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- 2026-06-24 22:53:17
- 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.”
- Company
- Pharma CEOs consider job cuts and reducing hiring in 2024
- by Kim, Jin-Gu Jan 05, 2024 05:41am
- 13% of pharmaceutical and bio company CEOs have announced plans to reduce employment this year. Apart from this, another 12% have indicated the possibility of reducing their workforce this year. Overall, the industry held a more cautious stance toward hiring this year. Compared to last year, the number of respondents who responded that they will increase hiring decreased, while the number of CEOs who plan to decrease employment has increased. Such figures suggest that the prolonged economic recession has deepened CEOs' concerns about hiring. Pharma CEOs more cautious about ‘expanding employment’…...15% last year→9% this year According to Dailypharm's 2024 survey of 53 CEOs in the pharmaceutical and bio industries on their plans for hiring in 2024, 77% (41 respondents) answered that they plan to keep hiring at the same level as last year. Only 9% (5 respondents) plan to increase hiring, and 13% (7 respondents) plan to decrease hiring. This differs from last year's employment plans of the companies. When asked how they expect employment to change compared with 2023, 74% (39 out of 53 CEOs) said it will ‘stay the same’, 15% (8) said it will increase, and 11% (6) said it will decrease compared with the previous year. Compared to the previous year, the companies’ inclination to expand hiring decreased from 15% to 9%, and their inclination to maintain hiring decreased from 77% to 74%. On the other hand, plans to reduce hiring increased from 11% to 13%. In just one year, plans for increasing or maintaining employment as is had decreased while plans for reducing hiring increased among the surveyed companies. Companies that performed worse last year were more likely to reduce employment this year. In fact, of the 6 CEOs who rated their company's performance as "poor" or "very poor" last year, 3 said they would reduce hiring this year. The other 3 said they would maintain their hiring levels. Only 1 CEO rated last year's business performance as "good" but said they would reduce hiring this year. When asked about the possibility of layoffs this year, 4% ‘is planning,’ 8% ‘is considering' reducing workforce Regardless of whether or not they are reducing hiring, 12% (6 out of 53) of respondents said they have ‘plans to reduce’ or ‘are reviewing reducing’ their workforce this year. Of these, 4%(2 respondents) clearly stated that they had plans to reduce their workforce, and 8% (4) said they were considering it. The remaining 89% (47) said they had no plans to reduce the workforce. Responses to the question of potential layoffs, the responses were consistent among domestic and multinational pharmaceutical companies, as well as large and small pharmaceutical companies. Of the 6 companies planning reductions, 4 were domestic pharmaceutical companies and 2 were Korean subsidiaries of multinational pharmaceutical companies. Also, the responses came 3 each from large and small pharmaceutical companies. While the majority of respondents have no plans to reduce their workforce, it is expected that the wave of restructuring in the pharma and bio industry that started last year may continue this year, with some companies taking the lead. Among domestic pharmaceutical companies, GC Biophamra, Ildong Pharmaceutical, KyungDong Pharm, Yuyu Pharma, Aprogen Pharmaceuticals, and Genome & Company started restructuring last year. Among the Korean subsidiaries of multinational pharmaceutical companies, MSD Korea, Pfizer Korea, and Novartis Korea conducted restructuring last year, and Sandoz withdrew its service in Korea. In particular, the restructuring decisions of large pharmaceutical companies like GC Biopharma and Ildong Pharmaceutical have spread anxiety across the pharma-bio industry. Both companies had received poor business reports last year. This raises concerns that the restructuring trend could spread across the industry if this year's results are weaker than expected. Hiring area priorities, Sales/Mareketing >R&D>Manufacturing/Control Amidst the overall hiring atmosphere, CEOs have forewarned plans that they aggressively hire for sales and marketing positions. Of the 53 respondents, 43% (23) said sales and marketing will be their top hiring priority this year. This was followed by 36% (19) in R&D, 13% (5) in production management, then 8% (4) in other roles. No respondents chose finance/accounting or IT/security. By company size, large and small/mid-sized pharmaceutical companies differed in their hiring plans for production management positions. 18% (6 out of 35) of the large pharma respondents indicated that they are prioritizing production management positions, compared to 1 out of 17 among small and midsize pharma respondents. Large pharma (38%) and small pharma (35%) were similarly likely to prioritize hiring R&D positions. There was no significant difference between large pharma (41%) and small pharma (53%) in their plans to focus on sales and marketing roles.
- Company
- Koselugo commences prescription with insurance coverage
- by Eo, Yun-Ho Jan 05, 2024 05:41am
- AstraZeneca Korea’s Koselugo (selumetinib), a neurofibromatosis treatment, has recently passed the Drug Committee (DC) of tertiary hospitals. Hospitals have started prescribing Koselugo, a treatment for pediatric neurofibromatosis. AstraZeneca Korea’s Koselugo (ingredient: selumetinib), a neurofibromatosis, has recently passed the Drug Committee (DC) of tertiary hospitals, including Seoul National University Hospital, Samsung Seoul Hospital, Seoul St. Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Some of these hospitals have assigned a prescription code for Koselugo following emergency DC. Koselugo has been listed for reimbursement starting this year. As a result, it is anticipated that more hospitals will be able to prescribe the drug in the future. On the third try, Koselugo passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee on the 7th of last month and settled in negotiations for reimbursement pricing with the National Health Insurance Service (NHIS) at the end of the year. Koselugo was the first drug to be designated by the ministry as a priority drug under the accelerated review system in October 2020. Subsequently, in May 2021, Koselugo won approval from the Ministry of Food and Drug Safety (MFDS) and was listed for reimbursement after approximately two and a half years. The reimbursement criteria for Koselugo apply to pediatric patients aged 3 to 18 years who have neurofibromatosis Type 1 (NF1) with inoperable plexiform neurofibromas and their condition meets any of the following: ▲Located in the head, neck, or other areas with a risk of airway obstruction or vascular damage ▲Causing compression or functional impairment of major nerves or nerve structures ▲Encasing vital blood vessels or organs, leading to significant functional impairment ▲Physical deformities resulting in motor or sensory dysfunction ▲Severe pain that persists despite the use of neuropathic pain medications, significantly affecting daily life ▲Other conditions where drug therapy is deemed necessary. Until now, patients with neurofibromatosis have relied on general remedies with no specific treatments available. Neurofibromatosis is a rare disorder characterized by tumors that develop in nerve tissue, bones, skin, and other parts of the body. Approximately 85% of cases are classified as type 1 (NF1), resulting from a mutation in the NF1 gene on chromosome 17. The prevalence of NF1 is about 1 in 3,000 individuals. The onset of neurofibromatosis typically starts during childhood. In most cases, the first symptom appears as 1-3cm sized coffee-colored patches on the skin. Around the age of 6, some children develop optic pathway glioma, a type of tumor, and between the ages of 6-10, many children develop scoliosis. In adult patients, Lisch nodules, which are tiny hamartomas affecting the iris, are commonly found. Currently, the treatment regimen for neurofibromatosis involves surgical removal when possible or anti-cancer and radiation therapies. However, even with surgery, these tumors often recur, and most surgeries are major procedures, posing a significant burden on both medical professionals and patients. Particularly in pediatric patients, frequent recurrences may require multiple surgeries, leading to the need for ongoing pain management and potentially resulting in language and motor impairments in many cases. Koselugo is a treatment jointly developed by AstraZeneca and MSD. The drug inhibits the activation of MEK and suppresses the growth of the cancer. In the Phase 2 SPRINT clinical trials that served as the basis for approval, Koselugo achieved an objective response rate (ORR) of 68% by reducing tumor size by 20% or more in treated patients. Furthermore, among patients who showed partial response, 82% maintained their response for over 12 months. Patients who did not receive treatment typically experienced disease progression within 1.5 years, while those treated with Koselugo had only about 15% experiencing disease progression even up to 3 years. “NF1 with plexiform neurofibroma is a severe condition that can involve symptoms such as severe pain, visual impairment, and spinal deformities. Furthermore, it can progress into a life-threatening malignant disease. The listing of Koselugo for reimbursement will be of great help in extending the lives and improving the quality of life for pediatric patients in the future,” Lee Beom-hee, Professor of Pediatric Endocrinology and Metabolism at Asan Medical Center, commented.
- Policy
- Need to specify conditions for postponing PE data submission
- by Lee, Tak-Sun Jan 05, 2024 05:41am
- Study on Improving the Pharmacoeconomic Evaluation Data Waiver (PE exemption) System The results of the research service that was ordered by the Health Insurance Review and Assessment Service to devise measures on improving the pharmacoeconomic data submission waiver system, or the PE exemption system, have been disclosed in full. The improvements suggested by the researchers include redesigning the PE exemption system into a PE deferral system, and establishing a process to demonstrate economic feasibility after listing. It was also suggested that a reevaluation system should be established for drugs that have already been listed through the PE exemption track. Based on the study, HIRA plans to come up with a follow-up and reevaluation plan for the PE exemption drugs. According to the results of the ‘Study on Improving the PE evaluation data waiver system (Seoul National University R&DB Foundation, Professor Tae-jin Lee, Principal Investigator)' that was released on the 3rd, ithe PE exemption system needs to be redesigned into a system that defers proof of economic feasibility for drugs when necessary, rather than a system for waiving submission of PE evaluation data overall. The PE exemption system was introduced in May 2015 and applied to 26 drugs until July 2022. Explaining the background of their proposal, the researchers said, "The introduction of the PE exmpetion system has had some positive effects on improving patient access, such as by improving the rate of new drug listings and shortening the listing period. However, when considering the various characteristics of subject drugs, there seems to be a high need for the PE exemption drugs to be managed within the basic principles of the positive listing system that is based on the demonstration of cost-effectiveness.” In this regard, the research team proposed ▲ redesigning the system into an economic feasibility demonstration deferral system ▲ establishment a post-listing economic feasibility demonstration process through a specific agreements on items that need to be clarified in advance ▲ establishment of a post-marketing and reevaluation system based on cost-effectiveness evaluations ▲ and others, such as increasing the practicality of total expenditures by setting a set amount for each disease unit or an expenditure cap and setting a reasonable baseline for the evaluation amount based on foreign drug price. The researchers also saw the need to reestablish the current PE exemption conditions. More specifically, the condition, ‘anticancer drugs or rare diseases for which no substitute or therapeutically equivalent product or treatment exist,' needs to be specified. On this, the researchers proposed limiting the condition to ‘rare disease drugs or anticancer drugs used for serious conditions that threaten survival, such as those for diseases with a life expectancy of less than 2 years,’ and to set specific requirements such as ‘drugs that bring a significant clinical improvement over nontreatment and has no other alternative treatment,’ or ‘provide a significant clinical improvement over existing treatments, such as a significant prolongation of survival.’ The reseachers also believed that the current grounds for lacking evidence were also inadequate. The current requirement is: drugs for a small number of patients, ▲ that were approved with single-arm clinical data without a control group, ▲ approved with a Phase II clinical trial that has a control group but without a conditional Phase III trial, or ▲ have other difficulties in producing evidence. More specifically, the researchers proposed ▲ cases where no clinical trial with a control group has been conducted and indirect comparison is difficult, ▲cases where PE evaluations have not been conducted in other countries as well, ▲cases where it is difficult to confirm the final effect due to immature clinical data, and it is not appropriate to conduct PE evaluation by estimating the final result through modeling. However, ▲if the size of the required finances is above a certain level, economic feasibility must be demonstrated. Also, the researchers pointed out that the requirement of a ‘small number of patients’ should also be revised to a ‘diseases with a prevalence 200 or less patients per independent condition.' In addition, the researchers claimed that drugs used for pediatric patients and tuberculosis treatments, which were added as PE exemption drugs last year, should be removed again as drugs that are not considered to be rare diseases but are life-threatening were waived PE data submissions even before the revisions were made. The researchers concluded that real-world evidence (RWE) can be recognized as a source of evidence after listing. They also suggested the need for a collective reevaluation of the listed PE exemption drugs. "In the case of PE exemption drugs they have already been listed, all other HTA-based countries have evaluated their economic feasibility after listing. Therefore, it is necessary to reevaluate the drugs even if their control period has been completed to manage the appropriate listing price of latecomers that will be listed using the PE exemption drugs as a comparator."
- Company
- Celltrion to divest prescription drugs acquired from Takeda
- by Kim, Jin-Gu Jan 04, 2024 05:33am
- (Credit: Celltrion) The Celltrion group is selling divestiture of primary care business rights in the Asia-Pacific region acquired from Takeda Pharmaceutical in 2020. Among the business rights acquired from the previous deal, Celltrion group will initiate the sales of business rights for prescription drugs, excluding those intended for the domestic market. They will also engage in separate negotiations with a different company for the business rights related to the over-the-counter (OTC) drugs. Celltrion group announced on the 2nd that the company will sign a contract to divest the primary care business rights in the Asia-Pacific region, which it acquired from Takeda Pharmaceutical. In 2020, Celltrion acquired the primary care business rights of Takeda Pharmaceutical for US$278.3 million (approximately 310 billion won). This acquisition included prescription drugs such as the DPP-4 inhibitor class diabetes medicine ‘Nesina (alogliptin)’ series, TZD class diabetes medicine ‘Actos (pioglitazone)’ series, and ARB class of hypertension treatment ‘Edarbi (azilsartan)’ series, as well as OTC drugs such as cold medicine ‘Whituben’ and stomatitis medicine ‘Albothyl’. The current divestiture encompasses the business rights for prescription drugs like Nesina and Actos in the Asia-Pacific region. The business rights of OTC drugs and domestic prescription drugs are excluded from the divestment. Major items that Celltrion acquired from Takeda Pharmaceutical in 2020. (Clockwise from the upper left) Product photos of Nesina, Actos, Edarbi, Albothyl, Whituben, and Nesinamet. The acquisition target is CBC Group, a Singapore-based global healthcare-focused private equity firm. CBC Group has established an overseas special purpose company (SPC) called 'HP Bidco 2 Limited' to proceed with the acquisition. The future business rights transfer agreement will be signed between Celltrion APAC and HP Bidco 2 Limited. The sales price is 5.58 billion Thai Baht (THB, approximately 210 billion won). Celltrion explained that the sale price for the business rights was determined based on a 3-year post-acquisition evaluation, considering increased business value resulting from revenue growth for related items (with an average regional sales growth rate of 13%) and cost savings through production internalization after the acquisition. The value of the business rights for prescription drugs in current sales represent approximately half of their value compared to when Celltrion acquired them in 2020. Celltrion explained that if the value of the items were recalculated based on 2020, it would amount to approximately 138 billion won, equivalent to 46% of the total value at that time. Celltrion will retain the business rights for domestic prescription drugs that were excluded from this sale. The company expects to maintain sales revenue from products like Nesina and Edarbi in the domestic market as before. Additionally, Celltrion plans to use these products as a foundation for developing incrementally modified drugs. At the same time, Celltrion has secured exclusive supply rights for Edarbi and Nesina series within the Asia-Pacific region. Celltrion Pharm will produce Edarbi and Nesina for supply to the CBC Group, which will then distribute these products in the Asia-Pacific region. This arrangement is anticipated to provide Celltrion Pharm with a stable source of revenue through the exclusive supply of the Edarbi and Nesina series. Celltrion is currently in negotiations with another company regarding the sale of the entire OTC drugs business rights for the rest of the Asia-Pacific region, including Korea. Celltrion has stated that it is in the final stages of negotiations with a strong candidate company. After re-selling the licensing rights after three years, Celltrion has generated considerable profit. By selling the licensing rights for prescription drugs in the Asia-Pacific region, excluding Korea, Celltrion has generated a profit of around 70 billion won compared to the initial investment of around 140 billion won. If the remaining negotiation for the sale of licensing rights for OTC drugs proceeds smoothly, Celltrion is expected to generate even higher investment profit. Celltrion views the sale of these business rights as a steppingstone to creating a foundation for integrated Celltrion to focus on its core businesses. "Selling the business rights was based on the strategic decision at a time when we are on the verge of significant growth upon the launch of integrated Celltrion. We have successfully concluded the sale, securing stable revenue through maintaining domestic business rights for core prescription drugs and acquiring exclusive product supply," a representative from Celltrion Group stated. "The proceeds from the sale will be invested in strengthening the new product portfolio and establishing a foundation for the sustainable growth of the Celltrion Group," the representative added.
