- LOGIN
- MemberShip
- 2026-05-08 00:02:42
- Company
- Will Piqray benefit be successful again?
- by Eo, Yun-Ho Feb 16, 2023 05:50am
- Attention is focusing on whether Piqray, a PIK3CA gene target anticancer drug, can succeed in re-challenge insurance benefits. According to related industries, Novartis Korea's breast cancer treatment Piqray is expected to be presented to the HIRA Cancer Disease Review Committee in March. The drug failed to pass the deliberation committee once in February last year and submitted a re-application at the end of last year. Piqray, approved in Korea in May 2021, is a "PIK3CA억제 inhibitor" that blocks excessive activation of PI3K-의 due to PIK3CA gene mutation and is a target anticancer drug prescribed in combination with Faslodex in patients with HR+/HER2- metastatic and progressive breast cancer who have previously failed treatment. Piqray proved its effectiveness through a SOLAR-1 study conducted in 572 menopausal women and patients with advanced or metastatic breast cancer who were given or received HR-positive, HER2 negative, aromatase inhibitor, or AI. Clinical results showed that when Faslodex and Piqray were used together in tumor patients with PIK3CA mutations, the median progression-free survival (PFS) in patients with PIK3 tumors improved from 5.7 months to 11 months. The objective response rate (ORR), which represents the proportion of patients whose tumor size decreased by at least 30%, was 35.7% in the combination therapy group, more than twice as different as 16.2% in the single therapy group. The secondary evaluation variable, Overall Survival in patients with PIK3CA mutation, was 39.3 months in the combination therapy group, which was about 8 months longer than 31.4 months in the monotherapy group, but was not statistically significant.
- Company
- Astellas Korea appoints Junil Kim as new head
- by Eo, Yun-Ho Feb 15, 2023 05:59am
- Astellas Pharma Korea will now be run by a Korean head. According to industry sources, Junil Kim (50) was appointed to succeed Marker Weber and head the Korean subsidiary of Astellas Pharma. With the appointment, Astellas Korea will be welcoming the first Korean head in 7 years since the resignation of Jung Hae-doh in 2017. After Jung, Astellas Korea maintained a foreign representative system, appointing Takenoya Osamu, Masujima Keita, then Marcus Weber as General Manager of the Korean subsidiary. Junil Kim is a seasoned veteran in the field. After graduating from Chung-Ang University School of Pharmacy, Kim entered the industry as a medical representative for GSK Korea, then held various roles at Bayer Singapore Asia Pacific headquarters, Bayer Korea, Bayer headquarters in Germany, and served as General Manager at Bayer Philippines. Astella Korea's former GM, Marker Weber, was appointed GM of the Korean subsidiary in April 2020. Weber was appointed to head the company's German subsidiary in 2023.
- Company
- Dementia with Lewy bodies rises as a new blue ocean
- by Feb 15, 2023 05:58am
- Byoung-Suk Ye, Professor of Neurology at Severance Hospital is presenting the latest findings in dementia (Pic: Dailypharm reporter Jin-Joong Hwang Dementia with Lewy bodies (DLB), the second most common type of neurodegenerative disease, is expected to rise as a blue ocean in the development of diagnostics and treatments for dementia. DLB has the limitation of being difficult to diagnose in the field as no clear diagnostic method has been developed for the disease. In the industry, the prevailing opinion is that Lewy bodies should also be considered in addition to Alzheimer's to develop more effective drugs for dementia. ◆No method available to diagnose Lewy bodies...additional studies needed According to industry sources on the 14th, Byoung-Suk Ye, Professor of Neurology at Severance Hospital, said, “Alzheimer’s is characterized by memory loss and is the most common cause of dementia, but it is not dementia itself. DLB is the second most common cause of dementia that often accompanies Alzheimer’s, but is rarely diagnosed clinically in the field" while presenting at the Seoul Innovative Medicine Salon that was held at Korea Development Bank the day before. Lewy bodies are pathologically defined by the cytoplasmic accumulation of alpha-synuclein deposited inside the patient's cerebral cortical neurons. The dementia symptoms are considered to occur when the cytoplasmic accumulation of alpha-synuclein (aSyn) deposition creates Lewy bodies. Alzheimer’s dementia, a representative neurodegenerative disease, and symptoms of dementia are known to be caused by beta-amyloid aggregation or hyperphosphorylated tau proteins. DLB and Parkinson's disease dementia (PDD) share pathological causes. In Parkinson's disease, a decline in motor function appears first, and dementia symptoms usually occur after a period of 1 to 2 years. However, in DLB, a decline in cognitive function occurs first or a decline in motor function and cognitive function at the same time. Characteristic symptoms of Alzheimer’s (left) and Lewy Body disease (Pic: Dailypharm reporter Jin-Joong Hwang) Major symptoms of DLB include a decline in cognitive function, visual disorder, REM (rapid eye movement sleep) behavior disorder, autonomic nervous system abnormalities, hypersomnia, loss of smell, hallucinations, and depression. Cognitive decline is more prominently shown in a loss in concentration, executive ability, and visuospatial function than in memory. Also, another characteristic is the unstable decline and improvement in cognitive function. On the other hand, in Alzheimer's dementia, memory relatively steadily declines. As of now, no clear method exists for its diagnosis. In the field, it is believed that Lewy bodies may be diagnosed using fluorodeoxyglucose (FDG)-positron emission tomography (PET). However, there is no study that quantitatively proves that Lewy bodies can be diagnosed with PDG-PET. With no proven diagnostic method available, there are limitations to distinguishing and diagnosing Lewy bodies in the clinical field. On the other hand, as Alzheimer's is known to be caused by the deposition of beta-amyloid, it can be identified relatively easily using amyloid-PET. Professor Ye said, “According to autopsy studies, 40% of patients with Alzheimer's disease also showed the pathological presence of Lewy body. Unless DLB is included in the diagnostic model, there is possibility that all dementias will be considered as Alzheimer's." Also, no diagnostic method yet exists to differentiate Lewy bodies from Alzheimer's in amyloid-positive patients. Professor Ye said, “When diagnosing dementia using only amyloid-PET, it is highly likely that many of the patients may have amyloid-positive and tau-negative Lewy bodies.” ◆Should consider patients with mixed dementia that may have a combined Alzheimer's, Parkinson’s, or Lewy body disease when developing a drug for dementia The reason why it is necessary to distinguish not only Alzheimer's or Parkinson's when diagnosing dementia-causing diseases, but also Lewy body disease, is that there are many cases where a mix of the three diseases appear. Even if a new drug that reduces beta amyloid proteins or tau proteins is developed, if alpha-synuclein, the cause of Lewy body disease remains accumulated in the brain, it is highly likely that the new drug’s treatment effect will not appear. In addition to diagnostics for Lewy body disease, a diagnostic method is also needed to distinguish mixed Alzheimer's, where a patient suffers from Alzheimer's and Lewy body disease at the same time. Professor Ye emphasized, “Patients with just Alzheimer's disease and patients with mixed Alzheimer's have different natural courses and responses to drugs. These patients need to be distinguished to accurately determine the effect of dementia treatments. Professor Ye added, "It is important to secure real-world data (RWD) by using approved Alzheimer's treatments in clinical practice. I have been explaining the importance of distinguishing Lewy bodies from other causes of dementia to large multinational pharmaceutical companies, however, the need has not been delivered well because the people in charge are not practicing on-site. However, interest has been increasing recently after scholars and experts in dementia treatment overseas began to emphasize the need to distinguish Lewy body disease.
- Company
- GSK immuno-cancer drug Jemperli begins free supply in Korea
- by Eo, Yun-Ho Feb 14, 2023 05:49am
- GSK has launched a free supply program for the immuno-cancer drug Jemperli. According to related industries, GSK Korea is currently conducting Expanded Access Program (EAP) at 15 major medical institutions. Unlike the same type of immuno-cancer drug, Jemperli, a PD-1 inhibitor, plans to provide a first prescription opportunity to patients who need it as it was first approved for dMMR and MSI-H endometrial cancer, which is undergoing treatment or post-treatment with platinum-based systemic chemotherapy. Endometrial cancer is cancer that occurs in the endometrium which constitutes the inner wall of the uterine body and accounts for most uterine body cancer. Approximately one in four endometrial cancer patients is progressive or experiences recurrence, and there is a limit to the limited treatment available when the disease recurs after platinum-based chemotherapy. Jemperli's permission was based on cohort A1 analysis results registered with recurrent or progressive dMMR/MSI-H endometrial cancer patients during or after platinum-based systemic chemotherapy during a multi-cohort phase 1 clinical GARNET study in patients with recurrent or progressive solid cancer. In particular, the cohort is the largest among PD-1 inhibitor-only therapy studies conducted so far for dMMR/MSI-H endometrial cancer patients. The primary evaluation variables of the study were the objective response rate (ORR) evaluated by Blind Independent Central Review (BICR) using the solid cancer response evaluation criterion Response Evaluation Criteria Solid Tumors (RECIST) and the duration of the reaction. An analysis of a total of 108 patients based on 16.3 months of median follow-up period found that Jemperli exhibited continuous anti-tumor activity and manageable safety profiles. The objective response rate according to treatment was 43.5% (95% CI, 34.0-53.4), and the duration of the reaction has not yet reached the median. The Disease Control Rate (DCR) was found to be 55.6% (95% CI, 45.7-65.1), with 97.9% and 90.9% of treatment responses lasting for 6 months and 12 months, respectively. Kim Jae-won, a professor of obstetrics and gynecology at Seoul National University Hospital (Chairman of the Korean Women's Oncology Association), said, "Most endometrial cancers are diagnosed early and have a relatively good prognosis, but there is a limit to the treatment that can be used when they recur after platinum-based chemotherapy." In addition, he explained, "Tumors with dMMR/MSI-H have a good response to PD-1 inhibitor treatment, and with the permission of Gemperry, which has a significant treatment effect, safety profile, and treatment convenience, new possibilities have been suggested for secondary treatment of recurrent or progressive dMMR/MSI-H endometrial cancer in Korea."
- Company
- SK Plasma is exclusively selling Dacogen in Korea
- by Chon, Seung-Hyun Feb 14, 2023 05:48am
- Chaeri Hwang, CEO of Janssen Korea (left), and Kim Seung-joo, CEO of SK PlasmaSK Plasma announced on the 13th that it has signed an exclusive domestic sales contract with Janssen Korea for the treatment of myeloid dysplasia syndrome and acute myeloid leukemia. Under the agreement, SK Plasma will be in charge of the domestic distribution and marketing of Dakogen, while Janssen Korea will be in charge of producing and supplying products. Dacogen is an intravenous anticancer drug essential for myeloid dysplasia syndrome and acute myeloid leukemia. Myeloid dysplasia syndrome is one of the blood cancers that occur in the bone marrow and is a disease characterized by abnormal blood cell formation in the bone marrow and reduction of normal white blood cells, red blood cells, and platelets in the peripheral blood. Acute myeloid leukemia is a type of leukemia in which a large number of myeloid hair cells, immature white blood cells, appear in the bone marrow and blood. In 2008, a new standard was applied to myeloid dysplasia syndrome, and the recognition standard was expanded for patients with acute myeloid leukemia twice in 2013 and 2023. Kim Seung-joo, CEO of SK Plasma, said, "This agreement has further strengthened our portfolio as a pharmaceutical company specializing in rare and intractable diseases," adding, "We will continue to strengthen our products related to rare and intractable diseases to help treat and improve the quality of life in Korea." SK Plasma is an independent corporation in charge of SK's blood products business. It was established as a 100% subsidiary of SK Chemicals through a physical division in May 2015. At the end of 2017, it was changed to a subsidiary of SK Discovery due to the transition of SK Chemicals' holding company system.
- Company
- The Paradox of Shingrix
- by Moon, sung-ho Feb 14, 2023 05:48am
- Domestic companies such as GC Pharma are in trouble. Shingrix Expected to Change the Domestic Shingles Vaccine Market With Expensive Premium Vaccine. Analysts say that two months after its launch in Korea, it is rarely showing its strength in the hospital and clinic markets. In particular, at the clinical site, GlaxoSmithKline (GSK) seems to be in confusion as some say that its competitors are benefiting from its marketing policy to raise awareness of shingles with the launch of Shingrix. According to the pharmaceutical industry and the medical community on the 11th, GSK's Shingrix vaccine was released in December last year and is currently available in hospitals and clinics. Shingrix is a vaccine used to prevent shingles in adults over the age of 50 and immunocompromised people over the age of 18. In particular, given that the prevention rate is more than 90% in all age groups over the age of 50, the prevention rate was dominant and the release of Shingrix would shake the domestic shingles vaccine market. Perhaps that's why competition among domestic companies over copyrights for Shingrix sales and marketing was fierce. As a result, the main character who won the copyright through fierce competition is "GC Pharma," which is called a vaccine master, and "Gwangdong Pharmaceutical," which maintains a continuous cooperative relationship with GSK. In the case of GC Pharma, the most vaccinated internal medicine is focused on sales and marketing, while Guangdong Pharmaceutical is focusing on otolaryngology, orthopedics, and rehabilitation medicine. Two months after Shingrix's launch in the hospital and clinic markets, the prevailing opinion is that there are not many patients who want to be vaccinated at the clinical site. It is evaluated that the relatively "high price" of Singrix served as a hurdle. According to the Medical Times report, the single inoculation price of Singrix in hospitals and clinics is between 250,000 won and 300,000 won. Considering that it is two inoculations, the inoculation price is distributed between 500,000 won and 600,000 won. Moon Yeon-hee, executive director of GSK's vaccine business division, explained at the launch meeting, "The price of Shingrix was set by comprehensively considering its efficacy and socio-economic effects on complications after shingles." The clinical site suggested that such a price setting was not suitable in the recent economic crisis caused by three high-interest rates, high prices, and high exchange rates. "As soon as Shingrix was released, we brought 20 to the clinic, but there are no inoculators yet," said a Seoul physician who asked not to be identified. "We offered 500,000 won for two inoculations, but patients want 300,000 won, which is impossible for clinics." Kwak Kyung-geun, vice president of the Korean Internal Medicine Association (Seoul Internal Medicine), said, "Patients are interested in it, but there is too much resistance to the price. Moreover, it is difficult for patients to actively explain the vaccine effect to patients because they understand that the benefits of vaccination are entirely taken by clinics." He said, "In Gangnam, etc., Shingrix can be inoculated, but this is not large considering the total consumer population," adding, "The company should reflect the level of medical services and the economic level, but I think the company has taken too far." Park Geun-tae, chairman of the Korean Internal Medicine Association (Park Geun-tae Internal Medicine Clinic), also said, "I think patients are reluctant to take Shingrix because it is too expensive," adding, "Moreover, the burden of getting it twice compared to other competing vaccines is also working." Both clinical sites and pharmaceutical industries are paying attention to GSK's recent activities to raise awareness of shingles such as TV advertisements. It is a shingles campaign advertisement with no product name or company name on the front of the advertisement featuring actor Ma Dong-seok. The Pharmaceutical Affairs Act is also related, but unlike advertisements by existing pharmaceutical companies, the main focus is to inform patients of the risk of shingles by focusing on diseases. This, was expected to raise public awareness of the need for shingles management. GSK official said, "Shingles is a disease that occurs a lot in the age of 50 or older in Korea," and stressed, "This advertisement is designed to provide accurate information and raise awareness of shingles disease." TV advertisements to raise awareness of shingles are working, but they pointed out that they are not leading to Singrix vaccination. This is due to the high inoculation price of 500,000 won to 600,000 won. Kwak Kyung-geun, vice president of the Medical Association, said, "TV advertisements have increased the number of patients inquiring about shingles vaccine," adding, "We compare and explain the antibody production rate for each shingles vaccine, but in terms of price, Shingrix tends to be burdened." "There are patients who are hepatically vaccinated with Zostavax or Sky Zoster while inquiring about shingles vaccine through TV advertisements," he said. As a result, some in the pharmaceutical industry say that competitors MSD or SK Bioscience are actually taking advantage of the shingles advertisement. According to the Health Insurance Review and Assessment Service, the average inoculation prices of MSD Zostavax and SK Bioscience Sky Zoster are distributed from 140,000 won to up to 190,000 won in Gangnam-gu, Seoul. Among them, Zostavax price is 10,000 to 20,000 won more expensive on average than Sky Zoster, but the price alone is more than 300,000 won cheaper than Shingrix. As a result, it is suggested that it is establishing itself in the market as a vaccine with "cost-effectiveness." A doctor-turned-domestic executive, who asked not to be identified, said, "One man windows and another man reps have raised awareness of shingles due to advertising effects, but competitors seem to be working. He hinted that sales and marketing will not be easy because it is difficult to release vaccine supplies to distributors in a situation where the margin rate is not large. This is a difficult part for GC Pharma and Kwangdong Pharmaceutical, which won the copyright by presenting a relatively low margin rate along with GSK, the developer of Shingrix. As local governments have recently competitively carried out projects to support shingles vaccination, the need to supply supplies to Zostavax and Sky Zoster is rather increasing. The supply of Zostavax and Sky Zoster has been insufficient in the general hospital and clinic markets. The shingles vaccine market is not reorganized around Shingrix, but rather, competitive items have recently benefited from reflection. Some even say that it is regrettable that the volume is rather small at a time when competitors are benefiting from shingles advertisements. Kim Joo-han, medical director of the Korean Society of Otolaryngologists (Open St. Mary's Otolaryngology Clinic), said, "Shingrix does not have many inoculations, but as local governments run shingles vaccine projects, even Zostavax and Sky Zoster supplies are insufficient."
- Company
- “5 of 10 TNF-αis prescribed last year were adalimumab”
- by Kim, Jin-Gu Feb 14, 2023 05:48am
- On the 13th, the healthcare big data analysis service Evidnet released the results of its analysis on the prescription data of 10 general hospitals nationwide last year. According to the results, ‘adalimumab (Humira)’ was the most frequently prescribed TNF- α inhibitor last year. Evidnet analyzed and announced 18,371 prescription data on TNF-α inhibitors from 10 general hospitals nationwide by indication and component last year. According to Evidnet, the most prescribed TNF-α inhibitor was adalimumab, which accounted for 50.7% of all prescriptions last year. Next was infliximab (Remicade) at 20.2%, followed by etanercept (Enbrel) at 15.1%, then golimumab (Simponi) at 14.0%. By indication, TNF-α inhibitors were most prescribed for ankylosing spondylitis, which accounted for 50.7% of all prescriptions, followed by rheumatoid arthritis (19.5%), Crohn's disease (13.0%), ulcerative colitis (5.7%), uveitis (5.3%), psoriasis (3.5%), then others (4.1%). by ingredient, etanercept (18.3%) and infliximab (16.4%) were prescribed the most for ankylosing spondylitis. In rheumatoid arthritis, adalimumab (46.0%), etanercept (30.2%), then golimumab (16.4%) were prescribed the most. On the other hand, for Crohn's disease, the most prescribed substances were infliximab (54.2%) and adalimumab (45.7%). For ulcerative colitis, the most prescribed were infliximab (47.5%), adalimumab (32.2%), and golimumab (20.3%).
- Company
- Forxiga's patent war ended after eight years
- by Kim, Jin-Gu Feb 13, 2023 05:59am
- The Supreme Court sided with Generic in the dispute over Forxiga patents for SGLT-2 inhibitor-based diabetes treatment. Patent challengers will be able to release generics early after April 7. The Supreme Court's special second division ruled in the morning of the 2nd that AstraZeneca would dismiss the appeal in an appeal filed against 17 companies, including international drugs. Forxiga is protected by two substance patents. The first substance patent (10-0728085) expires on April 7, 2023, and the second substance patent (10-1021752) expires on January 8, 2024. In March 2015, 17 companies, including Kukje Pharmaceutical, filed a trial for invalidation of the second substance patent. In the first trial, generic companies won. In August 2019, the Patent Tribunal made a trial decision on the establishment of the claim. AstraZeneca objected. The patent court, which is the second trial, also sided with generic companies. The Patent Court ruled against the plaintiff in October 2020. The Supreme Court also sided with generics following the first and second trials. This effectively ended the eight-year patent dispute. The ruling will allow patent challengers to release Forxiga generics early after April 7, 2023, when the first substance patent expires. Generics have already overcome all the remaining patents. Generics won the first trial in August 2020 and even received generic for exclusivity. This means that SGLT-2 inhibitor-based generics will pour into the diabetes treatment market after April.
- Company
- Daewoong Nabota has obtained an item license in Singapore
- by Kim, Jin-Gu Feb 13, 2023 05:59am
- Daewoong Pharmaceutical announced on the 9th that its botulinum toxin "Nabota" obtained an item license in Singapore on the 20th of last month. The acquisition of Singapore permits was the first of its kind among domestic botulinum drugs, and Nabota has increased the number of licensed countries worldwide to 62. Nabota 100 units are approved by the Singapore Health and Science Agency (HSA). Daewoong Pharmaceutical applied for an item license in September 2021. Daewoong Pharmaceutical plans to release Nabota in Singapore in the third quarter of this year. Hypens Pharma Pte Ltd is in charge of local distribution and sales. Hypens Pharma is a subsidiary of the SGX-listed Hypens Group. Compared to other Southeast Asian countries, Singapore has a smaller botulinum toxin market. However, as the beauty and medical industries are developed with high national income, it is considered a strategic point for expanding the regional market. For this reason, it is expected to gradually expand to neighboring countries and increase brand awareness. Park Sung-soo, vice president of Daewoong Pharmaceutical, said, "Singapore has a great influence on the Southeast Asian beauty and medical industry," adding, "Not only is it meaningful in that it is the first botulinum toxin brand in Korea to obtain Singapore approval, but it is expected to accelerate Nabota's market expansion in Asia." Nabota is a botulinum toxin preparation that Daewoong Pharmaceutical released in Korea in 2014. It is the only FDA-approved in Asia as well as in Korea. As of February 2023, 62 countries, including the United States and Europe, are providing excellent beauty and treatment options, and Singapore is also expanding its global business by obtaining permission.
- Company
- Generic for Dukarb is coming soon
- by Kim, Jin-Gu Feb 13, 2023 05:58am
- According to the second trial decision of Dukarb on the 16th of this month, it is decided whether to release the core capacity at the same time. With Boryung Kanarb's generic set to be released next month, attention is focused on the second trial of the patent dispute, which is three days away. This is because the decision of the patent court determines whether to release the Dukarb generic core capacity at the same time. ◆Dukarb's generic will be released sequentially after registering next month's benefit According to the pharmaceutical industry on the 13th, the material patent of Boryung Kanarb expired as of the 1st of this month. In principle, a generic for Kanarb has become available. In addition, the remaining generics, except for the core capacity of Dukarb, which is protected by patents for composite compositions, will also be available. The drug that generics are paying attention to is Dukarb. Currently, 27 pharmaceutical companies have been licensed for 72 items of Dukarb generics with different capacities. No single-system Kanarb Generic has been licensed. They received permission for related products from December to January this year. He then applied for a salary registration with the HIRA. According to related regulations, Health insurance benefits will be announced two months after the date of application and will be applied as of the 1st of the following month. Since generic companies applied for salaries in December last year, it will be announced at the end of this month and the salaries will be applied from the 1st of next month. As a result, Dukarb generic is expected to be released sequentially after next month. Products from the four companies approved in December last year are expected to be released first on the 1st of next month, followed by products from the remaining 23 pharmaceutical companies on April 1. The pharmaceutical industry's attention is focused on the second trial of the Dukarb patent dispute, which is just three days away. This is because the ruling determines whether Dukarb's core capacity will be released simultaneously. Dukarb is protected by a patent that expires in 2031. However, the scope of this patent is limited to Dukarb 30/5 mg. Except for this capacity, the rest can be released after the 1st of next month regardless of the 2nd trial ruling. The key is the 30/5 mg product. If the patent court sides with Generic on the 16th of this month, Generic can release 27 items of Fimasartan and S-Amlodipine 30/2.5mg products simultaneously as other generics. In the case of S-Amlodipine, it is interpreted as half the dose of Amlodipine. The combination of Fimasartan and S-Amlodipine 30/2.5mg chosen by generics means that it is virtually the same drug as the original drug Dukarb's 30/5mg. If the court sides with Boryung in the second trial following the first trial, the timing of the release of the 30/2.5mg product by generics will be postponed. The product can be released only when generic companies win a reversal decision from the Supreme Court through an appeal or win a separate invalidation trial. If both methods fail, the capacity product may not be released until 2031, when the Dukarb patent expires. According to UBIST, a pharmaceutical market research firm, Dukarb's prescription last year was 46 billion won. Boryung explains that more than half of the performance comes from 30/5mg products, which are core doses.
