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- 2026-05-10 01:23:39
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- Martín Corcoll, Boehringer Ingelheim Korea's new GM
- by Jul 03, 2021 05:56am
- Boehringer Ingelheim Korea announced the appointment of Martín Corcoll as the company’s new GM and Head of Human Pharm as of July 1st. Since joining Boehringer Ingelheim in 2006, the new GM Corcoll had accumulated extensive experience and expertise in the industry, serving in various positions and divisions for over 15 years. After graduating from the University of San Andrés in Argentina with a Bachelor’s degree in Business Administration, he obtained an MBA from ESADE Ramon Business & Law School in Barcelona, Spain. In 2006, Corcoll joined Boehringer Ingelheim Mexico as a central nervous system (CNS) and urology brand manager. After establishing a solid foothold as a cardiovascular marketing leader until February 2010, Corcoll moved on to the Boehringer Ingelheim's headquarters in Germany as a global brand manager of the company’s diabetes division. During his time in Germany, Corcoll was recognized for his expertise and successful contribution to the company’s growth in establishing international alliances for its diabetes division and leading the global launch of the company’s diabetes products. Until 2018, Corcoll served as the Marketing Head of Human Pharma at Boehringer Ingelheim Spain and oversaw the primary care and specialty care brands, after which he moved to the Austrian branch to serve as the Regional Business Manager and as became the Head of Human Pharma and GM of Boehringer Ingelheim Austria in 2019. “I am pleased to be joining Boehringer Ingelheim Korea. I had a great interest in our Korean branch as I often heard of the performance and growth it has made during my time in Boehringer Ingelheim.” said Corcoll. “Based on the company’s corporate vision, ‘create value through innovation,’ the company will strive to improve the health of our patients and animals in Korea by providing effective new drugs and healthcare solutions for diseases with a high unmet need.”
- Company
- Opdivo+Yervoy's negotiations failed to reach an agreement
- by Jul 01, 2021 05:56am
- Drugs for the combination of the immuno-cancer drugs Opidivo (Nivolumab) and Yervoy (Ipilimumab) in primary treatment for kidney cancer were not negotiated within days. In the end, it is expected to take longer to apply the benefit. According to related industries on the 1st, Ono Pharmaceutical and BMS have extended drug price negotiations with the NHIS for Opdivo and Yervoy kidney cancer primary treatment benefits. Earlier, Opdivo and Yervoy combination therapy was recognized for their benefit adequacy and began drug negotiations with the NHIS for "median or high-risk progressive neocyte cancer treatment" at the HIRA. Pharmaceutical price negotiations run for up to 60 days, and the recent period has expired. The NHIS and pharmaceutical companies never reached an agreement. However, they decided to extend it because they believed that additional negotiations were needed. PD-1 inhibitor immuno-cancer drugs Opdivo and CTLA-4 inhibitor immuno-cancer drugs Yervoy demonstrated excellent effectiveness in primary treatment of kidney cancer. In June 2020, and it passed the HIRA's Cancer Drugs Benefit Appraisal Committee. Later, it took about nine more months for the HIRA's Pharmaceutical Benefits Advisory Committee to recognize the benefit adequacy. In clinical trials of CheckMate-214 compared to the standard treatment of Sutene (Sunitinib Malate) in intermediate and high risk groups, Opdivo and Yervoy combined therapy showed a significant effect compared to the median (mOS) of 48.1 months, compared to 26.6 months. The objective response rate was also significantly higher at 41.9% to 26.8% and the rate of patients maintaining it was higher (65.2% to 49.6%). In particular, 10.4% of patients treated with combination therapy reached full response and received attention. Professor Park Soo-hyung of Kaist GMSE said, "In immune mechanism, CTLA-4 activates priming, which is the first antigen-specific immune response, to induce T-cell reactions, and anti-PD-1 prevents degradation of T-cells, which can create synergies." If Opdivo and Yervoy therapy are listed, the use of immunocancer drugs in kidney cancer is expected to become more active. This is also the first case in which immuno-cancer drug combination therapy is applied in chemotherapy. Both companies are also seeking to expand insurance coverage for Opdivo and Yervoy combined therapy in primary care for non-small cell lung cancer.
- Company
- Yuhan’s Leclaza reimb. held back by companion diagnostics
- by Eo, Yun-Ho Jul 01, 2021 05:56am
- Reimbursement of the novel domestic drug ‘Leclaza’ that was due today (July 1st) was postponed. The listing process of Yuhan Corporation’s new drug which had been progressing at an unprecedented pace came to a full stop due to ‘companion diagnostics.’ Dailypharm found that the Ministry of Health and Welfare had pulled a temporary stop on the enforcement of the notice related to Leclaza (lazertinib). Leclaza was supposed to be listed from July after passing the Health Insurance Policy Deliberative Committee’s review on the 25th of last month. The brakes were pulled by an objection that was registered during the pre-announcement of administration period regarding the lack of a companion diagnostics device Delayed listing of a drug that has already passed the HIPDC deliberations is rare. Since 2018, the Ministry of Food and Drug Safety had regularized a sort of ‘customized use’ of in-vitro companion diagnostics devices through the ‘Guideline on the Review & Approval of companion diagnostic medical devices,’ under which a drug and the companion diagnostics device used as the basis for medications and prescriptions are reflected together in the license. The measure was implemented to precisely screen patients eligible for each prescribed drug target. The problem was that no MFDS-approved diagnostic device existed for the purpose of prescribing Leclaza even though the drug already passed the HIPDC review. Under the current regulations, 3rd generation EGFR TKIs like ‘Tagrisso (Osimertinib)’ and Leclaza may only be prescribed to ‘patients whose EGFR T790M mutation status has been confirmed with an in-vitro diagnostic medical device approved by MFDS.’ In-vitro diagnostic medical devices that are approved and used to identify the EGFR T790M mutation status in Korea include the blood-based ‘Cobas EGFR Mutation Test,’ and ‘PANAMutyper EGFR Kit,’ among others. However, these devices are only approved to be used to screen patients for Tagrisso. In other words, the objection was that Leclaza prescriptions, if made, are all off-label prescriptions, and therefore unfit for reimbursement. As the health authorities have been limiting reimbursement of anticancer therapies with targets such as Tagrisso, the immunotherapy ‘Keytruda (pembrolizumab).’ ‘Tecentriq (atezolizumab),’ the ALK-inhibitor ‘Xalkori (crizotinib), and 'Alubrig (brigatinib)' to those that have used approved diagnostic devices to prescribe the therapies, it was difficult for the government to overlook the objections made regarding this matter. Accordingly, the MFDS had requested the Ministry of Food and Drug Safety to deliberate on whether the in-vitro diagnostic device needed for the prescription of Leclaza should be regarded as a 'companion diagnostics device.' To add an in-vitro companion diagnostic device to a drug's license, additional data that demonstrates that the diagnostic device used in the clinical trial and the device the company wishes to register is equivalent in identifying EGFR T790M mutations need to be submitted. Generally, it takes around 3 to 4 months for the tests to be conducted and the MFDS license to be updated.
- Company
- Hanmi’s Efpeglenatide reduces cardiovascular risk
- by Chon, Seung-Hyun Jul 01, 2021 05:55am
- Sanofi announced a study that reduces the risk of cardiovascular and kidney disease of new diabetes drugs that have returned rights to Hanmi. Hanmi plans to find new opportunities based on research results. According to Hanmi on the 29th, Sanofi held an independent session for Efpeglenatide at the American Diabetes Association (ADA) and announced the results of AMPLITUDE-O on eight subjects through eight researchers for two hours. Efpeglenatide is a GLP-1 family of diabetes drugs that Hanmi transferred technology to Sanofi in November 2015. It is a new bio-drug that extends daily injections from once a week to up to once a month. Sanofi conducts five clinical trials of Efpeglenatide. It finally gave back its rights to Hanmi in September last year. The findings released by Sanofi this time were conducted on more than 4,000 patients, the most among five clinical trials. AMPLITUDE-O Phase 3 clinical trials were given weekly Efpeglenatide or placebo to 4,076 patients with type 2 diabetes or cardiovascular disease in 344 regions in 28 countries. In type 2 diabetes patients, the risk of cardiovascular and kidney disease was significantly reduced when administered in two doses, Efpeglenatide 4mg and Efpeglenatide 6mg. The incidence of major cardiovascular diseases in the Efpeglenatide group compared to the placebo group decreased statistically to 27% and 32% in kidney disease. Professor Naveed Sattar of the University of Glasgow said, "The AMPLITUDE-O clinical trial safely reduced the incidence of major cardiovascular and kidney disease in low-risk and high-risk patients with type 2 diabetes." Major speakers and topics of the independent session for Efpeglenatide conducted by Sanofi (data: Hanmi) "Efpeglenatide has prepared a new opportunity to create another innovation," said Baek Seung-jae, executive vice president of Hanmi Pharmaceutical. "We are focusing our company's capabilities on expanding and materializing the potential of Efpeglenatide, which has been proven through large-scale global clinical trials," he expected. Another global clinical phase 3 (AMPLITUDE-M) result of Efpeglenatide, which was conducted on 406 type 2 diabetes patients whose blood sugar is not controlled by diet and exercise, was also introduced by Dr. Juan Frias, a leading researcher. The clinical trial, which was conducted with double blindness, divided Efpeglenatide into three dose groups (2mg, 4mg, and 6mg) for 56 weeks, compared Glycated hemoglobin with primary evaluation variables for 30 weeks, weight loss, and safety for 56 weeks. Studies have confirmed excellent blood sugar control and weight loss effects when Efpeglenatide is administered to type 2 diabetes patients. Treatment also remained stable for long periods of time. Glycated hemoglobin showed statistically superior improvements in all doses over placebo in Week 30 of treatment. Shortly after the announcement, the New England Journal of Medicine (NEJM) published a paper on Efpeglenatide. "Cardiovascular safety is an important factor that doubles the global competitiveness of drugs in large-scale clinical trials, allowing us to create other innovations and business opportunities," said Kwon Se-chang, CEO of Hanmi Pharmaceutical. Main screen of the New England Journal of Medicine (NEJM) introduced Efpeglenatide (reference: Hanmi)
- Company
- Generics for Pradaxa, Xarelto & Brilinta will be released
- by Kim, Jin-Gu Jun 30, 2021 05:57am
- Material patents of Pradaxa and Xarelto expire in July and October this year, respectively. As a result, 8 generics for Pradaxa and 200 generic for Xarelto are expected to be released early in the second half of this year. In November, 25 generics for Brilinta will be released. Ahn-Gook's generic for Galvus is expected to be released within the year according to the Supreme Court ruling. ◆Generics for Pradaxa & Xarelto in July and October Xarelto and PradaxaAccording to the pharmaceutical industry on the 28th, a total of 82 pharmaceutical patents will expire in the second half of this year. What attracts the most attention is the expiration of the material patent for two NOAC products. Material patent of Pradaxa expires immediately on the 17th of next month. Four companies received generic for exclusivity with a total of eight items. Ajou Pharm's Davitran, Intropharm's Davican, Jinyang Pharmaceutical's Pradabi and Huons' Hubitran can get the exclusivity to sell generics for nine months from July 18 to April 17 next year. Material patent of Xarelto expires in October. 23 companies such as SK Chemical, Chong Kun Dang, and Hanmi have avoided follow-up patents. Two of them received generic for exclusivity. SK Chemical's SK Rivaroxaban 2.5mg and Hanmi Pharmaceutical's Riroxban 2.5mg will be sold exclusively from October 4th to July 3rd next year. 62 companies have been licensed for 195 items. More than 200 generics are expected to be released after October 4, when material patents expire. The early launch of generics for Pradaxa and Xarelto contrasts with the withdrawal of Eliquis' generic market. Earlier, six to seven companies, including Chong Kun Dang, won the first trial on material patent of Elyquis. Thus, it has released generic early since June 2019. They have accumulated more than ₩10 billion in prescription performance through the first quarter of this year. In April this year, however, the Supreme Court sided with the original company, BMS. Generics voluntarily withdrew their products from the market. The early launch of generis of Pradaxa and Xarelto is expected to lead to a reorganization of the NOAC market. In the case of the two items, judgment of the decision to avoid the follow-up patent has been confirmed. As of last year, Pradaxa had ₩14.3 billion and Xarelto had ₩50 billion in outpatient prescription performance. Considering that generic for Eliquis has previously increased its market share around Clinics, generics for Pradaxa and Xarelto are also expected to be in the market. ◆25 generics for Brillinta are expected to be launched simultaneously after November The patent for the anti-platelet drug Brilinta expires in November. It is predicted that 25 generics will be launched at the same time as the patent expires. 25 items, including Boryung Ticagrelor by Boryung from November 21 this year to August 20 next year have acquired generic for exclusivity. Attention is also focusing on whether Ahn-Gook will be able to release Novartis' GPP-4 inhibitor family of diabetes drugs early on. The generic for exclusivity for generic for Galvus is the sole acquisition of Ann-Gook. The period is from 30 August to 29 May next year. In 2019, Ahn-Gook succeeded in invalidating some of the extended periods of material patents for the first time in Korea. As a result, it succeeded in pushing forward the expiration of material patent of Galvus, which was originally scheduled to expire in March next year, by about six months (187 days). However, Novartis appealed, and the Patent Court ruled that 55 days were invalid, not 187 days. The release date of generic for Galvus will be pushed back to January next year. The case now awaits the Supreme Court's final ruling. The Supreme Court's decision determines the timing of Ahn-Gook's generic for Galvus. If it accepts the judgment of the Patent Tribunal, it can be released in August. If the patent court accepts the ruling, it is expected to be released in January next year. If it accepts Novartis' claim, it can only be released after March of next year.
- Company
- JW Pharma acquires domestic license for fostamatinib
- by Chon, Seung-Hyun Jun 30, 2021 05:56am
- On the 28th, JW Pharmaceutical Corporation announced that it has entered into a licensing agreement with Kissei Pharmaceutical Co., Ltd for the development and commercialization rights in Korea of fostamatinib, a thrombocytopenia treatment. Under the licensing agreement, JW Pharmaceutical may develop, obtain regulatory approval, and market fostamatinib in the domestic market. Fostamatinib was originally developed by Rigel Pharmaceuticals, Inc., and Kissei acquired exclusive development and commercialization rights for fostamatinib in Japan, China, Korea, and Taiwan from Rigel in 2018. Immune Thrombocytopenic Purpura (ITP) is a condition in which the body’s immune system attacks platelets, causing the platelet count to become lower than normal. Patients with ITP are easily bruised, bleed easily, and have difficulty stopping bleeding. In severe cases, it can lead to cerebral hemorrhage or upper gastrointestinal tract bleeding, and therefore is a rare blood condition with a high unmet need. Fostamatinib is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP in adult patients. Contrary to existing treatments that boost blood platelet production, this first-in-class drug suppresses the destruction of platelets by macrophages and suppresses platelet depletion. Fostamatinib was approved by the U.S. FDA in 2018 for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatment, and is sold under the name ‘Tavalisse.’ According to post hoc analysis results of Phase III clinical trial presented at the 2019 American Society of Hematology (ASH) Annual Meeting, the use of fostamatinib as second-line therapy after treatment with corticosteroid showed a high treatment response rate in patients who have been diagnosed within a year. Also, fostamatinib has less dietary interference and drug-drug interactions than other oral formulations and may be taken regardless of food intake or other medications. JW Pharmaceutical plans to receive the orphan drug designation for fostamatinib in Korea to expand treatment opportunities for adult patients with thrombocytopenia. An official from JW Pharmaceutical said, “The company was able to add a new drug for a rare disease in our lineup through the agreement. We will work to progress the domestic approval process without any delay to provide treatment for patients suffering from chronic ITP.”
- Company
- Amitiza can be prescribed at general hospitals
- by Eo, Yun-Ho Jun 29, 2021 05:46am
- Amitiza, a chronic constipation drug, can be prescribed at general hospitals. According to related industries, Amitiza(Lubiprostone), which is conducting exclusive promotion activities in Korea through contracts with Takeda Pharmaceuticals, passed the drug committee (DC) of 42 medical institutions nationwide, including AMC and Severance Hospital. Amitiza is used to treat certain types of constipation (chronic idiopathic constipation, irritable bowel syndrome with constipation). Chronic idiopathic constipation has an unknown cause and is not due to diet, other diseases, or drugs. Lubiprostone is also used to treat constipation caused by opioid medications in people with ongoing pain due to medical conditions other than cancer. and was released in February last year. Amitiza, co-developed and marketed by Takeda with Sucampo Pharmacutics, obtained market approval from the U.S. FDA in 2006. Amitiza facilitates CIC-2 chloride channels to increase fluid secretion in the small intestine to relieve constipation symptoms. Clinical trials showed that 60% of constipation patients succeeded in natural bowel movements within 24 hours of taking Amitiza. Amitiza was sold about ₩688.2 billion last year alone in major countries including Japan, the United States and Europe. It is an oral bicyclic fatty acid that selectively activates type 2 chloride channels in the apical membrane of the gastrointestinal epithelium, resulting in increased fluid secretion Lee Kwang-jae, Professor of Gastroenterology at Ajou Medical School (chairman of the Korean Society of Neurogastroenterology and Motility), said, "As it is the first new mechanism in Korea, we expect it to be a primary treatment option for chronic constipation patients who experience daily discomfort."
- Company
- Select the right initial treatment for kidney cancer
- by Jun 29, 2021 05:46am
- Cancer immunotherapies are receiving the spotlight in the treatment of kidney cancer. Demonstrating superiority over existing therapies, these drugs are quickly gaining ground in the field of kidney cancer treatment. Recently, MSD’s cancer immunotherapy ‘Keytruda (pembrolizumab) received approval as first-line treatment in combination with Inlyta(axitinib). Afterward, the immuno+immunotherapy combo ‘Opdivo (nivolumab)+ Yervoy (ipilimumab)’ also received approval as a first-line treatment option. Dr. Chan Kim, Professor of Medical Oncology/Hematology at CHA Bundang Medical Center believes that the use of cancer immunotherapies will broaden in the field of kidney cancer. And there’s ample grounds to support Kim’s belief. Keytruda in combination with a different targeted therapy, ‘Lenvima (Lenvatinib)’ has recently produced even more superior data in a clinical trial. However, limitations do exist. Currently, cancer immunotherapies are approved only for the first-line indication. Therefore, if the patient had previously used other treatments, they may not be prescribed cancer immunotherapy drugs. Therefore, patients with Stage IV kidney cancer must carefully consider and select their first treatment. Dailypharm met with Professor Kim to seek his insight on the significance and prospect of cancer immunotherapy drugs in the field of kidney cancer. Professor Chan Kim-How has the kidney cancer treatment environment changed with the introduction of cancer immunotherapies? = Kidney cancer is a field known for its poor response to general chemotherapy or radiotherapy treatment. Due to this, cytokine-based immunotherapy has been used as an option for over 20-30 years in the field, but even this option has not been broadly used because its objective response rate is only around 10-20%, with serious side effects. This treatment paradigm for kidney cancer has completely changed with the introduction of cancer immunotherapy drugs (immune checkpoint inhibitors). Cancer immunotherapy drugs have fewer side effects than previous drugs and can be used safely even in elderly patients. Most of all, it showed a good therapeutic effect. However, immunotherapy drugs by themselves were not enough to produce satisfactory results as the objective treatment response rate of immunotherapy drugs alone was around 25-30%. As a result, attempts to use immunotherapies in combination with targeted therapies have been made, and clinical studies on this combination were released for kidney cancer in 2019. Results showed that the immuno+targeted therapy combination achieved a twice higher ORR than monotherapy, with an ORR of 55-60%. The uncrossed barrier of 30% was finally overcome. -Were many combination therapies implemented in practice after the data was presented on the immuno+targeted therapy combination? How effective is it in practice? =Use of the combination increased explosively after the presentation. In Korea, Keytruda in combination with the targeted therapy Inlyta is most commonly used. Much treatment data has been accumulated on the combination since its introduction in September 2019. Our hospital presented data on 42 kidney cancer patients who were treated with the Keytruda+Inlyta combination from September 2019 to March 2021 at the 47th Annual Meeting of the Korean Cancer Association that was held from the 17th to 18th this month. One key thing to note is that at the data cut-off point (June 3rd, 2021), the ORR was 54.3%, an excellent rate that is comparable to the clinical trial results. Also, among the patients, 2.9% achieved a complete response and 51.4% achieved a partial response. The median progression-free survival was 12.4 months, and the median OS was not reached in our study. In particular, tumor size in patients with aggressive tumors whose symptoms are difficult to control reduced significantly. 85% of the patients survived, and 63% are still continuing their treatment with the combination therapy. The 1-year survival rate is expected to be around the 90% range. In general, Real World Data (RWD) often does not produce as good a result as clinical trials that were conducted in controlled environments. In this context, the fact our results in the field showed a 90% survival rate that is similar to the clinical trial is encouraging news. -How would you interpret the 42 month long-term follow-up data on Keytruda+Inlyta that was recently presented in the 2021 ASCO Annual meeting? =The academic society had been unsure whether the combination would work in the long-term The data that was presented at the ASCO meeting holds significance as it demonstrated the long-term effect of Keytruda+Inlyta. More specifically, in the KEYNOTE-426 study, the overall survival of the combination therapy was 45.7 months, significantly longer than the 40.1 months when using the standard treatment, ‘Sutent (sunitinib).’ PFS also showed a significant difference of 14.7 months vs 11.1 months. OS at month 42 was 57.5% vs. 48.5%, respectively, and PFS at the same period was 25.1% vs. 10.6%, for the combination therapy group and Sutent group. ORR was 60.4% for the combination therapy and 39.6% for sunitinib. CR was also higher in the combination therapy group, being near 10%, compared to the 3.5% of sunitinib. -The Keytruda+Inlyta combination is currently approved only as a first-line treatment. Does this mean patients who already used other drugs do not have the chance to use the combination? =Yes. Patients often visit our hospital wanting to use Keytruda after using targeted therapies for a month or so. It is unfortunate, but these patients are not allowed to use Keytruda because it is only approved as first-line in Korea. This is why selecting the right initial treatment is ever so important for stage IV kidney cancer patients. If you hastily decide on using a treatment, it is highly likely that you may miss a good opportunity, so I ask the patients to make an informed decision after carefully collecting ample information in advance. -Recently, the Keytruda+Lenvima combination had also shown excellent, differentiated data results from previous kidney cancer treatments. =We have high expectations for the Keytruda+Lenvima combination. In the Phase III CLEAR study, the combination showed a median PFS of 23.9 months, which is over twice longer than the PFS shown in the Sutent group’s 9.2 months. The risk of mortality also decreased by 34% compared to the Sutent group. ORR of the combination therapy was 71%, and 16.1% of the patients reached complete response. The combination is expected to address all the limitations in effect and side effects that arose from previous treatments. If this combination is also approved in the future, 4 treatment options (targeted therapy, immuno+immuno combination therapy, Keytruda+Inlyta, Keytruda+Lenvima) will become the established options used to treat kidney cancer. Among these, the Keytruda + Lenvima combination is expected to be the most anticipated option in the field. -What role would cancer immunotherapies play in the field of kidney cancer in the future? =Cancer immunotherapies are already a well-established treatment option in kidney cancer, and its use will continue to expand in the future. I believe the new treatment trend would be for low-risk groups to first use targeted anticancer therapies and for mid-to high-risk groups to consider the use of immuno+targeted combination therapies. As the combination is yet non-reimbursed, not enough patients are benefiting from this effective treatment option. I hope the government will provide support as soon as possible in consideration of its excellent treatment effect.
- Company
- Attention focused on children’s NIP flu vaccine supply
- by Whang, byung-woo Jun 29, 2021 05:46am
- With the bid for the 8 million doses of influenza vaccine for seniors under the National Immunization Program nearly compete, the pharmaceutical industry is intently focused on the supply amount and bid that will be set for the children’s NIP flu vaccines that will follow. According to the Korea Disease Control and Prevention Agency and the industry, the expected NIP quantity of influenza vaccines for those aged 6 months to 12 years will be around 4.6 million doses and will be supplied under a third-party Unit Price Contract. The reason why the pharmaceutical companies are paying attention to the NIP influenza vaccine (hereinafter referred to as flu vaccines) supply for children and adolescents is because the bid amount could affect the number of vaccines that will be released to the private sector in the future. Last year, due to concerns over a ‘Twindemic,’ where COVID-19 and influenza spread simultaneously, the subjects for NIP flu vaccines were temporarily expanded to include those in the 13 to 18-year range, increasing the supply by 1.54 million people’s worth. From this year's perspective, this means that if the flu vaccines for adolescents are removed from the NIP supply this year, that amount will now return to the private sector. Generally, the third-party unit price contract for children’s flu vaccines under the NIP are made without a procurement contract. When the pharmaceutical company supplies flu vaccines to vaccinating medical institutions, the institutions vaccinate eligible children and receive expenses for the vaccination and execution from their local public health centers. The pharmaceutical companies also receive the price for the vaccine from public health centers. When the pharmaceutical company supplies flu vaccines to vaccinating medical institutions, the institutions vaccinate eligible children and then receive expenses for the vaccine and its administration from their local public health centers. The pharmaceutical companies also receive the price for the vaccine from the public health centers. Currently, around 5.2 million children and adolescents are eligible to receive the NIP flu vaccine based on the resident registration statistics in May. The NIP inoculation rate is expected to be around 80% of the eligible population, which means that NIP will roughly require 4.2 million doses. Adding the 500,000 that need to be inoculated twice to the supply, the total amount required will be around 4.7 million doses. Most domestic companies will take part in the bid as NIP suppliers for the pediatric flu vaccines, and Sanofi, which is known to have ramped up its flu vaccine volume by nearly 30% in the absence of SK Bioscience, is also expected to participate in the bid. The pharmaceutical industry expects the total vaccine supply, including the NIP amount, will be around 26 million doses this year. Taking into account the various factors, some believe that the competition among pharmaceutical companies will intensify as the number of flu vaccines released into the private market will be much greater than expected compared to the previous year. However, there also lies the possibility that these expectations will be reversed, as the eligibility age for NIP may continue to be expanded this year in line with the probable approval of the supplementary budget. Analysts predict that supplementary budget requests this year will not be rejected as the Ministry of Economy and Finance had underestimated last year's tax revenue by around 32 trillion won and will be reflecting this amount in the budget. At least, the NIP vaccine age expansion plan will unlikely be rejected due to the lack of a budget. In addition, NA member Jong Sung Lee of the People Power Party had pointed out that NIP for adolescents was virtually nonexistent except for the supplementary budget bill approved in 2020 to inoculate adolescents aged 14 – 18 years old. This pressure from the NA may also be positively reflected in the supplementary budget request. An official from a domestic pharmaceutical company said, “The total NIP amount will be determined according to whether the NIP age range will be expanded or not. The rest will be distributed in the private market. It’s not about whether we agree or disagree to the age expansion plan – the nay or yay needs to be sorted out as soon as possible so we can plan measures accordingly.” Also, the pharmaceutical industry believes that COVID-19 vaccination will be an important variable in establishing a competitive strategy for the flu vaccine market. “This year’s flu vaccine market size may be determined by the COVID-19 vaccination rate this year," a Sanofi official said. "The government will need to provide guidelines for inoculations as the COVID-19 vaccination completion period coincides with the flu vaccination period that was announced by the government."
- Company
- MET inhibitor ‘Tabrecta’ to overcome Tagrisso resistance?
- by Jun 28, 2021 05:50am
- A study that attempts to address the resistance issue by using the first-ever MET inhibitor ‘Tabrecta’ in combination with the EGFR-TKI ‘Tagrisso,’ will be conducted in Korea. According to the Ministry of Drug and Food Safety on the 25th, Novartis Korea’s application to conduct a Phase III trial on its non-small cell lung cancer treatment ‘Tabrecta (capmatinib)’ was approved that day. Tabrecta is the first-ever MET inhibitor to be approved by the U.S. FDA and was approved in June last year. In Korea, the drug has been designated as an orphan drug by the MFDS in the pre-approval stage. The new clinical trial that will be conducted by Novartis will be studying Tabrecta in combination with Tagrisso (Osimertinib). More specifically, the study will evaluate the treatment effect of Tabrecta+Tagrisso in comparison to platinum-based chemotherapy in patients with non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation, T790M negative, mesenchymal-to-epithelial transition factor (MET)-amplified who progressed following treatment with 1st/2nd generation EGFR tyrosine kinase inhibitors (TKIs) or Tagrisso. MET amplification is one of the known causes of EGFR TKI resistance, in which an EGFR-inhibited cancer cell activates alternative signaling pathways to escape inhibition. It is found in around 25% of all patients treated with Tagrisso and is considered the most commonly observed alteration with C797S mutations associated with resistance to Tagrisso. No treatment that targets the abovementioned mutations currently exists, therefore, patients who develop resistance have no option but to use cytotoxic agents. Thus, work to address these Tagrisso-resistant mutations has been continuing around the world. AstraZeneca is currently conducting a Phase II study on combination therapy using Tagrisso with its new MET inhibitor drug substance ‘savolitinib (product name: Orpathys).’ Savolatinib is a new lung cancer drug in development by AstraZeneca and the Chinese pharmaceutical company, Hutchison China MediTech (Chi-Med). The drug received its first approval in China on the 24th. In the first cohort study that was conducted initially on 46 patients, the combination was associated with an objective response rate (ORR) of 52% with 24 partial responses The median duration of response (DOR) was 7.1 months. In the second, the combination yielded an ORR of 28%, with 12 partial responses. The median DOR was 9.7 months However, the savolitinib+Tagrisso combination showed more side effects in the cohort study. Jassen and Yuhan Corp. is also developing a combination of Rybrevant (amivantamab) and Leclaza (Lazertinib) that targets MET amplification. According to a paper recently published at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, the combination resulted in a 36% ORR, with one complete response and 15 partial responses. Rybrevant and Leclaza are each currently approved in the U.S and Korea.
