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- 2026-05-10 01:23:35
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- Investigation of Varenicline has been undertaken
- by Chon, Seung-Hyun Jun 16, 2021 05:41am
- Health authorities have launched an investigation into Nitrosamines impurities in non-smoking drugs "Champix" and generics for Champix. According to industries on the 14th, the MFDS recently ordered pharmaceutical companies to follow up on Varenicline's impurities (Nitrosamines). The MFDS said, "Recently, there is a possibility of Nitrosamines impurities among Varenicline." The MFDS requested, "To take preventive measures, we will review the manufacturing process and follow-up measures such as testing impurities in Nitrosamines." Varenicline is a major active ingredient in Pfizer's anti-smoking drug Champix. 34 domestic pharmaceutical companies have generics for Varenicline. As the possibility of detection of nitrosamines impurities was confirmed by Varenicline, follow-up measures of domestic distribution products have been taken. "We requested follow-up measures to collect information on impurities from Varenicline," said an official from the MFDS. N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) detected in Valsartan, Losartan, Nizatidine, Ranitidine and Metformin in Korea since 2018. Pharmaceutical companies have completed inspections of Nitrosamine impurities such as NDMA and NDEA. In November 2019, the MFDS ordered pharmaceutical companies to submit a report on the possibility of Nitrosamine-based impurities in all raw materials and finished drugs, and the data submission was completed in a year and a half. The MFDS must submit data on impurities in all medicines to allow lot release without testing for Nitrosamines impurities. It is the second time this month that the MFDS has ordered investigations into impurities. Earlier on the 4th, the MFDS asked pharmaceutical companies to submit Azido impurities evaluation and test results of three raw materials, Irbesartan, Losartan and Valsartan, by the 14th. The MFDS ordered the raw material manufacturer to submit a statement of reasons even if it is impossible to obtain related data. This is a follow-up to the recent recovery of drugs with excess Azido impurities in Canada. Health Canada took measures on the 31st of last month to recover Irbesartan, Losartan and Valsartan that exceeded Azido from nine pharmaceutical companies, including Teva and Sandoz. Azido is a type of azide carcinogen. There is no known specific risk of cancer in the human body, although it may increase the risk of cancer. Nitrosamines impurities such as NDMA have been detected in Korea since 2018, but no recovery measures have been taken due to the detection of Azide-based impurities.
- Company
- Celltrion released the results of Regkirona's clinical trial
- by An, Kyung-Jin Jun 16, 2021 05:41am
- Celltrion Kim Sung-hyun, head of the medical division, is introducing the results of clinical trial toplineCelltrion is going to launch a global targeting of Regkirona (Regdanvimab), COVID-19 antibody treatment drug developed with its own technology. The government plans to eliminate controversy over efficacy and revitalize domestic and foreign markets through large-scale clinical trials. Celltrion held an online press conference on the morning of the 14th to introduce the results of clinical trials in Regkirona. Regkirona is a COVID-19 antibody drug developed by Celltrion. Based on the results of clinical trial in February, it has been supplied to medical institutions with conditional permission from the MFDS. Among patients confirmed with COVID-19, symptoms develop within seven days and do not require oxygen treatment and are administered to patients aged 60 or older or accompanied by underlying diseases such as cardiovascular disease, chronic respiratory disease, diabetes, and high blood pressure. Celltrion announced that it has proven its efficacy and safety by releasing the results of Regkirona's global clinical trials. This is the result of administering Regkirona to 1,315 patients with COVID-19 mild to moderate symptoms in 13 countries around the world, including South Korea, the U.S., Spain and Romania, starting in January this year. In April, all subjects completed the medication and announced the results of the top line after 28 days of treatment. Based on the previously conducted clinical trial, the dosage of Regkirona was determined to be 40 mg/kg, and the administration time was reduced from 90 minutes to 60 minutes. According to the announcement, the entire group of patients who received Regkirona secured statistical significance, with a 70% decrease in severe exacerbation compared to placebo groups. It is a similar level of treatment effect to 72% of patients with high-risk groups accompanied by elderly or underlying diseases. The time it took to improve clinical symptoms was 8.4 days for the entire Regkirona' administration group, down 4.9 days from 13.3 days for the placebo group. In the case of high-risk patients, the administration of Regkirona was reduced by more than 4.7 days compared to the placebo group to 9.3 days. However, in the case of patients who received placebo among high-risk groups, the number of patients who have had clinical symptom improvement by the 14th is less than 50%, which is difficult to compare accurately. In the analysis of safety assessment results, the number of patients who experienced adverse reactions in the Regkirona administration group and placebo group was similar. One out of 652 Regkirona groups was hospitalized for skin rashes, but recovered after treatment, and most of the abnormalities were mild. Celltrion expects to calm the controversy over efficacy at the time of the announcement of the trial by securing large-scale three-phase clinical results. "Clinical Phase 2 had a limit on the number of patients by treatment group and placebo group, but sufficient cases were secured in Phase 3 clinical trials," said Kim Sung-hyun, head of Celltrion's medical division in charge of the announcement. "As a result of statistical analysis by designating four major evaluation indicators for the most important clinical outcome, the severe exacerbation rate and time to improve clinical symptoms, we proved a clear difference between treatment and placebo groups in all evaluation indicators." Celltrion plans to apply for Regkirona's item approval from the MFDS based on data from the Phase III clinical trial. According to Kim, Celltrion has completed the supply of more than 5,000 Regkirona in Korea through a supply contract with the KDCA. More than 4,500 patients were given Regkirona at 84 designated hospitals nationwide for COVID-19 treatment. Celltrion is also expected to quickly approve Regkirona from major global regulators such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Celltrion will introduce Regkirona-related data at the "2021 ECCMID" oral presentation session, which will be held online from July 9 to 12. It plans to announce detailed results of phase 3 clinical trials of Regkirona within the first half of the year and update group companies' response strategies for COVID-19, including variable virus response strategies. Although the number of COVID-19 vaccinations has increased worldwide, the demand for COVID-19 treatments is still sufficient. He said,"It is difficult to accurately understand global demand for supply of Regkirona." However, there is a demand for Regkirona because the number of confirmed cases of COVID-19 is still continuously occurring. He added, "We are coordinating exports of Regkirona with major foreign countries including Europe. As we have proven the efficacy and safety of Regkirona through large-scale clinical trials, it will have a positive impact on more prescribed at home and abroad."
- Company
- The number of generics has been the lowest in 7 months
- by Chon, Seung-Hyun Jun 15, 2021 05:52am
- The number of Rx drugs' generic licences is the lowest in seven months since October last year. Recently, it was released in large numbers of generics for Atozet, but it fell back to its level shortly after the implementation of the drug price system. The proportion of consigned generics, which exceeded 80%, also fell to 50%. According to the MFDS on the 10th, the number of generics for Rx drugs was 44 last month. It is down 62% in a month from 116 in April. The figure is the lowest in seven months since 43 generics were licensed in October last year. The number of generic permits surged this year, but it plunged to the level in the second half of last year. In January, 102 generics were licensed and in February, 375 were licensed. In March and April, 177 and 116 generics were licensed, respectively. The reason for the surge in permits for generic products earlier this year is because of generics for Atozet. In February alone, 89 pharmaceutical companies were licensed a total of 256 of combinations of Atorvastatin and Ezetimibe. It is generic of Atozet sold by MSD and Chong Kun Dang. After Atozet's re-examination period expired on January 22, it applied for permission and received approval for sale at the same time. In February, 44 generics of MSD's diabetes drug Januvia were also licensed. However, as the number of Atozet's generic permits has decreased, the number of generic permits has dropped sharply. According to trends in number of licenses for generics, it has surged since early 2019 and slowed down in second half of last year. A total of 5,488 generics were licensed from January 2019 to May last year, averaging 323 per month. In 2018, a total of 1,110 generics were licensed, with an average of 93 per month. The number of permits has more than tripled in a year. The government's move to tighten generic regulations led to a surge in generic permits. The reorganized drug price system, which took effect in July last year, can maintain an upper limit of 53.55% compared to the original drug before the expiration of the patent only when generics meet both biological equivalence tests and use of registered raw materials. The system includes a stair-type drug price system in which the upper limit is lowered as the time for registration is later. If more than 20 generics are registered in Rx market, the upper limit of the newly registered items will be up to 85% of the existing lowest price. Since the implementation of the system, generic permits have been significantly reduced. The number of generic licenses, which reached 427 in May last year, fell to 73 in June. An average of 58 generics per month entered in seven months, including 74 in July, 51 in August, 45 in September, 43 in October, 58 in November and 69 in December last year. The average number of generic permits per month in the previous year and a half has been reduced to 18%. Until May last year, products that applied will be subject to previous drug price system. Generics, which has been approved since June and applied for the registration, receives low drug prices due to the new drug price system. This is why the number of new generic permits has plummeted since June. Among generics that were approved from October to December last year, 26%, 38%, and 70%, respectively. It rose to 82% in January this year, and recorded 85% in February-April, 80% and 78%. Last month it fell to 50%. It is the lowest level since November last year. The industry expects the number of generic licenses to vary depending on the opening of large new generics markets such as Atozet. In the case of Atozet, there was a large price deviation depending on the timing of the permit because it was newly formed. As drug prices fall depending on the timing of entry into the market, simultaneous competition for permits has been carried out. Competition for first generic to preoccupy drug prices is expected to be fierce because drug prices will be lower depending on the timing of entry into generic.
- Company
- Second trial on patent dispute over Bonviva
- by Kim, Jin-Gu Jun 14, 2021 05:56am
- There will be a patent dispute over the osteoporosis drug Bonviva (Ibandronate) again. It is an analysis of damages worth ₩tens of billions by domestic companies that are selling generics for Bonviva. According to the pharmaceutical industry on the 10th, British pharmaceutical company Atnahs Pharma, which owns patents of Bonviva, recently filed a lawsuit with the Patent Court to cancel the verdict of The Intelligent Property Trial and Appeal Board. In the previous first trial, Atnahs Pharma was defeated. The Intelligent Property Trial and Appeal Board ruled in March that Bonviva's patent was invalid. South Korean companies launched generic for Bonviva in 2012. Sales continued for years afterwards without patent disputes. Roche, the original company, held Bonviva's patent for use, but did not file a patent suit against the launch of the generic. Patent courts and Supreme Court did not recognize patents for indications/dosage. For the original company, there was no reason to dispute the patent because it was certain to lose. The situation was reversed in 2015. The Supreme Court scrapped existing cases in patent dispute of Baraclude (Entecavir) and admitted patents on indications/dosage. This also affected the patents of Bonviva. However, Roche did not file a separate patent dispute until then. The problem arose in 2018 when Bonviva's global patent rights were transferred from Roche to Atnahs Pharma in the UK. Atnahs Pharma has filed a lawsuit against local generics for Bonviva to ban patent infringement and seek massive damages. More than 10 generics, including Theragen, Alico, PharmGen Science, ChoA, Kolmar Korea, Huvist, and Dongkwang, which sold generics for Bonviva, jointly responded. The Intelligent Property Trial and Appeal Board sided with generic companies. With the appeal of Atnahs Pharma, the case was dealt with again in the second trial. According to UBIST, a pharmaceutical market research firm, Bonviva's prescription for out-of-pocket was ₩2.9 billion last year. It is sold by Handok in Korea. Generics for Bonviva are 93 items in Korea. Their prescription amount for last year is estimated to be around ₩10.3 billion. If the second trial makes a different ruling from the first trial, generic companies will have to deliver a large portion of their sales revenue to the original company since 2012.
- Company
- What's the future of vaccines after COVID-19 crisis?
- by Kim, Jin-Gu Jun 14, 2021 05:56am
- The rate of vaccinations against COVID-19 is increasing, especially in major developed countries. Experts say we need to brace ourselves for the 'Corona 21' and 'Corona 22' pandemic. As there is a high possibility that the pandemic will continue every year even if the current pandemic situation ends, the whole world should respond jointly. At the "2021 Bio Korea" held at COEX in Seoul on the 10th, a meeting was held to discuss future development and production of corona vaccines under the theme of "development of next-generation vaccines to cope with future infectious diseases." Experts agreed that COVID will repeat its epidemic every year in the future, just like the flu. Jerome Kim, Secretary-General of IVIAccording to him, global vaccine production in the first half of this year is worth 7.2 billion doses. Production is expected to increase to 12.6 billion doses in the second half of this year. However, if limited to vaccines officially recognized by the World Health Organization (WHO), the total number of doses in the first and second half of the year will be only 8.8 billion doses. Given that most vaccines are immunized with two doses, they are not sufficient to supply the world's population. The size is expected to increase to 1.12 million doses after next year, but there is still insufficient supply to meet global demand. "The COVID-19 virus epidemic will end in about a year and a half," he said. "Currently, global production capacity does not provide enough vaccines to underdeveloped countries. The CEPI has set a goal of supplying vaccines to 30% of the world's population by the end of this year, but vaccine producers around the world need to make efforts to ensure that they can be supplied more smoothly." "GSK, Merck, Takeda, and Daiichi Sankyo have not yet produced a vaccine for COVID" he said. Their development and mass production are required. "Various mutant viruses are reported," he added. "There must be mutant viruses that have not been reported yet," he said. "We also need to develop a Trivalent and Quadrivate vaccine to respond to them." Park Man-sung, a professor at Korea University of Medicine, also said, "We should prepare for the mutant virus epidemic." "Fortunately, COVID does not mutate as often as the influenza virus," he said. "However, numerous mutations have already been reported before the vaccine came out, and as the vaccination rate increases, COVID will adapt to it and change itself." He said, "Personally, I think there is a high possibility that COVID will evolve into a seasonal virus." "We don't know how long the immunogenicity of the vaccine we're currently inoculating will be maintained," he said. "We need to develop a new vaccine considering this situation." Variation virus reported before the start of COVID-19 vaccine. Even after the inoculation began, mutated viruses have been reported in Britain, South Africa, and India. Professor Park Man-sung predicted that more mutations will occur in the future and become a seasonal virus He also introduced plans to develop vaccines to prevent COVID and influenza at the same time. Since there is a high possibility that the two viruses will be prevalent simultaneously in winter, it is expected that demand will be very high if a vaccine is developed to prevent them at once. "Our laboratory is currently developing vaccines to prevent COVID and influenza viruses at the same time," said Professor Park Man-sung. "When initial development is completed, we will share technology with vaccine producers."
- Company
- Stephen Walter, Boehringer Ingelheim's CEO, will resign
- by Eo, Yun-Ho Jun 11, 2021 05:53am
- Boehringer Ingelheim's CEO, Stephen Walter will be replaced. According to related industries, Stephen Walter, the current CEO of Boehringer Ingelheim in Korea, will resign after this month (June). The successor is now known as the head of an Austrian corporation and will be officially appointed in July. Boehringer Ingelheim Korea Corporation will receive its fourth foreign representative after Guenter Reinke in 2005, Dirk van Niekerk in 2012 and Stephen Walter in 2018. Stephen Walter joined Beringer Ingelheim in July 2014 and until recently served as the general president of Beringer Ingelheim Vietnam, Cambodia and Myanmar, and was appointed as CEO of a Korean subsidiary in June 2018. At the end of this term, he is leaving the company. The resignation of Stephen Walter will also change the board directors of the Korean Research-based Pharmaceutical Industry Association (KRPIA). The association earlier confirmed that Lee Hye-young, CEO of Viatris Korea, was the new director of BOD following the resignation of Jenny Zheng, former CEO of Janssen Korea. Despite COVID-19 crisis, Boehringer Ingelheim's business units contributed to net sales and operating profit last year. Net sales rose 3% year-on-year to €19.57 billion. Net sales rose 5.6 % year-on-year when adjusting the exchange rate effect.
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- Hemlibra's reimbursement criteria to be rediscussed
- by Nho, Byung Chul Jun 11, 2021 05:53am
- Interest is rising as the Health Insurance Review and Assessment Service (HIRA) plans to call an expert advisory meeting to discuss the more effective operation of immune tolerance induction (ITI·antibody removal) therapies. At the end of this month, HIRA’s Pharmaceutical Standard Department plans to conduct deliberations to come up with reasonable improvement plans by comparing the review results regarding the revision of the reimbursement criteria for Hemlibra that was requested by academic societies and patient groups with cases overseas. The deliberation that will be held is significant in that it responds to the need for the re-establishment of the reimbursement criteria in accordance with the global trends, taking into account the hemophilia patients under the age of 12 that were unattended by existing standards and the convenience of administration. Of course, the best-case scenario would be to reflect the specific criteria for unfeasibility of ITI therapy to the notification in advance, however, the biggest victim and the ones worst affected by the criteria are the pediatric hemophilia patients who were discontinued prescription of Hemlibra since last April, pressing the need for the urgent revision of the standards. On the revision, the Korean Society on Thrombosis and Hemostasis has suggested improving the current reimbursement standards from three aspects. The first is for pediatric patients ineligible for ITI therapy. Patients who are not in year 1-5 of developing antibodies have a very low possibility of success using ITI therapies, however, under the current standards, these pediatric patients are not allowed to use the novel new drug Hemlibra injection until the age of 12 or older, and therefore has to use bypassing therapies. Other advanced countries abroad do not require compulsory use of ITI therapies through reimbursement criteria, and the domestic environment that restricts the use of new drugs needs to change. Also, the authorities do not not require prior use of ITI therapies for the use of bypassing therapies. Also, requesting objective data on why pediatric patients under the age of 5 cannot receive ITI therapy is considered to be the most difficult by HCPs in practice. In this sense, HIRA has the responsibility and duty to objectively and closely review such conditions to reflect reality. Other countries (U.K, Australia, etc.) are reviewing reimbursement for Hemlibra even in patients who are eligible for bypassing therapies. Cost-effectiveness analysis of pediatric patients showed that Hemlibra, which is used as maintenance therapy, is more cost-effective than bypassing therapies that can be used at every bleeding event. These data support the rational validity of the academic society's request to remove the priority consideration criteria of ITI therapies. Even HIRA’s Pharmaceutical Benefit Evaluation Committee had determined that the annual pharmaceutical expense of Hemlibra was cheaper than bypassing therapies in pediatric patients in October 2020. If the current reimbursement criteria reflect even a fraction of the requests and perspective of the patients and prescription circumstances, the situation would dramatically improve for the pediatric patients who were left to use only bypass treatment or bear the severe pain from bleeding. “We hope that the reimbursement criteria are revised soon in consideration of the pediatric hemophilia patients and their families," said an official from the Korean Society on Thrombosis and Hemostasis, expressing his hope.
- Company
- What is the most likely treatment for Alzheimer's?
- by Kim, Jin-Gu Jun 10, 2021 05:55am
- With 2021 Bio Korea held on the 9th, an innovative strategy session is being held for early diagnosis and treatment of Alzheimer As Biogen's Aducanumab (Aduhel) was approved by the U.S. Food and Drug Administration (FDA) for the first time in 18 years as a treatment for Alzheimer's, competition for development of Aducanumab. Currently, Roche, Eli Lilly, Ezai, Johnson and Johnson are considered companies that have started to develop treatments for Alzheimer's. In Korea, GemVax & KAEL and Aribio, Ildong, MEDIPOST, and Hyundai are developing dementia drugs. Among them, Zembax and Aribio are said to be fast in development. At the "2021 Bio Korea" held at COEX in Seoul on the 9th, the current status of development of Alzheimer's drugs at home and abroad was discussed under the theme of "Innovative Strategies for Early Diagnosis and Treatment of Alzheimer's Disease." In particular, the session drew keen attention due to the influence of Aducanumab's FDA approval a day ago. ◆Aducanumab, positive impact on development of dementia treatment drugs by domestic companies GemVax has completed phase 2 of GV1001 in Korea. Earlier this year, it applied for Phase III clinical trials, but the MFDS rejected. The reason was that the number of test subjects was insufficient. GemVax plans to re-apply for Phase III clinical trials by recruiting additional subjects. GemVax is also preparing for Phase II clinical trials in the United States. "We are actively discussing the resumption of clinical trials as COVID-19 situation calms down in the U.S.," Song Hyung-gon, CEO of GemVax & KAEL, said in an announcement on the day. "We are also in contact with local companies in Europe for clinical progress." Aribio is on clinical trial in the United States. In March, the company announced interim results of Phase II clinical trials on AR1001. In a six-month clinical trial of 210 patients, both Aribio 10 mg and Aribio 30 mg groups showed improved cognitive function. In the case of Aribio 10mg group, it was observed that the cognitive function improved 25.6% compared to the placebo group at 26 weeks. Based on these results, Aribio plans to apply for Phase III clinical IND in the United States within this year. With 2021 Bio Korea held on the 9th, an innovative strategy session is being held for early diagnosis and treatment of Alzheimer Ildong received approval for phase 3 clinical trials of 'ID1201' in South Korea in 2019. ID1201 is a natural product derived from the Pérsian lílac fruit. The company believes that the ingredient will improve cognitive function by inhibiting the production of β-amyloid and brain inflammatory substances. However, it is said that it is difficult to recruit subjects due to COVID-19 situation. MEDIPOST completed Neurostem's Phase I and Phase 2a clinical trials. In phase 2a, statistical significance was not obtained the Alzheimer's disease evaluation scale. However, MEDIPOST plans to confirm the tendency of β-amyloid levels to fall and reaffirm the results after long-term tracking by continuing clinical trials like Biogen. ◆Phase 3 clinical trials such as Roche's Gantenerumab and Solanezumab by Lilly are underway Colin Masters, Professor of University of Melbourne, introduced the development of global Alzheimer's drugs. According to him, in addition to FDA-approved Aducanumab by Biogen, there are Gantenerumab by Roche, Solanezumab and Donanemab by Lilly, Crenezumab co-developed by Roche and Genentech, Bapineuzumab co-developed by Pfizer and Janssen, and BAN2401 jointly developed by Eisai and Biogen. Progress in development confirms that Solanezumab and Gantenerumab are relatively advanced. Phase III clinical trials are under way. Both treatments target β-amyloid, such as Aducanumab. The target is the same, but there is a slight difference in how it is involved in β-amyloid. Aducanumab removes β-amyloid directly. Solanezumab neutralizes toxicity in the intermediate stage of β-amyloid formation. Gantenerumab prevents amyloid from accumulating in the first place. The β-amyloid reduction effect shown to date is comparable to that of Aducanumab. A PET scan of the brain's β-amyloid buildup showed that Aducanumab succeeded in removing 70%. Gantenerumab, Lecanemab, and Donanemab are similar. Bapineuzumab is 12-25% lower, while Solanezumab and Crenezumab do not have separate PET imaging data. "There is no doubt that we need to treat Alzheimer's with combination drugs," Professor Masters said. "We need to use a variety of mechanisms at the same time to lower our amyloid levels." However, it is appropriate to start with low capacity in the early stages and gradually increase it to high capacity."
- Company
- Korean novel drug Leclaza may become cheaper than Tagrisso
- by Eo, Yun-Ho Jun 10, 2021 05:55am
- The daily drug cost of Korea's novel anticancer drug 'Leclaza' is expected to be set at a level that is around ₩10,000 cheaper than ‘Tagrisso.’ Dailypharm found that the price of Yuhan Corp.’s 3rd generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Leclaza (lazertinib) was set at ₩69,000 per each 80mg tablet after drug pricing negotiations with the National Health Insurance Service (NHIS) on the 7th. If a patient takes the daily recommended dose of 240mg every day, the total cost will be around ₩207,000 per day. The recommended daily dose of Tagrisso (osimertinib) is 80mg, and each 80mg tablet costs ₩217,782. Both prices are based on the list price. The relatively generous price that was set for Leclaza, despite it being a latecomer drug, was deemed possible due to the drug being a domestic novel drug, and in consideration of its potential indication expansions in the future. Accordingly, if Leclaza passes the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee this month, the drug will be available with reimbursement from July. This may start a full-scale competition in the second-line treatment of non-small cell lung cancer (NSCLC) between Leclaza and AstraZeneca’s Tagrisso. Leclaza's reimbursement is being processed at an unprecedented pace. After receiving marketing authorization in Korea on January 18th of this year, in one month the drug passed the Health Insurance Review & Assessment Service’s Cancer Disease Deliberation Committee, then passed HIRA's Pharmaceutical Benefits Assessment Committee (PBAC) review in April. Also, MOHW had ordered a negotiation period a week earlier for Leclaza compared to other drugs that passed the PBAC to further speed up the listing process. If the drug is listed in July, the whole listing process from approval to listing would have taken less than 6 months in total. Leclaza was first approved for the second-line treatment of lung cancer, specifically, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive EGFR T790M mutation who have been previously treated with an EGFR-TKI. The approval was based on the clinical trial results of its Phase II clinical trial (therapeutic exploratory trial) that was conducted in Korea, under the condition that the company conducts and submits Phase III trial (therapeutic confirmatory study) data after the market release. Currently, first-generation EGFR TKIs AstraZeneca's Iressa (gefitinib) and Roche's 'Tarceva (erlotinib)'; second-generation EGFR TKIs 'Geotrif (afatinib)' and 'Vizimpro (dacomitinib)'; and third-generation EGFR TKIs Leclaza and Tagrisso(osimertinib) are being prescribed in Korea.
- Company
- Former GSK GM Yoo-Seok Hong to head D&D Pharmatech
- by An, Kyung-Jin Jun 10, 2021 05:55am
- Yoo-Seok Hong, New CEO of D&D Pharmatech Yoo-Seok Hong, former General Manager of GSK Korea will be joining the leadership of the biotech company, D&D Pharmatech. On the 9th, D&D Pharmatech had announced that the company has appointed Yoo-Seok Hong as its new CEO. Hong is a seasoned expert with extensive experience in marketing and business management at multinational pharmaceutical companies. Hong was as Marketing Director for Eli Lilly's osteoporosis treatment and Senior Director of Strategy in the Emerging Market Business Unit of Eli Lilly and Company, after which he served as General Manager at various Korean subsidiaries of multinational pharmaceutical companies including Lilly Korea, Teva-Handok, and GSK Korea. In February 2018., Hong was appointed General Manager of Pharmaceutical in GSK Canada, then as the Vice President of the GSK headquarters in the U.S., and was in charge of commercializing the company’s innovative liver treatment from September 2020. As a leader, Hong is considered to have played a significant role in elevating the status of Korean managers in the international market. D&D Pharmatech was established in 2014 by Professor Seulki Lee of Johns Hopkins School of Medicine. It has headquarters in Korea (Pangyo) and the U.S. (Gaithersburg, MD), and has five U.S. subsidiaries focusing on specific therapeutic areas, where it conducts global clinical research and development. 10 global clinical projects using new drug candidates that were developed by the company’s research team in Korea and abroad for neurodegenerative diseases, fibrotic diseases, and metabolic diseases are being tested at sites in the U.S. and Europe. The company’s treatment in development for Parkinson’s disease (PD) and Alzheimer’s disease (AD) is currently in a large-scale Phase II trial. Recently, the company has expanded its business to biomarkers that can diagnose neurodegenerative patients and big data to analyze its cause. D&D Pharmatech plans to present the proposal to appoint Hong Yoo-Seok as an inside director at the general shareholders' meeting on the 18th, and appoint Hong as CEO at the Board of Directors meeting. Through the appointment, the company will be operated under an independent representative system with Dr. Seulki Lee, the founder, and CEO overseeing the entire R&D business, and CEO Yoo-Seok Hong in charge of the company's business development, management, and operation. The company anticipates that Hong will speed up the global technology export and commercialization of ongoing clinical projects. On his appointment, Hong said, “I have high expectations for D&D Pharmatech’s core pipeline and believe in its market potential and possibility of success. As CEO, I aspire to create a successful Korean global biotech model in which its three components - continuous discovery of new candidate substances, successful clinical development, and global commercialization – can operate in harmony.”
