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- 2025-12-24 12:42:38
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- Bladder cancer drugs/new mechanisms appear one after another
- by Eo, Yun-Ho Mar 31, 2023 06:09am
- New treatment options for urothelial cancer are emerging one after another. Domestic commercialization of new drugs such as targeted anticancer drugs and antibody-drug conjugates (ADCs) is underway. Janssen's Balversa, which was approved at the end of last year, is suitable for patients with metastatic urinary tract disease with FGFR2 or 3 mutations who have progressed despite treatment with at least one chemotherapy agent or who have progressed within 12 months of adjuvant therapy before and after surgery including platinum-based chemotherapy. It can be prescribed for patients with epithelial cancer (bladder cancer). Bladder cancer is representative cancer for which there is no targeted anticancer drug. Balversa has become the first targeted anti-cancer drug for bladder cancer with a new mechanism of FGFR (fibroblast growth factor receptor) inhibition. FGFR is one of the biosignals involved in cancer cell growth and is associated with several carcinomas. In particular, FGFR mutations are commonly observed in bladder cancer, and about 20 to 30% of patients are known to have mutations. Phase 2 BLC2001, which served as the basis for Balversa's approval, targeted 99 patients with locally advanced metastatic urothelial cancer with FGFR mutations. The objective response rate of 87 evaluable patients was 32.2% based on the IRRC evaluation standard. The disease control rate was 78%, and the median duration of response was 5.4 months. mPFS and mOS were 5.5 months and 13.8 months, respectively. Astellas Pharmaceuticals' ADC drug 'Padcep (Enfotumabvedotin)' obtained domestic approval on the 10th. This drug can be prescribed for adult patients with locally advanced or metastatic urothelial cancer who have ▲PD-1 or PD-L1 inhibitors, ▲and platinum-based chemotherapy. Padcev, which targets the Nectin-4 protein, which is frequently observed on the surface of urothelial cancer cells, binds to Nectin-4 expressed on the cell surface and moves into the cell, inhibiting cell division within the cell. MMAE is released to induce apoptosis of cancer cells. Padcev's approval was a global phase 3 clinical study comparing Padcev with conventional chemotherapy in 608 patients with locally advanced or metastatic urothelial cancer who had prior experience with platinum-based chemotherapy and PD-1/L1 inhibitor treatment. This was done based on the results of EV-301. As a result of the study, the Padcev-administered group reduced the risk of death by about 30% compared to conventional chemotherapy, and the mOS of the Padcev-administered group was 12.9 months, demonstrating a significant improvement in survival time compared to 9.0 months of chemotherapy. Padcev's mPFS was 5.6 months versus 3.7 months for the control group, reducing the risk of disease progression by 38%.
- Company
- Generic for Godex development has come to an all-stop
- by Nho, Byung Chul Mar 31, 2023 06:09am
- As pharmaceutical companies preparing to release generics for Godex announced that they would give up development, Celltrion Pharm is expected to dominate. According to the industry, about three pharmaceutical companies have been identified that are preparing generics for Godex, but drug development has been suspended due to development difficulties/declining product margins. Reasons for stopping the release of generics can be roughly divided into difficulties in 'registering DMF' and 'securing bioequivalence', as well as rising costs following continued drug price cuts. In the meantime, the price of Godex is currently listed at 312 won after going through ten price cuts from 422 won at the time of permission in 2009. When a generic is released, the drug price will drop to W166, which could significantly lower margins to 144 won, the price of Nissel for a single Pharmaking BDD. Godex contains Biphenyl Dimethyl Dicarboxylate/BDD 25mg as the main ingredient, Carnitine Orotate 150mg, Adenine Hydrochloride 2.5mg, Antitoxic Liver Ext. 12.5mg, Cyanocobalamin 125μg, Pyridoxine Hydrochloride 25mg, and Riboflavin. In addition, it is observed that the biggest obstacle is the certification and confirmation of the drug substance registration (DMF) of Antitoxic Liver Ext., one of Godex. Except for some injections, DMF registration has been made mandatory for drug substances used in all medicines since 2017. In the case of Antitoxic Liver Ext., which is extracted from cow liver, DMF is not registered, so generic companies have to bear the burden of proving it by investing a huge amount of money. According to what is known, Celltrion Pharmaceuticals, the original developer, also has different laws and regulations at the time of product development and approval. If the lineup is expanded to tablets (pills) following existing capsules, DMF registration is required, making it difficult to launch new products with the same ingredients. the situation that might be possible. Meanwhile, BDD, the main component of Godex, is known to have been first developed by China's LIU in 1982. There is Pharmaking Nissel for BDD single drug and Pharmaking Pennel for a combination. The first company to launch a BDD single ingredient in Korea was Taerim Pharmaceutical, which changed its name to Pharmaking in 2005. Godex, which obtained permission in January 2000, is a blockbuster drug with 70 billion prescriptions as a 7-drug complex with 25mg of BDD as the main ingredient, the same as Nissel Pennel. BDD, the main component of Godex·Nissel·Pennel, rapidly lowers GPT, the level of liver inflammation, through antioxidant action, normalizes ALT level, and reduces the rebound phenomenon in which ALT rises again when medication is discontinued.
- Company
- Jemperli starts reimbursement process in Korea
- by Eo, Yun-Ho Mar 31, 2023 06:08am
- Jemperli, a new cancer immunotherapy is attempting reimbursement listing in Korea. According to industry sources, GSK Korea has recently submitted an application to list its PD-1 inhibitor Jemperli (dostarlimab) for reimbursement in Korea. With the application, whether another treatment option may be released into the market remains to be seen. Unlike other immunotherapies, Jemperli was first approved as a treatment for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy regimen. Therefore, the company plans to first provide treatment opportunities to patients in need. For the benefit of these patients, GSK has been carrying out an Expanded Access Program (EAP) in 15 major medical institutions in Korea since earlier this year before filing for reimbursement. Endometrial cancer develops in the endometrium, the inner lining of the uterus, and accounts for the majority of cervical cancer. Roughly, 1 out of 4 endometrial cancer patients are diagnosed to be in the advanced stage or experience recurrence, and patients whose disease recurs after platinum-based chemotherapy have limited treatment options. Jemperli’s approval was based on the cohort A1 analysis results of Phase I multicohort GARNET trial that included a cohort of patients with relapsed or advanced dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. In particular, this study had the largest cohort among PD-1 inhibitor monotherapy studies for dMMR/MSI-H endometrial cancer patients among those that have been conducted so far. The major efficacy outcome measures of the study were Objective Response Rate (ORR) and Duration Of Response (DOR) as determined by a Blinded Independent Central Review (BICR) according to (Response Evaluation Criteria Solid Tumors) RECIST v 1.1. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% (95% CI, 34.0-53.4) and the median DOR was not yet reached. Disease Control Rate (DCR) was 55.6%, and the proportions of responses lasting 6 and 12 months were 97.9% and 90.9%, respectively. Jae-Weon Kim, Professor of Obstetrics and Gynecology at Seoul National University Hospital (President of the Korean Society of Gynecologic Oncology), said, “Most endometrial cancers are diagnosed early and have a relatively good prognosis, but 7-15% of these early-stage patients experience recurrences, and a limitation existed in that area due to lack of treatments available for use in case of recurrence after platinum-based chemotherapy.” Professor Kim added, “Tumors with confirmed dMMR/MSI-H respond well to treatment using PD-1 inhibitors, and Jemperli, with its significant treatment effect, safety profile, and treatment convenience, has offered a new possibility as second-line treatment for patients with recurrent or advanced dMMR/MSI-H endometrial cancer.”
- Company
- Viatrice Korea appoints Bill Schuster as new CEO
- by Jung, Sae-Im Mar 30, 2023 05:42am
- Viatris Korea announced on the 28th that it would appoint Bill Schuster as its new CEO. New CEO Bill Schuster is an expert with more than 30 years of diverse business experience in the healthcare and pharmaceutical industries. Based on his career as a senior leader in Asia, the Americas, and Europe, he is highly regarded for his understanding of the diverse healthcare systems and cultural backgrounds of each region. Since the launch of Viatrice in 2020, Bill Schuster, the new CEO, has led the growth of the diverse product portfolio as Head of the Beatrice Brand Division in Japan. He also contributed to Beatrice Japan's strong growth by playing a pivotal role in Japanese digital channel innovation as well. Bill Schuster, the new CEO, was born in Ireland and received a Bachelor of Science and Ph.D. from Dublin University and an MBA from INSEAD Business School in France. He held key positions in marketing and business strategy at Shionogi Pharmaceutical, Takeda Pharmaceutical International, and Mylan Japan. He has worked as a marketing manager in charge of Japan and Korea at Boehringer Ingelheim and Novo Nordisk Pharmaceuticals in Japan. New CEO Bill Schuster said, "I am very pleased to serve as CEO of Viatrice Korea, one of the leading companies in the pharmaceutical industry in Korea." We will further solidify our position in the Korean market and continue to contribute to Korean society by realizing the company's mission of supporting.
- Company
- JW Pharma registers the first overseas patent for JW0061
- by Mar 29, 2023 06:02am
- A researcher at JW Pharmaceutical is conducting a candidate substance test. (Photo by JW Pharma)JW Pharmaceutical announced on the 27th that it has obtained a patent for 'JW0061', a treatment for hair loss targeting Wnt, from the Russian Intellectual Property Office. This patent is for JW0061, a new drug candidate for hair loss treatment based on the Wnt signaling pathway. The patent protects the composition of JW0061. This is the first time that the JW0061 material patent has been registered. JW Pharmaceutical has applied for patents in more than 10 countries including the US, Europe, Japan, and China as well as in Korea. JW0061 is a first-in-class candidate substance that promotes hair follicle proliferation and hair regeneration by activating the Wnt signaling pathway in skin and hair follicle stem cells. It is effective for hair loss symptoms such as androgenetic alopecia and alopecia areata and is expected to have excellent hair loss prevention effects. JW Pharmaceutical participated in the 'Wnt2022' conference held in Japan last November and disclosed the results of the preclinical study of JW0061. JW Pharmaceutical also disclosed the results of animal experiments that confirmed the superior hair growth and hair follicle generation effect of JW0061 compared to the placebo group. As a result of animal experiments where JW0061 was applied, the time to enter the hair growth phase, which took an average of more than 50 days, was advanced by more than 15 days (30%). JW Pharmaceutical is conducting GLP non-clinical toxicity evaluation with the goal of starting clinical trials of JW0061 in the first half of 2024. We are also conducting joint research with medical staff in the field of dermatology in the United States.
- Company
- Bridge Biotherapeutics applies to FDA for the phase 1/2 plan
- by Mar 29, 2023 06:02am
- Bridge BiotherapeuticsBridge Biotherapeutics announced on the 27th that it had applied to the FDA for a phase 1/2 clinical trial plan for 'BBT-207', a 4th generation non-small cell lung cancer drug candidate. BBT207 is a new drug candidate that targets the C797S mutation that can occur after using third-generation non-small cell lung cancer treatments such as Tagrisso. Bridge Biotherapeutics plans to conduct clinical trials at 15 to 20 institutions in the US and Korea when the phase 1/2 clinical trial plan is approved. This clinical trial is a study to evaluate the safety, pharmacokinetic/pharmacodynamic properties, and efficacy of BBT-207 in patients with advanced non-small cell lung cancer with EGFR mutation after EGFR TKI treatment. The dosage will be increased through a phase 1/2 study targeting 112 patients, and an appropriate phase 2 dose will be explored. Capacity expansion will follow. Bridge Biotherapeutics plans to attend AACR on the 18th (local time) and present the preclinical data of BBT-207 as a poster. Based on the results of additional animal experiments, the company plans to publish data related to antitumor efficacy, survival rate improvement in brain metastasis animal models, and brain metastasis inhibitory activity, which study the potential of BBT-207 for targeted treatment for C797S-positive mutations.
- Company
- TB treatment Dovprela lands in general hospitals in Korea
- by Eo, Yun-Ho Mar 29, 2023 06:02am
- ‘Dovprela,’ the first new drug introduced in the field of tuberculosis in half a century can now be prescribed at general hospitals in Korea. Viatris Korea's multidrug-resistant tuberculosis treatment Dobprela (pretomanid) passed the Drug Committees (DCs) of Seoul National University Hospital and Seoul Asan Medical Center. Dovprela, which was first approved in September 2019 in the US and in October 2021 in Korea, is indicated in combination with bedaquiline and linezolid to treat adult patients with extensively drug-resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) pulmonary tuberculosis (TB). Pretomanid is the first new drug introduced in the field in 50 years. The field of TB has been neglected by front-line pharmaceutical companies due to its lack of economic feasibility. In fact, Viatris developed the drug in collaboration with a non-profit organization, ‘TB Alliance,’ rather than a general pharmaceutical company. Multi-drug resistant tuberculosis is a type of TB that cannot be treated with two or more TB treatments due to intolerance including isoniazid and rifampicin, the two most effective anti-TB treatments. Its cause can be divided into primary resistance and acquired resistance. Primary resistance develops when a patient is infected with drug-resistant MTB or during the course of treatment due to arbitrary discontinuation of treatment or irregular administration, etc. The treatment success rate of multi-drug resistant tuberculosis is around 50%, therefore, the condition's treatment efficiency is low, and an increased number of adverse events occur with their use in the second-line compared to first-line drugs. Moreover, due to its longer treatment period of 18 to 24 months, its cost burden is high and may even require surgical operations to remove lesions. Also, the seven-drug combination therapy that includes bedaquiline (Bdq) that is used as the current standard treatment for multidrug-resistant tuberculosis is not well used in Korea due to its high drug resistance rate and long treatment period of 9 to 12 months. Due to the long treatment period, the 7-drug combination is difficult to manage and has a high failure rate. Meanwhile, Dovprela demonstrated its efficacy through the Phase III Nix-TB trial. Dovprela, in combination with bedaquiline and linezolid (BPaL), demonstrated 92% effect in patients with treatment-intolerant or nonresponsive multidrug-resistant TB and an 89% effect in patients with extensively drug-resistant TB within 6 months and demonstrated its potential as a new short-term combination therapy in the field. Also, it reduced the treatment period from 18-24 months to 6 months, and almost all patients with treatment-intolerant or nonresponsive multidrug-resistant TB and extensively drug-resistant TB were found to be sputum culture-negative within 16 weeks. As the first ready-to-use combination that consists solely of oral treatments, the BPaL regimen reported a 90% cure rate in patients with extensively drug-resistant tuberculosis when used for 6 months compared to the standard treatment that recommends the use of at least 4 drugs in the initial intensive phase.
- Company
- Daewoong succeeds in Entresto's unregistered patent
- by Kim, Jin-Gu Mar 28, 2023 05:56am
- A generic company succeeded in invalidating the unregistered patent of Novartis' heart failure treatment 'Entresto'. This patent was one of the hurdles that must be overcome for the early release of generics. As such, it is analyzed that generic companies are one step closer to the release of generic for Entresto. According to the pharmaceutical industry on the 23rd, the Intellectual Property Trial and Appeals Board made a ruling on the invalidation of the Entresto salt/hydrate patent recently filed by Daewoong Pharmaceutical against Novartis. This patent is not listed in the Ministry of Food and Drug Safety patent catalog. However, from the perspective of generic companies, it was a patent that must be overcome in order to release later drugs early. Novartis obtained approval for the crystalline form of sacubitril/valsartan, the main ingredient of Entresto, as '2.5 hydrates'. In the patent catalog, only 2.5 hydrates, which are directly related, are listed. Generic companies supplied crystalline raw materials as 'trihydrate' and 'tetrahydrate' instead of 2.5 hydrates. The problem is that Novartis did not register it in the patent catalog, but separately registered the trihydrate patent with the Korean Intellectual Property Office. From the perspective of a generic company, the unregistered patent trihydrate patent must be avoided or invalidated in order to release a trihydrate-based generic. In response, Daewoong Pharmaceutical filed an invalidation trial on this unregistered patent in April 2021. Afterwards, Erison Pharmaceuticals and Hanmi Pharmaceuticals joined by requesting the same judgment. The Intellectual Property Tribunal sided with Daewoong Pharmaceutical. It is expected that the same result will come out in the judgment of Hanmi Pharmaceutical and Erison Pharmaceutical, which has not yet been concluded. As a result, generic companies have succeeded in overcoming 5 out of 6 patents related to Entresto. The remaining patent that has not yet been overcome is 'Use Patent 2' related to heart failure, which preserves the ejection fraction, which Novartis registered after generic companies applied for product approval. Since Novartis registered the patent a step later, it does not have a big impact on the early release of generics by patent challengers. Generic companies have already applied for Entresto generic product approval since April of last year. In addition, in December of last year, Novartis' request for an injunction to ban the sale of generics was also rejected by the court. The remaining risk factor is the second trial of the patent dispute with Novartis. Novartis appealed to the Patent Court in December 2021 after a first-instance defeat for the crystalline patent. Then, in July of last year, after losing in the first trial related to patents, the case was similarly brought to the second trial. No conclusion has been reached yet. If generic companies win the second trial following the first trial, the timing of the release of Entresto's generics is expected to accelerate. According to UBIST, a pharmaceutical market research institute, Entresto's outpatient prescription performance last year was 40.6 billion won. Since its launch in 2017, Entresto's prescription performance has soared from 6.3 billion won in 2018 to 15 billion won in 2019, 23.5 billion won in 2020, and 32.3 billion won in 2021.
- Company
- Sam Chun Dang Pharm’s biosimilar equivalent to Eylea
- by Nho, Byung Chul Mar 28, 2023 05:56am
- On the 27th, Sam Chun Dang Pharm announced that it had received the final result report for its Phase III trial for SCD411 (Eylea biosimilar). The results are from a global phase III clinical trial that had been conducted on 576 patients at 132 hospitals in 14 countries from September 2020 to September 2022. Through the global Phase III trial, the company demonstrated the equivalence of SCD411 to the original Eylea in terms of efficacy (primary endpoint & secondary endpoint), safety, tolerance, effectiveness, and immunogenicity. The primary outcome measure, change from baseline in BCVA (best corrected visual acuity) measured from baseline to Week 8, fell within the equivalence limit interval set by the US FDA (Food and Drug Administration), EMA (European Medicines Agency), and Japan’s PDMA (Pharmaceuticals and Medical Devices Agency) compared to the original. UF FDA set the equivalence limit interval as a confidence interval of 90% with a treatment difference with the original between -3.0 to 3.0 characters, Europe’s EMA and Japan’s PMDA as a confidence interval of 95%, and a difference between -3.8 to 3.8 characters. The results of the primary outcome measure analysis showed that the differences in effect were between -1.6 to 0.9 characters under the US standards, and between -1.8 to 1.1 characters under the European and Japanese standards. Based on the results, Sam Chun Dang Pharm plans to apply for marketing approval of SCD411 in major countries such as the United States, Europe, and Japan and will supply and market the products through its partners as soon as it receives authorization.
- Company
- Erleada's reimb and lower coinsurance rate raise issue
- by Eo, Yun-Ho Mar 28, 2023 05:56am
- Most latecomer drugs are priced at a lower level than first-comer. This is an essential element in Korea's reimbursement listing system. However, a rare occasion occurred where patients are complaining over the lower price set for a latecomer drug. The drugs that arose as an issue were Janssen Korea’s prostate cancer treatment ‘Erleada (apalutamide),’ and Astellas Korea’s ‘Xtandi (enzalutamide)’ which was listed for reimbursement before Erleada. The situation goes as follows. The price difference (list price) between the two drugs is not large. However, the problem lies in the listing registration system the two drug companies selected and the patient's coinsurance. In August of last year, reimbursement for Xtandi was extended through a selective reimbursement system. Xtandi was first listed in 2014 as a treatment for metastatic castration-resistant prostate cancer (mCRPC). The selective reimbursement system is a system for listed drugs that authorities determine is urgent to expand coverage. To rapidly extend the scope of reimbursement for such drugs, the authorities waive the economic feasibility evaluation process but differentiate the copayment rate for the drug. Xtandi met the purpose of the system for the 'metastatic hormone-sensitive prostate cancer (mHSPC)' indication, which was why Astellas chose to receive reimbursement through the system. However, the situation was different for Erleada. As a newly listed new drug, Erleada did not have the option to choose selective reimbursement, therefore, it had to undergo the essential reimbursement processes, including the pharmacoeconomic evaluation process. This was why the time to the listing of the two drugs differed significantly. The two drugs passed review by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service in February last year, but Erleada is only being listed for reimbursement starting next month. Applying selective reimbursement to new drugs has remained a long-cherished desire in the industry. The different reimbursement tracks taken by the two companies led to the difference in the amount paid by patients as coinsurance. Xtandi’s coinsurance rate under the selective reimbursement system is 30%, whereas the rate is a mere 5% for Erleada which is applied essential reimbursement and special calculation of exemptions. If so, it would seem that existing patients can opt to use the cheaper Erleada, but it is impossible for patients taking Xtandi to switch to Erleada under the current reimbursement standards. In other words, dissatisfaction is arising among patients as existing patients could not benefit from the use of a cheaper drug option that became available. However, no one is to blame for the situation. Aside from the company's strategy, Astellas quickly offered a reimbursed treatment option in mHSPC through the selective benefit system. Janssen also has no fault. The prevailing view had been that it would be difficult for anticancer drugs with the mHSPC indication to be listed for reimbursement in Korea. This was why the news that Janssen completed final negotiations and successfully receive reimbursement after receiving pharmacoeconomic evaluations was received with surprise in the industry. Also, a solution does exist. The gap caused by the difference in coinsurance rates can be resolved if Xtandi also receives pharmacoeconomic evaluations and switches to an essential reimbursement like Erleada. However, it is unclear whether such a decision can be made quickly due to the nature of multinational pharmaceutical companies. A pricing official in the industry said, “Although it is uncommon, we should not overlook the fact that this can happen again in the future. Institutional improvement is needed to resolve the out-of-pocket burden that occurs with the entry of latecomers for selective benefit-applied items.”
