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- 2026-04-12 02:53:19
- Company
- Lilly appoints new CEO Christopher J. Stokes
- by jung, sae-im Aug 03, 2022 06:00am
- Christopher J. Stokes, new CEO of Lilly KoreaLilly Korea announced on the 1st that it has appointed Christopher J. Stokes as its new CEO. The new CEO is a pharmaceutical and healthcare expert who has extensive work experience in the global pharmaceutical industry for more than 15 years. He graduated from George Mason University in 2002 and earned a master's degree in public administration from Indiana University Bloomington in 2005. Stokes, who first joined Eli Lilly's U.S. headquarters as a public policy analyst in 2008, has demonstrated excellent performance and positive influence through various roles, from foreign cooperation to rental and drug prices, strategic planning, new product planning, brand policy marketing, and sales management. In particular, he established leadership by serving as Chief Operating Officer (COO) of the Neuroscience Director of Sales for the West Area and Eli Lilly headquarters. From 2020 until recently, he represented Eli Lilly's South Africa and Sub-Saharan Africa offices. CEO Stokes said, "As I am newly appointed as the representative of Lilly in Korea, I will do our best to help more Korean patients lead a better life through Lilly's innovative medicine and further deliver a positive influence on Korean society." Alberto Riva, who previously served as the representative of Lilly Korea, was newly appointed as the representative of the Brazilian branch of Eli Lilly. Since taking office in Lilly Korea in September 2019, President Riva has contributed to the growth of Lilly Korea by supplying treatments in various fields of diseases such as anticancer drugs, diabetes, and autoimmune diseases in Korea.
- Company
- Mundipharma is pushing for its first employee reduction
- by jung, sae-im Aug 03, 2022 06:00am
- The impact of Mundipharma's reduction of narcotic analgesics business is also affecting Korean corporations. A major reorganization is taking place, cutting two-thirds of the department's workforce. According to the pharmaceutical industry on the 3rd, Mundipharma is conducting ERP with the aim of finishing at the end of August. The target is the department in charge of narcotic painkillers among the two Rx departments. This is the first time Mundipharma has conducted an ERP. The voluntary retirement is attributed to global Mundipharma's massive reduction of its narcotic painkillers business. This is because opioid-based narcotic painkillers have emerged as a social problem in the U.S. due to death and addiction caused by overdose, and related pharmaceutical companies have been fined trillions of won. It is considered a "panic drug" and the number of deaths from drug abuse has increased rapidly. According to the CDC, opioid addiction killed about 500,000 people over the past 20 years from 1999. Purdue Pharma, the parent company of Mundipharma, admitted responsibility for overdosing opioids, filed for bankruptcy, and decided to pay 5 trillion won in settlements to 15 states, including New York. At the same time, he also expressed his willingness to sell Mundipharma. Until recently, follow-up measures have continued, such as pushing for the sale of Mundipharma's Chinese subsidiary. Mundipharma has stopped all research and development on narcotic painkillers and has launched a major reduction aimed at abolishing the division. The compensation condition is '2n+8 (two times the number of years of service plus eight months' salary), which is known as the industry's average level. On top of that, the company plans to pay additional special consolation money for annual leave. The problem is that there is a high possibility that ERP applicants will fall short of this due to the large number of job cuts planned by the global community. It is known that less than half of the applicants were applied a day before the actual application deadline. The company's plan to finish ERP within August is also tight. If the gap is large, conflicts between the management trying to fill the number of people somehow and workers to prevent it could arise. Mundipharma reportedly expressed its willingness to complete the ERP smoothly by consulting with the labor union as much as possible. A union official also said, "As global companies are pushing to reduce their business units, Korean corporations are also affected." Mundipharma said, "We will communicate closely with the company regarding ERP and try to solve the problem smoothly."
- Company
- LG Chem Applies to FDA for Phase 3 of Gout New Drug
- by jung, sae-im Aug 03, 2022 06:00am
- LG Chem announced on the 1st that it has applied for a phase 3 clinical trial plan for Tigulixostat, a new gout drug developed by the U.S. Food and Drug Administration (FDA). This is the first time that LG Chem has started phase 3 clinical trials of new drugs in global regions such as the U.S. The company's strategy is to significantly expand its bio business area centered on domestic demand and emerging markets to the U.S. and Europe. This clinical trial evaluates safety and effectiveness compared to placebo in 350 adult gout patients with hyperuricemia in multiple countries, including the United States, at the point of six months of taking Tigulixostat. The primary evaluation index was set as the proportion of patients who reached serum uric acid concentration of 6 mg/dL for 6 months. LG Chem will also apply to the FDA for a comparative test plan with Allopurinol, the primary treatment ingredient for gout patients with hyperuricemia. Its strategy is to prove differentiated efficacy and long-term use safety through recruiting large-scale global test groups. LG Chem aims to sell globally from 2028 after obtaining approval for item approval as a first treatment from the U.S. FDA in 2027. Tigulixostat inhibits the expression of the enzyme xanthine oxidease that produces uric acid, which is the main cause of gout. As a result of the U.S. Phase II results, Tigulixostat showed a rapid and strong uric acid drop effect, the company explained. According to the global market research firm CMI (Coherent Market Insights), the global gout treatment market is expected to expand from 3 trillion won in 2019 to 5 trillion won in 2027 due to aging population and increasing obese population. Currently, there are 35 million patients diagnosed with gout worldwide, of which the number of patients in the U.S. and China is estimated to be 10 million and 14 million, respectively. "Tigulixostat global phase 3 will be a solution to further strengthen LG Chem's new drug clinical, licensing, production, and sales capabilities," said Sohn Ji-woong, head of the Life Science Business Division. "We will lay a new turning point in the gout treatment market through clinical strategies and preemptive commercialization preparation."
- Company
- SK Bioscience has applied for CMA of SKY Covione
- by Kim, Jin-Gu Aug 02, 2022 06:02am
- SK Bioscience announced on the 29th that it has applied for Conditional Marketing Authorization (CMA) of the COVID-19 vaccine to MHRA, a British pharmaceutical regulator. The product name in the UK and Europe is SKY Covione. SK Bioscience explained that it has been conducting a Rolling Review since March to receive prompt approval from MHRA. Rolling Review is a system that quickly evaluates promising vaccines and treatments by submitting efficacy, safety, and quality data sequentially before applying for final permission. SK Bioscience submitted additional phase 3 clinical data recently secured to MHRA. MHRA will begin a full-fledged review for SKY Covione's CMA. Starting with the UK, SK Bioscience plans to apply for CMA to the European Medicines Agency (EMA) in the future and apply for registration on the World Health Organization's Emergency Use List (EUL). Ahn Jae-yong, president of SK Bioscience, said, "This application for permission will take the first step to introduce a domestic COVID-19 vaccine with excellent safety and immunity to the global big Pharma-centered COVID-19 vaccine market." Starting with the application for CMA in the UK, we will introduce Korea's technology to the global vaccine market through Europe and WHO EUL listing, he said. "In addition, it will contribute to restoring safe daily life through COVAX Facility." In June, SK Bioscience was approved for "SKY Covione multi injection" as the first domestic COVID-19 vaccine. SKY Covione is a COVID-19 vaccine developed by SK Bioscience based on its global network. It was jointly developed by IPD and SK Bioscience at the University of Washington, USA, and GSK's Adjuvant AS03 was applied to strengthen the immune response. It received development cost support from BMGF and CEPI from the early stage of development, and plans to be supplied to the global market through COVAX Facility after acquiring WHO EUL. SKY Covione demonstrated excellent immunogenicity and safety during basic vaccination through phase 3 clinical trials of 4,037 adults in five countries at home and abroad. Additional studies in phase 1/2 of the SKY Covione clinical trial showed a high immune response to the omicron mutation (BA.1). SK Bioscience is conducting clinical trials for ▲ heterogeneous booster shots and ▲ of the same kind of booster shot , and it plans to conduct ▲ an additional study to confirm the response effect of omicron mutations.
- Opinion
- [Reporter’s View] New guideline refrains off-label NOAC use
- by Eo, Yun-Ho Aug 02, 2022 06:02am
- Off-label refers to the use of drugs for an indication other than those approved by the Ministry of Food and Drug Safety. Although people may question the need for off-label use when the appropriate use for a drug has already been set by the health authorities, these off-label prescriptions are made at the doctor’s discretion. Often, off-label use of a drug is encouraged or shunned according the situation of each disease or drug. Voices on their necessity or non-necessity are also raised accordingly. The latter goes for new oral anticoagulants (NOACs). Relevant societies and specialists have continuously raised concerns over the prescription of low-dose NOACs, but still, this low-dose off-label prescription trend persists in Korea. Recently, the Korean Heart Rhythm Society (KHRA) published the revised “Guidelines for NOAC use in atrial fibrillation patients," which presented specific standards for NOAC use according to each situation. After collecting and discussing all data on the use of various doses, the KHRA guideline decided to recommend the use of on-label doses according to each indication. The first NOAC was approved in 2011 and listed for reimbursement in 2013. Currently, 4 NOACs have landed in the field in Korea. Quite a time has passed since NOACs landed in Korea, but still, off-label prescriptions of NOACs have not lessened much. According to the National Institute of Health, over half - 64.4% - of the patients that use NOACs in Korea are being prescribed low-dose NOACs. The leading cause of this off-label use is bleeding concerns. Asians have a smaller physique and different genetic characteristics than Westerners, therefore, worries that the bleeding risk may increase with the use of standard-dose NOACs is why doctors have been prescribing the low-dose NOACs against indications. Of course, off-label use of drugs is allowed at the doctor’s discretion according to his/her medical judgment. However, the indication of a drug is approved based on clinical research on a large number of patients that is conducted to identify the appropriate dose. The ultimate purpose of using NOACs is to prevent strokes. If prescribing low-dose NOACs in fear of bleeding rather increases the number of stroke patients, this in itself would be a huge loss. Off-label use of drugs is like a double-edged sword. It is this reporter's wish that the new guidelines will guide patients who are tired of using warfarin and practitioners that were reluctant to use anticoagulants due to lack of high-priced monitoring equipment and difficult prescription management to fully enjoy the benefits provided by NOACs.
- Policy
- Mandatory notification for correctional facilities
- by Kim, Jung-Ju Aug 02, 2022 06:02am
- A bill that stipulates that the MFDS should also notify the MFDS of narcotics prescriptions conducted at correctional facilities and military units will be promoted. Representative Choi Yeon-sook of the People's Power represented the partial revision bill of the Drug Management Act. With the increase in the handling of medical narcotics, the MFDS is reporting related matters from drug handlers through the integrated drug management system to manage the handling of narcotics. It is pointed out that the integrated drug management system cannot confirm the prescription of drugs in the correctional facility, and that it is difficult to confirm the prescription of drugs in the Ministry of National Defense under the current law. The main purpose of this amendment is to prevent misuse of narcotics and to resolve blind spots by stipulating to the MFDS about the prescription of narcotics and prescription of narcotics in the Ministry of National Defense. This bill is based on the premise of the resolution of the "Partial Amendment of the Act on the Execution of Sentences and the Treatment of Detainees" proposed by Choi. Therefore, if this bill is not resolved or revised, it must be adjusted accordingly. This initiative will be joined by Rep. Choi, Kang Min-guk, Kwon Eun-hee, Seo Byung-soo, and Chung Chang-min, Kim Min-seok of the Democratic Party of Korea, Rep. Ryu Ho-jung, and Rep. Lee Eun-joo of the Justice Party , Independent Party Yang Jung-sook and Yang Hyang-ja.
- Company
- Dong-A ST, applies for permission to Sugadapa
- by Kim, Jin-Gu Aug 02, 2022 06:01am
- Dong-A ST announced on the 29th that it has applied to the MFDS for the item license of type 2 diabetes complex Sugadapa. Sugadapa is a complex that combines Evogliptin 5mg, the main ingredient of the DPP-4 inhibitor-based diabetes drug Suganon, developed by Dong-A ST, and Dapagliflozin 10mg, the SGLT-2 inhibitor-based drug. DPP-4 inhibitors can control blood sugar without weight gain and hypoglycemic side effects. SGLT-2 inhibitors are known to reduce blood sugar while causing little hypoglycemia, reduce weight and blood pressure, and relieve heart failure. An official from Dong-A ST said, Sugadapa is expected to improve blood sugar control in diabetics and improve convenience and medication compliance, so we will lead the diabetes market with Sugadapa, which combines the advantages of Evogliptin and Dapagliflozin. Dong-A ST's Suganon was approved by the MFDS in 2015 as the 26th new drug in Korea. In 2016, it was approved for the approval of Sugamet, a combination of Suganon and Metformin. If Sugadapa is licensed, it will be the third drug in the Suganon series.
- Company
- SK Bioscience applies for CMA of its COVID-19 vaccine to EMA
- by Chon, Seung-Hyun Aug 02, 2022 06:01am
- On the 1st, SK Bioscience announced that it has submitted an application for a Conditional Marketing Authorization (CMA) of its COVID-19 vaccine, ‘SKYCovion,' to the European Medicines Agency (EMA), SKYCovion is a COVID-19 vaccine that induces neutralizing antibody responses by administering an antibody protein made with SK Bioscience’s recombinant protein vaccine technology. SKYCovion was developed with SK Bioscience’s recombinant protein vaccine technology and the ‘self-assembly nanoparticle’ design technology of the Institute for Protein Design (IPD) at the University of Washington School of Medicine. From the initial stages of development, SKYCovion has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI). SKYCovion will be available through the COVAX Facility, etc. for procurement and equitable allocation worldwide after it is approved for Emergency Use Listing (EUL) by the World Health Organization (WHO). The company had previously applied for a Conditional Marketing Authorization (CMA) of SKYCovion to the UK Medicines and Healthcare Products Regulatory Authority (MHRA). Starting with the U.K. and European countries, the company plans to introduce this competitive domestic vaccine to the rapidly growing global COVID-19 vaccine market. According to Airfinity, a global healthcare market analysis institution, the global COVID-19 vaccine market size is estimated at around $65.6 billion (₩78 billion) last year, which is twofold the market size of all other vaccines (estimated at $33 billion). With the European Centre for Disease Prevention and Control (ECDC) and EMA that oversees the disease control and healthcare policy in the European Union lowering the vaccination age for the fourth dose from 80 to 60, the European market size for COVID-19 vaccines is expected to further increase. Jaeyong Ahn, CEO of SK bioscience, said, “The daily lives of people around the world are being threatened with the repeated emergence of new COVID-19 variants. We aspire to fulfill our role and responsibility as a global vaccine hub by entering overseas markets with our self-developed vaccine and developing new platforms to respond to the endemic."
- Company
- Daewoong Pharmaceutical's biggest quarterly performance ever
- by Kim, Jin-Gu Aug 01, 2022 09:16pm
- Daewoong Pharmaceutical achieved its highest quarterly performance ever. Separately, sales in the second quarter increased 7.6% year-on-year to 293.8 billion won and operating profit increased 25.8% to 33.6 billion won. Both sales and operating profit are all-time highs based on quarterly performance. Earlier, Daewoong Pharmaceutical also set the highest quarterly operating profit in the first quarter. It then broke its quarterly operating profit record once again for the first time in a quarter. Nabota enters the European market in the second half of the year Daewoong Pharmaceutical cited Nabota's propaganda as one of the reasons for achieving its biggest performance. According to the company, Nabota's second-quarter sales amounted to 37.1 billion won, up 60% from 23.2 billion won a year earlier. Nabota's exports grew 105% from 14.2 billion won to 29.2 billion won during the same period. U.S. exports account for the largest share of Navota exports. Exports to U.S. sales partner Evans doubled from the previous year to 21.1 billion won. Daewoong Pharmaceutical explained that exports to Southeast Asia and Central and South America were also strong. The recent rise in the exchange rate also contributed positively to the improvement of export performance. Sales in the specialized medicine sector rose 5.5% to 205.8 billion won from 5.1 billion won in the second quarter of last year. High-yield products such as hyperlipidemia treatment Crezet, diabetes treatment "Diabex" and antithrombotic Anplone increased by 10% compared to the same period last year. Sales of Forxiga, a diabetes treatment drug in charge of domestic distribution by Daewoong Pharmaceutical, also grew by more than 30% in a year, contributing to sales expansion. The OTC sector posted 34.3 billion won in sales, up 19.9% from 28.6 billion won in the second quarter of last year. Due to the spread of COVID-19, the fever reducer EZN6 grew 45% year-on-year. Ursa, a liver improvement functional drug, also grew by more than 30% during the same period. In the case of health functional foods, sales doubled in a year. Daewoong Pharmaceutical said it is expected to continue to increase profitability in the second half of this year. Nabota, which has become Daewoong Pharmaceutical's new cash cow, is set to be released in Europe, Turkey, and Chile after the third quarter. The addition of FexuClue, a new drug for gastroesophageal reflux disease released by Daewoong Pharmaceutical earlier this month, is also expected to increase its performance. Daewoong Pharmaceutical is moving quickly to expand FexuClue's market share. In Korea, the special features of FexuClue are actively informed to medical staff across the country through various channels. In the case of overseas markets, it has signed 1.1 trillion won worth of technology exports with 15 countries around the world, and plans to expand its export range sequentially to foster it as a global blockbuster new drug. An official from Daewoong Pharmaceutical said, "Nabota's expansion of its market share in major global botulinum toxin markets, including the United States, led to the highest quarterly sales and operating profit ever." He said, "We expect the company's growth and return to rise together when sales of FexuClue, a new drug for gastroesophageal reflux disease, are visible in the third quarter and Nabota is released in Europe and elsewhere."
- Policy
- Daewoong sells the original Ebixa
- by Lee, Tak-Sun Aug 01, 2022 09:16pm
- Daewoong Pharmaceutical, which once sought to develop a high-dose dementia treatment Ebixa, sells original drug in Korea instead of giving it up. Ebixa 20mg, a higher dose than the existing product, is expected to greatly improve the convenience of taking it because patients only need to eat one dose a day. According to the industry on the 29th, Daewoong Pharmaceutical, which has signed a joint sales contract with the original company Lundbeck since 2019, will also carry out a copromotion of Ebixa 20mg, which will be listed on August 1. Ebixa 20mg will be listed at 1, 606 won starting August 1. It is twice the price of the existing Ebixa at 803 won. However, it improves the ease of use. Existing Ebixa requires two tablets a day, but Ebixa 20mg, which has increased the dose, requires only one tablet a day. Daewoong Pharmaceutical is conducting domestic sales and marketing of Ebixa in all sectors, including hospitals, hospitals, and clinics, while conducting a copromotion between Lundbeck and Ebixa in 2019. Ebixa is an NMDA receptor antagonist and has a mechanism to alleviate symptoms by inhibiting excessive NMDA receptor stimulation in the brain of Alzheimer's patients. It is the second most commonly used drug after Eisai's Aricept. Based on UBIST last year, Aricept was 86.1 billion won and Ebixa was 16.9 billion won. Lundbeck is counting on this Ebixa 20mg to close the gap with Aricept. It is calculated that as the convenience of taking has improved, the number of Rxs will increase. Daewoong Pharmaceutical also expects Ebixa 20mg to help improve the market share of dementia drugs in Korea. In particular, Daewoong Pharmaceutical attempted to develop 20mg of Memantine directly before Ebixa 20mg was approved in Korea. In April 2020, the MFDS approved a phase 1 clinical trial under the name DWJ1458, which is known as the development of Memantine 20mg.Daewoong Pharmaceutical stopped clinical research after two months of clinical approval. There were various interpretations of this at the time, but the original Ebixa 20mg copromotion solved the curiosity neatly. Aricept had the domestic license right. After that, the license was transferred to Handok, and Daewoong is currently registered as a consignment producer. Daewoong entered the dementia treatment market directly from Ebixa. Ebixa's propaganda is also needed to make up for the reduction in benefit through re-evaluation of its affiliate, Daewoong Bio's brain function improvement drug Gliatamin.
