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- 2025-12-25 04:43:00
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- Why MSD raised the price of Gardasil 9 for two years?
- by May 17, 2022 06:02am
- As MSD Korea raised the supply price of Gardasil 9, a cervical cancer vaccine, by 25% in two years, attention is being paid to the background. Some interpret the decision ahead of the application of Gadasil 9's health insurance benefits, which was President Yoon Seok-yeol's pledge, or an alternative to fill the sales gap due to the reduction of Januvia drug prices. According to MSD Korea on the 17th, the supply price of Gardasil 9 will increase by 8.5% from July 1st. This is the first measure in a year and three months following a 15% increase in April last year. The supply price of Gardasil 9, which was 106,300 won (excluding VAT) early last year, rose 15,945 won to 122,245 won in April of that year. With the decision to raise the price further this year, Gardasil 9 will be supplied at 132,636 won starting in July. Various interpretations have been made about the increase in Gardasil 9 for the second consecutive year of MSD in Korea. It then rose 25% in two years as the price was raised again in a year and three months. The average total inoculation cost of Gardasil 9 (three times), calculated as the average inoculation price per session (215,555 won), amounts to 631,665 won. Various interpretations are exchanged over the measure of raising Gardasil 9 for the second consecutive year by MSD Korea. In particular, the backlash was so strong that a national petition against a price hike appeared last year. This is why attention is focused on the background of pushing ahead with another increase in supply prices despite worsening public opinion. President Yoon promised to expand Gardasil 9 insurance when he was a candidate. The vaccines included in the existing National Essential Vaccination (NIP) are Cervarix and Gardasil. The pledge is to support free vaccination of Gardasil 9, which has a wider range of prevention. The scope of support will also be greatly expanded. It encompasses not only women aged 12 to 17, women from low-income families aged 18 to 26, but also women aged 9 to 45 and men aged 9 to 26, who are currently eligible for NIP. As a way for the government to support Gardasil 9, a plan to expand the scope of NIP and include Gardasil 9 or to provide health insurance benefits for Gardasil 9 is cited. Both measures are more likely to fall in price than before through bidding or drug price negotiations. This is the background of the interpretation that the supply price hike is a preemptive measure in preparation for the future reduction of Gardasil 9. It is also interpreted as a countermeasure to fill the sales gap caused by lowering drug prices of other drugs such as Januvia. MSD Korea asked to "trade off" in negotiations with the government to expand the primary benefit of non-small cell lung cancer of Keytruda, a blockbuster immuno-cancer drug. Instead of expanding Keytruda's benefit, it has decided to voluntarily cut drug prices for 15 items, including Januvia Family, which has an outpatient prescription of 171 billion won, from at least 3.2% to up to 77%. The opinion is that price increase of Gardasil 9 is a strategy to fill the sales gap caused by drug price cuts. In response, MSD Korea drew a line, saying, "The price increase of Gardasil 9 is the result of price adequacy evaluation." The company conducts a price adequacy evaluation of medicines at the global level every year, and this increase is only a result of the evaluation and has no other impact. It was also judged that the drug price cut would not hurt overall sales due to Keytruda's rise. The price increase is not limited to Korea, but also applied to other countries that supply Gardasil 9. While Gardasil 9 price hikes have only recently been carried out in Korea, the company also emphasizes that it has increased by an average of 5% every year in the United States. An official from MSD Korea said, "It is difficult to disclose specific evaluation criteria, but the policy of Gardasil 9 price has only changed, and there is no other impact."
- Company
- Prescription of CGRP migraine drugs to begin in earnest?
- by Eo, Yun-Ho May 17, 2022 06:01am
- CGRP-targeted migraine treatments are gaining better access as prescriptions. The first drug introduced is nearing insurance benefit listing and the second drug is landing in general hospitals. According to industry sources, the Calcitonin gene-related peptide (CGRP)-targeted migraine treatment ‘Emgality (galcanezumab)’ has passed deliberations by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 12th. The latecomer ‘Ajovy (fremanezumab)’ also applied for insurance benefits earlier this year but was not set for deliberations in the recent DREC meeting. However still, Ajovy passed the drug committees (DCs) of Seoul Asan Medical Center and Sinchon Severance Hospital. If Emgality successfully receives reimbursement approval, Ajovy’s reimbursement would also be plausible with the pharmaceutical companies’ will. Both drugs are humanized monoclonal antibody drugs that bind to the CGRP ligand that plays a key role in inducing migraine symptoms to inhibit its binding to its receptor. Although the two drugs are of the same class, Severe migraine patients are approaching the drugs with different expectations due to their differences in dosage and administration, etc. Emgality can currently be prescribed in medical institutions nationwide, including the ‘Big 5’ that includes the Seoul National University Hospital and Sinchon Severance Hospital, as well as other institutions nationwide, such as the Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center. Meanwhile, Emgality’s approval was based on results of the EVOLVE-1 and EVOLVE-2 trials which involved 1,773 patients with episodic migraine (at least 4 to 14 migraine headaches days [MHDs] a month) for 6 months, and the REGAIN trial which involved 1,113 patients with chronic migraines (at least 15 headaches days per month with at least 8 MHDs per month) for 3 months. Results of the two trials on episodic migraine patients comparing the changes in MHDs per month over 6 months showed that, compared to baseline (Emgality group 9.2 days, placebo group 9.1 days), Emgality demonstrated efficacy over placebo in treating migraines. In the case of Ajovy, the drug comes in two formulations, one which is administered in a monthly dosage and the other that comes in a quarterly dosage that is administered every 3 months. The drug demonstrated its efficacy at the HALO EM/CM clinical trial that was conducted for 12 weeks on 2,000 episodic migraine (EM) and chronic migraine (CM) patients. In the HALO EM study that was conducted to verify the efficacy and safety of Ajovy in comparison to the placebo, Ajovy met the primary endpoint by significantly reducing the monthly number of migraine days in both the monthly and quarterly dosed groups. WonGu Lee, Professor of Neurology at Kosin University Hospital, said, “Unlike existing preventive treatments that required daily dosage, patients may manage their migraines with once-a-month injection with CGRP-targeted antibody drugs. The treatment cost remains an issue, however, we neurologists have high expectations for these drugs because the condition becomes easier to treat with more targeted therapies.”
- 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.
- 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.
- 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."
- Company
- LG Chem’s partner enters Phase I trial on its immunotherapy
- by Kim, Jin-Gu May 13, 2022 05:45am
- On the 12th, Cue Biopharma, LG Chem’s partner in developing a cancer immunotherapy, announced it had won FDA approval to initiate Phase 1 clinical trials for ‘CUE-102 .’ LG Chem has exclusive rights to develop and market the candidate in 11 Asian countries including Korea, China, and Japan. With the trial approval, Cue Biopharma will assess CUE-102’s safety, tolerability pharmacokinetics, pharmacodynamics, and preliminary efficacy in treating Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers, with an initial focus on gastric, pancreatic, ovarian and colon cancers. CUE-102 is a cancer immunotherapy that selectively engages and modulates targeted T cells that recognize and remove WT-1-positive tumors. Unlike existing T cell treatments that require the patients' T cells to be extracted, modified outside the body (ex vivo), and reinfused, CUE-102 is delivered directly into the patient's body (in vivo), In the preclinical trial, the candidate was found to proliferate and activates T cells that selectively respond to WT-1 positive tumors. CUE-102’s development is expected to accelerate further as the Phase I trial was approved as a dose-escalation trial to begin dosing at 1 mg/kg was supported by the interim safety and tolerability data from a Phase I trial for CUE-101, the first biologic from the CUE-100 series. In the trial for CUE-101, the starting dose was 0.06 mg/kg and required approximately 9 months to dose escalate from 0.06 mg/kg to 1 mg/kg. Based on the Phase I trial data of its partner, LG Chem will be designing the Phase II trial and directly participating in its development in the Asian region. With the trial entry of CUE-102, LG Chem’s anticancer candidate pipeline has increased to 4. In addition to Que Biopharma’s CUE-101·CUE-102, LG Chem also owns Korean Genome&Company’s solid cancer treatment ‘GEN-001' by the and Belgium and Frech PDC*line Pharma’s NSCLC treatment ‘PDC Lung.’ GEN-001 is now in Phase I trials in the US, and PDC lung is in Phase I trials in Europe.
- Company
- K-Cab & Fexuclu are quickly targeting the global market
- by Chon, Seung-Hyun May 12, 2022 06:07am
- New drug products developed by domestic pharmaceutical companies with their own technologies are accelerating their targeting in the global market. However, some point out that it is difficult to predict commercial success because there are many variables such as the situation of the local market even if they have reserved to enter the overseas market. ◆K-Cab Expands to 34 Export Contracting Countries...Maximum contract size of ↑1 trillion won According to the industry on the 11th, HK inno.N signed a contract with Indian pharmaceutical company Dr. Reddy's Laboratories to export new K-Cab for gastroesophageal reflux disease. Seven countries have signed export contracts, including India, South Africa, Russia, Kazakhstan, Uzbekistan, Ukraine and Belarus. With this contract, the number of countries where K-Cab has entered the market in the form of technology exports or finished product exports has increased to 34. HK inno.N signed a technology export contract with Chinese pharmaceutical company Luoxin for K-Cab in 2015. It is a condition to receive $18.5 million in technical fees for each stage according to down payment, clinical development, permission, and commercialization. The company estimated that if royalties from sales occur after local commercialization, the contract will rise to $95.29 million. In February 2019, HK inno.N signed an export contract for K-Cab with Mexican pharmaceutical company Laboratorios Carnot to 17 Latin American countries. It is worth $84 million over 10 years, including the amount of supply of products. Export contracts have become more active since K-Cab was released in Korea. In September 2019, contracts were signed to supply finished drugs to Indonesia, Thailand, and the Philippines, and in 2020, export contracts were signed to Mongolia and Singapore. Last year, it signed export contracts for Vietnam, Malaysia, the U.S., and Canada. The largest export contract of K-Cab is technology exports signed with U.S. company Braintree Laboratories Inc. in February, with a contract size of up to $540 million. The company explained that K-Cab's export contract will exceed KRW 1 trillion. ◆Fexuclu, export contract to 15 countries, maximum Contract Size 1.2 Trillion Among the new drugs developed in Korea, Daewoong Pharmaceutical's Fexuclu is showing the most active entry into the overseas market. Fexuclue is a potassium competitive gastric acid secretion inhibitor (P-CAB)-based gastroesophageal reflux disease treatment drug, which is the same as K-cap. It received domestic permission at the end of last year and is expected to be released in the second half of this year. Through six export contracts, Daewoong Pharmaceutical has booked Fexuclu exports to 15 countries including North America, Latin America, China and the Middle East. Daewoong Pharmaceutical began to enter Latin America in 2020 by handing over the local permission and sales rights of Fexuclu to Mexican pharmaceutical company and Brazilian pharmaceutical company EMS, respectively. In March last year, it signed an export supply contract worth about 384.5 billion won with Shanghai Haini of China. In June last year, it handed over Fexuclu's right to develop, license, and sell in the U.S. and Canada. Under the contract, Daewoong Pharmaceutical secured a 5% stake in Neurogastrx as an upfront fee and was guaranteed up to $430 million in the name of a step-by-step technology fee (milestone) for development, licensing and commercialization stages. Daewoong Pharmaceutical was promised to enter 10 countries in Latin America and the Middle East through two export contracts last year. Daewoong has secured up to 1.2 trillion won through Fexuclu's export contract. ◆ There are many cancellations and returns after the export contract Variables such as changes in the local market environment The industry expects K-Cab and Fexuclu to achieve commercial results in overseas markets. Domestic new drug products have tapped overseas markets in various ways, but have yet to produce successful cases. This is because even if an export contract is signed, the export contract does not guarantee commercial performance due to the nature of taking a considerable amount of time to sell through local licensing procedures. Overseas drug expansion is largely divided into technology transfer and exports of finished drugs. Technology transfer is a structure in which partner companies are in charge of commercializing products that have not yet been developed. Technology transfer is often terminated or rights returned depending on the partner company's intention to develop or the marketability of drugs. The contract for the supply of finished drugs is a structure in which exporters sell products that have succeeded in commercialization abroad. Although it is evaluated that the success rate of contract implementation is relatively high compared to technology transfer, there may be a number of cases that are terminated depending on local circumstances. The export contract between K-Cab and Fexuclu has a large proportion of completed drug supply contracts. It is a structure in which profits are generated only when sales are made through overseas local licensing procedures. In the case of K-Cab, it received Chinese permission last month and is expected to make full-fledged overseas sales are expected. Fexuclu is in the process of licensing items in the Philippines, Indonesia, and Thailand. Another variable is that the down payment already secured is not large. Although HK inno.N did not disclose the amount of down payment secured by K-Cab's export contract, it is known to be insignificant compared to the total size of the contract. There are two down payments secured through the Fexuclu export contract disclosed by Daewoong Pharmaceutical. In March last year, 6.8 billion won in advance received from Shanghai Haini was the largest. Daewoong Pharmaceutical's 5% stake from Neurogastrx was valued at 4 billion won as of the end of last year. An industry official said, "Even if finished drugs are already well-selling in Korea, various unexpected variables such as changes in the market environment will inevitably occur in overseas markets," adding, "Even if there is no problem with the product, it is highly likely that they will not achieve the export target set in the first place."
