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- 2025-12-26 22:50:17
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- Targeted therapy Tagrisso back on track expanding coverage
- by Eo, Yun-Ho Sep 25, 2020 06:06am
- A third generation targeted therapy Tagrisso is getting back on its track to seek reimbursement as a first-line treatment for patients with lung cancer. The pharmaceutical industry sources confirmed, AstraZeneca Korea has submitted an application to expand reimbursement on its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) as a first-line treatment. After failing to pass the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee in last May, the company is resuming the process in five months. Adding the first-line treatment indication in December 2018, Tagrisso sought after the reimbursement expansion in 2019, but the South Korean health regulators deferred the decision by claiming the decision should be made when the Phase III FLAURA study reveals full data on overall survival (OS) as a first-line therapy. Although the company handed in additional data from the FLAURA study and accepted the government-proposed financial burden sharing plan, the Cancer Deliberation Committee members argued the treatment demonstrated issues in clinical efficacy and denied the reimbursement expansion. AstraZeneca’s new weapon of choice is the FLAURA China extension cohort study unveiled as a poster presentation at European Society for Medical Oncology (ESMO) conference convened online recently. The study provides specific OS data in Asian race. The toughest barrier that hindered Tagrisso from expanding the reimbursement was the Asian subset analysis. The study found Tagrisso’s OS was at 38.6 months, which improved OS in Iressa (gefitinib) and Tarceva (erlotinib) by 6.8 months. The findings were encouraging as Tagrisso was the first EGFR TKI, and the researchers counted even the cross over prescription on patients with confirmed T790M mutation. However, the subset analysis on Asian race showed skeptical hazard ratio (HR). Among the Asian participants, the HR was only around 0.995. The figure was basically within the margin of error from the value 1, which meant the targeted therapy failed to show meaningful improvement compared to the controls. Based on the unsatisfying result, the scholars claimed “The Tagrisso OS in Asian race, also covering the South Koreans, is not credible,” and the claim eventually influenced the Cancer Deliberation Committee’s decision. Now that Tagrisso has prepared the study results from China, the previous decision on reimbursement expansion could be overturned. The FLAURA China study incorporated a total of 71 participants using Tagrisso and 65 participants using control in China cohorts. The control group participants were allowed to cross over to Tagrisso as a second-line treatment, once they advanced as T790m-positive, in which 22 out of 65 patients were the case. As a result, Tagrisso group’s OS median reached 33.1 months, or 7.4 months longer compared to the control group with 25.7 months, while the risk of death was reduced by 15.2 percent.
- Company
- Janssen MA Director Lim Kyunghwa promoted to Janssen APAC
- by Eo, Yun-Ho Sep 24, 2020 11:59am
- Director Lim Kyunghwa Market Access (MA) Director Lim Kyunghwa at Janssen Korea is to be promoted to Janssen Asia Pacific. The pharmaceutical industry sources reported, Director Lim would be appointed as a new MA Director at Janssen Asia Pacific from coming October. Temporarily, Lim would be remotely working from South Korea amid COVID-19, but she would be working at the Asia Pacific Region Office later. Director Lim, currently leading the MA at Janssen Korea, has earned her master’s and doctorate degrees from Sookmyung Women’s University, as well as MBA from Korea University. Her career in MA started when she joined Chong Kun Dang, and she gained rich MA experiences from Boehringer Ingelheim and Novartis. Moreover, Director Lim is currently serving as a Co-chair of MA Committee at Korean Research-based Pharmaceutical Industry Association (KRPIA). Due to her promotion, KRPIA is to appoint a new co-chair on Sept. 28. KRPIA is also readying for a series of new personnel changes in Board of Directors, as the current Chairman Avi BenShoshan and Vice-Chair Julien Samson are returning back to the headquarters.
- Company
- Suganon by Dong-A ST, approved for Phase II/III in the US
- by An, Kyung-Jin Sep 24, 2020 06:19am
- Suganon Dong-A ST announced on the 22nd that the diabetes treatment 'Suganon' (Evogliptin) has been approved by the US Food and Drug Administration (FDA) for Phase IIb/IIIa clinical trial plan (IND) for aortic heart valve calcification. Suganon is a diabetes treatment based on DPP-4 inhibitor developed by Dong-A ST. In order to use Suganon other than diabetes, Dong-A ST transferred the technology of a substance patent for Suganon and a patent for the treatment of aortic heart valve calcification of Asan Medical Center in Seoul, and established a joint venture Rednvia. In January of last year, Rednvia signed a technology transfer contract with Dong-A ST for the development and sale of aortic heart valve calcification treatment for Suganon and has been developing it. In June 2019, the MFDS approved Phase II Clinical Trial Plan (IND) for aortic heart valve calcification, and initiated Phase II clinical trial in Korea for 225 patients. In July of this year, the FDA received Phase IIb/IIIa clinical trial IND. Researchers from renowned medical institutions in the United States, such as Mayo Clinic and Massachusetts General Hospital, have confirmed participation in this clinical trial. Rednvia has unveiled its plan to accelerate product commercialization as much as possible by working closely with researchers from these institutions and receiving clinical research funding from the National Institutes of Health (NIH). Dong-A ST Chairman Eom Dae-sik said that this clinical trial is an attempt to re-create a drug for a new drug that has been successfully developed and we will work closely with us to complete the development of the treatment. Rednvia CEO Hoonmo Lee said, "I am very pleased to be able to obtain the approval of Sugarnon's US clinical IND after collaborating with excellent researchers and institutions, and we will do our best to successfully perform clinical trials." According to the data provided by the company, the treatment of aortic heart valve calcification is entirely dependent on surgery as there is currently no cure. In particular, elderly patients have a high risk of death during surgery, and there is a problem that reoperation should be considered every 10 years. If the oral drug Suganon completes clinical trials in Korea and the United States and succeeds in commercialization. High marketability is expected if commercialization is successful. Rednvia is known to be examining the discovery of a combination drug candidate targeting fibrosis in order to develop Suganon as a treatment for not only aortic heart valve calcification, but also non-alcoholic steatohepatitis (NASH).
- Company
- Suganon, a new domestic drug that is evolving
- by An, Kyung-Jin Sep 23, 2020 08:06pm
- Suganon Suganon (Evogliptin), a diabetes treatment developed by Dong-A ST's proprietary technology, has stepped up its competitiveness. Despite the return of rights, efforts are being made to improve the value of new drugs while seeking new indications. The growth of domestic sales has gained momentum, and it is advancing into overseas markets by completing sales in India and Russia. According to Dong-A ST on the 23rd, the cumulative sales of two types of Suganon and Sugamet this year were ₩16 billion, which doubled from the same period last year. This is the figure calculated based on the company's own shipments from January to August this year. In eight months, the company announced a new record in annual sales, surpassing ₩14.2 billion in sales last year. Suganon is a diabetes treatment based on DPP-4 inhibitor developed by Dong-A ST. It has a mechanism of action that inhibits insulin-secreting hormone-degrading enzyme (DPP-4). Dong-A ST entered the domestic DPP-4 inhibitor market with the release of Suganon in March 2016. In May of the same year, it launched Sugamet, a combination drug that combines Metformin with Suganon, and is in fierce competition with competitors. Suganon and Sugamet had difficulty in securing market share at the beginning of their release as they entered the market as the latest among the nine DPP-4 inhibitors sold in Korea, but their market influence is steadily increasing. From mid-2018, the third year of its release, its quarterly sales exceeded ₩3 billion, and since the second quarter of last year, it has become the company's flagship item by breaking the record for quarterly sales. It is analyzed that the fact that the high selectivity to DPP-4 enzyme is high and that it has little effect on the metabolism of other drugs was actively appealed, and that the reliability of medical staff increased as the prescription experience in the treatment field was accumulated. Quarterly sales of Suganon and Sugamet (Unit: ₩100 million, Source: Dong-A ST) Suganon will also enter the overseas market. Dong-A ST has signed technology transfer contracts with many global pharmaceutical companies, including India and Nepal in December 2012, Brazil in 2014, 17 countries in South America and 3 countries in the CIS (Commonwealth of Independent States) including Russia in 2015. After signing a contract with Alkem, an Indian pharmaceutical company in 2012, it completed the sale of Suganon in India in March of last year, after obtaining approval for sale from the Drug Controller General of India (DCGI) in December 2018 and March 2019. It also started sales in Russia through Geropharm, a Russian pharmaceutical company that it had a relationship with in 2015. Entering this year, it applied for a new drug license (NDA) for Suganon to a Brazilian regulatory agency, and 17 countries in South America are also undergoing national development and approval procedures. Dong-A ST is also focusing on developing a new market for Suganon. It was exported to the US pharmaceutical company Tobira Therapeutics in 2016 for a technology export of 61.5 million dollars, and returned it after 1 year and 6 months, and the goal of developing a treatment for non-alcoholic steatohepatitis (NASH) was failed. This is because Tobira's R&D strategy changed as it was acquired by a large global pharmaceutical company Allergan. Suganon In January of last year, Dong-A ST signed a technology transfer contract with Rednvia for the development and sale of aortic heart valve calcification treatment for Suganon and began development. Rednvia is a joint venture established by transferring technology to a substance patent for Suganon, a diabetes treatment drug developed by Dong-A ST, and a patent for aortic heart valve calcification treatment at Asan Medical Center. Rednvia began its global clinical development step in earnest by receiving approval from the US Food and Drug Administration (FDA) for a local Phase IIb/IIIa clinical trial plan (IND) that evaluates the efficacy and safety of Suganone in treating aortic heart valve calcification. Researchers from renowned medical institutions in the United States such as the Mayo Clinic and Massachusetts General Hospital have confirmed their participation, reflecting the high interest of the treatment field. Rednvia has been conducting phase II clinical trial in 225 patients with aortic valve calcification in Korea since last year. The goal is to accelerate the commercialization of products as much as possible by receiving clinical research funding from the National Institutes of Health (NIH) while simultaneously operating both Korean and US clinical trials. Since there is no officially licensed treatment for aortic heart valve calcification, and it has to rely entirely on surgery, it is expected that if Suganon succeeds in commercialization, it will have high marketability. Rednvia is also re-challenging for NASH indications, which were once frustrated. In order to develop a combination drug that targets fibrosis in NASH patients, it is examining the discovery of candidate substances that can create synergy with Suganon.
- Company
- Samsung signed manufacturing collaboration with AZ
- by Eo, Yun-Ho Sep 22, 2020 05:47pm
- AstraZeneca and Samsung Biologics announced the signing of a long-term supply agreement. Under this agreement, valued at approximately $330.8 million, Samsung Biologics will provide large-scale commercial manufacturing for drug substance and drug product of AstraZeneca biologics therapeutics. The contract value could grow to $545.6 million upon each other’s agreement. Today’s announcement follows a Letter of Intent that was signed in June at Samsung Biologics headquarters in Songdo, South Korea, jointly with AstraZeneca’s Korean office represented by Country President, Mr. Juno Sangpyo Kim and Samsung Biologics CEO Dr. Tae Han Kim. Also present at the event were South Korean government officials, and Kim JaeJoon, Director of Bio-Convergence Industry, Ministry of Trade, Industry and Energy and Jung Taegil, Director of Division of Health Industry Promotion , Ministry of Health and Welfare. Mr. Leif Johansson, Chairman of the Board and Ms. Margareta Ozolins Nordvall, Senior Vice President Supply APAC of AstraZeneca joined via a virtual meeting platform. The new collaboration enables AstraZeneca to build on Korea’s world-class bio-health industry and to expand its biologics manufacturing capabilities into Asia Pacific. Pam Cheng, EVP Global Operations and IT, AstraZeneca said, “This long-term partnership with Samsung Biologics strengthens our manufacturing capabilities, and ensures we are well-positioned to continue to deliver our exciting portfolio of new and established biologics medicines to patients with quality, speed and efficiency.” Dr. Tae Han Kim, CEO of Samsung Biologics mentioned, “We are very proud to partner with AstraZeneca, a company with a rich history of science-led innovation to serve patients,” and added, “At Samsung Biologics, our people share this common purpose to help our clients bring innovative solutions to different arrays of diseases, and we look forward to delivering on our promise to aid in AstraZeneca’s ongoing expansion program.” In December last year AstraZeneca signed a collaboration agreement to accelerate Korean bio-health innovation with leading governmental and industry partners. As part of the agreement, AstraZeneca is accelerating efforts to drive collaboration with Korean biopharmaceutical manufacturers. AstraZeneca also has manufacturing collaborations with SK biotek and SK bioscience.
- Company
- Cyramza+Tarceva shoots for first-line in EGFR NSCLC patients
- by Eo, Yun-Ho Sep 22, 2020 06:27am
- A combined targeted therapy is seeking for healthcare reimbursement as a first-line treatment in patients with non-small cell lung cancer (NSCLC). The pharmaceutical industry source reported Lilly Korea has recently submitted an application to expand reimbursement on a vascular endothelial growth factor (VEGF) receptor 2 antagonist Cyramza (ramucirumab), combined with endothelial growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKI) Tarceva (erlotinib), to enhance treatment access to patients with NSCLC. Also, Lilly is simultaneously applying for reimbursement on Cyramza, as a single agent, treating patients with hepatocellular carcinoma (HCC) who have an alphafetoprotein (AFP) of ≥400 ng/ mL and have been treated with Nexavar (sorafenib). Since it expanded two indications in last July for the South Korean market, the treatment is quickly proceeding with the reimbursement expansion. The ramucirumab plus erlotinib combination therapy has been approved by European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in last January and June, respectively. The combination targeting both VEGF and EGFR has attracted wide attention as the combination showed relatively stronger efficacy in patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation. Phase III clinical trial RELAY has confirmed the efficacy of Cyramza plus Tarceva combination. The study found the combination has lowered the risk of death by 40 percent over Tarceva alone, and progression-free survival (PFS) was seven months longer with the combination at 19.4 months. The overall survival (OS) has been confirmed, yet. At the median follow-up of 20.7 months, the objective response rate in Cyramza combination group demonstrated 76.3 percent and also erlotinib-only group showed similar rate of 74.7 percent. But their median duration response in respective groups showed a significant gap at 18.0 months compared to 11.1 months. And the findings of the RELAY study are more meaningful to the South Korean patients as 70 percent of the participants were East Asians. By signing the refund type risk sharing agreement (RSA), Cyramza was listed for reimbursement in May 2018 as a second-line treatment for patients with stomach cancer. In South Korea, the treatment is indicated as a second-line treatment in patients with advanced and metastatic stomach cancer; a combination therapy with irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) to treat patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaplatin, and fluoropyrimidine; a combination therapy with docetaxel in patients with metastatic NSCLC with disease progression on or after platinum-based chemotherapy.
- Company
- Ho-jin Choi inaugurated as CEO of Ono Pharma Korea
- by An, Kyung-Jin Sep 22, 2020 06:26am
- Ho-jin Choi as new CEO of Ono Pharma KoreaOno Pharma Korea said that it has elected Choi Ho-jin, vice president of Ono Pharma Korea, as its new chief executive officer effective on Oct. 1. Ono Pharma Korea was established in December 2013 as a Korean subsidiary of Ono Pharmaceutical Co., Ltd. in Japan. New CEO Choi has contributed significantly to the local launch and reimbursement of the firm’s immunotherapy drug Opdivo (Nivolumab), the company said. Before joining Ono Pharma Korea as the general director of its sales marketing division in 2014, Choi also served at various Korean offshoots of multinational pharmaceutical companies, such as J&J, AstraZeneca, and Allergan. “Ono Pharma Korea is a region that is also important to the firm’s headquarters, and I am happy and excited to be appointed as the new CEO,” Choi said. “As a pharmaceutical company that develops and provides more innovative medicines to help patients, we will do our best to contribute to Korean society, patients, and medical staff.”
- Company
- Combination therapy of Mabthera is on the rise
- by Eo, Yun-Ho Sep 22, 2020 06:26am
- Mabthera In the field of Chronic Lymphocytic Leukemia (CLL), a combination therapy of a new drug and 'Mabthera (Rituximab)' is attracting attention. According to related industries, the combination therapy of 'Imbruvica (Ibrutinib)' and Mabthera recently obtained approval in Europe after the US. The HIRA’s Pharmaceutical Benefits Advisory Committee is about to propose a combination therapy of 'Venclexta (Venetoclax)' and Mabthera, which has obtained global approval and entered Korea. Imbruvica-based therapy was recently approved as a first-line treatment for CLL based on phase III E1912. In this study, Imbruvica-based therapy improved Progression-Free Survival (PFS) compared to patients treated with Fludarabine, Cyclophosphamide and Rituximab (FCR) combination therapy. 88% of patients recorded 37 months of PFS, surpassing 75% of the FCR group, and overall survival (OS) also showed significant improvement. Venclexta-based therapy is currently in the process of listing benefits for a second-line combination therapy for relapsed, refractory chronic lymphocytic leukemia (CLL) that received previous treatments including at least one chemotherapy. This drug started the registration process immediately after adding the indication for the combination therapy of 'Mabthera (Rituximab)', which was proposed to the Cancer Disease Review Committee in last March. It shows the presence of Venclexta in the CLL area. Venclexta's effectiveness in second-line therapy was demonstrated in Phase III study MURANO. As a result of the first evaluation index analysis, the PFS of the combined Venclexta and Mabthera group was significantly improved. The risk of disease progression or death was reduced by 83%, and the overall survival rate was higher than that of the standard treatment group, Bendamustine and Mabthera. Meanwhile, Venclexta was approved by the MFDS in May 2019 as a monotherapy for patients with chronic lymphocytic leukemia who are relapsed or refractory to chemoimmunotherapy and B-cell receptor pathway inhibitors, and it was listed on the salary list since last April with this indication.
- Company
- Korean companies take drug patent strategy to next level
- by Kim, Jin-Gu Sep 22, 2020 06:26am
- The South Korean pharmaceutical companies are evolving their patent strategies. In the first half of the year, the companies set the historic record of registering the most number of patents. Apparently, their number of patents is on par with multinational pharmaceutical companies’. According to Ministry of Food and Drug Safety (MFDS) and Korean Intellectual Property Office (KIPO) on Sept. 17, total 134 pharmaceutical and bio related patents were newly registered in the first six months of the year. And 67 patents were applied by Korea companies. In other words, the multinational companies had 67 patents applied. For the first time in the history, the Korean companies had the number of registered patents even with the multinational companies. Number of patent registration in half a year by Korean companies (Unit: cases) Source: MFDS and KIPO So far, patenting was mostly owned by multinational pharmaceutical companies. From 2014 through the first half of 2020, total 1,331 patents were registered, but only the 26 percent, or 341 patents, are registered by the Korean companies. As the multinational companies had more originals, naturally they had more patents. But as more Korean companies have succeeded in developing new drugs recently, their number of registered patents has increased as well. But because there are more Korean companies disputing over patents, the Korean companies with original drugs feel the need to prepare for patent defense strategy. As for this year, Chong Kun Dang, SK Chemicals, Boryung Pharmaceutical and LG Chem led the wave of patent registration. Especially, Chong Kun Dang registered total 15 patents associated with Telminuvo (4), Certirobel (4), Raparobell (3), Eso Duo (3), and Tenofobell (1). SK Chemicals had total 13 patents for Renexin (3), Qudexy (4) and Ongentis (6). Boryung Pharmaceutical had 10 patents with Dukaro, Jeil Pharmaceutical had eight patents with Lonsurf, and LG Chem had five patents each for Zemiro and Zelief Extended Release. Sources also confirmed Kolon Pharma registered three patents, Daewon Pharmaceutical, GL Pharma, Korea United Pharm, Halim Pharm have registered two patents, respectively, and Daewoong Pharmaceutical, GL Pharm Tech, Taejoon Pharm and Hanmi Pharmaceutical have registered one patent each. The industry experts say they have to see the statistics for the latter half of the year is to name such surge in patent registration by Korean companies as either a temporary phenomenon or a new trend. Nevertheless, the number of registered patents for last three months from July through September shows the Korean companies have registered 17 patents (40 percent) out of 42 and multinational companies registered 25 patents (60 percent). Compared to previous years, the ratio of Korean companies’ patents has gone up. An insider from the Korean pharmaceutical industry noted, “Lately, Korean companies are more aggressively registering patents,” and “they are expanding the patent scope by registering several patents for one pharmaceutical substance.” Ratio of patent registration by Korean companies vs. multinational companies (Unit: %) Source: MFDS and KIPO The total number of new patents in half a year hit the historic high in the first half of 2020 since 2014, due to the boost from the Korean companies. The movement to register Korean patents registration took off from 2012, when the KORUS FTA was signed. For two years from 2012 through 2013, the exploding number of patents applications was submitted. In year 2012 and 2013, 563 patents and 868 patents were registered, respectively. Experts say the patents left unregistered until the KORUS FTA were all registered in the two years of time. Since 2014, the number of patent registration has been around 200 per year. From 2014 through 2019, 181 patents, 234 patents, 223 patents, 223 patents, 126 patents and 210 patents were registered, receptively. In the first six months of this year, total 134 patents were registered. It was the highest number of patents registered in six months time. The pharmaceutical patent experts explain the Korean companies have become assertive with patent registration as a defense mechanism against generic companies’ patent challenges. Number of patent registration by half a year (Unit: cases) Source: MFDS and KIPO
- Company
- Sales in the outpatient prescription drug market are active
- by Chon, Seung-Hyun Sep 21, 2020 06:13am
- It has been shown that the outpatient prescription drug market has not been hit even with the recent spread of COVID-19) patients. Even though sales activities contracted due to level 2 social distancing, the total prescription drug volume recorded a growth trend last month. According to UBIST, a drug research institute on the 20th, the amount of outpatient prescriptions last month was ₩1.2491 trillion, an increase of 3.2% from the same period last year. There is no significant difference, compared to the amount of prescriptions that rose 4.4% from the previous year in August last year. This means that the conventional prescription drug market has continued to grow. Monthly outpatient prescription amount trend (Unit: ₩100 million, Source: UBIST) Last month, social distancing was strengthened due to the spread of COVID-19. Since 103 new cases were recorded on the 14th of last month, the spread of new infections showed a trend. At the end of last month, the number of new confirmed cases expanded to 400. From the 23rd of last month, the government raised social distancing to the second stage. Although external activities declined due to reinforced social distancing, the prescription drug market was not affected. After the second stage of social distancing, pharmaceutical companies have been working from home. While the number of salespeople's visits to medical institutions has been minimized, normal business activities have contracted. This year, the prescription drug market has been showing ups and downs. In January, prescriptions decreased by 4.4% from the previous year, but in February they increased by 13.0%. As the Lunar New Year holidays this year was pulled to January, which is earlier than the previous year, it is analyzed that the increase and decrease rate of prescriptions in January and February showed a deviation according to the increase or decrease of the number of business days.. Prescription performance in April and May decreased by 8.7% and 9.4% from the previous year, respectively. The industry believes that the slowdown in the prescription drug market in April and May was the impact of COVID-19. It is analyzed that a considerable prescription gap occurred in the second quarter as patients with chronic illnesses, who are reluctant to visit medical institutions, were prescribed in large quantities of necessary medicines. In fact, when the number of COVID-19 patients surged, it is known that the number of cases receiving prescriptions for 3 to 6 months in advance increased significantly. Monthly outpatient prescription amount increase/decrease from the same period last year (Unit: %, Source: UBIST) In fact, from June, the prescription drug market has shown a recovery trend. In June, the prescription size was ₩1.2667 trillion, up 11.7% from the same period last year, and in July, it recorded a growth rate of 1.8%. As the use of medicines continues to increase due to the increase of the elderly population and the number of chronic diseases, the entire industry will not shrink due to short-term issues such as infectious diseases. Unlike the tourism and cultural industries, which fell into extreme crises after COVID-19 outbreak, the pharmaceutical industry is affected by the demand of patients rather than the external environment, so it is difficult to lead to a sudden downturn. Until last month, the total accumulated prescription amount was ₩9,8876 trillion, an increase of 0.6% from the same period last year. It was estimated that the prescription drug market was superior to other industries, although it was slower than the cumulative prescription growth rate of 6.7% until August last year.
