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- 2026-04-17 06:15:02
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- FDA approves Phase III Actemra COVID-19 trial
- by An, Kyung-Jin Mar 26, 2020 06:11am
- Actemra product image A late-phase clinical trial in patients with severe case of the 2019 novel coronavirus (COVID-19) would be conducted with Actemra, solely distributed by JW Pharmaceutical in Korea. Roche Group’s Genentech has announced on Mar. 23 the U.S. Food and Drug Administration (FDA) has approved Actemra’s (tocilizumab) Phase III clinical trial in adult patients hospitalized with severe case of COVID-19 to test the medication’s treatment effect and safety profile. The news was out three days after the company informed Actemra is in discussion with FDA about a clinical trial to confirm its effect on COVID-19. Genentech is co-conducting the study with Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Department of Health and Human Service (HHS) Office of the Assistant Secretary for Preparedness and Response. The primary and secondary endpoints are clinical status of a patient and mortality rate, and necessity of mechanical ventilator and ICU. Prior to the U.S. health authority’s approval, Actemra’s clinical trials in COVID-19 patient have been initiated globally to test effect and safety. But the study distinguishes itself from the previous studies with intricately designed protocol. Genentech stressed, “Actemra has not been indicated to treat patients with COVID-19, and its medical evidence on benefit to COVID-19 treatment has been limited.” Following the U.S. HHS’ order, the company plans to provide 10,000 vials of Actemra to the U.S. government. Alexander Hardy, the CEO of Genentech stated, “We thank the FDA for rapidly expediting the approval of this clinical trial to evaluate Actemra in critically ill patients suffering from COVID-19,” and “the company has decided to conduct this clinical trial in partnership with BARDA and to provide Actemra to support the national stockpile, through the efforts of Secretary Azar and HHS” Actemra is a humanized interleukin-6 (IL-6) receptor antagonist. The subcutaneous injection is widely used to treat rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and cytokine release syndrome (CRS). In 2009, JW Pharmaceutical has signed a deal with Chugai Pharmaceutical under the Roche Group over Actemra for the co-development and exclusive sales in Korean market. The medication was released to the Korean market from 2013, after completing a Phase III study. In July 2014, Actemra SC injection with improved patient adherence was released in the Korean market.
- Company
- Celltrion, clinical trial in COVID-19 in July
- by Lee, Seok-Jun Mar 26, 2020 06:10am
- Chairman Jeong-jin Seo of Celltrion said on the 23rd, "This July, human clinical trials will be started for the development of COVID-19 treatments". He added, "It is possible to develop a therapeutic antibody for 1 million people per month after human administration". Chairman Seo shared this business plan through an online press conference held on the same day. According to the company, Celltrion is developing antibody treatments from February to receive COVID-19 confirmed patient's blood. Currently, 300 candidates have been obtained. Antibodies with excellent virus neutralization ability will be selected by April. It is administered to patients as early as mid-July. Celltrion will begin production of cell lines for mass production of antibodies from May, and production of clinical substances to be administered to the human body will be completed by mid-July or end of July. After the human administration has started, it will develop a therapeutic antibody for 1 million people per month. Antibody means an immune protein that binds to an antigen and interferes with the action of the antigen or removes the antigen. Overseas, Genentech and Eli Lilly are developing COVID-19 antibody treatments. The rate of antibody therapeutic development was the fastest. "COVID-19 neutralizing antibody therapeutics are being developed by five companies, including Korea Celltrion, two global large pharmaceutical companies, and two overseas biotechs", said Seo. He added that "Celltrion can be competitive in future developments due to its mass production capacity. In case of emergency, it has also planned to prepare for supply by using CMO partners". Celltrion also undertakes 'super antibody' screening to neutralize various coronaviruses (mutations, etc.). "In March, we will be screening for super antibody screening that neutralizes the COVID-19, as well as the SARS and even the common cold-causing corona virus. We will collect more blood samples and go ahead in speed", he said. It accelerates the development of the COVID-19 diagnostic kit prototype. The product that Celltrion is developing is a method to detect the S protein that is only present in COVID-19. It is different from the existing rapid diagnosis kit that detects the N protein commonly held by various types of corona viruses. "The Celltrion kit is expected to show performance close to RT-PCR, a standard diagnostic method for COVID-19 positive. 15-20 minutes is enough for test results, so it has the advantage of being able to check the test results on the spot". It is planned to apply for CE certification for export to Europe by completing the production of prototypes in late April and completing clinical trials by the end of May through collaboration with specialized companies.
- Policy
- Researchers from Korea start verifying COVID-19 treatments
- by Lee, Tak-Sun Mar 25, 2020 09:57am
- Treatments such as Hydroxychloroquine, used in COVID-19 infected patients, have entered clinical trials in earnest. Large hospitals, such as the AMC, have tried to verify safety and effectiveness through sponsor-investigator trials. Other hospitals besides the AMC have also been reported to apply for a clinical trial for Hydroxychloroquine and are waiting for approval. Jin-Young Yang, deputy director of the MFDS, said on the 24th that five cases of COVID-19 treatment were applied for clinical trials and are currently being reviewed. The cases include 'Panaphix' of Kormipharm, which has already announced the application for clinical trial through public announcement and drugs of some bio companies. In particular, it is said that there is also a clinical trial of researchers on 'Chloroquine' which recently became the topic of discussion that US President Trump recently announced as a treatment for COVID-19 The AMC sponsor-investigator trial has been approved for Hydroxychloroquine as well as Kaletra on the 20th. The AMC plans to conduct a study by March 2025 on 150 mild patients with COVID-19 over 18 years of age. It is planned to take Hydroxychloroquine 400mg once a day for 7 to 10 days, and verify the efficacy through virus levels. Kaletra is also planned to be taken twice a day for 7 to 10 days to verify efficacy in the same way. Kaletra and Hydroxychloroquine are currently being used in Korea as a primary treatment for COVID-19 infection. Kaletra (Ritonavir-Lopinavir) is a product of AbbVie and is an antiviral agent used to treat HIV-1 (human immunodeficiency virus) infection in combination with other antiretroviral agents. Hydroxychloroquine is used for the treatment and prevention of rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin disease and malaria. In Korea, there are Duroc by PMG Pharm, Aruquin by Unimed, Oxiquine by Telcon-pharm, Oxiklorin by Elyson, Chlorquine by Myung In Pharm, Polanil by LegoChem Pharma, Halrochrosin by koruspham, Haloxin by Hanlim, Hyroquin by BCworld Pharm. In a recent overseas study, the efficacy of COVID-19 treatments such as Hydroxychloroquine and Kaletra is insufficient. It is noteworthy what domestic researchers will conclude through clinical trials..
- Company
- Balloon effect from impurity measures?
- by Chon, Seung-Hyun Mar 25, 2020 06:03am
- Recently, the number of new anti-ulcer drugs that enter the market is rapidly increasing. As the alternative drug market expanded after the Ranitidine’s withdrawal due to excessive detection of impurities in September last year, pharmaceuticals are also actively targeting the generic market. In addition to H2 receptor antagonists such as Famotidine and Laputidine, similar generic products such as Esomeprazole and Artemisia Princeps have also increased significantly. It is pointed out that the generic turmoil in the similar drug market is intensifying due to the balloon effect following the government's strong follow-up of impurities. According to the MOHW's revised notice on a partial revision of Criteria for pharmaceutical reimbursed list & reimbursed upper limit table, from April 1, 9 generic products of “Famotidine 20mg” will be listed on the pharmaceutical reimbursed list. Mirae Pharm, TDS Pharm, Theragen Etex, CMG Pharma, PMG Pharm, SCD Pharm, Daehan New Pharm, and Daewoong Bio sell Famotidine product. Kukje pharm, Arlico, Newgen Pharm, Korea Prime Pharm, Medix Pharm, Eden Pharma, Youngil pharm, Generic products with 'Laputinine', which were approved by eight companies including Kukje pharm, Arlico, Newgen Pharm, Korea Prime Pharm, Medix Pharm, Eden Pharma, Youngil pharm, were also newly added to the list. Famotidine and Laputidine are H2 receptor antagonist drugs and are used for gastric ulcer and duodenal ulcer. It is analyzed that drug companies are actively entering the alternative drug market since last year's banned sales of Ranitidine. The MFDS banned the sale of all products of 'Ranitidine' in late September last year. The market was virtually decided to exit due to the excess detection of the carcinogen N-nitrosodimethylamine (NDMA). September 2019 and April 2020 Famotidine 20mg (left) and Laputidine 10mg (right) Number of health insurance benefits registered (Unit: number, Data: the HIRAAccording to the HIRA, on September 1, last year, a total of 35 other companies were listed for Famotidine 20mg before the ban on the sale of Ranitidine was imposed. However, Famotidine 20mg, listed on April 1, increased 56 companies by 60%. In the case of Laputidine 10mg, the number of products on the reimbursed list increased 11 products from 29 in September last year to 40 in April. The surge in prescriptions of similar drugs after the ban on the sale of Ranitidine drugs is also analyzed as a factor that has pushed the market for pharmaceutical companies. According to UBIST, a pharmaceutical research institute, in December of last year, Outpatient prescriptions for five components, except Ranitidine, of H2 receptor antagonists such as Famotidine, Laputidine, Nizatidine, Cimetidine, and Roxatidine, were ￦10 billion. The prescription size soared 69.5% from August before the occurrence of impurities. The growth of Famotidine and Laputidine was steep. In December of last year, the prescription scale of the single component of Famotidine was ￦3.1 billion, more than three times higher than in August. The size of prescription for Famotidine last year was ￦17.5 billion, an increase of 38.0% compared to the previous year. In December last year, the amount of outpatient prescription for Lafutidine increased by 131.8% from August to ￦3 billion. As the prescription size of Famotidine and Laputidine expanded due to the reflex profit from the withdrawal of Ranitidine, pharmaceutical companies’ market activity was also active. Trends in monthly outpatient prescriptions by component of major H2 receptor antagonists (Unit: ￦1 million, Source: UBIST) Other drugs with similar uses to Ranitidine have also seen a significant increase in the number of generics. In the case of Esomeprazole 20mg (generic for Nexium) increased 16 from 108 to 124 on the benefit list in September. Esomeprazole is a proton pump inhibitor (PPI) -based drug and is most often used as an anti-ulcer agent. Esomeprazole also enjoyed the Ranitidine reflex benefit. Esomeprazole's prescription amount last year was ￦189.3 billion, up 17.1% from the previous year. Esomeprazole's prescription amount increased 20.6% from ￦15.1 billion in September last year to ￦18.2 billion in one month. In December of last year, it exceeded ￦20 billion. September 2019 and April 2020 Artemisia Princeps 90mg Health Insurance Benefits Registered (Unit: pcs, Source: the HIRA)The number of generics participating in the gastritis treatment Stillen market is also on the rise. Stillen is a gastritis treatment with 'Artemisia Princeps' as an active ingredient. Last year, the prescription size of Artemisia Princeps increased by 17.4% from the previous year to ￦87.5 billion. In September of last year, 15 Artemisia Princeps 90mg products were listed, which rose 73% to 26 in 7 months. The industry also complains that the government has been pushing the generics market for alternative medicines as a result of strong measures against impurity medicines. All products of Ranitidine have been discontinued in Korea, while pharmaceutical manufacturers have recovered their products by lot number in the US and Europe. The domestic market containing Ranitidine is about ￦200 billion per year. It is a reality that pharmaceutical companies that have suffered losses due to the sale of Ranitidine have a strategy to make up for other products. An industry insider said, “Excluding all products that have not been found to be harmful to the human body, considerable losses were inevitable and forced to compete in similar markets to make up for the losses”. The US Food and Drug Administration (FDA) issued a statement in November last year that "the hazards of NDMA detected in Ranitidine are comparable to those exposed when eating roasted or smoked meat". An official from a pharmaceutical company criticized, "The ban on the sale of all Ranitidine products in Korea also caused an excessive number of generics".
- Policy
- Advanced payment for COVID-19, expanded
- by Lee, Hye-Kyung Mar 25, 2020 06:02am
- care benefits, which were currently applied only to medical institutions in Daegu and Gyeongbuk. However, the support organizations are dedicated to the prevention of COVID-19 spread and treatment of patients and are limited to medical institutions, excluding pharmacies, The NHIS is expanding the nation's special cases of advance payment for medical and health institutions. With regard to the exclusion of pharmacies, an official from the NHIS said, “The special payment for medical care benefit is a measure to alleviate the financial difficulties of medical institutions dedicated to treatment related to the spread of COVID-19”. "The existing medical institutions located in Daegu and Gyeongbuk will expand the exemption of advance payments nationwide,and applications and submissions are accepted from the headquarters of the Corporation and the regional headquarters starting today (23rd)", the NHIS said in a press release on the 23rd. In the case of Daegu and Gyeongbuk areas that have already been accepted, additional support may be received in May, like other areas that are expanding. The amount of support will be paid from the end of March as the average monthly amount of medical care benefit expenses paid for three months from March to May 2019. Institutions with direct influence, such as medical institutions in Daegu and Gyeongbuk regions, infectious disease management institutions, and outbreak patients and treatment institutions, pay 100% of the average monthly reimbursement for March~May of the previous year and 90% for other medical institutions. The standard of payment is the same as that of MERS outbreak, and the monthly reimbursed costs are first subtracted from the applied amount, and if there is an additional claim within the month after the advance payment, the balance is paid after the first offset from the advance payment settlement. This will be offset equally from the cost of medical reimbursement to be paid from July to December (six months). It is explained in detail in the news of the newsletter of the NHIS and the information category of the medical institutions.
- Policy
- Eligibility standards on RSA change for better accessibility
- by Kim, Jung-Ju Mar 25, 2020 06:02am
- The risk sharing agreement (RSA) system implemented to enhance reimbursement access on an expensive drug would be amended and applied on follow-on drugs as well. To this date, multinational pharmaceutical companies and related industry have been strongly demanding for the change. They are now anticipating the change to resolve issues in high-cost new drug accessibility and fairness in pharmaceutical coverage. Korea’s Ministry of Health and Welfare (MOHW) has preannounced the revised ‘Pharmaceutical Decision and Adjustment Standard’ with the said changes on Mar. 23. Accordingly, the ministry is accepting related public opinion until June 11. The main objective of the revision is to reflect changes made from the revised ‘Regulation on National Health Insurance Reimbursement Standard,’ and to improve RSA system to apply the terms on follow-on drugs as well. The revision has expanded RSA-eligible subject scope to include follow on drugs, more specifically cost-effective drugs at a treatment level on par with RSA-covered first-in-class drug. At the moment, RSA is limited to first-in-class drug. However, the RSA subject scope has been constantly criticized as its subject drugs are mostly expensive anticancer or rare disease treatments, and the public has raised issues of fairness in the RSA eligibility. Trying to keep RSA as limited as possible to protect the positive listing system, the government had not expanded RSA eligibility onto follow-on drugs. But as the focus of reimbursement listing system has shifted towards patient-centered accessibility, the government has decided to make the change. Along with the eligibility expansion, the government has established a legal basis to apply RSA on pharmacoeconomic evaluation-exempted drug and drugs approved on condition to conduct Phase III clinical trial that meet the cost-effectiveness assessment criteria. And also, complicated combination formulation with two or more agents would be eligible for RSA. The pharmaceutical adjustment standard would be newly added for drugs with expanded indication as well. The maximum price of a drug, with change in indication, would be adjusted based on the Minister of Health and Welfare’s assessment on the adequacy of the maximum price. The maximum price adjustment would be recalculated based on ‘Pharmaceutical Decision and Adjustment Standard.’ However, depending on an assessment by the Drug Reimbursement Evaluation Committee (DREC), the adjustment could be based on the drug’s history of reimbursement listing and unique quality. After accepting the public opinion, the government is planning to enforce the changes from the day the revision notice is issued.
- Policy
- Reformed listing procedure requires generic to negotiate
- by Kim, Jung-Ju Mar 25, 2020 06:02am
- The Korean government is ready to finalize a legal basis requiring generic drugs to negotiate and sign a compliance agreement with the government and insurer. Currently, generics are listed for reimbursement comparatively easier than the drugs taking the regular pricing track,. Also, the legal basis would stipulate the government to legally block off some pharmaceutical companies evading drug pricing reduction imposed for providing illegal rebate. The Ministry of Health and Welfare (MOHW) has preannounced the revised ‘Regulation on National Health Insurance Reimbursement Standard,’ and started accepting public opinion until Mar. 23. The revision would provide a foundation for the drug pricing system improvement plan the government has reported to Health Insurance Policy Deliberation Committee (HIPDC) subcommittee in last December. Previously, the government has posted a draft of the revision on the Ministry of Government Legislation website’s Government Legislation Process Board, but it was taken down shortly to make more changes. The revision would focus on following four key changes; improving healthcare reimbursement decision-making principle and implementing prioritization for pharmaceutical reimbursement listing; implementing a regulation to reject listing application from a company trying to evade imposed drug pricing reduction; unifying reimbursement listing procedure; stipulating government-authorized adjustment on drug with changed indication. Compared to the initial draft, the latest version has narrowed government-authorized adjustment related subject scope and removed redundant phrases in the new negotiation order. Also, the latest revision has added improved healthcare reimbursement decision-making principles, and adopted a prioritization system for pharmaceutical reimbursement listing. The revised regulation would stipulate deciding reimbursed items considering the sustainability of limited National Health Insurance (NHI) financial resources has been stipulated, and prioritizing pharmaceutical reimbursement based on reimbursement decision principles. And the legal basis would enable the government to preemptively shut off pharmaceutical companies attempting to evade imposed pricing reduction penalty. Some drugs subject to price reduction due to providing illegal rebate tend to apply for reimbursement as another drug to evade the penalty. But the new regulation would legally stipulate government to reject the application. The pharmaceutical reimbursement listing procedures would be unified as well. The revised regulation would require all drugs qualified to receive reimbursement to negotiate before the listing. Drugs like generics that received automatically calculated pricing would be subject to a reimbursement negotiation track and reach an agreement with National Health Insurance Service (NHIS). Unlike regular new drugs, negotiation-exempted drugs were not required to negotiate drug pricing, projected use volume, and other supply related essential and additional agreement terms affecting patient’s accessibility. However, the revised regulation would mandate the generic makers to negotiate and sign an agreement on compliance of supply duty, safety net for patient (accessibility), and other terms about financial stability with the insurer. The detailed terms are identical to negotiation standards offered to new drugs. Within 60 days of negotiation, the applicant company may decide to suspend the process or postpone the negotiation, and also it could engage in a pre-negotiation with the President of NHIS to streamline the actual negotiation procedure. Also, the new regulation would also stimulating immediate reporting the deliberation result of Drug Reimbursement Evaluation Committee (DREC) to the president of NHIS. Moreover, the regulation would also stipulate the government-authorized drug pricing adjustment on drugs with changed indication, if need be. The government would review the necessity of pricing adjustment on a drug with expanded label based on the drug’s approved indication and reimbursement status in foreign countries and related literature review. To improve drug adjustment calculation and procedure, the initial draft of the revision used to include redundant terms about the negotiation order and change in listing procedure changed with authorized adjustment. But the latest version seems to have removed the redundant terms.
- Product
- Who will succeed in COVID-19 treatment?
- by choi-sun Mar 25, 2020 06:01am
- As pharmaceutical companies around the world are plunging into the development of vaccines and treatments for COVID-19 treatment, attention is focused on who will succeed in commercialization. Among the treatments, Gilead Sciences entered Phase III of clinical trials, and in the field of vaccines, it entered Phase I by Moderna Therapeutics. However, it is not the first to release it because it may fail clinically. Among the other candidates that follow, the mechanism is slightly different, and it is also a concern that they may be able to get the title of a COVID-19 treatment or COVID-19 vaccine. ▲Treatment = Pre-Clinical ~ Phase III There are two ways to respond to the COVID-19. There is a 'therapeutic agent' that suppresses the proliferation of the virus after infection, and there is a 'vaccine' that focuses on preventing infection. COVID-19 is a type of RNA virus that shares its roots with SARS and MERS. A similar principle is that previously used Ebola treatments are used to treat COVID-19. #Remdesivir, an Ebola treatment that Gilead Science is developing, has a mechanism to inhibit RNA polymerase necessary for virus replication and proliferation. It is for this reason that it quickly entered phase III clinical trials. On the 26th of last month, Gilead started phase III of Remdesivir in the United States and China, followed by investigational new drug application on the 2nd of this month in Korea and completed clinical preparation. In fact, Seoul National University Hospital on the 9th concluded a clinical research agreement with the National Institutes of Health and started enrolling patients immediately from this day, so it is expected that the results will be confirmed in the first half of this year. The main goal is whether to lower the boby temperature and get cured within two weeks at the same time. However, it is still unknown whether Ebola virus clinical trials will lead to commercialized products in that it failed with a high mortality rate compared to competing drugs. The rest of the treatment remains in the Pre-Clinical, except that Remdesivir is in Phase III clinical trials. This means that it takes at least one or two years to confirm the reality. Johnson & Johnson is approaching COVID-19 as a treatment and vaccine development based on its past experience in developing Ebola and Zika viruses. Johnson & Johnson is developing a virus-inactivating vaccine at the preclinical stage, and is also working with the Biomedical Advanced Research and Development Authority (BARDA) to develop therapeutics for patients who are already infected. Through this, it is examined whether existing medicines, such as Remdesivir, an Ebola treatment, Kaletra, an AIDS treatment, and Avigan, a flu drug developed in Japan, are effective in suppressing COVID-19. US bio-company Regeneron Pharmaceuticals is focusing on the development of antibody therapeutics through genetic engineering. Although it is still in the preclinical stage, Regeneron plans to develop an antibody therapy against COVID-19 through mouse genetic manipulation technology capable of producing human antibodies. The candidate is expected to go into animal testing soon, and is preparing for human clinical trials by the third quarter of this year. In fact, during the Ebola incident in 2015, Regeneron had experience in developing a mixed-antibody drug that doubled the patient's survival rate. Vir Biotechnology is also developing antibody-based therapeutics. The difference from Regeneron is that instead of generating antibodies by genetic manipulation, antibodies that are naturally produced after infection with similar corona-like viruses such as SARS in the past are used. In fact, this method has been applied to MERS and SARS in the past. A method of collecting serum from a patient who formed a natural antibody and administering it to a serious patient was achieved. Vir Biotechnology is investigating whether the SARS virus is similar to COVID-19, so that antibodies from patients recovering from SARS can be isolated and applied to COVID-19. #Vir is in the early stages of development in cooperation with Chinese company WuXi Biologics, and it is not clear when the clinical trial is expected. ▲Vaccine = Pre-Clinical ~ Phase I Currently, phase I is at the forefront from vaccine development. Modena therafutics developed the vaccine candidate mRNA-1273 only 42 days after the nucleotide sequence of the COVID-19 was confirmed and jumped to the promising group. mRNA has a mechanism in the body that allows cells to form antibodies on their own. Modena is expected to begin research next month with healthy volunteers in cooperation with the National Institutes of Health (NIH). Once the safety of mRNA-1273 has been demonstrated, Phase II will be undertaken to confirm the effectiveness of the vaccine in hundreds. However, Modena, which is developing mRNA or mRNA designed for cells in the body to produce antibodies against viruses, has not been approved by the FDA as a related drug. Except for Modena, vaccines of various mechanisms are still in the Pre-Clinical. CureVac, like Modena, develops a vaccine that promotes the production of antibody proteins using synthetic mRNA. It is expected to be ready for clinical trials within a few months. China's Clover Biopharmaceuticals, was transferred its technology to a proprietary adjuvant compound that improves the effectiveness of the vaccine from GSK in February and started developing vaccines. The company is developing a vaccine against infection by injecting a protein that stimulates the immune response and activating body immunity, but the clinical trial plan has not yet been detailed. Inovio, the United States, has been developing DNA medicines for the past 40 years, and has received subsidies for the development of DNA-based vaccines from the Coalition for Epidemic Preparedness Innovations (CEPI). In partnership with Chinese manufacturer Beijing Advaccine Biotechnology, INO-4800 candidate vaccine is in Pre-Clinical, and clinical trials are expected in the second half of this year. Sanofi, which has successfully developed a yellow fever and diphtheria vaccine, is working with the BARDA to develop COVID-19 vaccine. Sanofi aims to create a chimeric DNA vaccine that activates the patient's immunity by mixing a portion of the DNA of COVID-19 with the genetic material of the harmless virus. The vaccine candidate is expected to be tested in the laboratory within 6 months, and the clinical trial is expected to be available within 1 to 18 months. Sanofi said the technology has been applied to SARS. However, Sanofi expects to take at least three years to get approval. Experts say it is too early to make a positive outlook, as various therapeutics and vaccines are still in the Pre-Clinical of exploring candidates and evaluating safety. Professor Ki-seok Jeong of the department of Pulmonology at Hallym University said, "I think it is difficult to cure the drug in the near future. However, in the case of Remdesivir, an ebola drug, it would be better if indications were added as much as it promotes clinical trials in Korea". "An RNA virus has many mutations, so it is not easy to develop a therapeutic drug and it is more difficult to develop a vaccine. Considering that multinational companies spend ￦1 trillion on new drug development, a government-level investment in development is necessary" he advised.
- Policy
- Coxib-tramadol pain reliever readies commercialization
- by Lee, Tak-Sun Mar 24, 2020 05:21am
- The original celecoxib drug ‘Celebrex’ by PfizerCommercialization for a combination drug based on anti-inflammatory coxib and tramadol is in currently in development. The pharmaceutical industry anticipates it would be the next generation pain reliever with improved effect. According to the industry, coxib-tramadol hydrochloride combination drug is preparing for a launch. On Mar. 16, Yuhan’s subsidiary, Add Pharma has reportedly received Ministry of Food and Drug Safety’s (MFDS) approval on Phase I clinical protocol to test celecoxib-tramadol hydrochloride combination drug. Previously, Yooyoung Pharmaceutical has been approved to conduct a clinical trial on ‘YYC301,’ a combination drug with celecoxib and tramadol hydrochloride in 2017. The company stated it developed the combination drug to relive patients’ pain with osteoarthritis still struggling with celecoxib alone. In August 2018, the company received another approval on Phase II protocol for YYC301 in patients with osteoarthritis in knee joint. In March 2018, Crystal Genomics was cleared to run a clinical trial on a combination drug consisting of its coxib drug Acelex and tramadol hydrochloride. The combination drug is in development to treat patients with osteoarthritis (degenerative arthritis) with moderate to severe level of pain. Widely used on patients with osteoarthritis, Coxib drug selectively inhibits COX-2 inducing inflammation and pain. For an original celecoxib drug, Pfizer’s Celebrex is the most famous brand name. A non-opioid pain reliever, tramadol is serotonergic that inhibits reuptake of norepinephrine and serotonin, and it also suppresses pain by agonizing mu receptor that transports pain to central nervous system. Tramadol-acetaminophen combination drug is widely used in Korea for its powerful pain relieving effect. Janssen’s Ultracet is one of the most well-known brand names. Ultracet (including Ultracet ER) is a blockbuster drug that generated 22.3 billion won last year from outpatient prescription. The coxib-tramadol combination drug in development is targeting the Ultracet’s market. An industry insider commented, “Coxib-tramadol combination drug has never been released in Korean market, but the industry is highly anticipating its commercial success in the competition against Ultracet with even more powerful pain-relieving effect.”
- Company
- Jina Lee at Bayer stepped up as CEO of Thai Corporation
- by Eo, Yun-Ho Mar 24, 2020 05:20am
- 이진아 총괄Jina Lee, Health BU Head at Bayer, will be represented as the CEO of Thai corporation. Bayer Korea recently announced in its internal announcement that Jina Lee will be appointed as the CDH (Country Division Head) of the Thai Pharmaceutical Division. However, due to the aftermath of COVID-19, the exact departure schedule and the like have not been confirmed. Jina Lee, graduated from the Department of Pharmacy at Duksung Women's University, joined Merck Sereno in 2006 after joining Roche Korea in 1994 and joined Bayer in 2013 as Heart Health BU Head at Bayer. In 2018, she dispatched to Germany's head office marketing department, gained her experience, and returned to a Korean corporation in February last year. From October of last year, she was also a temporary representative for the pharmaceutical business division of a Korean corporation because former Ingrid Drexel was announced as a Turkish corporation. The Korean subsidiary later appointed the new CEO Freda Ta-Ling Lin in December of last year. Meanwhile, Bayer is divided into subsidiaries in the fields of medicine, chemical, and animal medicine such as healthcare, crop science, and material science. After joining Bayer, Jina Lee is said to be leading the cardiovascular business unit, and it is considered to be the leader of the growth of Xarelto (Rivaroxaban).
