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- 2026-03-19 04:10:02
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- Social distance postponed tax investigations
- by Nho, Byung Chul Apr 09, 2020 06:26am
- In order to prevent the spread of COVID-19, tax investigations by some pharmaceutical companies in progress are reportedly delayed. According to the industry, Daewoong Bio, Bayer Korea, and Hanmi Pharm are currently under investigation by the National Tax Service. This survey is believed to be a regular tax investigation, not a special tax investigation. On the 30th of last month, the National Tax Service announced the policy of minimizing on-site tax investigations of local tax offices and front-line tax offices to actively participate in the government's social distance following COVID-19. As a result, the pharmaceutical industry's tax investigation schedule is also postponed until the COVID-19 situation calms down. When conducting an on-site tax investigation, the National Tax Service is minimizing on-site investigations based on the judgment that face-to-face contact with investigators and the company's working team is inevitable, and it can also put more psychological burden on the company. However, it said that it is performing as scheduled on issues that are bad or urgent such as act of cornering and hoarding of masks or hand sanitizers. Since mid-February, the NTS Jungbu Regional Office has been conducting tax investigations by dispatching employees from the Bureau 1 to the Daewoong Bio Office. A representative of Daewoong Bio explained, "The NTS Jungbu Regional Office Bureau 1, 2, and 3 are usually in charge of general tax investigations. Since 2015, they have been faithfully engaged in regular tax investigations received in five years." In the 2015 tax investigation, the NTS Jungbu Regional Office judged the commission paid by Daewoong Bio to CSO (sales agency) in full, and collected ₩15.3 billion in taxes the following year. In response, Daewoong Bio brought a judgment against the Tax Tribunal and was finally judged by the National Tax Service's misconduct. In 2017, there was a precedent that received a total of ₩15.3 billion back, which is the total collection tax amount related to sales agency fees. Unlike the claims of the Korea Customs Service, through the final ruling, the tax tribunal clearly identified the substance of the CSO, paid a fee according to the contract, and the CSO also filed a tax return as an import amount while also acting as a pharmaceutical sales agent for pharmaceutical companies other than Daewoong Bio. Was judged to be a normal business activity. In addition, on the basis of the fact that it was difficult to judge that the CSO sales agency activity violated related laws and social order, such as the pharmaceutical affairs law the company decided that it was difficult to consider the company to spend entertainment expenses. At the time, about 40% of the fees that Daewoong Bio paid to the CSO were judged as entertainment expenses, and taxes were collected. In a ruling, the tax tribunal said that there was no specificity at the industry's normal level. Currently, the pharmaceutical industry typically pays 40% to 50% of the fees paid to CSOs. The owner-related specialty corporation mentioned in the last tax investigation was also found to be one of the largest number of CSOs operated by Daewoong Bio, which is currently less than 1% of the total CSO operation fee. At that time, Daewoong Bio was using about 200 CSOs.
- Company
- HIRA Cancer Committee canceled and postponed again
- by Eo, Yun-Ho Apr 08, 2020 06:24am
- The talks on anticancer treatment coverage enhancement has been postponed yet again. Pharmaceutical industry sources reported the Korean health authority has canceled the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee’s meeting, initially scheduled today on Apr. 8. The government agency plans to push the meeting back two weeks later. After postponing the Cancer Deliberation Committee meeting from Feb. 26, the schedule has been called off again. Affected pharmaceutical companies are expressing their concerns, now that Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW has been reportedly dispatched to Central Disaster and Safety Countermeasure Headquarters on COVID-19. The delayed meeting schedule has added more items on the committee’s agenda, and some items were inevitably put off to May agenda depending on their priority level. Originally, major items like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) were supposed to be deliberated in February. And in April, the Cancer Committee was supposed to review BMS’ multiple myeloma treatment Revlimid (lenalidomide) and MSD’s immunotherapy Keytruda (pembrolizumab). A multinational pharmaceutical company official said, “Despite the national emergency, cancer patients are still waiting for their treatment to get listed. Delaying the meeting twice would cause a significant damage. The government should be more considerate of those patients when handling pharmaceutical reimbursement listing and expansion.” Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso has an ongoing deliberation over expanding its reimbursed indication to cover a first-line treatment for patients with EGFR-mutated non-small cell lung cancer (NSCLC). PD-1 inhibitor Opdivo has a number of indications seeking for reimbursement, such as renal cell carcinoma-treating first-line combination therapy with Yervoy, second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic head neck squamous cell carcinoma, and second-line treatment for classical Hodgkin’s disease. But, the controversial indication as a second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application. Moreover, Revlimid was targeting reimbursement expansion on its maintenance treatment indication as a monotherapy, and Keytruda’s reimbursement expansion application included an indication as a first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also included two new indications—first-line treatment for metastatic non-squamos NSCLC as a combination therapy with pemetrexed and platinum chemotherapy, and first-line treatment for metastatic squamous NSCLC as combination therapy with carboplatin and paclitaxel.
- Company
- Tylenol shortage boosts Penzal sales by over 40%
- by Jung, Hye-Jin Apr 07, 2020 06:40am
- Due to the COVID-19 outbreak, acetaminophen’s top brand product Tylenol has been experiencing shortage and seemingly other alternatives are seeing a surge in sales. Chong Kun Dang Pharmaceutical official announced on Apr. 2 the sales volume of Penzal-Q in last February and March has soared over 40 percent than same time last year. And Penzal ER tablet’s volume in the same period has also leapt by 56 percent than the previous year. Besides the popular OTC, Penzal brand has a prescription tablet line and the surge in the prescribed ER tablet volume could mean it was an easy option for pharmacies to replace Tylenol. In last March alone when the acetaminophen shortage issue has surfaced, the combined volumes of Penzal-Q and Penzal ER tablet have spiked 48 percent more than the year before. Accordingly, the industry experts view the Korean-made acetaminophen brand sharing a common substance with Tylenol has profited it. Recently, the World Health Organization (WHO) recommended ‘consuming acetaminophen instead of ibuprofen as a nonsteroidal anti-inflammatory drug to relieve symptoms suspected of COVID-19,’ but the organization withdrew the recommendation after two days. However, the two days were enough to hype the demand on acetaminophen in the market. Regardless of prescription or OTC line, Tylenol has become rare to find in the market. The supplier, Janssen Korea claims the product is distributed in Korean market in the same amount as pre-COVID-19 outbreak, which supports the theory that the exponential increase in demand on Tylenol has caused the shortage. Undergoing a product renewal and price raise in April, Samjin Pharm’s Geworin has doubled in sales from February to March. However, considering the pharmacies were stocking up the product before the price jump, it is too early to conclude the COVID-19 outbreak was the direct cause of the surge. The direct correlation would be apparent in the next second half of the year when the re-order has been made. An insider from the distribution industry commented, “On the day Tylenol comes in stock once in a month, all the stock is exhausted within the same day. It seems like the both consumers demand and pharmacies’ preorder volume have skyrocketed.” The distribution industry also agrees the general acetaminophens sales have increased. The sales volume of acetaminophens recorded by the top distributor has shown a significant rise in OTC acetaminophens. Some items’ volumes have even doubled from February to March. A pharmaceutical company associate noted, “The public’s heightened interest in acetaminophens has boosted demands in specific items, and it eventually affected their sales volume. The industry has recognized the COVID-19 outbreak as one of causes of the sales influx.”
- Company
- Big5 general hospitals codes in 2nd PARP inhibitor Zejula
- by Eo, Yun-Ho Apr 06, 2020 06:28am
- The world’s second poly ADP-ribose polymerase (PARP) inhibitor Zejula’s drug code has been implemented by Big 5 general hospitals in Korea. A pharmaceutical industry source reported an ovarian cancer treatment by Takeda Pharmaceuticals Korea, Zejula (niraparib) has been registered by drug committees (DC) around 24 general hospitals so far since its reimbursed release in last December, The prescription code for the treatment was passed by regular DC in Seoul National University Hospital, Seoul Asan Medical Center and Seoul St. Mary’s Hospital, and by emergency DC in Samsung Seoul Medical Center and Severance Hospital. Currently, the code landing procedure is in process at Jeonbuk National University Hospital, Chonnam National University Hwasun Hospital, Kyungpook National University Chilgok Hospital, and Chunguk National University Hospital. A first PARP inhibitor to be used regardless of BRCA mutation, Zejula was approved in Korea as a monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to second or later-line platinum-based chemotherapy. Although it was listed for reimbursement last December, the first reimbursement standard was limited to patients with gBRCA mutation. However, in major clinical studies, Zejula has demonstrated outstanding improvement on median Progression-Free Survival (mPFS) against placebo regardless of gBRCA mutation. Takeda Pharmaceuticals is currently working on expanding Zejula’s reimbursement standard. The anticancer treatment is targeting two additional indications; monotherapy for the maintenance treatment of gBRCA-negative patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy; and monotherapy to treat relapsed ovarian cancer after receiving fourth or later-line chemotherapy. The fourth or later-line indication has been approved based on multicenter, open-label QUADRA study in adult patients with ovarian cancer, who have been treated with third or later-line therapy. During the clinical study, Zejula reached its primary efficacy endpoint and demonstrated clinical efficacy with an object response rate (ORR). The patient group with platinum-sensitive homologous repair deficiency (HRD) demonstrated ORR of 24 percent, where as BRCA-positive platinum-sensitive group, BRCA-positive platinum-resistant group and BRCA-positive platinum-refractory group recorded ORR of 39 percent, 29 percent and 19 percent, respectively.
- Company
- Otsuka is setting new records for sales & operating profit
- by An, Kyung-Jin Apr 06, 2020 06:27am
- Korea Otsuka Pharmaceutical has achieved the best performance since its launch last year. Although the sales of healthcare products were low due to the boycott of Japanese-made products, sales of professional medicines surged, setting new records for both sales and operating profit According to the audit report of Korea Otsuka Pharmaceutical, which was submitted to the Financial Supervisory Service on the 4th, the company's sales were ₩180.2 billion last year, up 11.4% from the previous year's ₩161.7 billion. During the same period, operating profit was ₩38.5 billion, an increase of 23.0% from the previous year. Both sales and operating profit are the largest since the establishment of the Korean subsidiary. Otsuka Korea Otsuka Pharmaceutical is a foreign-invested company founded on July 9, 1982. Otsuka Pharmaceutical Co., Ltd. of Japan owns 70% of the shares as the largest shareholder, and Jeil Pharma Holdings Holds 22.5%. In the industry, there were many observations that the sales of Otsuka Pharmaceutical were inevitable due to the boycott of Japanese products triggered by export restrictions by the Japanese government last year. Men's skin care brand 'Uros', sold by Korea Otsuka Pharmaceutical, was also mentioned as a representative boycott product on the 'Nono Japan' site. In fact, the company explained that the healthcare business including cosmetics sales have suffered. However, even growth in the range of specialized pharmaceutical products offset the decrease in sales in the healthcare sector such as cosmetics. Sales of existing products such as 'Abilify' and 'Mucosta' continued to grow, and new products such as 'Iclusig' and 'Samsca' successfully entered the market, leading to increased sales. Otsuka According to the drug market research institute IQVIA, the two types of drugs, 'Abilify' and 'Abilify Maintena', were combined with sales of ₩42.6 billion. This is an increase of 24.9% from the previous year's ₩37 billion. Abilify Maintena was released in 2016 as a long-acting injection of Aripiprazole. When administered once, the drug lasts for 4 weeks and can be administered once a month. The oral formulation, Abilify, has experienced a synergistic increase in sales since its exposure to generic competition after the expiration of the patent in March 2014, but increased exposure since the release of Abilify Maintena. Since 2015, the annual sales growth rate of double digits has been recorded, and the company's signature products have recovered. Sales of gastritis and gastric ulcer drugs 'Mucota' are also on the rise. Last year, sales were ₩15.3 billion, up 7.0% from the previous year. Since the second half of last year, 'Samsca' has been recognized as a health insurance benefit for autosomal dominant polycystic kidney disease (ADPKD), its sales have doubled compared to the previous year. In 2018, 'Iclusig', a leukemia treatment drug that had been controversial due to unsuccessful supply, began to be prescribed in earnest, and sales volume has tripled. An official at Korea Otsuka Pharmaceutical said that continued growth of flagship products and successful market entry of new products are considered to be the main causes of sales growth last year and as the drug sales grew and management efficiency efforts to improve per capita productivity achieved, the operating profit margin increased.
- Company
- 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.
