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- 2026-05-16 03:41:27
- Policy
- Discussions on the benefits of migraine txs begin in earnest
- by Lee, Tak-Sun May 16, 2022 06:14am
- Emgality that passed the Drug Reimbursment Evaluation Committee on the 12thAs Lilly Korea's Emgality passed the HIRA's Drug Reimbursment Evaluation Committee, discussions on the benefit of the migraine txs are rapidly progressing. Following Emgality, Handok Teva's Ajovy, the same (CGRP) target treatment, is also seeking to enter the benefit. Reyvow of Ildong Pharmaceutical, which was approved in Korea on the 12th, is also speeding up the payment process through the approval-benefit evaluation linkage system. On the 12th, the Drug Reimbursment Evaluation Committee of the HIRA held the fifth meeting in 2022 and judged that Lilly's Emgality was eligible for the benefit. Accordingly, Emgality will enter the stage of drug price negotiations with the NHIS. Emgality is currently licensed for three products in Korea. In September 2019, Emgality 120 mg/ml PFS and Emgality 120 mg/ml PFS Pen, and Emgality 100 mg/ml PFS were licensed in May 2020. The product that passed the Reimbursment Evaluation Committee this time was Emgality 120mg/ml PFS, which was recognized as a migraine prevention drug in adults. Triptan-based painkillers are used as migraine treatments, but side effects such as vascular over-contraction are often pointed out. Recently, new drugs for migraine are attracting attention as their effects have improved as they overcome the side effects of existing drugs. A representative drug is an antibody new drug that directly targets CGRP receptors. Emgality and Teva's Ajovy are typical CGRP drugs. Emgality submitted in March last year and passed the Reimbursment Evaluation Committee more than a year ago. Ajovy also reportedly submitted in January. A new oral tx has also emerged. It is Reyvow, which acquired domestic copyrights by Ildong Pharmaceutical. It was originally confirmed to be introduced in Korea in 2013 when Ildong signed a development partnership and domestic sales license agreement with CoLucid Pharmaceuticals, a developer. Since then, Eli Lilly acquired CoLucid Pharmaceuticals in 2017, and in 2019, it has also obtained US FDA approval under the name Reyvow. Ildong then began testing bridges for domestic sales permits and submitted an application for permits immediately after the end of last year. Recently, the drug is known to be undergoing a review at the same time as permission. Accordingly, Emgality's benefit is expected to be the standard for other migraine new drugs. For now, Emgality is also expected to negotiate with the industrial complex. Teva is also expected to establish a benefit strategy while looking at the results of Emgality's negotiations. The domestic migraine treatment market is smaller than that of patients. The annual prescription amount of tryptan-based drugs remains at 15.5 billion won based on UBIST in 2020. However, the prevalence of migraine in Korea is not small at around 6%. According to the HIRA statistics in 2020, 550,000 patients visited the hospital for migraine and received treatment, but about 2 million patients have not visited hospitals. Therefore, pharmaceutical companies expect that the market size will be much larger than it is now if the migraine tx, which has been upgraded from the existing drug, is reimbursed.
- Company
- Servier launches supply of new acute leukemia drug Oncaspar
- by Eo, Yun-Ho May 16, 2022 06:14am
- Servier Korea began supplying Oncaspar Lyophilized Inj, a combination treatment for "acute lymphocytic leukemia (ALL)" from the 10th. It was supplied through the rare drug center, but the license holder, Servier, was in charge of the supply, and insurance benefits have not yet been registered. Servier Korea is undergoing prescription procedures at major general hospitals to ensure that Rx for Oncaspar can continue smoothly as supplies to rare drug centers are exhausted. Acute Lymphoblastic Leukemia (ALL) treatment was approved by the MFDS as a rare specialty drug in February last year as a combination therapy with other anti-tumor drugs. Oncaspar is a drug that maximizes the half-life of drug circulation through PEGylation, dramatically reducing the frequency of administration to be administered once every 14 days compared to L-Asparaginease, which was previously administered once every other day. Considering that ALL has a high incidence rate, especially in pediatric patients, the improved method is expected to reduce the injection burden, physical pain, and hypersensitivity reactions of pediatric patients and patient guardians suffering from frequent anticancer injections. It is expected to have a positive effect on medical costs such as hospital visits or hospitalization for injection treatment. Oncaspar, which was first approved as a secondary treatment for ALL in the United States and Germany in 1994, was recognized as a primary treatment for ALL in the United States in 2006. Since birth in Europe in 2016, it has been approved as a combination therapy with other anticancer drugs in 18-year-old children and adult ALL patients. Oncaspar is primarily recommended in major international guidelines and treatment protocols such as NCCN and ESMO and Children's oncology group (COG) as a treatment for acute lymphocytic leukemia and is used in 62 countries. Servier Korea CEO, Melanie Loresry said, "We are happy to supply Oncaspar, an innovative treatment option, to patients suffering from ALL and hematologic oncologists. "This release reveals Servier's hope to better treat rare cancer and lead tumor treatment," he said.
- Company
- Huons' local anesthetics export contract with FPI Canada
- by Kim, Jin-Gu May 16, 2022 06:14am
- CEO Yoon Sang-bae (left) and CEO FPI Lee Mangubat are taking a commemorative photo after holding a contract ceremony to export local anesthetics to Canada at the Pangyo headquarters in Seongnam, Huons on the 12thHuons announced on the 13th that it has signed an export contract with Canadian pharmaceutical company Formative Pharma Inc (FPI). Items signed an export contract are▲1% Lidocaine hydrochloride injection 5mL, ▲ 0.75% Bupivacaine hydrochloride injection 2ml, and ▲ 1% lidocaine hydrochloride injection 5mL vial. These items were obtained from April 2018 to May 2020 by the U.S. Food and Drug Administration (FDA). Huons plans to work with FPI to obtain permission from Health Canada. It is expected that it will be able to complete the license application by June and start local sales within the third quarter of next year. "The Canadian generic basic injection market is worth $712 million, of which Huons enters the aseptic injection market of $21 million to $25 million," said Lee Mangubat, CEO of FPI. "There are many opportunities as large pharmaceutical companies are suffering from continuous shortfalls due to financial difficulties." An official from Huons said, "If we enter Canada following the U.S., our position in the North American injection market will be stronger." "With this contract, we plan to discuss expanding items with FPI to target the Canadian generic aseptic injection market," he said. FPI is a pharmaceutical import company established in Ontario, Canada in 2018.
- Policy
- Daewoong’s P-CAB drug Fexclu receives conditional approval
- by Lee, Tak-Sun May 16, 2022 06:14am
- Daewoong Pharmaceutical’s P-CAB class gastroesophageal reflux disease (GERD) treatment ‘Fexclu’ has received conditional approval from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee. The committee decided reimbursement was appropriate for the drugs if the company accepts a price below the appraised amount. Accordingly, their reimbursement will be determined in the drug price negotiations with NHIS that will follow. The NHIS announced that it held the 5th 2022 Drug Reimbursement Evaluation Committee (DREC) meeting on the 12th to deliberate on the adequacy of providing insurance benefits to 4 drugs including Fexclu. The 4 drugs that were deliberated were fexuprazan hydrochloride products including Fexclu Tab. 40mg, etc that Daewoong’s subsidiaries Daewoong Pharmaceutical, Daewoong Bio, Hanall Biopharma, iN Therapeutics received approval for. DREC determined that reimbursement was appropriate if the companies accept a price below the appraised amount for the treatment of erosive gastroesophageal reflux disease (GERD). In other words, the company needs to accept the appraised price to receive reimbursement. The decision will now depend on the NHIS negotiations that will follow. The reimbursement process will progress rapidly if Daewoong and the other pharmaceutical companies accept the appraised price, but be difficult otherwise. The Donerion/Donesive patch (donepezil) developed by Celltrion·Icure also received conditional approval from DREC. The drug is the first patch to be developed using donepezil, the ingredient most widely used for the treatment of Alzheimer's-type dementia. As in the case of fexuprazan, DREC determined that reimbursement for donepezil was appropriate if the companies accept a price below the appraised amount for the treatment of Alzheimer's-type dementia symptoms. On the other hand, new drugs developed by multinational pharmaceutical companies were determined appropriate for reimbursement without any condition, and their progress to reimbursement is expected to proceed more quickly. Novartis Korea’s SMA treatment ‘Zolgensma (onasemnogene abeparvovec-xioi)’ and Lilly Korea’s migraine prophylaxis drug ‘Emgality (galcanezumab)’ were recognized as appropriate for reimbursement. In the case of Zolgensma, the drug was approved appropriate for reimbursement in patients with SMA with a bi-allelic mutation in the SMN1 gene under the condition that the drug receives prior approval for medical care benefits and is applied the patient-unit performance-based RSA and an expenditure cap. Emgality was determined appropriate for reimbursement as a preventive treatment of migraine in adult patients.
- Company
- The introduction of Biogen Aduhelm in Korea is also unclear
- by May 16, 2022 06:13am
- Biogen has decided to minimize the commercialization infrastructure of the Alzheimer's drug Aduhelm and focus on developing subsequent drugs. In fact, it is unclear whether Aduhelm, which is in the process of eviction, will be introduced in Korea. Biogen announced in its first-quarter earnings announcement on the 3rd (local time) that CEO Michel Vounatsos will resign due to responsibility for Aduhelm. CEO Michel Vounatsos will retire as soon as a successor is decided. At the same time, what attracts attention is the announcement that it will drastically reduce Aduhelm's commercial infrastructure. Biogen said it minimizes all infrastructure for Aduhelm's commercialization. In the previously announced $500 million annual cost reduction plan, it will save an additional $500 million. In fact, it is interpreted as a decision to give up the commercialization of Aduhelm. Biogen's move to give up Aduhelm is pointed out as the decisive background for the rise to the surface of the water, which is the restriction on the application of Aduhelm insurance by Medicare, a U.S. public health insurance. CMS in the U.S. made a final decision last month to apply insurance benefits only to patients who participated in clinical trials of Aduhelm. CEO Michel Vounatsos said in a performance announcement, "This decision is very disappointing as it virtually rejects Aduhelm from all Medicare subscribers." "As a result, Biogen will substantially eliminate commercial infrastructure for Aduhelm," he said. Aduhelm is also increasing the financial burden on the company. Biogen said it was negatively affected by $275 million in inventory amortization costs for Aduhelm and $45 million in idle capacity costs in the first quarter. Instead, Biogen plans to accelerate the development of follow-up drugs. The subsequent drug is another new Alzheimer's drug, Lecanemab. It is being developed jointly with Eisai and Biogen plans to begin the process for Lecanemab's acceleration approval this year. The pharmaceutical bio industry interprets that Biogen's decision has also made it unclear about the commercialization of Aduhelm in Korea. Biogen had already voluntarily withdrawn Aduhelm's application for European permission in April. After the EMA refused to approve Aduhelm in December last year, it reapplied for approval, but soon voluntarily decided to withdraw it. Biogen applied for Aduhelm from the MFDS in July last year. It is predicted that the MFDS, which has currently started the screening for Aduhelm, has possibilities to refuse the permission by referring to EMA's decision. However, Biogen expressed its original position, saying that it has not changed its domestic commercialization plan. An official from Biogen said, "We confirmed the decision of the global headquarters through the article, and there were no guidelines for commercialization in Korea."
- Company
- Wet AMD tx new option to shorten Eyelea's minimum cycle
- by May 16, 2022 06:13am
- Bayer's macular degeneration treatment Eyelea took the lead in establishing an optimized treatment strategy for patients by shortening the minimum treatment cycle. It is evaluated that a new option was presented in macular degeneration treatment that determines the treatment cycle according to the patient's condition. According to the pharmaceutical industry on the 6th, Eylea's minimum administration interval has recently been shortened from 8 weeks to 4 weeks. Accordingly, medical staff can increase the treatment interval from at least 4 weeks to up to 16 weeks through monitoring after injection once a month for the first three months of treatment with Eyelea. As T&E therapy is widely used in macular degeneration treatment, the medical staff believes that there is room for reducing the minimum dose interval to address the unmet demand. T&E therapy is a method of monitoring patients after initial three-month treatment and adjusting the treatment interval. It is a widely used treatment method around the world by overcoming the shortcomings of the post-treatment method, such as PRN therapy, which is more efficient than fixed treatment cycles and continues treatment when symptoms worsen. Dailypharm listened to the meaning of changing minimum administration cycle of Eyelea through Director Jang Woo-hyuk. Director Jang served as a clinical doctor at the Wills Eye Institute at Thomas Jefferson University in Philadelphia and a professor at the ophthalmology department at Yeungnam University University. Director Jang Woo-hyuk Macular degeneration begins with dryness and progresses into habit. Dry macular degeneration is a stage in which only wastes accumulate in the retina. When waste accumulates and oxygen permeation becomes difficult, new blood vessels are created to forcibly supply oxygen. In the process, abnormal neoplasms bleed and exudates leak out. This stage is wet macular degeneration. Failure to receive proper treatment can lead to blindness. The number of patients with habitual macular degeneration is also rapidly increasing due to rapid aging. Director Jang said, "There are overwhelmingly many elderly patients in the clinical field. This is because aging is the biggest cause of wet macular degeneration. Environmentally Westernized eating habits and the increase in adult diseases are also affecting it, he explained. The most important goal of treating wet macular degeneration is to preserve vision that can maintain the quality of life. Therefore, it can be seen that the core of the treatment is to restore vision as much as possible with initial active treatment and then maintain vision at least with damage. The drug mainly used for treatment is an anti-VEGF injection. Representative treatments include Eylea and Lucentis, and recently Beovu has also emerged as new treatment options. The medical staff determines the drug according to the patient's condition because the medication cycle varies slightly from drug to drug. According to IQVIA, a pharmaceutical market research firm, Eyelea is the treatment that generates the most sales in Korea, recording sales of 70.5 billion won last year. In response to the recent reduction in the minimum administration interval for Eyelea to four weeks, Director Jang said, "There was clearly a need for injections at clinical sites at shorter intervals than eight weeks. Even after injection treatment every eight weeks, there are no signs of deterioration, no improvement, or persistent exudation causes vision to gradually decrease," he said. "In the past, in this case, we had no choice but to use off-label drugs or increase the dose, but even this was not very effective. The reduction of the minimum administration interval of Eylea to four weeks is a very welcome change," he said. Reducing the administration interval to 4 weeks mainly occurs in long-term treatment. This is because the drug's effectiveness decreases even if it is injected every eight weeks because of long treatment. "There are few patients who need to be treated every four weeks from the beginning. If resistance develops or the effectiveness of the drug decreases after a year or two of treatment, we will consider shortening the interval," he added. In order to perform only four-week intervals, anatomical examinations must show clear deterioration. There are still ambiguous situations where it is difficult to boldly apply the four-week interval. Director Jang explained, "This is the case when it continues to not deteriorate when it is done every eight weeks, or when there are findings of exudation in monitoring, it is better than eight weeks ago." He said, "At this time, medical staff tend to worry about reducing the interval to four weeks and then reducing the benefit. Since the four-week interval has not been long since it was applied, it is difficult to reduce it to four weeks unless there are clear deterioration findings," he said. Patients with good treatment effects are treated by widening the interval to a maximum of 16 weeks. According to Director Jang, about 20 to 30% of all patients show good treatment results, extending it to 16 weeks. "The longer the injection period is, the more patients are satisfied. There may be anxiety about watching without treatment for four months, but experience has shown that the symptoms rarely worsen severely among patients who have extended it to 16 weeks. If there is any recurrence, the interval will be reduced by two weeks again, he said.
- Company
- Bio Clusters gather to compete at BIO Korea 2022
- by Kim, Jin-Gu May 13, 2022 05:46am
- Major Bio Clusters of local governments have gathered in one place. Major Bio Clusters of local governments including Osong, Incheon, Hongneung, Gimhae, Wonju, and Daejeon municipalities as well as the event’s co-host Chungcheongbuk-do are in heated competition to promote their cluster in the ‘BIO KOREA 2022’ event that is being held from May 11th to the 13th at Coex Seoul to promote their region. At the event, the clusters are working hard to attract companies and investments by distributing handouts to participants and introducing the features of each bio cluster to corporate officials. ◆ Chungcheongbuk-do Bio Valley = Chungcheongbuk is promoting 5 Bio Valleys in its province. The five Valleys are ‘Osong Bio Valley,’ which has the Osong High-Tech Medical Complex, the ‘Chungju Bio Valley,’ which is scheduled to be completed by 2027, ‘Jecheon Oriental Medicine Bio Valley,’ ‘Okcheon Medical Device Valley’, and ‘Goesan Organic Bio Valley.’ The Chungcheongbuk-do province had released a blueprint to attract 1,600 bio-companies in its 5 Bio Valleys by 2030. The region has attracted 422 companies up to now. Through the recruited companies, the region aims to increase production from the current ₩ 1.8 trillion to ₩7 trillion and human resource training from 3,050 to 50,000. In particular, the province has been introducing corporate support incentives in detail at the exhibition hall. Up to 24% of facility investment made by the companies will be supported by the province. Also, a ₩500,000 subsidy for employment and education & training will be provided per month for all individuals for one year, and ₩2 million per month for one year if the company hires researchers. The province also emphasized its tax reduction benefits. In the case of the national tax, the corporate tax on capital gains is deferred for 5 years, then can be paid out in installments in the following 3 years. Corporate tax is reduced by 100% for 7 years and 50% for 3 years thereafter. Chungbuk will be also reducing the local acquisition tax and property tax by 75% each for 5 years. ◆ Osong High-Tech Medical Complex = The Osong Medical Innovation Foundation prepared a separate exhibition hall from Chungbuk to promote its Bio Cluster. Osong emphasized that it can provide full-cycle support for new drug R&D. By full cycle, the complex provides support from basic research to the derivation of candidate materials, clinical trials, permission, and production through its New Drug Development Support Center, Non-Clinical Support Center, Advanced Medical Device Development Support Center, Laboratory Animal Center, Biopharmaceutical Manufacturing Center (GMP), and Korea Bio Human Resources Development Center. Also, officials added that further support will be provided through the Advanced Clinical Trial Center which is scheduled to open this year, and the Innovation Startup Technology Commercialization Center, which is scheduled to open in 2024. In addition, the complex is close to the Osong Health Technology Administration Town where the ▲Ministry of Food and Drug Safety, ▲ National Institute of Food and Drug Safety Evaluation, ▲Korea Disease Control and Prevention Agency ▲National Institute of Health reside and have great accessibility to national and public research institutes such as the ▲National Biobank of Korea, ▲ National Center for Stem Cell and Regenerative Medicine Research, ▲ National Center for Medical Information and Knowledge, and the ▲Korean Vaccine Research and Development Center for Public Vaccines. In addition, the complex also actively promoted its Osong Bio Industrial Complex and Osong Cosmetics Industrial Complex which are scheduled to be sold in 2023, and the Osong 3rd Life Science Complex which is scheduled to be sold in 2025. ◆Incheon Technopark = Incheon Technopark, where Celltrion·Samsung Biologics reside, also introduced its various business support services. The supports provided by the Incheon Technopark include support for bio equipment use support, bio-health care product development, bioproduct effectiveness evaluation, biopharmaceutical raw material commercialization, etc. The support for bio equipment includes the use of 80 or more equipment including HPLC, GC-FID, MALDI-TOF, etc. at an inexpensive price at the joint laboratory. Companies that move into the Bio Cluster will receive a 20% discount on equipment usage. As efficacy assessment support, the Bio Cluster will support ₩18 million for non-clinical and clinical drug trials to 3 companies selected among those that have moved into the Incheon Bio Cluster. As startup support, the Incheon Technopark introduced the establishment of a K-Bio Health regional center, the Incheon Startup Park support project, the creation and operation of the Incheon start-up fund, and support for the Bio Cluster establishment. ◆Seoul Biohub= The city of Seoul also promoted its Seoul Biohub, located in Hongneung-dong, Seoul. Seoul Biohub first made a kick-off in 2017 with the opening of the Industrial Support Building. In 2019, the city added a research laboratory building, and an open region building, and in 2020, the Seoul Bio-Innovation Community Center and Industry-University Cooperation Center were opened. Last year, the BT-IT Convergence Center was opened to expand the bio-startup ecosystem. The Seoul Biohub is concentrating on attracting bio startups. The companies will be able to move into the biohub in 2 years and are provided opportunities to pursue joint challenges with global bio companies such as Johnson&Johnson, Novartis, and MSD. In particular, the companies may receive policy support for new technology demonstration and tax reduction as the region was designated as a special Innotown in 2020. ◆ Gimhae Biomedical Industry Promotion Agency = The Gyeongnam Gimhae city plans to establish a biomedical industry complex that specializes in the manufacture of medical devices by 2025 around the Biomedical Center it established in 2008. In addition, the city aims to bring in technologies such as AI-based image reading, bio-functional materials, and 3D bioprinting. Companies that move into the complex will receive various development support including those for patents, certification, and design development as well as marketing support such as for participation in domestic and foreign exhibitions. The city plans to discover R&D projects jointly with local medical institutions such as the Inje Paik Hospital and Pusan National University Yangsan Hospital, and provide clinical trial support.
- Policy
- MOHW holds a launching meeting of the pharmaceutical team
- by Kim, Jung-Ju May 13, 2022 05:46am
- The MOHW (Minister Kwon Deok-cheol) announced at 3 p.m. on the 12th that it will hold a launching meeting of the mid- to long-term strategic planning team for the pharmaceutical industry to establish the "third comprehensive plan for fostering and supporting the pharmaceutical industry." The government shall prepare a five-year comprehensive plan to promote the creation of a foundation for the development of the pharmaceutical industry and strengthening international competitiveness. The comprehensive plan to be established this time is the third plan since the implementation of the system in 2012, and will present a mid- to long-term vision of the pharmaceutical and bio industry promotion policy for the next five years from 2023 to 2027. The MOHW formed a strategic planning team including industry and academic experts (Lee Hyung-hoon, director of health and industry policy at the MOHW, and Lee Byung-gun, chairman of the Korea Sponsor Board of the International Vaccine Research Institute). The strategic planning team will be appointed as a sub-division of each industry (4) and strategy (4) to discuss the basic direction (vision, goal, strategy) of the comprehensive plan and comprehensively review the detailed implementation tasks discussed in each department. At the launching meeting, the results of the second comprehensive plan (2018-2022) were shared, and the strategic planning team and the division's operation plan were discussed. The main achievements of the second comprehensive plan were the expansion of R&D investments by the government and the private sector to promote new drug development, including the Ministry of Health, Science and Technology, Information and Communication, and Trade. To establish the third comprehensive plan, the strategic planning team will hold a meeting at least once a month, and it plans to first operate the industry division in May to June to find tasks for each field, and then prepare detailed action plans in each strategy division. The government plans to operate a strategic planning team (including the division) by the end of this year and announce the third comprehensive plan around December this year after deliberation by the Pharmaceutical Industry Promotion and Support Committee (Chairman, Minister of Health and Welfare). Lee Hyung-hoon, director of the Health and Industry Policy Bureau, said, "The year 2022 when the third comprehensive plan is established is an appropriate time to create a bio-health innovation ecosystem beyond the turning point of COVID-19 and to discuss mid- to long-term directions for Korea to become a pharmaceutical and bio powerhouse." He said, "As this comprehensive plan has been open to various opinions from academia and industry since the beginning of its establishment, industries and research circles will actively participate to express their outlook and opinions, and the planning team will prepare policy tasks and deliberate by the committee."
- Policy
- Vaccine consultative body launched
- by Kim, Jung-Ju May 13, 2022 05:45am
- Representative vaccine companies in Korea will launch a "Vaccine consultative body" to establish vaccine sovereignty and enhance international competitiveness, and actively cooperate with the aim of strengthening R&D capabilities in the industry and promoting vaccine commercialization. The MOHW (Minister Kwon Deok-cheol) and the Vaccine Practicalization Technology Development Project Group (Director Sung Baek-rin, professor of Yonsei University Medical School) held the launch ceremony of the Vaccine Practicalization Council at COEX at 3 p.m. today (12th). This reflects the need to secure vaccine sovereignty triggered by COVID-19, and companies have agreed to achieve self-sufficiency of essential vaccination vaccines as well as responding to the global pandemic (pandemic) of future infectious diseases. The consultative body will participate in 14 representative vaccine companies participating in research and development projects supported by the vaccine commercialization technology development project group, and support the overall operation as an executive agency. Participating companies are GC Pharma, LG Chem, SK Bioscience, EyeGene, Boryung Biopharma,HK inno.N, EuBiologics, InThera, Genexine, GeneMatrix, Geneone, Cha Vaccine Research Institute, QuadMedicine, and Quratis. The council is divided into two vaccine divisions: self-sufficiency of essential vaccinations, future response, and unresolved, and plans to seek alternatives and promote vaccine commercialization through follow-up research and discovery of new research needs. At the launch ceremony, the participating companies adopted a joint cooperation declaration to the effect of "cooperation to protect public health, establish vaccine sovereignty, and enhance international competitiveness as Korea's representative vaccine companies." Companies declared that they would strengthen their R&D capabilities, promote the commercialization of domestic vaccines, and actively cooperate with the government to come up with countermeasures in the event of an infectious disease-related national health crisis. Sung Baek-rin, head of the Vaccine Practicalization Technology Development Project, said in his opening speech, "The Vaccine Practicalization Technology Development Project is a large project involving domestic industry, academia, research, and disease experts, and it will be an opportunity to develop their research capabilities and draw collective intelligence." Park Geum-ryul, a leading medical support officer at the MOHW, said in a congratulatory speech, "We strongly sympathize with the purpose of the launch of the consultative body, and we hope that active exchanges and discussions will take place as it is launched with the full support and participation of representative companies in the future."
- Company
- Lumakras is a new opportunity for lung cancer patients
- by May 13, 2022 05:45am
- "Lumakras is the first-in-class and best-in-class for patients with KRAS G12C mutated non-small cell lung cancer who failed existing treatment. The reliability of drugs has also increased over the past two years with long-term data, and it is expected that they may be used in combination with other drugs such as immuno-cancer drugs in the future." Kim Hye-ryeon, a professor of oncology at Yonsei Cancer Hospital, expressed the meaning of the launch of the new cancer drug Lumakras. Lumakras is the first and only KRAS targeted anticancer drug that was approved by the MFDS in February. It targets non-small cell lung cancer KRAS G12C mutations. KRAS gene mutation is common in non-small cell lung cancer. In Asia, EGFR mutations are the second most common. Although the KRAS tumor gene was already discovered 40 years ago, it remained a homework that could not be solved for a long time due to molecular biological characteristics and drug toxicity. Amgen succeeded in commercializing it with FDA approval three and a half years after first discovering the Lumaras candidate material in November 2017. Lumakras binds to a P2 pocket near KRAS G12C Switch II to immobilize the mutant protein in an inactive state. By selectively blocking tumor-causing signals, only cancer cell growth can be prevented without affecting the KRAS normal gene. Professor Kim said in a meeting with Dailypharm, "The prognosis of patients for KRAS mutated non-small cell lung cancer has not been good because there is no targeted treatment. KRAS mutated non-small cell lung cancer is closely related to smoking, and nine out of 10 people have previously smoked or are currently smoking, so the high tumor heterogeneity is also considered a cause of poor prognosis, he said. "The launch of Lumakras is significant in that it has met the medical demand for lung cancer treatment." Since KRAS mutations generally do not overlap with other gene mutations with targeted treatments such as EGFR and ALK, chemotherapy was the only drug that patients could use. Fortunately, immuno-cancer drugs that can be used by patients without EGFR and ALK mutations have recently emerged, but the regret remains that there are no targeted treatments. This is because drugs that have a definite response and guarantee effectiveness are rare as targeted treatments that target specific gene mutations. Professor Kim said, "It is a retrospective study, but there are reports that the survival rate of patients has increased after targeted treatment in lung cancer treatment. Given the experience of prescribing other gene mutations, I think it is basic to use the treatment first." Amgen recently released long-term Lumakras data for two years, increasing reliability. This is the result of follow-up observation of 174 patients who participated in the Phase 1/2 CodeBreaK100 study, which was the basis for permission, for two years. It is the longest-running follow-up observation among targeted treatments for non-small cell lung cancer of KRAS G12C mutation. In this study, Lumakras confirmed long-term efficacy and safety. The ORR including CR and PR in the Lumakras administration group was 40.7%, and the reaction duration mDOR was 12.3 months. In addition, DCR 83.7%, mPFS 6.3 months, and OS 12.5 months were found. At the time of two years of treatment, 32.5% of all patients were alive. For two years of treatment, there were no reports of new adverse reactions that had not existed before. Regarding the two-year long-term data, Professor Kim said, "From the perspective of medical staff, 'long-term data' means really reliable," adding, "There are treatments that usually show good results in the first half of the phase, but Lumakras showed better response rates in the two-year long-term follow-up." In particular, considering that they are patients who have failed existing treatments, I think they are clinically valuable." The release of Lumakras has also changed the diagnosis of lung cancer. Professor Kim said, "When diagnosed with non-small cell lung cancer adenocarcinoma, this hospital based on five tests, including PD-L1, an indicator of immuno-cancer drugs, along with representative lung cancer genetic mutations such as EGFR, ALK, BRAF, and ROS1. With the emergence of treatments targeting minority mutations, including KRAS targeted treatments, we will now conduct additional NGS (next-generation gene sequencing) tests that can check other gene mutations together if all four previous gene mutations are confirmed negative, she explained. Professor Kim highly predicted the possibility of expanding Lumakras in the future. This is because immuno-cancer drugs and good synergy are expected. She said, "There have been no cases in which targeted treatments and immuno-cancer drugs have been approved for other gene mutations such as EGFR and ALK. This is because the treatment effect was not significant and the drug toxicity was strong. However, the KRAS mutation showed good results in the target + immunotherapy in the in vivo test. It is speculated that the high association with smoking may be affected, he said. "The response rate is also high when treating immuno-cancer drugs, so clinical trials related to targeted + immuno-combination therapy are actively being conducted."
