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- 2026-04-16 01:49:56
- Company
- Lilly implements ERP for the sales department
- by Nov 05, 2020 11:03am
- On the 4th, Lilly Korea announced the implementation of ERP to all employees of the sales department. It is known that the ERP compensation condition adds 8 months to twice the number of years of service, and provides annual consolation money. Although the exact size is undecided, it is intended for all employees of the sales organization, including non-core sectors. About 100 employees in the sales department of Lilly Korea. The background of this ERP is part of the reorganization that is going on at the global level. An official from Lilly Korea explained, "We want to improve the business model at Lilly," and "Lilly Korea's ERP will also be carried out as part of this." This Early Retirement is about 3 years since the small ERP in 2017. Earlier, Lilly implemented ERP in 2014 and 2015 as well. Some say that a large-scale ERP will take place this year, centering on the sales department in charge of non-core products. In response, Lilly Korea said, "We are receiving voluntary early retirement applications not from all sales departments."
- Company
- Zuellig Pharma union reports company’s abusive practice
- by An, Kyung-Jin Nov 05, 2020 06:41am
- The Zuellig Pharma Solutions Service Korea Chapter is protesting in front of the president’s residence (Source: Korea Democratic Pharmaceutical Union) The management and labor union dispute in Zuellig Pharma Korea’s subsidiary Zuellig Pharma Solutions Service Korea seems to be intensifying fast. According to the pharmaceutical industry sources on Nov. 3, Korea Democratic Pharmaceutical Union has recently reported Zuellig Pharma Solutions Service Korea management for their unfair labor practices on three members of the company’s labor union to the Western Seoul District Office of Ministry of Employment and Labor (MOEL). The Democratic Union accused the management assigned the three labor union members on an in-between job waiting list, when the salary negotiation between the management and the labor union did not follow through. The Democratic Union stated Zuellig Pharma Solutions Service Korea and the Zuellig Pharma Solutions Service Korea Labor Union Chapter had eight sessions of salary negotiation for 2020, but they could not reach an agreement. The union claims the management assigned Chief Yang Hee-Jin of the Zuellig Pharma Solutions Service Korea Chapter on an employment waiting list on Oct. 15, when the Chapter requested the Seoul Labor Relations Commission to arbitrate the negotiation and showed possibility of a strike. The Zuellig Pharma Solutions Service Korea Chapter insider noted, “When the negotiation fell through and the arbitration began immediately, the Chapter chief was suddenly removed from the previous position. The management has not disclosed a detailed reason, other than a report of workplace bullying.” The Democratic Labor Union Zuellig Pharma Solutions Service Korea Chapter has earned the right to strike on Oct 26, as the Seoul Labor Relations Commission decided to halt the arbitration. However, the company management again assigned a director and a member of the Chapter on the waiting list. In just about two weeks, three members of the labor union were removed from their original positions. Legal Director General Cho Guk-Hyun of the Democratic Pharmaceutical Union said, “The Article 97 of the negotiated agreement signed by both the company and the Union in last May states the Union and the management must jointly form an investigation council and conduct an audit on the workplace bullying. Any penalty or personnel transfer made during the period of strike is a violation of the Paragraph 2 of the Article 117.” The director general pointed out the company management was abusing the Article 76-2 of the Labor Standard Act on workplace bullying ban to oppress the labor union. Regarding the issue, the company management has not issued any official statement. Zuellig Pharma Solutions Service Korea is a global marketing agency that provides healthcare communication service as a subsidiary of Zuellig Pharma. Its labor union, formed in March last year, joined the Korea Democratic Pharmaceutical Union as a new chapter. Beyond the legal dispute, the labor union is also taking an organized action. In the afternoon of Oct. 30, all members of the Chapter went on a strike, which would continue with the second strike from Nov. 2 through 13. From the morning of Nov. 3, the union member began protesting in front of the residence of Zuellig Pharma Korea President Erwan Vilfeu, who is technically overseeing Zuellig Pharma Solutions Service Korea as well. An insider from the Zuellig Pharma Solutions Service Korea Chapter stated, “Backed by a major law firm, the management is overtly oppressing the labor union with abnormal procedure that violates the Labor Relations Act and the agreement. Their illegal practice would be uncovered soon. We would fight until the laborers working normally and earnestly are rightfully recognized by the company.”
- Company
- Gilead, registered 6 patents for Remdesivir in Korea
- by Kim, Jin-Gu Nov 05, 2020 06:40am
- Remdesivir It is confirmed that Gilead recently registered a patent related to Remdesivir (Veklury) in Korea. Remdesivir is currently the only drug approved for the treatment of COVID-19. In Korea, it was supplied in earnest from last July. According to the MFDS and the KIPO on the 3rd, Gilead registered six patents related to Remdesivir in the domestic patent catalog at the end of last month. There are two material patents, composition patents, and application patents. Two '1'-substituted carba-nucleoside analogs' for antiviral therapy expiring on April 22, 2029, two'methods and compounds for treating Paramyxoviridae virus infection' expiring on July 22, 2023, Two cases of'How to Treat Filoviridae Virus Infection' that expire on October 29, 2035, and so on. However, it is confirmed that a patent for use limited to the treatment of the Corona 19 virus has not been registered. In Korea, this patent right was registered in 2016 (material patent) and 2018 (composition patent and use patent). However, the'non-exclusive licensee registration' was not done because the drug was not introduced in Korea. Non-exclusive licensee means the subject and qualification to exclusively exercise overseas (head office) patent rights in Korea. In this case,'Gilead' is the case. In other words, after the Corona 19 epidemic, Remdesivir was introduced in Korea by Gilead, and Gilead was registered as a non-exclusive licensee at the end of last month. In August, an opinion was raised to urge the'forced implementation' of the Remdesivir patent mainly by civic groups. It was argued that the government should force the production of generics before the expiration of patents in national crises such as the public health crisis. At that time, eight civic groups, including the Pharmacy Society, Health Department Alternatives, and Participation Solidarity for a healthy society, issued a statement and raised their voice saying, "The government should immediately produce a cure for Corona 19 without noticing anyone." They argued that "the dosage of treatment depends on the amount of supply rather than medical considerations, which is why Gilead is monopolizing the supply of Remdesivir," and argued that "the government should issue a mandatory patent enforcement of Remdesivir right now and expand the treatment production facilities." In response to these arguments, the government has indicated'the possibility of review', but has not come out in earnest. As of 16:00 on October 30th, there were 715 confirmed patients using Remdesivir in 64 hospitals.
- Company
- MSD Korea appoints Seongpil Kim as executive director
- by Nov 05, 2020 06:40am
- Kim Seong-pil (left), new executive director of MSD Korea anticancer drug division, Jae-yeon Choi, new CEO of Taiwan MSD (right) MSD Korea (CEO Kevin Peters) announced on the 1st that it had appointed Kim Seong-pil (43 years old), executive director of the anticancer drug division. In December 2018, the new executive director of Seongpil Kim joined MSD Korea as the 'Commercial Operations Lead', which led to double-digit growth. He has also contributed significantly to the implementation of the biomarker strategy so that the company's anticancer drug portfolio can be used for patients in need. Prior to joining MSD Korea, he served as CEO at Elanco. Prior to that, he managed the sales of the anticancer drug division, the cardiovascular division, and the diabetes division at Lilly Korea. He graduated from Korea University Department of Business Administration and obtained an MBA from Northwestern University's Kellogg School of Business. Managing Director Seong-pil Kim said, "MSD's anticancer drug business unit gathered employees with extraordinary passion and vision to lay the foundation for MSD to grow into a leading company in the anticancer drug field in a short time." He said, "Based on our excellent organizational capabilities, we will continue to position ourselves as a business unit that can contribute to Korean medical staff and cancer patients." On the other hand, Choi Jae-yeon (47 years old), managing director of MSD Korea's anticancer drug division until recently, led the business growth and organizational innovation of the division, and was recognized for the achievement of making the company a leading company in the field of anticancer drugs. This is the first time a Korean has been elected as the CEO of MSD. Jae-yeon Choi, the new representative of Taiwan MSD, joined MSD Korea in 2017 and led external cooperation departments such as market access, rental, communication, etc. Prior to joining MSD Korea, she oversaw the marketing team and anticancer drug division of Lilly Korea, leading product and portfolio strategy and digital marketing. She majored in French from Hankuk University of Foreign Studies and obtained an MBA from Northwestern University's Kellogg School of Business.
- Company
- Multinational companies rush to appoint new CEOs
- by Eo, Yun-Ho Nov 05, 2020 06:40am
- (From left) CEO Kim Younhee, Choi Ho-jin and Kim So-eun Multiple Korean subsidiaries of multinational pharmaceutical companies are reporting their news of newly appointed top executives. Just in the latter half of the year, six companies have welcomed their new leaders. According to pharmaceutical industry sources, Sanofi Pasteur Korea, Galderma Korea, Ono Pharma Korea, MSD Korea, Organon Korea and GlaxoSmithKline (GSK) Korea eighter elected or nominated new CEOs. Apparently, South Korean CEOs were appointed at Galderma Korea, Ono Pharma Korea and Organon Korea. Since October, Galderma Korea elected CEO Kim Younhee, a new Korean CEO after two years. Former CEO Rene Wipperich, elected after former CEO Park Heung Bum, was transferred to Swiss office after serving two years in South Korea since September 2018. Ono Pharma Korea welcomed a new leader only after a year as former CEO Yang Min-yeol retired. A South Korean would continue to oversee the multinational company as former Vice-president Choi Ho-jin is taking over the position. Prior to CEO Yang’s appointment, former CEO Takashi Kishi used to manage the company. Along with CEO Choi’s personnel news, Ono Pharma is resuming its process to seek reimbursement and expand indication on immunotherapy Opdivo that the industry once evaluated the company’s attempt to be sluggish. Split from MSD, Organon has nominated the current South Korean External Affairs Lead, Kim So-eun, as a new CEO. Kim would lead the company from February next year. While former CEO Avi BenShoshan has been promoted to take a position at the headquarters, MSD Korea nominated Kevin Peters, from the Thai office, as a new CEO. (From left) CEO Kevin Peters and Pascal Robin Regarding the Organon spin-off, MSD’s Korea labor union and the management are in dispute. The new CEOs would have to face the imminent issue and urgently take actions to successfully complete the corporate reorganization procedure. Besides MSD Korea, Sanofi Pasteur Korea and GSK Korea are also maintaining the non-Korean leadership. In last August, Pascal Robin stepped in as a new CEO of Sanofi Pasteur Korea. The position was vacant for a couple of months, as former CEO Baptiste de Claren resigned last June. GSK Korea is bidding farewell to current CEO Julien Samson by the end of the month for him to take his position at the headquarters. Robert Kempton, a vice-president from the U.S. North Carolina office, is now nominated as a new CEO at the Korean office. Leading the South Korean branch since February 2018, Samson was the first foreigner CEO of the office. Previously, CEO Hong Yoo-seok was elected in 2014 as a successor of former CEO Kim Jin-Ho, who led the company from the time of GlaxoWellcome. Hong later nominated Samson as a next CEO, when he was promoted to lead the pharmaceutical business unit (therapeutics and vaccines) at GSK Canada in 2018.
- Company
- Soliris competitor Roche’s Enspryng readies for South Korea
- by Eo, Yun-Ho Nov 04, 2020 06:09am
- Apparently, Enspryng, a Soliris (eculizumab) competitor, is making a move to enter the South Korean market. The pharmaceutical industry sources reported Roche Korea has recently submitted an approval application on a neuromyelitis optica spectrum disorder (NMOSD) treatment Enspryng (satralizumab) to the Ministry of Food and Drug Safety (MFDS). The final decision on the approval would be made in the first half of next year. Previously, the drug was designated as a rare disease drug. When Enspryng is released to the market, Soliris developed by Alexion and supplied to the Korean market by Handok would be the sole competitor of the drug. However, Enspryng is expected to dominate the NMOSD therapeutic area, as Soliris is only indicated to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) in South Korea. Currently in the U.S. market, Enspryng and Soliris are in competition, where Enspryng is highlighted with comparatively inexpensive price. In June last year in the U.S., Alexion was able to expand Soliris’ indication to treat NMOSD, but the company has not taken a related action in the South Korean market. Enspryng’s efficacy was confirmed in SAkuraStar and SAkuraSky studies with Aquaporin-4 (AQP4) antibody-positive adult patients. In the SAkuraStar monotherapy study’s AQP4 antibody-positive group, 76.5 percent of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1 percent with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with baseline immunosuppressant therapy, 91.1 percent of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8 percent with placebo. NMOSD is a rare, lifelong and debilitating autoimmune disease of the central nervous system that primarily damages the optic nerves and spinal cord, causing blindness, muscle weakness and paralysis. The autoantibody destroying the function of AQP4 on nerve cell is the main cause of the disease. Without a specialized treatment available to date, patients are typically prescribed with high dose of steroid, and the patients with severe level of condition either use immunoglobulin as a blood product or undergo plasmapheresis.
- Policy
- The HIRA is conducting RWE research on cancer & rare dz
- by Lee, Hye-Kyung Nov 04, 2020 06:09am
- The HIRA will be conducting prospective clinical research to secure real world evidence (RWE) for cancer and rare disease treatments in earnest starting next month. From last year to recently, the RWE guidelines were created through retrospective studies, and from this year to 2023,'prospective clinical research to prepare a platform for actual clinical basis for drug payment management' will be conducted. The HIRA will complete the selection of the final researchers by this month and collect data on whether or not treatments for rare diseases, anticancer drugs, and expensive new drugs are showing effects in the actual clinical environment after listing. Jin-Yong Lee, director of the Health Insurance Review and Assessment Research Institute, said in a briefing by the Journalists Association on the 3rd, "RWE research is the next-generation resource in domestic pharmaceutical policy, and it is a must." He said, "In pharmaceutical companies, Korea is a single market with a population of 50 million, and it has to go through for the registration of drugs in East Asia, but once listed, the drug price remains unchanged." He said that after marketing, RWE should be compared to see if the efficacy is the same as in clinical trials. "After 2-3 years of drug price registration, if the effect is lower than the clinical result in the RWE study, the drug price should be reduced, and if the effect is high, the drug price should be increased." He also said that it will take at least five years for the results of the RWE study to be linked to drug price adjustment. Regarding the opposition of pharmaceutical companies over the introduction of RWE in Korea, he said, "100 people participated in the clinical trial of a drug worth ₩100 million per dose, and the effect was 90%. If the effect is reduced to 50% in the results of the medication, shouldn't the drug price be readjusted?" He explained, "It's actually happening in the US, and that's why the RWE issue came out in Korea." He said, "The HIRA will evaluate it directly, and if it does not work, we will lower the drug price, and if it works, we will approach it from the perspective of expanding the scope of indications and benefits, and adjusting drug prices." He added, "If clinical professors participate in prospective clinical research from December, they will select drugs and conduct RWE research together for 3 years." Prior to the start of prospective clinical research, the HIRA Forum was held to disclose the results of the retrospective RWE research conducted from May last year to July of this year based on request data and medical records for all gastric cancer and breast cancer patients in Korea. It will be released. He took office as the 7th Director of the Health Insurance Review and Assessment Research Institute on August 18th. He is a person who worked as the head of the Department of Public Medicine at SNU Boramae Medical Center and worked on public quarantine in the field as the head of the Epidemiological Investigation Technical Support Team in response to COVID-19 in Seoul. He said that he applied for the public recruitment of the director of the review and evaluation researcher after much thought. He said that the institute, which has more than 200 members, is one of the largest national research institutes in Korea, and that the review and evaluation institute will be able to serve as a think tank for establishing health insurance policies. To this end, it was planned to promote the registration of academic journals, establish a website dedicated to the HIRA policy trends, and form a specialized academic journal in the field of health insurance policy. He said, "As the organization of the research center grows, we are determining what to do with the increase in manpower and work management." "Like the RAND Corporation of the United States, I will try to make this institute a think tank proactively proposing policies," he stressed.
- Policy
- New reimbursement standards on Rinvoq and Remicade
- by Kim, Jung-Ju Nov 04, 2020 06:09am
- Starting this month, the drug reimbursement would be granted on AbbVie Korea's rheumatoid arthritis treatment Rinvoq Sustained-release Tablet (upadacitinib) 15mg. As a result, the reimbursement standards have been changed for drugs with other various substances available for a treatment switch, and the combination therapy with the drug would be included in the reimbursement standards. Janssen Korea's Remicade (infliximab) injection, an immunosuppressant drug used in adult patients with Crohn's disease, has been newly indicated to treat intestinal Behçet's disease and received expanded coverage. South Korea's Ministry of Health and Welfare's (MOHW) partially revised standards of the healthcare reimbursement (pharmaceuticals) has come in effect from Nov. 1. ◆New and revised standards on pharmaceuticals: As Rinvoq is newly listed from this month, a new reimbursement standard for upadacitinibs, including Rinvoq, was added. An additional six months of reimbursed use would be permitted, if DAS28 score is decreases by 1.2 or more after six months of the use. From then on, the score would be evaluated every six months and the continuous administration would be approved if the evaluation results from the first six months are maintained. Due to the new reimbursement standard on the injection, the standards for other substance drugs eligible for switching have been added and changed. Following are the drugs, including upadacitinib, to be applied with modified standards; Janssen Korea's rheumatoid arthritis treatment Simponi (golimumab) Prefilled Syringe Injection 50 mg, JW Pharmaceutical's Actemra (tocilizumab) Injection and Actemra Subcutaneous Injection 162 mg, Korea BMS' Orencia (abatacept) 250 mg and Orencia SubQ-Prefilled Syringe 125 mg, AbbVie Korea's Humira (adalimumab) Injection, Pfizer Pharmaceuticals Korea's Enbrel (etanercept) Injection, and Roche Korea's lymphoma treatment Mabthera (rituximab). ◆Newly listed Pencivir Cream: A new reimbursement standard was established to list a herpes simplex virus infection treatment Pencivir (penciclovir) Cream by Kolmar Korea. According to the detailed criteria of the reimbursement, the healthcare benefit would be limited to the use within the approved indication of the drug (herpes simplex virus infection (herpes labialis)). ◆Additional changes on Remicade Injection: Among all infliximab drugs, immunosuppressant Remicade Injection by Janssen Korea was able to expand indication to treat intestinal Behcet's disease. The coverage would be limited to the drugs with the indication. As orally taken upadacitinib is newly listed, the reimbursement standard for the drug would add the name of the ingredient for a prescription switch. The healthcare benefit on treating intestinal Behçet's disease is granted on patients older than 19 years of age, diagnosed with Behçet's disease, confirmed an intestinal ulcer via endoscopy, and not responsive to standard of care (SOC) (two or more drugs) or discontinued treatment due to adverse reaction. Further sustained administration would be approved when the Behcet Disease Activity Score for Intestinal Behcet's Disease (DAIBD) is decreased by over 20 points within 14 weeks after the initial administration (administered three times).
- Policy
- Hanmi’s generic for Nexavar has been approved
- by Lee, Tak-Sun Nov 04, 2020 06:08am
- Hanmi's generic for Nexavar (Sorafenib, Bayer) was first approved in the liver cancer treatment market. In addition, it acquired exclusive rights in the generic market for nine months after its launch. On the 29th, the MFDS approved Hanmi's Soranib 200mg. Soranib is generic for Nexavar. It is used for hepatocellular carcinoma, advanced renal cell carcinoma, refractory to radioactive iodine, locally recurrent or metastatic advanced differentiated thyroid cancer, which has failed previous cytokine therapy, or for which this treatment regimen is not appropriate. Nexavar is the only oral drug for the first-line treatment of liver cancer since it obtained a domestic product license in 2008. Last year, when Eisai's Lenvima (Lenvatinib) was approved as the first-line treatment for liver cancer. Last year's IQVIA sales of Nexavar was about ₩25 billion. Hanmi will participate as the only generic competitor in this market. Hanmi won Nexavar's lawsuit for invalidation of patents for formulation and use. If it was lost, it could only be released after February 22, 2026, when the patent expires. Hanmi also obtained a generic for exclusivity license, which grants exclusive rights to the generics market. Accordingly, the ban on the sale of same active ingredient drugs is for 9 months from today (October 30) to July 29 next year. Considering the time it takes to acquire drug prices, the generic for exclusivity can be extended within the range of two months, so Hanmi is expected to enjoy exclusive rights without entering other generics for nine months after the release of benefits. Currently, other generic companies such as Kwang Dong are preparing to commercialize generic for Nexavar. The success or failure of the market depends on how much Hanmi's share of the original Nexavar during the generic for exclusivity period. Although it is the only generic drug, it is expected that it will be a difficult challenge as most of the liver cancer treatments are used in large hospitals and original product (Nexavar) are mainly prescribed.
- Company
- AstraZeneca objected to the second judgment of Forxiga
- by Kim, Jin-Gu Nov 04, 2020 06:08am
- Forxiga AstraZeneca lost the second trial of Forxiga's material patent. And AstraZeneca announced that it would appeal to the Supreme Court. AstraZeneca said in a separate statement on the 30th that it disobeyed the judgment of the Patent Court of Korea on the 29th. The Patent Court of Korea sided with 19 companies including Kukje Pharma in a lawsuit related to Forxiga substance patents on the 29th. AstraZeneca said that the criteria for judging the progressiveness of optional inventions are too strict in Korea. AstraZeneca argues that the criteria for judging the progressiveness of optional inventions currently applied by the courts were established by the Supreme Court rulings in the late 1990s and early 2000s, and that the criteria do not meet international standards. AstraZeneca said, "There is a possibility that Eliquis' substance patent, which is pending in the Supreme Court, has recently been referred to the entire consensus, and a new standard for judging the progressiveness of the optional invention is proposed." It criticized, "Even so, we are sorry for the patent court ruling that was made without confirming this case." AstraZeneca said, "No one will be willing to invest in the Korean pharmaceutical industry unless the protection of substance patents is faithfully implemented in Korea." And it also stressed, "We hope that excellent patents in the pharmaceutical field will receive reasonable protection." There are a total of two Forxiga material patents. One expires on April 7, 2023, and the other expires on January 8, 2024. The ruling, which was won by 19 generic companies, concerns a patent that expires in 2024. In the case of the patent expiring in 2023, Dong-A ST is the only one who won the first trial with the “Pro-drug” strategy.
