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- 2025-12-23 22:35:25
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- BeiGene’s ‘Brukinsa’ to be prescribed in general hospital
- by Eo, Yun-Ho Apr 25, 2023 05:56am
- Chinese pharmaceutical company BeiGene Korea's first new drug, 'Brukinsa', has been approved to be prescribed in general hospitals. According to sources from related industry, the BTK inhibitor Brukinsa (Zanubrutinib) has passed the Drug Committee of tertiary hospitals such as Samsung Medical Center, SNUH, and Asan Medical Center. As reimbursement is expected to be applied in May, it is believed that prescriptions will be available quite soon after being listed. Brukinsa has been approved in Korea in 2022, as ▲ monotherapy for adults with mantle cell lymphoma (MCL) who have received at least one prior therapy, and ▲ monotherapy for adults with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy. Among them, reimbursement is for the 'Waldenström's macroglobulinaemia' indication. After approval, only the reimbursement standard for WM was introduced and has been set at the HIRA's Review Committee for Cancer Diseases. In September of the same year, the company tried to add MCL to the list, but the results were not good. Since then, Brukinsa passed the Drug Benefit Evaluation Committee in February of this year and has recently concluded drug price negotiation and is set to be finally listed. Brukinsa is a targeted anticancer medicine that inhibits the survival and proliferation of malignant B cells by blocking the Bruton's tyrosine kinase protein, a signaling molecule that affects the survival and development of B cells. BTK inhibitors approved in Korea include Janssen's Imbruvica (Ibrutinib), AstraZeneca's Calquence (Acalabrutinib), and Ono Pharmaceutical's Velexbru (Tirabrutinib).
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- The atopic dermatitis tx market has grown into children
- by Hwang, byoung-woo Apr 24, 2023 05:53am
- Product photos of major atopic treatments Competition in the atopic dermatitis treatment market is intensifying again as new treatments have been made into health insurance benefits one after another. This is because salaries for severe atopic treatments have been expanded from April to children and adolescents. More fierce competition for market share is expected because the demand is high enough to insist on continuously expanding salaries in the clinical field. Experts say that Dupixent and Rinvoq, which directly benefited from the expansion of the salary range, have different characteristics, the choice of clinical sites will also depend on the patient's situation. According to the pharmaceutical industry on the 14th, competition among pharmaceutical companies has been accelerating as the scope of benefits for severe atopic treatments has been expanded from April to children and adolescents. Previously, patients with severe atopic dermatitis in children and adolescents over the age of 6 had a high burden of disease, but limited treatment options that could be used safely in the long run. TCS and Cyclosporine are mainly used to treat atopic dermatitis in children. Patients with moderate-severe atopic dermatitis needed additional systemic treatment because it did not improve with local treatments. Still, there were concerns about local side effects when using even low-grade TCS for a long time in thin skin areas. In addition, in the case of pediatric atopy, it was pointed out that it was difficult to use treatments strongly due to growth and development, so it was not in line with reality to apply for the existing special calculation benefits. "Symptoms such as severe itching caused by atopic dermatitis can have a greater negative impact than adults, such as hindering adolescents' growth and studies," said Woo Sang-wook, chairman of the Korea Atopic Dermatitis Association (KOREA University Ansan Hospital). Dupixent is expected to be most affected by the expansion of the salary range. In the case of Rinvoq, the salary target has increased for teenagers aged 12 or older, while Dupixent has a wider benefit standard for those aged 6 or older. Looking at the new standards for severe atopic patients in children and adolescents, the salary standards for adolescents are the same as those for adults aged 18 or older. The Dupixent benefit standard for children aged 6-11 is relatively low in cases where the ecological severity evaluation index (EASI) is 21 or higher before the start of ▲ Dupixent administration for more than 4 weeks, or cannot be used as a side effect. Chairman Son said, "There will be no major difficulty in using Dupixent because it uses topical treatment for 4 weeks in pediatric atopy and immunotherapy is included in the standard." Then, how will the choice of the clinical site be divided into the severe atopy of adolescents where Dupixent and Rinvoq will face off? Experts predicted that prescriptions would be made considering the method of administration, the speed of effectiveness, and safety according to the patient's condition. Ahn Ji-young, a professor of dermatology at NMC, said, "Since they are children, I think there will be more considerations than adults, such as preferences depending on how they think of injections and the burden of visiting the hospital." Along with this, the part that can be considered is the drug price. This is why Dupixent is expected to cost up to 1.33 million won to 1.74 million won although the patient's burden will be greatly reduced at the time of application. In the case of Rinvoq, it costs 60,300 won based on the premise that a month is 30 days with a drug price of KRW 20,010 per day of 15 mg. If 10% of the calculation special case is applied here, the patient burden is 60,030 won, which costs 72,360 won when converted into a year, so the patient burden is less than Dupixent. "It is true that Rinvoq has a few hundred thousand won less burden on patients compared to Dupixent," said a professor of pediatrics at A University Hospital. "However, I don't think there is a big difference between treatments, and I think which treatments will be more effective for patients will be a priority."
- Company
- Myelofibrosis new drug Inrebic can be prescribed
- by Eo, Yun-Ho Apr 24, 2023 05:52am
- The Myelofibrosis drug Inrebic is now available for prescription in general hospitals. According to related industries, Inrevic, a myelofibrosis treatment drug from BMS Pharmaceuticals, passed the Drug Committee (DC) of general hospitals such as SMC and Seoul St. Mary's Hospital. Inrebic received domestic approval in April of last year as 'treatment for splenomegaly or symptoms related to primary myelofibrosis, polycythemia vera, and myelofibrosis after essential thrombocythemia in adult patients previously treated with Jakavi. After that, he submitted an application for benefits but failed to pass HIRA once in June of last year. After re-applying, it passed both the Cancer Disease Review Committee and the Pharmaceutical Reimbursement Evaluation Committee last month, and the results of the drug price negotiations with The NHIS are expected to be released soon. This drug is a JAK-2 inhibitor and is expected to be different from Jakavi, a JAK1/2 inhibitor. Inrebic is the first to obtain approval for an oral once-a-day drug that greatly reduces the burden of spleen volume and symptoms in patients with myelofibrosis who have not had a history of treatment. Myelofibrosis is a rare blood cancer that affects the bone marrow and interferes with the body's normal production of blood cells. Patients suffer from symptoms such as an enlarged spleen, fatigue, itching, weight loss, night sweats, fever, and bone pain, which affect their quality of life. experience symptoms. Jakavi was the only JAK inhibitor approved for the treatment of myelofibrosis, and there was no alternative for patients who failed treatment. Inrebic is a treatment that appeared 10 years after Jakavi in the myelofibrosis market, where there was no second-line treatment option. Inrebic is currently covered through the Cancer Drug Fund in the UK. In 2021, NICE refused to apply Inrebic to NHS benefits. However, CDF recommends the use of Inrebic within its oncology fund for the treatment of splenomegaly or other symptoms associated with the disease in patients with myelofibrosis who have previously been treated with Jakavi.
- Company
- Will reimb limitations for Xospata be resolved this time?
- by Eo, Yun-Ho Apr 24, 2023 05:52am
- Whether Xospata will be able to produce results and receive reimbursement extensions this time is gaining attention. Dailpharm’s coverage showed that the agenda on expanding reimbursement standards for Xospata will likely be deliberated by the Health Insurance Review and Assessment Service(HIRA) Cancer Disease Deliberation Committee. The drug had been first approved for reimbursement in March of last year, but demand had been rising for its improvement due to the low effectiveness of the set standards. The drug is indicated for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation (FLT3mut+). However, only patients who received allogeneic hematopoietic stem cell transplantation are eligible for reimbursement for up to 4 cycles. It has been pointed out that there were insufficient medical grounds to say that patients with a large therapeutic benefit were first offered benefits due to limited NHI finances, and various voices of concern followed immediately after the reimbursement was applied. As an acute disease, the current benefit restriction has been pointed to as an issue that needs to be addressed to save patients from missing real treatment opportunities. The current best option for a cure in AML patients is hematopoietic stem cell transplantation, but this is accompanied by a high risk of recurrence, and transplantation is not an option for the large number of elderly AML patients that exist. Therefore, there is no suitable treatment alternative other than Xospata available for patients who cannot undergo hematopoietic stem cell transplantations, and these patients are still using the chemotherapy that was developed over 40 years ago due to ineligibility for reimbursement of Xospata. Also, Xospata can offer an opportunity for a complete cure in patients who cannot receive transplantation from their initial treatment stage, but the limited reimbursement standards are depriving patients of the opportunity to start their initial treatment with Xospata. Therefore, it remains to be seen whether Xospata’s reimbursement extension will be deliberated in the upcoming CDDC meeting and produce positive results. Xospata targets both types of FLT3 mutations, FLT3-ITD and FLT3-TKD, and may be self-administered at home as a single oral tablet once daily without frequent hospital visits. Also, Xostapa has improved efficacy compared with existing chemotherapy.
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- Hanmi Pharm, leading the outpatient prescription market
- by Chon, Seung-Hyun Apr 24, 2023 05:52am
- Hanmi Pharmaceutical continued its strong performance in the outpatient prescription market. With self-developed new complex drugs such as Rosuzet and Amosartan, it has been at the forefront of domestic and foreign pharmaceutical companies. Chong Kun Dang and Daewoong Pharmaceutical took the lead with high growth, while Daewoong Bio showed a steep rise. According to UBIST, a pharmaceutical research institute, on the 24th, Hanmi Pharm raised the highest outpatient prescription amount of 219 billion won in the first quarter, taking the lead among domestic and foreign pharmaceutical companies. It rose 7.0% from the previous year, predicting the lead for six consecutive years. Hanmi Pharmaceutical ranked first in prescription performance for the first time in 2018, and has been ranked first for five consecutive years until last year. Hanmi Pharmaceutical continued its leadership in the prescription drug market with new combination drugs. Rosuzet, a combination drug for hyperlipidemia, recorded W41.5bn in prescriptions, up 13.1% YoY in 1Q. Among all pharmaceuticals, it ranked second after Lipitor. Launched at the end of 2015, Rosuzet is a combination drug for hyperlipidemia consisting of Rosuvastatin and Ezetimbibe. Rosuzet is experiencing rapid growth thanks to market dominance and the popularity of its statin-ezetimibe complex. Rosuzet exceeded 100 billion won in prescriptions for three consecutive years from 2020. Rosuzet has been recording more than 10 billion won in prescriptions for 25 consecutive months from March 2021. Although domestic pharmaceutical companies are entering the statin/ezetimibe market in droves and competing overheated, Rosuzet has continued to grow rapidly based on its accumulated reliability. Amosartan also showed off its health. Along with Amosartan, Hanmi Pharmaceutical is selling Amosartanplus, Amosartan Q, and Amosartan XQ. Amosartan prescriptions increased 3.6% YoY to W22.1bn in the first quarter. Amosartanplus posted KRW 7.6 billion, up 6.5% YoY, and Amosartan XQ recorded KRW 2.3 billion, more than doubling from 1Q last year. Chong Kun Dang and Daewoong Pharmaceutical showed high growth and chased the leader. Chong Kun Dang's outpatient prescriptions in the first quarter were 172 billion won, up 14.9 percent from the previous year, ranking second. Chong Kun Dang ranked second in prescription performance for five consecutive years from 2018 to last year. Chongkundang Gliatirin, a brain function enhancer containing choline alfoscerate, recorded KRW 26.9 billion in prescriptions in the first quarter, up 13.7% from the previous year. Emorton, an osteoarthritis treatment, recorded KRW 14.4 billion in prescriptions in the first quarter, up 15.9% from the previous year. Imotun is an OTC made from extracts of 'Avocado-Soya Unsaponifiables'. As a result of the re-evaluation of benefits, the health authorities concluded at the end of last year that Emorten's benefits were appropriate, and it escaped from the danger of deleting benefits and its prescription performance increased further. Chong Kun Dang's new combination drug, Telminuvo, recorded KRW 13.4 billion in prescriptions, up 8.5% YoY in 1Q. Telminuvo is a combination drug combining Telmisartan and S-Amlodipine. Daewoong Pharmaceutical recorded KRW 137.6 billion in outpatient prescriptions in the first quarter, up 16.4% from the previous year. A new drug, Fexuclue, has been newly added. Fexuclue recorded KRW 10.8 billion in outpatient prescriptions in the first quarter. Fexuclue is a P-CAB class drug for the treatment of gastroesophageal reflux disease. Fexuclue received marketing permission from the Ministry of Food and Drug Safety in December 2021 and started selling in earnest as it was listed on the health insurance reimbursement list in July of last year. Fexuclue recorded KRW 3.3 billion in prescriptions in January, and expanded its prescription volume to KRW 3.6 billion and KRW 4 billion in February and March, respectively. Daewoong Bio showed the highest growth rate among major pharmaceutical companies. Daewoong Bio's first quarter prescriptions increased by 24.7% year-on-year to KRW 100.9 billion. Prescriptions for gliatamine, a component of choline alfoscerate, increased 25.8% from the previous year to KRW 37.1 billion in the first quarter.
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- Dong-A ST, preclinical results for immuno-cancer drugs
- by Kim, Jin-Gu Apr 23, 2023 09:44pm
- Dong-A ST announced on the 20th that it announced the results of a preclinical study of the immuno-cancer drug candidate "DA-4505" at the American Association for Cancer Research, AACR) 2023 held in Orlando, Florida from the 14th to the 19th. The American Cancer Research Association is called the world's top three cancer societies, and is an annual academic conference where pharmaceutical bio companies from 120 countries participate to share cancer-related knowledge and research results. At the conference, Dong-A ST announced the "anti-tumor effect of DA-4505, a new aryl hydrocarbon receptor antagonist as an immune treatment in a tumor microenvironment," and "improving the efficacy of anticancer surgery and chemotherapy through the anti-tumor effect of a new AhR antagonist DA-4505. DA-4505 is an aryl hydrocarbon receptor (AhR) antagonist. AhR is a factor that regulates the immune system and plays a role in suppressing the immune response and preventing tumor cells from being attacked. Preclinically, DA-4505 has been shown to restore the inhibited immune response in the tumor microenvironment by inhibiting AhR. It has also been observed that stimulating immune cells such as dendritic cells and T cells are activated and cancer cells inhibit immunity. The improved tumor suppression effect was confirmed through preclinical comparison with AhR antagonists under development by global pharmaceutical companies. In addition, the increased tumor suppression effect was confirmed through the combination of DA-4505 and global pharmaceutical companies' anti-PD-1 immune checkpoint inhibitors. Global pharmaceutical companies are competing to develop AhR antagonists with new mechanisms of anticancer drugs, said Park Jae-hong, president of the R&D division of Dong-A ST. "We plan to apply for phase 1 clinical IND of DA-4505 in the second quarter of this year," he said.
- Company
- Patent dispute for Soliris faces 2nd trial/original company
- by Kim, Jin-Gu Apr 23, 2023 08:22pm
- SolirisThe dispute over Soliris patents between Samsung Bioepis and Alexion will be dealt with in the second trial. According to the pharmaceutical industry on the 19th, Alexion recently filed a lawsuit against Samsung Bioepis to cancel the trial decision. Alexion registered two Soliris patents. However, among the two patents, the composition patent expired in July 2015. The remaining patents are patents for use that expire in 2025. In June last year, Samsung Bioepis filed a request for invalidation of the patent for use. In February this year, Samsung Bioepis won the first trial. Samsung Bioepis qualified for the release of the Soliris biosimilar by winning the first trial. However, there is a possibility that a reversal ruling will be made in the second trial, so the product release is burdensome. Samsung Bioepis completed Phase 3 clinical trials for Soliris biosimilar in October 2021. He then applied for an item license to the Ministry of Food and Drug Safety in July last year. In November last year, it applied for and registered trademarks under the names of EPYSQLI and EPIZQA. If the patent dispute with Alexion is resolved and the item is approved, the product can be released. Soliris is a rare disease treatment developed by Alexion in the United States. It is known to be an ultra-high-priced drug with an annual drug cost of 500 million won. In Korea, AstraZeneca Korea is in charge of sales. In January 2010, it was approved in Korea as an indication of PNH. Since then, indications have expanded to atypical uremic syndrome, systemic septal work force, and optic nerve ulcer. The pharmaceutical industry is paying attention to the timing of Samsung Bioepis' release of the Soliris biosimilar. This is because Soliris is rapidly being replaced by Ultomiris, a follow-up drug. According to IQVIA, a pharmaceutical market research firm, Soliris' sales were 10.1 billion won last year. It decreased by one-third from 31.1 billion won in 2021. Ultomiris, on the other hand, increased 2.2 times from 19.5 billion won to 43.2 billion won during the period.
- Company
- Pfizer Launches 'Pfizer Pro', a Customized Digital Platform
- by Eo, Yun-Ho Apr 23, 2023 07:48pm
- Pfizer Pharmaceutical Korea (CEO Oh Dong-wook) announced on the 12th that it has launched an integrated digital platform "Pfizer PRO" for health and medical experts to strengthen its Omni-Channel strategy. Pfizer Pro can be easily subscribed to by any health care professional and provides optimal content according to the preferred channel and format. Users can receive various pharmaceutical-related data, including the latest updates on Pfizer products, related disease information, and overseas treatment trends, and will be able to check product-related events and conference information and apply for participation right away within Pfizer Pro. Virtual Connect (VCC), a video meeting with a professional representative, can also be conveniently applied on the platform. Virtual Connect is a one-on-one video meeting held with professional managers on desired devices such as mobile, desktop, and tablet PCs at any time and place desired by medical staff. Pfizer Pro is an integrated customer communication channel prepared at the global level, has the same design and format around the world, and can be used intuitively with a UI configuration based on customer convenience. This is part of Pfizer's strategy to strengthen omnichannel, which puts customer-centered communication and experience first, and has been transformed into an integrated platform at the enterprise level by expanding the existing digital channels operated by each business unit. In the future, functions tailored to the needs of health care experts, such as communication channels, will be continuously developed and strengthened. Oh Dong-wook, CEO of Pfizer, said, "Pfizer is using bold investments and strategies that prioritize customer-centered innovation to provide the optimal customer experience in a rapidly changing market. We will not stop at the launch of this platform, which will play a pivotal role as a hub for various channels to communicate with customers, but will continue to lead various challenges and innovations according to customer needs."
- Company
- Piqray to soon be deliberated by CDDC for reimb
- by Eo, Yun-Ho Apr 21, 2023 05:55am
- Whether reimbursement discussions for the PIK3CA gene-targeting anticancer drug ‘Piqray’ will make progress is gaining attention. According to industry sources, Novartis Korea’s Piqray (alpelisib) is expected to be deliberated at the coming Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee meeting. The drug had been unable to pass deliberations from the same committee in February last year and had refiled an application for reimbursement at the end of last year. However, based on CDDC’s A8 country assessment results that were disclosed after the meeting, reimbursement standards discussed this time will be narrowed to PIK3CA mutation-positive patients whose tumor had progressed after being treated with CDK4/6 inhibitor·aromatase inhibitor combination therapy. Currently, Piqray is being reimbursed in HTA countries including the UK and Canada. What kind of results Piqray and its narrowed reimbursement standards will produce this time remains to be seen. Piqray, which was approved in Korea in May 2021, is a PIK3Caα inhibitor that blocks the overactivation of the PI3K pathway by inhibiting the over-activation of PI3K-α caused by a mutation of a PIK3CA gene. The targeted therapy is prescribed in combination with ‘Faslodex (fulvestrant)’ for patients with HR+/HER2- metastatic or advanced breast cancer who have progressed on or after prior therapies. Meanwhile, the efficacy of Piqray was demonstrated in the SOLAR-1 trial, a study on 572 men and postmenopausal women with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor. Results showed that Piqray, when used in combination with Faslodex, improved the median PFS (Progression- Free survival) of cancer patients with the PIK3CA mutation from 5.7 months to 11 months. The objective response rate (ORR) that shows the proportion of patients whose tumor size had reduced by 30% or more was 35.7% in the combination therapy group, which was over a twofold difference from the 16.2% in the monotherapy group. Although the secondary endpoint, overall survival (OS) in the PIK3CA-mutated cancer group was 39.3 months in the combination therapy group, 8 months longer than the 31.4 months in the monotherapy group, the results were not statistically significant.
- Company
- Expansion of reimbursement for DM drugs
- by Moon, sung-ho Apr 20, 2023 05:58am
- Donga ST Suganon and LG Chem Zemidapa Amid the expansion of reimbursement criteria between diabetes treatments by class from April, attention is focused on the expansion of the two-drug combination of SGLT-2 inhibitor and DPP-4 inhibitor. This is because pharmaceutical companies are waiting for a reimbursement after receiving approval for a combination of DPP-4 inhibitor + SGLT-2 inhibitor. According to the pharmaceutical industry on the 11th, HIRA recently provided guidance through Q&A on matters to be aware of when prescribing medical institutions in accordance with the expansion of the reimbursement standard for diabetes treatment by category. First of all, since April, the number of subjects for the three-drug therapy has also increased. If the HbA1C is 7% or higher even if the two-drug regimen is administered for more than 2 to 4 months, combination therapy with one diabetes drug of a different mechanism added is acceptable. For the three-drug regimen, reimbursement standards for the combination of 'metformin + SGLT-2 inhibitor + DPP-4 inhibitor' and 'metformin + SGLT-2 inhibitor + Thiazolidinediones' have been set. However, combinations of drugs that are not recognized in the two-drug regimen should not be included. Among them, Steglatro has been excluded from the combination of metformin + SGLT-2 inhibitor + TZD. What is noteworthy is that the two-drug combination of 'SGLT-2 inhibitor and DPP-4 inhibitor', which was highly demanded in the April reimbursement standard expansion, was not included. Pharmaceutical companies are competitively launching 'SGLT-2 inhibitor and DPP-4 inhibitor' combination drugs. Recently, Dong-A ST obtained approval for Sugadapa, a combination drug of the SGLT-2 inhibitor family, and announced the release. Sugadapa is a combination drug that combines Evogliptin, the main ingredient of the DPP-4 inhibitor diabetes treatment 'Suganon' developed by Dong-A ST, and Dapagliflozin, an SGLT-2 inhibitor. Ildong Pharmaceutical is also actively conducting academic marketing for Qtern, which was introduced from AstraZeneca and released as a non-reimbursement, while LG Chem recently launched Zemidapa, a new diabetes combination drug based on Zemiglo. Zemidapa is also a combination drug that combines Gemipliptin, a DPP-4 inhibitor, and Dapagliflozin, an SGLT-2 inhibitor. Dong-A ST made it official that "Sugadapa will go through the health insurance registration process when the combined benefit is expanded after the release of non-coverage." The pharmaceutical industry evaluated that the two-drug regimen between SGLT-2 + DPP-4 inhibitors is also busy, as it is about to be reimbursed. An official from the pharmaceutical industry, who requested anonymity, said, "Since the two-drug regimen between SGLT-2 + DPP-4 is also scheduled to be reimbursed, pharmaceutical companies are also conducting various sales and marketing activities to preoccupy the market." There are concerns that it may not be able to preoccupy its position in the clinical field due to the expansion of reimbursement standards and the pouring in of numerous generic items,” he expressed regret. He said, “We are looking forward to clinical site launches according to reimbursement application within the first half of the year.” “Since it is a newly approved item, it seems to have been excluded from the reimbursement standard revision because it is necessary for the reimbursement application process such as drug price setting. I have no choice but to," he said.
