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- 2026-06-21 01:28:14
- Company
- Takeda's Firazyr reimbursable up to four doses per Rx
- by Whang, byung-woo Dec 23, 2024 05:49am
- Product photo of Firazyr Takeda Pharmaceuticals Korea announced on December 19 that the National Health Insurance reimbursement coverage for Firazyr (ingredient: icatibant acetate), a treatment for acute attacks of hereditary angioedema (HAE), has been expanded to up to four doses per prescription starting this December. According to partial revisions to the 'Coverage and Scope of Benefits (Pharmaceuticals),' as notified by the Ministry of Health and Welfare (MOHW), reimbursement coverage for Firazyr has been expanded from two to up to four doses per prescription. According to the revised criteria, patients with a history of at least three self-administrations who, in the past three months, have experienced ▲Either one or more acute attacks per month or ▲Required additional doses for an acute attack, are now eligible for reimbursement for up to four doses per prescription. Firazyr was approved in South Korea in June 2014 and has been reimbursed for adult patients since September 2018. In July 2019, the eligible age group was expanded to include pediatric patients aged two years and older, establishing a basis for quick response during emergencies across various age groups. Since March 2021, reimbursement for up to two doses per prescription has been implemented, allowing patients to better prepare for additional acute attacks. This recent reimbursement expansion reflects the need to address the limitations of previous reimbursement of up to two doses per prescription and improve treatment accessibility for HAE patients in Korea, considering the unpredictable onset and severity of acute swelling episodes. HAE patients often hesitated to use medication during initial acute swelling symptoms due to concerns about depleting their remaining treatment supply, resulting in repeated delays in addressing acute episodes. This status conflicted with international treatment guidelines, which recommend 'prompt treatment at the onset of acute swelling symptoms.' Both patients and healthcare professionals have consistently emphasized the need for improvements in the timeliness and safety of HAE disease management. In response, the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service reviewed textbooks, clinical guidelines, and expert opinions comprehensively and decided to expand reimbursement for Firazyr to cover up to four doses per prescription for patients experiencing frequent acute swelling episodes or requiring additional doses. This measure has been implemented three years and nine months after the reimbursement of up to two doses per prescription. Analysis suggests that it is part of Takeda Pharmaceutical Korea's effort to provide a stable treatment environment for patients with hereditary HAE and solve unmet healthcare needs. "Expanded scope of reimbursement for Firazyr will strengthen treatment access to patients with HAE in South Korea. It is an important improvement implementing the recommendations by the international treatment guidelines," Kim Na-kyung, Takeda Korea Rare Disease Business Unit Head, said. "We are pleased to provide a stable treatment environment to patients who experience anxiety and risks associated with acute attacks due to HAE."
- Company
- LG Chem wins Zemiglo patent dispute
- by Kim, Jin-Gu Dec 20, 2024 05:46am
- Pic of Zemiglo LG Chem has won the 2nd trial of a patent dispute over the use of DPP-4 inhibitor diabetes drug Zemiglo (gemigliptin). The company was able to reverse its first trial loss and won the second trial, enabling it to prevent patent challengers from launching their generic versions early. The pharmaceutical industry's attention has now turned to another second trial. LG Chem is battling generic companies in patent court over the invalidity of its use patent. If LG Chem wins, it will make it even harder for generics to launch their generic versions of Zemiglo early. The 5th Division of the Patent Court ruled in favor of the plaintiffs in the passive scope of rights confirmation review trial filed by LG Chem against 8 generic companies, including Shin Poong Pharm. The court overturned the decision of the Patent Trial and Appeal Board and ruled in favor of the original company, LG Chem. The Zemiglo patent dispute began in May last year when generic companies filed for both passive confirmations of scope and patent invalidation at the same time. Shin Poong Pharm, Daehwa Pharmaceuticals, DongKoo Bio&Pharma, Boryung, Sam Chun Dang Pharm, Celltrion Pharm, Jeil Pharmaceutical, and Korea Prime Pharm were among the companies that filed for the judgment. Generic companies have filed two judgment requests for the same patent, signaling their intention to launch generics early. They planned to avoid or invalidate the use patent and launch generics early. In the first instance, the generic companies won. In April this year, they won the patent avoidance case, and in September, they won the invalidation case. LG Chem appealed the decision to the patent court. Upon appeal, LG Chem got the first laugh. The patent court overturned the first court's ruling that was in favor of generics and sided with LG Chem. The pharmaceutical industry's attention now turned to the company’s appeal of the invalidity judgment, which is yet to be decided. Upon. If LG Chem wins, it will likely block generic entry until 2039, when the patent expires. However, this also depends on the generic companies’ appeal to the Supreme Court and a reversal. On the other hand, if LG Chem loses, it will encourage generic companies to launch their product early. If the generic companies win and Zemiglo’s patent is invalidated, they can overcome the remaining two patents and launch Zemiglo-Zemimet generics. Quarterly prescriptions of Zemiglo and Zemimet (Unit: KRW 100million, Data: UBIST) Zemiglo is currently protected by three patents. The use patent expires in October 2039, the salt-hydrate patent expires in October 2031, and the substance patent expires in January 2030. For Zemimet (gemigliptin + metformin), there are two additional composition patents that expire in October 2033 and May 2039, respectively. Generic companies plan to overcome Zemiglo’s use patent first and then overcome the remaining patents to launch generics early in time for the expiration of its composition patent. According to the market research institution UBIST, Zemiglo-Zemimet is the top prescribed diabetes drug in the DPP-4 inhibitor class. In the third quarter of this year, Zemiglo's prescriptions totaled to KRW 10.5 billion and Zemimet's totaled to KRW 25.6 billion, up 1% year-on-year. Zemiglo and Zemimet became the leading diabetes drugs in the third quarter of last year.
- Company
- 'Vyloy' to expand treatment options for gastric cancer
- by Whang, byung-woo Dec 19, 2024 05:52am
- Vyloy (active ingredient: zolbetuximab), a Claudin-18.2-targeting gastric cancer therapy, is rising as the new treatment option for stage 4 gastric cancer despite an issue related to companion diagnostics. As the number of newly diagnosed patients with Claudin-18.2 increases in clinical practices, the drug will be more widely used from the early next year when it launches as non-reimbursed. Vyloy logoVyloy is the first and only Claudin-18.2-targeted treatment. A monoclonal antibody that is designed to work by binding to It binds to Claudin-18.2, a protein expressed in the stomach. In South Korea, Vyloy was approved by the Ministry of Food and Drug Safety (MFDS) as a 'First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with CLDN18.2-positive, HER2-negative unresectable, locally advanced, or metastatic gastric adenocarcinoma or esophageal cancer.' It is gathering attention from experts since a new targeted treatment option for stage 4 gastric cancer has emerged decades after the introduction of 'trastuzumab'-based therapy for HER2-positive patients. At the Korean Society of Medical Oncology-American Association for Cancer (AACR) joint symposium held last month, two accounts of Phase 3 clinical trials were presented. The SPOTLIGHT and GLOW studies, which conducted sub-group analysis of Korean patients, show that the drug has reduced the risk of death by half in patients with locally advanced and metastatic gastric cancer. The Vyloy group had a median progression-free survival (PFS) of 12.8 months compared to 8.1 months of the placebo group, which shows that both groups had longer PFS than all patient groups. 12‧24 months PFS for the Vyloy group were 53% and 30%, and those for the placebo group were 32% and 23%. Additionally, the Vyloy group had a median overall survival of 30.0 months, twice longer than the 15.8 months of the placebo group. 12‧24 months overall survival for the Vyloy group was 78% and 54%, whereas those for the placebo group were 65% and 34%, demonstrating that the Vyloy group's death risk was lower by 50%. "The introduction of Vyloy, targeting the new biomarker for gastric cancer Claudin-18.2, will bring paradigm shift of the treatment outcome of locally advanced or metastatic gastric cancer with limited treatment options until now in South Korea," Dr. Keun-Wook Lee, Professor in the Department of Oncology at Seoul National University Bundang Hospital. The drug's clinical application in South Korea was likely to be delayed as a companion diagnostic (CDx) used to diagnose Claudin-18.2 has been considered for assessment as a new health technology. However, the drug is categorized as having 'companion diagnostic pricing (Level 1).' "The pathology department states that Level2 companion diagnostic pricing is needed for the drug that requires companion diagnostic. However, now, patients can be readily treated with the drug as Level1," Professor A from a tertiary general hospital, who requested to remain anonymous, said. In other words, If Vyloy's companion diagnostics had been assessed as a new health technology, the drug's entry into the domestic market would have been delayed by over one year. However, such concerns have now been resolved. Clinical anticipates Vyloy's prescription to be made in early 2025 when Vyloy launches in South Korea. "Diagnosis reveals that Claudin-18.2 is more frequent than expected with 3-4 individuals out of 10 new patients," Professor A said. "We expect the drug to be in stock by the end of January or February. Its use in patient treatment is expected to be higher."
- Company
- Kuhnil signs licensing agreement with Mochida
- by Whang, byung-woo Dec 18, 2024 05:55am
- Kuhnil Pharm announced on the 16th that it has signed a sales partnership agreement for Epadel, an original version of the highly purified eicosapentaenoic acid (EPA) ethyl ester formulation, with Mochida Pharmaceutical in Japan. Founded in 1913, Mochida Pharmaceuticals is a leading Japanese innovative pharmaceutical company that has played a leading role in the development of high-purity omega-3 fatty acid products. Epadel (generic name: icosapent) is a highly purified EPA ethyl ester formulation developed by Mochida as the world's first medical drug. The drug is indicated for hyperlipidemia and ulcer, pain, and chilliness associated with arteriosclerosis obliterans in Japan. Through this agreement, Kuhnil Pharm will own exclusive development and marketing rights to Epadel in Korea. Epadel has demonstrated an effect in preventing cardiovascular disease through Japan’s EPA Lipid Intervention Study (JELIS Study). Currently, Epadel’s active pharmaceutical ingredient is supplied by Nissui Corporation, which has advanced EPA purification technology and the capacity for mass production. Han-Kuk Lee, CEO of Kuhnil Pharm said, “The agreement allows us to add a new formulation to our existing portfolio, which includes Omacor and Rosumega, which have been leading the market for hyperlipidemia treatment, and further strengthen our leadership in the Korean hyperlipidemia market. Epadel will be a great treatment option for hyperlipidemia patients in Korea.
- Company
- Celltrion launches subsidiary 'BioSolutions' for CDMO
- by Cha Jihyun Dec 18, 2024 05:55am
- Seo Jung-jin, chairman of Celltrion Group (source: virtual press conference photos).Celltrion group launches Celltrion BioSolutions, a company specializing in drug contract development and manufacturing organization (CDMO). The company aims to build a manufacturing plant and research center next year and generate sales from 2028. According to the Financial Supervisory Service on December 17, Celltrion acquired 2 million shares of Celltrion BioSolutions for KRW 10 billion. After the acquisition of shares, Celltrion will secure 100% of the shares of Celltrion BioSolutions. "We have decided to commence the CDMO business in September, considering increased demands for biological drugs globally and consistent requests for CDMO services from Korea and foreign markets," Celltrion said. "We have quickly established a corporate body and initiated establishing infrastructure, such as a manufacturing facility, and running the business." The new corporate body plans to provide services for drug development spanning all stages, including new drug candidate identification, cell culture, manufacturing development, clinical trial planning, regulatory document preparation, and commercial production. Lee Hyuk-jae, senior vice president of Celltrion, has been appointed the CEO of Celltrion BioSolutions. Lee has experience in product approval, clinical trials, and production. Based on Celltrion's experience running a contract manufacturing organization (CMO) service, Celltrion BioSolutions aims to challenge the competition. Previously, Celltrion had a history of running a CMO service in 2002. However, as the company reestablished its core value of the company as a biosimilar developer in the late 2000s, the company discontinued the CMO service. "We plan to secure production by reducing the cost of expansion based on Celltrion's experience running a drug CMO service for global pharmaceutical companies spanning all phases of the pharmaceutical business, such as various business project records, proprietary production, and approvals, and also by securing price-cost competitiveness through high production·efficiency," Celltrion said. The company is reviewing site candidates for the new corporation's production facilities. Celltrion plans to design production facilities in South Korea with a maximum capacity of 200,000 liters, beginning construction on the first plant with a 100,000-liter capacity next year. The company will continuously assess the optimal location to ensure sustainable production and supply while expanding production capacity. The investment in the new company will be funded through internal capital and external funding. Initially, Celltrion plans to allocate up to KRW 1.5 trillion of its capital to establish facilities and launch contract development (CDO) services. Following this, the company plans to secure an additional KRW 1.5 trillion in external funding to expand specialized overseas research centers and to develop next-generation modality production facilities. The company plans to place multiple large·small-scale bioreactor placements to enable mass production in the new facility. Celltrion also plans to establish production facilities for next-generation modalities, including antibody-drug conjugates (ADC), multi-antibody therapies, cell and gene therapies, and peptide-based new drugs. To expand into new modality areas, strengthen production capabilities, and enhance technological competitiveness, the company will establish specialized research centers domestically and internationally, including in the United States, Europe, and India. The company aims to offer an integrated CDMO solution through the convergence of technologies. The company expects commercial production to begin in 2028, which is expected to generate significant revenue. "Based on our know-how accumulated over 20 years, Celltrion has commenced a CDMO company that could provide customized service spanning all phases of drug development for clients," Celltrion said. "Celltrion BioSolutions will strive to provide truly end-to-end service based on cost-price competitiveness and customer-oriented policy."
- Company
- Numerous K-Bio drugs secure FDA ODD
- by Son, Hyung Min Dec 18, 2024 05:55am
- Korean pharmaceutical and biotech companies seek to enter the market for rare diseases through the orphan drug designation. Th rare disease field has a small pool of patients, but companies can obtain an exclusive status by acquiring innovative new drugs when they succeed and create high-added value. New drug candidates from various companies, including Hanmi Pharm, GC Biopharma, GI Innovation, and Rznomics, successfully obtained the U.S. Food and Drug Administration (FDA)'s Orphan Drug Designation (ODD). According to industry sources on December 16, twenty-one new drug candidates under development by Korean pharmaceutical and biotech companies received ODD from the FDA. ODD provides companies developing treatments for patients with rare and intractable diseases, which have a disease prevalence of under 100,000 population, benefits such as expedited review, tax reductions, and exclusive status for new drugs. Pharmaceutical companies, Boryung·GC Biopharma, have secured FDA's ODD in the first half of the year In the first half of this year, new drug candidates by Boryung, Rznomics, NeoImmuneTech, SPARK Biopharma, SN BioScience, Oscotec, Ingenium Therapeutics, Dr. Noah Biotech, Hanmi Pharm, GC Biopharma, and GI Innovation have successfully obtained ODD. First half-year 2024 report: new drug candidates by Boryung, Rznomics, NeoImmuneTech, SPARK Biopharma, SN BioScience, Oscotec, Ingenium Therapeutics, Dr. Noah Biotech, Hanmi Pharm, GC Biopharma, and GI Innovation have successfully obtained ODD. Boryung's BR-101801, a novel drug candidate to treat blood cancer, was the first to receive FDA ODD this year. Boryung is investigating BR-101801's potential in various blood cancers, including peripheral T-cell lymphoma and mycosis fungoides. In January, it received the approval for the treatment of angioimmunoblastic T-cell lymphoma. BR101801 is the first-in-class drug candidate to inhibit phosphoinositide 3-kinase (PI3K)γ/ δ and DNA-dependent protein kinase (DNA-PK). It can effectively induce cell death through triple target inhibition and suppress a cancer protein c-Myc. NeoImmuneTech's NT-I7 received an ODD in the treatment of pancreatic cancer. NT-I7 is a novel drug candidate that targets interleukin (IL)-7, which regulates T-cell development and function. It has been investigated for various indications. Besides the current ODD for pancreatic cancer, NT-I7 received ODDs in the treatment of CD4 lymphocytopenia (2019), multifocal leukoencephalopathy (2020), and glioblastoma (2023). A Fabry disease treatment, LA-GLA, developed jointly by Hanmi Pharm and GC Biopharma, successfully received an ODD in the United States. LA-GLA is formulated for once-per-month subcutaneous administration. Fabry disease is a type of lysosomal storage disorder (LSD) resulting from a genetic deficiency in a particular enzyme, leading to metabolic alterations. In June, GI Innovation's GI-102, a candidate immunotherapy for cancer, received FDA ODD. The company is developing GI-102, which acts on CD80 and interleukin (IL)-2. IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA-4, a receptor preventing immune cells from attacking cancer cells. In the second half of this year, 11 new drug candidates received FDA's ODD In the second half of this year, eleven new drug candidates from Korean pharmaceutical and biotech companies received ODD in the United States. Second half-year 2024 report: new drug candidates by K-Bio companies, including Zymedi, Connext, iLeadBMS, HysensBio, and Rezolute, successfully received the FDA Zymedi successfully received the FDA's ODD for its antibody-drug ZMA001 in July. ZMA001 targets intractable disease, pulmonary hypertension. Pulmonary hypertension is a disease characterized by narrowing of the blood vessels in the lungs, leading to increased pulmonary blood pressure and ultimately causing heart failure. In South Korea, approximately half of the patients with pulmonary hypertension die within five years of diagnosis. While treatments such as phosphodiesterase type 5 (PDE5) inhibitors and calcium channel blockers (CCBs) have been used, they only provide symptom management. More new drugs are needed. ZMA001, a human monoclonal antibody, prevents inflammatory macrophages from infiltrating the lungs, fundamentally inhibiting pulmonary hypertension symptoms from the initial stage. In preclinical animal model studies, ZMA001 demonstrated superior efficacy to existing drugs. In August, Connext's acute graft-versus-host disease (GVHD) treatment, 'CNT101,' was added to the FDA's ODD list. CNT101 is a recombinant protein that targets the TLR5 receptor expressed on epithelial and immune cells and is being developed as a treatment for acute radiation syndrome caused by radiation exposure. Connext explains that CNT101 minimizes gastrointestinal tissue damage resulting from radiation toxicity during hematopoietic stem cell transplantation, thereby preventing the onset of GVHD. In October, a Target Protein Degrader (TPD) molecular glue from iLeadBMS, Ildong Pharmaceutical's subsidiary specializing in new drug development, was designated as the FDA's ODD. iLeadBMS is developing a molecular glue that targets cyclin-dependent kinase 12 (CDK12), a protein that controls the expression of cancer-related genes. A complex formation between CDK12 and Cyclin-K is known to influence the growth and metastasis of cancer cells in refractory cancer. Earlier this year, iLeadBMS presented preclinical results at the ESMO Targeted Anticancer Therapies Congress 2024 (ESMO TAT 2024), demonstrating that its molecular glue effectively inhibits CDK12 activity and induces degradation of Cyclin-K, thereby suppressing the growth of HER2-negative gastric cancer cells. This success led to the designation of the drug as an orphan drug for gastric cancer. In December, HysensBio's treatment for amelogenesis imperfecta received ODD in the United States. Amelogenesis imperfecta is a rare genetic disorder that impairs the formation of enamel on teeth. The disease causes symptoms such as tooth sensitivity, erosion, and fractures, and currently, no effective treatment options are available. Rezolute, Handok’s US subsidiary, received the FDA ODD for its 'RZ358,' a treatment for tumor-mediated hyperinsulinism. VasThera's pulmonary arterial hypertension therapy 'VTB-10' also received the FDA's ODD this month.
- Company
- SK Plasma will exclusively distribute Janssen’s Velcade
- by Nho, Byung Chul Dec 17, 2024 05:51am
- (From the left) Seungjoo Kim, CEO of SK Plasma, Christian Rodseth, Managing Director of Janssen Korea) SK Plasma, which specializes in plasma derivatives, has secured an additional rare disease treatment for its portfolio. SK Plasma (CEO: Seungjoo Kim) announced on the 16th that it had signed an exclusive domestic distribution agreement for the multiple myeloma and mantle cell lymphoma treatment Velcade inj (bortezomib triple complex) with Jassen Korea, Johnson & Johnson’s pharmaceutical division. Under the agreement, Janssen will manufacture and supply Velcade Inj, and SK Plasma will be responsible for its distribution and marketing in Korea. With this agreement, SK Plasma now owns a portfolio of leading blood cancer treatments, including Dacogen (myelodysplastic syndromes, acute myeloid leukemia) and Velcade (multiple myeloma, malignant lymphoma). “This agreement strengthens our oncology portfolio and enables us to supply a drug that has become a standard of care for multiple myeloma patients,” said Seungjoo Kim, CEO of SK Plasma. ”We will continue to develop and introduce various treatments for rare and incurable diseases to contribute to improving the quality of life for patients in Korea.” Meanwhile, SK Plasma signed an exclusive agreement with Janssen Korea in 2023 to market and sell Dacogen Inj (decitabine), a treatment for myelodysplastic syndromes and acute myeloid leukemia.
- Company
- Celltrion receives CHMP positive opinion for 4 biosimilars
- by Chon, Seung-Hyun Dec 17, 2024 05:51am
- Celltrion announced on the 16th that the. European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorizations for its 4 biosimilar candidates. With the recommendations, Celltrion’s 4 biosimilar versions for Actemra, Eylea, Prolia, and Xgeva are expected to be approved in Europe. The biosimilars are named Avtozma, Eydenzelt, Stoboclo, and Osenvelt, respectively. Avtozma is a biosimilar version of the original Actemra, which is used to treat autoimmune diseases such as rheumatoid arthritis and giant cell arteritis. Celltrion’s biosimilar demonstrated bioequivalence and similarity to the original in a global Phase III clinical trial. The original Actemra posted global sales of approximately KRW 4 trillion last year. Eylea, the original version of Eydenzelt is used to treat ophthalmic conditions such as (wet) age-related macular degeneration (AMD), retinal vein occlusion macular edema, and diabetic macular edema. It generated global sales of about KRW 12 trillion last year. Stoboclo and Osenvelt are biosimilar versions of Prolia and Xgeva, respectively. Prolia and Xgeva are based on different doses and dosing intervals of the active ingredient denosumab. Prolia is approved for the treatment of osteoporosis and Xgeva is approved for the prevention of skeletal-related events in patients with bone metastases and the treatment of giant cell tumors of the bone. Together, Prolia and Xgeva generated KRW 8 trillion in sales last year. If Celltrion’s 4 biosimilars receive marketing authorization in Europe, Celltrion will be able to achieve its goal of securing 11 products in its portfolio by 2025. Celltrion currently has received approval or recommendation for approval for 11 biosimilars: Remsima, Remsima SC, Zymfentra, Yuflyma, SteQeyma, Avtozma, Herzuma, Truxima, Vegzelma, Omlyclo, Eydenzelt, Stoboclo, and Osenvelt. The global market size for all of the original products is nearly KRW 13.5 trillion. A Celltrion official said, “It is rare for the CHMP to recommend marketing authorization of 4 products from a single company at the same time, which became an opportunity for us to demonstrate our technology and development capabilities globally. We look forward to completing the remaining marketing authorization process and commercializing our products in Europe.”
- Company
- Keytruda and Vyloy to transform gastric cancer treatment
- by Moon, sung-ho Dec 17, 2024 05:51am
- Metastatic gastric cancer has long been labeled as a drug-barren area on site. Various clinical studies have been conducted to develop new therapies for the area, but most have been unsuccessful. This is due to the tumor's heterogeneity, which makes it difficult to prove the efficacy of treatments. However, the recent introduction of immuno-oncology drugs and targeted therapies has changed the treatment strategy in clinical practice. # The treatment paradigm for gastric cancer has now reached a state where the use of anticancer drugs is indispensable. However, due to obstacles in the domestic health insurance system, such as reimbursement and companion diagnostics, the use of these drugs in clinical practice is still limited. And pharmaceutical companies that are well aware of the situation have been scrambling to solve the problem. According to industry sources on the 13th, several drugs from global pharmaceutical companies have been approved in Korea for metastatic gastric cancer this year and are now available for clinical use. One representative drug is MSD Korea’s Keytruda (pembrolizumab). Keytruda was approved for the first-line treatment of metastatic HER2-positive gastric cancer, and in March this year, the indication was expanded to include HER2-negative gastric cancer. This makes Keytruda the first immuno-oncology option approved for both HER2-positive and HER2-negative gastric cancer. In the case of metastatic HER2-positive gastric cancer, the new indication was based on KEYNOTE-811, which was presented at the European Society for Medical Oncology’s ESMO Congress 2023. Specifically, after a median follow-up of 28.4 months, the Keytruda-trastuzumab-chemotherapy combination (10.0 months) reduced the risk of disease progression or death by 28% compared to trastuzumab-chemotherapy (8.1 months), resulting in a statistically significant improvement in PFS in the advanced HER2-positive gastric cancer ITT(intention to treat) population. The KEYNOTE-811 study, in particular, was expanded to a global clinical trial based on a trial led by Professor Sun Young Rha (Medical Oncology) at Yonsei Cancer Hospital. In addition, Keytruda was approved in March this year for the first-line treatment of HER2-negative gastric cancer, demonstrating clinical utility over chemotherapy regardless of the patient’s PD-L1 expression. Results from the KEYNOTE-859 trial, which became the basis of the drug’s approval for the indication, showed that at a median follow-up of 31 months, the median overall survival (OS) of the Keytruda-antineoplastic chemotherapy combination was 12.9 months, compared to 11.5 months with chemotherapy alone, and the risk of death was reduced by 22%. If Keytruda has changed the landscape of gastric cancer treatment as an immuno-oncology agent, Astellas' Vyloy (zolbetuximab) is the representative targeted therapy option. Vyloy is the first globally approved Claudin 18.2-targeted treatment, an immunoglobulin monoclonal antibody that binds to Claudin 18.2, a protein expressed and exposed in the stomach. Its approval in Korea allows Vyloy to be used in combination with fluoropyrimidine and platinum-based chemotherapy as a first-line treatment for patients with Claudin 18.2-positive, HER2-negative, unresectable locally advanced or metastatic gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma. The approval of Vyloy was based on two Phase 3 trials in patients with Claudin 18.2-positive and HER2-negative unresectable, locally advanced or metastatic gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma, the SPOTLIGHT and GLOW studies. In SPOTLIGHT, the median progression-free survival (PFS) in the Vyloy arm was 10.61 months, compared to 8.67 months in the control arm, reducing the risk of disease progression or death by approximately 25%. The secondary endpoint, median OS, was significantly higher in the Vyloy arm at 18.23 months versus 15.54 months in the placebo arm. Professor Sun Young Rha (Medical Oncology, Yonsei Cancer Hospital), Chairman of the Korean Cancer Association, said, “With an estimated prevalence of more than 100,000 patients with Stage IV gastric cancer in Korea, the approval of the first Claudin 18.2-targeted therapy will provide a breakthrough in the treatment of metastatic gastric cancer, an area that had limited options. In addition to expanding treatment options, the significant improvement in mOS compared to conventional chemotherapy, as Vyloy reduced the risk of disease progression or death by approximately 25%, is very encouraging in the treatment of metastatic gastric cancer due to its stagnant survival rate.” Keytruda’s expanded indication and the introduction of Vyloy have changed the treatment strategy for metastatic gastric cancer in Korea, but institutional obstacles have been obstructing its full use on-site. In the case of Keytruda, it has been difficult to cross the threshold of the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee. It has applied for reimbursement for 17 indications but is being held up by the CDDC because it would require a significant investment in health insurance finances. As of August, the company has applied for insurance reimbursement benefits to the CDDC for a total of 17 indications, upon being granted marketing authorization for 33 indications in 17 cancers. After applying for reimbursement for 13 indications last year, the company added four more indications to the application this year, including MSI-H gastric cancer, MSI-H biliary tract cancer, HER2-positive gastric cancer, and HER2-negative gastric cancer. In addition, MSD Korea submitted a new reimbursement proposal in October to expand the reimbursement standard for 17 indications, including gastric cancer and is making every effort to set reimbursement standards this year. For reference, HIRA’s last CDDC meeting this year is scheduled for the 18th. However, it has been reported that there has not been a proper discussion made on the gastric cancer indication yet. If it fails to pass this year's CDDC review, Keytruda's application will enter its third year of deliberations. An MSD Korea official said, “Patients with gastric cancer, triple-negative breast cancer, and head and neck cancer, for which there are no current therapies available, are longing for the opportunity to be treated with Keytruda, which has demonstrated sufficient clinical utility. This reimbursement submission also includes the gastric cancer indication for which we applied for additional reimbursement expansion earlier this year. We hope it will be included in the final CDDC review.” Vyloy’s situation is different, but similar to Keytruda's. Companion diagnostics are required to use the drug, but this restriction is holding the drug’s use back. This is because HIRA is reportedly considering whether Roche Diagnostics' companion diagnostic test for Claudin 18.2, immunohistochemistry (IHC), should be evaluated as a new health technology in the reimbursement review process. If it is subject to a new health technology assessment, it would be difficult to utilize Vyloy in clinical practice during the review period, apart from its reimbursement. “If the companion diagnostic test method for Vyloy is subject to new health technology assessments, the introduction of the treatment in Korea may be delayed for up to a year,” said Rha. Targeted anticancer drugs and companion diagnostics inevitably go hand in hand, but the current system has structural limitations that do not support this, and patients are left to suffer the consequences. The KCA will continue to advocate for policy changes.”
- Company
- Soaring exchange rate causes pharma asset value to fluctuate
- by Kim, Jin-Gu Dec 16, 2024 05:53am
- The sharp rise in the won-dollar exchange rate in the aftermath of the impeachment and martial law has had a significant impact on the asset value of pharmaceutical and biotech companies. Companies with much foreign currency assets held in dollars have shown a significant increase in their asset value due to the high exchange rate, such as Samsung Biologics and SK Biopharm, which have a large share of overseas business. On the other hand, companies with large foreign currency liabilities held in dollars experienced a decrease in asset value due to the rise in the exchange rate. #SB 'High exchange rate' gains for firms with large dollar assets...Samsung Biologics’ asset value rises to KRW 112.9 billion when the exchange rate rises by 10% According to industry sources, the won-dollar exchange rate closed at KRW 1,432.80 on the Seoul foreign exchange market on the 14th, up 1.00 won from the previous trading day. The won-dollar exchange rate has recently remained above KRW 1430 in the aftermath of the declaration of emergency martial law and failed the impeachment vote. In Q3, the average won-dollar exchange rate was KRW 1,358.55. In the 3 months since it has risen to over KRW 1430, an increase of over 5%. Compared to last year, the increase is even greater. In Q4 last year, the average exchange rate was KRW 1321.24, which rose more than 8% in a year. Some analysts predict that if the current turmoil continues, the won-dollar exchange rate could reach KRW 1,500. Changes in the won-dollar exchange rate The rise in the exchange rate can have a modest impact on the asset value of pharma-bio companies. In particular, companies with a large proportion of overseas business are greatly affected by the exchange rate due to the assets and liabilities they hold in foreign currencies. If the company owns much foreign currency assets in dollars, the asset value will increase due to the rise in the exchange rate, and conversely, if there are many financial liabilities borrowed in dollars, the asset value will decrease. In its latest quarterly report, Samsung Biologics explained that every 10% rise in the won-dollar exchange rate increases its net income before corporate taxes by KRW 112.9 billion. Considering that the current KRW-dollar exchange rate has risen by about 5% compared to the average exchange rate in the third quarter, the time of the quarterly report, it is calculated that the recent rise in the exchange rate has increased the corporate’s asset value by about KRW 50 billion. In the case of SK Biopharmaceuticals, every 10% rise in the exchange rate increases the value of its assets by KRW 7.8 billion. Chong Kun Dang’s asset value increased by KRW 1 billion. The analysis is that companies that own more assets than liabilities held in dollars would show an increase in asset value. #SB Cashable assets of Samsung Biologics, Celltrion, Dong-A ST, increase due to exchange rate fluctuations The rise in exchange rates will especially affect the cash and cashable assets of major pharmaceutical and biotech companies. They have already increased their cash and cash equivalents by hundreds of millions of won to tens of billions of won in the third quarter due to the rise in the exchange rate. If the current high exchange rate continues to the fourth quarter, it is expected that the companies’ cash and cashable assets will increase even further. Samsung Biologics reported cash and cash equivalents of KRW 540.2 billion at the end of the third quarter, an increase of KRW 172.3 billion from the KRW 367.9 billion at the end of the second quarter. The increase in cash and cash equivalents was partly driven by a rise in the exchange rate. The company explained that the effect of foreign exchange rate fluctuations on cash and cash equivalents amounted to KRW 19.9 billion. Approximately 9% of the increase in cash and cash equivalents in the third quarter (KRW 172.3 billion) was attributable to foreign exchange rate changes. During the same period, Celltrion's cash and cash equivalents increased by KRW 408.1 billion, up from KRW 564.6 billion to 972.7 billion, of which KRW 4.1 billion was attributable to foreign exchange rate changes. Dong-A ST's cash and cash equivalents increased from KRW 212.8 billion to KRW 301.3 billion. Of this, the increase in cash and cash equivalents due to exchange rate fluctuations amounted to KRW 700 million. In the case of SK Biopharm, cash and cash equivalents increased from KRW 239.7 billion to KRW 266.0 billion, with the effect of exchange rate fluctuations amounting to nearly KRW 200 million. In the case of Chong Kun Dang, Hanmi Pharmaceutical, and Daewoong Pharmaceutical, the companies’ cash and cash equivalents decreased in the third quarter compared to the second quarter, but cash and cash equivalents ultimately increased due to the effect of exchange rate changes. Exchange rate changes partially offset the decrease in cash and cash equivalents. At Chong Kun Dang, cash and cash equivalents decreased from KRW 219.6 billion at the end of the second quarter to KRW 203.1 billion at the end of the third quarter. However, it increased by KRW 1.3 billion due to exchange rate changes. If the exchange rate had not risen, the decrease in cash and cash equivalents would have been even greater. Hanmi Pharmaceutical's cash and cash equivalents decreased from KRW 55 billion to KRW 48.2 billion. However, it increased by KRW 1.6 billion due to the effect of exchange rate fluctuations. Daewoong Pharmaceutical saw a decrease in cash and cash equivalents from KRW 111.5 billion to KRW 94.6 billion, with an increase of KRW 1.1 billion due to the effect of exchange rate changes. If the current high exchange rate continues, the effect of the exchange rate fluctuations is expected to contribute more significantly to the overall increase in cash and cash equivalents of corporations. At Yuhan Corp, cash and cash equivalents decreased from KRW 299.3 billion at the end of the second quarter to KRW 229.9 billion at the end of the third quarter, with a decrease of KRW 500 million in cash and cash equivalents due to exchange rate fluctuations over the same period. The decrease in cash and cash equivalents is attributed to the exchange rate rise, as the companies had more financial liabilities in dollars than financial assets.
