and non-small-cell lung cancer.
- Company
- AstraZeneca appoints Sewhan Chon as new Country President
- by Eo, Yun-Ho Dec 01, 2023 05:35am
- Sewhan Chon, new Country President of AstraZeneca Korea. Sewhan Chon (49), former Country President of AstraZeneca Indonesia, has been appointed the new Country President of AstraZeneca Korea. According to industry sources, Sewhan Chon has officially taken office as the Country President of AstraZeneca Korea as of the 1st. With the appointment, the former Country President, Kim Sang-pyo (53), has resigned. Kim has had led AstraZeneca Korea for 5 years since being appointed in 2018. The new Country President Chon had previously served as the Business Unit Director of the Cardiovascular, Renal, and Metabolic Disease BU until August 2020, then was promoted to lead the Indonesian subsidiary in September of the same year. Chon had also served as the Interim Country President of AstraZeneca Korea after Liz Chatwin, former Country President of the Korean subsidiary, was appointed to head the Australia and New Zealand subsidiary from September 2017 until Kim’s appointment. Chon graduated with a BA in Business Administration from Korea University and received an MBA from the Wharton School of the University of Pennsylvania. Before joining the pharmaceutical industry, he worked as a financial expert at global accounting consulting companies including Price Waterhouse Coopers (PWC), Afterward, he entered the pharmaceutical industry as a finance manager at Abbott Laboratories and continued to build his career at Novartis headquarters, its US subsidiary, and AstraZeneca Korea, building capabilities not only in finance but also in R&D and BD, to rise to the position of Country President.
- Company
- Demand for ADC Enhertu rise despite nonreimbursement
- by Kim, Jin-Gu Nov 30, 2023 05:55am
- Cumulative sales of Daiichi Sankyo’s HER2-positive breast cancer treatment ‘Enhertu (trastuzumab-deruxtecan)’ have exceeded KRW 10 billion even without reimbursement. According to the market research institution IQVIA on the 27th, Enhertu's cumulative sales were KRW 13.8 billion by Q3 this year. Sales steadily increased from KRW 2.2 billion in Q1, to KRW 5.2 billion in Q2, then to 6.4 billion in Q3 this year. In other words, the drug has posted cumulative sales of more than KRW 10 billion without insurance reimbursement. The non-reimbursed administration cost of Enhertu is known to be around KRW 7 million for each cycle that consists of 3 doses. For patients who participate in the company's Patient Assistant Program (PAP), the price drops to the high KRW 5 million range, which still poses quite a burden to the patient. Sales show that quite a few patients are in need of the drug. Voices calling for Enhertu's reimbursement were even raised during the National Assembly audit. At the NA audit on the National Health Insurance Service and Health Insurance Review and Assessment Service, Rep. Ki-Yoon Kang of the People Power Party, said, “I do not understand why Enhertu, which is undergoing pharmacoeconomic evaluations, cannot be reimbursed even though its global clinical trials are complete. Please review its reimbursement so no patients are left to die due to a lack of treatment.” Enhertu is a treatment for HER2-positive breast cancer. It is an antibody-drug conjugate (ADC) that has recently attracted attention and was approved by the Ministry of Food and Drug Safety in September last year. It is indicated for ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment), and ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including an anti-HER2-based regimen. It further expanded indications in December and can be used in patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. However, it has been making less progress in receiving insurance reimbursement. Although the agenda had passed HIRA’s Cancer Disease Deliberation Committee review after redeliberation in May, it remains pending without being presented for review at the Drug Reimbursement Evaluation Committee level. The company had recently submitted supplementary pharmacoeconomic evaluation data to HIRA and is again awaiting DREC review. However, the company and the government are having difficulty reaching a consensus regarding Enhertu’s pharmacoeconomic evaluation results. The industry analysis is that Enhertu's superior effect is hindering economic evaluations. For pharmacoeconomic evaluations, Enhertu’s cost-effectiveness is being compared to that of Kadcyla. Enhertu demonstrated an extension in median progression-free survival (mPFS) by more than 22 months compared to existing drugs. The prolonged survival leads to an increased administration period. However, the current economic evaluation system is known to have difficulty reflecting this. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The median PFS for patients in the Enhertu arm was 28.8 months compared with 6.8 months for the T-DM1 arm. Also, in terms of OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1. Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with a confirmed objective response rate (ORR) of 60.9% % (95% CI, 53.4-68.0) and a mPFS of 16.4 months.
- Company
- Samsung Biologics’ CMO orders exceed KRW 3 trillion this yr
- by Chon, Seung-Hyun Nov 29, 2023 05:50am
- Samsung Biologics Samsung Biologics announced on the 28th that its contract manufacturing organization (CMO) orders this year will exceed KRW 3 trillion. On the day, the company publicly announced that it signed 1 new and 4 expanded CMO deals. Samsung Biologics signed a CMO deal worth KRW 588.8 billion with Asian pharmaceutical companies. In addition, the CMO order amount increased by KRW 171.9 billion with the 4 expanded contracts, As a result, the company's cumulative annual CMO order amount has reached KRW 3.4867 trillion, surpassing KRW 3 trillion for the first time since its establishment. The company explained, “Based on the solid trust we have built with our customers, large multinational pharmacuetical companies. that have initially signed agreements with us have all expanded the contracted line of products or increased the production scale of previously contracted quantities, strengthening partnerships thereafter.” The company’s fourth plant, which began full operations in June, is the world's largest facility with a production capacity of 240,000 liters. The plant has been continuously recording a high utilization rate due to the increase in large-scale orders from large multinational pharmacuetical companies. Samsung Biologics is currently operating 4 biopharmaceutical manufacturing plants. The company further strengthened its CMO capacity by starting its fourth factory 23 months after construction in October last year, which has the world's largest production capacity (240,000 liters) for a single plant. Samsung Biologics has secured a total production capacity of 618,000 liters along with the existing 3 factories (Plant 1 30,000 liters, Plant 2 152,000 liters, Plant 3 180,000 liters). In order to preemptively respond to market demand, Samsung Biologics began construction of a fifth plant with a 180,000 capacity last April with the goal of completion in April 2025. When the fifth factory is completed, Samsung Biologics' total production capacity will be expanded to 784,000 liters.
- Company
- Korean companies bid to break AZ’s monopoly with FcRN drug
- by Son, Hyung-Min Nov 28, 2023 05:42am
- With new FcRn antibody drugs secured by Korean pharmaceutical companies demonstrating efficacy in myasthenia gravis, these new FcRn antibody drugs are expected to rise as a competitor to C5 complement inhibitors such as AstraZeneca’s Ultromiris and Soliris that currently occupy the market in Korea. to industry sources on the 27th, Handok is preparing to apply for marketing authorization of its new FcRn antibody drug Vyvgart (efgartigimod). The company had signed an agreement with the Belgian company Argenx for the marketing authorization, reimbursement, and exclusive distribution of Vyvgart in Korea. Vyvgart is a human Immunoglobulin G1 (IgG1) antibody fragment that binds to the neonatal. Fc receptors (FcRn). The mechanism of action reduces and blocks the circulation of IgG antibodies that cause diseases. FcRn binds to IgG antibodies, preventing them from being destroyed in the lysosome. Vyvgart is currently approved as a treatment for adult patients with generalized myasthenia gravis in the U.S., Europe, the U.K., Israel, and China. In the Phase III ADAPT trial, a significant 68% of anti-AChR antibody-positive gMG patients responded to Vyvgart therapy, compared to 30% of patients on placebo on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale during the first treatment cycle. Furthermore, patients who were treated with Vyvgart showed an improvement over those who received a placebo on the Quantitative Myasthenia Gravis (QMG) scale. Also, Argenx received approval for the subcutaneous formulation of its Vyvgart from the US FDA. In clinical trials, the subcutaneous injection formulation of Vyvgart reduced average IgG by 66.4% on the 29th day, which was higher than the 62.2% achieved using the existing intravenous injection formulation of Vyvgart. On the 23rd, Mirae Asset researcher Seung-min Kim selected FcRn antibody treatment as the most promising candidate for immune and inflammatory diseases in his 2024 Pharmaceutical Bio Outlook Report. Researcher Kim said that the FcRn antibody drug Vyvgart has the potential to become a blockbuster and that HanAll Biopharma, which is developing a treatment in the same class, also deserves attention. HanAll in Phase III trial for batoclimab…achieved positive results in the Phase I IMVT-1402 trial HanAll Biopharma is also developing a subcutaneous injection dosage formulation of its GcRn antibody treatment candidate, batoclimab (HL161). Its licensed partner in China, Harbour BioMed, is conducting clinical trials on the candidate to confirm the potential of batoclimab as a treatment for various autoimmune diseases. HanAll Biopharma obtained positive Phase III trial results with batoclimab in China in March. The trial was conducted by its Chinese partner Harbour BioMed on 132 patients with myasthenia gravis. In the trial, patients were randomly assigned to two groups and evaluated the candidate’s symptom improvement effect and safety at each designated cycle. Results showed that batoclimab met its primary endpoint and demonstrated statistically significant improvement over placebo. Also, batoclimab achieved the key secondary endpoints. It showed consistent safety and tolerability with the previous Phase II trial, and there were no newly discovered adverse reactions. Also, HanAll Biopharma is setting out to receive US approval with its US partner Immunovant. In addition to batoclimab, which is currently in the later stage of clinical trials, a Phase I trial is underway for IMVT-1402, another new FcRn antibody drug candidate. According to the interim results of the Phase I trial that was released last September, IMVT-1402 decreased blood IgG concentration, the efficacy endpoint, by 63%, and no decrease in albumin, a safety indicator, was observed. The ongoing Phase I trial administered IMVT-1402 and placebo as a subcutaneous injection formulation to randomly assigned healthy adults, in increased dosages for each patient group with single or repeated administrations. HanAll Biopharma plans to develop IMVT-1402 to target various autoimmune diseases in addition to myasthenia gravis. No.1 drug for myasthenia gravis in Korea is Ultomiris IV When introduced, the FcRn antibody treatments are expected to compete fiercely with existing AstraZeneca treatments in the market. AstraZeneca had successfully acquired Alexion, a rare disease specialized company that developed the C5 complement inhibitors Soliris (eculizumab) and Ultomiris (ravulizumab), which are treatments for myasthenia gravis. Currently, the domestic market is dominated by AstraZeneca's Ultomiris. The drug absorbed most of the market share that had been previously occupied by Soliris. According to the market research institution IQVIA, Ultomiris recorded KRW 43.2 billion in sales last year. This year, it raised KRW 37.8 billion by Q3. Soliris recorded sales of KRW 10.1 billion last year and KRW 6.5 billion through Q3 this year. Based on the performance, AstraZeneca is evaluated to have successfully made the switch from Soliris to Ultomiris. Soliris, which is indicated both for paroxysmal nocturnal hemoglobinuria (PNH) and myasthenia gravis, had maintained its first place in the market for a long time, but then, a change in the market was detected with the full-scale introduction of Ultomiris in 2021. Ultomiris succeeded in increasing the dosing interval while maintaining its effect compared with Soliris. The dosing interval for Ultomiris has been extended to once every 8 weeks compared to Soliris, which is administered intravenously once every 2 weeks. However, no subcutaneous injection formulation currently exists in the field, so the new FcRn antibody treatments are expected to have high marketability.
- Company
- Budesonide’s price will be increased by up to 19%
- by Chon, Seung-Hyun Nov 28, 2023 05:41am
- The insurance ceiling price for asthma treatments containing ‘budesonide’ will be increased by up to 18.5%. The annual prescription market is expected to increase by more than KRW 1.5 billion. Once the supply and demand imbalance is resolved, the scope of market expansion is expected to increase further. According to the Ministry of Health and Welfare on the 27th, the prices of Pulmican and Pulmicort will increase starting December 1. The price of Kuhnil Pharmaceutical's Pulmican will increase by 18.5% from KRW 946 to KRW 1,121. The price of AstraZeneca's Pulmicort will rise 12.5% from KRW 1,000 to KRW 1,125. Pulmican and Pulmicort contain budesonide and are used to treat bronchial asthma and acute laryngotracheobronchitis in infants and children. As supply shortages have frequently occurred due to a recent surge in demand, a decision was made to increase drug prices after discussing with health authorities and pharmaceutical companies to encourage increased production. Prescriptions for Pulmican and Pulmicort both surged with the COVID-19 endemic. According to the pharmaceutical research institution UBIST, the prescription amount for Pulmicort and Pulmican in Q3 this year was KRW 1.6 billion. The amount decreased by 0.2% from Q3 last year but is 155.8% in 2 years from the KRW 600 million in Q3 2021. In 2020, the prescription market for budesonide was only KRW 3.8 billion. The average quarterly prescription amount was less than KRW 1 billion. In 2021, prescription performance was less than KRW 1 billion from Q1 to Q3. Budesonide prescriptions increased 39.0% YoY to KRW 1.4 billion in Q4 2021, then soared to KRW 3 billion in Q4 last year. This year, sales of budesonide continued to increase, recording KRW 2.5 billion and KRW 2.8 billion in Q1 and Q2, respectively. The cumulative prescription amount for budesonide in Q3 this year was KRW 6.9 billion, approximately 3 times higher than the KRW 2.3 billion it had raised during the same period in 2021. The prescription market for budesonide increased significantly with the surge in the number of confirmed COVID-19 cases since the end of 2021. Recently, the demand for asthma drugs has increased due to the increase in not only confirmed cases of COVID-19 but also cold and flu patients, resulting in a supply-demand imbalance where supply cannot meet demand Prescriptions for Pulmican and Pulmicort both surged from the end of 2021. Pulmicort’s quarterly prescriptions from 2020 to Q3 2021 ranged around KRW 300 million to 500 million. It jumped 36.6% YoY to KRW 800 million in Q4 2021 and exceeded KRW 1 billion in Q4 last year. The cumulative prescription amount for Pulmicort in Q3 this year was KRW 3.4 billion, up 194.7% from the cumulative KRW 1.2 billion in Q3 2021. Pulmican’s quarterly prescriptions from Q1 2020 to Q3 last year fell below KRW 1 billion. However, sales surged to KRW 1.8 billion in Q4 last year, and recorded KRW 1.5 billion and KRW 1.4 billion in Q1 and Q2 this year, respectively. The cumulative prescription amount of Pulmican in Q3 this year was KRW 3.4 billion, a threefold increase from 2 years ago. The price hike for Pulmicort and Pulmican is expected to expand the prescription market for budesonide. However, since the market size is not large, its financial burden on Korea’s health insurance is expected to be minimal. Pulmican recorded prescriptions worth KRW 4.7 billion from Q4 last year to Q3 this year. If a drug price increase rate of 18.5% is applied, the annual prescription volume will increase by about KRW 900 million. Pulmicort has recorded prescriptions worth KRW 5.3 billion in the past year, and if its drug price increases by 12.5%, the annual increase is expected to be about KRW 700 million. When the cost structure of Pulmican and Pulmicort is improved and the supply and demand instability is resolved through increased production, the prescription volume is expected to increase further. The price hike of Pulmican and Pulmicort is the fourth drug price increase case. The Ministry of Health and Welfare raised the insurance price ceiling of 18 acetaminophen 650mg items by up to 76.5% in December last year. The insurance price limit for 650mg acetaminophen, which ranged between KRW 43 to 51 before then, was raised to KRW 90. The government made an unprecedented decision to raise the price of all acetaminophen together when pharmaceutical companies expressed reluctance to increase production due to the drug’s poor cost structure. However, it is a temporary increase that will be adjusted to KRW 70 from December this year. The MOHW has also raised the price of magnesium hydroxide-based laxatives since last June. The price of Magmil was raised by 27.8% from KRW 18 to KRW 23. Cho-A Pharmaceutical's Marogel was raised from KRW 15 to KRW 22, and Sinil Pharm’s M Tab Sinil was raised from KRW 16 to KRW 22. In October, the prices of the 4 types of pseudoephedrine single-agent drugs were increased by up to 45%. The insurance price of Sinil Pharm’s Pseudoephedrine Tab Sinil increased by 45% from KRW 20 to KRW 29. The price of Sam Il Pharmaceutical's Sudafed rose 39% from KRW 23 to KRW 32. The insurance drug price of Sama Pharm’s Schdafen and Kolon Pharmaceutical's Cosue was raised by more than 30% from KRW 23 to KRW 30 and KRW 31, respectively.
