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- 2025-12-23 15:46:23
- Company
- New antibiotic to be listed for reimb, following Zerbaxa
- by Eo, Yun-Ho Jan 03, 2024 05:40am
- Pfizer Pharmaceutical Korea is currently in negotiations for reimbursement pricing for its Zavicefta Inj (ceftazidime·avibactam). Zavicefta, the next-generation antibiotic, is progressing towards reimbursement listing. According to the industry, Pfizer Pharmaceutical Korea is currently in the final round of discussions with the National Health Insurance Service (NHIS) to settle the reimbursement pricing negotiations for its Zavicefta Inj (ceftazidime·avibactam). Zavicefta received approval from the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee in September 2023, and its negotiations began in November. When negotiations reach a settlement without any delays, it is anticipated that Zavicefta will be able to get listed for reimbursement next month. Until now, apart from MSD Korea’s Zerbaxa Inj (ceftazidime·tazobactam), new antibiotics have not produced satisfactory results. Therefore, it is noteworthy to watch whether Zavicefta will successfully receive reimbursement listing. Zavicefta has been developed in response to the urgent need for new antibiotics to treat serious infections that are becoming increasingly resistant, such as multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL-producing Enterobacteriaceae. Zavicefta, an intravenous injection, is targeted for use in the treatment of adult patients suffering from complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); and, the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. Zavicefta was initially developed by AstraZeneca and later became the property of Pfizer when Pfizer acquired AstraZeneca’s antibiotics business in 2016. Securing new alternative treatments for carbapenem-resistant Gram-negative pathogens is a global health priority, as announced by the WHO. Multi-drug resistant P. aeruginosa has seen a global increase and is causing serious problems in recent healthcare-related infections. The WHO has appointed carbapenem-resistant Gram-negative pathogens as one of the pathogens requiring high-priority research and development of new antibiotics. The rate of gram-negative pathogens exhibiting carbapenem resistance in Korea is 30.6%, ranking as the second highest among the countries surveyed, with Greece being the highest. ESBL-producing Enterobacteriaceae confers resistance to most cephalosporins-class antibiotics, which are typically effective against a broad range of gram-negative pathogens. To date, new antibiotics introduced in Korea include MSD’s Zerbaxa (ceftazidime·tazobactam) and Pfizer’s Cresemba (isavuconazonium), etc. Zavicefta has recently passed the Drug Committee (DC) of the “Big 5” hospitals, including Seoul National University Hospital, Samsung Seoul Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. It has secured prescription in approximately 40 hospitals in Korea.
- Company
- ‘Drug pricing and reimb' needs most regulatory improvement
- by Chon, Seung-Hyun Jan 03, 2024 05:40am
- CEOs of both domestic and multinational pharmaceutical companies alike identified 'drug prices and reimbursement as in need of most regulatory improvement. CEOs of multinational pharmaceutical companies only gave a 2-point range satisfaction score in terms of satisfaction with Korea’s drug pricing and reimbursement regulations. This indicates how CEOs are even more dissatisfied with regulations that affect the management of pharmaceutical companies, such as new drug registration, generic reevaluation, and reimbursement reevaluations. According to Dailypharm's survey of 53 CEOs of pharmaceutical companies, CEOs of both domestic and multinational pharmaceutical companies had a negative perception of government regulations. Among the 42 CEOs of domestic pharmaceutical companies, 34% said that their attitude towards government regulations was negative, which is three higher than the 10% who said they had a positive attitude. More than half of domestic pharma CEOs described government regulation as ‘moderate.’ CEOs of multinational pharmaceutical companies were even more towards government regulations. Of the 11 multinational pharmaceutical company CEOs, 73% had a negative view of government regulation. "Very negative" and "negative" responses accounted for 18% and 55%, respectively. Not one respondent had a positive view of government regulation. The area with the most common complaints was drug pricing and reimbursement.’. When asked to name the most unreasonable regulations, 57% of respondents cited reimbursement and drug pricing. This means that three out of five pharma CEOs perceive reimbursement and drug pricing regulations as the most unreasonable. 25% of respondents cited licensing, production, and quality control as having the most unreasonable regulations. Only 11% said distribution, sales, and marketing regulations were the most unreasonable. Both domestic and multinational pharma CEOs were most dissatisfied with drug price and reimbursement regulations. Nearly half, 48%, of the 42 CEOs from domestic pharmaceutical companies said that reimbursement and drug pricing regulations were the most unreasonable. Licensing, production, and quality control followed at 29%. More than 10 out of 11 (90%) multinational pharma CEOs perceived that the drug pricing and reimbursement system was unreasonable. It is noteworthy that the multinational pharmaceutical companies, which are responsible for a sizable proportion of new drug listing and sales, are most dissatisfied with drug pricing and reimbursement listing regulations in place for market entry. The dissatisfaction with the drug pricing and reimbursement system among MNCs was also evident in the specific indicators. CEOs of multinational pharmaceutical companies gave a satisfaction score of 2.90 points for Korea’s drug pricing and reimbursement system. This is significantly lower than the 3.24 score given by domestic pharmaceutical CEOs. 73% of multinational pharma CEOs said that new drug approval is in need of the most urgent improvement. Even if a new drug is developed and approved by company headquarters after a long period of research and development (R&D), there are many cases where their launch is delayed or abandoned in Korea due to inadequate drug prices or reimbursement. CEOs of domestic pharmaceutical companies perceived post-generic drug price reductions as the most problematic. Last year, the government lowered the prices of more than 7,000 drugs through generic drug price reevaluations, and the industry complained that repeated generic drug price reductions due to system changes threaten business. CEOs of domestic pharmaceutical companies also pointed out the need to improve reimbursement reevaluations (21%) and price-volume agreement systems (18%).
- Company
- SK Chemicals ends copromotion agreement with Eli Lilly
- by Lee, Tak-Sun Jan 02, 2024 05:45am
- SK Chemicals announced that its copromotion agreement with Lilly Korea for the antidepressant Cymbalta Cap (duloxetine hydrochloride) and the migraine treatment Emgality (galcanezumab-gnlm) has been brought to an end. Cymbalta is the number one selling antidepressant on the market. Sales of Emgality have also been rising since last year's reimbursement approval. SK Chemicals has co-marketed Cymbalta since 2017 and Emgality since July 2020 with Lilly. According to industry sources, SK Chemicals will supply Cymbalta until Dec. 31 last year and Emgality until Jan. 31 this year with the termination of the co-promotion agreement with Lilly Korea. Cymbalta is the No. 1 antidepressant in Korea's KRW 30 billion antidepressant market, with sales of KRW 9.7 billion last year, according to IQVIA. It is mainly prescribed for depression but is also used to treat diabetic peripheral neuropathic pain, fibromyalgia, and osteoarthritis pain that has not responded adequately to non-steroidal anti-inflammatory drugs. SK Chemicals has been responsible for marketing and sales activities for Cymbalta's pain-related indications since January 2017. The announcement this time marks the end of the co-promotion agreement in 5 years. Emgality, a migraine prevention drug, has been co-marketed by the companies since July 2020. SK Chemicals had been in charge of marketing the drug in domestic clinics, and the two companies worked together on marketing it in general hospitals. Emgality is the first drug to be introduced in Korea to prevent migraines and offers convenience as a once-a-month subcutaneous injection therapy. Emgality has been listed for reimbursement since September last year, and sales have been on the rise ever since The drug, which generated sales of KRW 5.7 billion last year, has posted sales of KRW 3 billion in the first half of the previous year alone, according to IQVIA.
- Company
- CMV treatment Livtencity lands in Big 5 hospitals in KOR
- by Eo, Yun-Ho Jan 02, 2024 05:45am
- Takeda Pharmaceuticals Korea’s Livtencity (maribavir) has recently passed the Drug Committee (DC) of the “Big 5” hospitals. Livtencity, a cytomegalovirus (CMV) treatment, is nearing prescription at tertiary general hospitals. According to industry sources, Takeda Pharmaceuticals Korea’s Livtencity (maribavir) has recently passed the Drug Committee (DC) of the “Big 5” hospitals, including Seoul National University Hospital, Samsung Seoul Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Takeda Pharmaceuticals Korea submitted its reimbursement application for Livtencity in Q3 of 2022 and successfully cleared the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee in October of the same year. Currently, negotiations for Livtencity’s drug pricing are ongoing, and its subsequent listing for reimbursement is anticipated to lead to immediate prescriptions. CMV is a type of herpesvirus that 60% of adult populations globally are infected with at least once in a lifetime. CMV is one of the common diseases that occur in Hematopoietic Stem Cell Transplantation (HSCT) patients during the time of immunosuppression. The development of CMV remain critical complications, with 30%-70% of HSCT recipients experiencing CMV viral infections. In HSCT recipients, CMV infections can result in multi-organ dysfunctions, such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis. Among these, the mortality of patients with pneumonia is approximately 60%. CMV development in immunocompromised patients can be fatal. Therefore, the patients typically received first-line treatments and were prescribed medications such as ganciclovir, valganciclovir, foscarnet, and cidofovir. In most cases, hospitalization was necessary. Additionally, the mechanism of action of these treatments is similar, so when patients develop tolerance to one treatment, it is highly likely that they may not respond well to other treatments. Livtencity may offer patients hope for second-line treatment options. Compared to existing treatments, Livtencity has fewer side-effects and can serve as an alternative treatment option when patients develop tolerance to existing treatments. The antiviral activity of Livtencity, through its novel multimodal mechanism of action, works by inhibiting HCMV-specific UL97 Protein Kinase, thereby inhibiting CMV replication and transport. Its effect is not limited to inhibiting DNA from exiting the cell; it also inhibits DNA replication and viral encapsulation. Livtencity received approval from the U.S. FDA in November 2021 as the first treatment for patients with CMV infection and subsequently received approval in Korea in December 2023.
- Company
- Celltrion merges and launches with founder’s son as leader
- by Kim, Jin-Gu Dec 29, 2023 05:40am
- Celltrion’s Chair of the Board, Jin-Seok Seo, the eldest son of Celltrion’s Chairman Emeritus Jung-jin Seo, will helm the newly merged Celltrion. The new CEO Seo will lead the company in a 3-person representative system with Hyung-Ki Kim, current CEO of Celltrion, and Hyung-Ki Kim, former CEO of Celltrion Healthcare. Celltrion announced on the 28th through a resolution of its board of directors that it has completed the merger with Celltrion Healthcare and will be rebranded as a unified Celltrion. At the meeting, the board also approved the appointment of three new Vice-chairs: Woo-Sung Kee, Vice Chairman of the Manufacturing & Development Division (currently CEO of Celltrion), Hyung-Ki Kim Vice Chairman of the Global Sales Division (former CEO of Celltrion Healthcare), and Jin-Seok Seo, Chairman of the Management Division (currently Chairman of Celltrion's Board of Directors). Celltrion expects that the three-person representative system will enable faster decision-making and accelerated growth of the newly merged Celltrion. (from the left) Representatives Woo-Sung Kee, Hyung-Ki Kim, and Jin-Seok Seo, Celltrion expects the combined entity to consolidate assets that were previously spread across the two companies and leverage significant resources. The new company will invest more aggressively in securing new growth engines such as biosimilar and new drug pipeline development, in-licensing, mergers and acquisitions (M&A), and digital healthcare. In addition, the company expects to gradually reduce its cost of sales to 40% from the current level of 70% through business structure consolidation. In particular, the company plans to expand its entry into major global markets rapidly increase sales, and expand the market share of its drugs based on the lower cost rate. Currently, Celltrion has successfully commercialized 6 products – Remsima, Herzuma, Truxima, Vegzelma, Yuflyma, and Remsima SC (Zympentra). Celltrion's strategy is to secure an 11-product lineup by 2025 and a total portfolio of 22 products by 2030. In the case of Zympentra (the U.S. brand name for Remsima SC), which is expected to be launched as a new drug in the U.S. next February, is expected to become the flagship product of the integrated Celltrion. The U.S. TNF-α inhibitor market, which includes infliximab, is the world's largest at $47.36 billion (KRW 62.570 trillion) as of last year, and the inflammatory bowel disease (IBD) market, which Zympentra seeks to target first, is said to be worth about $9.827 billion (KRW 12.8 trillion). Starting with Zympentra, Celltrion aims to generate 40% of its future sales from new drugs through a portfolio of promising new drugs including antibody-drug conjugates (ADCs), bispecific antibodies, and microbiomes. For this, the company explained that it is focusing on securing a new drug pipeline through in-house development as well as collaboration with various domestic and foreign companies. In addition, it plans to develop customized disease prevention and management solutions using clinical and genomic data it acquired over the years, and actively expand its business to the field of digital healthcare.
- Company
- K-similars set out to enter the global market
- by Son, Hyung-Min Dec 29, 2023 05:40am
- Domestic companies are now ready to launch homegrown biosimilars into the global market next year. According to industry sources on the 28th, Celltrion, Samsung Bioepis, and Dong-A ST have completed Phase III clinical trials of its biosimilars and applied for approval from overseas regulators. The companies have successfully developed biosimilars for their global blockbusters such as Stelara and Prolia and are seeking approval next year. Celltrion expects to receive approval for 3 biosimilars next year Celltrion has the largest biosimilar pipeline among domestic companies. To date, the company has 12 pipelines, with six products on the market that include the COVID-19 drug Regkirona, and four more that completed Phase III trials and are on track for marketing authorizations. Celltrion's products that are expected to be approved next year are its Prolia biosimilar CT-P41, Xolair biosimilar CT-P39, Stellara biosimilar CT-P43, and Eylea biosimilar CT-P42. In Phase III trials, the four candidates demonstrated non-inferiority to their respective original drugs. Based on the global Phase III results of CT-P41 this month, Celltrion filed for marketing authorization of CT-P41 for all of Prolia's U.S. indications. Prolia is an Amgen-developed osteoporosis treatment with multiple indications, including giant cell tumor of bone and bone loss. After the U.S., Celltrion plans to file for approval in other key global markets, including Europe. This month, Celltrion also completed the filing of a marketing authorization application for CT-P39 in Canada. The original CT-P39 product, Xolair, is an antibody biologic developed by Novartis for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyposis, and chronic spontaneous urticaria. Xolair is a blockbuster product that generated approximately $5 trillion in global sales last year. Celltrion is also nearing commercialization of its Stelara biosimilar CT-P43. To date, it has filed for approval in the U.S., Europe, South Korea, and Australia. Stelara is an interleukin (IL)-12 and 23 inhibitor developed by Johnson & Johnson’s subsidiary Janssen and is used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The global Stelara market was valued at approximately $23 trillion last year. Celltrion finalized an agreement with Johnson & Johnson last year that will allow the drug to be sold in the US starting Feb. 22 next year. Celltrion also recently completed a Phase III clinical trial for its Eylea biosimilar CT-P42 and recently filed for its marketing authorization in the U.S. and Europe. Ayla is a blockbuster macular degeneration treatment developed by Bayer and Regeneron that generated approximately $12 trillion in global sales last year. With such a diverse pipeline, Celltrion aims to have a portfolio of 22 biosimilars by 2030. Samsung Bioepis nears approval of its Prolia biosimilar next year Samsung Bioepis has successfully commercialized five biosimilars in overseas markets in collaboration with its global marketing partners Biogen and Organon. Its candidate that is closest to approval next year is SB16, a Prolia biosimilar. In a Phase III clinical trial conducted on postmenopausal osteoporosis patients, SB16 demonstrated equivalent efficacy to the original drug in terms of change from baseline in lumbar spine and bone mineral density at 12 months after administration. Also, Samsung Bioepis has completed clinical trials of SB15, its Eylea biosimilar, and is pursuing approval procedures in the U.S. and Europe. Samsung Bioepis conducted a Phase III clinical trial involving 449 patients with wet age-related macular degeneration (nAMD) in 10 countries, including the United States and Korea. In the trial, Samsung Bioepis evaluated patients' best-corrected visual acuity (BCVA) up to 56 weeks of treatment with SB15 and found comparable BCVA improvements compared to the original drug. Samsung Bioepis plans to accelerate its expansion in the European market by emphasizing that its biosimilar, SB15, is interchangeable with the original drug. In addition, in May last year, Samsung Bioepis obtained domestic marketing authorization for Lucentis' biosimilar Amelivu, which was approved in the U.S. and Europe in the second half of 2021. Lucentis, a macular degeneration treatment developed by Novartis, is a blockbuster drug that generated global sales of around KRW 4 trillion in 2020. Dong-A ST and Sam Chung Dang Pharm enters the biosimilar competition…submits an application to regulatory authorities Dong-A ST’s Stellara biosimilar DBM-3115 is expected to be approved in Europe next year. The company completed submitting its application to the European Medicines Agency (EMA) in June after demonstrating therapeutic equivalence between its DBM-3115 and Stellara in a global Phase III trial. The company is also preparing for U.S. approval next year. Last month, Sam Chun Dang Pharmaceutical applied for domestic approval for both vials and prefilled syringe formulations of its Eylea biosimilar candidate SCD411. Sam Chun Dang is also preparing for its approval in the United States and Europe. The application was made based on the results of the global Phase III clinical trial on SCD411. In a clinical trial involving 576 patients with macular degeneration, SCD411 demonstrated equivalence to Eylea. In addition, Huon's Global subsidiary, Huons Lab, is also accelerating the development of its Prolia biosimilar, HLB3-013. In February, the company announced that it had confirmed equivalence in nonclinical animal efficacy studies compared to the original product.
- Company
- Integrated Celltrion launches with goal of 40T market cap
- by Kim, Jin-Gu Dec 29, 2023 05:39am
- Celltrion and Celltrion Healthcare are set to launch an integrated corporation. The market capitalization of the integrated Celltrion is expected to reach around 40 trillion won. The launch of the integrated Celltrion is anticipated to unify the previously dispersed biosimilar production and distribution processes. This merger may address longstanding controversies such as allegations of unfair business partnership and inflation of sales figures. The newly merged entity aims to expand its business focus from primarily biosimilars to a new drug development. Seo Jung-jin, the chairman of Celltrion, announced company’s initiative to increase the sales to 12 trillion won by 2030 through this integration. Celltrion and Celltrion Healthcare set to launch integrated corp…Next merger with Celltrion Pharm within six months. According to the pharmaceutical industry on the 28th, Celltrion and Celltrion Healthcare are launching their integrated corporation. Celltrion will acuire Celltrion Healthcare through absorption-type merger. The merger will be carried out by issuing new shares of Celltrion to the shareholders of Celltrion Healthcare. The listing of the new shares of Celltrion is scheduled for Jan. 12, 2024. Once the listing is completed, all merger procedures will be finalized. After the merger, there will be a minor change in the ownership structure of the Celltrion Group. Currently, Celltrion Holdings holds 20.1% stake of Celltrion and 24.3% stake of Celltrion Healthcare shares. Celltrion is still holding 54.8% stake of Celltrion Pharm. 합병 후 예상 지배구조(자료 셀트리온) After the merger, Celltrion Holdings will acquire 21.5% stake in integrated Celltrion. Integrated Celltrion will continue to have 54.8% stake in Celltrion Pharm. The next merger plan of Integrated Celltrion is to merge with Celltrion Pharm within the next six months. Celltrion Group initially considered a three-company merger but decided to proceed with two-phase merger because of potentially conflicting shareholder interests. Merger would help dispel accusations of ‘unfair business partnership’ · ‘inflation of sales figures’, and they will reinforce transparency The launch of the integrated Celltrion is expected to unify the previously dispersed biosimilar production and distribution operations that were divided between the two companies. This move is also anticipated to address persistent controversies such as 'unfair business partnership ' or ‘inflation of sales figures.' Until now, Celltrion Group's biosimilar business operated in a structure where Celltrion developed and manufactured products, and these products were subsequently purchased by Celltrion Healthcare for distribution and sales in international markets. Since Celltrion Healthcare had an exclusive deal to sell Celltrion's biosimilar products, there were consistent allegations in the industry of a single business partnership. Additionally, when Celltrion Healthcare purchased products from Celltrion for international markets, sales were recorded for both companies, leading to criticisms of inflated sales figures. According to the Fair Trade Commission, Celltrion Group had the highest proportion of internal transactions last year among large corporations (those with assets over 5 trillion won) required to disclose their business operations. For six consecutive years since 2017, Celltrion Group ranked first, with 62.5% of their total sales originating from transactions within the group. In comparison, the average proportion of internal transactions for large corporations was 33.4%. The launch of the integrated Celltrion would effectively address these controversies. This is attributed to the fact that drug development, manufacturing, and distribution will all be consolidated within a single entity, simplifying the transaction process, reducing costs, and enhancing transparency. The market cap of the integrated Celltrion will reach 40 trillion won… Blueprint of “becoming a global big pharma developing biosimilars & new drugs” The pharmaceutical industry anticipates that the integrated Celltrion's market capitalization will reach 40 trillion won. This would place the company as the 8th largest company on the stock market, comparable to Hyundai (41.8621 trillion won) and POSCO Holdings (21.7782 trillion won) and higher than Kia (38.7571 trillion won) and Naver (36.0547 trillion won), in terms of market value based on the closing price on the 27th. After completing the merger with Celltrion Pharm next year, the total market capitalization of the group is expected to expand to 42 trillion won, leaping from the 13th to the 6th largest company on the stock market. 셀트리온 통합법인의 2030년 매출 12조원 목표(자료 셀트리온) The newly launched integrated Celltrion is aimed at becoming a global big pharmaceutical company, expanding business from biosimilars to new drug development. The chairman, Seo, has set a goal of achieving 12 trillion won in sales by 2030. The company’s initiative for its biosimilars business is aimed at commercializing 22 products by 2030. In line with this, the company is considering the construction of a fourth plant. Additionally, in the new drug business, the focus will be on Zymfentra, which recently received approval from the U.S. Food and Drug Administration (FDA) in October. Starting next year, the company will also initiate new drug development projects using ADC and mRNA platforms with the goal of making the new drug division contribute 40% of the total sales by 2030.
- Company
- Medytox submits BLA to FDA for its next-gen botulinum
- by Chon, Seung-Hyun Dec 29, 2023 05:39am
- Medytox is working to enter the U.S. market with its next-generation botulinum toxin product, which technology has been reverted to the company after being transferred to a foreign company. Pic of Medytox headquartersOn the 27th, Medytox announced that it has filed a biological license application (BLA) to the U.S. Food and Drug Administration (FDA) for its next-generation non-animal liquid botulinum toxin, MT10109L. Medytox has submitted a Biologics License Application (BLA) to the FDA for MT10109L for the treatment of moderate-to-severe frown lines and crow's feet. MT10109L is characterized by the lack of use of animal-derived ingredients throughout the entire manufacturing process, including strain culture and solution preparation, and by not using human serum albumin (HSA) as an excipient, eliminating the possibility of animal-derived virus infection. The company explained that it had minimized the number of chemical processing steps, reducing the potential for denaturation of the active neurotoxin protein. In February, Medytox completed five large global Phase 3 clinical trials of MT10109L, totaling 1,300 patients at medical centers in the U.S., Canada, and Europe. The trials demonstrated significant results in improving the rate of frown lines and crow's feet compared to placebo, as well as long-term safety results with repeated dosing. "Having successfully developed the world's first liquid formulation of botulinum toxin, Medytox will target the world's largest market, the United States with MT10109, its next-generation liquid toxin formulation. To date, there is no liquid formulation of botulinum toxin available in the United States. MT10109L is a product for which Medytox transferred technology to Allergan but was reverted the rights. In 2013, Medytox signed a license-out agreement with Allergan worth up to $362 million for botulinum toxin product MT10109L. However, AbbVie, which acquired Allergan, returned the rights in 2021. After receiving the returned rights for MT10109L, Medytox analyzed clinical results and applied for FDA approval in two years. Hyun-ho Jung, CEO of Medytox said, “We have been focusing on preparing for due diligence and improving our internal capabilities for a long time to enter the U.S., the world's largest market. We will make sure that our next-generation liquid toxin formulation, MT10109L, successfully enters the U.S. market.”
- Company
- Hugel Resolves to Retire 371,563 shares of its own stock
- by Nho, Byung Chul Dec 28, 2023 01:14pm
- Hugel, a global total medical aesthetics company, announced that it has held a board of directors meeting on the 22nd and passed a resolution to retire 371,563 shares of its own stock to enhance the shareholder’ value. This is equivalent to around 3% of the total outstanding shares (12,385,455 shares), and the expected value of the retired stocks amounts to 54,587,063,456 KRW based on the average acquired unit price. The total number of outstanding shares will decrease, but there will be no decrease in capital. The scheduled retirement date is the 29th of this month.
- Company
- Tezspire lands in Korea…joins 6-way race
- by Dec 28, 2023 06:02am
- The new drug for severe asthma that emerged joined the competition with the five existing biologics that were being used in Korea. AstraZeneca, which recently received domestic approval for its new drug, plans to differentiate itself from existing treatment options with new mechanisms of action and formulations. According to industry sources on the 26th, AstraZeneca Korea's severe asthma drug Tezspire (tezepelumab) was recently approved in Korea. This brings the total number of biologics approved for the treatment of severe asthma in Korea to six, following Novartis Xolair (omalizumab) and GSK Nucala (mepolizumab) in 2016, Teva-Handok's Cinquar (reslizumab) in 2017, AstraZeneca’s Fasenra (benralizumab) in 2019, and Sanofi Dupixent (dupilumab) in 2021. Xolair is an anti-IGE antibody that targets allergic asthma. Anti-IL-5 drugs such as Cinquar, Nucala, and Fasenra, are used to treat eosinophilic asthma. Dupixent is an anti-IL-4/IL-13 agent used for type 2 inflammatory asthma. Tezspire, which was jointly developed by AstraZeneca and Amgen, is approved in Korea as a maintenance treatment for patients with severe asthma. Tezspire is an anti-TSLP monoclonal antibody therapy that binds to thymic stromal lymphopoietin (TSLP), which causes airway inflammation, whereas other biologics inhibit IL-5 lgE. Tezspire is the first drug that targets this mechanism to tackle asthma. Two Phase 3 studies, PATHWAY and NAVIGATOR, demonstrated the efficacy of Tezfir compared to placebo. The primary endpoint in both studies was the rate of clinically significant asthma exacerbations measured over 52 weeks. In the PATHWAY study, which followed a total of 550 patients with severe asthma aged 18 years and older for 52 weeks, Tezspire had a 52-week asthma exacerbation rate of 0.20 compared with 0.72 in the placebo group, which is a significant difference. In the NAVIGATOR study, which followed a total of 1061 patients with uncontrolled severe asthma aged 12 years and older for 52 weeks, Tezspire demonstrated a 52-week asthma exacerbation rate of 0.93, an improvement over the 2.10 found in the placebo group. The secondary endpoints in both trials - percent change in forced expiratory volume in one second (FEV1) from baseline - improved with the use of Tezspire compared with placebo. In terms of safety, the most common adverse events with Tezspire were pharyngitis, rash, arthralgia, and injection site reactions. Dupixent remains non-reimbursed…whether reimbursement will be granted remains key The race between biologics is expected to come down to reimbursement. Currently, only Xolair, CInquair, and Nucala are reimbursed for severe asthma. Although the various treatment options target different asthma conditions, reimbursement for them is currently limited. #Cupixent has a novel mechanism of action that targets type 2 inflammatory asthma by inhibiting IL-4 and IL-17. However, to date, it has not been reimbursed for severe asthma. Biologics, even when effective, are too expensive for patients to pay out-of-pocket. In the case of Dupixent, its price varies from hospital to hospital, but it costs around KRW 700,000 for a single dose. Therefore, the industry eyes whether Tezspire, which entered the market as a late entrant, may quickly achieve reimbursement. Unlike other biologics that inhibit interleukins, Tezspire’s mechanism targets thymic stromal lymphopoietin, a key cytokine-like protein that triggers inflammation, differentiating gits mechanism of action from other biologics. In addition, Tezspire has the advantage of offering different formulations. The currently approved formulations of Tezspire are both subcutaneous injections, including Tezspire AutoInjector and Tezspire Prefilled Syringe Injection. In January and February of this year, AstraZeneca and Amgen received approval from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), respectively, for the pen formulation of Tezspire. The company's strategy is to differentiate itself from other biologics that are injected subcutaneously with its pen formulation that can be self-administered. Therefore, if the pen formulation enters the domestic market, the new mechanism of action and formulation is likely to help support the drug’s reimbursement.
