- LOGIN
- MemberShip
- 2026-03-18 20:22:38
- 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.
- Company
- Lilly's Olumiant, is clinically approved for COVID-19
- by Kim, Jin-Gu Sep 18, 2020 06:30am
- Olumiant Eli Lilly's autoimmune disease treatment 'Olumiant (Baricitinib)' has begun phase III clinical trial targeting COVID-19 patients in Korea. It is the second clinical trial in Korea related to COVID-19 after Remdesivir by Gilead Science. On the 7th, the MFDS approved a phase III clinical trial plan of Baricitinib (LY3009104) in Lilly Korea for COVID-19 patients. This clinical trial is part of Lilly's global phase III clinical trial. It will be held from this month to next October, and the size of the clinical trial is 600 sujects. Among them, 15 domestic patients are expected to receive medication at Ajou University Hospital. Lilly has already started clinical trial in the US and Europe since last June. According to the company, Olumiant is expected to be able to reduce cytokine storms, one of the symptoms of infection complications caused by COVID-19. In clinical trials previously conducted in Italy, etc., positive results were found in improving the symptoms of COVID-19 patients. The most representative study was conducted in 7 hospitals in Italy from February 20 to March 15 this year. It was published in 'The Journal of Infection' on the 23rd of last month. The researchers administered Olumiant and Kaletra (Lopinavir + Ritonavir) together to 113 patients for 2 weeks in 192 COVID-19 patients, and only Kaletra to the remaining 78 patients. Olumiant Kaletra Lopinavir / Ritonavir As a result, the mortality rate, the intensive care unit admission rate, the discharge rate, and COVID-19 virus detection rate were all positive in the group administered with Olumiant. As for the mortality rate, there were no dead patients in the Olumiant co-administration group, while 5 (6.4%) died in the control group. There was also no intensive care unit admission rate in the co-administration group, whereas 14 patients (17.9%) in the control group occurred. As for the discharge rate, 88 out of 113 patients in the co-administration group were discharged, recording 77.9%, whereas in the control group, 10 out of 78 patients were discharged, which was 12.8%. Two weeks after treatment, the detection rate of COVID-19 was 12.5% in the co-administered group and 40% in the control group. Results of a study on the therapeutic effect of COVID-19 in the combination of Olumiant + Kaletra (Data The Journal of infection) Remdesivir is the only treatment for COVID-19 officially recognized in Korea so far. It is expected to be the second treatment if Olumiant finishes phase III clinical trial and obtains approval as a treatment for COVID-19. Remdesivir In the case of Remdesivir, the effect of shortening the hospital stay has been proven in clinical trials. However, it failed to prove the improvement in mortality. If Olumiant proves an improvement in mortality in this clinical trial, it is expected to receive more attention than remdesivir.
- Company
- Julien Samson will be relocating to the UK headquarters
- by Eo, Yun-Ho Sep 18, 2020 06:29am
- Julien Samson According to related industries, GSK Korea held a town hall meeting on the 16th, and Julien Samson, announced that his current term of office as the head of the Korean subsidiary will be ended in this November. Julien Samson will be relocating to the UK headquarters in December. The successor to lead the Korean subsidiary was Robert Kempton, vice president of the current North Carolina branch. He joined GSK as a field vice president, with responsibility for sales of GSK's ELLIPTA portfolio in 2017 and is currently serving as vice president, global commercial lead, specialty medicine related to infectious diseases from 2018 to the present. Julien Samson, who has been leading GKS Korea since February 2018, was the first foreign president of a domestic corporation. The company has appointed President Hong Yoo-seok in 2014 after former chairman Jin-ho Kim, who has been leading the company since GlaxoWellcome, and CEO Julien Samson was appointed as CEO of GSK Canada's pharmaceutical business (treatment and vaccine) corporation in 2018. After working in public hospitals and government agencies in France, he joined GSK in 2012, and recently, he was in charge of establishing a global sales marketing strategy at the GSK respiratory disease business headquarters in the UK headquarters. Meanwhile, the head of MSD's Korean subsidiary is also replaced. Avi BenShoshan (49), the current CEO, will move to the US headquarters as of November, and MSD Korea will appoint Kevin Peters, the current president of MSD Thailand, as its successor president. With the overseas appointments of Avi BenShoshan and Julien Samson, the composition of the KRPIA’s council is also predicted to change. Abi Benshosan is currently chairman of KRPIA, and Julien Samson is vice chairman.
- Company
- “APAC countries need NPM in the age of expensive drugs”
- by Eo, Yun-Ho Sep 17, 2020 06:30am
- A pharmaceutical industry expert suggested Asian-Pacific countries should also take novel payment models into account in this age of high-cost drugs. On Sept. 16, the ‘International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Asia Pacific 2020’ hosted a web session on ‘ICER Threshold for Innovative Medicines – Harmonization with Novel Payment Model (NPM).’ A presenter for the session, Dr. Kevin Haninger of the Pharmaceutical Research and Manufacturers of America (PhRMA) explained about the concept of NPM and introduced various cases in HTA countries including Canada, Australia and the U.K. Following are the NPM types Dr. Haninger talked about; Combination-based pricing: This NPM type grants pricing specifically based on a drug the applicant drug is combined with. For instance, the pricing of ‘Drug A’ would differ when it is used alone, or used in combination with ‘Drug B.’ Switzerland and Italy are using the NPM type at the moment. Indication-based pricing: Considering the number of drugs expanding its indication is increasing lately, the NPM differentiates a drug’s pricing depending on the level of innovativeness each indication has. Such NPM was addressed during recent talks on expanding indications for an immunotherapy, and Korean Research-based Pharmaceutical Industry Association (KRPIA) has also proposed it to the South Korean health authority as an amendment to the current regulation. At the moment, Australia, Switzerland, the U.S and other countries have adopted the system. Outcome-based payments: An outcome-based payment model is also used in South Korea, as a type of risk sharing agreement (RSA). The model allows the health authority to share the risk in pricing depending on the level of demonstrated drug efficacy. Roche’s immunotherapy Tecentriq has received healthcare reimbursement after accepting the differentiated reimbursement coverage based on patient reaction rate. Over-time payments: The model applies stepped pricing and offers payment installments depending on the patient’s administration period. This type has been suggested when discussing reimbursement on one-time treatment Zolgensma treating spinal muscular atrophy (SMA) or CAR T-Cell therapy. The U.S. and Italy are currently using the system. Reviewing each model, Dr. Haninger recommended using the combination-based pricing and indication-based pricing. According to him, only Australia among all Asian-Pacific countries has implemented the NPM types. He elaborated, “As more and more innovative but expensive treatments are developed, we to think of more broadened approach. Currently, most of Asian-Pacific countries are highly dependent on incremental cost-effectiveness ratio (ICER) threshold based on quality-adjusted life-year (QALY), which hinders improvement in patient’s treatment access.” “By applying various NPM, the health authorities should strengthen medical accessibility in general. NPM can be a solution for the delayed reimbursement listing procedure caused by foreign governments referring to pricing in other countries,” he added.
- Company
- Hanmi promotes clinical use of Keytruda & FLX475
- by Sep 17, 2020 06:29am
- Hanmi is entering a phase II clinical trial that uses a combination of CCR4 target oral immuno-cancer drug (FLX475), which is being developed in Korea, and MSD's immuno-cancer drug Keytruda (Pembrolizumab). To this end, Hanmi announced on the 15th that it has signed a contract with MSD to supply Keytruda for clinical cooperation and clinical cooperation with FLX475-Keytruda. In the first half of next year, Hanmi plans to start phase II in Korea and China, which measures the efficacy and safety of combination therapy for gastric cancer patients in Korea and China. Keytruda, which is necessary for clinical use, is provided by MSD for free. FLX475 is the first oral regulatory T-cell inhibitor developed by US biotechnology company RAPT Therapeutics, and Hanmi secured exclusive rights for development and commercialization in China, including Korea, Taiwan, and Hong Kong by transferring this candidate substance from RAPT Therapeutics last December. Although the prevalence of gastric cancer in Korea is the second largest among all carcinomas, there are limited known appropriate treatments. Hanmi expects this clinical trial to be a test that can confirm the value of the combination therapy of FLX475 and Keytruda in the field of gastric cancer. Se-Chang Kwon, President of Hanmi, said, "As Korea is the country with the highest incidence of gastric cancer in the world, the clinical development of these two drugs is expected to be an innovative treatment option for patients in need of treatment. We will do our best to obtain rapid development and approval." Hanmi is currently building and developing around 30 innovative new drug pipelines in the fields of metabolic diseases, anticancer and rare diseases such as NASH, and is continuing its efforts to expand its innovative portfolio of anticancer drugs through open innovation. Based on multilateral cooperation with various partners, the anticancer pipeline will be further strengthened.
- Company
- Sanofi, to supply flu vaccine, Vaxigriptetra nationwide
- by Sep 17, 2020 06:29am
- Sanofi Pasteur (CEO Pascal Robin) announced on the 15th that it has supplied the flu vaccine 'Vaxigriptetra' nationwide. Sanofi Pasteur said that this year's flu vaccine is included in the NIP, and as the number of recipients expanded due to the spread of COVID-19, patients in need of flu prevention can receive the vaccine on time. Vaxigriptetra can be inoculated at public health centers, consigned medical institutions, and major hospitals and clinics from this day. Sanofi Pasteur selected Singer Song Ga-in, friendly to all ages, as a model of Vaxigriptetra to actively promote the importance of preventing flu, which is emphasized by COVID-19. It conveys the message, 'This year's flu prevention is not an option, it is essential.' It is said that Song Ga-in's positive image across all generations and particularly favorable to the elderly and chronically ill patients who need flu prevention, effectively conveyed the message 'Flu prevention is essential'. Vaxigriptetra was conducted in 6 large-scale global clinical trials (4 continents including Europe, Asia, South America, Oceania, etc.) with more than 13,000 participants. Good immunogenicity and safety data were confirmed. Vaxigriptetra is an imported finished product that Sanofi Pasteur, a global vaccine specialist with 120 years of tradition, completes from raw material to packaging at a production facility in France and supplies it to Korea. Sanofi Pasteur supplies the flu vaccine to 150 of 227 countries (about 66%) worldwide. "Flu prevention is more essential than ever to support the healthcare system in the threat of COVID-19," said Pascal Robin, general manager of Sanofi Pasteur. “It is important to recognize that people can play a major role in building immunity to protect themselves, their families, and those vulnerable to infection,” he added.
