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- 2026-05-08 14:07:35
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- Chong Kun Dang CKD-701, equivalent to Lucentis' original
- by Chon, Seung-Hyun Nov 24, 2022 05:50am
- A panoramic view of Chong Kun DangChong Kun Dang announced on the 23rd that the results of phase 3 clinical trials of the macular degeneration treatment Lucentis biosimilar CKD-701 were published in the SCI-level international academic journal PLoS One. Chong Kun Dang conducted phase 3 clinical trials of CKD-701 in 312 patients with neovascular age-related macular degeneration at 25 hospitals, including Seoul National University Hospital, from September 2018 to March 2021. In phase 3 clinical trials, the percentage of patients with vision loss of fewer than 15 characters in the primary efficacy evaluation index comparing the maximum calibration vision (BCVA) at 3 months after drug administration was 97.95% (143/146) in the CKD-701 administration group and 98.62% (143/145) in the original drug administration group. The change in maximum corrected vision (BCVA) improved by 7.14 characters in the CKD-701 administration group and 6.28 characters in the original administration group, showing no significant difference between the two drugs. It was confirmed that drug efficacy, safety, immunogenicity, and pharmacokinetic characteristics were clinically equivalent to the original drug through indicators such as the ratio of patients with less than 15 characters of vision loss and vision improvement, respectively, after 3, 6, and 12 months of drug administration. CKD-701, which was approved by the Ministry of Food and Drug Safety last month, is a high-purity Lucentis biosimilar mainly composed of Ranibizumab. Chong Kun Dang's pure independent technology, which is an antibody fragment raw material manufacturing technology, has been applied. CKD-701 is a drug with clinical equivalence compared to Lucentis, the original drug, in significant indicators, including maximum calibration vision, the primary evaluation index, said Professor Hyung-gon. "Pro Re Nata (PRN) is expected to stabilize the condition of macular degeneration disease and reduce the patient's burden of treatment." PLoS One is an online journal specializing in science and medicine published by the Public Library of Science (PLoS) since 2006. It has been listed on SCIE and SCOPUS, a global academic paper database platform for the past five consecutive years.
- Company
- SK Bio "hasn't manufactured SKYCovione after first batch"
- by Kim, Jin-Gu Nov 24, 2022 05:50am
- SK Bioscience On the 23rd, SK Bioscience publicly announced that the manufacture and supply of its self-developed COVID-19 vaccine ‘SKYCovione’ have currently been discontinued. SK Bioscience received marketing authorization for SKYCovione in Korea in July this year. In September, the company supplied an initial batch of 60 thousand doses of the 10 million doses that the government pre-purchased through an agreement. However, further manufacture and supply of the vaccine have been discontinued. One reason is that the overall vaccination rate has fallen with the slowdown of the COVID-19 outbreak and the increasing number of people with immunity. According to the Korea Disease Control and Prevention Agency, the cumulative number of people vaccinated with SKYCovione in Korea as of November 22nd was only 3,787. In other words, only 0.6% of the 600,000 doses supplied to the government were used. Its performance is sluggish compared to its competitors. The government has been recommending winter season COVID-19 vaccinations from October 11. People can choose from vaccines including SKYCovione, Pfizer’s BA1·BA.4/5-adapted vaccines, Moderna’s BA.1-adapted vaccine, and Novavax’s winter season vaccine. Among these, a cumulative 1,530,332 people received vaccination with Moderna’s vaccine. 754,058 received Pfizer’s vaccine, and 23,156 received Novavax’s vaccine. In the same period, only 1,759 people opted to receive SKYCovione. Due to such circumstances, SK Bioscience plans to continue producing the vaccine solution and wait for additional orders from the government. An official from SK Bioscience said, “Basically, the finished vaccine product is manufactured when requested by the government. We are not producing additional finished vaccines because we have not received additional requests after the initial supply." “Apart from the finished product, we have been manufacturing the vaccine solution. We will resume production and supply the request of the government in the future” The official added, “We are also undergoing global approval processes.” In July, the company applied for a Conditional Marketing Authorization (CMA) of SKYCovione (SKYCovion™ in Europe) to the Medicine and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), and then submitted an Emergency Use Listing (EUL) application to the World Health Organization in September. However, the applications have not been approved yet.
- Company
- Kadcyla can be prescribed after registering benefit
- by Eo, Yun-Ho Nov 23, 2022 06:04am
- According to related industries, anticancer drugs such as ADC and Antibody-drug conjugate Kadcyla and CDK4/600 inhibitor Verzenio are entering the early breast cancer area in Korea. Kadcyla was already listed on the insurance benefit list in July, and the actual prescription began. The drug, which was used for the second or more treatment of HER2-positive metastatic breast cancer, has expanded access to postoperative adjunct therapy in HER2-positive early breast cancer patients with invasive residual lesions after receiving prior chemotherapy, including Taxane and Trastuzumab. The effectiveness of Kadcyla's early breast cancer was confirmed through an open-label study in phase 3 (KATHERINE). KATHERINE is a study comparing the efficacy and safety of the Kadcyla-only and Trastuzumab-based preoperative adjuvant group in 1,486 HER2-positive early breast cancer patients who were confirmed to have invasive residual lesions in the surgical site or armpit lymph nodes even after undergoing taxane and Trastuzumab-based preoperative adjuvant therapy. As a result of the study, the 3-year invasive disease-free survival (iDFS) of the Kadcyla solo administration group was 88.3%, an 11.3% improvement over the Trastuzumab solo administration group (77.0%), and a 50% reduction in the risk of disease recurrence or death. Verzenio succeeded in securing HER2-negative early breast cancer indication. This drug obtained additional approval from the Ministry of Food and Drug Safety on the 19th for HR+/HER2-, high-risk early breast cancer with lymph node-positive recurrence. The enlargement of the indication was based on the results of the Phase III clinical study cohort 1 of Verzenio's monarchE in 5,637 adult women and men at high risk of lymph node-positive type HR+/HER2- who underwent resection. As a result of the monarchE study, both IDFS (Invisible Disaster-Free Survival) and DRFS (Distant Relapse-Free Survival) at the time of follow-up 3 years showed significant improvement compared to the control group in the Verzenio administration group. The Verzenio administration group showed a 30% reduction in risk of recurrence and death within 3 years compared to the control group (88.8% of the 3-year IDFS ratio with Verzenio+endocrine therapy, 83.4% of the endocrine therapy alone), and a 31% decrease in risk of remote recurrence and death. The proportion of early breast cancer patients, which is between 0 and 1, accounts for more than half of the total breast cancer patients (as of 2018), emphasizing the importance of reducing recurrence rates through optimal treatment.
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- Imjudo is expected to be introduced in Korea
- by Eo, Yun-Ho Nov 23, 2022 06:03am
- Another immuno-cancer drug with CTLA-4 inhibitory mechanism is expected to be introduced in Korea. According to related industries, AstraZeneca Korea has submitted an application for domestic permission for CTLA-4 inhibitor Imjudo, a partner in combination therapy for PD-L1 inhibitor Impinzi. The combination therapy of Impinzi and Imjudo was approved by the U.S. FDA last month as an irreversible hepatocellular carcinoma treatment. Combination therapy is the only dual immuno-cancer therapy allowed to date for the first round of liver cancer. Combination therapy is a STRIDE (Single Tremelimumab Regular Interval Durvalumab) strategy in which Impinzi is additionally administered at regular intervals every 4 weeks after one dose of Impinzi 1500 mg and Imjudo 300 mg. This combination therapy demonstrated OS benefits in phase 3 clinical HIMALAYA study, lowering the risk of death by 22% compared to the control Nexavar monotherapy. The overall survival rate in the third year was 31% in the Impinzi and Imjudo combination therapy group and 20% in the Sorafenib monotherapy group. Imjudo combination therapy recently added a lung cancer indication in the United States. In phase 3 clinical POSEIDON study on which the permit was based, the patient group receiving a combination of Impinzi, Imjudo, and platinum-based chemotherapy showed a 23% lower risk of death compared to various chemotherapy controls. The overall survival rate in the second year was 33% in the combined group and 22% in the control group. Meanwhile, Imjudo is conducting a phase 3 study of combination therapy with Impinzi in several types of cancers, including local liver cancer (EMERALD-3 study), small cell lung cancer (ADRIATIC study), and bladder cancer (VOLGA and NILE study).
- Company
- Attention focused on whether Luxturna will be reimb in Korea
- by Eo, Yun-Ho Nov 22, 2022 06:04am
- Discussions on expanding coverage of the one-shot gene therapy ‘Luxturna’ is not making much progress. Therefore, the industry’s eyes are on whether Novartis Korea’s Inherited Retinal Dystrophy (IRD) treatment Luxturna (voretigene neparvovec) will be presented as an agenda for deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee within this year. Novartis Korea applied for reimbursement of the drug in September last year, but no news has been heard on its passage of the Drug Reimbursement Standard Subcommittee until now. However, based on the speed of progress, the drug can still be listed in the first half of next year at the earliest. By replacing the defective or defective RPE65 gene - one of the causes of IRD - with a normal gene, Luxturna restores the visual function of an IRD patient with a single administration. In other words, the drug provides a fundamental cure for IRD. After being granted a Breakthrough Therapy Designation by the FDA in 2014, the drug was approved as an orphan drug in 2016, then granted priority review and a fast-track designation in 2017. IRD is a rare disease in which vision loss occurs due to mutations in genes responsible for the structure and function of retinal photoreceptors. In addition to over 20 ophthalmologic diseases, IRD leads to vision loss and may cause complete blindness in certain patients. There are currently over 300 genes that have been identified as being associated with IRD. IRD, which is caused by the mutation in RPE65 gene, causes abnormalities in the visual cycle of the retina that converts visual information into a neural signal and delivers it to the brain. The mutation in the RPE65 gene reduces the RPE65 protein essential to the visual cycle and destroys the retinal cell, gradually narrowing the field of vision to eventually result in blindness. Meanwhile, the efficacy of Luxturna was established in a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, which was 1.6 points higher than the 0.2 points in the control group.
- Company
- GSK Duodart can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 22, 2022 06:04am
- Duodart, a prostate hypertrophy compound, has settled in general hospitals. According to related industries, GSK Korea's Duodart recently passed DC of Big 5 General Hospitals such as Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Sinchon Severance Hospital. This drug has been applied to insurance benefits since March. Duodart's benefit target is ▲ an International Prostate Symptom Score (IPSS) of 8 or more when administered to positive prostate hypertrophy, ▲ when the size of the prostate is 30ml or higher, the occupational balance test shows moderate or higher benign prostatic hypertrophy, or the Prostate specific antigen (PSA) level meets two conditions: 1.4ng/ml or higher. Duodart is the first combination of Dutasteride and Tamsulosin introduced as a treatment for prostate hypertrophy in Korea and can be used as an oral administration of one capsule once a day to treat symptoms. It was approved by the EU and the U.S. FDA in 2010 and was approved in Korea in May last year. Combination therapy of 5α-reducing urea inhibitor (Dutasteride) and α1a-adrenaline receptor blocker (Tamsulosin HCl) is recommended in global guidelines. The complementary mechanism of two components can be expected to improve symptoms quickly and control the progression of long-term diseases. Duodart showed statistically significantly higher compliance than conventional 5α-reducing factor inhibitors and α1a-adrenergic receptor blockers Free combination through real-world data. The European Association of Urology recommends introducing 5-ARI and α blocker combination therapy from the beginning as an appropriate and effective treatment for prostate hypertrophy patients with severe or moderate lower urinary tract symptoms (LUTS) with increased risk of disease progression. The AUA also recommends the introduction of combination therapy from the beginning to treat prostate hypertrophy. Duodart demonstrated efficacy and safety through a licensed clinical combAT study evaluated against Dutasteride or Tamsulosin monotherapy. In the third month of treatment, the Duodart administration group showed a rapid improvement in symptoms similar to that of the monotherapy administration group, and from 9 months, superior symptom improvement was confirmed, and the effect was maintained until 48 months. In addition, Duodart's combination therapy was 12.6% (17.8% Dutasteride monotherapy and 21.5% Tamsulosin monotherapy) and 4.2% (5.2% Dutasteride monotherapy and 11.8% Tamsulosin monotherapy) in the progression of symptoms of prostate hypertrophy. Chung Chang-wook, a professor of urology at Seoul National University Hospital, said, "With the introduction of Duodart, among prostate hypertrophy patients currently being treated, those who had difficulty suppressing disease progression and improving symptoms with existing drug therapy can choose a new treatment."
- Company
- Evrysdi can be prescribed with non-reimbursement
- by Eo, Yun-Ho Nov 21, 2022 05:56am
- Evrysdi, an eating spinal muscular atrophy treatment, can be prescribed at hospitals and is still non-reimbursement. According to related industries, Roche Korea's Spinal Muscular Atrophy treatment passed through D.C. at medical institutions such as Severance Hospital, Seoul National University Hospital, Yangsan Pusan National University Hospital, and Yongin Severance Hospital. Evrysdi, which was approved in Korea in November 2020, was first approved for "adult and infant SMA patients for more than 2 months." On top of that, the U.S. recently expanded the scope of administration to infants under 2 months of age in the United States. Evrysdi, the first oral 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 sluggish. Solidarity Against Disability Discrimination issued a statement last month when Zolgensma's benefit was applied, calling on the HIRA to abolish the criteria for suspension of Spinraza's benefit, the same SMA treatment, and implementation of Evrysdi discussions as soon as possible. Evrysdi points out that SMA patients are emerging in the blind spot of therapy as the Korea Appraisal Board continues to withhold discussions on benefits just because they will discuss them in the future in line with the adjustment of Spinraza's application standards. Currently, the SMA area lists Biogen's Spinraza and Novartis' Zolgensma. Evrysdi proved its efficacy through a FIREFISH study conducted on infants of 2 months to 7 months and a SUNFISH study conducted on children and adults aged 2 to 25. In SUNFISH conducted in 180 SMA type 2 or type 3 patients, Evrysdi demonstrated improvement in motor function at 12 months when measured with MFM-32, an exercise function evaluation measure. In addition, in FIREFISH conducted on infant SMA patients with type 1 2 to 7 months of age, 88% of patients who received Evrysdi for 2 years continued to survive without a ventilator for 2 years. During the two-year period, 59% of infants could sit unaided for at least 5 seconds on a BSID-III basis, which measures total infant and infant development exercise. In addition, 65 percent of infants were able to hold their throats for a year, 29 percent were able to turn themselves over for a year, and 30 percent were able to stand using support.
- Company
- Dong-AST ended the clinical trial of Stelara biosimilar
- by Chon, Seung-Hyun Nov 21, 2022 05:56am
- A panoramic view of Dong-A ST headquartersDong-AST announced on the 17th that the global phase 3 clinical trial of Stella biosimilar DMB-3115 has ended. Phase 3 of global clinical trials of DMB-3115 was conducted for 52 weeks in a total of 605 patients in 9 countries, including Poland, Estonia, and Latvia, starting in the United States in 2021. Phase 3 of this global clinical trial was conducted with random assignment, double-blinding, multi-organ, and active-controlled trials to compare the efficacy, safety, and immunogenicity of DMB-3115 and Stelara subcutaneous injection in moderate to severe chronic plate psoriasis patients. Clinical samples produced by STGEN BIO, a biopharmaceutical CDMO affiliate of Dong-A Socio Holdings, were used. Dong-AST plans to apply for DMB-3115 item permits in the U.S. and Europe in the first half of 2023 when positive data are derived by analyzing the results of phase 3 global clinical trials. Stelara, developed by Janssen, is a treatment for inflammatory diseases such as plate psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is a blockbuster product that recorded sales of 9.134 billion dollars (about 11.64 trillion won) last year. Since 2013, Dong-A Socio Holdings has promoted the joint development of the DMB-3115 with Meiji Seika Pharma. In July 2020, Dong-AST took over the right to develop and commercialize the global development project with the aim of promoting the efficiency of the global development project and jointly developed it with Meiji Seika Pharma. In 2019, phase 1 European clinical trials comparing the pharmacokinetic properties of DMB-3115 and Stelara in healthy adults demonstrated pharmacokinetic similarities between DMB-3115 and Stelara. Dong-AST signed a technology export contract for DMB-3115 with multinational pharmaceutical company Intas Pharmaceuticals in July last year. Intas Pharmaceuticals has secured exclusive rights to licenses and sales in global regions except for Korea, Japan, and some Asian countries. Global commercialization will be handled by Accord Healthcare, a subsidiary of Intas Pharmaceuticals. Dong-AST and Meiji Seika Pharma are responsible for the research and development of DMB-3115 and for the exclusive supply of products to Intas and Accord Healthcare.
- Company
- KPBMA visits Boston...expands exchanges with MIT, etc.
- by Chon, Seung-Hyun Nov 18, 2022 06:04am
- On the 14th (local time) KPBMA Director Hee-Mok Won (8th from the left), Huons Vice Chairman Sung-Tae Yoon (9th from the left), MIT Corporate Relations Executive Director John Roberts is taking a commemorative photograph at the EB that was held at MIT ILP Office at Boston, Cambridge, US On the 17th, Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) announced that its delegation had visited Boston, US to network with local companies and institutions. Hee-Mok Won, Director of KPBMA, Sung-Tae Yoon, Chairman of KPBMA, and other representatives of Korea’s pharmaceutical and bio business attended the executive briefing (EB) prepared through MIT Industrial Liaison Program (ILP) especially for Korean companies for 4 days from the 14th. In June 2020, KPBMA became the first association to join the consortium-type membership in the history of MIT ILP. The EB held this time was the first face-to-face event since the KPBMA became a member, and was held to directly communicate with MIT’s innovation ecosystem. At the event, member companies in the consortium discussed research technologies face-to-face with MIT's top professors in the field of their interest, such as oncology and new drug development. Also at the event, Professor Connor W. Coley from MIT presented on the development of AI-based organic compound synthesis. Also, Professor Arturo Vegas from Boston University and Sean Quinnell presented pm a small molecule inhibitor to the cytokine interleukin-4 related to inflammation and cancer. Then, presentations from MIT spin-off companies followed, including presentations on ▲Small molecule new drug development platform (Deepcure), ▲Innovative treatment methods for resting cancer cells (Felicitex Therapeutics), ▲ Effective drug delivery technology using high molecule dissociation oral administration (Veramorph), ▲Groundbreaking blood clotting diagnostics platform (Coagulo Medical Technologies). Heads and Business Development and R&D executives from Korean pharmaceutical and bio companies including Samjin Pharm, Yuhan Corp, Ildong Pharmaceutical Hanmi Pharmaceutical, and Huons sought partnership opportunities with startups that own advanced biotechnology in addition to MIT’s various academic achievements. After the event, the delegation visited Ginkgo Bioworks, a world-class biofoundry company, to discuss ways to cooperate with domestic companies. Ginko Bioworks, a bioventure that spun off from MIT in 2008, owns its own cell programming platform and provides services that meet the needs of customers in various industries. KPBMA Director Hee-Mok Won said, “In only three years since Korean pharmaceutical companies entered the Cambridge Innovation Center (CIC) and began industry-academia cooperation with MIT in earnest, more than 15 companies have entered the market. We will expand cooperation with Boston’s innovative ecosystem including MIT and new startups to bring practical results.”
- Company
- Generic companies won 9 out of 10 patent disputes
- by Kim, Jin-Gu Nov 17, 2022 05:54am
- In a patent dispute between the original company and the generic company over generic for exclusivity, a study found that the generic company's first trial winning rate reached 88.5%. Lee Myung-hee, a senior researcher at the KIIP, announced the results of the impact assessment of the licensing patent-linked system at the 2022 Pharmaceutical Intellectual Property Policy Forum co-hosted by the Ministry of Food and Drug Safety and the Korea Intellectual Property Protection Agency on the 15th. According to the researcher, a total of 1,087 patent trials have been filed over the nine years since 2013 until the end of last year. Generic companies have a winning rate of 88.5%. Generic companies claim the patent held by the original company in three ways. They include a passive judgment for confirming the scope of rights, a judgment for invalidation, and a judgment for invalidation of the extension of the duration. Among them, the passive judgment on the scope of rights has the highest winning rate for Generic companies. Since 2013, 795 passive rights scope confirmation trials have been filed, of which 767 (96.5%) have been cited. Some citations include 19 cases (2.4%), 8 cases (1.0%), and 1 case of withdrawal. If Generic companies request a passive judgment on the scope of rights, 98.9% of them were cited or partially used. In the case of invalidation trials, the winning rate of General Motors is a little low at 78.9%. A total of 218 invalidation trials were filed over the nine years from 2013 to last year, of which 161 (73.9%) were cited and 13 (6.0%) were partially cited. The winning rate of generic companies, which combines citation and partial citation, is 79.8%. The Korean Intellectual Property Tribunal's rejection (24 cases), partial dismissal (13 cases), and withdrawal (7 cases) were 20.2%. In other words, if General Electric filed for invalidation judgment, the original company succeeded in one out of five cases. Generics have not won the trial that was filed to invalidate some of the extended patent duration. There were a total of 74 trials for invalidation of the extension of the patent duration from 2013 to last year. Among them, only two cases (2.7%) were cited. There were 68 cases of rejection (91.9%), and 4 cases of withdrawal (5.4%). This means that most of the original companies won the dispute over the extended patent duration. Lee Myung-hee, a senior researcher, said, "The Ministry of Food and Drug Safety's approval rate for generic exclusivity sales items is 79.2%, which can be interpreted as meaning that generics are taking on patent challenges with considerable grounds."
