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Company
Hanmi’s Rolvedon tops KRW 73 bil in US sales
by
Son, Hyung-Min
Mar 15, 2024 05:49am
The U.S. sales of Rolvedon (Korean product name: Rolontis), a treatment for neutropenia discovered by Hanmi Pharmaceutical, surpassed KRW 70 billion last year. Assertio plans to conduct additional clinical trials and demonstrate a competitive edge. According to the reports by Assertio on the 13th, Rolvedon generated $11 million in Q4 sales last year, showing a 38% increase from the previous quarter. Rolvedon’s sales last year amounted to $55.6 million (approx. KRW 73 billion). Rolvedon is a novel anti-cancer drug discovered by Hanmi Pharm. In 2012, Hanmi Pharm transported Rolvedon technology to U.S. Spectrum. After Assertio acquired Spectrum in April last year, it secured the licensing of sales and development of Rolvedon and lung cancer therapy poziotinib. Asserito is a pharmaceutical company specializing in developing treatments for the central nervous system and inflammation. It owns indomethacin, a nonsteroidal anti-inflammatory drug, and simvastatin, an oral film formulation. After the acquisition of Spectrum, Assertio further strengthened its pipelines. Quarterly Rolvedon sales trend (Unit: $1 million). Since its release in the United States in October 2022, Rolvedon has recorded sales of $10 million within three months. After the product launch, 70 distributors purchased Rolvedon. It was then utilized by the top three community oncology networks, accounting for 22% of the clinic market share. It continued to show strong sales up to Q2 last year. Rolvedon generated sales of $15.6 million in Q1 last year, and in Q2, it recorded $21 million (approx. KRW 28 billion), an increase of 34.6% from the previous quarter. Rolvedon’s sales in Q3 last year slowed down since its launch. It recorded $8 million in Q3 last year, a decrease of 62% from the previous quarter. According to Assertio, the demand for Rolvedon after applying the reimbursement system was below expectations. Rolvedon became available on the U.S. public reimbursement list with a permanent reimbursement J-code of 'J1449' starting last April. However, the current reimbursement system is less favorable than when Rolvedon was launched. However, Rolvedon rebounded in Q4 last year, generating $11 million in sales. “Rolvedon’s rebound was made possible by maintaining the principle of Rolvedon pricing and employing an updated commercialization strategy,” Assertio explained. “Rolvedon is expected to generate over $100 million in sales by improving patient accessibility and securing new sales channels,” Assertio stated. They added, “We will continue to conduct a clinical study of same-day administration to implement a differentiated strategy.” Conventional treatments for neutropenia, such as Neulasta, can only be administered 24 hours after cancer therapy, thereby prolonging hospitalization. Assertio plans to gain a competitive edge with its strategy of Rolvedon's same-day administration method. The Phase 1 clinical trials for same-day administration of Rolvedon are being conducted in the United States.
Company
Sam Chun Dang seeks EMA approval for its Eylea biosimilar
by
Nho, Byung Chul
Mar 15, 2024 05:48am
Sam Chun Dang Pharm announced today that its European partner has simultaneously filed for approval of both vial and prefilled syringe formulations of its Eylea biosimilar (SCD411) in Europe. The application is notable as it is the first application filed in Europe following Korea for the prefilled syringe formulation. The application will undergo the EMA’s Centralised Procedure (CP). If the European Medicines Agency (EMA) reviews and approves the application, the drug will be approved simultaneously in more than 30 European countries. An official from Sam Chun Dang Pharm said, ‘The pre-filled syringe formulation is more difficult to develop than vials due to difficulty in developing the manufacturing process, including patent evasion and sterilization, but Sam Chun Dang Pharm focused all its capabilities on developing the prefilled product and was able to complete development and apply for approval before our competitors.” “We applied for the Centralized Procedure (CP) to shorten the approval period and quickly enter the market. The actual application was filed a long time ago, but it took some time for us to agree on whether to disclose the fact with our partners, which is why we disclosed it now." Sam Chun Dang Pharm filed for approval in Korea and Europe in March last year based on the final report of the Phase III clinical trial of its Eylea biosimilar and is in the process of negotiating supply contracts with partners in the U.S., Russia, and the Middle East.
Company
Yuhan’s external investments totaled KRW 85 bil last year
by
Chon, Seung-Hyun
Mar 14, 2024 05:42am
Yuhan spent a total of KRW 85 billion in external investments. By acquiring equity investments in companies across various sectors, such as biotech venture and health-functional food, Yuhan scouted for additional acquisitions to expand its business areas. According to the Financial Supervisory Service on the 12th, Yuhan made ten external investments last year. Yuhan invested a net amount of 84.7 billion in other incorporations, including three new investments and seven additional investments. Yuhan has undertaken new investments, including ProGen, Fermentec, and Meritz Suseong Global Bio No.1. Last May, Yuhan invested KRW 30 billion to acquire the biotech venture ProGen. By acquiring existing shares and issuing new shares, Yuhan invested a total of KRW 30 billion, becoming the largest shareholder of ProGen with a 38.9% stake. ProGen is a company holding a multi-specific antibody-based platform technology. Established in 1998, ProGen is an R&D-focused company that utilizes genetic engineering. In September 2022, Yuhan and ProGen signed a memorandum of understanding (MOU) for research collaboration in innovative new drug development. Yuhan and ProGen plan to jointly develop next-generation innovative bio candidates such as multi-specific antibody therapeutics. Last September, Yuhan invested KRW 5.7 billion in the health-functional food company Fermentec, acquiring a 10.0% stake. Fermentec's primary business is in the manufacturing of microbial fermenters. As of the end of 2022, Yuhan Medica holds a 42.11% stake, making it the largest shareholder. Yuhan Medica is a subsidiary of Yuhan. Yuhan invested in Fermentec to produce high-quality, low-cost probiotics. Yuhan has increased its investment in companies it already owns. At the end of last year, Yuhan acquired KRW 28.2 billion worth of shares in ImmuneOnsia. Yuhan purchased the shares in ImmuneOnsia previously held by Sorrento Therapeutics. In 2016, Yuhan established ImmuneOnsia through a joint venture with Sorrento Therapeutics, a Nasdaq-listed company. ImmuneOnsia focuses on developing immune checkpoint inhibitors targeting PD-L1 with 'IMC-001' and CD47 with 'IMC-002'. ImmuneOnsia collaborates with Yuhan Research Institute and Sorrento's antibody library to supply promising clinical candidates, maximize drug value, and engage in technology exportation. Yuhan initially invested KRW 17.8 billion at the establishment of ImmuneOnsia and later invested KRW 6 billion as a strategic investor (SI) during ImmuneOnsia's pre-IPO fundraising round in 2022, raising a total of KRW 24.5 billion. Last year, Yuhan invested an additional KRW 7 billion in AtoGen. In September 2022, Yuhan acquired AtoGen by investing KRW 10.5 billion. By purchasing 338,000 shares (52.15% ownership) held by AtoGen's largest shareholder, Tony Mori, and shares held by venture capital, Yuhan secured a 59.9% stake in AtoGen. Based on its independent development platform, AtoGen is developing microbiome therapies for various diseases, such as metabolic disorders, immune disorders, and muscular diseases. It also possesses R&D capabilities for developing health-functional food probiotic materials with specific functionalities. By acquiring AtoGen, Yuhan plans to expand its business by developing microbiome-based therapies and functional probiotics. Last December, Yuhan invested KRW 6 billion to acquire 43,550 common shares of SB BioPharm. SB BioPharm specializes in developing and manufacturing veterinary medicines and food, while Neodin BioVet. Laboratory and Zoonolab focus on conducting diagnostic tests and producing diagnostic kits for companion animals. In 2021, Yuhan purchased KRW 7 billion worth of redeemable convertible preference shares from SB BioPharm and made additional investments last year. Yuhan launched the pet care brand Wilopet in collaboration with SB BioPharm. In partnership with SB Biopharm, Yuhan plans to release various new products in pet medicines, over-the-counter medication, premium pet nutrition, and veterinary diagnostics. Last year, Yuhan invested KRW 2 billion J INTS BIO and KRW 1 billion in Aimedbio. J INTS BIO is a bio company focused on the development of novel anticancer drugs. It acquired new pipelines through a transfer agreement of two products, 'JIN-A01' and 'JIN-A02,' developed by Kwangho Lee of the Korea Research Institute of Chemical Technology and Byoung Chul Cho of the Lung Cancer Center at Yonsei Cancer Hospital. Yuhan entered into a partnership with J INTS BIO by investing KRW 20 billion each in equity in 2021 and 2022. Last May, Yuhan signed a licensing agreement with J INTS BIO for the targeted therapy ‘JIN-A04’. The technology transfer agreement has a total contract size amounting to KRW 429.8 billion, with a non-refundable upfront payment of KRW 25 billion. Yuhan invested KRW 8.5 billion in equity investments and upfront payments for technology transfer. Yuhan Pharmaceuticals invested KRW 1 billion in acquiring Aimedbio's redeemable convertible preference shares in October last year. Aimedbio is focused on developing new antibody drugs in the field of brain science. In 2021, Yuhan invested KRW 3 billion in Aimedbio, acquiring a 3.0% stake in its common stock. Furthermore, Yuhan made additional investments last year. Yuhan increased its investment in MediRama, a clinical development strategy consulting company. Over a year, Yuhan’s ownership in the stock rose from 8.1% at the end of 2022 to 15.0%.
Company
Yuhan Corp and BMS will copromote Sotyktu and Zeposia
by
Nho, Byung Chul
Mar 13, 2024 05:32am
(From the left) Hye-Young Lee, Country Manager of BMS Korea and Wook-Je Cho, CEO of Yuhan Corp Yuhan Corp (CEO: Wook-Je Cho) announced that the company has signed a copromotion agreement with BMS Korea (Country Manager: Hye-Young Lee) for BMS’s plaque psoriasis drug ‘Sotyktu (deucravacitinib)’ and ulcerative colitis drug ‘Zeposia (ozanimod)’ on the 11th. This strategic partnership for joint sales and marketing in Korea marks the first partnership between the two companies and will begin in March. Sotyktu is the first TYK2 inhibitor approved by the Ministry of Food and Drug Safety for moderate-to-severe plaque psoriasis in adults. The convenient, once-daily oral treatment was approved by the MFDS in August 2023 for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy. The drug’s efficacy and safety profile were demonstrated through the Phase III POETYK PSO-1 and POETYK PSO-2 clinical trials. Zeposia is the first shingosine 1-phosphate receptor (S1P) modulator to be approved in Korea to treat moderate-to-severe active ulcerative colitis. The drug was granted reimbursement in January of this year for the treatment of adult patients with moderate-to-severe active ulcerative colitis who have not had an adequate response to or are intolerant of conventional therapies (such as corticosteroids, 6-mercaptopurine or azathioprine) or for whom these agents are contraindicated. Zeposia’s clinical efficacy and safety were confirmed through the ‘TRUE NORTH’ trial. Wook-Je Cho, CEO of Yuhan Corp, said, “We expect the partnership and the innovative medicines will help us provide new therapeutic benefits to patients in Korea with plaque psoriasis and ulcerative colitis.” Hye-Young Lee, Country Manager of BMS Korea, said, “We look forward to promptly bringing the therapeutic benefits of the orally-administered, convenient Sotyktu and Zeposia to more patients in Korea, We will continue to work with other members of Korea’s healthcare ecosystem to improve patient access in a variety of disease areas with high unmet need."
Company
Bosulif prescriptions now available at general hospitals
by
Eo, Yun-Ho
Mar 13, 2024 05:32am
Pfizer Korea’s Bosulif (bosutinib). Bosulif (bosutinib), a drug used to treat leukemia, is now available for prescription at general hospitals. According to the industry sources, Pfizer Korea’s Bosulif, a drug used to treat Chronic Myelogenous Leukemia (CML), has passed the drug committee (DC) of general hospitals, including Seoul National University Hospital, Seoul St. Mary's Hospital, and Pusan National University Hospital. It is also preparing for the landing at other tertiary general hospitals, including Samsung Seoul Hospital and Seoul Asan Hospital. After securing a reimbursement listing in January, Bosulif has been expanding its prescription domain. However, patients are complaining about the reimbursement criteria. Bosulif is reimbursed for ‘the second-line treatment of adult patients over ages of 18 years old with chronic phase, accelerated phase, or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who have previously demonstrated resistance or intolerance to neoadjuvant therapy including Glivec (imatinib).’ However, since the indication for the basis of approval does not include age limits and the drug can be prescribed beginning from the first-line treatment, patients are pointing out the problem of the narrow reimbursement criteria. The Korean Leukemia Patients Organization has stated, "As suggested by the medical community, Bosulif may be considered the preferred choice for patients who suffer from, or are at risk of, cardiovascular diseases. Therefore, we request that Pfizer and the government take necessary steps to improve reimbursement criteria, enabling the drug to receive reimbursement benefits even when used as a first-line treatment.” It is to be watched if Bosulif, a new drug for CML, can resolve issues of reimbursement criteria and expand its prescription domain. Bosulif is a second-generation, targeted anti-cancer drug alongside Novartis Korea’s ‘Tasigna (nilotinib)’, BMS Korea’s ‘Sprycel (dasatinib)’, and Il-Yang Pharmaceutical’s ‘Supect (radotinib).’ The efficacy and safety of Bosulif have been confirmed in the Phase 3 NCT02130557 clinical study, which involved newly diagnosed patients with CML. The primary endpoint of Bosulif was major molecular response (MMR) by 12 months. Bosulif-treated patients had MMR of 47%. Patients treated with the comparator drug, first generation drug Glivec (imatinib), had MMR of 36%. MMR by Month 60 was 74% for Bosulif versus 66% for Glivec. After 60 months of follow-up, the median time to MMR in responders was 9.0 months for bosutinib and 11.9 months for Glivec.
Company
Quadrivalent meningococcal vaccine MenQuadfi approved
by
Eo, Yun-Ho
Mar 12, 2024 05:49am
The quadrivalent meningococcal vaccine MenQuadfi has landed in Korea. The Ministry of Food and Drug Safety granted marketing authorization for Sanofi's invasive meningococcal disease (serogroups A, C, Y, W) vaccine, MenQuadfi (MenACYW-TT) on the 6th. MenQuadfi is a fully liquid quadrivalent meningococcal vaccine that protects against meningococcal serogroups A, C, W, and Y. It was approved as a single-dose vaccine for persons aged 2 to 55 years. MenQuadfi is administered intramuscularily as a single 0.5ml into the deltoid region or anterolateral thigh depending on the recipient's age and muscle mass. When evaluating immunogenicity and safety with other existing meningococcal quadrivalent vaccines, MenQuadfi demonstrated non-inferiority across all four serogroups. The seroprotection rates were 94.7% for serogroup A, 95.7% for serogroup C, 96.2% for serogroup W, and 98.8% for serogroup Y in people aged 10 to 55 years that were vaccinated with MenQuadfi. Also, compared with the company’s previous meningococcal vaccine that used the diphtheria protein, MenQuadfi uses a tetanus protein and contains more antigens. Meningococcal disease, which can be prevented with MenQuadfi, has been regarded as a global public health concern. Meanwhile, meningococcal disease is a Class 2 infectious disease with a fatality rate ranging from 10-14%. The disease affects 500,000 people worldwide each year. Symptoms include headache, fever, neck stiffness, vomiting, and decreased consciousness, and are often accompanied by petechiae or purpura fulminans. 11-19% of recovered patients suffer from sequelae such as hearing loss, cognitive impairment, and neurological disorders, underlining the importance of its prevention In particular, as meningococcal disease is transmitted person-to-person by respiratory droplets or secretions, vaccination is recommended for those who are about to enter a group setting. For example, new recruits at companies and college students who will be living in dormitories may want to consider meningococcal vaccination.
Company
Ilaris’s reimb again at a standstill… bumpy road ahead
by
Eo, Yun-Ho
Mar 12, 2024 05:48am
The road to reimbursement for ‘Ilaris,’ a treatment used by around ten patients in Korea, continues to be bumpy ahead. According to Dailypharm’s coverage, the government’s ‘reimbursement adequacy’ decision made for Novartis Korea’s Ilaris (canakinumab) has been put on hold after the company failed to meet the government's request for additional data. The drug, which is a treatment for hereditary recurrent fever syndrome, had previously received conditional approval from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee. Novartis has since requested the government to revisit the data submission requirements to the extent possible, and has recently filed a request with HIRA for Ilaris’s reimbursement. Ilaris is indicated in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF), and ▲ Systemic juvenile idiopathic arthritis (JIA). The indications for CAPS, TRAPS, and FMF were deemed conditionally adequate for reimbursement by the DREC last month. At the time HIRA set out evidence submission and follow-up management as conditions for the reimbursement of these indications. In general, the condition set out by DREC is ‘accepting a price below the appraised value'. It is rare for a drug to be approved with such strict conditions. Given the circumstances, the government's requirements are likely to be difficult for the company to meet. The question is to what extent Novartis can accommodate the additional data requested by the government, and whether HIRA will accept the amount of data that the company believes it can submit rather than all of the data and grant reevaluations. Since being approved in 2015, Ilaris has already failed two reimbursement attempts. With patients waiting more than eight years, it will be interesting to see if the government and the pharmaceutical company can reach an agreement and move toward expanding coverage. A Novartis official said, "We are fully aware of the patients’ wait. As this is our third reimbursement attempt, we are exploring all measures available for reimbursement listing, and requested reevaluation so that the post-submitted evidence requirement presented by HIRA be adjusted to a realistically achievable level.
Company
SK Bioscience breaks ground on vaccine plant expansion
by
Chon, Seung-Hyun
Mar 11, 2024 05:55am
From the left, Dong-ho Oh, CEO of SK ecoengineering, Ki Chang Kwon, Mayor of Andong, Cheol-Woo Lee, Governor of Gyeongsangbuk-do, Jaeyong Ahn, CEO of SK bioscience, Pascal Robin, General Manager and Representative Director of Vaccines at Sanofi Korea, and other distinguished guests are commemorating a major expansion of Andong L HOUSE in South Korea. SK Bioscience announced on the 7th that the company broke ground on a vaccine plant, ‘Andong L HOUSE,’ located in Andong, Gyeongsangbuk-do, South Korea. The plant will be expanded to install new equipment. This expansion aims to increase vaccine production capacity for global supply by raising the existing vaccine plant within L House from one floor to three floors, securing a new space of approximately 4,200 ㎡. SK Bioscience and global pharmaceutical company Sanofi have made a large-scale joint investment to expand this facility. The facility will be used to commercially produce the next-generation pneumococcal vaccine candidate product, called "GBP410." SK Bioscience and Sanofi jointly developed GBP410, which includes 21 serotypes. In March 2014, SK Bioscience signed a joint development and sales agreement with Sanofi for the next-generation pneumococcal vaccine. Last June, SK Bioscience and Sanofi announced positive results from Phase 2 clinical trials evaluating the safety and immunogenicity of "GBP410" in infants. Based on the positive results from Phase 2 clinical trials, both companies are preparing for global Phase 3 clinical trials to submit an approval application in 2027. SK Bioscience plans to swiftly secure cGMP, the United States standards for pharmaceutical manufacturing and quality control, alongside the facility expansion, to enhance the global market competitiveness of GBP410. "With the expansion, the Andong L-HOUSE, which has proven its global production capacity, will solidify its position as a global vaccine hub," SK Bioscience CEO Jaeyong Ahn stated. "We are dedicated to creating and distributing highly effective vaccines with the potential to be blockbusters," Ahn added.
Company
Jemperli can be prescribed at general hospitals in KOR
by
Eo, Yun-Ho
Mar 11, 2024 05:55am
Jemperli, the first immuno-oncology option introduced to the field of endometrial cancer, can now be prescribed in general hospitals in Korea. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has passed the drug committee (DC) reviews of tertiary hospitals in Korea. Including the Seoul National University Hospital and Seoul Asan Medical Center. The company has been gradually expanding its prescribing area after receiving reimbursement for Jemperli in December last year. While the number of hospitals that granted use of the drug is still small, GSK has been working to create an enabling environment for Jemperli prescriptions even before the reimbursement process, implementing an Expanded Access Program (EAP) in 15 major medical institutions in Korea. In the multi-cohort Phase 1 GARNET study that was conducted on patients with recurrent or advanced solid tumors, Jemperli demonstrated efficacy with the Cohort A1 analysis results, which enrolled patients with recurrent or advanced dMMR/MSI-H endometrial cancer who progressed during or after platinum-based systemic chemotherapy. The cohort was among the largest conducted for PD-1 inhibitor monotherapies in advanced dMMR/MSI-H endometrial cancer to date. The primary efficacy outcome measures of the study were Objective Response Rate (ORR) and Duration Of Response (DOR) as determined by a Blinded Independent Central Review (BICR) according to (Response Evaluation Criteria Solid Tumors) RECIST v 1.1. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% and the median DOR was not yet reached. The Disease Control Rate (DCR) was 55.6%, and the proportions of responses lasting 6 and 12 months were 97.9% and 90.9%, respectively. On the 7th, Jemperli was additionally approved as a first-line treatment in combination with platinum-based chemotherapy for patients with Mismatch Repair Deficient/Microsatellite Instability-High (dMMR/MSI-H) recurrent or advanced endometrial cancer.
Company
Hemlibra shows big sales rise, Advate loses ground
by
Kim, Jin-Gu
Mar 11, 2024 05:55am
Hemlibra, introduced to South Korea by JW Pharmaceutical, is a drug used to treat Type A hemophilia. The market for Type A hemophilia has shifted significantly, with JW Pharmaceutical's 'Hemlibra' expanding sales considerably after receiving reimbursement expansion. However, Takeda Pharmaceutical’s 'Advate,' which has been recording the highest sales in the market for an extended period, lost ground. Advate sales decreased by over 20%, recording sales lower than Hemlibra’s. Hemlibra sales KRW 7.6 billion → KRW 19 billion…As a result of acquiring reimbursement expansion According to a pharmaceutical market research company IQVIA on the 8th, the market size of Type A hemophilia last year was KRW 77.1 billion, up 17% from KRW 66.2 billion in 2022. In this figure, sales data from hospitals run by the Korea Hemophilia Foundation were not included. JW Pharmaceutical's Hemlibra sales increased about 2.5 times year-over-year (YoY), surpassing the annual sales of KRW 10 billion for the first time. Its sales last year were KRW 19 billion. Hemlibra, introduced to South Korea by JW Pharmaceutical, is a drug used to treat Type A hemophilia. It utilizes dual-specific antibody technology that binds simultaneously to clotting Factors IX and X. Unlike traditional Factor VIII treatments, Hemlibra is the first non-Factor VIII medication that can be administered subcutaneously up to once every four weeks. JW Pharmaceutical secured the domestic development and sales rights for Hemlibra from Chugai Pharmaceutical in 2017. It acquired Korean BLA in January 2019 and launched in May 2020. After recording KRW 2.1 billion in sales in the first year of launch, its sales expanded to KRW 7.2 billion in 2021 and KRW 7.6 billion in 2022. The significant increase in Hemlibra’s sales last year may be attributed to its reimbursement expansion. Since May, Hemlibra has been reimbursed for ‘patients over the age of one with Type A hemophilia who do not have Factor VIII antibodies.’ In just three years, Hemlibra has expanded its reimbursement for non-antibody patients following its initial insurance coverage for patients with severe Type A hemophilia. Top Type A hemophilia drugs by sales statistics. Moreover, an increase in sales of Hemlibra may be due to its improved administration methods compared to existing treatments. Hemlibra is the first subcutaneous injection formulation, offering patients a more convenient option. Previous treatments required patients to locate a vein and self-administer injections, which was inconvenient and difficult for many patients, especially for children and teenagers. Advate sales, down 22%... Adynovate and Greengene F show weakness in sales overall On the other hand, Takada Pharmaceutical's Advate, which has established a strong position in the market, experienced a significant decrease in sales. Advate's sales last year were KRW 15.1 billion, down 22% compared to KRW 19.5 billion in 2022. Expanding the periods further, it has steadily declined since 2019. Sales of Advate, which stood at KRW 27.7 billion then, decreased to KRW 25.8 billion in 2020, KRW 22.9 billion in 2021, and KRW 19.5 billion in 2022. Advate has demonstrated a strong presence in the hemophilia A market for an extended period. By jointly selling products with GC Biopharma, which significantly influences the domestic hemophilia treatment market, Advate consistently recorded annual sales of over KRW 20 billion. However, Advate is gradually losing its strength as Hemlibra rapidly expands its influence. During the same period, Novo Nordisk Pharma's Novoseven RT sales increased from KRW 5.5 billion to KRW 17.3 billion, exacerbating Advate's decline. Another hemophilia A treatment from Takeda Pharmaceutical, Adynovate, also saw a 20% decrease in sales from KRW 6.8 billion to KRW 5.4 billion. GC Biopharma's GreenMono slightly increased from KRW 6.6 billion to KRW 6.7 billion, while another GC Biopharma's Greengene F, decreased by 35% from KRW 2.7 billion to KRW 1.8 billion. Including joint sales, three out of four products sold by GC Biopharma experienced a more than 20% drop in sales over the past year. However, GC Biopharma is still reported to maintain significant performance in the hemophilia treatment market through the Korea Hemophilia Foundation . The industry expects that Hemlibra's upward trend will continue in the future. This year, we expect to see more prominent effects from expanded reimbursement. It is estimated that there are around 1,700 hemophilia A patients in South Korea. Among them, it is estimated that 60% of non-inhibitor patients with hemophilia A in South Korea are eligible for Hemlibra reimbursement. A critical factor in the current situation is the renegotiation of Hemlibra's reimbursement terms. The risk-sharing agreement (RSA) contract for Hemlibra is scheduled to expire on the 30th of next month. JW Pharmaceutical had previously entered into an RSA contract with the government for Hemlibra, operating under a total expenditure cap model.
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