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- 2026-05-20 12:09:15
- Policy
- Penalty on 14 drug companies failed to report serialization
- by Lee, Hye-Kyung Jun 26, 2020 06:20am
- 14 pharmaceutical manufacturers and importers are facing administrative actions for neglecting serialization reporting mandate. Penalties on the nine out of 23 companies announced initially were dropped as the authority accepted their appeals. According to the ‘2019 Semi-annual Report on Manufacturer and Importer Subject to Administrative Penalty,’ Korea’s Health Insurance Review and Assessment Service (HIRA) has decided to request administrative action on 14 companies. The penalty for violating serialization reporting mandate is imposed on pharmaceutical companies failed to meet semi-annual average shipment serialization reporting rate of 95 percent, or not complying to 100-percent serialization reporting rate for more than three times (reporting less than 95 percent for more than once is subject to penalty). After reviewing submitted explanatory evidence during the appeal period, 14 pharmaceutical companies and 246 items are subject to the action. The detailed list of the companies and items are kept undisclosed but informed to affected companies, individually. 178 companies that retrospectively reported the serialization after the reporting deadline would receive mitigated penalty. The mitigated level of the penalty would be at two-thirds of the full penalty level as stated in the ‘Regulation on Pharmaceutical Safety Management.’ The standard of administrative penalty and fine imposes one-month business suspension on a company failed to meet the serialization reporting rate for a first offense. Meanwhile, the penalty has been already imposed on 13 distributors that failed meet the shipment serialization reporting rate of 55 percent in the second half of last year. The standard of administrative penalty and fine stipulates 15-day business suspension on distributor for a first offense. The business suspension period extends a month, if the company violates the regulation for a second offense.
- Policy
- The goal is to develop a corona vaccine in next year
- by Lee, Jeong-Hwan Jun 26, 2020 06:20am
- The Ministry of Health and Welfare said it was supporting a domestic COVID-19 vaccine with the goal of developing in the second half of next year and in 2022. Corona vaccines such as MERS and SARS were not developed because of the low global demand for vaccines. On the 24th, the MOHW replied to the written question of Nam In-soon, Democratic Party Member of the National Assembly's Health and Welfare Committee. Nam asked the prospects, such as when to develop a domestic COVID-19 vaccine. He also asked why corona vaccines such as MERS and SARS were not developed. The Ministry of Health and Welfare said it was supporting the private sector with the goal of developing a domestic Corona 19 vaccine in the second half of 2021 or 2022. The reason for the undeveloped corona vaccine is that world demand is low. The high fatality rate of SARS was ended during R&D, and the low infectious MERS occurred only in the Middle East. The MOHW said, "The domestic corona vaccine is expected to be developed in the second half of next year and in 2022."SARS was ended during vaccine research and development, and MERS only occurred in the Middle East, so the worldwide demand was low and vaccines were not developed."
- Company
- New products join the already competitive bowel prep market
- by Lee, in-bok Jun 26, 2020 06:19am
- The bowel preparation market valued at 50 billion won is fluctuating noticeably. New products flooding in just a few years time have overly crowded the market. These products are jumping into the market with improved drug compliance for examinees and patients, but the market has not been easy for them to survive. Three types of bowel preparations approved in Korea In Korea, only three types of bowel preparations are approved by the health authority. Two types of polyethylene glycol (PEG) are most popular aside from oral sulfate solution (OSS). Iso-osmotic and non-absorbable PEG products are considered as the safest to use with lower risk of adverse change in electrolytes and metabolism. These are the reasons why Korea uses PEG the most. High-dose PEG, such as Colyte Powder and Colonlyte Powder, is usually supplied in 4 liter. Low-dose PEG, such as Coolprep Powder and Clicool Powder, is in 2-liter unit. Recently, many of PEG products are designed to be administered at minimum dose for better drug compliance. In fact, the majority of PEG products were in 4-liter unit when the U.S. Food and Drug Administration (FDA) first approved it in 1992, but now the market trend is leaning towards 2-liter dose after FDA approved the lower-dose product in 2006. OSS in tablet form was released to the market to enhance drug compliance with small amount. The world’s first incrementally modified OSS, Orafang by Pharmbio Korea is a well-known OSS tablet. While PEG still dominates the market, Orafang struggles to settle down Currently, Taejoon Pharmaceutical owns the biggest pie in the bowel prep market. The company generates over 10 billion won, easily topping the market valued at 50 billion won. In 1990s, Taejoon Pharmaceutical imported Colyte Powder and Colyte F Powder, and continued to dominate the market over a decade with FDA-approved Coolprep and other various doses of PEGs. The Korean company has the fullest line up in the market. Joining the race late, Pharmbio Korea seems to have avoided PEG by launching the world’s first incrementally modified OSS Orafang in May last year. To snatch a chance to compete in the bowel prep market, the company had to find a key product besides PEG. Pharmbio actually has tried the market with PEG before, but the performance was underwhelming. Although it was dropped during clinical stage in 2013 due to unforeseen renal issues, the conveniently administered Orafang came back in tablet form with most of the problematic part sorted out. Phase III trials conducted in eight hospitals like Seoul National University Hospital and Korea University Medical Center have confirmed Orafang’s bowel cleansing efficacy at 95.5 percent non-inferior against other OSS in liquid form at 98.2 percent. But apparently, the OSS was faced with limitation in the PEG-dominated market. The biggest difficulty was entering university hospitals. A head of general medical checkup center at one of Big Five hospitals hinted, “We are aware of Orafang, but the hospital does not use it or have a plan to consider using,” and “checking at conferences and seminars, majority of university hospitals were not interested in entering the product’s prescription code.” New products flooding in, the latecomer competition also unavoidable Regardless of the world’s first incrementally modified drug struggling to expand in the market, new products are released one after another in the Korean bowel prep market. The latecomers’ competition would inevitably heat up high as the market is already crowded with firstcomers. Korea Pharma has signed an exclusive deal with Norgine, a Dutch company specializing in bowel prep, for supplying PLENVU in the Korean market. Kolmar Korea is readying for the launch of Easyprep 1.38 Power that reduced the regimen amount down to 1.38 liter. The company has received Ministry of Food and Drug Safety’s (MFDS) approval on the incrementally modified drug. Dong Seok Ho, a President of the Korean Society of Health Screening and Promotion, stated “The board of directors is also reviewing newly released bowel preps through product presentation,” but “as all of them have clear advantages and differentiate themselves by improved drug compliance, products with high level of safety and bowel cleansing efficacy would ultimately win the market.”
- Company
- Pharmacist's No. 1 product among athlete's foot tx, Tiersil
- by Lee, Seok-Jun Jun 25, 2020 07:02am
- The pharmacist's recommendation for 'once-form athlete's foot treatment' was found to be due to patient convenience (40.4%), medication compliance, and therapeutic effect (39.9%). The pharmacist's No. 1 product among athlete's foot fungus drugs was investigated as 'Tiersil Once (Terbinafine Hydrochloride)’. Dailypharm conducted an online survey of 1,970 pharmacists on the 10th of this month to understand the current status of over-the-counter medications for athlete's foot. Athlete's foot is a disease that occurs well in summer. According to the results of the survey, 99% of pharmacists analyzed that they were primarily recommending 'Terbinafine' when administering athlete's foot medicine. 'Terbinafine' is known to have a fast and excellent treatment effect against dermatophyte, the main cause of athlete's foot, compared to 'Clotrimazole', an extensive antifungal agent. The reason that athlete's foot treatment was not properly treated with athlete's foot treatment was that 53.1% of the patients judged that they had improved themselves and stopped. Next, it was followed by 'because the treatment for athlete's foot that needs to be applied daily is uncomfortable and annoying (22.2%)', and the treatment period is too long (16.9%)'. Discomfort is the biggest reason. The actual once formulation does not have the hassle to apply daily, such as a cream or gel, as the drug continuously penetrates for up to about 2 weeks when applied once. In particular, it has the advantage of being effective because it is possible to forcefully treat athlete's foot to the end. However, pharmacists ranked the preferred athlete's foot treatment formulations as cream (48.2%), gel (41.1%), and once (5.8%). The advantage of Once is clear, but 'Cream' type is the most well-known formulation because it is familiar to patients, and 'Gel'type is the second because of patient’s compliance. Among the once formulations, the pharmacist's preference was ranked 1st at Tier Silence (41.6%) and 2nd at Lamisil Once (35.7%). It also works with figures. According to 1Q IMS data in 2020, Tiersil Once was ranked 49.1% in the market of 'Once', surpassing 'Lamisil once' and ranked first in the market share. Sales grew 961.4% YoY. The key to the popularity of Tiersil Once is the convenience and effectiveness of the once-in-the-box formulation, as well as 'high margin rate (44.4%) in pharmacies', 'brand and product awareness (27.5%)', and 'high repurchase rate (10.6%)'. Some suggested that using Trot star Song Ga-in as a model increased awareness. Tiersil Once used a 'silicone film' that has excellent drug treatment and a high raw material cost compared to other raw materials because its drug delivery power is up to 3 times higher. Although the cost of the product is high and it is an advertising product, it is evaluated to coexist with pharmacies because it does not lower the margin rate. There was also an opinion on combination therapy. 94% of pharmacists recommended two or more formulations for effective athlete's foot treatment. 'Combination therapy' mainly used a combination of a product (cream, gel, once) and a product to spray (spray, aerosol). There was also a response that containing the 'once' formulation that treats athlete's foot with a single application and 'Lidocaine', which can quickly relieve itching, can conveniently maximize the therapeutic effect by using athlete's foot medicine in combination. Athlete's foot types are divided into interstitial, angular, and blister types. 'Tiersil Once' can be applied to all athlete's foot except for chronic keratinized athlete's foot. In addition to Once, there is also 'Tiersil Aerosol' in the Tiersil athlete's foot lineup.
- Policy
- COVID-19 global clinical growth rate is about 17 times
- by Kim, Jung-Ju Jun 25, 2020 06:31am
- The global clinical trial of 'COVID-19' is steadily increasing. The increase rate is close to 17 times from March to the present. 15 cases have been approved in Korea, and research is actively underway, and as a whole, clinical trials of plasma devices using plasma of cured patients have surged 36 times. According to the trend of domestic and foreign clinical trials for the development of vaccines and treatments for COVID-19 vaccines updated by the Korea National Enterprise for Clinical Trials (Chairman Byung-Joon Bae) on the 23rd, there were 941 Drug Interventional Clinical Trials in COVID-19 newly registered at the National Institutes of Health (NIH) ClinicalTrials.gov on the 22nd. As of March 11, the total number of clinical trials increased 16.8 times from 56 cases to 941 cases. In particular, the number of sponsor-investigator trials increased by 19.1 times from 32 to 612, and it was analyzed that the sponsor-investigator trials aimed at the public interest in responding to the national public health crisis are driving clinical research. 905 were clinical trials related to treatment and 36 were clinical trials related to vaccines of the 941 clinical trials. Among clinical trials related to treatment, 591 cases of researcher's clinical trials, 297 of clinical trials of pharmaceutical companies, NIH and U.S. Fed-sponsored clinical trials were 17 cases, and the proportion of sponsor-investigator trials was 65.3%. In particular, clinical trials for blood plasma treatments using plasma of cured patients surged 36 times from 3 cases to 108 cases as of March 11th. COVID-19 related clinical trial plans approved by the MFDS were 15 cases on the 22nd of this month. 13 clinical trials related to treatments and 2 clinical trials related to vaccines were conducted, and 7 clinical trials (46.7%) were reported to be in progress. Meanwhile, information on the current status of clinical trials related to COVID-19 can be viewed and downloaded from the Korean Clinical Trial Portal (K-CLIC).
- Company
- Hanmi Science Presents 6 Great Visions for Post COVID-19
- by dailypharm Jun 25, 2020 06:09am
- Hanmi Science with the gene of 'Innovation' presented six great visions for the post COVID-19. Hanmi Science's 6 visions, abbreviated as 'Cydio Cigma', imply key words as 'Cyber Education','Digital Bio','Oral Bio','City Bio','Green Bio', and 'Marine Bio'. For the vision business, CEO Chong-Yoon Lim promised to raise outstanding employees’ annual salary by 100% regardless of the ranks. “Where there is no innovation, there is no development! Those who shrink from challenges are branded as cowards ! The cyber education business, digital bio business, oral bio business, city bio business, green bio business, marine bio business, and Cydio Cigma are our goals and commitments for the post-COVID-19. ” These are the 6 great visions of Hanmi Science unveiled at the 'Tea Time' executive meeting, which is also the tradition of Hanmi, on the 15th at 7:30 am. The road map of the post-pandemic era was presented. Hanmi Pharmaceutical Group has always been recognized as an innovative company in Korean pharmaceutical bio industry. Through the equation "Hanmi = R&D", it has become a classic example of innovation in the pharmaceutical and biological industries, as well as a symbol of the company that represents the development of new drugs. Now, the case of Hanmi's innovation and R&D has gone beyond the development of new drugs, and deviated from the framework of all existing industries, drawing a blueprint on a blank sheet of paper. With the mission of combating the post-COVID-19 era, Hanmi, as a leader of K-Bio, has formulated six visions with Hanmi's macroscopic future pharmaceutical, bio, and health and welfare solution strategies. Hanmi Science's 6 great visions, abbreviated as 'Cydio Cigma', imply key words as 'Cyber Education','Digital Bio','Oral Bio','City Bio','Green Bio', and 'Marine Bio'. Each item for the six businesses is Cyber Education, Digital Bio, Oral Bio, City Bio, Green Bio, and Marine Bio. On this day, CEO Chong-Yoon Lim promised to change the existing HR resources system by offering 100% annual salary increases and job titles to those who deliver concrete performance related to those 6 great visions Goal & Promise, is a personnel management system for actualizing management goals of Hanmi, and publicly proposed to discover talents inside the company that transcend positions to perform and participate in the 6 vision projects. Hanmi Pharmaceutical Group (hereinafter referred to as Hanmi) officially declared its macroscopic goals, changes and wills in order to cope with the post-COVID-19 era. Launched “Cyber Industry-University Cooperation Academy” in cooperation with global leading bio-medical universities Looking specifically at the six visions proposed this time, first of all, the framework of "Cyber Education" is the establishment of K-Bio and K-Med graduate schools, attracting more than 5,000 foreign experts. Hanmi Science Group has been accumulating cooperation and joint research courses with overseas medical, bio-related universities and research institutes over the past few years. It was not a temporary solution, but rather it’s in line with the most important policy of R&D in Hanmi Pharmaceutical Group. Starting with a joint research agreement for public health in Korea-Italy with Catholic Medical School in Rome, Italy and the Policlinico Universitario Agostino Gemelli in late 2017, CEO Chong-Yoon Lim established a global research network based on joint research for low birth rates, neonatal health and postpartum care and other common problems between Korea and Italy. Cooperating with Beijing Union Medical School, which participated as a consortium, he has expanded the concept to fit China, and is conducting research to suit the characteristics of Korea, China, and Italy by adding in-depth research on the need for advanced maternal and child health and the possibility to improve the efficiency of social health economy through pregnancy management in a country with 20 million newborn babies. Hanmi defines Digital Bio The following is about "Digital Bio", one of the 6 great visions. Hanmi Science is promoting the 4th medical industry revolution by combining information and communication technology and big data through continuous investment in research and development capabilities. Hanmi Science launches Paltan Smart Plant equipped with a cutting-edge technology and unveils the next-generation innovative medical infrastructure system based on the know-how of Hanmi's electronic distribution network management system, unmanned prescription system, and hospital information system over the past 20 years. Hanmi is not a base for electronics, portals, or online distribution, but is a specialized bio-medical group that has been conducting more than 500 drug developments and clinical trials of more than 30 new bio drugs over 50 years. Currently, various organizations, including the Ministry of Health and Welfare and the U.S. FDA, recognize the importance of participating in such innovative medical systems with verified professional companies. In addition to chronic disease and pregnancy health care, Hanmi is applying for a number of global patents for medical software to cure COVID-19 and is working with the National Institute of Health and Welfare to develop a system that will be applied to the site. Since it can be applied simultaneously in cooperation hospitals in China and Italy, it is expected that such efforts will lead to the positive results of the K quarantine. Leading the Oral Bio new drug business, Most domestic new biologics are still injectables. However, Hanmi, which has developed more than 400 oral medicines, as a leader in the healthcare/medicine market in the post-COVID-19 era, has the world's best technology in oral treatment development. This is a completely differentiating strategy from existing major bio companies based on large biosimilar (biopharmaceutical generics) factories. In particular, among the factories owned by Hanmi, Paltan Smart Factory is the world's best smart factory capable of producing 6 billion tablets annually and 90% unmanned processes. In addition, Oraxol, which applied the patent platform technology 'Orascovery', transferred technology to Athenex, a US biopharmaceutical company in 2011, recently announced cases of complete recovery from the most difficult groups of patients to treat at ASCO, as a result of the recent third-phase global clinical trial. Seeing the post-COVID-19 era as a innovative breakthrough and opportunity, Hanmi unveiled a blueprint for the next generation of Orascovery. Currently, about 800 new COVID-19 related drugs are being developed around the world, but new drugs developed as oral or non-injection drugs are rarely found. It is also considered the most reckless attempt. But worth it. The biggest problem under the pandemic situation is the shortage of medical staff including nursing personnel, the lack of medical facilities, and the time from treatment development to commercialization. As an influential treatment for COVID-19 that can overcome these difficulties, we develop an oral (non-injection) vaccine containing the next-generation Orascovery technology. "We have already experienced countless failures and overcomes. In response to the challenge faced by human beings called Pandemic, Hanmi will start preclinical trials of "COVID MDT", the safest and most effective treatment by integrating accumulated technology and innovative treatment models. There is no more failure than fear of not challenging," he expressed with confidence. Signed MOU 'City Bio' with Gyeongsangbuk-do, Pohang-si and Daegu-Gyeongbuk Free Economic Zone Authority Hanmi Science leads the creation of Smart Health care City. Hanmi Science and the Gyeongsangbuk-do, Pohang-si, and Daegu-Gyeongbuk Free Economic Zone Authority signed an MOU for biomedical smart city with a business size of about 300 billion won including education, R&D and manufacturing facilities in Pohang Convergence Technology Industrial Zone on the 15th. Smart Eco City, which will be unfolded on a green area of 15,000 square meters, is a prototype city that manages life quality from birth to daily life through a pollution-free bio-environment for all cities and citizens with "administrative regional medical resource management" suitable for the post-COVID-19 era. The computing center, which corresponds to the brain of this smart city, is a kind of cloud-based solution similar to a large ERP system designed to enable real-time continuous analysis of biological activity in the region, citizen health care, medical resource management, knowledge data base, world-class education, quality of life including food, exercise, culture, and medical institutionalization of all urban facilities in case of emergency. In addition, it is equipped with educational facilities capable of real-time linking to advanced overseas research institutes, so it is possible to respond to joint research by sharing bio-bank data in medical and medical situations of world-class medical staff if necessary. As a post-COVID-19 vision business called City Bio, it will be built as a 'Future City' that combines the 50-year know-how of the global Hanmi. Green Bio, applying plant biotechnology, expanding global healthcare group Hanmi Science signed a strategic business agreement with BioApp, a promising venture company in the field of plant biotechnology in Korea, and promised joint development and joint marketing of plant-based bio products, also known as "green vaccines," for domestic and international markets. In particular, the two companies announced that they will collaborate on the development and commercialization of green vaccines against various diseases including COVID-19, which is a recent issue. In addition, the two companies agreed to establish a joint venture for the overseas sales of the world's first plant-based swine fever marker vaccine product that has been developed and commercialized by BioApps, and announced that they would select China as the first market and proceed with joint venture establishment and product registration in the near future. This model has received a great deal of attention from the industry because it is a collaboration between the outstanding technology of domestic bio companies and Hanmi Science's “Open Innovation” method, which has already pioneered overseas markets. The two companies are ultimately drawing a blueprint to challenge Human Madison based on plant biotechnology. Hanmi Science signed a technology transfer contract with Duhu Liu, a professor at the Chinese Academy of Agricultural Sciences, for a new drug candidate related to metabolic disease, and started developing a new green bio drug. In order to sign a vision business contract with China's top bio-biotechnology organization, CEO Chong-Yoon Lim visited China more than three times to discuss marketability for related technologies and discuss development roadmaps with the Chinese Academy of Agricultural Sciences. Through this agreement, Hanmi Science and the Chinese Academy of Agricultural Sciences announced that they will jointly complete the preclinical studies necessary for clinical trials of new drug candidates, and to work closely with the Beijing Hanmi Research Institute in the clinical process. According to Hanmi Science officials, in addition to the candidate materials, it was emphasized that a review of the application of plant and biotechnology to blockbuster-class pipelines also began inside the company. Now, Hanmi Science has joined forces with researchers who has the best green bio technology in both Korea and China to realize the fifth vision of the post-COVID-19 era to "Revolutionize" the huge production and research costs of existing bio-new drugs development. Marine Bio,Open a convergence Marine Bio Center in Pohang Penta City Hanmi is looking for a future vision business in the 'Ocean', which is the original birthplace of living thins on the Earth, and a bio-bank of all living creatures that preserve the evolutionary process and covers 70% of the Earth's surface. In other words, Hanmi Science threw a vote in an unfamiliar area called Marine Bio. This is a vision project for understanding, protecting, preserving of marine bio resources,where 80% of the world's species are inhabited but commercial utilization is less than 1% and researching new drug development mechanisms and deriving lead materials. In 2004, the pain reliever Prialt, which was created using the toxicity of sea snails, was reported to have generated $27 million in sales in 2017, while the black beach sponges-based anti-cancer drug, developed in Japan and approved FDA in 2010, generated $3.6 billion worldwide in 2017. With the marine bio industry expected to grow into a market worth about $8.05 billion by 2030, given the domestic situation focused on the aquatic food processing industry, Hanmi Science's Marine Bio Vision business is a roadmap to bring Korea back into the ocean power. In particular, Pohang is the best place to have the best conditions for the location of marine resources, with the long history of proving it, and the fourth generation of accelerators. Through marine bio research, it is possible to study the underlying biological mechanisms by studying genomic studies before and after evolution, understanding of the inter-microbial ecosystem of viruses, and the origin of human cell functions. Hanmi's Marine Bio Center is expected to be the Noah's Ark of the marine life system. In regards to Korean NIH's announcement on April about discovering potential COVID-19 vaccine using VLP(virus like particle), Hanmi Science and the authority are seriously considering possible measures to co-develop the candidate.
- Company
- Sanofi to dismiss 3 sales reps breaching compliance
- by An, Kyung-Jin Jun 25, 2020 06:08am
- Accused of false reporting client visits, three sales reps from Sanofi-Aventis Korea may be dismissed as recommended by the headquarters. The sales department seems to be stirred by the management and commented, “The management has made a harsh decision disregarding the possibility of system error.” The sign of internal dispute is apparent as the labor union pointed out the Korean branch proceeding the headquarters’ disciplinary decision straight. According to the industry sources on June 25, Sanofi-Aventis Korea has referred two sales reps to its disciplinary committee on June 18. The committee review was conducted to verify the accusation of the sales reps falsely reporting the number of client visitation, which the headquarters said to ‘recommend dismissal.’ Another disciplinary committee review session is scheduled on June 29 for the same accusation on a different sales rep. The committee is deferring the decision on the first two for now. The level of disciplinary action would be finalized after accepting and reviewing additional explanatory evidence for a week since the disciplinary committee review. The incident began back in late last year. An insider from Sanofi says Ethics and Business Integrity (EBI) department at Korean branch, in charge of compliance affairs, received a report and called in a number of sales reps affiliated under Daejeon, Jeonju, Busan and Daegu offices to Seoul headquarters for further investigation. The reason for investigation was the unmatched information among call records (number of healthcare provider visitation by sales rep) in Centrix, highway toll payment system Hi-pass, parking receipt, and corporate card history documented from February to May of 2019. The EBI department reported three of the investigated sales reps for making ‘false calls’ as some of their Centrix call records, time and location were not matching and did not follow the initial plan. The headquarters assessed the report and officially ‘recommended dismissal’ on the three reps, which now convened the disciplinary committee. Sanofi sales department is reportedly shaken by the management’s decision. Sanofi has ordered dismissal on some sales reps for breaching the compliance code. The employees are complaining the management’s disciplinary actions are extreme and unfair as they are solely dependent on electronic records and overlooking troubles in the sales scene. An insider from Sanofi sales department noted, “Changes in planned call is always occurring depending on the paper work, team meeting, corporate training and client situation. Inputting calls into Centrix within three days causes error or inevitably mixed up time input due to limitations in the system.” The sales department explains the employees’ performance is reviewed focusing more on the frequency of product detailing, meal with client, monthly seminar and other indicators than on call records in Centrix. The insider complained, “The sales department directors do not even pay attention to the Centrix call records. Without sufficient explanatory evidence, making a harsh disciplinary decision like dismissal only based on electronic data is unjust.” The labor union in Sanofi-Aventis Korea expressed concern about the disciplinary committee and their effectiveness. Appealing to the disciplinary committee in Korean branch is merely a formality, and the headquarters’ decision is most likely to become the final decision. The head of Sanofi-Aventis Korea Labor Union, Park Young stated, “Stressing on the principle of ‘Zero Defect Zero Tolerance,’ the French headquarters has been making disciplinary decisions without fully considering the Korean employees’ circumstances. The employees are growing increasingly frustrated with the bureaucratic management by the Korean branch management and CP department, and superficial procedure taken by the disciplinary committee,” and “if their past conduct is repeated, the labor union would fight with everything to protect the union member.” In 2016, Sanofi has dismissed two sales reps for paying their team dinner with corporate card as ordered by the team manager. In 2019, a sales rep, affiliated under consumer healthcare sector handling OTC, was dismissed after being accused of deliberately returning the product late to keep incentives. Two cases fired up the criticism of unjust dismissal as the employees’ appeals were not accepted according to the French headquarters’ principle of ‘zero tolerance on breaching compliance.’ The corporate management says a detailed answer cannot be given at this point with the internal review still ongoing. A Sanofi-Aventis Korea official stated, “We are aware of the responsibility in credibility the patients, families and healthcare providers have on the company. To fully serve the social responsibility, the company would always strive to strictly follow the business ethics and compliance code.”
- Company
- Hanmi's Gugu was released in Japan
- by Chon, Seung-Hyun Jun 25, 2020 06:08am
- Hanmi's erectile dysfunction treatment 'Gugu' was released in Japan as a treatment for prostate hyperplasia. According to Hanmi on the 23rd, Sandoz began to sell Gugu 2.5mg and 5mg from all over Japan on the 18th. The Japanese product name is “Sandoz Tadalafil” (Tadalafil Tablets 2.5mg∙5mg ZA SANDOZ). Gugu released in JapanGugu is generic for Cialis, an erectile dysfunction treatment. It was approved from Ministry of Health, Labour and Welfare of Japan as a first generic for treating prostatic hyperplasia in February. Hanmi produces Tadalafil from Paltan smart plant and supplies them to Sandoz. Sandoz goes through the packaging process and conducts sales and marketing across Japan. Hanmi plans to continue close cooperation with Sandoz with the goal of securing the largest share of the Japanese prostate hyperplasia treatment market. An official from Hanmi said, “Googu has established itself as a leader in the domestic urinary treatment market based on excellent product strength, trust from medical staff, and patients. Through close cooperation with Sandoz, we will try to achieve remarkable results in new markets.”
- Company
- COVID-19 devastates outpatient prescription in April-May
- by Chon, Seung-Hyun Jun 25, 2020 06:07am
- Top pharmaceutical companies have been struggling with outpatient prescription sales for two consecutive months. The COVID-19 seems to have slowed down drug prescription for nine out of ten major pharmaceutical companies in last two months and impacted the overall prescription volume this year. On June 22, pharmaceutical market research firm UBIST found Hanmi Pharmaceutical has achieved the highest outpatient prescription sales at 271.5 billion won accumulating from this year January to May. The company made a growth of 0.1 percent from last year same time and topped the market. Regardless, the growth was rather sluggish. Major pharmaceutical companies’ cumulative outpatient prescription sales in May (Source: UBIST) Most of the major pharmaceutical companies took a severe hit with the prescription drugs compared to last year. From January to May, Chong Kun Dang made 242 billion won and came in second, but the cumulative sales were 3.0 percent lower than last year same time. Also, Pfizer Pharmaceutical Korea’s prescription sales were dipped by 6.3 percent. 12 out of top 20 companies, including Chong Kun Dang, Pfizer, Daewoong Pharmaceutical, MSD Korea, Novartis Korea, Yuhan, Dong-A ST, Daewon Pharmaceutical, Jeil Pharmaceutical, Ildong Pharmaceutical Astellas Pharma Korea and Samjin Pharmaceutical, accumulated prescription sales less than last year. Particularly, Daewoong and Ildong took a steep fall over 10 percent this year. The stagnation in this year’s prescription drug sales worsened in April and May. 18 out of top 20 companies had April and May prescription sales lower than last year. It means 90 percent of the companies failed to reach last year’s sales. Performances in those months contrasted to that of the first quarter, when most of the pharmaceutical companies performed better than last year. In the first quarter, only six out of the 20 companies—Pfizer, Daewoong, MSD, Novartis, Yuhan, Ildong, Astellas and Samjin—performed worse than last year. But the prescription sales noticeably stagnated in slow April and May. Hanmi and Chong Kun Dang, the two market leaders, recorded 8.3 percent and 9.5 percent decrease in April and May prescription sales against last year. Major pharmaceutical companies’ outpatient prescription sales in April and May combined (Source: UBIST) Hanmi’s first quarter prescription sales grew by 6.2 percent from last year’s first quarter. But it fell by 8.7 percent and 7.9 percent in April and May, respectively. Pfizer’s first quarter prescription sales this year was dropped by 4.1 percent from last year, but April and May sales were brought down further by 9.3 percent. Daewoong, MSD, Novartis, Yuhan, Daewon, Ildong and Astellas’ prescription sales fell by over two-digit in this April and May. Following the 7.0-percent fall in the first quarter, Ildong’s sales fell by 20.8 percent in April and May from previous year. The market experts analyze many of the patients with chronic disease refrained from visiting healthcare institutes and hoarded necessary drug in advance, which created a significant prescription void in April. In fact, when the number of confirmed COVID-19 cases dramatically surged, many of those patients requested for prescription lasting three to six months. On top of everything else, the experts suspect visit to healthcare providers has gone down, because postponed school semester, social distancing and keeping personal hygiene reduced the disease prevalence in infants and children. The overall outpatient prescription sales in this year’s first quarter reached 3.70 trillion won, showing 2.7-percent growth from last year at 3.60 trillion won. But the outpatient prescription sales in April and May combined was at 2.36 trillion won, sliding down 9.4 percent from last year. The prescription sales in this year’s April and May against last year plummeted by 8.7 percent and 9.4 percent, respectively. On the contrary, Celltrion and Hutecs Korea Pharmaceutical exhibited outstanding growth despite general stagnation in prescription drug sales. Surging 32.0 percent, Celltrion’s cumulative prescription sales in May reached 89.4 billion won. Celltrion continued to make striking growth of 21.0 percent in this year’s April and May against last year, after making 40.6 percent surge in the first quarter. Hutecs’s cumulative sales in May this year grew by 12.6 percent, generating 90.7 billion won. This year’s first quarter prescription sales marked 55.6 billion won increasing by 20.1 percent from last year. April and May prescription drug sales this year only grew by 2.3 percent than last year, but the company and Celltrion were the only two companies that maintained the growth.
- Policy
- The addition of Lipiodol will end in next May
- by Kim, Jung-Ju Jun 24, 2020 11:07am
- Lipiodol (Iodized oil) was lowered by 30% due to the government's authority adjustment, and was confirmed until the end of the addition. This is because Fattiodol by Dongkook has been released. Anagre by Yuhan and Agrylin by Shire Plc have secured the same number of products, and the surplus, which has been retained since the end of the second half, will be reduced by 20%. According to the pharmaceutical industry, the MOHW is pursuing a partial revision of criteria for pharmaceutical reimbursed list and limit amount table'. It will take effect on July 1st once the amendment is confirmed. ◆Addition and Termination= 8 items are subject to next month's addition, of which 6 items add up to 59.5% of the same price as the highest price. The government adds 59.5% for the first year (first generic) to the price calculated at the same price as the highest price if the upper limit price of the same product is different from other companies. If the number of companies with the same product is 3 or less, it is applied until 4 or more. Daewoo Pharmaceutical's Pajilect 1 mg (Rasagilin mesylate), Ahn-gook’s Risirect 1 mg and Ilhwa’s Maorect 1 mg cost ₩ 2,083 for each item, 0.5mg dose of these products are ₩ 1,397 each. Addition is due until January 31 of next year. As of July 1st, 2 items were added. In the case of biopharmaceuticals, the total amount of biopharmaceuticals is added for 2 years from the date of the initial notice of the same biopharmaceuticals, and if the number of companies with the same product is less than 3 companies, the addition is maintained within an additional 1 year. By item, Yuhan's Anagre Capsule 0.5mg, dropped 21.1% from ₩2,748 to ₩2,167, and Shire's Agrylin capsule 0.5mg fell 23.5% from ₩2,832 to ₩2,167. ◆Compulsory arbitration and compulsory arbitration product addition end= As generics are listed, the upper limit value of the first listed product and the product with the same administration route, ingredients, and formulation as the first listed product is lowered by the government's authority adjustment. There are a total of 7 items that are cut in this way due to the adjustment of authority on the first day of next month. Huons’ Zopista (Eszopiclone) 1mg is ₩92, 14.8%, 2mg dose is 29.6%, 3mg content is 30% drop. Astellas Pharmaceutical's Betmiga PR 50mg (Mirabegron) is ₩498, and 25mg content is ₩332, each dropping by 30.1%. Hanmi's Liplatin 5mg/ml (Oxaliplatin) is also cut by 14.6% to ₩317,627. In particular, Guerbet Korea's Lipiodol Ultra Liquid, which had influence over the state audit due to the suspension of supply two years ago, will be cut by 30% from ₩193,000 to ₩133,000. The drug has emerged as a social issue in the aftermath of the supply disruption in the past, and the system has been strengthened so that the strengthening of supply responsibility for pharmaceutical companies can be selectively adopted in the contents of the current drug price agreement. Currently, Dongkook’s Fattiodol has been registered on May 1st, and domestic replacement items have been secured. All six items that were cut due to the next month's authority adjustment were products that had been added, and their closing date and the upper limit after the completion were also confirmed. As of next June 1, Zopista 1mg will be cut to 23.9%, ₩70, Zopista 2mg to 23.7%, ₩87 in the same month, and Zopista 3mg to ₩109 in the same month. Betmiga PR 50mg is reduced by ₩381, and Betmiga PR 25mg by 23.5% ,₩254, respectively, and Lipiodol falls by 23.5% to ₩101,745.
