- LOGIN
- MemberShip
- 2026-03-19 01:38:07
- Company
- Boycott Japan: Drug import rather increased in a year
- by Kim, Jin-Gu Jun 29, 2020 06:13am
- During a year of the Koreans boycotting against Japanese-made products, the total imported Japanese pharmaceutical sales have increased even more. But the trade balance has improved as the Korean-made pharmaceuticals exporting to Japan surged as well. Daily Pharm analyzed Korea Customs Service today and found the Japanese-made pharmaceutical import volume has increased by 2.1 percent from the time before the boycott. From the start of the boycott against Japanese product in June last year to May this year, the overall USD 390 million (approximately 469.6 billion won) of Japanese-made pharmaceuticals were imported in the year. Compared to the year before (June 2018 to May 2019), the figure jumped 2.1 percent (approximately 459.9 billion won) from 382 million dollars. The pharmaceutical import contrasts greatly against the overall Japanese product import volume plummeting by 11.8 percent from 51.54 billion dollars to 45.48 billion dollars. However, the trade balance has apparently improved with a steep increase in Korean-made pharmaceutical export to Japan. A year prior to the boycott, the export to Japan generated 193 million dollars, but during the year of boycott the figure leapt by 56.1 percent recording 310 million dollars. Due to the boycott, the trade deficit with Japan was dropped by about 100 million dollars from 189 million dollars to 89 million dollars. The change in pharmaceutical import and export with Japan from a year before (June 2018 to May 2019) and after (June 2019 to May 2020) the boycott against Japan. The Japanese-made pharmaceutical import rose (left) slightly, whereas the overall Japanese product import plunged by over 10% (Unit: USD 1 million) Source: Korea Customs Service The statistics show Korea has made trade surplus with Japan in January, April and May this year. For last two years, the pharmaceutical trading with Japan has never marked a monthly trade surplus. The pharmaceutical trade surplus with Japan generated 10 million dollars (exported 35 million dollars, imported 26 million dollars), 2 million dollars (exported 34 million dollars, imported 31 million dollars) and 3 million dollars (exported 24 million dollars and imported 21 million dollars) in January, April and May, respectively. The changes in trade balance with Japan in last two years. Korea made surplus in January, April and May this year (Unit: USD 1 million won) Source: Korea Customs Service The rare trade surplus aside, the Koreans boycotting against Japanese products does not seem to have brought a dire impact on the pharmaceutical sector. The monthly pharmaceutical import from Japan has been fluctuating from June to December last year, respectively marking 32 million dollars, 46 million dollars, 24 million dollars, 32 million dollars, 37 million dollars, 31 million dollars and 33 million dollars. The impact of boycotting was insignificant in pharmaceutical import this year as Korea imported 26 million dollars, 38 million dollars, 38 million dollars, 31 million dollars, and 21 million dollars of Japanese-made pharmaceuticals in January to May, respectively. Changes in Japanese pharmaceutical import from June 2018. Since June 2019 when the boycott movement started, the import volume fluctuated noticeably (Unit: USD 1 million) Source: Korea Customs Service The trend is also apparent in the outpatient prescription drug sales of top Japanese pharmaceutical companies in Korea until May. A pharmaceutical market research firm UBIST found Astellas Korea, Daiichi Sankyo Korea, Eisai Korea, Takeda Pharmaceutical Korea, Santen Pharmaceutical Korea and Korea Otsuka Pharmaceutical have generated total of 663.9 million won from outpatient sales within a year (June 2019 to May 2020). Compared to the outpatient drug sales performance in the year before (June 2018 to May 2019) at 662.7 million dollars, the figure only grew by 0.2 percent. Basically, the boycott has not affected the prescription drug sales. The change in prescription sales of Japanese pharmaceutical company product from a year before (June 2018 to May 2019) and after (June 2019 to May 2020) the boycott against Japan. Six companies did not demonstrate significant difference. (Unit: KRW 100 million) Source: UBIST The Koreans have revved up the boycott against Japanese products from June last year. When the Japanese government has reportedly decided to restrict the export of key material used in semi-conductor manufacturing, a large number of Korean consumers responded back by boycotting against Japanese-made beer, automobile, and consumer products. Regardless, the consumer boycott was unnoticeable in the pharmaceutical industry. The industry experts claim the boycott would have unlikely to target prescription drugs as they are, unlike OTC drugs, directly related to the people’s health. The majority of Japanese-made prescription drugs are original drugs with no alternative options used for highly severe diseases, which is why the switching drugs for the sake of boycotting would be unconvincing. In fact, Korean pharmacist groups have assertively participated in the boycott, but healthcare professionals did not openly join the movement.
- Company
- Dong-A ST is first to evade antidiabetic Forxiga patent
- by Lee, Tak-Sun Jun 29, 2020 06:13am
- For the first time in Korea, Dong-A ST has successfully evaded pharmaceutical patent on sodium-glucose co-transporter-2 (SGLT-2) inhibiting antidiabetic treatment Forxiga (dapagliflozin) by AstraZeneca. According to the pharmaceutical industry on June 25, Dong-A ST’s request for the negative scope confirmation on two Forxiga patents was accepted on June 23. The original drug has two substance patents to expire on Apr. 7, 2023 and Jan. 8, 2024, respectively. Following the legal proceeding, Dong-A ST would be the first company to knock on the follow-on dapagliflozin drug market. Dong-A ST is the only company that either evaded or nullified the original’s patent expiring on Apr. 7, 2023. The company would be able to launch a dapagliflozin product immediately after receiving the government’s approval. Other companies cannot launch a follow-on drug until Apr. 7, 2023 when the patent actually expires. The key to Dong-A ST’s patent evasion was modifying the original drug structure. For the patent-evaded dapagliflozin drug, the Korean company plans to conduct a Phase I trial and apply for item approval in the second quarter next year. If the product gets released next year, it would be two years earlier than other competitors. In the current antidiabetic treatment market dominated by DPP-4 inhibitor and SGLT-2 inhibitor, Dong-A ST would significantly expand its pie in the market with its independently developed new dipeptidyl peptidase 4 (DPP-4) inhibitor Suganon and the SGLT-2 inhibitor.
- 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.
- 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.
- Company
- COVID-19's budget is being delayed in the National Assembly
- by Nho, Byung Chul Jun 24, 2020 06:14am
- With the global spread of COVID-19, vaccines and treatments are urgently needed, and the government's promised support budget plan is not in progress. Unlike the fast and full support in developed countries, there is concern that the support may be delayed and the golden time to overcome COVID-19 may be missed. As of the 23rd, 15 domestic COVID-19 related vaccines and treatments are being conducted by pharmaceutical companies and research institutes in Korea. In addition to Remdesivir which is recommended for the treatment of COVID-19 by the central clinical committee for emerging disease control, anti-viral drugs, immunotherapeutics, and preventive vaccines, which have been developed in-house, have entered clinical trials. Even though the industry suffered from COVID-19 patient loss, there are many pipelines related to COVID-19 that have not yet entered clinical trials. The industry and research institutes are doing their best because they need to succeed in developing vaccines and therapeutics that can produce and supply their own products to prevent the spread of COVID-19 in Korea and prepare for the post COVID-19 era where new infectious diseases can occur. Countries around the world are removing various regulations for the rapid release of vaccines and treatments, and investing in R&D even in the economic crisis. First of all, the United States is running an ultra-high-speed project that cuts the expected vaccine development time by half from one to a year and a half. As the government invested about 10 billion dollars in the project, US President Trump has repeatedly expressed his willingness not to spare money for vaccine development. The ‘Global Cooperation in COVID-19 Vaccine Development’, which the European Union and about 40 countries participated in, said that it will raise approximately $8.2 billion in grants for research on therapeutics and vaccines. China is also developing vaccines aiming to be completed by the fall of this year at the Chinese Academy of Sciences to take the lead in COVID-19 vaccine. President Moon Jae-in visited the Institut Pasteur Korea in Seongnam, Gyeonggi-do in April, and pledged full support by saying, "Develop the best for the treatments and vaccines." It also suggested that the government can purchase and store sufficient amounts of money even if there is no economic or commercial value in the market, so that efforts and costs in development can be compensated. This was reflected in the supplementary budget to provide 111.5 billion won for full-cycle R&D such as 'pre-clinical, clinical, and global phase III' for the early commercialization of promising candidates for therapeutics and vaccines. There were also plans for subsidies for each stage of development, including ₩9 billion for phase I, ₩24 billion for phase II and ₩15 billion for phase III. If successful in the development of vaccines and treatments, it is also essential to build infrastructure such as production facilities for rapid supply, so the budget for vaccine and treatment production facilities and process management support has been raised to ₩10 billion. However, as mentioned earlier, the budget is not passed by the National Assembly, and the industry is nervous about it. Concerns are raised that it is also a matter of time before companies that are accelerating the development of vaccines and treatments are braking the driving force for R&D. There is no commitment to support production facilities that need to secure infrastructure quickly in line with the development of vaccines and treatments. An official from the pharmaceutical industry said, "The whole world is committed to the development of COVID-19 vaccines and treatments. In Korea, even the determined budget is tied to the National Assembly." "The decision of the National Assembly is urgent."
- Company
- Penmix in trial to evade patent on fat dissolving Belkyra
- by Nho, Byung Chul Jun 24, 2020 06:14am
- An injection CDMO Penmix (CEO Park Dongkyu) succeeded in evading patent on Allergan’s under-chin fat reducing injection Belkyra (desoxycholic acid). On June 19, Intellectual Property Trial and Appeal Board validated the negative confirmation of patent scope on Belkyra’s desoxycholic acid and other pharmaceutical substance based on the salt (to be expired on Aug. 23, 2031) as requested by Penmix. Belkyra is a first injection the U.S. Food and Drug Administration (FDA) approved to treat moderate-to-severe convexity or fullness associated with submental fat in adults, and it was introduced to the Korean market in 2017. With the latest decision, Penmix has passed the first threshold of patent evasion. And if the company wins the litigation on two divisional patents owned by Allergan, it would be able to apply for the first approval after Aug. 24, 2023 when Belkyra’s post-marketing surveillance (PMS) ends. Moreover, if the Korean company wins the Belkyra patent (‘mechanism of reducing fat and related pharmaceutical patent’) invalidation trial, currently ongoing in partnership with Daewoong Pharmaceutical, Pinmex would be able to release its generic product early on May 19, 2025 before the patent expires. At the moment, the Korean fat dissolving injection market does not have any effective option besides Belkyra. Penmix and Daewoong Pharmaceutical stated, “The Korean companies are developing both the Belkyra generic and new innovative fat dissolving injection to expand the related market in Korea.” The relevant industries are keeping a close eye on Penmix and Daewoong Pharmaceutical’s patent trial results as Allergan’s Belkyra owns the exclusive indication. Currently, Jurlique is handling the distribution of Belkyra.
