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- 2025-12-27 08:45:29
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- GC Pharma: all capacity focused on COVID-19
- by Kim, Jin-Gu Apr 06, 2020 06:26am
- The GC Corporations Group says ‘all hands on deck’ to fight against COVID-19. The group has a plan to cover all—from diagnostics to preventive and treatment—with the group’s test kit, vaccine and specialized treatment. On Apr. 2, GC Pharma disseminated a press release and announced “The company would commercialize a plasma-derived treatment for patients with severe case of COVID-19 in later this year.” The press release supported a former Prime Minister and the Chair of COVID-19 Response Committee of the Democratic Party, Lee Nak-yeon’s comment regarding ‘developing a treatment within this year.’ GC Pharma introduced a plasma treatment for COVID-19 in development, ‘GC5131A’ that fractionally extracts hyperimmune globulin from blood plasma of patients who have recovered from COVID-19. Unlike typical new drug, GC Pharma expects the development of the plasma treatment would take shorter time as it only extracts hyperimmune globulin. The company said the treatment would be released in the second half of the year. However, the treatment would be used on treating patients with severe symptoms and as a preventive measure for the high-risk group due to the limited access to blood plasma of completely recovered patients and the yet-to-be confirmed treatment effect. President Heo Eun-cheol of GC Pharma commented, “The treatment is in development to treat patients with severe symptoms requiring urgent care and to prevent infection in high-risk group, such as front-line healthcare workers (through passive immunization),” and accordingly, “a clinical trial would be initiated soon to confirm the treatment effect.” GC Pharma is also in development of a COVID-19 vaccine. The company has announced on Mar. 9 that “Answering Korea Centers for Disease Control and Prevention’s (KCDC) call for state initiative against the outbreak, GC Pharma has started developing COVID-19 related vaccine and treatments.” The vaccine would be developed in subunit vaccine style. A fragment of a pathogen on a surface of coronavirus would be extracted as candidate substance and it would be mass produced through genetic recombinant technology. Compared to live-attenuated vaccine using weakened virus or germs, subunit vaccine is considered safer as it is protein-based. Besides, GC Pharma noted the vaccine would use vaccine adjuvant to boost the effect. GC Pharma’s affiliate, GC LabCell has announced it would use natural killer (NK) cell to develop a COVID-19 treatment. GC LabCell official stated on Mar. 31, the company and the U.S.-based biotech company KLEO Pharmaceuticals are collaborating on a research for the COVID-19 treatment development project. The Korean company is tentatively planning to start a clinical trial in Korea and the U.S. later this year. The project is based on a two-track approach. First, the NK cell-based COVID-19 treatment would be developed to let the cells attack the infected cells and activate other immunocytes to induce their long-term immune response. And another COVID-19 treatment development would utilize the ARMs’ function of neutralizing antibody along with NK cell’s function. Another affiliate, GCMS is well-into developing a test kit. On Mar. 23, GCMS official said “The company has signed a partnership deal to collaborate with a liquid biopsy-specialized company, Genecast.” GCMS would be in charge of commercialization, production and sales, whereas Genecast would develop the product. The COVID-19 test kit in development, 'GCare SARS-coV-2,' is based on RT-qPCR. A sample would be taken from upper and lower respiratory tract to amplify specific gene sequencing of the COVID-19 virus.
- Company
- FMC-Korea, names Hee-gyeong Kim as new CEO
- by An, Kyung-Jin Apr 03, 2020 06:34am
- CEO Hee-gyeong Kim of FMC-KoreaFMC Korea has replaced its representative for the first time since its establishment in Korea. FMC Korea said that it has appointed Hee-gyeong Kim as the new chief executive officer effective on April 1. This is the first time the company has replaced the CEO since the establishment of a domestic corporation in 1997. Former CEO Seong-ok Choi (65), who had worked for 23 years, retired and appointed Kim as his successor. The new CEO Kim graduated from Yonsei University and earned an MBA from Duke University. Since then, she has gained extensive experience in the domestic and foreign healthcare and medical device industries. She has held various roles in sales and marketing in Johnson & Johnson Medical Korea and Johnson & Johnson Korea Vision Care for 16 years and after that, she served as representative in Johnson & Johnson Korea Vision Care (2014-2018) and in Johnson & Johnson China Vision Care (2018-2020). When she served as CEO of Johnson & Johnson Vision Care in China, she was evaluated to have successfully built new organizational capabilities in the big data and e-commerce sectors through strengthening external partnerships. Jean DeSombre, President of FMC in North Asia, the new representative, Hee-kyung Kim, has a proven track record of success and leadership capabilities. He was convinced that she would contribute to leading Fresenius Medical Care Korea to the next level of growth.
- Company
- Daxas' generic by Sama succeeded in patenting
- by Kim, Jin-Gu Apr 02, 2020 06:26am
- Sama Pharm succeeded in avoiding the patent for Daxas (Roflumilast), a treatment for chronic obstructive respiratory disease (COPD). Sama Pharm's success in avoiding this patent attracts attention because large companies have failed in succession. The IPT took the side of a generic company in a trial to confirm the passive scope of the patent for Daxas that was patented by Sama Pharm against AstraZeneca on the 31st of last month. Daxas is the only oral medication used for COPD. Most COPD treatments are in the form of inhalers. However, the sales were not excellent because it is used only for severe patients. Last year, the outpatient prescription amounted to ₩900 million. Daxas, developed by Takeda, was taken over by AstraZeneca in 2015. Dong-A ST Hanmi Chong Kun Dang Yuhan Yungjin BCWorld Pharm, Ahn-gook, Boryung Daxas has received patent challenges from many domestic pharmaceutical companies. In 2015, Dong-A ST, Hanmi Pharm, Chong Kun Dang, Yuhan Corporation, Yungjin Pharm, BCWorld Pharm, Ahn-gook, and Boryung Pharm challenged. As a result, in the patent dispute that lasted for over 2 years, all pharmaceutical companies failed to attack. they were denied the claim, or withdrew theirselves. In this situation, Sama attempted a patent in May, later than other pharmaceutical companies. However, the approach method was different from the previous pharmaceutical companies. Dong-A ST, etc., challenged the formulation patent through an invalidation trial. Sama attempted to evade formulation patents through defensive confirmation trial for the scope of a right. Sama's strategy was right. Although the trial has not been released yet, it is presumed to have succeeded in overcoming some patent items in a narrower range than the invalidation trial. As a result, Sama succeeded in half done of the early launch of generic for Daxas. As the substance patent expires in July, it will be able to be a generic if it exceeds two formulation patents. This is one of the two patents that Sama succeeded. The other one is currently proceeding with trial. If Sama succeeds in evading the remaining one patent, it will be possible to release generics two and a half years before the expiration of the formulation patent (February 19, 2023).
- Company
- Hemlibra's indications are expanded
- by Nho, Byung Chul Apr 02, 2020 06:25am
- As a global new drug, indications & dosage standards for Hemlibra, a hemophilia preventive drug, have been expanded. JW Pharmaceutical said on the 31st, that Hemlibra (Emicizumab), which dramatically improves the convenience of administration, is additionally approved by the MFDS as a routine preventive therapy for non-antibody patients. Hemlibra is a genetic recombination drug that is a routine preventive therapy for hemophilia A caused by the deficiency of factor VIII of blood clotting. It is a first in class drug that bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective hemostasis. Following the change in the permit, Hemlibra expanded the scope of treatment to severe A hemophilia patients who did not have antibodies within a year after being approved as a preventive treatment for hemophilia A with antibodies earlier this year. Hemlibra is currently marketed in more than 90 countries, including the United States, Japan, and Germany, and is recognized worldwide for its drug effect as a first in class drug. It has already been approved for antibody patients in over 90 countries, and has been approved for prescription in non-antibody patients in over 70 countries. In addition, the indications and dosages are not limited to the existing once-weekly subcutaneous injection method, and the dosage interval can be increased at the discretion of the medical staff. All of the prophylactic treatments released so far had to be intravenously administered 2-3 times a week, but Hemlibra can be administered subcutaneously once a week, once every two weeks, and up to once every 4 weeks, dramatically improving patient dosing convenience. Helimbra is the only drug in Korea that has been approved for the prevention of hemophilia, which is administered directly subcutaneously (under the skin) rather than intravenously (intravascular). Helimbra was also designated as an orphan drug for the first time in February, as a treatment for severe non-antibody hemophilia. According to the MFDS' notice, △ diseases where the number of patients in Korea is 20,000 or less △diseases that do not have appropriate treatment methods or drugs, or only drugs with significantly improved safety or effectiveness than existing alternative drugs are designated as orphan drugs An official from JW Pharmaceutical said that the company has been continuously pushing for permission to improve the quality of life for people with hemophilia A who need treatment for a lifetime. And, since most patients with hemophilia A do not have antibodies, he expects more patients will be able to benefit from treatment by expanding the indications. The domestic hemophilia treatment market size is estimated to be about ₩150 billion (Source: the HIRA). Hemophilia is classified according to the type of insufficient blood coagulation factor, and type A hemophilia caused by the lack of factor VIII of blood clotting accounts for more than 80% of all hemophilia. As of 2018, there were a total of 1889 patients with hemophilia A in Korea, 51 patients (3%) with double antibody and 1838 patients (97%) with non-antibody.
- Company
- GC LabCell to develop COVID-19 treatment using NK cell
- by Lee, Seok-Jun Apr 01, 2020 06:17am
- GC LabCell is developing a COVID-19 treatment using natural killer (NK) cell. The Korean company is tentatively planning to start a clinical trial in Korea and the U.S. later this year. On Mar. 30, GC LabCell announced the company and the U.S.-based biotech company KLEO Pharmaceuticals are collaborating on a research for the COVID-19 treatment development project utilizing GC LabCell’s NK cell treatment technology and KLEO’s antibody recruiting molecules (ARMs). The project is based on two-track approach. First, the NK cell-based COVID-19 treatment would be developed to let the cells attack the infected cells and activate other immunocytes to induce their long-term immune response. And another COVID-19 treatment development would utilize the ARMs’ function of neutralizing antibody along with NK cell’s function. The initial research would be conducted with National Institute of Allergy and Infectious Diseases (NIAID), operating under the U.S. National Institute of Health (NIH), and Professor Choi Young Ki’s team at Chungbuk National University. The Korean company plans to start the first-in-human trial after June this year. GC LabCell’s NK cell treatment is a unique treatment type made from allogeneic NK cell that could be mass produced. Other NK cell treatments cannot be mass produced as it extracts the cells from a patient’s body.
- Company
- Samsung Epis, made a surplus of ₩122.5 billion
- by Chon, Seung-Hyun Apr 01, 2020 06:16am
- Samsung Bioepis has made a surplus for the first time since its inception. It has been in deficit every year since its inception in 2012, but it recorded operating profit of ₩122.5 billion due to the growth of biosimilars in overseas markets. Sales also grew more than twice that of the previous year. According to Samsung Bioepis' audit report submitted to the Financial Supervisory Service on the 29th, the company's operating profit last year was ₩122.5 billion, which turned to surplus compared to the previous year. It was the first surplus since it was founded in 2012. Sales Trend of Samsung Bioepis Sales by Year (Unit: KRW 100 million, Source: The Financial Supervisory Service) Since 2010, Samsung Biologics and Samsung Bioepis have been established in April 2011 and February 2012, respectively, after designating biopharmaceuticals as promising business in 2010. Samsung Bioepis' largest shareholder is Samsung Biologics, which holds a 50% stake. Samsung Bioepis recorded a deficit every year due to huge research and development costs. In the first year of 2012, it suffered an operating loss of ₩43.8 billion, and in 2015, 2017, and 2018, the loss amount exceeded ₩100 billion. By 2018, the cumulative operating loss amounted to ₩631.9 billion. In the early days of Samsung Bioepis, Samsung Biologics was invested by Samsung Group through a paid-in capital increase by allocation to stockholder, and some of them were invested in Samsung Bioepis. Samsung Biologics received a total of ₩1178.4 billion from the group through 11 paid-in capital increase from July 2011 to July 2015. Of these, ₩578.4 billion was invested in Samsung Bioepis as a paid-in capital increase method. Samsung Bioepis received a total of ₩640.5 billion in investments from the major shareholder Biogen's participation in paid-in capital increase. Since then, Samsung Biologics has invested ₩400 billion in Samsung Bioepis twice in the ₩2.25 trillion raised on the stock market in November 2016. The total amount of funds Samsung Bioepis has invested from a company is ₩1.04 trillion. The reason behind Samsung Bioepis' strong performance last year is the sales of biosimilars in overseas markets. Samsung Bioepis has launched three biosimilars, Benepali, Flixabi, and Imraldi in the European market. Samsung Bioepis Pipelines (Source: Samsung Biologics) According to Biogen's performance last year, three types of biosimilars such as Benepali, Flixabi, and Imraldi made a total of $838 million in sales last year. In 2018, sales were 35% higher than $550 million, making the highest sales ever. Biogen, the second largest shareholder of Samsung Bioepis, is responsible for distribution and sales of biosimilars in Europe. Although Benepali's sales growth slowed, Imraldi’s sales rose sharply. Benepali, Enbrel's biosimilar, posted sales of $ 486.2 million last year. This is similar to $ 485.2 million in 2018. Benepali led the growth of all biosimilars with 2018 sales up 30.9% year over year. Benepali has the largest share in Europe's Big 5 countries such as Germany, France, the United Kingdom, Italy and Spain. In the past four years, it has accumulated cumulative sales of a total of ₩1.6 trillion in the European market. Humira's biosimilar, Imraldi, posted sales of $ 184 million last year. It's more than 10 times higher than $ 16.7 million in 2018. In October 2018, Imraldi was released to major European countries such as the United Kingdom, France, Germany, Spain and Italy when Humira's material patent expired. The sales volume of Samsung Bioepis has also expanded significantly. The company's sales last year were ₩765.6 billion, more than doubled from the previous year's ₩368.7 billion. Last year's sales were close to 80% of the cumulative sales of ₩974.7 billion for 7 years from 2012 to 2018.
- Company
- Xeljanz to be used with caution in thrombosis patients
- by Nho, Byung Chul Mar 30, 2020 06:18am
- Among the indications for Pfizer's JAK inhibitor Xeljanz (Tofacitinib citrate), the standard for 10 mg high dose prescription of ulcerative colitis has changed. Pfizer recently changed the permission, and added that patients with risk factors for thrombosis should avoid using this drug and patients with signs·symptoms of thrombosis should be evaluated urgently and discontinued if thrombosis is suspected, regardless of efficacy and dosage. In this regard, Pfizer immediately posts the relevant contents on the product homepage, as well as black box warning processing on the package insert, sending hospitals safety letter, and regularly reporting the results of the PMS risk assessment to the MFDS in order to prevent prescription confusion and side effects. Pfizer's actions are attributable to the impact of the results of a post-marketing interim analysis of Xeljanz and TNF blockers such as Humira and Remicade . According to the analysis data, there were significant differences between 3,884 patients in the Xeljanz group (patient-years), 19 cases of pulmonary embolism, and 45 cases of death, whereas 3 cases of pulmonary embolism, and 25 cases of death per 3,982 patients in the TNF-administered group. In July of last year, the US FDA changed the license for ulcerative colitis, one of the indications for Xeljanz, from primary treatment to secondary treatment (only for patients with ulcerative colitis who have failed the existing TNF blocker). In November of the same year, the EMA also announced that it should not use 10 mg maintenance therapy twice a day with Xeljanz for patients with ulcerative colitis at high risk of thrombosis, unless there is no alternative. If high doses must be used in ulcerative colitis, it is recommended that patients at risk for embolism should not start, and that patients in risk groups should be switched to other drugs. Xeljanz is administered 5mg twice a day for rheumatoid arthritis, whereas 10mg twice a day for 8 weeks for ulcerative colitis, followed by 5mg or 10mg twice a day depending on the treatment response. Xeljanz is the first oral drug to appear in the market for rheumatoid arthritis and ulcerative colitis, which has been dominated by biologic injections for the past several decades.
- Company
- SK nabs approval for cilostazol-ginko combination SR drug
- by Lee, Seok-Jun Mar 29, 2020 11:19pm
- On Mar. 25, SK Chemicals has announced the Korean health authority has approved sustained release tablet version of antiplatelet drug Renexin. Renexin is a combination drug consisting of antiplatelet agent cilostazol (200 mg) and ginko biloba extract (160 mg). The combination drug, with cilostazol and ginko biloba extract inhibiting platelet aggregation and blood clot formation, has been confirmed to be effective on improving chronic total occlusions in peripheral arteries-induced ischemic events and preventing recurrent stroke. The Korean-made drug is the world’s first drug to combine the two agents. Moreover, Renexin sustained-release (SR) tablet has significantly reduced the number of adverse events like headache in cilostazol. A Phase III clinical trial conducted in 18 Korean clinical institutes including Severance Hospital has found Renexin SR tablet reduced the prevalence of adverse events by 43 percent than the existing tablet. The SR tablet has also enhanced patients’ drug adherence and convenience with once-daily administration.
- Company
- Lipitor and Vytorin to be priced lower than generic?
- by Eo, Yun-Ho Mar 29, 2020 11:18pm
- An odd phenomenon of the original’s pricing dipping down to 85 percent of the lowest generic pricing may actually happen in Korea. The stepped drug pricing system coming in effect from July prices same-substance drugs under differentiated pricing depending on drugs meeting two qualifying standards. But from 21st same-substance drug, the pricing is fixed at 85 percent of the lower price between the lowest price of the drugs or 38.69 percent of the original’s price. However, a controversy sparked when the Ministry of Health and Welfare (MOHW) explained the stepped drug pricing system would be applied on ownership-transferred drugs. Pharmaceutical companies splitting recently like Pfizer and MSD are currently in process of transferring multiple original products to their spin-offs. And these companies may get impacted critically by the government’s interpretation. ◆"Transferred original? To the back of the line!” The controversy over the reduced original pricing started from the ‘Pharmaceutical Decision and Adjustment Standards’ revised in last February. The Section Ma (마) of the revised drug pricing notice stipulates a drug applying for pricing decision, listed previously but removed, would be priced at its latest maximum price, if it is either a transferred drug by inheritance, business transfer or merge as stated by the Pharmaceutical Affairs Act Paragraph 1 of Article 89, or a transferred drug by importer’s inheritance, business transfer or merge as stated by the Pharmaceutical Affairs Act Paragraph 2 of Article 42. In other words, the manufacturer (usually a Korean company) or the importer (multinational company) transferring a drug with a business license would not be subject to pricing reduction. Nevertheless, the Section Ba (바) of the notice stipulates a drug applying for pricing decision, listed previously but removed, would be priced at a lower price between its latest maximum price or newly calculated price, if it is a transferred drug by the manufacturer’s business transfer as stated by the Pharmaceutical Affairs Act Paragraph 2 of Article 89. This could mean the drug reapplying for pricing could face pricing reduction depending on the number of listed generics and standard qualification stated by the drug pricing notice. For example, the first-in-class pharmaceutical reimbursement on Lipitor (atorvastatin) is removed in the process of Upjohn splitting off from Pfizer and taking over the drug. But Lipitor’s price would fall at 85 percent of same-substance drugs as it would be treated as a generic when reapplying for the listing with more than 20 generic already listed. MOHW official commented, “The Pharmaceutical Decision and Adjustment Standards do not distinguish original or generic, but it manages listing of ‘drugs.’ We see no reason for us to exempt first-in-class drug (usually an original) from the newly revised pricing calculation standards.” ◆"Inconsistent with the policy’s objective, exempt the original from pricing reduction” Basically, the industry is a turmoil. Some of them are considering on taking legal actions to protect their originals getting a price lower than generics. Nevertheless, there is a chance for pharmaceutical companies to protect the original’s pricing even with imminent business and product transfer issues. MOHW has decided to apply the existing standards on products applying for listed pricing by May 2020, unless the products have special condition or need to submit additional data. Therefore, if Upjohn and Organon splitting off from Pfizer and MSD, respectively, were to process the transfer fast enough, they would be able to avoid the pricing reduction. Upjohn would take over Lipitor, Norvasc and Celebrex, whereas Organon is planning to take over Vytorin, Singulair and Zetia. But the window is opened to those two companies only. Multinational companies splitting off-patent drug specializing division in the future would take a heavy blow. In fact, many of global companies are either planning to or considering on a spin-off. Increasing number of Korean companies is also shooting for transferring originals. Because of the situation, Pfizer and MSD may request for rapid approval from their respective headquarters to finalize the transfer earlier. The pharmaceutical industry is infuriated at the Korean government. Considering the generic pricing system revision started from the safety issue of valsartan, the companies cannot accept the Pharmaceutical Decision and Adjustment Standards working against the original and reducing its price. Korean Research-based Pharmaceutical Industry Association (KRPIA) insider noted, “Although the generic pricing calculation has been modified, the contradicting factor in the existing regulation has not been touched up and created a loophole. The association has delivered the industry’s opinion, but we did not get the answer we wanted. The government would have to promptly set down correct interpretation of the regulation coinciding with the original objective of the revision and prevent any confusion in the market.” Regarding the issue, Attorney Lee Hyeong Gun and Song Hyun Ah at Lee & Ko commented, “The new generic pricing system affecting the original’s price when transferring seems to contradict the initial objective of the policy. Not only should the government thoroughly review the interpretation from legalistic point of view, but also it should take into account the possible impact on the original and patient’s options.”
- Company
- Novartis vs. Hanmi: Galvus generic to ignite legal dispute
- by Eo, Yun-Ho Mar 26, 2020 06:12am
- A conflict between Novartis and Hanmi Pharmaceutical is expected to deepen over the generic of the DDP-4 inhibitor Galvus. Novartis Korea is apparently preparing legal actions against Korean pharmaceutical companies attempting to evade patent infringement on Galvus (vildagliptin) by excluding one indication. The legal dispute over the patent would begin from next month as the reimbursement listing on Hanmi Pharmaceutical’s generic ‘Vildagle’ has been decided recently. Hanmi Pharmaceutical won an approval in January on four of indications of the original Galvus, except for the indication to treat a patient unable to control blood sugar level sufficiently with metformin monotherapy. The patent on the last indication is to expire in August 2021. Hanmi Pharmaceutical has requested negative confirmation of scope on the rest of the patents in last December to the Intellectual Property Trial and Appeal Board. The confirmation is still in process. Within the industry, the patent evading strategy has been used previously. Chong Kun Dang has launched a generic Dutesmol before the extended patent term of the original benign prostate hyperplasia and hair loss treatment Avodart (dutasteride) by GSK was expired. But according to Novartis, Galvus’ case is different from the precedent. Unlike Avodart with two contrasting indications of treating benign prostate hyperplasia and hair loss, all indications of Galvus are commonly treating type 2 diabetes. So evading infringement of extended patent term by dropping one indication would be unfeasible. Moreover, it would be impossible to confirm an off-label prescription of the generic for the patented indication as the Korean medical field only gives one prescription code on each disease. And Novartis has warned of forthcoming legal action against the Korean company. Novartis official stated, “The company sees this matter seriously and if the reimbursed Vildagle is to push on with the launch schedule before the patent expires, the company would take all possible legal actions including sales ban. Patent and intellectual property is the driving force of new drug development and pharmaceutical industry’s future advancement.” Regarding the issue, Hanmi Pharmaceutical official stated, “The official release date for Vildagle has not been set due to the COVID-19 outbreak. But the company would do everything to improve patient’s access to treatment and to relieve patients from financial burden by providing high quality generic to them.”
