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- 2026-05-13 22:01:06
- InterView
- “AstraZeneca’s sincerity in oncology drives cont. growth"
- by Eo, Yun-Ho Oct 17, 2022 06:03am
- AstraZeneca is known for its ‘sincere attitude’ towards R&D. Not only is the company in the top ranks in terms of its investment amount, but it has also always been at the forefront in terms of R&D-to-Total-revenue ratio as well. In 2021, AstraZeneca’s R&D-to-Total-revenue ratio stood at 26%, the highest in the industry. Due to their invested interest, the company is rarely behind in recognizing new drug development trends. More often, AstraZeneca has led the trend, releasing first-in-class drugs. AstraZeneca developed the antidiabetic SGLT-2 inhibitor ‘Forxiga,’ a drug that has recently been receiving attention for demonstrating cardiovascular benefit, and the oral antiplatelet ‘Brilinta,’ the only contender of Plavix (clopidogrel). Also, 'Crestor (rosuvastatin)’ which had threatened the sales of ‘Lipitor (atorvastatin),’ and the ICS/LABA combination ‘Symbicort’ are also some of AstraZeneca’s well-known products. Building on this solid foundation, AstraZeneca is now busy reinforcing its Oncology pipeline. In addition to the third-generation epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) ‘Tagrisso (osimertinib),’ the company has added the PD-L1 inhibiting immuno-oncology drug ‘Imfinzi (durvalumab)’ to its portfolio. In other words, the company's oncology pipeline is no longer represented by its first-generation EGFR TKI “Iressa (gefitinib).” Dailypharm met with Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca to hear about the company’s oncology drug development. Trained as a clinical oncologist and Ph.D., EVP Galbraith has been leading Oncology R&D at the company for the past 12 years. -Which product were you most deeply involved in developing? I would have to say that I am most fond of Tagrisso. AstraZeneca aspires to become a leader in Oncology. When I joined the company, hormonal treatments such as Faslodex, as well as Iressa were already developed, and Tagrisso was in the development stage. My first work after joining AstraZeneca was to organize the company’s research portfolio. At the time, I suggested that we should focus on products with higher potential rather than products that have less chance of success. This was even before a project name had been coined for the development of Tagrisso, but I believed in the potential of the substance and made the decision to accelerate its development. Many patients who were treated with existing targeted therapies at the time had been developing resistance or intolerance to their treatments. They developed secondary mutations, and the drugs were not binding well in their targeted sites. I saw the potential of Tagrisso in addressing this unmet need. So Tagrisso was first administered to a patient in 2013. The Seoul National University Hospital in Korea also participated in our Phase I clinical trial, and tumor size was reduced in 2 of the 4 patients that were administered Tagrisso at the time. Resistance to existing treatment options -the T790M mutation - is found in around 50% of all EGFR-mutated lung cancer patients. Although we weren’t testing for the T790M mutation at the time, the tumor size reduction in 2 of the 4 patients raised hopes on how the drug targets the T790M mutation and brings therapeutic benefits. I still remember telling the chemist that developed the substance the good news about how promising the substance was. AstraZeneca was able to gain such insight based on solid collaboration with healthcare professionals in Asia. Our collaboration with healthcare professionals in Korea, Japan, and Taiwan greatly contributed to our discovery by helping us secure information on the resistance mechanism in advance. -As you mentioned, AstraZeneca’s oncology pipeline is rising in prominence. The pipeline, which had already existed for a while, seems to be getting stronger. You already own extensive product lines in Respiratory, Cardiovascular, and Endocrinology, does this mean you will be focusing on oncology drugs in the future? That’s not so. Rather than concentrating on either part, we are making efforts to build a balanced portfolio that can cover various treatment areas. Although 40-50% of our R&D budget is being invested in oncology drugs, we also have pipelines in various other treatment areas including Cardiovascular (CV), Renal, Respiratory, Immunology, Vaccines, etc. Oncology drugs do take up much of our interest, but it is not our sole area of interest. We have recently seen reports on how Forxiga, our antidiabetic drug, has significantly improved the risk of cardiovascular death. -It is also impressive that the company collaborated with Asian researchers from early phase trials for Tagrisso. Contrary to how Korea actively attracts Phase III trials, there has been criticism on how global pharmaceutical companies lack investment in early phase trials in Korea. I hope more opportunities will come in the future for Korea to collaborate with AstraZeneca. We are very interested in seeking opportunities in Korea. South Korea has been an innovation hub in developing new drugs for quite a long while and is leading in clinical trials. It is number three in contribution to global oncology clinical trials worldwide. In fact, involvement in the early phase clinical trials is something we have been doing with South Korea for many years and has built on year-on-year. -AstraZeneca’s competitivity has been further reinforced with the addition of the PARP inhibitor Lynparza to the pipeline. On the other hand, your immuno-oncology drug Imfinzi has been showing less impressive performance. Do you believe there is an opportunity for its comeback? We were excited to present data on the first improvement seen in biliary tract cancer for many years with Imfinzi. Biliary tract cancer is quite prevalent in Asia, and the addition of Imfinzi to first-line chemotherapy improved the treatment effect. The Imfinzi combination therapy was approved in the US based on this TOPAZ study, and we look forward to its approval in Japan as well. We also presented data earlier this year for the HIMALAYA study in liver cancer, in which the combination of Imfinzi with ‘Tremelimumab (anti-CTLA4 antibody)’ in a regimen where just one higher dose of Tremelimumab in order to improve the tolerability profile showed an improvement in the long-term survival benefit in liver cancer patients. I hope to hear from the US FDA on an indication based on the HIMALAYA study within the year. In addition, we have also submitted data in the first-line and non-small cell lunger cancer setting for the combination of Imfinzi with Tremelimumab added to chemotherapy.
- Policy
- 780,000 doses of Comirnaty 2 will be national lot released
- by Lee, Hye-Kyung Oct 17, 2022 06:03am
- The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced that the mRNA COVID-19 vaccine imported by Pfizer Pharmaceutical Co. released 780,000 doses of Comirnaty 2 for two weeks on October 14. National lot release refers to a system that comprehensively evaluates the results of tests and testing results for each lot before vaccines are distributed on the market to check the quality once more. The Ministry of Food and Drug Safety thoroughly conducted a national lot release based on scientific evidence, putting safety first. As a result of conducting a test on 780,000 doses of 0.1 mg/mL of Comirny 2 and reviewing the manufacturing and test data of the manufacturer, it was determined that it met the approved quality standards and decided to release the national lot. The Ministry of Food and Drug Safety said it expects COVID-19 to help prevent COVID-19 as the vaccine is national lot released, and it will do its best to ensure a stable supply of quality vaccines by quickly and thoroughly verifying the COVID-19 vaccine.
- Policy
- Hemlibra's benefit speeds up to strengthen accessibility
- by Lee, Jeong-Hwan Oct 17, 2022 06:03am
- Kim Sun-min, director of the HIRA, promised to speed up the Hemophilia treatment Hemlibra benefit screening to strengthen accessibility for patients. On the 13th, Kim Sun-min, director of the HIRA, answered the on-site questioning of Kang Sun-woo, a lawmaker of the Democratic Party of Korea, at the NHIS parliamentary audit. Lawmaker Kang Sun-woo stressed that Hemlibra dramatically increases the quality of life of hemophilia patients and their families compared to other treatments that need to be intravenously administered as a subcutaneous injection. In particular, he stressed the need to expand the current standard for applying for Hemlibra benefits only to hemophiliac antibody holders to those who do not have antibodies. Director Kim Sun-min replied that she would speed up the ongoing screening of expanding Hemlibra benefits for non-antibody patients. Director Kim said, "I express my deep regret for the pain of hemophilia patients and their families."Director Kim said, "We are reviewing the clinical usefulness, safety, and cost-effectiveness of Hemlibra's expansion of non-antibody benefits. "We will try to strengthen accessibility by speeding up the screening process as much as possible," she said.
- Company
- Pfizer Korea leaves its beloved 15-year Myeongdong office
- by Eo, Yun-Ho Oct 14, 2022 05:53am
- Pfizer Korea will be soon leaving its Pfizer Tower in Myeongdong where it had resided for 15 years. The company will relocate to the nearby Namsan State Tower later this month. In other words, the company’s lease contract for the Myeongdong Pfizer Tower will expire on the 30th. The new office building may be smaller in size, and executive rooms including the one for the CEO will be removed. Also, the smart office format will be expanded in line with the recent trend of multinational pharmaceutical companies' increased telecommuting, etc. The Pfizer Tower, which had been under sale, is now back on the market. GRE Partners, the owner of Pfizer Tower recently suspended the sales process that it had started in May. Although the company had selected JLL Korea as its sales agent and started a bid, the bid price reportedly fell short of the seller's desired amount. A Pfizer official said, “Our new office was designed to be more efficient, modern, and an inspiring workplace for our executives and employees, based on which we expect to provide an environment that can realize our purpose of ‘delivering breakthroughs that change patients’ lives.’” Pfizer had relocated from Gwangjang-dong in Gwangjin-gu, Seoul to the Myeongdong office in June 2007. Before then, in June 2006, the company bought the Myeongdong office at KRW 58 billion. According to real estate agents, the price of Pfizer Korea’s Myeongdong office is estimated to be around KRW 100 billion to 120 billion. This is a profit of over KRW 60 billion generated in 13 years. The sales and relocation of the previous Pfizer office are being made due to the spin-off of Viatris, which was formed through the merger of Patent’s off-patent drug division and Mylan.
- Company
- Xofluza, is aiming for a rebound in sales
- by Oct 14, 2022 05:53am
- As soon as it was released, Xofluza, an unfortunate flu treatment that had little sales due to COVID-19, is seeking to rebound. As the flu pandemic warning has been issued for the first time in three years and the number of flu patients is increasing, Roche will also start selling Xofluza in earnest. ◆ New drug Xofluza for the first time in 20 years Xofluza is the next generation of flu treatment that Roche will succeed inTamiflu. Tamiflu is the only drug for new influenza and is a representative flu treatment for 20 years. Developed as a new mechanism of action in 20 years, Xofluza inhibits polymerase acid endonuclease, which is essential for cloning influenza viruses, preventing the progression from the early stages of virus replication. Xofluza dramatically reduced the number of doses. Unlike Tamiflu, which requires taking twice a day for five days, Xofluza only needs to be taken once within 48 hours of symptoms. In other words, 1 tablet of Xofluza can replace 10 tablets of Tamiflu. Xofluza, which received a lot of attention even before its approval and was approved by the Ministry of Food and Drug Safety in November 2019, had low sales due to the massive outbreak of unexpected COVID-19. As expected, sales of Xofluza had to rise from the 2020-2021 season, there were few opportunities for Xofluza to be used due to the unusually low flu epidemic for two consecutive years. This is because the entire nation is obligated to wear masks and social distancing has been strengthened. According to IQVIA, a pharmaceutical market research firm, Xofluza's quarterly sales were less than 100 million won. In the fourth quarter of 2020, which had the most sales, was only 75 million won. Despite sluggish sales, Xofluza has steadily expanded its indication. In January 2021, an indication of influenza prevention therapy was added. Xofluza can be taken as a preventive measure if in contact with an influenza-infected patient. In addition, in the United States this year, the indication has been expanded so that children aged 5 to 11 can use Xofluza. In Korea, only adolescents or adults aged 12 or older are subject to administration. Based on related research data, the age at which administration can be administered is expected to expand in Korea in the future. ◆Re-examination of Xofluza in the flu pandemic warning Xofluza, which has not been seen for two years due to COVID-19, is expecting a full-fledged increase in sales this year. This is because the flu is expected to be prevalent in the 2022-2023 season. The Korea Centers for Disease Control and Prevention issued a national flu pandemic warning for the first time since the COVID-19 pandemic. From the 4th to the 10th of last month, the proportion of influenza doctors (patients with suspicious symptoms) met the epidemic standard at 5.1 per 1,000 people and issued a pandemic warning earlier than usual. Trends in the proportion of suspected flu patients in the 2022-2023 season (Data: Korea Centers for Disease Control and Prevention) In fact, the number of patients with suspected symptoms per 1,000 outpatients is rapidly increasing. In the last week of September (September 25 to October 1), the number of patients showing suspicious symptoms per 1,000 outpatients was 7.1 per 1,000 patients, up 44.9% from the previous week. In preparation for the increase in the number of flu patients, Roche has also secured enough supplies of Xofluza. The Xofluza effect was demonstrated in phase 3 clinical trials (CAPSTONE-1, CAPSTONE-2, BLOCKSTONE). In a CAPSTONE-1 clinical trial of 1,436 patients aged 12 and over, Xofluza shortened the duration of influenza-related symptoms by more than one day compared to a placebo. It had a slight edge over Tamiflu. Xofluza significantly reduced the time to improve symptoms compared to placebo in high-risk groups aged 65 or older with a high risk of accompanying influenza complications (CAPSTONE-2). Subsequently, as a result of prophylactic administration of Xofluza to family members in contact with influenza-infected patients, the risk of developing influenza was reduced by 90% compared to the placebo (BLOCKSTONE). In order for Xofluza to be widely used like Tamiflu, it must be made. Roche attempted to register Xofluza salary in 2020 but received conditional non-payment at HIRA, the first gateway. The Pharmaceutical Evaluation Committee attached the condition that benefits are possible if the evaluation amount is less than or equal to the evaluation amount. Xofluza is still non-reimbursed as it ran parallel in the drug price negotiation process. It is not expected to be easy to apply for benefits during the 2022-2023 flu season. If Xofluza is prescribed as a non-payment, the price of the drug that the patient has to pay is known to be around 80,000 won to 90,000 won.
- Policy
- Proposal for improvement of omission of PE data submission
- by Lee, Jeong-Hwan Oct 14, 2022 05:53am
- Critics said the HIRA's plan to improve the PE data submission system is actually reducing the scope of application of drugs that can be omitted. It is pointed out that the amendment should be fully reviewed as an amendment to destroy President Yoon Suk Yeol's pledge to expand the coverage of severe and rare diseases. On the 13th, Kang Sun-woo of the Democratic Party of Korea criticized the plan to improve the PE system submitted by the Ministry of Health and Welfare and the HIRA. In August, The HIRA announced a partial amendment to the "Regulations on Evaluation Standards and Procedures, such as whether drugs are eligible for medical care benefits," which calls for shortening the processing period of drugs that can be omitted and expanding drugs that can be used for PE biological drugs. The reason for the revision of the regulations explained by the HIRA is to expand the number of medicines that can be omitted from submitting PE data. Kang argued that contrary to the HIRA explanation, when the amendment is applied, the drugs subject to the PE system will be rather reduced. It is pointed out that the standard for "minority of target patients," which has been one of the conditions for medicines that have been omitted from submitting PE data, will be changed to the basic condition in the revision, reducing the scope of major drugs. "Developed countries such as the U.S. and the EU have 5 and 6.4 patients per 10,000 people, respectively," Kang said. "Korea should also recognize exceptions considering the disease characteristics to expand or flexibly apply the number of PE patients in line with advanced countries." Rep. Kang said, "If the meaningful quality of life improvement is proven in children, it is considered meaningful, but even in this case, the expected number of patients is limited to 200, and drugs that can prove the meaningful quality of life improvement in children are still excluded."
- Policy
- CDDC blindly opposes applying RSA to Tabrecta and Rybrevant
- by Lee, Jeong-Hwan Oct 14, 2022 05:53am
- The National Assembly criticized how the Cancer Disease Deliberation Committee has been undermining the purpose of the Risk-Sharing Agreement system that waives submission of PE evaluation data and disapproved reimbursement of anticancer drugs and rare disease treatments. The committee has not allowed reimbursement of these drugs that have already been granted marketing authorization from the Ministry of Food and Drug Safety for lacking Phase III trial data, although the drugs cannot conduct Phase III trials. On the 13th, Rep. Ki-Yoon Kang of the People Power Party claimed so while referring to the data submitted by the National Health Insurance Service. According to the minutes of the CDDC meeting from 2018-2020, HIRA opposed reimbursing Tabrecta tab., which is used to treat patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. HIRA also rejected reimbursement of Rybrevant, a rare NSCLC treatment present in only 2% of all NSLCL patients with EGFR mutations in Korea. As conducting a placebo-controlled Phase III trial on the small number of end-stage cancer patients that are eligible for the drug was impossible due to ethical reasons, the companies of the two drugs demonstrated the clinical efficacy and safety of their drugs through a single-arm Phase II trial, received MFDS approval, then applied for reimbursement to HIRA after satisfying the RSA requirements. Rep. Kang criticized how the CDDC blindly opposed their reimbursement for being unable to evaluate the drug’s efficacy with only Phase II trials without considering the circumstances. According to Article 6-2 of the ‘Regulations on the Evaluation Standards and Procedures to Determine Eligibility for Reimbursement Benefits,’ the RSA Pharmacoeconomic evaluation exemption regulation was established to reinforce patient access to severe and rare disease treatments, and 2-a of the same clause allows PE exemption for drugs that were approved by the MFDS with single-arm clinical trial data that does not have a control group. Anticancer drugs like Tabrecta or Rybrevant that treat life-threatening conditions have already been recognized for their clinical efficacy by the Ministry of Food and Drug Safety through a single-arm Phase II trial, but it is ethically impossible to set up a control group that consists of severe cancer patients who have less than a year of expected survival period left. This is why there is criticism that the CDDC’s disallowance of reimbursement of these drugs under the pretext of the absence of Phase III clinical trial data undermines the purpose of the PE Waiver System which works to reinforce patients' access to treatments for severe rare diseases. In addition, Rep. Kang also criticized the CDDC's decision for violating the function of the MFDS itself, which evaluates and approves the efficacy and safety of drugs. Rep. Kang said, “The CDDC’s non-allowance of reimbursement of drugs that have no alternatives and cannot conduct Phase III trials completely contradicts the national task of increasing patient access to treatments by rapidly listing drugs that treat life-threatening conditions. CDDC should review reimbursement of anticancer drugs and rare disease treatments that are directly related to the survival of patients in accordance with regulations.” He added, “The CDDC requesting Phase III clinical data for drugs that meet the requirements of the PE exemption system is excessive administration, and the committee needs to focus on reviewing the clinical necessity in line with its original function to allow patients to receive reimbursement as soon as possible.”
- Company
- PARP anticancer drugs raise expectations of ovarian cancer
- by Oct 14, 2022 05:53am
- Lee Taek-sang, professor of obstetrics and gynecology at Boramae Hospital, Seoul Metropolitan Government As benefits are applied to the primary maintenance therapy of PARP inhibitors in ovarian cancer treatment in Korea, the treatment site is rapidly changing. Above all, a specialist evaluates that the use of PARP inhibitors for early treatment has significantly improved the patient's prognosis. However, the expansion of benefits and commercialization of HRd diagnosis in BRCA negative patients are considered tasks to be improved. ◆ Improved prognosis with recurrent ovarian cancer and PARP inhibitors Unlike other solid cancers, ovarian cancer has less remote metastasis and excellent sensitivity to anticancer drugs. Therefore, regardless of the stage of ovarian cancer, surgery and chemotherapy are considered the first-line treatment. However, the initial symptoms were insignificant, so cancer was often diagnosed after progression, and eight out of 10 patients suffered recurrence after the first treatment, making treatment difficult. PARP inhibitors have made new changes in the treatment of ovarian cancer. In the past, in addition to cytotoxic anticancer drugs, vascular endothelial growth factor (VEGF) inhibitors have appeared, but they were far from customized treatments due to specific biomarkers. PARP inhibitors were able to perform customized treatment according to biomarkers such as BRCA and homologous recombination deficiency (HRd). In an interview with Dailypharm, Lee Taek-sang, a professor of obstetrics and gynecology at Boramae Hospital, said, "PARP inhibitors have improved ovarian cancer prognosis and changed the treatment paradigm with survival rate. The PARP inhibitors used in Korea are Takeda's Zejula and AstraZeneca's Lynparza. Recently, PARP inhibitors in the U.S. have withdrawn their indications for the fourth or higher treatment of ovarian cancer, but the impact is expected to be minimal as both drugs are used in early treatment such as primary maintenance therapy. ◆ Same but different Zejula Lynparza Zejula and Lynparza show some differences in primary maintenance therapy. Basically, both drugs are used as maintenance therapy in platinum-sensitive patients, while Zejula can be used regardless of BRCA or HRd, while Lynparza can be used alone in BRCA-positive and in combination with Avastin in HRd-positive patients. Professor Lee said, "Lynparza is also likely to be effective in patients without BRCA or HRd mutations, but there is no indication because it was only for patients with BRCA mutations in the clinical trial on the basis of permission." Zejula added that through large-scale phase 3 clinical trials, consistent data are also available in BRCA-negative and HRp (homologous recombinant negative) patients. Health insurance benefits apply only to BRCA-positive patients on both drugs. In addition, when Lynparza is used as primary maintenance therapy, the benefit is applied only up to two years after initial administration, while Zejula can be used continuously until recurrence. This is because the follow-up period was only up to two years in clinical trials on which Lynparza permits were based. In addition, the two drugs also show differences in the number, dose, and safety profile of the drug. This difference is the standard for selecting drugs in the clinical field. Professor Lee said, "Lynparza is taken twice a day, but Zejula is taken only once a day. In addition, Zejula has data that shows consistent treatment effects even with adaptive doses, he said. "The more worrisome part is the benefit recognition period, and patients taking Lynparza are converted to non-reimursement two years after the benefit is applied," he said. ◆What is the direction of ovarian cancer treatment? The disappointing part of the benefit standard is the BRCA-negative patient. Zejula also demonstrated consistent benefits in BRCA-negative patients but was not recognized for benefit adequacy in the group. Professor Lee said, "It is certain that Zejula is helpful in this patient group, but the patient has to make a difficult decision because the drug has to be used as a non-payment." For HRd biomarkers, improving the diagnostic environment is a priority. Unlike the BRCA test, the HRd test method has not yet been commercialized, so it is limited to some institutions on a trial basis. The cost of the test also amounts to 5 million won. It is judged that more patients will be able to benefit from PARP inhibitors only when an environment where HRd tests can be freely used at the medical site is created. Professor Lee said, "If the results show that PARP inhibitor + Avastin combination therapy is more meaningful, the treatment pattern and paradigm can be changed again. In this case, the drug will be selected in consideration of the side effects and cost problems caused by Avastin, he said. "If the non-inferiority results show that there is no significant difference between the two treatments, it is expected to be a landslide victory for PARP inhibitor alone."
- Company
- The release of a flu vaccine exclusively for the elderly
- by Oct 13, 2022 06:09am
- The development of domestic companies is still far away. In order to prevent influenza (flu) infection in the elderly, a high-performance vaccine with improved preventive effects will appear in Korea. One of the two representative products has been approved in Korea, and the other is likely to be introduced. According to the pharmaceutical industry on the 13th, CSL Seqirus's tetravalent flu vaccine Fluad, which contains immunostimulants for the elderly aged 65 or older, has completed domestic approval and is preparing for its introduction. Due to the schedule, it is difficult to sell in the 2022-2023 season, but it is expected to be released next year during the flu season. Sanofi is also considering introducing a high-dose flu vaccine in Korea for those aged 65 or older. In the United States, it has been sold under the name Fluzone since it was approved in 2019. ◆ Influenza vaccines that have increased effectiveness for the elderly with reduced immunity appear Older people aged 65 or older are considered high-risk groups for flu, so active prevention is recommended with vaccination. Korea provides free flu vaccinations to senior citizens aged 65 or older through NIP. However, with conventional vaccines, the preventive effect tends to be somewhat reduced in the elderly with a reduced immune system. Accordingly, flu vaccine developers have started to develop new vaccines to increase preventive effects. Fluad, developed by CSL Seqirus, can improve the immune response by adding an immune enhancer called MF59. MF59 is an immune enhancer made using squalene ingredients produced in the liver. MF59 induces a cellular immune response to promote antigen absorption by antigen-presenting cells, thereby increasing the immune response through the activation of T cells and B cells. Even with a small amount, it can exert a strong antibody effect. MF59 was also used during the swine flu epidemic in 2009. According to a study by CSL Seqirus comparing the difference in disease burden according to the type of vaccine for senior citizens aged 65 or older in Korea, it is predicted that the burden of flu-related diseases will be significantly reduced when switching from the existing flu vaccine to a vaccine containing immune enhancers. Vaccines containing immunostimulants are expected to prevent 35,390 cases of flu, 1,602 cases of flu-related complications, 709 cases of hospitalization, and 145 cases of deaths per year compared to existing vaccines. Fluzone, developed by Sanofi, is a product that increases the number of antigens, unlike Fluad, which has added immune enhancers. It is known to have four times more antigens than existing doses. It was first approved in the U.S. in 2019 and is considering introducing in Korea. It is predicted that vaccinations with high doses will reduce the burden of diseases similar to vaccines containing immunostimulants. ◆ Vaccination for the elderly being reorganized with high-performance In the United States, flu vaccines for the elderly are changing mainly to high-performance products. This is because the analysis of studies in recent years has proved that high-performance vaccines are more advantageous in reducing the risk of hospitalization and death in the elderly over 65. In terms of safety, side effects such as pain at the injection site were reported more frequently after high-performance vaccination, but they were resolved naturally over time. Based on this, the U.S. ACIP revised its flu vaccination guidelines and recommended that senior citizens aged 65 or older receive a high-dose flu vaccine (Fluzone) or a flu vaccine containing immunostimulants. On top of that, only recombinant vaccines containing three times more antigens than existing vaccines were additionally included in the recommendation list for vaccination for the elderly. When the domestic high-performance flu vaccine market opens, multinational pharmaceutical companies are expected to dominate the market for a while. This is because only one domestic company is developing a high-performance flu vaccine, and even this has been slow to develop. GC Pharma has started developing GC3114, the first high-capacity flu vaccine in Korea. In 2018, the phase 2 clinical trial plan of GC3114 was approved and the clinical trial was completed the following year, but it was found to be in a holding state for three years. It is estimated that it will take more than five years to commercialize it as it has not yet entered phase III and has not set a specific schedule.
- Company
- How about collaboration?
- by Kim, Jin-Gu Oct 13, 2022 06:09am
- 4th largest population in the world, the advantage of clinical performance. Indonesia is emerging as a new market for the Korean pharmaceutical bio industry. In addition to the potential of being the world's fourth-largest population, the pharmaceutical market seems to be expanding rapidly as national income has recently increased overall. In line with this trend, the Indonesian government is strengthening benefits for locally produced drugs. Analysts say that for Korean pharmaceutical bio companies seeking to enter Indonesia, establishing local subsidiaries or collaborating with Indonesian companies will be an effective strategy rather than directly exporting. ◆ Indonesian government emphasizes local production On the 12th, "Global Bio & Pharma Plaza 2022" was held at Lotte Hotel World in Songpa-gu, Seoul, hosted by the Ministry of Trade, Industry and Energy. Dr. Banun attended the "Pharmaceutical Overseas Advancement Strategy Briefing" held together on the same day at the Indonesian Ministry of Health to explain the recent changes in Indonesia's policy to foster the pharmaceutical industry. According to him, the Indonesian Ministry of Health has been planning to foster the pharmaceutical and medical device industries with a 10-year long-term plan since 2016. The key is to encourage the production of medicines, raw materials for medicines, and medical devices in Indonesia. Tinkat Komponen Dalam Negeri (TKDN) was specified, and for raw material drugs, the proportion of domestic production was increased to 65%. Through this, the Indonesian government's goal is to reduce the high dependence on imports of raw materials and drugs. Dr. Banun said, "By 2024, we will make efforts to develop the pharmaceutical industry at the national level." He said, "In particular, we are focusing on the domestic manufacturing and production of medicines. "We will spare no financial support for the domestic production of major drugs," he explained. "Whether it's raw material or finished product, it's giving a lot of benefits to companies that produce medicines in Indonesia," he said. He said, "We are attracting overseas pharmaceutical companies by establishing free economic zones along with special tax cuts. "If Korean pharmaceutical companies collaborate with Indonesia, we expect good results," he stressed. ◆"Daewoong and Chong Kun Dang's cooperation with local companies, best practices for entering Indonesia" Dr. Banun cited Daewoong Pharmaceutical and Chong Kun Dang's entry into Indonesia as an exemplary example. Among Korean pharmaceutical companies, Daewoong Pharmaceutical entered Indonesia in 2012 and Chong Kun Dang in 2015 through joint ventures with local companies. Daewoong Pharmaceutical completed the construction of a pharmaceutical plant in Surabaya in cooperation with local pharmaceutical company Infion. This factory is certified halal for medicine. Currently, it ranks first in the anemia treatment (EPO) market in Indonesia. Chong Kun Dang entered the local market through a joint venture with another local pharmaceutical company, OTTO. In 2018, it completed the first halal-certified anticancer drug plant in Indonesia. Dr. Banun emphasized the "halal certification" received by the two pharmaceutical companies. Halal certification is essential in addition to its own GMP certification to enter Indonesia, he explained. "Daewoong Pharmaceutical and Chong Kun Dang have successfully established themselves as halal-certified pharmaceutical companies," Dr. Banun said. "It is a successful case of cooperation between Korean and Indonesian companies." Dr. Banun said, "In Indonesia, Halal certification is required. If there is a Korean company entering Indonesia, (the Ministry of Health of Indonesia) will help with quick certification, he said. "If we get halal certification here, it will be easy to enter the Middle East or other Southeast Asian countries that need the same certification." ◆ Interested in cooperation with Korean pharmaceutical companies in drug and health product development" In the case of Genexine, a joint venture named Kalbe and KGBIO is being established and developing immuno-cancer drugs GX-17 and new anemia drug GX-E4. "In the case of Indonesia, it has the advantage of conducting clinical trials as the world's fourth-largest population," said the CEO. "In recent years, interest in health products has also been heating up." "We are interested in developing cooperative relationships with Korean pharmaceutical companies that have excellent health products," he said.
