- LOGIN
- MemberShip
- 2026-05-20 07:30:58
- Company
- Korean drug trade in May makes first surplus amid COVID-19
- by Kim, Jin-Gu Jun 16, 2020 06:20am
- In May, the Korean pharmaceutical export volume has hit the historic high. It also was the first month to make pharmaceutical trade surplus in Korea. Europe, where the COVID-19 started spreading later than in Korea, had a sharp surge of demand on essential drug that boosted the drug trade in Korea. ◆New historic high trade volume in two months, topping 700 billion won in a month According to the Korea Customs Service (KCS) trade statistics published on June 16, Korean-made pharmaceuticals generated USD 589.47 million (716.2 billion won) in May alone. Compared to May 2019 (265.49 dollars), the figure multiplied by 2.2 times. The data only accounted for pharmaceutical export volume, excluding the COVID-19 testing kit export. Even against April 2020 (470.44 million dollars), the May export volume increased by 25.3 percent. The record high monthly export volume reached in March 2020 (537.39 million dollars) was outdone in only two months. The total pharmaceutical import volume in May reached 548.02 million dollars (approximately 665.8 billion won). As the export volume exceeded the import volume, Korea had its first pharmaceutical trade surplus of 41.46 million dollars (approximately 50.4 billion won). Monthly pharmaceutical export volume in May 2020 reached another record high in two months (Unit: USD 1,000) Source: Korea Customs Service Korea’s pharmaceutical trade has never made surplus since 2000. The yearly trade deficit marked 324.76 million dollars in 2000 and reached 1.21 billion dollars, 2.45 billion dollars and 2.63 billion dollar in 2005, 2010 and 2015, respectively. Korea made trade deficit of 2.98 billion dollars last year. Korea has made first pharmaceutical trade surplus in May 2020 (Unit: USD 1,000) Source: Korea Customs Service The good news in the Korean pharmaceutical industry contrasts with other general industries struggling in trade. In May, the overall export volume in Korea marked 34.9 billion dollars, dipping sharply by 24 percent against last year same month and by 4 percent against last April. ◆Ildong, Daewon and Hana urgently export essential drugs to Europe in distress Some analyze the COVID-19 pandemic has taken a rather positively effect on Korean drug manufacturing and export. The U.S. and Europe have experienced pharmaceutical shortage due to the pandemic continuing on, and Korean pharmaceutical companies have been swiftly answering those countries requesting for drug supplies. In fact, Ildong Pharmaceutical announced on May 13 that an infection treating Cycin injection was exported to Luxembourg. Daewon Pharmaceutical urgently exported intravenous anesthetic Freepol-MCT injection (propofol), Hana Pharm exported muscle relaxant Atra injection, heart stimulant Hana Dobutamine HCl injection, and anesthesia Vascam injection in April and May. Although not included in May statistics, Bukwang Pharm has exported midazolam injection to France on May 6 as emergency drugs. The industry experts also evaluate supply setback from China and India has also affected the increase in Korean pharmaceutical export. First, the Chinese pharmaceutical supply was impeded, and India banned export of some domestically made drugs. Eventually, other countries turned to Korea for drug supplies. Reviewing the export volume by countries in May, the Korean drug export volumes to Germany, Spain, Italy and France have gone up rapidly. The export volume to Germany reached 177.52 million dollars, showing 429 percent increase from last year same time. The export volumes to Italy (867 percent), France (353 percent) and Spain (163 percent) have also soared. Moreover, the export volume to the U.S. has increased by 587 percent. An official from the Korean company that urgently exported drugs to Luxembourg noted, “The use of essential drug in other countries centering Europe has skyrocketed amid COVID-19 pandemic. European-made drug supplies are insufficient to meet their demand,” and “besides Luxembourg, the company is currently in talks with other countries like Sweden and Israel for their emergency request for pharmaceutical supply exports.”
- Company
- Antidiabetic Suganon readies clinical trial for CAVD
- by Nho, Byung Chul Jun 16, 2020 06:20am
- Diabetes treatment Suganon (evogliptin) has started a clinical trial to receive an indication to treat calcific aortic valve disease (CAVD). In North America, the number of CAVD patients is projected at 1.50 million to 11.5 million (prevalence rate ranging from 2.5 percent to 25 percent in age group over 65), and the related prosthetic valve replacement market is projected at 15 trillion won. For the disease, no other synthetic or biologic treatment options are available, yet. The pharmaceutical industry sources reported RedNVIA has been preparing for a global clinical trial from last year to confirm repurposed evogliptin’s effect in patients with CAVD. RedNVIA has licensed out evogliptin from Dong-A ST in 2019 to develop and market a CAVD treatment. In June 2019, the Korean government approved of the company’s Phase II Investigational New Drug (IND) application with a protocol to test 225 CAVD patients in Korea. And in last month, the company completed the U.S. Food and Drug Administration (FDA) Pre-IND application procedure, and plans to initiate Phase II and III global clinical trial from the third quarter when the IND application is approved. Drug repurposing is finding a new indication by redeveloping an already-commercialized drug with an initial indication or reevaluating a drug not recognized as a novel drug due to insufficient clinical efficacy. The clinical trial in preparation aims to repurpose Suganon to seek new treatment mechanism and indication. Unlike other novel drug development, the repurposing would reduce cost and time spent on candidate medicine exploration and safety confirmation, as well as the risk of clinical trial failure. RedNVIA conducted a retrospective study using hundreds of thousands of patient data in clinical setting to confirm treatment effect and safety of the drug. The study result statistically proved evogliptin-like dipeptidyl peptidase 4 (DPP-4) inhibitor is effective in treating CAVD. Cooperating with Mayo Clinic and Massachusetts General Hospital, RedNVIA constructed a clinical protocol based on ‘Seamless Adaptive Phase II/III Design’ to shorten clinical trial period and expedite commercialization. The protocol would narrow the gap between Phase II and Phase III by approximately more than ten months. In the past, global pharmaceutical company MSD has applied Seamless Adaptive Phase II/III Design on its DPP-4 inhibitor Januvia and received marketing approval earlier than the competing Novartis’ DPP-4 inhibitor Galvus, although the competitor’s development started earlier.
- Policy
- Phase III trial of Eylea biosimilar is ready to kick off
- by Lee, Tak-Sun Jun 16, 2020 06:20am
- Samsung Bioepis is accelerating the development of a macular degeneration treatment, Eylea biosimilar (Aflibercept, Bayer Korea). The development stage is the most advanced in Korea. On the 11th, the MFDS approved phase III global clinical trials for Eylea biosimilar ‘SB15’ by Samsung Bioepis It is phase III trial comparing the effectiveness, safety, pharmacokinetics and immunogenicity between SB15 and Eylea in subjects with neovascular age-related macular degeneration. As a multinational clinical trial, 66 out of 446 subjects participated in Korea. Clinical trials are conducted at Kyunghee University Hospital, KUMC, KU Ansan hospital, Nune Eye Hospital, Pusan National University Hospital, Bundang Seoul National University Hospital, Samsung Medical Center, YUMC, Haeundae Paik Hospital, and AMC. Eylea, along with Lucentis, is the world's most used treatment for macular degeneration. It was released in July of that year with domestic approval in March 2013. As of IQVIA, 2019 domestic sales amounted to ₩46.8 billion. The domestic market outperformed Lucentis (Novartis), which recorded ₩30 billion. Domestic indications include not only for the treatment of neovascular age-related macular degeneration, but also for the treatment of vision damage caused by retinal vein obstructive macular edema/diabetic macular edema and by choroidal neovascularization due to pathological myopia. The domestic related patent (Modified chimeric polypeptide with improved pharmacokinetic properties) is expected to expire on January 9, 2024. There is no commercially available Eylea biosimilar to date. SCD Pharm and Alteogen are developing along with Samsung Bioepis in Korea. SCD Pharm was approved for phase III clinical trial by the US FDA in May. However, domestic clinical trials have not yet been approved. Alteogen was approved for clinical trial I by the MFDS in May last year, and was administered to the first patient in February. Eylea Biosimilar by Alteogen will be manufactured and supplied by DMBio and will be sold in the domestic market by Hanlim Pharm when commercialization and development are completed. Samsung Bioepis is the first phase III trial in Korea. Since 2017, Samsung Bioepis has also been conducting phase III clinical trials of the Lucentis biosimilar, which is the competitive drug of Eylea, and is expected to be approved soon as it is said to have been completed at the end of last year.
- Company
- Takeda to sell 18 items of diabetes & OTC to Celltrion
- by Eo, Yun-Ho Jun 16, 2020 06:19am
- The sale of some items of diabetes and OTC by Takeda was confirmed. Celltrion is the company that acquires these items. Recently, the headquarters of Takeda trademarks, for patents, trademarks, and rights to sell 18 non-core generic and OTC sold in nine countries, including Korea, Thailand, Taiwan, Hong Kong, Macau, Philippines, Singapore, Malaysia, and Australia, signed a contract to sell the rights to sales to Celltrion for ₩33.2 billion. The acquisition is through a Singapore subsidiary. The acquisition is through a Singapore subsidiary. The 18 items sold include Nesina, Actos, Edarbi, and OTC such as Whitetuben and Albothyl. The product group has generated sales of approximately $140 million as of 2018. In the industry, rumors over the sale of Takeda's items and related primary care division (PCBU) and consumer healthcare division (OTCBU) were booming, but both divisions were included. In accordance with the production and supply agreement between Takeda and Celltrion, Takeda will continue to take charge of producing assets for sale, and will supply it to Celltrion. In the future, the technology transfer process will supply the main products acquired by Celltrion Pharmaceutical's cGMP (Current Good Manufacturing Practices) facility to domestic and overseas markets. Under the terms of the agreement, Celltrion will take over the rights of the portfolio in the Asia-Pacific market through procedures such as the Fair Trade Commission. Celltrion is expected to end its business acquisition in the fourth quarter of this year after approval by local authorities, such as a business combination report. With this acquisition, Celltrion has secured the rights to patent, trademark, and sell 18 items in nine countries. Celltrion Pharmaceuticals and Celltrion Healthcare, which have sales networks in Korea, Southeast Asia, and Australia, are in charge of sales. This acquisition is also Celltrion's first major merger and acquisition (M&A). Celltrion explained that the acquisition of the chronic disease treatment market is increasing in importance, and that the company has decided to acquire it as a step toward becoming a global comprehensive pharmaceutical bio company. Celltrion said, "It is expected that Celltrion will strengthen its chemical product line with biopharmaceutical products that have maintained its global competitiveness, such as autoimmune disease treatments and anti-cancer drugs, and make it a leap forward to become a global pharmaceutical pharmaceutical company." Meanwhile, Takeda completed a deal in March to sell non-core assets in the Russia-CIS region to Stada for $660 million, and non-core assets in the Near East, Middle East and Africa were sold to Acino for $200 million. In last July, it sold Xiidra to Novartis for approximately $5.3 billion. Earlier this year, non-core assets in Latin America were $825 million for Hypera Pharma and in Europe, the sale was confirmed to the Orifarm Group for about $670 million, including two production bases located in Denmark and Poland.
- Company
- Newly approved JAK inhibitor Rinvoq to apply for reimburseme
- by Eo, Yun-Ho Jun 15, 2020 06:17am
- The fourth Janus kinase (JAK) inhibitor in Korea Rinvoq is swiftly pursuing the healthcare reimbursement listing. According to the pharmaceutical industry sources, AbbVie Korea submitted the healthcare reimbursement application for Rinvoq (upadacitinib) on June 4, immediately after receiving the market approval. Considering Pfizer’s Xeljanz (tofacitinib) and Lilly’s Olumiant (baricitinib) in the same class are already listed, Rinvoq is most likely to take the pricing negotiation-exempted track by accepting the weighted average pricing for an alternative drug. The third JAK inhibitor Smyraf (peficitinib) by Astellas is also on the same track. In the setting of autoimmune disease, the interest on JAK inhibitors has been growing as a first oral option with confirmed effect equal to anti-tumor necrosis factor (anti-TNF) drugs. However, the JAK inhibitors’ impact in the market has not been too prominent as other biologics. Compared to the market leader anti-TNF drug and popular anti-interleukin drugs, JAK inhibitors’ indications are limited to rheumatoid arthritis and to some disease. It also means, JAK inhibitors have potential to grow. The first-in-class Xeljanz has expanded its indication to treat ulcerative colitis and psoriatic arthritis, and other follow-on drugs have ongoing studies to expand indication in autoimmune diseases like atopic dermatitis, Crohn’s disease and ankylosing spondylitis. When Smyraf and Rinvoq are listed for reimbursement, the competition between the two pharmaceutical companies would intensify. Rinvoq has confirmed its treatment effect in 4,443 patients with severe level of active rheumatoid arthritis through five Phase III SELECT trials (SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY). The result found using Rinvoq alone or with conventional synthetic DMARD (csCMARD) showed lower disease activity and improved remission rate, compared to using a placebo, methotrexate or Humira (adalimumab).
- Company
- Takeda Korea, announces massive ERP
- by An, Kyung-Jin Jun 15, 2020 06:16am
- The aftermath for the sale of the Takeda’s business division began. According to the industry on the 12th, Takeda Korea held a town hall meeting for all employees this morning, and had a time to share information related to the sale of the business division. This is a follow-up procedure following the formalization of a contract to sell 18 copyright of medicines sold in 9 countries in Asia Pacific, including Korea, Australia, Hong Kong, Macau, Malaysia, Philippines, Singapore, Taiwan, and Thailand, to Celltrion. According to an internal employee who attended the Town Hall meeting, Takeda Korea officially formulated the position that it would be inevitable to operate the ERP, without the 'employment succession' of Korean subsidiaries included in the terms of the business transfer agreement. The specific ERP-related schedule, implementation scale, and conditions have not yet been confirmed. Management announced that it would notify employees of ERP-related progress in consultation with the union. This contract includes 12 kinds of specialized medicines such as 'Nesina', 'Actos' and 'Edarbi' in charge of the Primary Care Division (PC BU), and six generic drugs such as 'Whitetuben' and Albothyl in charge of the Consumer Healthcare Division (OTC BU). It is known that there are about 70 employees belonging to the two divisions. About one-third of the 210 employees of Takeda Korea are applied to ERP. "The ERP fact was formalized at the town hall meeting this morning," said an official from the KDPU Takeda Branch. ERP notices embarrassed the internal staff. After Takeda's merger and acquisition of Shire, there were rumors that it would sell PC and OTC business division in the Asia-Pacific region to reduce debts, and similar contracts were signed in other regions of the GEM BU, where Korean subsidiaries belong, but the succession of employment to most employees was guaranteed. An official from the union said, “In other countries included in this contract, such as Australia and the Philippines, employment success has been achieved. However, Korea is the only one to carry out ERP, and it is expected that a detailed discussion will be possible from now on since the company has to notify the union 50 days before the restructuring by agreement.”
- Company
- The KDPU joined the memorial against racism
- by An, Kyung-Jin Jun 15, 2020 06:16am
- A performance scene in honor of George Floyd The domestic pharmaceutical industry gathered to honor memory of George Floyd, a black man who died from the abuse of public power by the American police. On the afternoon of the 11th, Lundbeck Korea branch of the Koea Democratic Pharmaceutical Union held a memorial performance for George Floyd during a protest rally in front of the Lundbeck headquarters in Songpa-gu, Seoul. This was the union's response to the request for participation by the Uni Global Union (UNI) to commemorate George Floyd's sad death. On this day, participants of the Lundbeck Picket protest in Korea knelt down and shouted the protests, "Black Lives Matter," and "We Against Racism." UNI is an industrial group consisting of trade unions of white-collar/financial workers around the world, and has been in exchange with the KDPU since 2018. Floyd's neck was pressed against the police's knee last month in Minneapolis, Minnesota, USA. Floyd was taken to the hospital, but he died. Protests against Floyd's death are spreading beyond the United States to the world. Chairman Dong-Hee Joo of the Fresenius Kabi Korea Union branch said, "We have been participating in the commemoration of George Floyd, who has unfortunately died according to the request of an international UNI organization that has exchanged for nearly two years." "We plan to continue solidarity and cooperation with international UNI organizations." The protest rally by the Lundbeck Korea union continues on the 51st day. In the process of dismissal of former union member A, the Lundbeck union is conducting picket protests during morning time and lunch breaks about the company's unfair labor practices. The union has a policy of continuing the outside struggle until there is a sincere apology from the company.
- Policy
- 18 Champix IMD suspected of selling before patent expiration
- by Lee, Tak-Sun Jun 15, 2020 06:16am
- Pfizer 18 incrementally modified drugs (IMDs) of Champix (varenicline) are undergoing administrative measure for selling the products before the original’s patent was expired. Some of their item approvals have been revoked by the related administrative measure. Before the Champix’ patent expires next month, the follow-on drug market would fluctuate depending on the administrative measures. Korea’s Ministry of Food and Drug Safety (MFDS) announced on June 11, the ministry’s regional offices are reviewing 18 IMDs (nine 0.5 mg products and nine 1 mg products), which have been accused of going on sale before the original extended the patent term. The licenses on Korea Prime Pharm’s Champion in 0.5 mg and 1 mg tablets have been revoked by related statutes. Administrative measures on other items would be finalized when the regional offices complete respective reviews. Apparently, these items are suspected of going on sale before Champix extended the patent, although they stated the sale would be withheld until the expiration date as they were approved by the health authority. Champix’ substance patent expiration date before extension was on Nov. 11, 2018. And extended term would expire on July 19, 2020. Based on the Korean court’s ruling, most of the IMDs have gone sale from Nov. 14, 2018, when the original’s patent expired. But when the Supreme Court overruled the preceding decision and disapproved of IMDs evading patent infringement during the extended patent term, all IMDs have ceased manufacturing and sales. Instead, they are to resume the sale starting from July 19, when the extended patent term expires. The items receiving the administrative measure were supposed to resume the sale from next month. But, the sales plan could be scrapped as they are suspected of selling the products before the patent expiration. Relevant pharmaceutical companies would be affected as the item approval on an IMD selling before the patent expiration is immediately revoked, according to the highest level of administrative measure.
- Policy
- The packaging unit of self-injectable medicine is improved
- by Lee, Tak-Sun Jun 15, 2020 06:15am
- The packaging unit of self-administered injections such as Saxenda, which is used for appetite suppression, is expected to be subdivided. In order to prevent misuse, it was decided to put one in one package. In addition, safety information is produced for patients to use it correctly, and educational program development and medication guidelines are prepared. The MFDS announced on the 11th that it is pursuing a comprehensive measure to support the safe use of self-administered injections, which the patients themselves directly inject. It is said that this measure was prepared to strengthen the safe use and to eliminate medicine’s abuse as the product launch and use expanded due to the convenience of self-administered injection. First, the safety use information that the patient participates in is produced. The intention is to construct a patient panel for self-administered injections to produce safety use information that reflects consumer opinions from the planning stage to delivery and provision. In addition, the existing promotional materials will be reviewed. Patient education programs are also established through consultation with groups of doctors or pharmacists. The doctors' association decided to develop an education program and practice training for patients using self-administered injections. In addition, it was decided to form a consultative body with the pharmaceutical assiociation to prepare a method for strengthening medication guidance for patients and a medication guide. In order to prevent abuse, the product packaging unit is also reduced. The plan is to improve the current packaging unit, which is packed up to five per product, to one. In addition, it was decided to add 'self-administered injection' to the subject of risk management plan submission and to describe in detail how to use it in containers, packaging, and attached inserts The MFDS also plans to promote the use of self-administered injections at home and abroad and research on the current education status. An official from the MFDS said, “We are looking forward to creating an environment where patients can safely use self-administered injections without fear of misuse through this measure. And, we will do our best to continue to communicate with patients, experts, and the industry to expand the foundation for safety commercial use.”
- Company
- KARS and Galderma to run first rosacea campaign in Korea
- by Eo, Yun-Ho Jun 12, 2020 06:12am
- Korean Acne and Rosacea Society (KARS) and Galderma Korea are conducting a campaign to raise awareness in early symptoms and diagnosis of rosacea. From May 6, Galderma Korea has been disseminating rosacea diagnostic checklist, developed with the board of KARS, to private dermatology clinics for the visiting patients and doctors to use. As rosacea usually relapses and needs differential diagnosis, it is crucial for patients to quickly notice the symptoms of the disease and see a specialist. However, a report by Korean Dermatological Association found most of the patients have not heard of the disease name ‘rosacea,’ and most of the survey participants did not recognized the disease to require early attention. Moreover, it is integral for the patients to receive accurate diagnosis from a dermatologist and treatment as the disease show ambiguous symptoms similar to that of acne, perioral dermatitis, seborrheic dermatitis, demodicidosis and systemic lupus erythematosus. In fact, surveying 554 patients and 710 doctors in six countries, 29 percent of patients felt even their doctors does not consider the disease to be serious, and 37 percent of them said their family and friends were not familiar with the disease. The findings showed the patients need understanding and support from doctors and surrounding people. And one third of the survey participants said rosacea has impacted their quality of life either significantly or extremely. The rosacea checklist for the patient provides information on the disease and a list of symptoms to review by themselves. Early symptoms of rosacea includes regularly expressed severe erythema in the center of face, dilated capillaries, itching, hot flush, dried skin, irritated swollen and red eyes, piercing pain and acne-like pimples. People finding these symptoms should seek for dermatologist’s attention. The checklist for doctors provides the latest rosacea treatment standard, factors worsening the disease, and early symptoms for the doctors to refer when accurately diagnosing and treating the patients. According to the latest rosacea diagnosis standard, a person with a symptom either regularly expressed severe erythema in the center of face or rhinophyma-like change in nose can be diagnosed as a patient with rosacea. President Lee Jee-bum of KARS commented, “After missing the time for early treatment, a rosacea patient is most likely to fail to recover completely. But so many of patients not recognizing or ignoring the early symptoms as a disease, but they rely on folk remedy. Because fast and accurate diagnosis and treatment are the most important steps of rosacea treatment, people seeing red spots in the center of face with itching and dried sensation should visit a dermatologist for more details.” CEO Rene Wipperich of Galderma Korea explained, “We anticipate the campaign to better inform specialists and patients visiting dermatologists about rosacea and provide an opportunity to treat it from early stage.”
