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- 2026-05-07 16:19:06
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- Dong-A ST introduces candidate substance technology
- by Kim, Jin-Gu Dec 22, 2022 05:52am
- Global joint development of immuno-cancer drugs under the mechanism of double fusion antibodies and acquisition of exclusive sales rights Dong-A ST announced on the 21st that it has signed a license agreement with Kanaph Therapeutics to license candidate substances for immuno-cancer drugs under the dual fusion antibody mechanism. Dong-AST will introduce global joint research and development and exclusive sales rights of preclinical immuno-cancer drug candidates held by Kanaph Therapeutics, a domestic pharmaceutical bio-venture. Dong-AST will pay Kanaph 5 billion won in advance and up to 18 billion won in additional payments depending on the development milestone. It also plans to pay up to 180 billion won more depending on sales if it succeeds in commercialization. Royalty is separate and will be paid at a certain rate according to the sales profit after the product is released. According to Dong-AST, the substance is an antibody and cytokine fusion protein. It is a mechanism to activate immunity by transferring cytokines specifically to tumors using antibodies to proteins expressed in the tumor microenvironment. At this time, cytokines are not delivered to normal tissues, so side effects of systemic immune activity can be prevented.
- Company
- PO SMA tx Indication of Evrysdi expands
- by Eo, Yun-Ho Dec 21, 2022 06:05am
- Evrysdi, a PO SMA treatment, can be used for infants under 2 months in Korea. According to related industries, Evrysdi recently obtained approval from the Ministry of Food and Drug Safety to expand the indication. Accordingly, Evrysdi can be administered to newborns before symptoms appear in Korea. The expansion of neonatal indications was based on the results of phase 2 clinical RAINBOWFISH. In the study, the efficacy, safety, pharmacokinetics, and pharmacokinetics of Evrysdi were evaluated for asymptomatic SMA patients who were genetically diagnosed up to 6 weeks of age regardless of the number of SMN2 genes. The primary target point was set as the proportion of patients who could sit without assistance or support for 5 seconds. By the time of the data cutoff, a total of 26 patients were registered. Their age was 28.5 days (central value), and they were diagnosed with SMA based on genetic testing but had no symptoms. Evrysdi, the first PO option as an SMA treatment, has the advantage of being able to be customized according to age and weight. The process of registering insurance benefits is still slow. It is not on the HIRA's public list of any committees. It remains to be seen whether Evrysdi will be able to expand its coverage in 2023 along with the expansion of the indication. Meanwhile, Biogen's Spinraza and Novartis' Zolgensma are currently listed in the SMA area in Korea.
- Company
- Organon sold 3 types of infertility & contraceptives
- by Dec 21, 2022 06:05am
- Organon announced on the 19th that it will conduct direct sales and marketing of infertility and contraceptive products. According to Organon, the company will directly sell and market the infertility treatments Puregon and Organutran, and the implantable contraceptive Impranon in the body from next year. The company explained that it is a strategic business decision to realize the promotion of women's health. The goal is to strengthen competitiveness in infertility and contraception markets, including existing women's health products. Impranon will start direct marketing on January 1, 2023. Puregon and Orgalutran will be in charge of Organon Korea after the co-promotion contract with Han Wha, scheduled for the first half of next year. The three products that are converted to direct sales are representative infertility and contraceptive drugs sold in Korea over the past 20 years. Puregon has established himself as a representative of follicle-stimulating hormone, an ovulation-inducing agent. Orgalutran is a GnRH antagonist and has been used to prevent early ovulation spikes in women undergoing hyperovulation induction for assisted reproduction.Impranon is a long-term persistent reversible contraceptive inserted under the skin, with a 99% contraceptive effect lasting up to three years. CEO Kim So-eun said, "We will make significant progress in promoting women's health by strengthening expertise and differentiating based on various women's health product portfolios."
- Company
- Verzenio attempts reimb in early breast cancer in Korea
- by Eo, Yun-Ho Dec 20, 2022 06:06am
- The anticancer drug ‘Verzenio’ is attempting reimbursement listing for early breast cancer in Korea. According to industry sources, Lilly Korea has recently submitted an application for the reimbursement listing of its CDK4/6 inhibitor ‘Verzenio (abemaciclib)’ as a treatment for early-stage breast cancer with a high risk of recurrence. The company has been rapidly progressing its reimbursement procedure since the drug’s indication was expanded last month. The drug was approved by the Ministry of Food and Drug Safety as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence, in combination with endocrine therapy. Verzenio’s efficacy in early breast cancer was demonstrated through the monarchE trial. The Phase III monarchE trial was the only trial to confirm successful results in 20 years as an adjuvant treatment for HR+/HER2- early breast cancer in combination with endocrine therapy in 20 years. The results from Cohort 1 of the monarchE trial, which became the basis for the indication expansion last month, showed that Verzenio+endocrine therapy not only demonstrated a reduction in the risk of recurrence compared to endocrine therapy alone through an improvement in invasive disease-free survival (IDFS), but it also confirmed a reduction in risk of remote recurrence through an improvement in distant relapse-free survival (DRFS). Joohyuk Sohn, Professor of Medical Oncology at Severance Hospital said, “Early breast cancer patients mainly experience recurrence after primary treatment in their first 1-2 years. This is why these patients need a more effective adjuvant treatment to reduce the risk of recurrence and death. An unmet medical continued to exist in the field due to a lack of new treatment options for patients with HR+/HER2- early breast cancer after the introduction of aromatase inhibitors in the early 2000s." Verzenio is currently reimbursed in Korea for the treatment of HR+, HER2- advanced or metastatic breast cancer ▴ in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; ▴in combination with Faslodex for women with disease progression following first-line therapy.
- Company
- MSD-Boryung Bio will copromote Prodiax 23 in Korea
- by Dec 20, 2022 06:05am
- On the 19th, MSD Korea announced it has selected Boryung Biopharma as its new distributor and supplier for its pneumococcal vaccine, ‘Prodiax 23.’ Under the agreement, Boryung Biopharma will be distributing and supplying both the private and contract Prodiax 23 products under the National Immunization Program starting January 1, 2023. MSD Korea’s copromotion agreement with its previous supplier, HK.Inno.N, is set to end at the end of this year. MSD Korea explained that the agreement had been made after reviewing the company’s vaccine product portfolio and long-term strategy from various angles. Boryung Biopharma’s main portfolio consists of vaccines and biological agents and owns a stable cold chain system. MSD Korea believed that Boruyng Biopharma’s experience in directly supplying flu vaccines for the NIP will create a synergy effect. MSD’s 23-valent pneumococcal polysaccharide vaccine, Prodiax23, was approved in 2000. The vaccine covers the widest spectrum of serotypes among pneumococcal vaccines available in Korea. People aged 65 or older may receive pneumococcal vaccines for free under the NIP. Jaeyong Cho, Executive Business Unit Director of Vaccines at MSD Korea, explained, “The interest and demand for our pneumococcal vaccine has been rising in line with the rising public interest in infectious respiratory diseases. Our agreement with Boryung Biopharma was made to instantly and actively respond to this rise in demand.”
- Company
- Shingrix presents a new paradigm for shingles prevention
- by Eo, Yun-Ho Dec 20, 2022 06:05am
- Professor YoonKorea GSK's herpes zoster vaccine "Shingrix" announced its official launch. GSK held a press conference at InterContinental Seoul COEX on the 15th to commemorate the launch of Shingrix, a shingles-prevention vaccine, in Korea. At the meeting, Yoon Kyung-young, an infectious medicine professor at Korea University Anam Hospital, introduced the epidemiology of shingles, the risk of diseases and complications, and strategies to prevent shingles through unmet needs and vaccines. Shingles occur when the varicella-zoster virus, a chickenpox-causing virus, is reactivated. Shingles are accompanied by unbearable pain, and some patients may experience neuralgia (post-shingles neuralgia) that lasts for months to years even after the shingles rash disappears. Professor Yoon said, "The risk of shingles is increasing in the elderly, where the immune system is strong and cannot maintain an effective immune response due to aging. "In the elderly and immunodeficiency cases, chronic pain caused by neuralgia after shingles, as well as complications such as invasion of eye nerves, facial paralysis, and damage to the auditory nerve are often leading," he explained. In addition, "Sherpas zoster complications lower the quality of life of patients, so it is important to prevent it in advance as a shingles vaccine." Shingrix emphasized that it will present a new paradigm for preventing herpes zoster in Korea as the first and only recombinant inactivation vaccine in Korea that has proven its preventive effect and safety profile through global clinical research. Under the theme of "Major Clinical Research Results of R&D and Shingrix in Recombinant Shingles Vaccine (RZV)," Kim Hyung-woo, managing director of GSK Medical Department, explained the implications of Shingrix's innovative mechanism and development. Shingrix, a Recombinant Zoster vaccine, is the first shingles vaccine in Korea approved by combining GSK's immune enhancer with a non-live antigen. It can help prevent the risk of developing shingles in adults over the age of 50 due to naturally weakened immunity due to aging. Shingrix showed 97.2% preventive effect in two global phases 3 clinical trials (ZOE-50, ZOE-70) conducted on 15,411 adults over the age of 50, and more than 90% preventive effect in all age groups over the age of 70. Significant adverse reactions were similar in the Shingrix administration group and the placebo administration group. An interim analysis of ZOSTER-049 (ZOE-LTFU) conducted by an extensive study of ZOE-50 and ZOE-70 confirmed that the shingles-prevention effect of Shingrix persists for at least 10 years after initial inoculation. In addition, Shingrix confirmed the safety profile through five clinical trials targeting immunocompromised people aged 18 or older. Based on this, Singrix can be vaccinated even in immunosuppressive diseases such as autologous hematopoietic stem cell transplant patients, solid cancer, blood cancer, and solid organ transplant patients, which have a higher risk of shingles than the general public. "Based on a number of clinical results, Shingrix is an innovative vaccine that is recommended to prevent shingles in adults over 50 years of age, not only in the United States but also in Canada, Germany, and the Netherlands, so it can be an effective alternative to prevent shingles in Korea," Kim said. Meanwhile, Shingrix was approved by the Ministry of Food and Drug Safety in September last year. It can be used for the purpose of preventing shingles in adults over 50 years of age or over 18 years of age who are at high or expected to have an increased risk of shingles due to immunodeficiency or immunosuppression due to disease or treatment. It is available in more than 20 countries worldwide, including the United States, Canada, Germany, Belgium, Australia, and Japan. In Korea, vaccinations are expected to be available at major general hospitals, hospitals, and clinics across the country starting this week.
- Company
- Reimb for Revlimid as maintenance therapy near after 4 yrs
- by Eo, Yun-Ho Dec 19, 2022 04:35am
- After 4 long years of await, Revlimid as maintenance therapy is nearing reimbursement listing in Korea. According to industry sources, the agenda of reimbursing Revlimid as maintenance therapy that has passed deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in June will be deliberated at this year’s final Health Insurance Policy Deliberation Committee meeting. If this last procedure progresses and is completed without issues, the drug’s reimbursement is expected to be expanded from 2023. The agenda of using Revlimid as maintenance therapy had undergone various twists and turns in Korea. Since 2019, BMS Korea had actively sought to list the drug for reimbursement, but made no progress. The agenda has also been listed for deliberation by the CDDC in September 2019, June 2020, then again in September last year at the CDDC meeting that gained attention due to its deliberation of the CAR-T therapy ‘Kymriah (tisagenlecleucel),’ but to no avail. “A drug that prevents or delays recurrence of cancer” This is an extraordinary concept. All cancer survivors would jump to take that option. Revlimid has presented such an option for the first time in the field of multiple myeloma, a type of blood cancer that has a recurrence rate of 70-80%. The National Comprehensive Cancer Network made a Category 1 recommendation for the Revlimid maintenance therapy as the only option allowed for in all patients, regardless of eligibility for transplant. The European Society for Medical Oncology guidelines also recommends Revlimid as the only maintenance therapy to be used after autologous stem-cell transplantation. The significance of Revlimid, which has settled as the global standard of care as a maintenance therapy, has been demonstrated through a meta-analysis of 3 clinical trials (CALGB 100104, IFM 2005-02, GIMEMA RV-MM-PI-209). In a median follow-up of 79.5 months on 1,209 patients, PFS (progression-free survival) of patients that used Revlimid maintenance as monotherapy was 52.8 months, which was a significant improvement from the 23.5 months observed in the control arm that did not use maintenance therapy. the study demonstrated Revlimid’s clinical efficacy with more than double extension in PFS. In the follow-up study that was conducted for 88.8 months, the OS (overall survival) of the control group that did not receive maintenance therapy was 86.9 months. On the other hand, the Revlimid maintenance therapy arm’s OS was 111 months, demonstrating a significant improvement. The study showed that maintenance therapy can be a solution to prevent recurrence and improve the quality of life in multiple myeloma patients that experience frequent recurrence. Since patients with multiple myeloma experience worse symptoms when their cancer recurs, it is most important to prevent or delay recurrence after transplantation. Ki-Hyun Kim, Professor of Hemato-oncology at the Samsung Medical Center (Chair of the Multiple Myeloma Research Committee of the Korean Society of Hematology), said, “The prognosis for multiple myeloma deteriorates significantly and the treatment options narrow greatly with every recurrence, therefore using good treatments at the start of treatment is important. It is a shame that we cannot actively recommend maintenance therapy to patients despite their proven clinical efficacy due to the realistic issue of ‘non-reimbursement’.” “If the maintenance therapy is also approved for reimbursement in addition to RVD therapy, it will greatly improve the long-term quality of life in patients in Korea.”
- Company
- Severe asthma treatment Fasenra seeks reimb in KOR
- by Eo, Yun-Ho Dec 19, 2022 04:34am
- Another severe asthma treatment is attempting insurance reimbursement in Korea. According to industry sources, AstraZeneca is undergoing the reimbursement process for its monoclonal antibody for asthma, Fasenra (benralizumab). Other biological drugs including GSK’s ‘Nucala (mepolizumab),’ and Teva-Handok’s ‘Cinqair (reslizumab)’ have also been reattempting reimbursement in Korea as well. Fasenra was approved in Korea in 2019 as an add-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled with existing treatment options. The drug is administered once every 4 weeks for the first 3 months, then every 8 weeks thereafter. One of the main purposes of asthma management is to reduce the risk of asthma exacerbations. Fasenra directly binds to the alpha subunit of the interleukin-5 receptor (IL-5Rα) to induce apoptosis. The drug demonstrated efficacy in reducing asthma exacerbation and improving lung function. In the global SIROCCO trial that was conducted to evaluate the effect of Fasenra in treating asthma exacerbations in 1,205 asthma patients including 122 Korean patients, the annual rate of clinically significant asthma exacerbations was reduced by 45% in patients who were treated with Fasenra once every 4 weeks, and by 51% in patients who were treated with Fasenra once every 8 weeks. Also, in the CALIMA trial, Fasenra demonstrated a significant reduction in asthma exacerbations compared to the placebo. In the trial, the annual rate of asthma exacerbations was reduced by 36% in patients who were treated with Fasenra once every 4 weeks, and by 28% in patients who were treated with Fasenra once every 8 weeks compared with placebo. In both trials, a change from baseline in mean FEV1 (forced expiratory volume in 1 second) was observed using Fasenra, and a consistent improvement compared with placebo. The long-term efficacy and safety of Fasenra in severe eosinophilic asthma were evaluated through the BORA trial, a long-term extension trial on 1,926 patients that participated in the SIROCCO and CALIMA trials. In terms of safety, Fasenra showed no significant difference compared to the placebo, and 72% of the patients that were administered Fasenra did not experience asthma exacerbations and were able to maintain their FEV1. Surprisingly enough, asthma is associated with a high mortality rate. The mortality rate of hospitalized patients due to asthma exacerbation is nearly 1/3, and the expenses spent by patients that require emergency treatment or hospitalization due to asthma exacerbation account for more than 80% of the total asthma-related cost, representing a high burden of social cost. Eosinophilic inflammations are found in 50% of all asthma patients and may lead to reduced lung function or asthma exacerbations. In particular, eosinophilic asthma patients that show increased blood eosinophil levels despite appropriate ICS therapy are inadequately controlled with existing treatment therapy including ICS and LABA therapy. Therefore, the quality of life of these patients is threatened by the pain caused by the symptoms and the frequent exacerbation of the disease. Meanwhile, AstraZeneca sought to expand its indication to uncontrolled Fasenra to chronic rhinosinusitis with nasal polyp (CRSwNP), but FDA turned down the final approval and requested additional data.
- Company
- Asthma treatment Cinqair attempts reimb again in Korea
- by Eo, Yun-Ho Dec 15, 2022 05:55am
- The asthma treatment Cinqair for asthma is again attempting reimbursement listing in Korea. According to industry sources, Teva-Handok has recently submitted an application for the reimbursement listing of its interleukin-5 antagonist monoclonal antibody Cinqair (reslizumab). Following Cinqair’s steps, other biological drugs for asthma including GSK Korea’s ‘Nucala (mepolizumab) are also moving to start their reimbursement listing processes as well. As an interleukin-5 antagonist, Cinqair reduces levels of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. The drug had first been first approved in Korea in 2017 as an add-on maintenance treatment for adult patients with an eosinophilic phenotype of asthma (those who have a blood eosinophil count of at least 400/㎕ before treatment) that were not adequately controlled with existing treatments. The company had applied for its reimbursement being launched without reimbursement in 2018 but failed. Teva-Handok has been jointly marketing Cinqair with Handok Pharmaceutical since its release. Meanwhile, Cinqair’s efficacy had been demonstrated through five placebo-controlled clinical studies that evaluated the safety and efficacy of Cinqair 3mg/kg in 1,028 adult and adolescent asthma patients that were uncontrolled with currently available therapies. In three Phase III clinical trial programs that were conducted on asthma patients with high blood eosinophil counts, Cinqair reduced the frequency of asthma exacerbations by up to 59% and significantly improved lung function, symptoms, and the asthma-related quality of life. Also, Cinqair received attention for releasing the post-hoc analysis results of asthma patients that require Step 4 and Step 5 treatment among all patients that participated in the Phase III trials. Cinqair reduced the clinical degree of asthma exacerbations in patients classified as Step 4 or 5 under the Global Initiative for Asthma guidelines by 53% and 72%, respectively, and increased the level FEV1 (forced expiratory volume in 1 second) by 103ml in Step 4 patients and by 237ml in Step 5 patients, demonstrating that the benefit was found to be greater in Step 5 patients.
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- Verzenio expects to address the unmet demand
- by Eo, Yun-Ho Dec 15, 2022 05:55am
- Professor Son Joo-hyuk Expectations are high for securing early breast cancer indications for Verzenio, a breast cancer treatment with CDK4/600 inhibition mechanism. Lilly Korea held a press conference on the 14th to commemorate the expansion of permission for early breast cancer indications at high risk of recurrence of the anticancer drug Verzenio. Verzenio obtained approval from the Ministry of Food and Drug Safety on the 18th of last month as a treatment used in combination with hormone receptor-positive, human epithelial cell growth factor 2 negative (HR+/HER2-), early breast cancer adult patients at high risk of recurrence of lymph node-positive, and endocrine therapy. Verzenio's approval is meaningful in that the first CDK 4&6 inhibitor for early breast cancer patients at high risk of HR+/HER2-lymph node-positive recurrence was introduced in Korea. Sohn Joo-hyuk, a professor of oncology at Severance Hospital, shared the medical unfulfilled needs of HR+/HER2-lymph node-positive recurrence early breast cancer patients and the clinical value of Verzenio confirmed through the monarch clinical study, which was the background of approval of MFDS. In the first topic of the presentation, "HR+/HER2-High-Risk Early Breast Cancer Patients' Medical Unfulfilled Demand," Professor Sohn said, "Most of the female cancers in Korea are diagnosed early due to screening activation, especially in the standard treatment of HR+/HER2- patients, to prevent recurrence after surgery. He added, "The prognosis of HR+/HER2-early breast cancer is generally known to be good, but high-risk patients are highly likely to recur, making it difficult to expect long-term survival." According to domestic statistics, the survival rate of general early breast cancer patients is more than 90%, which is higher than that of other diseases. However, patients with recurrence risk factors such as lymph node-positive, high tumor grade, large tumor size, and fast cell proliferation are known to have a higher risk of remote recurrence and death than general patients. Studies have shown that if the tumor size exceeds 5cm, the 5-year survival rate of breast cancer patients decreases from 57% (without lymph node metastasis) to 21% (with lymph node metastasis). Professor Son said, "The recurrence of early breast cancer patients after the first treatment is usually one to two years, and more effective postoperative auxiliary treatment is needed to reduce the risk of recurrence and death." However, since the introduction of aromatase inhibitors in the early 2000s, the absence of new treatment options for HR+/HER2-early breast cancer patients has led to a medical non-fulfillment demand." Verzenio's monarch clinical trial is the only study that has confirmed successful results in about 20 years as a combination of endocrine therapy as an adjunct treatment for HR+/HER2-early breast cancer. In monarch cohort 1, which served as the basis for this indication expansion permit, Verzenio+ endocrine therapy confirmed remote recurrence risk reduction results through Distance Relapse-Free Survival (DRF) indicators as well as Invisible Disease-Free Survival (IDFS) indicators compared to endocrine therapy alone.
