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- 2026-04-16 08:12:13
- 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.
- Product
- Pharmacies rage on non-refundable price-reduced drug
- by Jung, Heung-Jun Sep 23, 2020 06:21am
- The pricings of four doses of Novartis’ immunosuppressant Certican have been brought down by 30 percent as of Sept. 20, and pharmacies are outraged with the pharmaceutical company refusing to refund the single tablets. Pharmacists are questioning the company’s refund policy as it would solely burden the pharmacies with the differences made due to pricing reduction. A pharmacist at a pharmacy near by a general hospital in Seoul noted, “Certican is an expensive immunosuppressant. Even though the price was lowered as of Sept. 20, the distributors are rejecting pharmacy’s request to refund the single tablets as Novartis would not accept them,” and “regarding the issue, pharmacists near the tertiary hospitals were in an uproar. If the story is true, many would think the pharmaceutical company is not in the right mind.” The cost of a single pharmacy has to handle would not be detrimental, but the sum of the cost all affected pharmacies to pay would be significant. Another pharmacist at a different pharmacy complained, “Calculating the price difference of Certican, our pharmacy would lose about 100,000 won. The cost of one pharmacy may not be so excessive, but think of how much pharmacies around the country would have to lose out on.” The pharmacist raged, “The distributor claims the company headquarter would not take the drugs back. They say they would ask the company again, but we have not heard anything from them, yet. If both of them argue they are not responsible, ultimately the pharmacies would have to pay the cost. Even the government is being blatantly blind about the problem.” The pharmacist urged the pharmacies should not pay the cost of pricing reduction, only because they have prepared drugs a requested by the nearby hospitals. The same pharmacist argued, “How can pharmacies stock up expensive drugs from now on if this happens regularly? The pharmacists should unite and boycott against the company.” “Apparently, the loss from pharmacies with enough deals is covered by the distributor employee’s pocket. But that is not even an official refund policy by the distributor, so it cannot be a fundamental solution to the problem,” the pharmacist added. Regarding the issue, Novartis official stated “Due to the headquarters’ refund policy, single tablets are not refundable regardless of the pricing reduction.”
- Policy
- Italian-made Gliatirin and Vesseldue-F efficacy questioned
- by Lee, Tak-Sun Sep 23, 2020 06:21am
- ‘Aju Vesseldue-F Soft Capsule A series of drugs from Italian manufacturers are in a tight spot, as they have been selected as an efficacy reevaluation subjects. These drugs do not have sufficient evidence to prove the efficacy, because they hardly have much records of use in countries other than South Korea. The pharmaceutical industry sources reported on Sept. 20, South Korea’s Ministry of Food and Drug Safety (MFDS) has unveiled its plan to conduct clinical reevaluation on three drugs. In last January, June and August, Kolmar Pharma’s cinnarizine, choline alfoscerate and heparinoids received order to undergo reevaluation, respectively. Particularly, the public’s spotlight was on reevaluation for cognitive function enhancer choline alfoscerate with the biggest market value in Korea, and anticoagulant heparinoids. Both the original choline alfoscerate Gliatirin and the best-selling heparinoids Vesseldue-F have been developed by Italian pharmaceutical companies. An Italian-based Italfarmaco developed Gliatirin and signed a license with Daewoong Pharmaceutical in 2000 for the marketing in Korea. Currently, the deal has been taken over by Chong Kun Dang. Choline alfoscerate, the main substance of Gliatirin, generates 300 billion won annually in Korea. However, the drug’s sales in some countries have been restricted, except in South Korea and Italy. While the drug is used as a health supplement in the U.S., most of the choline alfoscerate products have been withdrawn from the Japanese market after reevaluation. Learning from those countries, Korean Pharmacists for Democratic Society and other civic groups raised the issue and the National Assembly audit last year questioned the medicine’s efficacy. In early this year, the drug was called out for reevaluation and the government put limitation on the use. The clinical reevaluation was also ordered on heparinoids as their uses in foreign countries raised questions. One of heparinoids, Vesseldue-F (sulodexide) sold by Aju Pharm in Korea, is a bestseller generating 25 billion won annually. A heparin antagonist, heparinoids are extracted from porcine cartilage. The substance is known to have anticoagulant effect like heparin. In the recently disclosed minutes from Central Pharmaceutical Affairs Deliberation Committee discussing the heparinoids clinical reevaluation, experts apparently mentioned of the need for the drug use. An expert participating in the meeting pointed out, “It is true that latest evidences in efficacy of heparinoids are insufficient,” but also defended the drug by stating “The drug has been used frequently in the past, and has relatively low bleeding tendency compared to antiplatelets agent.” Another expert elaborated, “Heparinoids are used to treat peripheral vascular and venous diseases. Although the drug lacks vast amount of evidence of improving survival rate, the drug still has evidence of improving the symptoms of those disease,” and “in some cases, patients with phlebothrombosis switch to heparinoids after using NOAC for six months.” The heparinoids market leader, Vesseldue-F was first developed by an Italian company Alfa-Wassermann. Aju Pharm licensed in the technology and received the Korean health authority’s approval in 1997 under the name of ‘Aju Vesseldue-F Soft Capsule.’ Italy is one of A8 countries MFDS refers to when reviewing pharmaceuticals. Drugs with use history from the A8, consisting of the U.S., the U.K., France, Italy, Japan, Germany, Switzerland and Canada, are highly likely to pass the license renewal review. Choline alfoscerate was able to renew the license in 2018 with its prescription history from Italy. But as clinical reevaluations were recently ordered on two Italian-made drugs, some claim the A8 roster should be revisited. A pharmaceutical industry insider commented, “Coincidentally, a couple of drugs made by Italian companies have been controversial with their efficacy,” and “because a number of drugs developed in Italy are old, some countries have started not using them.”
- 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.
- Policy
- Generic companies for Atozet are interested in contractors
- by Lee, Tak-Sun Sep 22, 2020 06:27am
- Atozet It is known that generic companies of the hyperlipidemia complex Atozet(Atorvastatin-Ezetimibe, Chong Kun Dang) will sign a consignment contract with Chong Kun Dang today (22nd). Generic companies are paying attention to the number of final contractors and scrutinizing their strengths and weaknesses. According to the industry on the 21st, Chong Kun Dang requested that the contract be revealed by the 18th after holding a consignment meeting on the 16th. And it is reported that the final contract will be made on the 22nd. Chong Kun Dang is recruiting 21 consignment companies. However, generic companies seem to be struggling until the last minute because the number of companies may decrease at the time of the final contract. However, most of them are expected to proceed with the contract. The reason they are interested in the number of companies is that the price of drugs varies depending on the number. In the new cascading drug price system, they can get high prices up to 20 items or less. Drug prices drop from 21 in the order of listing. However, if only 17 companies participate in the entrustment, A total of 19 items will be listed, including the original Atozet and Chong Kun Dang's incrementally modified drug(IMD). Therefore, the next generic also has an opportunity to receive high drug prices. The company entrusted with the first generic company, which is listed after the bioequivalence test, is also licensed at the same time, so it can receive high drug prices. The industry expects that consignees such as Dongkoo Bio&Pharma will enter the market by applying for permission after the PMS expires in January next year. Even if the entry order is late, it is an opinion that if the drug price is the same as that of Chong Kun Dang, it is not bad to belong to the generic group that goes through bioequivalence test. This is because the commissioned production cost of generic group, which had bioequivalence test, is lower. Due to such a complex formula, various theories are arising in the industry, such as a dual contract between Chong Kun Dang and Dongkoo Bio&Pharma. However, no content has been confirmed yet. The reason why it is so difficult to decide on generics for Atozet is that the cascade drug prices system, which has been in force since last July, are acting as a final blow. According to this system, up to 20 items in the order of listing will receive 53.55% of the drug price compared to the original if the conditions such as bioequivalence test and the use of DMF are met. However, starting from 21 generics, the order of approval became important as drug prices were calculated at 85% of the lowest price. Generic for Atozet that have been tested for bioequivalence can apply for permission in time for the expiration of PMS in January next year. However, Chong Kun Dang product that has undergone clinical trial is not generic, but is a drug for data-based re-evaluation, so it is expecting final approval in October. Chong Kun Dang is conducting a commissioned generics consignment production project that recruits consignors through grant (data sharing) and can enter more quickly than generics. Chong Kun Dang's products and delegated generics receive preferential drug prices over generics that have been tested for bioequivalence because they are listed in a faster order.
- Policy
- ORR 100%, Phase III of Lazertinib combination was approved
- by Lee, Tak-Sun Sep 22, 2020 06:26am
- The clinical trial of Lazertinib-Amivantamab, which was released by Janssen at the European Society for Medical Oncology (ESMO) on the 20th, is also being conducted in Korea. As a result of this interim study, the response rate (ORR) was 100%, raising expectations as a treatment for non-small cell lung cancer that threatens Tagrisso. Lazertinib is a new drug developed by Yuhan in Korea and exported to Janssen, a multinational pharmaceutical company. On the 21st, the MFDS approved a multinational phase III clinical trial for the combination of 'Lazertinib (JNJ-73841937)' and Amivantamab submitted by Janssen Korea. Lazertinib is a 3rd generation tyrosine kinase inhibitor (TKI) candidate, and Amivantamab is a bispecific antibody targeting EGFR-MET. This trial is the primary treatment for clinical trial subjects with local advanced or metastatic non-small cell lung cancer with EGFR mutations. Osimertinib, generic for Tagrisso versus Lazertinib compared to the combination therapy of Amivantamab and Lazertinib. This is a phase III, randomized clinical trial. 8 were domestic patients of the total 120 subjects. The examination will be conducted at Seoul National University Bundang Hospital, Samsung Medical Center, Seoul National University Hospital, and Shinchon Severance Hospital. Earlier, Janssen revealed the results of an interim analysis of the clinical trial of combination of Lazertinib-Amivantamab at the ESMO 2020 online meeting on the 20th at local time. According to the published contents, the combination therapy of 'Lazertinib-Amivantamab showed a high response rate in the patient group (45 patients) among the non-small cell lung cancer patients with EGFR exon 19 defect or L858R mutation, a group of patients without prior treatment experience (20 patients) and 3rd generation TKI 'Tagrisso' (Osimertinib) showed recurrence after taking. For patients without prior treatment experience, such as EGFR-targeted anticancer drugs, tumors in all 20 patients reduced and the objective response rate (ORR) was 100% (95% CI, 83-100) when evaluated at 7 months (median, range 3-19 months) after drug treatment. In addition, among patients who showed recurrence after administration of Tagrisso, the tumor size decreased in 16 patients. According to the clinical results, Lazertinib-Osimertinib is expected to be the next treatment for patients who are resistant to Tagrisso and as a first-line treatment.
- 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.”
- Policy
- Goal of generic for Atozet is to be approved in next January
- by Lee, Tak-Sun Sep 22, 2020 06:26am
- Atozet by MSDChong Kun Dang's consignment-produced hyperlipidemia combination drug 'Atozet (Atorvastatin-Ezetimibe) is known to have applied for approval this month and is aiming for approval in next January. In that Atozet’s PMS by MDS will expire in next January, it is faster to acquire product approval than generics that have undergone bioequivalence testing. Accordingly, it will be advantageous in terms of drug prices. Chong Kun Dang recently held a meeting with 21 outsourced companies and announced plans to proceed with item approval. Chong Kun Dang applied for approval of a drug with the same ingredients as Atojet, which had undergone its own clinical trial in April. This drug is expected to be approved as a drug for data-based re-evaluation in October. At the same time, it is expected to receive Atozet's remaining PMS (expired on January 22, 2021). Prior to this, Chong Kun Dang recruited 21 consignment companies for the drug. It is known that the selection of 21 companies was referred to in the order of sales of Atorvastatin formulations. It is reported that on the 16th, at the consignee meeting, the details of the item permission plan were announced. According to the industry, the consignment item plans to complete the application for permission this month and obtain an item approval in next January. After going through the insurance payment process, it will start selling from April. In this case, after the expiration of PMS in January, it will enter the market ahead of generics that apply for permission. In addition, the price of drugs is expected to be higher than those of generics depending on the cascade drug prices system. Chong Kun Dang's self-developed drug for data-based re-evaluation is expected to be approved in October. However, it is known that Chong Kun Dang will not release it first, but will sell it at the same time as the consignment companies. However, as Chong Kun Dang is currently jointly selling the original 'Atozet' with MSD, it is unclear whether Chong Kun Dang will directly release the generic. Accordingly, some say that it is highly likely to pass the sale of drugs developed after Chong Kun Dang to other companies. Atozet is a large-scale drug that recorded an outpatient prescription of ₩63 billion last year. With Chong Kun Dang's product development and PMS expiration, it is expected to turn into a competitive system from next year. However, since various interests such as drug price issues and co-promotion are complicated, it is expected that each company will have a great deal of effort in establishing strategies.
- 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.
