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- 2026-03-17 18:03:05
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- The development of Kcav's Mucovac is in full swing
- by Dec 27, 2021 05:57am
- A spray-type COVID-19 vaccine sprayed on the nose, not on injections, is being developed by domestic company. Amid the trend of muscle injection, attention is focused on claims that mucosal immunity is more effective in defending the COVID-19 virus. Kcav (CEO Song Chang-seon) announced on the 27th that Mucovac, a COVID-19 mucosal vaccine candidate that is jointly researching with Konkuk University and Bionote, has succeeded in entering the second stage of the "Bio Medical Technology Support Project" supported by Ministry of Science and ICT and National Research Foundation of Korea. Accordingly, Kcav will receive 2 billion won in research funds for non-clinical trials and clinical sample production necessary for submitting the clinical trial plan (IND) of the COVID-19 mucosal vaccine Mucovac. Mucovac, which is being developed by Kcav, is a candidate substance for the COVID-19 mucosal vaccine derived by combining the ECSL immune enhancer, which signed a contract with Eubiologics in March, with a new antigen developed by Bionote. Mucovac confirmed that nasal administration using hACE2 TG Mice and Ferret animal Model enhances body fluidizing antibody and cellular immunity (IFN-r ELISPOT) to the COVID-19 virus. In addition, as a result of conducting attack vaccination tests using Wuhan and Delta, the Mucovac vaccine group showed a 100% survival rate. In particular, Kcav is planning to analyze Mucovac's ▲MoA-related analysis ▲ Evaluation of defense ability through attack inoculation after the sale of Omicron mutant and ▲ Boostershot application test (existing muscle vaccination + Mucovac inoculation). Since many pathogens, including COVID-19, invade through mucous membranes, mucosal vaccines can be said to serve as the first defense mission against pathogens invading from the outside. Since injection needles are not used, they can be administered safely and easily. It has been argued that vaccines using nasal cavity are more effective against COVID-19 than through veins and muscles. Currently, there are about 100 vaccines being developed worldwide, of which seven are vaccines using nasal cavity. This is why the Korean government desperately needs support for the success of commercialization of Mucovac while global efforts are underway to overcome the COVID-19 pandemic situation. An official from Kcav said, "The mucous membrane vaccine currently under development is a spray-type vaccine sprayed on the nose, not a conventional injection vaccine." He explained, "When applied with booster shots to existing vaccinations, it induces not only systemic immunity but also mucosal immunity." "We expect Mucovac to increase the ability to prevent infection through the respiratory tract of COVID-19 and respond to various mutant viruses," he said. "We have already confirmed our defense against delta mutant as well as Wuhan." Kcav has already confirmed its ability to defend against the SARS-Cov-2 virus of COVID-19 mucosal vaccine candidates using ECLS immunostrengthening agents by receiving research funding from the Global Health Technology Research Fund "RIGHTFUND," co-invested by the Bill & Melinda Gates Foundation, and eight domestic life science companies in 2020. Meanwhile, Kcav was established in 2014 by Professor Song Chang-sun of Veterinary Science College as the first subsidiary of Konkuk University's technology holding company. It has secured a variety of vaccine pipelines for animals and humans using core platforms such as Live attenuated vaccines and Newcastle Disease vector vaccines.
- Company
- To introduce a phase 3 clinical drug preferential policy
- by Nho, Byung Chul Dec 27, 2021 05:56am
- Attention is focusing on whether the industry, the National Assembly, and the MOHW will be able to derive a reasonable and efficient institutional direction in relation to the "policy for preferential treatment of new drugs in phase 3 clinical trials for Koreans." According to related industries on the 23rd, after the drug preferential regulations for innovative pharmaceutical companies were deleted during the 2018 Korea-US FTA negotiations, Article 17-2 of the Pharmaceutical Industry Promotion Act was introduced, but the legislation process seems urgent. Generic, which is released by innovative pharmaceutical companies, can get additional drug prices if it meets certain items of drug decision and adjustment standards, while there is no incentive for new drugs developed by all domestic and foreign pharmaceutical companies, that is, new drugs that have conducted clinical trials in Korea. As the global innovative drug preferential system was virtually stranded due to trade friction such as WTO and FTA three years ago, drug preferences such as 10% of the highest price of alternative drugs to encourage innovative pharmaceutical companies to develop new drugs and application of similar drugs (adjusted lowest price) in A7 countries have disappeared. With the outbreak of the COVID-19 Pandemic, public opinion on the formation of public opinion on the independence of vaccines and treatments and the government's justification for establishing pharmaceutical sovereignty is also gaining momentum. As Big Pharma such as Pfizer, Moderna, AstraZeneca, and MSD exclusively develop vaccines and treatments, other countries may suffer supply and demand difficulties at any time, as well as the fact that they are not the main clinical subjects. The "Phase 3 Clinical New Drug Treatment for Koreans" is a system that benefits 5-10% of alternative drugs when domestic and foreign pharmaceutical companies conduct clinical trials (300-1000 people) or higher in Korea when developing innovative drugs. In order to prevent international trade problems such as negotiations on the revision of the Korea-US FTA in 2018, there is an international obligation to introduce a drug price system within the scope of compliance with the agreement. The regulations in question in the FTA agreement at the time allow drug and medical device registration or procedures, rules, standards, and guidelines applied to establishing benefits for medicines and medical devices to apply for benefit based on evidence of safety. The phase 3 clinical drug preferential treatment for Koreans is a system that provides common benefits not only to domestic companies but also to foreign companies, so there is no concern about trade friction. In the case of new drugs that have proven that there is no difference in safety and effectiveness of drugs due to ethnic factors, they have the advantage of creating customized drug therapy, providing appropriate treatment, and securing clinical data while maintaining the maximum drug effect. The revision of the HIRA's drug adjustment standards can achieve the desired results, preventing waste of time and unnecessary costs due to the preparation of new bills such as legislation of the National Assembly and government. According to Article 7 (7) of the Drug Adjustment Standard, the cost of medical care benefits for drugs that omit drug price negotiations is 90% of the weighted average price of alternative drugs, but exceptionally 100% for new drugs, biopharmaceuticals, and rare diseases. An industry official said, "As a result of reviewing 122 drugs registered over the past six years, 4·13 domestic and foreign drugs will be applied to the preferential treatment of phase 3 clinical drugs in Korea." This can benefit in common from domestic and foreign pharmaceutical companies through various legal review, so there is no concern about trade friction due to the application of special cases, he said. In addition, he predicted, "Multinational pharmaceutical companies' drugs are unlikely to be subject to the revision as they are exempted from submitting Bridge study data due to anticancer drugs and rare drugs, and biological drugs will need to be given 100% of the average drug price."
- Company
- Reimb of SGLT-2i combos unclear... nears PMS expiry
- by Eo, Yun-Ho Dec 24, 2021 05:49am
- SGLT-2 inhibitors approved in Korea Anticipation has turned to tension. The companies that own SGLT-2 and DPP-2 combination therapies are facing hardships ahead of their post-marketing surveillance period expiry. At the diabetes expert meeting that was held by the Health Insurance Review and Assessment Service in September, the members concluded that the authorities should integrate and accept reimbursement of 2-drug and 3-drug combinations that use DPP-4 inhibitors with SGLT-2 inhibitors. The conclusion harbored industry hopes of being granted reimbursement listing for their non-reimbursed combinations. However, no progress has been made since in extending the insurance benefits to the combinations so far, putting pressure on the Post Marketing Surveillance (PMS) results. The PMS results of combination therapies such as Boehringer Ingelheim Korea’s ‘Esglito (empagliflozin/ linagliptin), AstraZeneca’s Qtern (dapagliflozin/saxagliptin)’ that is sold by Ildong Pharmaceutical, and MSD Korea’s ‘Steglujan (ertugliflozin/ sitagliptin) is due to the MFDS by 2023-2024. Only 1-2 years are left until the deadline. However, hundreds to thousands of patients need to enroll and register to conduct PMS, and due to the nature of the diabetes treatment market, it is difficult to recruit and attract prescriptions for non-reimbursed drugs. In other words, unless the drugs receive reimbursement, the companies will not be able to meet the number of patients required for PMS that was set by the Ministry of Food and Drug Safety. An official from a pharmaceutical company with an SGLT-2 inhibitor said, “In this pace, the license will inevitably be revoked. With the government policy supporting the active use of combinations, treatment accessibility is hindered if patients cannot be prescribed the drug due to non-reimbursement. I hope reimbursement is extended to SGLT-2 inhibitor combinations as soon as possible.” Meanwhile, at the expert meeting, the authorities decided that TZD class drugs that have cardiovascular risks should be reviewed ‘case by case.’ Therefore, the use of TZD combinations will continue to be restricted depending on individual ingredients.
- Company
- GI Innovation·A/Z, a study on immuno-cancer drugs combined
- by Nho, Byung Chul Dec 24, 2021 05:48am
- The appearance of GI Innovation clinical team members challenging large-scale global clinical trials. (Photo provided = GI Innovation)GI Innovation (CEO Hong Joon-ho) announced on the 17th that it has signed a clinical supply contract with AstraZeneca in the UK to develop a combination therapy with GI-101, an immuno-cancer drug, and Impinzi (Durvalumab). With this contract, GI Innovation will conduct clinical trials with AstraZeneca to evaluate the combination of immuno-cancer drugs GI-101, Impinzi, and chemotherapy. This clinical trial targets patients with small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer and triple-negative breast cancer in the United States, Australia, and Korea. GI Innovation will be provided with Infinzi necessary for this clinical trial from AstraZeneca, and it will gain the driving force to conduct successful clinical trials by jointly designing clinical trial designs based on AstraZeneca's expertise in developing immuno-cancer drugs. The clinical trials of both companies aim to treat patients with combination therapy with GI-101, an immuno-cancer drug, in addition to the current standard treatment, chemotherapy, in metastatic and advanced cancers. Despite the use of immuno-cancer drugs in clinical settings, small cell lung cancer, gastric/gastroesophageal junction cancer, biliary tract cancer, and triple negative breast cancer did not show sufficient efficacy alone. To compensate for this problem, a combination of chemotherapy and immuno-cancer drugs has recently been attempted, and some carcinomas have shown encouraging therapeutic effects. A typical example is that a combination of chemotherapy and Imfinzi in small cell lung cancer has been approved as a primary treatment. GI Innovation is a strategy to maximize the treatment effect through the combination of GI-101, chemotherapy, and Imfinzi. The IL-2 site of GI-101 not only directly proliferates and activates apoptotic T cells and natural killer cells in the tumor microenvironment, but also effectively inhibits CTLA-4, an immune gateway expressed in immune cells through CD80. Through CD80-CD28 interaction, it is also possible to activate the immune response of cell killing T cells. Finally, it also has a mechanism to relieve immunosuppression by regulatory T cells that express CTLA-4, an immune gateway, in large quantities. Another immune gateway, PD-L1, can be expected to have excellent anticancer immunity when used in combination with Imfinzi, which activates immune cells. GI Innovation's clinical trial was designed as an adaptive and basket trial to confirm the anticancer activity of four solid cancers in one clinical trial and to register more patients in solid cancers that are effective depending on the results of interim analysis. The clinical trial will be conducted at about 20 medical institutions in Korea, the United States, and Australia. Yoon Nari, head of GI Innovation's clinical division, said, "GI-101 is a bispecific fusion protein that has a complex immune regulation function that proliferates and activates cell-killing T cells and natural killer cells only with monotherapy. The combination of GI-101, Imfinzi, and chemical anticancer drugs is designed to fully utilize the inherent mechanisms of the drug to recover the degraded immune response in cancer patients, respectively. Through this clinical trial, we will do our best to secure meaningful clinical differentiation data.
- Company
- MSD's Delstrigo can be prescribed in general hospitals
- by Eo, Yun-Ho Dec 23, 2021 05:42am
- Delstrigo, an HIV combination that succeeded in registering insurance benefits, is preparing to enter the market in earnest. According to related industries, the HIV combination Delstrigo ( Doravirine 100 mg, Lamivudine 300 mg and Tenofir Disoproxil Fumarate), which is taken once a day by MSD Korea, has now passed the DC of medical institutions such as Sinchon Severance Hospital. The drug was approved in Korea in January last year, submitted a benefit application at the beginning of this year, and was listed in January. Delstrigo's benefit indication is "the treatment of HIV-1 infection in adults who have no previous anti-retrovirus treatment experience." Among the ingredients, Doravirine 100mg was approved by the MFDS under the brand name Pipeltro as of November 22, 2019, and is required to be administered in combination with other anti-retroviral drugs. Both Pipeltro and Delstrigo received indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients who had no previous anti-retroviral treatment experience. Delstrigo was confirmed its validity through DRIVE-AHEAD clinical trials. In the clinical trial, Delstrigo proved non-equivalence compared to therapy of Efavirenz ·Emtricitabine·Tenofovir. The proportion of patients who reached viral inhibition (less than 40 copies/mL of HIV-1 RNA) at 48 weeks was 84% in Delstrigo treatment group and 80% in EFV/FTC/TDF treatment group. The rate of discontinuation of treatment due to adverse reactions was 3% and 6.6%, respectively, which was lower in the Delstrigo treatment group. Meanwhile, Gilead, GSK, MSD, Janssen, AbbVie, and BMS are currently competing in the HIV sector, of which Gilead and GSK account for about 90% of the market.
- Company
- [2021 Pharmaceutical Patent Settlement] The target is Dukarb
- by Kim, Jin-Gu Dec 23, 2021 05:41am
- Generics' challenge was found to have been concentrated on patents for Boryung's hypertension complex "Dukarb," Novartis' heart failure treatment "Entresto," and Hanmi Pharmaceutical's asthma treatment "Monterizine. The number of companies targeting the patent alone amounts to 45 Dukarb companies, 24 Entresto companies, and 22 Monterizine companies. ◆Focus on requesting a trial on Dukarb, Entresto, and Monterizine patents According to the pharmaceutical industry on the 22nd, referees have been filed for 20 patents for 9 drugs so far this year. A total of 68 companies have requested patent trials. Patent attacks were concentrated on Boryung's Dukarb. After Arlico filed a passive trial to confirm the scope of rights for patents for complex composition in February, 44 more companies challenged. Analysts say that as the expiration of material patent of Kanarb (Fimasartan) is just two years away, it is scrambling to target patents for composite drugs. The material patent expires in February 2023. If the Dukarb patent's challenge is successful, generic companies will be able to release generics early in time for the expiration of the material patent. Dukarb has the highest prescription sales among Kanarb combinations. According to UBIST, a pharmaceutical market research firm, Dukarb was prescribed 36.1 billion won last year, followed by 30.2 billion won by the third quarter of this year. Five companies in the second half of the year gave up their challenge. Yuyu Pharmaceutical, Hanwha Pharmaceutical, Daehan New pharm, Kims, and PharmGen Science chose to give up their challenge one after another. The pharmaceutical industry is paying keen attention to whether more companies will give up patent challenges, citing the fierce competition in the ARB+CCB-based high blood pressure second-drug market. Twenty-four companies challenged Novartis' Entresto. In January, after Elyson Pharmaceutical filed a passive rights scope confirmation trial for a decisive patent, a passive rights scope confirmation trial and invalidation trial were filed for five patents registered in Entresto. In the case of Entresto, Hanmi Pharmaceutical, Daewoong Pharmaceutical, Daewon Pharmaceutical, Dasan Pharmaceutical, Shinil Pharmaceutical, MFC, Kyperions and Corepharmbio voluntarily withdrew the passive trial to confirm the scope of rights filed in the decisive patent. Hanmi Pharmaceutical, Daewoong Pharmaceutical, and Daewon Pharmaceutical plan to continue challenging patents for use, composition patents, and pharmaceutical patents. In the case of Entresto, there is no separate material patent. Instead, patents for use and composition, which expire in 2027, are serving as material patents. Twenty-two companies have also challenged Hanmi Pharmaceutical's asthma treatment Monterizine. Monterizine is protected by four patents that expire in 2032. In September, Hanwha Pharmaceutical filed a passive rights scope confirmation trial for all four patents, followed by 21 companies joining the dispute. However, as Genuonescience voluntarily withdrew, the dispute is expected to lead to a showdown between 21 companies and Hanmi Pharmaceutical. ◆Genuone, Kyung Dong, Mothers; Tenelia MSR patent avoidance, generics can be released next year Alvogen Korea and Samsung Bioepis have filed for invalidation of three patents for Roche's targeted anticancer drug Avastin (Bevacizumab). Both companies are participating in the development of Avastin biosimilars. Alvogen Korea is said to be developing biosimilars at the global headquarters level, not at its Korean subsidiary. Daewoong Pharmaceutical filed a passive trial to confirm the scope of rights in Amgen's psoriasis treatment Otezla drug. Daewoong Pharmaceutical also filed a request for a trial on one other drug patent and a patent for use last year. At that time, Daewoong won the first trial in the patent trial. However, the case is still underway with Amgen's appeal. The dispute over patents for use has not yet ended. A patent challenge on BMS's leukemia treatment "Sprycel" also continued. Daewoong Pharmaceutical filed a trial for invalidation of the Sprycel patent in January. Boryung Pharmaceutical filed a trial on the same patent last year, and in December this year, it filed a passive trial to confirm the scope of rights for a crystalline patent. Genuonescience, along with Mothers Pharmaceutical and Kyungdong Pharmaceutical, requested a passive rights scope confirmation trial for a patent for Handok's diabetes complex "Tenelia M SR." With the victory of the dispute in May this year, they can launch generics after October 2022 when the material license of Tenelia, a single drug, expires. BCWORLD challenged Chong Kun Dang's two patents of Telminuvo. They won in October and November.
- Company
- MNC employees enjoy 17 days maximum as year-end holidays
- by Eo, Yun-Ho Dec 22, 2021 05:57am
- As in any year, the multinational pharmaceutical companies are again closing down for a long-term year-end holiday. According to Dailypharm’s research of 23 major pharmaceutical companies in Korea, 6 companies have set a 10-day or longer year-end holiday. Also, more than 10 pharmaceutical companies will be closing down for nine days. Also, in consideration of the COVID-19 pandemic, many multinational pharmaceutical companies are allowing their employees and executives to use their annual leaves to extend their holidays. Abbvie and Takeda Pharmaceutical are taking the longest days off. The companies have been closed since the 17th, for 17 days until January 2nd, 2022. Amgen’s employees are given a 13-day break, the Sanofi group 12 days, AstraZeneca 11 days, and Astellas 10 days. Companies and associations including Daiichi Sankyo, Roche, Boehringer Ingelheim, Viatris, Organon, Otsuka, Pfizer, BMS, Korean Research-based Pharmaceutical Industry Association, MSD will start their annual year-end holidays from the 25th. This means that 16 pharmaceutical companies will close their doors on Christmas Day. Most other companies including Gilead, Lilly, Merck, Biogen, Bayer, Janssen, GSK will be taking their year-end holidays by using their annual leaves. Although the employees are advised to use their annual leaves as they please, these employees will also be enjoying over 10 days as year-end holidays. Regardless of the designated holiday period, many employees have already been using their annual leaves to start their break early from this week. A pharmaceutical company official said, “Many employees are enjoying over 20 days of the holiday by using their annual leaves before and after the set days. I am pleased to be able to take the time to recharge as this year has been particularly exhausting for us and the industry with the aftermaths of COVID-19, among others.”
- Company
- JW Pharm to discuss technical partnerships for its gout Tx
- by Lee, Seok-Jun Dec 22, 2021 05:56am
- JW Pharmaceutical will be discussing technical partnerships for its key new drug candidates such as URC102 and JW2286 with global pharmaceutical companies. On the 20th, JW Pharmaceutical announced that it will be attending the ‘2022 JP Morgan Healthcare Conference’ that will be held online from the 10th next month (local time) and introduce its research projects to overseas pharmaceutical companies and global investors and conduct one-on-one virtual partnership consultations. The company plans to discuss tech partnerships for its self-developed innovative drug candidates at the conference. For example, the company will be promoting the technology export of its gout treatment URC102 to the global market, other than China. JW Pharmaceutical had signed a technology transfer agreement for URC102 with a Chinese company, Simcere Pharmaceutical, in 2019. The safety and efficacy of URC102 were demonstrated through a Phase 2b clinical trial that was completed in March. The company had also started a clinical trial to extend the eligibility of the drug to patients with nephropathies. A Phase III trial on these subjects is expected to start next year. Also, the company will promote technology partnerships for its STAT3-targeted anticancer drug, JW2286. JW2286 inhibits STAT3 and is indicated for the treatment of solid tumors, such as triple-negative breast cancer, gastric cancer, colorectal cancer, etc. The company is conducting nonclinical studies and drug manufacturing research to initiate clinical trials. STAT3 is a protein that promotes the expression of multiple genes. The abnormal activation of STAT3 causes tumor cell growth, proliferation, metastasis, and drug tolerance, but none had succeeded in developing anticancer drugs targeting STAT3 so far. Also, JW Pharmaceuticals will share its latest research and clinical development strategies on JW0061, a new drug candidate for hair loss that differentiates and promotes hair follicle stem cells involved in hair formation by activating the Wnt signaling pathway that regulates cell proliferation and regeneration, and JW1601, a drug that is extending its indication to age-related macular degeneration and ophthalmologic diseases such as allergic conjunctivitis, etc.. Around 1,500 pharmaceutical and bio companies from 50 countries attend the JP Morgan Healthcare Conference every year. Companies attend the conference to introduce their pipelines and technology to global healthcare companies. Also, participating companies are provided with an opportunity to meet with funds like venture capitals, hedge funds, PFEs, etc.
- Company
- "MET-targeted therapy as a new personalized NSCLC solution"
- by Eo, Yun-Ho Dec 21, 2021 06:05am
- Professor Ji-Youn Han HER2, ALK, EGFR, ROS1, NTRK. These keywords have been frequent visitors in articles on anticancer drugs recently. With the discovery that effective anticancer treatments differ depending on the patient’s genetic mutation status, personalized treatments that target specific genes of each individual are being introduced. And the development of precision medicine has heralded the paradigm shift of cancer treatments to ‘gene-specific treatment’ from ‘diseases-specific treatment.’ Amid rising expectations, the first anticancer treatment that targets the MET gene was newly introduced to Korea. The treatment, Novartis’ ‘Tabrecta (capmatinib),’ was authorized for the treatment of metastatic non-small cell lung cancer (NSCLC) with MET exon 14 deletions. The new introduction of an option in this rare type that occurs in approximately 3-4% of patients with NSCLC is gaining much attention in the medical community. Dailypharm met with Ji-Youn Han, Professor of Hemato-oncology at the National Cancer Center to hear about the use and potential of MET-targeted anticancer therapies and personalized treatment that has been implemented but is yet unfamiliar to the general public. - A treatment that targets the MET mutation has landed in Korea. What significance does the introduction of this new drug bring to the lung cancer treatment paradigm? The MET exon 14 skipping mutation is very rare in lung cancer. Various clinical trials have confirmed that exon 14 skipping mutation is an oncogenic driver mutation of lung cancer. Also, patients who have MET amplification or overexpression have very poor prognoses. In this sense, the approval of Tabrecta, a treatment that demonstrated clear efficacy in MET exon 14 skipping mutation, holds great significance as the prompt introduction of MET inhibitors has become ever important. - Not many patients may be eligible to use the drug. How many will be eligible, in Korea and what other characteristics do eligible patients have? In the West, patients with MET exon 14 skipping mutations account for approximately 3% of all NSCLC patients, In Korea, the reported rate is around 2-3%. One clinical feature of the disease is that it occurs more often in elder patients than younger patients. According to clinical studies, the median age of patients was around 70. -How is the MET diagnosis environment in Korea? Several hospitals have brought in NGS testing devices after NGS-based gene panel tests were applied selective reimbursement in 2017. The MET gene is an important oncogenic driver gene that is included in most NGS panels. However, identification of MET exon 14 skipping mutation is diagnostically difficult and requires further considerations. Also, by genetic mutations, some are more fit for RNA-based NGS tests rather than DNA-based NGS tests. In particular, identifying MET exon 14 skipping mutation through a DNA-based NGS test requires further detailed diagnosis to identify hundreds of mutations that can cause exon 14 skipping mutations. On the other hand, as an RNA-based NGS test can easily discern exon 14 skipping mutations, the RNA-based NGS test may be needed to identify exon 14 skipping mutations. But in practice, RNA-based tests are used less than DNA-based tests. - Commercialization of other MET inhibitors like tepotinib is also imminent. The MET inhibitor tepotinib had differentiated patients according to treatment experience in its clinical design. According to the Phase II GEOMETRY mono-1 trial, patients who used Tabrecta as first-line had shown higher objective response rates (ORR). On the other hand, the response rate was similar in patients using tepotinib regardless of treatment history. The efficacy and safety of the two were comparable in clinical trials. The IC50 value of the two drugs that determine how much of a drug is needed to inhibit cell growth by 50%, was slightly better for Tabrecta. However, most anticancer drugs are best effective in the subject patients when prescribed at the earliest. In particular, not all patients with MET exon 14 skipping mutations who have high PD-L1 expression respond to immunotherapy treatment. Using a combination of immunotherapy-chemotherapy as first-line can increase the financial burden borne by the patients and even be less effective than Tabrecta. This is why some advanced countries like Canada believe it is necessary to thoroughly check for MET exon 14 skipping mutations by using biopsy as well as liquid biopsies in order to reduce patient burden. -Also, studies on the combined use of MET inhibitors and EGFR TKIs are also active. In particular, there are expectations that the MET inhibitors may resolve the resistance issue of 3rd generation EGFR TKIs. Around 10% of the EGFR mutated lung cancers occur due to METs. This is why a smart MET inhibitor partner may be needed to address the acquired resistance to EGFR TKI. There had been a clinical trial that tested the combined use of Tabrecta and EGFR TKI. As it is unclear which causes EGFR mutations in lung cancer - MET amplification or overexpression – the study enrolled both patients. In the trial, a patient with EGFR exon 19 deletion mutation who have experienced primary resistance participated in the trial and reached complete remission (CR). One thing to note is that we do not need to only use 3rd generation EGFR TKIs like ‘Tagrisso (osimertinib)’ when attempting combination therapies. Not only because of the price, but I believe that 1st and 2nd generation EGFR TKIs can also be sufficient partners. Also, a study on Tabrecta+Tagrisso in patients with EGFR resistance is in progress, which medical institutions in Korea are also planning to participate in.
- Company
- Is there a shortage of chickenpox vaccines?
- by Moon, sung-ho Dec 21, 2021 06:05am
- Contrary to the opinions of the medical community, SK Bio and GC Pharma said, "There is no problem in supplying chickenpox vaccines." The shortage of influenza (flu) vaccines in the second half of this year is causing confusion due to concerns that chickenpox vaccines may also be insufficient. Pharmaceutical and bio companies that produce chickenpox vaccines say there is no problem with supply, but there are already opinions that they should prepare for the shortage of vaccines at medical sites centered on related societies. According to the medical and pharmaceutical industries on the 25th, GC Pharma's "Barycela" is currently available for vaccination. There are 'Vari-L Vaccine' by Boranpharma and Sky Varicella by SK Bioscience. Among them, as the government recently declared "With Corona", there are opinions concerned about the increase in the number of people with infectious diseases such as flu and chickenpox at the medical site. Professor Eom Joong-sik (Infectious Medicine) at Gil Hospital said, "According to related data, infectious medicine doctors believe that the rate of wearing masks has definitely fallen. Considering that the flu and chickenpox are often occurring, the amount of contact is increasing." Accordingly, medical scientists and societies are concerned about the shortage of chickenpox vaccines and are preparing for the possible shortage of vaccines through changes in vaccination guidelines internally. There is a sense of crisis due to the fact that they already experienced a shortage of flu vaccines in the second half of the year. Currently, the government is vaccinating chickenpox vaccines free of charge for infants 12 to 15 months old. A KAPID executive said, "GC Pharma has stopped supplying chickenpox boxes and the launch of a next-generation vaccine, an alternative item, is also being delayed. It was originally scheduled to be released last year, but it was postponed to early this year, but we haven't heard of the release plan yet. As a result, we believe there is a possibility that the launch will be delayed further, he hinted. Another KAPID executive said, "In the case of chickenpox, if there is a shortage of vaccines, we are internally sharing the opinion that new, that is, initial vaccinations should be delayed and patients subject to secondary vaccinations should be vaccinated first." He then said, "It hasn't happened yet, so we're preparing for now." He said, "It would be fortunate if SK Bioscience, which accounts for the largest volume, supplies it normally." Pharmaceutical and bio companies that are supplying chickenpox vaccines to Korea say there is no problem at the moment. They say they are overly concerned at the clinical site. GC Pharma explains that it can supply its new product Barycela in earnest from the second half of this year, replacing Suduvax, which has decided to suspend supply. It is true that the plan to start supply in January this year after obtaining product approval in March last year has been delayed due to problems such as prolonged Corona and delayed NIP registration, but it has entered the normalization stage from the second half of the year. An official from GC Pharma said, "After deciding to stop supplying Suduvax, we will be able to supply Barycela, which was developed as a next-generation vaccine, without any problems. As a result of internal confirmation, we believe that the supply is going well enough." SK Bioscience, which accounts for the largest portion of the domestic chickenpox vaccine supply, is in a position that there will be no problem in supplying vaccines like GC Pharma. An official from SK Bioscience said, "As of the third quarter, Sky Varicella's share among chickenpox vaccines in Korea was 43%," and emphasized, "In the case of flu vaccines, there were some difficulties in producing and supplying chickenpox vaccines."
