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- 2026-05-06 10:21:34
- Company
- GC Biopharma says its ‘Shingrix vaccine shows effect in P2T
- by Lee, Seok-Jun Jan 09, 2024 05:49am
- GC Biopharma (CEO Eun-cheol Heo) today announced positive Phase 2 results for its shingles vaccine, CRV-101 (ingredient name amezosvatein),’ which is being developed by its U.S. partner Curevo Vaccine. The data represent top-line results from a head-to-head comparison of GSK's market-leading shingles vaccine, Shingrix, and CRV-101, which meets all primary endpoints and demonstrated non-inferiority and superior tolerability to GSK’s shingles vaccine Shingrix. To evaluate the immunogenicity and safety of CRV-101, Curevo Vaccine inoculated 876 healthy adults aged 50 years and older with two different vaccines, at 2-month intervals, as the second booster shot. The results showed that CRV-101 met its primary endpoint, demonstrating non-inferiority to Shingrix through humoral immune responses. The Vaccine Response Rate (VRR) for CRV-101 was 100%, compared to 97.9% for Shingrix. The Phase 2 results provided a basis for dose selection, which Curevo plans to build upon to initiate a Phase 3 study later this year. CRV-101 is a premium herpes zoster vaccine developed by genetic recombination with an immune-boosting adjuvant. It is designed to induce an optimal immune response with a low risk of side effects. According to the global market research firm Evaluate Pharma, the global market for shingles vaccines is expected to reach $5.85 billion by 2028, including the U.S. market.
- Policy
- Data Exclusivity Bill for IMDs may soon be legislated
- by Lee, Jeong-Hwan Jan 09, 2024 05:49am
- A bill to amend the Pharmaceutica Affairs Act, which grants a 6-year data exclusivity for incrementally modified new drugs that have obtained domestic marketing authorization, was reviewed during the plenary session of the Legislation and Judiciary Committee that was held on the afternoon of the 8th. If approved by the committee, the bill will be passed during the plenary session tomorrow (Sept. 9) and be legislated. The bill also suggest abolishing the drug re-review system and replacing it with a risk management plan (RMP). In particular, there is great interest in the new provision in the bill that recognizes exclusive rights to new and incrementally modified drugs and protects clinical trial data submitted at the time of drug approval. Specifically, the bill provides 10 years of protection from the date of approval for orphan drugs. This can be extended by an additional year if a pediatric indication is added. New drugs are granted 6 years of data exclusivity from the date of approval, and drugs that submit new clinical trial data, such as cto hanging the type of active ingredient to improve the safety, efficacy, and utility of already approved drugs, are granted 6 years of exclusivity from the date of approval. Based on this provision, IMDs can be granted a 6-year data protection period based on the provision. In addition, drugs designated by the Prime Minister's Decree that require submission of new clinical trial data are granted a 4-year data protection period. The existing reexamination system provides 10 years of data protection for orphan drugs, 6 years for new drugs and drugs with new active ingredients, formulation ratios, and routes of administration, and 4 years for new drugs with new efficacy and effect. If the bill passes the National Assembly, it is expected the data exclusivity of IMDs developed many domestic pharmaceutical companies will be recognized, Teh bill provides exclusivity when developing improved versions of their existing drugs, especially in terms of fficacy or utilit, with raises possibility of the development of a cash cow during new drug development. The bill is likely to pass the National Assembly because the Ministry of Food and Drug Safety (MFDS) is in favor of it and has been involved in its legislation, and it is in line with the government's policy of creating domestic blockbuster drugs. The MFDS said, "We agree with the purpose of the amendment to reduce the burden of data submissions to the pharmaceutical industry by integrating the drug reexamination system and risk management system, and to enhance Korea R&D capabilities in the pharmaceutical industry by establishing a legal basis for the drug data protection system."
- InterView
- ‘RCC treatment should reflect international guidelines’
- by Son, Hyung-Min Jan 09, 2024 05:49am
- In-Keun Park, Professor of Oncology at Seoul Asan Medical Center The treatment paradigm for renal cell carcinoma has been changing with the emergence of immuno-oncology drugs, but the latest practice guidelines for the disease are not being reflected in practice in Korea. In-Keun Park, Professor of Oncology at Seoul Asan Medical Center stressed how treatment options for patients with recurrent renal cell carcinoma are limited. In the first-line treatment of renal cell carcinoma, immuno-oncology drugs have been approved and have been successful in improving survival rates. However, treatment options for recurrent patients remain limited. As renal cell carcinoma is often diagnosed at an advanced stage, it has a poor prognosis and a high rate of recurrence. Therefore, it is important to secure a variety of options for each line of treatment, but when looking at the currently available second-line options, there are fewer drugs available in the second-line than in the first-line. Professor Park stressed how securing treatment options for RCC after immuno-oncology drugs by referring to international guidelines can improve the survival rate of RCC patients in Korea. Introductino of immuno-oncology drugs for renal cell cancer change the treatment paradigm Professor Park believes that the introduction of immuno-oncology drugs has completely transformed the treatment paradigm for renal cell carcinoma. Currently, 4 treatment options that include immuno-oncology drug combinations are approved in Korea as a first-line treatment for renal cell carcinoma. ▲The combination of BMS's immuno-oncology drugs Opdivo (nivolumab) and Yervoy (ipilimumab); ▲combination of Opdivo and Ipsen's targeted anticancer drug Cabometyx (cabozantinib); ▲ combination of MSD's immuno-oncology drug Keytruda (pembrolizumab) and Eisai’s targeted anticancer drug Lenvima (lenvatinib); and ▲ combination of Keytruda and Pfizer's targeted anticancer drug Inlyta (axitinib) are available for the first-line treatment of renal cell carcinoma. The Immuno-oncology drug+ immuno-oncology drug and immuno-oncology drug+targeted anticancer drug combinations have increased survival in patients with renal cell carcinoma. However, in Korea, only the combination of Opdivo+Yervoy is granted reimbursement. Also, the insurance only covers treatment with the combination for two years. Professor Park said, “Immuno-oncology drugs are a game changer that transformed the treatment of renal cell carcinoma. Before, when the targeted anticancer drug Sutene (sunitinib) was the standard of care, patients with poor prognostic factors had a life expectant that did not last one year," He added, “In Korea, the Opdivo+Yervoy combination is the most commonly used, and its progression-free survival (PFS) often exceeds 1 year. However, the combination is only covered for two years in Korea, so it is difficult to predict the outcome after that." While it is possible for patients to treatment with immuno-oncology drugs without reimbursement, its cost is burdensome. For Opdivo alone, patients have to pay more than KRW 4 to 5 million a month as out-of-pocket costs. “Also, due to the limited reimbursed options in the first-line, patients are almost always forced to use the Opdivo+Yervoy combination. Major guidelines recommend the Opdivo+Cabometyx combination and the Keytruda combination for low-risk patients in first-line treatment, but these are difficult to use in the field due to their non-reimbursement." Limited reimbursed treatment options after first-line treatment Immuno-oncology drugs have been successful in improving survival in first-line renal cell carcinoma, but treatment options for recurrent patients remain limited. Reimbursed second-line treatment options for renal cell carcinoma in Korea are Pfizer's Sutene, GSK's Votrient( pazopanib), and Inlyta. Cabometyx has demonstrated improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) over Novartis’ Afinitor (everolimus) in recurrent renal cell carcinoma patients, but is non-reimbursed in Korea. In the METEOR trial, Cabometyx demonstrated a median PFS of 7.4 months, OS of 21.4 months, and ORR of 24%, making it the only second-line treatment option in renal cell carcinoma that showed efficacy in all three measures. However, its use is further limited due to its indication in addition to its non-reimbursement. The drug is approved in Korea as a monotherapy for patients with advanced renal cell carcinoma who have been previously treated with VEGF (vascular endothelial growth factor) targeted therapy. In-Keun Park, Professor of Oncology at Seoul Asan Medical Center Moreover, Cabometyx is not indicated for use in patients who developed resistance to first-line standard-of-care immuno-oncology combination treatment, because a VEGF inhibitor has not been used in the previous line of treatment. Professor Park explained, “Studies have confirmed the efficacy of Cabometyx over other second-line treatments, and has shown better results compared to Sutene as a first-line treatment in intermediate- and high-risk renal cell carcinoma.” He added, “When we look at the data from recent real-world studies and smaller studies where patients were administered Cabometyx after immuno-oncology treatment, the results are not bad. We're seeing response rates from 30%, up to 50%. However, its limited indication has made it difficult to use Cabometyx as second-line therapy.” The treatment paradigm is shifting...expert and international practice guidelines should be reflected#EB Professor Park emphasized that as international guidelines for renal cell carcinoma have changed, these latest treatment trends should also be reflected in Korea as well. International guidelines, including the National Comprehensive Cancer Network (NCCN), the European Society for Medical Oncology (ESMO), and the European Association of Urology (EAU) recommend Cabometyx as the first-line treatment for renal cell carcinoma after use of immuno-oncology drugs in the first-line. However, in Korea, it is difficult to prescribe Cabometyx in the second line due to its limited indications and reimbursement conditions. Professor Park said, “I understand that the government needs to closely review the effectiveness of drugs based on clinical results. However, in line with the changing environment for first-line treatment of renal cell carcinoma, the insurance standards for later lines of treatment should reflect the opinions of experts related to pharmacological mechanisms and international guidelines. This is because many limitations remain to reconduct clinical trials and change the indication.” In other countries like Japan, Japan allows reimbursement for a single cancer type, regardless of the stage of treatment. In the United States, therapies are allowed to be used off-label if there is evidence to support it. As such, Professor Park explained that the treatment paradigm for renal cell carcinoma has changed internationally, but is not being reflected in Korea and goes against the constantly changing treatment trends with the excuse that it lacks clinical results. "We should aim for evidence-based medicine, but in the end, I would like the government to be more considerate of what is the optimal treatment for the people. In the process, treatment standards should be based on expert opinions and international guidelines.”
- Company
- Recent tech export deals boast record-high upfront payments
- by Chon, Seung-Hyun Jan 09, 2024 05:49am
- Since the end of last year, Orum Therapeutics, Chong Kun Dang Pharmaceutical (CKD Pharm), LegoChem Biosciences, and others have successfully secured large-scale technology transfer agreement with an upfront payment of 100 billion won. Out-licensing contracts with upfront payment scale over 10% of the total contract value have been on the rise due to the high value of technology exports for new drugs. According to the industry on the 9th, LG Chem signed a technology transfer agreement with Rhythm Pharmaceuticals on the 5th for a rare obesity drug candidate LB54640. Under the agreement, Rhythm Pharmaceuticals will acquire the global development and sales rights of LB54640. LB54640 is the world's first oral MC4R agonist, and the results of its Phase 1 clinical trials have shown a dose-dependent trend in weight loss and safety. LB54640 successfully completed Phase 1 clinical trials and commenced Phase 2 clinical trials in October. Rhythm Pharmaceuticals will acquire the rights to LB54640 and continue its development. Under the agreement, the price for technology transfer amounts up to $305 million (about 400 billion won), including the upfront payment of $100 million (approx. 130 billion won). The upfront payment of $100 million is the third-largest in technology transfer agreement for a new drug signed by a Korean pharmaceutical firm. Recently, in the technology transfer agreements of pharmaceutical and biotech firms (including Hanmi Pharm, SK Biopharmaceuticals, LG Chem, LegoChem Biosciences, Orum Therapeutics, Chong Kun Dang Pharm, and others), upfront payments have been a substantial component of the total contract value. (Source: Financial Supervisory Service, Pharma companies) The highest record of upfront payment for technology transfer agreements is held by Hanmi Pharm. In Nov. 2015, Hanmi Pharm signed a technology transfer agreement for three new diabetes drugs with Sanofi, which initially involved an upfront payment of approximately EUR 400 million. The contract was later revised, reducing the upfront payment to EUR 204 million, but it still stands as the highest upfront payment in such agreements. Hanmi Pharm also holds the record for the second-highest upfront payment with $105 million in an agreement with Johnson & Johnson’s Janssen for its obesity drug in 2015. The upfront payment of $100 million in a technology transfer agreement between SK Biopharmaceuticals and Arvelle Therapeutics for cenobamate, an anti-epileptic drug, ranks third to date. Recently, LG Chem also secured the third in rank with an upfront payment of $100 million in a technology transfer agreement for a new drug, LB54640. The technology export contracts that were finalized since the end of last year have ranked among the top contracts in terms of upfront payments. Orum Therapeutics signed a technology transfer agreement with BMS for the new candidate product ORM-6151 in Nov. 2023. The total contract value was set at a maximum of $180 million, which included the upfront payment of $100 million. ORM-6151 is a candidate product developed utilizing the antibody-based protein degradation platform of Orum Therapeutics. It has received approval for Phase 1 clinical trials from the U.S. Food and Drug Administration (FDA) as a potential treatment for myeloid leukemia and high-risk myelodysplastic syndromes. LegoChem Bio also finalized a technology transfer agreement with an upfront payment of $100 million. In December of the previous year, LegoChem Bio signed a technology transfer agreement with Janssen Biotech for the development and commercialization of "LCB84." The contract included an upfront payment of $100 million (approx. 130 billion won), an additional $200 million (approx. 260 billion won) payment for the exclusive development rights, and further milestone payments linked to development, approval, and commercialization, amounting to a total of up to $1.7 billion (approximately 2.24 trillion won). LCB84 is an Antibody-Drug Conjugate (ADC) drug that combines LegoChem Bio's next-generation ADC platform technology with the Trop2 antibody technology acquired from Mediterranea Theranostic. CKD Pharm signed a technology transfer agreement with Novartis for the new drug candidate CKD-510 in Nov. 2023. The non-refundable upfront payment for this agreement was $80 million, ranking seventh to date. Including milestones of $1.225 billion based on development and approval stages, the total contract size amounts up to $1.35 billion. CKD-510 is a new drug candidate developed by CKD Pharm, utilizing a highly selective non-hydroxamic acid (NHA) platform technology-based HDAC6 inhibitor. Recently, in the technology transfer agreements of pharmaceutical and biotech firms, upfront payments have been a substantial component of the total contract value. LG Chem's LB54640 technology transfer agreement had an upfront payment that accounted for 32.8% of the total contract value, which is a significantly higher proportion than the usual practice where upfront payments typically do not exceed 10% of the total contract value. LG Chem explained that this high value reflects the positive assessment of LB54640's growth potential by their technology transfer partner. Orum Therapeutics received an upfront payment of $100 million, which accounted for 55.6% of the total contract value in their technology transfer agreement with BMS last year. However, Orum Therapeutics' technology transfer involved the transfer of a new drug candidate, which contributed to the larger upfront payment. Typically, pharmaceutical companies receive milestone payments based on the progress of development in technology transfer agreements. In this case, Orum Therapeutics chose to transfer rights and received a larger upfront payment. Hanmi Pharmaceutical's technology transfer agreement with Sanofi for three diabetes drugs, holding the record for the highest upfront payment, had an upfront payment representing 10.3% of the total contract value. However, Hanmi Pharmaceutical and Sanofi's technology transfer agreement saw a reduction in contract size through a revised contract, with the upfront payment ratio decreasing to 7.2%. In 2015, Hanmi Pharmaceutical's technology transfer to Janssen for an obesity and diabetes treatment recorded a high upfront payment ratio of 11.5%. Despite being in the early stages of development, the technology transfer partner assessed the candidate substance with high value. In 2019, SK Biopharmaceuticals entered into a technology transfer agreement with Arvelle Therapeutics for cenobamate, and the upfront payment representing 18.9% of the total contract value. At that time, cenobamate was already in the process of FDA review in the United States, indicating a high likelihood of commercialization, which contributed to the substantial upfront payment in the agreement. The proportion of upfront payments to the total contract value for CKD Pharm and LegoChem Biosciences accounted for 6.1% and 5.9%, respectively. The analysis suggests that the high upfront payments were made because the partnering companies have made positive assessments of new drugs, even though they are in the early stages of clinical trials.
- Company
- K-pharma to participate in J.P. Morgan Healthcare Conference
- by Jan 08, 2024 06:09am
- The J.P. Morgan Healthcare Conference is scheduled to take place in San Francisco, the U.S., from Jan. 8-11. (screen captured from J.P. Morgan homepage)# Korean pharmaceutical and biotech firms are fully prepared to attend the J.P. Morgan Healthcare Conference, the first international event of the year. The spotlight is on what accomplishments Korean pharmaceutical and biotech firms might achieve at this event, where they will join global companies to discuss large-scale technology transfers and partnership agreements. According to the pharmaceutical and biotech firms on the 4th, companies participating in the J.P. Morgan Healthcare Conference include Yuhan Corporation, Hanmi Pharm, Dong-A ST, and SK Biopharmaceuticals. Companies such as Samsung Biologics and Lotte Biologics, with plans to expand their contract development and manufacturing organization (CDMO) businesses, will also participate in the J.P. Morgan Healthcare Conference to share their mid-to-long-term business strategy. The J.P. Morgan Healthcare Conference, hosted by U.S. investment bank J.P. Morgan, is the biopharmaceutical industry’s premier investment event that brings together global investors, including venture capital (VC) and hedge funds. The event is scheduled to take place in San Francisco, the U.S., from Jan. 8-11. Pharmaceutical industry aiming for global entry showcases R&D achievements in the New Year. Yeul-Hong Kim, R&D President of Yuhan Corporations, and Donghoon Lee, CEO of SK Biopharmaceuticals, will present in the Asia-Pacific (APA) session. Yuhan Corporation#Yuhan Corporation will showcase its key pipelines, including Leclaza (ingredient: Lazertinib), a new drug for treating non-small cell lung cancer (NSCLC). Currently, Leclaza has submitted a new drug application with the U.S. Food and Drug Administration (FDA) to be used in combination with Rybrevant. In December of last year, Johnson & Johnson (J&J) submitted an application for its combination therapy to be used as a first-line treatment of EGFR-positive NSCLC. The recent submission is based on results from the Phase 3 MARIPOSA clinical study, which tested the effectiveness of the combination therapy of Rybrevant and Leclaza compared to existing Tagrisso monotherapy. Yuhan has reached an agreement with Johnson & Johnson (J&J) for the technology transfer of Leclaza following discussions in the J.P. Morgan Healthcare Conference. The contract was initiated in 2018, and both companies have since engaged in joint research. SK Biopharmaceuticals#SK Biopharmaceuticals will showcase its achievements with Xcopri (cenobamate), a new medication for epilepsy. Xcopri achieved a monthly total prescriptions (TRx) of 22,000 in the U.S. last year. SK Biopharmaceuticals aims to optimize the sales performance of Xcopri in the North American market. Additionally, SK Biopharmaceuticals will unveil its plan to advance in targeted protein degradation (TPD), cell and gene therapy (CGT), and radiopharmaceutical therapy (RPT) as part of its strong growth engine. Hanmi Pharm#Hanmi Pharm will showcase its entire pipelines, which includes HOP (Hanmi Obesity Pipeline). Hanmi is actively conducting clinical development of Efpeglenatide, a new drug candidate designed for the treatment of obesity and non-alcoholic fatty liver disease (NAFLD). The candidate drug has a multifaceted mechanism of action, activating glucagon, which increases energy metabolism, Glucagon-like peptide-1 (GLP-1), which stimulates insulin secretion and reduces appetite, and GIP receptor, which stimulates insulin secretion and promotes anti-inflammatory signaling. Additionally, Hanmi’s Efinopegdutide is a dual-action treatment that simultaneously activates both the GLP-1 receptor, which helps to suppress insulin secretion and appetite, and the glucagon receptor, increasing energy metabolism. Hanmi licensed out efinopegdutide to MSD in August 2020. Dong-A ST#Dong-A ST is expected to participate in the event, with representatives from its research center and business development team attending. They will be focusing on strategizing agendas, networking, and exploring partnering with global pharmaceutical companies during the event Dong-A ST’s DBM-3115, a biosimilar referencing Stelara, is likely to receive European approval by next year. The company has successfully completed its global Phase 3 clinical trials, demonstrating therapeutic equivalence between DBM-3115 and Stelara, and submitted its application for approval to the European Medicines Agency (EMA) in June of last year. Additionally, Dong-A ST is preparing the U.S. Food and Drug Administration (FDA) approval next year. Through its subsidiary NeuroBo Pharmaceuticals, Dong-A ST is also developing the obesity treatment DA-1726. Recently, Neurobo submitted a global Phase 1 Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for the development of DA-1726 as an obesity treatment. The preclinical research results have demonstrated that DA-1726 exhibited significant weight loss effects, even with a similar food intake to GLP-1 analog semaglutide, in animal models of obesity. Samsung Biologics and Lotte Biologics to promote CDMO, and Celltrion plans to present key biosimilar pipelines. Samsung Biologics#Samsung Biologics will present its achievements from last year and its plans for the future in the main track on the 9th. Samsung Biologics plans to establish manufacturing facilities for Antibody-Drug Conjugate (ADC) production starting this year, following its investment in Araris Biotech, a company focused on the development of ADC therapies, through the Life Sciences Fund it established with Samsung C&T in April of this year. Lotte Biologics#Lotte Biologics plans to promote its contract development and manufacturing organization (CDMO) capabilities at this conference. Lotte Biologics plans to expand its ADC facility within the Syracuse factory in the United States. Following this expansion, the company will offer contract services for the entire process of ADC-related pharmaceuticals, from product development to commercial production. The company's strategy involves targeting both domestically developed new drug candidates and new drugs from multinational pharmaceutical companies as CDMO customers. Lotte Biologics is also expressing interest in ADC. In addition to last year's investment in the ADC specialist company Pino Bio, Lotte Biologics has signed a business agreement with KANAPH Therapeutics for the establishment of an ADC technology platform. Celltrion#Celltrion is set to present its key pipelines, including biosimilars, during the main track of the conference on the 10th. Zymfentra received approval as a biosimilar subcutaneous (SC) product referencing Remsima inn October of the previous year. Celltrion is anticipating approval for several biosimilars, including CT-P41, referencing Prolia, CT-P39, referencing Xolair, CT-P43, referencing Stelara, CT-P42, referencing Eylea. These four candidate products demonstrated non-equivalence compared to the original medicine in the Phase 3 clinical trials. SK Biosciences#SK Biosciences has received officially invitations for one-on-one meetings with investors. As part of its efforts to enhance the global competitiveness of its CDMO products, the company is currently establishing a global R&D center in Incheon, Songdo. SK Biosciences has a mid-to-long-term plan to expand its CDMO business not only in traditional vaccine platforms but also in new platforms such as mRNA (messenger ribonucleic acid) and CGT (cell and gene therapy). This strategy aims to secure new sources of growth for the company. Biotech venture companies such as GI Innovation, ABL Bio, and SyntekaBio will be attending. The J.P. Morgan Healthcare Conference is scheduled to take place in San Francisco, the U.S., from Jan. 8-11. (screen captured from J.P. Morgan homepage)0#GI Innovation will attend the conference to promote its pipelines under development. GI Innovation is currently conducting the Phase 1 clinical trial of evaluating the effectiveness of the combination therapies of new drug candidate GI-101, a potential anti-cancer immune drug, and MSD’s Keytruda in the U.S. The company aims to acquire indication in solid cancer, including biliary tract cancer. The company is assessing the potential for commercialization of combination therapies with various anti-cancer immune drugs, including Keytruda, and is also exploring combination therapies with AstraZeneca's Imfinzi (durvalumab) and other drugs. The J.P. Morgan Healthcare Conference is scheduled to take place in San Francisco, the U.S., from Jan. 8-11. (screen captured from J.P. Morgan homepage)1#ABL Bio will also participate in the event and share its achievemnets on developments of new drug candidates. ABL Bio is currently developing ADC product candidates ABL201, a candidate to treat blood cancer, and ABL202, a candidate to treat solid cancer. ABL Bio has achieved a successful technology transfer of ABL201 to LegoChem Biosciences, a biotech venture company. Additionally, ABL202 is currently in development, incorporating LegoChem’s ADC linker technology. The J.P. Morgan Healthcare Conference is scheduled to take place in San Francisco, the U.S., from Jan. 8-11. (screen captured from J.P. Morgan homepage)2#SyntekaBio will participate in BioPartnering Conference and Biotech Showcase in the J.P. Morgan Healthcare Conference. The company will showcase its artificial intelligence (AI)-based new drug platform, called DeepMatcher, and explore partnering opportunities with new clients.
- Company
- LG Chem transfers its rare obesity drug rights for KRW 130B
- by Kim, Jin-Gu Jan 08, 2024 06:09am
- LG Chem announced on the 5th that it had licensed out its new drug candidate that targets a rare genetic disease characterized by severe appetite control dysfunction to the U.S-based Rhythm Pharmaceuticals. The agreement, which amounts to USD 350 million (KRW 400 billion), includes an upfront payment of USD 100 million (KRW 130 billion). Upon successful commercialization, the company will receive separate sales royalties based on annual sales. The candidate targets a rare form of obesity. This form of rare obesity is characterized by abnormalities in appetite control due to defects in the pathway of the satiety signaling gene, ‘MC4R (Melanocortin-4 Receptor),’ resulting in persistent and severe obesity. Its symptoms typically appear in childhood. LB54640 is the world's first orally administered MC4R agonist, and LG Chem has confirmed its dose-dependent weight loss tendency and safety through a Phase 1 trial. Based on the Phase I trial results, the company entered Phase 2 clinical trials in the U.S. in October last year in patients with rare forms of obesity. Rhythm Pharmaceuticals plans to take over the trials and begin recruiting patients in earnest in the near future. LG Chem expects the partnership to accelerate the development of LB54640 and the provision of a more convenient treatment option for the patients. Recruiting patients is one of the biggest challenges for orphan drugs, and LG Chem expects the technology transfer agreement with Rhythm Pharmaceuticals, which invests a lot of resources in identifying potential patients, will support more efficient development. Rhythm Pharmaceuticals was founded in 2010 in Boston, USA. It was listed on the NASDAQ in 2017. It successfully developed and commercialized the world's first MC4R agonist, IMCIVREE (setmelanoatide), and established itself as a leading company in the global rare obesity drug market. Jee-woong Son, Head of LG Chem’s life sciences division, said, "Rhythm Pharmaceuticals is the right partner for the successful development of LB54640. We will actively collaborate with our partner to promptly provide safer and more effective new drugs to patients suffering from rare obesity worldwide.” David Meeker, CEO of Rhythm Pharmaceuticals, said, "The results from LG Chem's Phase 1 study of LB54640 confirm the candidate’s potential as a novel drug with a high level of safety. The collaboration will allow us to expand our portfolio of rare obesity drugs and provide each patient with an optimal treatment option fit to their needs."
- Company
- Trodelvy can be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Jan 08, 2024 06:09am
- Another new antibody-drug conjugate drug for breast cancer, ‘Trodelvy,’ can now be prescribed at general According to industry sources, Gilead Science Korea’s triple-negative breast cancer (TNBC) treatment ‘Trodelvy (sacituzumab govitecan-hziy)’ has recently passed the drug committee review of Seoul Asan Medical Center. In addition, landing procedures for the drug are also underway at tertiary hospitals such as Samsung Medical Center, Seoul National University Hospital, and Sinchon Severance Hospital. Trodelvy passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in November last year and is currently awaiting review by the Drug Reimbursement Evaluation Committee. Gilead has also been offering an early access program for non-reimbursed prescriptions since last month. Although a number of treatment options target novel mechanisms and genes have been introduced for TNBC until now, none of them have been approved for reimbursement in Korea as of yet. Another ADC, ‘Enhertu (trastuzumab deruxtecan)’ passed the CDDC review in May, but its reimbursement agenda has not been presented for deliberation to the DREC until now. Whether Trodelvy will be able to overcome the difficulties and succeed in being reimbursed in Korea remains to be seen. Trodelvy is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and ‘SN-38,’ a TOP1 inhibitor payload. The drug received approval from the Ministry of Food and Drug Safety in May to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, including at least one prior therapy for metastatic disease. Trodelvy is the only non-cytotoxic chemotherapy approved as a second line or higher line of treatment for the entire TNBC patient population in Korea and can be used regardless of genetic mutations or biomarkers. The National Comprehensive Cancer Network (NCCN) guidelines recommend Trodelvy as a Category 1 preferred treatment option for adult patients with metastatic TNBC who have received prior treatment. Trodelvy’s clinical efficacy was confirmed through the Phase III ASCENT study. In the study, Trodelvy significantly reduced the risk of death by 49% compared with a treatment of physician’s choice (TPC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Also, the Trodelvy arm showed a 57% improvement in progression-free survival (PFS). These effects were observed regardless of the patient’s brain metastasis status.
- Opinion
- [Reporter's View] No regulatory innovation, no future
- by Son, Hyung-Min Jan 08, 2024 06:09am
- The importance of Decentralized Clinical Trials (DCT) through digital biomarkers in developing digital therapeutics (DTx) is gaining attention. Biomarkers are usually indicators used to detect changes within one’s body, using proteins, DNA, RNA, metabolites, etc. Digital biomarkers are an extension of this concept and refer to biomarkers collected using digital technologies. Digital biomarkers are used for DCT, as they enable remote monitoring and treatment of patients. It offers the advantage of enabling patient recruitment via website and mobile channels in addition to the traditional offline recruitment, to maximize recruitment speed and participation rates in clinical trials. Unlike how DCT is being more and more widely used around the world, it is relatively less used in Korea. From 2019 to 2022, only 1.1% of multinational clinical studies conducted in Korea utilized DCT. In the UK, the rate was 14.6% during the same period. It's no secret why DCT is underutilized in Korea. This is due to the strict regulations set on the use of personal information for telemedicine and access to electronic medical records (EMR) in Korea. Although the pharmaceutical and IT industries and clinical trial-related organizations agree on the need to use DCT, they are having difficulty with its implementation due to the strict regulations. There are already DCT guidelines established in Europe and the United States. Since 2021, some countries in Europe have issued DCT guidelines, and in 2023, the U.S. Food and Drug Administration (FDA) released its draft guidance, called ‘Decentralized Clinical Trials for Drugs, Biological Products, and Devices.’ As such, countries overseas have already been creating an environment where patients may participate in clinical trials without visiting medical institutions. The pharmaceutical and bio industry invests astronomical amounts of money in clinical trials despite its little probability of success. The longer the clinical trial process takes, the more expensive the new drug development becomes. It's not as if the industry can just wait for new technologies to emerge without making changes. The shift from randomized controlled trials (RCTs) to DCTs will not only provide accurate medical information but also reduce costs. To foster an advanced medical environment, clear guidelines will need to be set for clinical trials, including the use of digital therapeutics. Only bold regulatory innovations made by the government will be able to advance the development of the digital healthcare industry to the next level.
- Company
- GMP issues causing delays in new drug approval
- by Eo, Yun-Ho Jan 08, 2024 06:08am
- The bottleneck in Good Manufacturing Practice (GMP) assessments is causing delays in the approval of global pharmaceuticals. The GMP process, which inspects the manufacturing facilities for pharmaceutical products, has been identified as a contributing factor to the delay in the approval of pharmaceuticals. The Ministry of Food and Drug Safety (MFDS) has acknowledged the issue, but they have not yet addressed alternative solutions. Consequently, the bottleneck in GMP for global pharmaceuticals awaiting approval is worsening. To gain approval for pharmaceuticals in Korea, pharmaceuticals undergo a series of evaluations, including safety and effectiveness evaluation, Good Manufacturing Practice (GMP) evaluation, and quality evaluation. Among these, the GMP evaluation examines the manufacturing facility of the pharmaceuticals seeking approval, and pharmaceuticals produced in international facilities, including global pharmaceuticals, may require an on-site audits as part of the process. The MFDS has demonstrated flexibility in its policy management over the past three years, including implementing remote GMP audits during the COVID-19 pandemic. However, as the audits have shifted back to full on-site audits, concerns are arising about the backlog in audits. According to the industry, these policy changes are exacerbating the backlog of GMP on-site audits for global pharmaceuticals. Currently, the average waiting time per drug is over 20 months. This delay in the domestic approval schedule is particularly problematic for pharmaceuticals, including new drugs and other formulations of already licensed drugs. What would be the solution? During the National Assembly's audit, In Jaekeun, a member of the Health and Welfare Committee from the Democratic Party, raised questions to the MFDS regarding the delay in on-site audits of overseas manufacturing facilities, which has led to the issue of global pharmaceuticals not being supplied to domestic patients in a timely manner. In response to the question about the status of backlog in the GMP on-site audits for global pharmaceuticals, "Our analysis is that on-site audit backlog has worsened due to the inability to conduct on-site audits at global pharmaceutical manufacturing facilities during the Covid-19 pandemic," an official of the MFDS's Pharmaceutical Quality Division answered. In response to the question about specific plans to address the backlog in GMP on-site audits for global pharmaceuticals, "We are working on increasing manpower of GMP investigators responsible for conducting on-site audits," an official stated. Currently, there are 16 GMP-related personnel within the MFDS's Pharmaceutical Quality Division. Based on the schedule of GMP investigators for on-site audits posted on the MFDS website, 11 investigators were scheduled to undertake international business trips for conducting on-site audits in December of last year. The solution proposed by the MFDS, which involves increasing manpower for GMP audits, has a potential pitfall. It requires securing the budget in advance, and the recruitment of new personnel for the division takes time. This means that the MFDS's suggested solution takes some time to implement effectively. The ongoing backlog of global pharmaceuticals awaiting GMP audits in Korea has significant implications for patients waiting for these medications. While increasing manpower is a long-term solution, it's crucial to implement short-term measures to address the immediate problem and reduce delays in approval processes. The pharmaceutical industry has proposed an alternative solution, suggesting a preliminary examination of pharmaceuticals that are in high demand within society. The suggestion aligns with the direction of MFDS. MFDS had announced that they will prioritize conducting an investigation of the pharmaceuticals meeting the following criteria: ▲Pharmaceuticals designated for preliminary examination according to Article 35-4 of the Pharmaceutical Affairs Act, ▲National essential drugs designated as requiring administrative support according to Article 83-4 of Pharmaceutical Affairs Act. "The current criteria for selecting pharmaceuticals for preliminary examination include drugs for the treatment of severe or rare diseases, and in cases where there are ▲no alternative pharmaceuticals, ▲medical gaps due to supply shortages, or ▲when there is a possibility of replacing pharmaceuticals experiencing supply shortages, GMP on-site audits should be prioritized," a pharmaceutical company's approval authority stated. Furthermore, the pharmaceutical industry emphasizes the need to expedite the revision of national essential drugs. Since the change of administration in 2022, national essential drugs have been excluded from policy priorities. It was only in November, almost two years after the last update in December 2021, that some pediatric drugs were added to the list. Many essential drugs required in the healthcare field are still waiting for approval. Therefore, there is a suggestion to consider designating these essential drugs as new national essential drugs to address this issue.
- Company
- Roche’s Lunsumio and Columvi win approval in Korea
- by Jan 05, 2024 05:41am
- Kim Seok Jin, professor of the Department of Hematology and Oncology at Samsung Medical Center. Roche's Lunsumio and Columvi are the first bispecific antibodies for lymphoma treatment, showing effectiveness as a third-line treatment for patients with lymphoma. These two drugs are highly regarded for their clinical advantages, as they have additional specific antigen-binding sites compared to monoclonal antibodies. Roche Korea held a media session on the 3rd, celebrating the Korean approval of CD20/CD3 bispecific antibodies Lunsumio (mosunetuzumab-axgb) and Columvi (glofitamab). Lunsumio is a CD20/CD3 T-cell engaging bispecific antibody that was initially indicated to treat relapsed or refractory diffuse large B cell lymphoma (DLBCL). Lunsumio received approval from the Ministry of Food and Drug Safety (MFDS) as the first medicine to be listed as ‘Global Innovative products on Fast Track (GIFT)’ in October last year. As a result, Lunsumio may be prescribed for the treatment of adult patients with relapsed or refractory DLBCL after at least two or more earlier systemic therapy. Relapsed or refractory DLBCL, a type of non-Hodgkin lymphoma caused by malignant transformation of cells of lymphatic tissues, is associated with poor prognosis with recurrence. As a result, there is a critical need for effective treatment options for relapsed patients. Results from the Phase 2 GO29781 trials have demonstrated the effectiveness of Lunsumio in adult patients with relapsed or refractory DLBCL after at least two lines of previous systemic therapy. Lunsumio has shown effectiveness with a primary endpoint of complete response (CR) rate of 60%, as assessed by the independent review committee. The objective response rate (ORR) was 80%, and the estimated median duration of response rate (DOR) was 22.8 months. In terms of safety measures, the most frequently reported adverse reaction associated with Lunsumio was cytokine-releasing syndrome, and the most frequent severe adverse reaction observed was a reduction in neutrophil counts. Nine patients discontinued the treatment due to side effects of the medicine. "Third-line treatment options for DLBCL are limited, with chemotherapy such as Mabthera being the primary option. Chemotherapy yields a treatment effect of only 15%," Kim Seok Jin, professor of the Department of Hematology and Oncology at Samsung Medical Center, stated. "Lunsumio has shown promising effectiveness in clinical trials and may become a valuable third-line treatment option." Columvi, confirmed effectiveness in DLBCL third-line treatments Columvi was approved in Korea on the 7th of last month as a treatment for patients with relapsed or refractory DLBCL after two or more lines of previous systemic therapy. DLBCL is a disease in which B cells, a lymphocyte responsible for protecting the body, either grow or replicate uncontrollably. DLBCL can have a poor prognosis after multiple treatment regimens because of the fast progression of the disease. However, the third-line treatment options are currently limiting for the patients who failed first- and second-line treatment regimens. Columvi has demonstrated effectiveness in the Phase1/Phase2 NP30179 clinical trials enrolling 155 patients with relapsed or refractory DLBCL after two or more lines of previous systemic therapy. The clinical outcome has shown that Columvi recorded CR of 40% and ORR of 81%. The effect was consistent in the sub-group analysis. The most frequently reported side effect was cytokine releasing syndrome. Columvi is anticipated to be a valuable third-line treatment options for patients with DLBCL, alongside Kymriah, a Chimeric Antigen Receptor (CAR)-T Cell therapy. “CAR-T treatment and bispecific antibody may complement each other. Patients can start with Kymriah, a CAR-T therapy, in third-line treatment, or they can begin with Columnvi,” the professor Kim stated. “I believe the treatment choice may vary depending on individual patient’s characteristics and the progression of the disease.”
