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- 2026-05-08 22:44:25
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- Viatris Korea will participate in the IMPACT WEEK
- by Eo, Yun-Ho Nov 22, 2021 05:52am
- Vitris Korea celebrated its first anniversary. On the 16th, Viatris announced that it will participate in the IMPACT WEEK designated by the world to mark the first anniversary of its launch, reflect on the past year, and carry out activities to commemorate the first anniversary with executives and employees. During Impact Week, Viartris will hold various events with executives and employees around the world under the theme of "Advancing Access: Everywhere Health Matters." On November 16th, U.S. time, an opening bell event and an outdoor advertisement campaign for the New York Times Square electronic display are scheduled to mark the first anniversary on the New York Stock Exchange. Linkedin Live discussion will also be held with various stakeholders to discuss ways to strengthen drug accessibility and events with the U.S. media the Hill. In addition, it plans to celebrate its first anniversary by communicating with Viatris employees around the world through the application. They will have time to express gratitude to employees around the world for their hard work over the past year and draw the future of Viatris together. In particular, Viatris Korea has time to express gratitude to employees and colleagues who have created our new journey together over the past year. Viatris Korea obtained domestic approval for MDR-TB tx Doveprella (Pretomanid) in October this year to increase access to patients in areas where unmet medical needs exist. Since domestic MDR-TB tx options have been limited over the past 50 years, it is meaningful in that it provides new treatment options to patients through the introduction of new treatments. In addition to Lipitor, Novasc, and Lyrica, Viatris Korea plans to realize its vision by expanding its portfolio to new treatment areas and enhancing accessibility. Lee Hye-young, CEO of Viatris Korea, said, "During the year of launch, the company has successfully adapted to the rapidly changing environment and has shown various results, and both the company and its employees are continuing a rewarding journey to become a 'company they want to work' with a new and healthy culture." In addition, she stressed, "As a new type of healthcare company, we will continue to do our best to contribute to the development of the domestic health care environment through active collaboration with various stakeholders." Meanwhile, Viatris is a global healthcare company launched in November 2020 by the combination of Upjohn and Mylan companies, which were Pfizer's business divisions, and was selected as Fortune Journal's 2021 Change the World in recognition of its accessibility to innovative HIV treatments over a decade.
- Company
- All-round prostate cancer treatment Xtandi with solid growth
- by Nov 18, 2021 05:55am
- Xtandi (enzalutamide)' rose to the ranks and became a blockbuster drug last year after continuously extending its indication in prostate cancer, a field that lacked treatment options. Although the drug was approved later than its competitor, through its continuous expansion effort, Xtandi became the only single-agent drug that is approved for use in both metastatic and nonmetastatic prostate cancer. Enzalutamide inhibits the AR signaling pathway by binding to the male hormone Androgen receptor (AR) to suppress the proliferation of cancer cells. Although the drug was approved later than its competitors such as ‘Zytiga (Janssen)’ or ‘Jevtana (Sanofi),’ in June 2013, Xtandi was the first to be approved for reimbursement. Xtandi was listed for reimbursement in November 2014 under the refund-type Risk-Sharing Agreement (RSA) scheme. During the 3.5 years that other drugs it took for the other drugs to receive reimbursement, Xtandi gradually took over the market as a second-line treatment for metastatic castrate-resistant prostate cancer. Xtandi sold over 10 billion to 20 billion in sales according to IQVIA from 2015 to 2017, when it was the only drug approved for reimbursement, while Zytiga sold 1 billion won and Jevtana 0.4-0.5 billion won in the same period. The multinational pharmaceutical company Pfizer recognized the potential of Xtandi and added it to its portfolio through an M&A with its original developer, Medivation. In Korea, Xtandi is continuously being supplied by Astellas, which had entered into a sales agreement with Medivation. It is distributed by Pfizer and Astellas in the U.S. ◆Used for all castration-resistant prostate cancer regardless of metastasis…Rises to the rank as No.18 blockbuster drug Xtandi gradually expanded its indications from its first indication as second-line treatment for metastatic castration-resistant prostate cancer to first-line, then to non-metastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer. Through its continuous expansion effort, Xtandi became the only single-agent drug that covers all metastatic and nonmetastatic, hormone-sensitive (castration-sensitive), and castration-resistant prostate cancer. The NCCN recommends Xtandi as a first-line treatment in metastatic castration-resistant prostate cancer, and as Category 1 in metastatic hormone-sensitive prostate cancer. With the recommendations, Xtandi has established its position as a leading prostate cancer treatment. Source: IQVIA In terms of domestic sales (based on IQVIA), Xtandi’s sales increased continuously since receiving reimbursement in November 2014 to record 13.9 billion won in 2015 to 18.8 billion won in 2016, 20 billion won in 2017 and 23.8 billion won in 2018. It is the highest-grossing new prostate cancer drug. It recorded the highest sales among new prostate cancer drugs. Although its sales briefly slowed down to 23 billion won in 2019, it rebounded last year to record nearly 30 billion won. Globally, Xtandi also outperformed the other drugs and rose to the ranks to become one of the top 20 blockbuster drugs for the first time last year. Last year, Xtandi sold 4.39 billion dollars (approx. 5.19 trillion won) in global sales and became the 18th best-selling drug in the world. Projected sales per Xtandi Furthermore, Astellas expressed its ambition to maximize Xtandi’s sales over the next five years. In the new strategic planning meeting that was held in May, Astellas projected that Xtandi will sell 600 billion to 700 billion yen (approx. 6.20 trillion-7.24 trillion won) at maximum by the fiscal year 2025 (March 2026). Astellas also plans to extend the indication to high-risk non-metastatic hormone-sensitive prostate cancer next year. ◆The introduction of new latecomer drugs and Zytiga’s late but rapid chase … use of PARP inhibitors allows for more specified treatment strategies The competition in the prostate cancer treatment market is intensifying. New drugs such as ‘Erleada (Janssen),’ ‘Nubeqa (Bayer)’ etc. are continuing to be introduced while PARP inhibitors that target BRCA mutation like ‘Lynparza (AstraZeneca)’ is expanding their scope to cover prostate cancer as well. Erleada is approved for non-metastatic hormone-sensitive and nonmetastatic castration-resistant prostate cancer in the US, and Nubeqa is approved for the high-risk nonmetastatic castration-resistant prostate cancer indication. Also, a PARP inhibitor was recently approved for prostate cancer and settled as a new treatment strategy and option for castration-resistant prostate cancer patients with BRCA 1/2 and DNA Damage Response (DDR). In particular, Lynparza in combination with Zytiga emerged as a stronger option by meeting the primary endpoint of radiological progression-free survival. The Lynparza+Zytiga combination aims to become a first-line treatment for metastatic castration-resistant prostate cancer regardless of genetic mutations. In Korea, the fact that Xtandi’s sales fell short in metastatic hormone-sensitive prostate cancer, which is the second-most on-demand area after metastatic castration-resistant prostate cancer, also leaves much to be desired in terms of expanding Xtandi sales. Zytiga added the indication in June 2018, and the latecomer Erleada was also approved for the indication at the end of last year, Xtandi only received approval for the indication in September this year. While Xtandi made no further progress since expanding reimbursement to first-line treatment in metastatic castration-resistant prostate cancer in May 2019, Zytiga persisted on the path to be approved for selective reimbursement in high-risk groups among metastatic hormone-sensitive prostate cancer patients in April this year. Although Xtandi was approved for both the high-risk and low-risk groups, Zytiga, which received limited approval for the high-risk group, holds the immediate upper hand in prescriptions. After the reimbursement expansion, Zytiga’s quarterly sales surged from 2 billion won to approximately 4 billion won. In response, Astellas is seeking a way to extend its indication and expand reimbursement of Xtandi from the current metastatic hormone-sensitive indication to cover all patients. In addition, the company is seeking a new treatment strategy through a clinical trial in combination with Pfizer’s PARP inhibitor ‘Talzenna.’ The clinical trial is expected to end in three years. Astella said, “We expect sales of Xtandi is to continue to grow due to its competitive price and the yearly increase of prostate cancer, the fourth most common cancer in men. Depending on the domestic situation, we are also considering adding further indications, and are planning to expand reimbursement to the treatment of metastatic hormone-sensitive prostate cancer regardless of the degree of risk.”
- Company
- Domestic approval of Tabrecta is imminent
- by Eo, Yun-Ho Nov 18, 2021 05:54am
- According to related industries, the MFDS is conducting a final review for marketing approval of Tabrecta (Capmatinib) of Novartis Korea. Approval is possible within this year. MET mutations account for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing. Tabrecta targets hepatocyte growth factor receptor (c-Met) and was first approved in the United States in May last year as a treatment for MET exon14 mutated metastatic non-small cell lung cancer (NSCLC). It was confirmed to be effective through a phase 2 GEOMETRY mono-1 study of 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among the patients who took Tabrecta, the median response duration (DoR) of previously untreated patients was 12.6 months and the patients treated were 9.7 months. Tabrecta is also spurring research for future combination therapy. In particular, it is expected to be able to solve the resistance problem of EGFR TKI in lung cancer. In fact, Tabrexta is conducting a clinical trial in combination with AstraZeneca's third-generation EGFR TKI Tagrisso. Combination therapy of Tabrecta and Tagrisso are compared with platinum-based chemotherapy in patients with EGFR mutated non-small cell lung cancer with T790M negative and amplified MET genes during treatment with 1st and 2nd generation EGFR TKI or Tagrisso. Janssen Korea has also applied for permission for Rybrevant (Amivantamab) to lower the MET. In the case of Rybrevant, it obtained US permission in May, blocking EGFR and MET mutations at the same time. The first indication of this drug is non-small cell lung cancer with EGFR Exon20 mutation.Rybrevant is conducting a study in combination with Leclaza (Lazertinib) of Yuhan Corporation, a new domestic drug.
- Company
- Hugel's toxin has been approved for national lot release
- by Nho, Byung Chul Nov 17, 2021 05:44am
- Status of approval for national lot release of Hugel toxin drugs published in the MFDS. As Hugel recently obtained approval from the Ministry of Food and Drug Safety for three types of botulinum toxin products, administrative measures such as "cancellation of permission" and "suspension of product sales" on the 10th proved once again that there was a difference in legal interpretation of indirect exports, not quality and safety issues. According to the status of national lot release approval for botulinum toxin posted on the website of the MFDS, Hugel received approval for 50 units of botulinum toxin formulation Botulax and 200 units of Botulax on the 15th. A day later, on the 16th, domestic sales of three Botulax products resumed as additional approval for 100 units of Botulax was obtained. Including the number of national lot releases, Hugel has obtained 156 cumulative approvals this year. It is the largest number of botulinum toxin companies in Korea. Competitors Daewoong Pharmaceutical, Medy Tox, and Huons have obtained national lot release approval for 84, 80, and 44 cases, respectively. Earlier on the 10th, the MFDS announced that it would start administrative disposition, collection, and disposal procedures for the company's products against Hugel for violating the national lot release. Hugel immediately announced its position and applied for cancellation and suspension of execution, including an order to suspend manufacturing and sales, to the Seoul Administrative Court on the same day. On the morning of the 11th, the next day, it submitted a provisional application for suspension of execution of the Ministry of Food and Drug Safety's disposition, and the court cited it, enabling the sale of four types of Botulax in Korea. An official from Hugel said, "This disposition by the MFDS is only a problem caused by differences in legal interpretation of indirect exports to the Pharmaceutical Affairs Act, and has nothing to do with the product quality of Botulax manufactured and produced by Hugel." He said, "Hugel has received the national lot release without any problems in terms of quality such as effectiveness and safety in compliance with the Pharmaceutical Affairs Act." Biological agents such as botulinum toxin must be approved for lot release to be sold in Korea.
- Company
- Rinvoq combo rises as optimal option in rheumatoid arthritis
- by Nov 17, 2021 05:44am
- AbbVie’s JAK inhibitor ‘Rinvoq (upadacitinib)’ in combination with MTX was found to improve the clinical remission achievement rate over the TNF-α inhibitor ‘Humira (adalimumab)’ combination therapy in rheumatoid arthritis. The Rinvoq combination therapy achieved a 20% range remission rate in the most commonly used DAS28 index as well as the strictest Boolean index. In the SELECT-COMPARE trial that was conducted on patients who had an inadequate response to MTX, 29% of the patients treated with Rinvoq+MTX achieved clinical remission per DAS28 at Week 12, which is a higher rate than the 18% in those treated with the adalimumab combination. Such results were consistent under other evaluation indexes such as the SDAI, CDAI, Boolean index. The differences were also consistent in the evaluations made at Week 26 and Week 48. At Week 48, Rinvoq’s remission achievement rate was 38% per DAS28, 25% per CDAI, and 21% per Boolean. Achievement of clinical remission in SELECT-COMPARE trial by disease activity evaluation index ◆Rinvoq maintained a 20% range remission rate with the Boolean index, a more stringent index than DAS28 DAS28 is the most widely used index to measure the achievement of clinical remission in rheumatoid arthritis, but Boolean is considered the most stringent index. First, DAS28 is evaluated using three thresholds in 28 joints - tender joint count (TJC), swollen joint count (SJC), and patient pain score on a visual analog scale (VAS). DAS28-CRP, which adds the C reactive protein (CRP) that is related to the progression of rheumatoid arthritis to DAS28, is most widely used. With the Boolean index, the ▲number of tender joints (TJC)≤1 ▲number of swollen joints (SJC)≤1 ▲CRP≤1mg/dL ▲Patient Comprehensive Assessment (PGA)≤1 (on a scale of 0-10) needs to all be satisfied to be considered to be in remission, therefore the range considered and accepted as remission is narrower with the Boolean index. This is why a study that analyzed the remission achievement rate of 3,209 rheumatoid arthritis patients in Korea with five disease activity indexes showed that the Boolean index had the lowest patient remission rate. ◆Remission achievement rate low for existing treatments when measured by various indexes…”We should consider new treatment options to meet new treatment goals” Based on data from the Korean College of Rheumatology Biologics Registry (KOBIO), the KCR Clinical Research Committee had previously presented the reemission achievement rate of rheumatoid arthritis patients who have been treated with biologics and oral targeted therapies during the past 5 years. Treatments included in the analysis were TNF-α inhibitors such as Humira, etc.; ‘Actemra (tocilizumab),’ ‘Orencia (abatacept),’ and ‘Xeljanx (tofacitinib).’ The KCR analyzed the remission achievement rate of the treatments above with five disease activity assessment indexes - DAS28-CRP, DAS28-ESR, CDAI, SDAI, Boolean - and the result showed that the achievement rate differed greatly by index. At week 48 after starting treatment, the remission achievement rate was near 56.0% per DAS28-CRP, but the dropped greatly to 10.4%, 12.7%, and 12.9% per more stringent indexes such as CDAI, SDAI, and Boolean, respectively. The rate of patients that maintained remission for 2 or more years, or ‘continuous remission,' was 62% per DAS28-CRP, but 8%, 11%, 13% per CDAI, SDAI, Boolean, respectively. With the remission rate of existing treatments falling to a 10% range in indexes that are relatively stringent compared to DAS28, the analysis was that a more detailed consideration is needed in setting a treatment strategy. Young-Il Seo, professor of Rheumatology at Hallym University Sacred Heart Hospital Pyeongchon, said, “the low remission achievement rate observed with CDAI, SDAI, and Boolean index suggests that patients experience greater difficulties in reality and that improvements are needed to increase treatment satisfaction. In this sense, we would need to more actively consider using treatment options that meet various indexes.”
- Company
- Exports of Botulinum drugs to the U.S. doubled
- by Kim, Jin-Gu Nov 17, 2021 05:44am
- The cumulative exports of domestic botulinum toxin drugs amounted to 220 billion won this year, the report showed. Exports to China, which had consistently accounted for a high proportion, have decreased, but exports to the U.S. and other countries have increased. According to the Korea Customs Service on the 15th, the cumulative exports of domestic botulinum toxin drugs amounted to $190.28 million between January and October this year. Compared to $161.09 million during the same period last year, it increased 18%. Looking at major exporters, dependence on China has decreased significantly compared to last year. Instead, exports to the U.S. and Brazil increased. Between January and October this year, domestic botulinum toxin exports to China amounted to $78.11 million, down 13% from $89.97 million during the same period last year. During the period, China's share of total botulinum toxin exports decreased by 15%p from 57% to 42%. Exports to the United States increased 110% from $12.2 million to $25.61 million. The share of U.S. exports increased from 8% to 13%. It is analyzed that exports to the U.S. more than doubled due to the end of the Nabota-related dispute. Earlier this year, Daewoong Pharmaceutical's U.S. partner Evolus concluded the dispute with Medy Tox and Allergan by agreement. Since then, Nabota's monthly exports to the U.S. have been around $2.5 million to $3 million. This is in contrast to exports from the second half of 2019 to the beginning of last year, when the dispute was in full swing. In addition to the U.S., exports to Brazil and Japan have increased. In Brazil, it increased 59% from $10.5 million between January and October last year to $16.74 million between January and October this year. In the case of Japan, it increased 39% from $6.54 million to $9.11 million during the period. Thailand, a major exporter, fell 16% from $13.83 million to $11.58 million. As exports to Brazil increased significantly during the same period, the third-largest exporter of domestic Botulinum toxin changed from Thailand to Brazil.
- Company
- Celltrion's COVID-19 tx is approved for sale in Europe
- by Chon, Seung-Hyun Nov 17, 2021 05:44am
- Regkirona, a COVID-19 antibody treatment developed by Celltrion, has been approved in Europe. Celltrion announced on the 15th that the EC approved Regkirona on the 12th (local time) for the final sale for the purpose of treating COVID-19. Regkirona has been approved for the treatment of adult patients aged 18 or older who have been confirmed with COVID-19 who do not require oxygen supply and are likely to be severely transmitted. It is a single administration of 60 minutes intravenously, the same as domestic item permission. Regkirona officially received an item license from the EC a day after obtaining an approval recommendation from the CHMP under the European Medicines Agency (EMA) on the 11th. Celltrion said, "If CHMP usually recommends approval for new drug approval, EC's final item approval will be completed 1-2 months later, but in this case, official item approval continued in a day," and explained, "It can be interpreted as an EC-level effort to quickly cope with the surge in the number of COVID-19 confirmed cases in Europe." Regkirona is the first new antibody drug developed in Korea to obtain an official item license in Europe. Regkirona obtained emergency approval from the BPOM and the ANVISA in July and August, and in September, it obtained a formal item license from the MFDS in Korea. Regkirona is administered to 22,587 patients in 129 hospitals as of the announcement of Central Disaster and Safety Counters Headquaters (CDSCHQ) on the 12th and is actively used to treat COVID-19 patients in Korea. Regkirona confirmed the safety and effectiveness of the global phase 3 clinical results conducted on 1,315 mild and moderate COVID-19 patients in 13 countries around the world, including Korea, the United States, Spain, and Romania. In the high-risk group of patients administered Regkirona, the incidence of severe patients decreased by 72% compared to the placebo group, and the clinical symptom improvement time was also reduced by more than 4.7 days compared to the placebo group in the high-risk group. An official from Celltrion said, "We will do our best to help many COVID-19 patients in Europe benefit from Regkirona's proven safety and effectiveness, and to contribute to the end of the global COVID-19 crisis."
- Company
- Drug price negotiations for Xospata began
- by Eo, Yun-Ho Nov 16, 2021 05:53am
- The new leukemia drug Xospata is in the final procedure for insurance benefit registration. According to related industries, Astellas recently entered into drug price negotiations with the NHIS for Xospata(Gilteritinib), a treatment for Acute Myeloid Leukemia (AML). The negotiation deadline is until the 20th of next month. After receiving a conditional benefit decision at the HIRA's Drug Reimbursement Evaluation Committee in September, the drug accepted the proposed valuation amount and went through a drug price negotiation process. It remains to be seen whether Xospata will be able to complete negotiations with the government until the end and be listed. Xospata is the first FLT3 targeted anticancer drug in Korea to be approved by the MFDS as a target treatment for FLT3 mutation positive (FLT3mut+) recurrence or refractory (R/R) AML. This drug targets both FLT3-ITD and FLT3-TKD, which are divided into two mutant forms, and is a monotherapy that is taken once a day and can be treated on its own at home without frequent hospital visits. It also showed higher effectiveness and safety than conventional chemotherapy. In addition, Xospata has been classified as 'Category 1', the highest recommended grade for the treatment of patients with recurrent or refractory AML with positive FLT3 mutation in the latest guidelines of NCCN. Kim Hee-je, a professor of hematology at Seoul St. Mary's Hospital, said, "With the approval of Xospata in Korea, patients can relieve anxiety. Of course, there are still cost issues, but we expect it to become a standardized treatment as soon as possible after registering benefit, the professor said.
- Company
- Somavert can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 16, 2021 05:52am
- According to related industries, Pfizer Korea's Somavert (Pegvisomant) has currently passed the Drug Committee (DC) of medical institutions such as Seoul National University Hospital and Sinchon Severance Hospital, and is also undergoing procedures at medical institutions such as Seoul National University Bundang Hospital, Wonju Severance Hospital, and Samsung Medical Center. In the case of terminal hypertrophy, Sinchon Severance Hospital is taking care of the largest number of patients, so it is expected to lead to prescription fast. Somavert has been listed on the insurance benefit list since September. Somavert demonstrated its validity through a 12-week randomized, double-blind study of 12 patients with terminal hypertrophy. The study found that the median serum IGF-I concentration at 12 weeks of study compared to the baseline was 4.0±16.8%, 26.7±27.9%, 50.1±26.7%, and 62.5±21.3%, respectively, in the placebo group, Pegvisomant 10 mg group, Pegvisomant 15 mg group, and Pegvisomant 20 mg group. The proportion of patients whose serum IFG-I concentration returned to normal compared to baseline was also found to be significantly higher than that of placebo, Pegvisomant 10 mg/day administration group, Pegvisomant 15 mg/day administration group, and Pegvisomant 20 mg/day administration group, respectively, indicating that Pegvisomant was significantly higher than placebo. Meanwhile, Somavert was approved in Korea in September last year for the treatment of adult terminal hypertrophy patients who do not respond appropriately to surgery and radiation therapy, or whose IGF-I (Insulin-like growth factor I) concentration is not normalized by somatostatin analog therapy, and was designated as a rare drug in 2018.
- Company
- Sales of Arcoxia (Etoricoxib) are sluggish
- by Kim, Jin-Gu Nov 16, 2021 05:52am
- Generics for Arcoxia, an anti-inflammatory pain reliever based on COX-2 inhibitors (Etoricoxib) have been released, but sales in the market are sluggish. This is because there is still a high preference for original drugs at the medical site, and even the original drugs are pushed back by Celebrex, a leading item in the same family market. According to UBIST, a pharmaceutical market research firm on the 11th, the total prescription amount for generics for Arcoxia from June to September is around 31 million won. During this period, the original prescription amount is around 730 million won. Generic prescriptions account for only 4% of the original. Generics challenged Arcoxia's patent in September 2019. In April last year, it won the passive trial to confirm the scope of rights. It succeeded in avoiding patents that were scheduled to expire in 2023. Theragen Etex, Guju, Hana, Hutechs, Union Korea, Aju, Daewoo, Boryung, Arlico, and Reyon received generic for exclusivity from April this year to January next year. Generics have been released in earnest since June this year. Aju, Arlico, Hutechs, Hana, Theragen, and Etex are confirmed to have released generics one after another. However, for four months, their total prescription amount is only 31 million won. Hana's sales are the highest at 19 million won, and sales of the other generics are less than 10 million won. This is because the original preference is still high at the prescription site. As of last year, outpatient's prescription for Celebrex amounted to 44.7 billion won. It is more than 12 times Arcoxia's sales of 3.5 billion won.42 billion won and 2.7 billion won worth of prescriptions were prescribed by the third quarter, respectively, widening the gap by 15 times. Since 2010, more than 200 generics for Celebrex have been competing. Generics for Arcoxia have little time to compete. The generic for exclusivity period will end in January next year, but no company has started developing generics for Arcoxia yet.
