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- 2025-12-22 07:37:45
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- Is RWD needed for post-listing control of PE exempt drugs?
- by Eo, Yun-Ho Dec 02, 2024 05:49am
- The budget is tight, but the use of high-priced drugs continues to rise. The government is beginning to feel the strain of the systems it has put in place to increase access to new drugs, especially the pharmacoeconomic evaluation (PE) exemption system, which is increasingly being utilized and being subject to criticism. "The purpose of the post-listing control system is to secure additional evidence for medicines that have unclear safety and efficacy for patients. It will improve the quality of Korea’s healthcare by providing a medical reaffirmation process for such medicines." This was the government's stated intent. The government's good intentions aside, the industry has not received it well. This is due to the fear that the introduction of the system will eventually lead to "drug price cuts". Add to that the idea of using real-world evidence (RWE), or real-world data (RWD), to reevaluate drugs reimbursed through the PE exemption track, the concept has raised industry eyebrows. RWE lacks evidence base...encourages “Korea passing” The approval of a new drug is usually based on a randomized controlled trial (RCT). The PE evaluation and cost-effectiveness of the new drugs are also conducted based on this data. However, unlike RCTs, RWDs are not controlled data that are designed to accurately determine the efficacy of a drug. There are many variables that can introduce bias, such as what comorbidities the patient has, what prior medications they have taken, and whether the patient was adherent to the dose and frequency of the medication. The generally accepted levels of data evidence from high to low are meta-analyses, systematic reviews, RCTs, controlled clinical and observational studies, uncontrolled observational studies, case reports, and expert opinion; RWE is considered to be at the "uncontrolled observational study-case report" level. The Korean Research-based Pharmaceutical Industry Association (KRPIA) said, "RWE can be used to extract any desired results, depending on the intent of the collating entity. It is a risky idea to use data with a high risk of bias for the post-listing control of listed drugs. Since it is not generated in a controlled environment like an RCT, there are too many other factors to consider, including numerous crossovers, comorbidities, and use of concomitant medications." "RWEs can create contradictions and can overturn the results of RCTs that are higher level evidence. Rather, RWE should be used as a complementary tool to address uncertainties at the approval stage." Some argue that the introduction of such a post-listing control system could aggravate the "Korea passing" phenomenon in the pharmaceutical industry. If the government requires companies to submit data such as RWE post-listing, the companies will have to spend additional costs and time to generate such data, and if the data is then used as a basis for drug price cuts, it is inevitable that more pharmaceutical companies will be skeptical about launching new drugs in Korea. "Creating customized RWE data for each individual country is a huge burden for pharmaceutical companies," said a Market Access (MA) representative from a multinational pharmaceutical company. Even if a post-listing control system is introduced, the necessary data should be generated by a state-led registry, and the quality be assured." Must it be RWD? Can’t the drugs be managed with existing systems? Whether RWD is necessary is quite controversial. Korea's post-listing control system is already criticized by the industry for being tight. The Ministry of Health and Welfare proposed a plan to strengthen reimbursement management for high-priced drugs for serious diseases in 2023. In the plan, "high-priced drugs" were defined as ▲"one-shot drugs" that are expected to have long-term effects with a single treatment or drugs that require more than KRW 300 million/year of national health insurance finances per person, and were subject to reimbursement management measures. As a result, currently listed innovative drugs that have uncertainties (e.g., Kymriah, Zolgensma, Luxturna) are managed through the “performance-based reimbursement” type of the Risk-Sharing Agreement (RSA) scheme as well as the cost-effectiveness-based post-marketing evaluations, etc. The industry’s point is that systems already in place today are sufficient to manage the uncertainty that accompanies the effect of new drugs. "High-priced drugs have been reimbursed through various types of RSA, including performance-based and expenditure cap type RSA, so it is questionable whether additional follow-up measures are really necessary in addition to these arrangements, especially when the pharmaceutical companies already filter out patients that show uncertain efficacy and safety with their drugs and refund the expenses to the government under performance-based RSA," said KRPIA. "For ultra-high-priced drugs that cost over KRW 300 million per person a year and have a small number of target patients, they should be managed through a patient-level performance-based RSA or an individual contract-based drug performance evaluation system that generates individual data for each drug's situation," it added.
- Company
- oHCM drug 'Camzyos' gets greenlight for reimb
- by Eo, Yun-Ho Nov 29, 2024 05:55am
- Product photo of BMS Korea’s Camzyos 'Camzyos,' a new drug to treat obstructive hypertrophic cardiomyopathy (oHCM), will finally be listed for reimbursement. The Ministry of Health and Welfare (MOHW) held the 23rd Health Insurance Policy Review Committee meeting on November 28, announcing that BMS Korea’s Camzyos (mavacamten), a new drug used to treat obstructive hypertrophic cardiomyopathy (oHCM) will be reimbursed. As a result, prescriptions for Camzyos are expected to increase starting in next year (December). Camzyos, which was approved in May 2023, received a re-assessment status during the Drug Reimbursement Evaluation Committee (DREC) review of the Health Insurance Review and Assessment Service (HIRA). After that, it passed the DREC review and entered a drug pricing negotiation in August, but no decision was reached regarding Camzyos during the negotiation period (60 days). Camzyos is the only drug that selectively inhibits cardiac myosin-actin cross-bridge formation, which is the cause of oHCM. Camzyos' mechanism involves dissociating myosin from actin, relaxing overstimulated heart muscle, and thereby improving left ventricular outflow tract (LVOT) structure and LVOT outflow obstruction. Due to the lack of available treatments for oHCM for a long time, off-label medications have been used to manage symptoms. After Camzyos launched, the European Society of Cardiology (ESC) updated its guidelines for managing cardiomyopathy for the first time in about nine years. Previously, the guidelines for HCM were based on evidence limited to small-scale monitoring data, retrospective analysis results, and consensus opinion. However, Camzyos has completely changed this situation. Two large-scale, phase 3 clinical trials conducted as randomized controlled trial (RCT) have confirmed the significant effect of Camzyos. Consequently, ESC guidelines recommend Camzyos with the highest evidence level A for the first time in treatment options. American College of Cardiology (ACC) and the American Heart Association (AHA) are preparing to update their guidelines. Furthermore, based on this phase 3 trial evidence, the U.S. FDA granted Camzyos Breakthrough Therapy Designation (BTD) and approval. Meanwhile, the efficacy of Camzyos was demonstrated through Phase 3 EXPLORER-HCM trials. In this trial, Camzyos improved primary endpoints, which were the patient’s symptoms (NYHA classification) and exercise capacity measured with peak oxygen uptake (pVO2), more than twofold compared to the placebo. 20% of the patients treated with Caymzyos met the NYHA classification and pVO2 improvements. It also reduced the LVOT outflow obstruction index by four-fold after exercise. 7 out of 10 patients who received Camzyos treatment had improved indexes and ended up not considering surgery, and they maintained the effects for 30 weeks.
- Company
- Deregulate to foster new modalities like ADC, gene therapy
- by Son, Hyung Min Nov 29, 2024 05:55am
- Seung-Kyou Lee, Vice President of KoreaBio New modalities (therapeutic approaches) such as antibody-drug conjugates (ADCs), obesity drugs, and gene-editing technologies need dramatic regulatory relief to settle in Korea, said experts. On the 14th, KoreaBio held a seminar on trends and prospects of the bio-industry at the El Tower in Seocho-gu, Seoul. At the event, Seung-Kyou Lee, Vice President of KoreaBio, presented his assessment of the bio-industry this year and its prospects. Lee cited gene therapy drugs, obesity and diabetes drugs, and ADCs as new modalities that the Korean pharma-bio industry is interested in and developing. With the recent commercialization of gene therapy drugs such as Exa-cel, and Lyfgenia overseas, domestic companies with genetic scissors technology have also started busily developing new drugs. Genetic scissors are molecular biological tools that recognize and cut specific areas in the DNA to edit genes. Currently, domestic biotech companies such as ToolGen, Organoid Sciences, and GeneKOre have entered the market and started developing products. Lee said that the LMO Act should be revised to vitalize the domestic gene therapy market. Recently, the LMO Act was proposed to distinguish between genetically engineered organisms (GEOs) and genetically modified organisms (GMOs) to exempt them from regulations. The LMO Act aims to separate GEOs from GMOs and exempt them from the regulations that apply GMOs, ultimately to foster Korea’s GEO industry. "Gene therapy is rapidly emerging as a global industry trend. If Korea’s regulations are not eased, it will be difficult for domestic companies to grow," he said, adding, "GMO exemptions or ease of regulations for gene-edited crops/seeds is necessary." Diabetes, obesity drugs, ADCs also on the rise..."Need more government R&D support for biotechs" Treatments for obesity and diabetes have also emerged as a major R&D trend in the Korean biotech industry. The use of glucagon-like peptide (GLP-1) injectables has grown dramatically due to their ability to achieve effective weight loss. As GLP-1-based obesity drugs such as Saxenda, Wegovy, and Zepbound have shown dramatic weight loss effects in clinical trials, newcomers are mostly targeting GPL-1. Currently, various domestic pharmaceutical biotech companies such as Hanmi Pharmaceutical, Peptron, Inventage Lab, Dong-A ST, and Progen have entered the market. Lee explained, "The number of companies developing drugs for diabetes and obesity will continue to grow. However, investment sentiment in biotech companies is weak. This is why it is time to expand government R&D support for biotech companies." He pointed to "ADC" as one of the modalities that will emerge as an R&D trend this year and beyond. ADCs are anticancer drugs made by linking antibodies that bind to specific target antigens on the surface of cancer cells with drugs that have cell-killing properties. ADCs have the advantage of using the selectivity of the antibody to its target, and the killing activity of the drug that selectively acts on cancer cells, thus increasing the therapeutic effect while minimizing side effects. LigaChem Biosciences, Pinotbio, and Orum Therapeutics have succeeded in exporting ADC technology to multinational pharmaceutical companies and are being recognized for their technology. "It's time for a different level of effort to be invested compared to what we've been doing so far," said Lee, adding that securing funding is essential for biotechs to focus more on drug development. "I hope a small fund of KRW 30 billion to 50 billion can be created to be invested in the biotech sector." "We need to improve the conditions for maintaining the special listing in bio technology, such as relaxing the legal loss requirement and the threshold of KRW 3 billion in sales, and we would like to see support and incentives established for the self-reliance of Materials, Components, and Equipment businesses and stabilization of the supply chain of raw materials and pharmaceuticals."
- Company
- Samsung Bioepis names Kyung-Ah Kim as new CEO
- by Nov 29, 2024 05:55am
- Kyung-Ah Kim, President and CEO of Samsung Bioepis Samsung Bioepis has changed its CEO for the first time since its launch. Kyung-ah Kim (56), Executive Vice President and Development Division Leader, has been appointed as CEO. This is the first female CEO appointed in the Samsung Group. Hansung Ko, who has served as CEO for 12 years since the launch of Samsung Bioepis, will take over as head of Samsung Future Business Division. Samsung Bioepis today announced the promotion of Kyung-Ah Kim to the position of President and CEO. Born in 1968, Kim completed her bachelor's and master's degrees in pharmacy at Seoul National University. She then earned a doctorate in toxicology from Johns Hopkins University in the United States. Kim is from the Samsung Advanced Institute of Technology (SAIT), which marks the start of Samsung Group's bio business. She joined SAIT in 2010 as a principal scientist in bio-drug development. Then she joined Samsung Bioepis in 2015 and has played a key role in all aspects of the business, including biosimilar development, process, quality, and licensing. The company said, “As the first female professional CEO of Samsung Group, Kim will not only provide a vision for growth and an opportunity for female talents to take on bold challenges, but will also serve as a role model for women, who make up more than half of Samsung Bioscience's workforce, and is expected to bring new energy into the organization.” Hansung Ko, who was appointed CEO of Samsung Bioepis upon its foundation in 2012 and led the company for 12 years, will head Samsung Electronics' Future Business Division. The Future Business Division was established in November last year, and Mr. Koh will lead the discovery of new businesses for Samsung Group.
- Company
- 'Global obesity drug market 79 times bigger than Korea'
- by Son, Hyung Min Nov 29, 2024 05:55am
- Kang-Bok Lee, Marketing & Sales Excellence Lead at IQVIA Multinational pharmaceutical companies have been achieving significant growth through a strategy that focuses on core industries and key therapeutic areas (TA)s. On the 14th, KoreaBIO held a seminar on trends and prospects of the bio-industry at Yangjae El Tower. On this day, Kang-Bok Lee, Marketing & Sales Excellence Lead at IQVIA, shared the trends of the global pharmaceutical industry. According to Lee’s data, the global pharmaceutical market was worth USD 1.44 trillion (about KRW 191.6 trillion) last year. This is 79.1 times the size compared to Korea's market, which is USD 18.2 billion (about KRW 25.5 trillion), The growth of the global pharmaceutical market was driven by diabetes, obesity, anticancer, and autoimmune disease drugs. In particular, GLP-1 class diabetes and obesity drugs showed remarkable growth. Eli Lilly's GLP-1 diabetes drug Mounjaro generated KRW 6.48 trillion in sales last year, up 971.2% from 2022. Launched in May 2022, Mounjaro grew rapidly last year after generating KRW 640 billion in sales the same year. Novo Nordisk's GLP-1 class of diabetes drugs also had a strong year. Ozempic generated sales of KRW 5.48 trillion last year, up 52% from the previous year. Sales of Rybelsus, an oral treatment with the same ingredient generated KRW 1.44 trillion, up 140% from 2022. The obesity drug Saxenda generated KRW 1.225 trillion in sales last year, up 9.8% year-on-year. Wegovy surpassed KRW 300 billion in sales last year despite facing supply challenges. "The growth of global innovation brands is being driven by a small number of countries, products, and companies. Premium, innovative new drugs such as Keytruda and obesity treatments have driven growth in the global pharmaceutical industry." Global pharmaceutical companies steadily launch new drugs..."Expect to focus on core industries and TA" He expects an average of 70 new drugs to be launched between next year and 2028, with anticancer and obesity drugs driving growth. "Immuno-oncology drugs like Keytruda have a wide range of indications. The development of one drug has the effect of developing multiple therapies. Therefore, multinational pharmaceutical companies are showing a trend of new drug development that focuses on core industries and core therapeutic areas." "Oncology and obesity are expected to be the fastest growing segments. Oncology is expected to grow at a CAGR of 15% and obesity at a CAGR of 26% through 2028." In particular, Lee noted that companies that focus on one area, such as Mounjaro, Wegovy, SKYRizi, and Keytruda, are seeing strong growth, driving label expansions and ingredient re-engineering. "Novo Nordisk, Lilly, AbbVie, and MSD are companies that have seen success by focusing on a single therapeutic area. We believe that their products will continue to lead the global pharmaceutical market in the future,” said Lee. "Just as GLP-1 obesity drugs were developed as diabetes treatments and then became highly successful as obesity treatments, we expect re-engineering and labeling to emerge as a global R&D trend in the future."
- Company
- Sales rights for Viviant·Tuvero·Akarb to be transferred
- by Kim JiEun Nov 28, 2024 05:55am
- Due to changes in sales rights for blockbuster items that are frequently dispensed, the pharmaceutical supply and demand are expected to be affected in the end-of-year period and early 2025. According to the pharmaceutical distributor industry on November 26, several pharmaceutical companies are expected to change their distributors at the end of this year or early next year. Medication with confirmed changes to sales rights is Pfizer's Viviant Tab. Pfizer Korea has recently sent an official letter to wholesale distributors, hospitals, and pharmacies notifying 'The changes to the supply chain for Viviant.' Pfizer stated in the official letter that Pfizer will be responsible for distributing Viviant Tab 200 mg, previously distributed by Handok, starting December 1. The company requested that any inquires about returns for remaining stock from previously distributed items to be maded to Handok, and any inquiries after December 1 be directed to Pfizer. Pfizer also announced that the distribution of Caverject Injection 10 ug and 20 mg, previously distributed through Novamedix will be changed to direct distribution effective December 1. Pfizer stated any inquiries about remaining distributing stock for this item could be made to Novamedix, and inquiries related to distribution after December 1 should be directed to Pfizer. In addition to these items, more products with expected changes to sales rights in early next year. Sales rights for most of Boryoung's items will be changed, and the company seems to be informing its pharmaceutical distributors. The wholesale distributor said that Daewon Pharmaceutical has been responsible for distributing Boryoung's Tuvero Tab and Akarb Tab, but Boryung will directly distribute them starting next year. Yungjin Pharmaceutical has been distributing Boryung Buspar Tab since 2018. Boryung is highly like to distribute the drug directly next year. As changes to distributors have been announced, it is expected to affect the end-of-year pharmaceutical supply and demand. "Special circumstances such as changes to the distributor are likely to affect the supply and demand. The effective date may be postponed beyond what the pharmaceutical companies have previously announced," a pharmaceutical wholesale employee said. "We must prepare for possibilities such as difficulty in returning remaining stocks and unstable supply and demand for such items in early next year."
- Company
- Lilly appoints Stacie Liu to head the CardioMetabolic Health
- by Eo, Yun-Ho Nov 28, 2024 05:54am
- Stacie Liu, Senior Director, CardioMetabolic Health Business Unit, Lilly Korea Lilly Korea has named Stacie Liu (37), as the new Senior Director of its CardioMetabolic Health Business Unit On the 1st, Lilly Korea announced that it had appointed Stacie Liu as the Senior Director of its CardioMetabolic Health Business Unit. In this role, Liu will be responsible for setting and executing the business strategy for Lilly's diabetes and obesity portfolio in Korea, including the company's type 2 diabetes and obesity treatment, Mounjaro. Lilly's decision is notable in that Liu is a young, foreign, female leader. This is in line with Lilly's culture, which believes in the power of diversity, equity, and inclusion. As of 2023, one in two (49%) of Lilly’s executives were women. This represents a 4%p increase over 4 years from 2019. Five of the 12 Board of Directors are also women, with their ages ranging from early 50s to late 60s. “At Lilly, our goal is to help people live better everyday lives through dedicated and exploratory development of new medicines, and we need the best and brightest minds with the most creative ideas to address the world's most pressing health challenges,” said Liu. “Lilly's success today is founded on the corporate culture that embraces diversity and values equity. Based on this culture, Lilly Korea will be committed to delivering life-changing medicines promptly to patients in Korea.” Liu has previously held positions at Lilly's Shanghai office and U.S. headquarters and has a bachelor's degree in International Relations and Affairs from Fudan University in Shanghai, China. Fudan University is a world-renowned university, ranked 31st in the world and 3rd in China as of 2022.
- Company
- ‘The new ATTR-CM treatment can improve patient survival’
- by Whang, byung-woo Nov 27, 2024 05:50am
- With the possibility for reimbursement coverage for the ultra-rare disease, transthyretin amyloid cardiomyopathy (ATTR-CM) rising, excitement is also rising in the clinical site. Due to the short life expectancy of ATTR-CM - 2-3.5 years after diagnosis – and no clear treatment option available, the benefits of a new treatment option are expected to be significant. As an extremely rare disease with a small number of patients, challenges still remain in identifying and diagnosing patients early. Dailypharm met with Dr. Junho Hyun, Professor of Cardiology at Asan Medical Center in Seoul, to discuss Korea’s treatment environment for ATTR-CM and the changes made since the reimbursement of its treatment option. Junho Hyun, Professor of Cardiology, Seoul Asan Medical Center ATTR-CM is a rare, progressive disease where a protein called transthyretin (TTR) misfolds and forms harmful amyloid deposits in the heart. Although it is caused by genetic issues, it can also occur with aging. In particular, ATTR-CM is a rare disease that is most commonly found in patients over the age of 65, so experts believe its patient population could grow as Korea enters an aged society. "The exact prevalence of ATTR-CM patients in Korea is unknown, but what is known is that it is expressed in a different form in Korea than in other countries," said Professor Hyun. "In the United States, the number of affected patients was identified through the patient registration system and the introduction of its treatment was also fairly quick. Korea needs to improve the overall treatment environment for ATTR-CM patients, including its management, diagnosis, and treatment," said Dr. Lee. "The most common cause of cardiac amyloidosis is AL amyloidosis, followed by ATTR amyloidosis, so we test for these 2 possibilities at the time of initial diagnosis," he said. "We also use nuclear scintigraph to diagnose ATTR-CM, and then genetic testing to differentiate between the hereditary and wild-type. In some cases where nuclear scintigraphs are not available, we test the heart tissue." According to Professor Hyun, the diagnosis of ATTR-CM patients in the United States is slowly increasing. He believes that this is due to increased awareness, which, like other diseases, has led to the development of treatments. In the past, patients with hereditary ATTR-CM often died suddenly without knowing the cause of their disease due to low awareness, but early identification of patients has led to higher diagnosis rates the patients’ families can also be diagnosed and treated. From a treatment standpoint, prior to the approval of Vyndamax (tafamidis) in 2020, the doctors had lacked options - using diuretics to relieve symptoms or carrying out heart and liver transplants. However, despite the emergence of a treatment, its high price remains a hurdle. Recently, Vyndamax’s reimbursement agenda passed the review of the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service 4 years after its approval, leaving only drug price negotiations with the National Health Insurance Service. "With a median survival of only 2-3 years, patients with ATTR-CM despair due to the fact that treatment options are available but unaffordable. It's very unfortunate that there is a cure, but it's not covered by insurance, which limits treatment," added Hyun. While he understands the limitations that exist due to government budgets, Hyun believes that reducing mortality through early treatment of ATTR-CM patients is more cost-effective. "In Korea, the deterioration of ATTR-CM symptoms slowed down or even improved in some cases in patients who used the drug through patient support programs. However, it is less effective if the timing of treatment is delayed due to delayed access and the disease progresses, so it is necessary to set reimbursement standards so that the drug can be used from an early stage in addition to patients with severe symptoms." "ATTR-CM is like cancer in that it has a very short median overall survival, so it is very unfortunate that its treatment options are being restricted because it is a rare disease with a small number of patients," said Professor Hyun. "The medical gap that exists due to the high treatment cost is a social problem, which requires serious government consideration.”
- Company
- Active development of new drugs for myasthenia gravis
- by Son, Hyung Min Nov 27, 2024 05:50am
- Competition in the pharmaceutical market is heating up to secure myasthenia gravis indication. UCB's new drug was approved in South Korea, and Janssen finished the phase 3 trial, aiming to acquire regulatory approvals worldwide. In South Korea, Handok seeks to enter the market with its acquired new drug. HanAll Biopharma is conducting a Phase 3 trial and investigating the potential of commercialization. According to industry sources on November 27, UCB's 'Zilbrysq' was approved in South Korea on November 21. Zilbrysq can be used as an add-on to standard therapies, such as cholinesterase inhibitors, steroids, and immune checkpoint inhibitors. This therapy is a complement C5 inhibitor and works by inhibiting the complement-mediated damage to the neuromuscular junction (NMJ). Product photo of UCBDue to this approval, Zilbrysq became the first treatment that can be self-administered, unlike other domestically approved treatments for adult myasthenia gravis. 'Ultomiris,' a complement C5 inhibitor used to treat existing myasthenia gravis, is an intravenous injectable that requires administration at hospital visits every 8 weeks. Generalized myasthenia gravis (gMG) is a chronic autoimmune rare disease in which nerves fail to transmit signals to muscles, leading to skeletal muscle weakness. This disease induces fluctuating weakness of systemic muscles, affecting daily activities such as standing, swallowing, and breathing. Zilbrysq's approval is based on the Phase 3 'RAISE' study. The study evaluated the efficacy and safety of Zilbrysq in 174 adult patients with anti-acetylcholine receptor (AchR) positive gMG. The primary endpoint was the 'Myasthenia Gravis-Activities of Daily Living (MG-ADL)' for gMG. Typically, an MG-ADL score of 2 or higher or a Quantitative Myasthenia Gravis (QMG) score of 3 or higher indicates clinically significant improvement. The clinical results showed that the Zilbrysq group showed a clinically significant reduction by a total score of 4.39 from baseline at 12 weeks compared to the score of 2.30 of the placebo group. In addition to working on Zilbrysq, UCB is preparing to expand approvals of 'Rystiggo,' UCB's additional treatment for myasthenia gravis, in countries. Rystiggo obtained the U.S. Food and Drug Administration (FDA) approval in June 2023 and was also approved in Europe in January of this year. Janssen has recently completed the Phase 3 trial of 'nipocalimab,' a new drug candidate for myasthenia gravis and the company is preparing to obtain approval. Janssen applied to obtain approvals from the FDA in August and the European Medicines Agency (EMA) in September. Nipocalimab works by a novel mechanism that blocks the Fc receptor (FcRn), a protective immunoglobulin G (IgG) receptor. This mechanism reduces IgG antibodies that cause the disease and inhibits their recycling process. Nipocalimab binds to FcRn to prevent the degradation of IgG antibodies. The Phase 3 Vivacity-MG3 study demonstrated the efficacy of nipocalimab in combination with standard therapy compared to the placebo. The clinical study confirmed a statistically significant result, with nipocalimab recording an MG-ADL score of 4.70. Also, nipocalimab improved the myasthenia gravis patients' muscular strength and function compared to the placebo. Handok·HanAll aim to commercialize their treatments with a similar mechanism to nipocalimab In South Korea, Handok is preparing for the new drug approval for the treatment of myasthenia gravis. In August. Handok signed an agreement with argenx, the Belgium-based developer of Vyvgart. Handok is now responsible for domestic approval registration, applying for reimbursement, and exclusive distribution. Like nipocalimab, Vyvgarth is a new drug targeting the FcRn. It has been approved in several countries, including the United States, Europe, the United Kingdom, Israel, and China, for treating adult patients with generalized myasthenia gravis. The clinical efficacy of Vyvgarth was demonstrated in the Phase 3 clinical trial named ADAPT. It was shown that Vyvgarth recorded a 68% responder rate based on the MG-ADL scale, significantly higher than the 30% of the placebo. Additionally, Vyvgarth demonstrated an improved score compared to the placebo group on the QMG scale. HanAll Biopharma is also developing an FcRn antibody treatment candidate, batoclimab (HL161), as a subcutaneous injectable. In December 2023, HanAll Biopharma's Chinese partner, Harbour BioMed, secured Phase 3 clinical trial results and submitted an approval application to Chinese regulatory authorities. Harbour BioMed said that batoclimab improved symptoms in myasthenia gravis patients based on MG-ADL and QMG scales. HanAll Biopharma is conducting a phase 3 trial for batoclimab in the United States. HanAll Biopharma's U.S. partnering company Immunovant finished registering patients for the Phase 3 clinical for myasthenia gravis. Immunovant plans to present top-line results of the phase 3 clinical trial in the first half of 2025. HanAll Biopharma and Immunovant plan to investigate the potential of batoclimab for various autoimmune disease indications, including thyroid eye disease and chronic inflammatory demyelinating polyneuropathy. In addition to developing batoclimab, both companies will develop new drugs for additional myasthenia gravis indication. HanAll Biopharma and Immunovant are conducting a phase 1 trial of IMVT-1402, a new FcRn antibody drug candidate product. Unlike conventional FcRn antibody treatments, IMVT-1402 is not known to affect the LDL-cholesterol level. In the Phase 1 clinical trial, subcutaneous injection of IMVT-1402 and placebo are administered to randomized healthy adults. Each patient group receives a single-dose or multiple doses with a dose-escalation.
- Company
- 4 of 5 listed pharma companies expand investments
- by Chon, Seung-Hyun Nov 26, 2024 05:54am
- Pharmaceutical companies have significantly expanded their research and development (R&D) investments to discover their next item. Five out of five major pharma and biotech companies increased their R&D spending this year compared to the previous year. The top pharmaceutical companies in terms of sales have been investing heavily in R&D to develop new drugs. Yuhan Crop, Celltrion, and Dong-A ST showed a significant increase in R&D expenditures. According to the Financial Supervisory Service on the 25th, the cumulative R&D investments of 20 major pharmaceutical and biotech companies totaled to KRW 1.867 trillion in Q3, up 14.5% from the KRW 1.6387 trillion in the same period last year. The data was compiled from 20 listed pharmaceutical companies with the highest sales of main drug products. Ildong Pharmaceutical, which spun off its R&D subsidiary last year, was not included in the survey. Sixteen of the 20 major pharmaceutical companies increased their R&D investment this year compared to the same period last year. Celltrion, Samsung Biologics, Yuhan Corp, Daewoong Pharmaceutical, Hanmi Pharmaceutical, SK Biopharmaceuticals, Chong Kun Dang, Dong-A ST, HK Inno.N, JW Pharmaceutical, Boryung Pharmaceutical, Daewon Pharm, Huons, Dongkook Pharmaceutical, Dongwha Pharmaceutical, and Celltrion Pharmaceutical showed an increase in R&D expenditures through the third quarter compared to last year. Yuhan Corp showed the largest increase in R&D expenditure this year. The company invested KRW 201.1 billion in R&D through the third quarter, up 48.5% from KRW 135.4 billion it had invested in the same period last year. The increase was largely due to the reallocation of technology fees it accrued from its anti-cancer drug Leclaza. In August, the U.S. Food and Drug Administration (FDA) approved Leclaza in combination with Rybrevant for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation. Yuhan Corp received a USD 60 million technology fee from Janssen Biotech for the FDA approval of Leclaza. Of the total Leclaza royalties received, 40% was paid to the original developer, Oscotec. In 2016, the company acquired the preclinical development rights to Leclaza from Oscotec and its subsidiary Genosco. The technology fees redistributed to Oscotec were recognized as R&D expenses. This significantly increased the company’s R&D expenses as Yuhan paid more than KRW 30 billion to Oscotec out of the royalties it had received for Leclaza. In the first half of the year, Yuhan’s R&D expenses were high due to the introduction of promising technologies from bioventures. In March, the company paid KRW 6 billion to acquire the technology of SOS1-inhibiting anti-cancer drug candidates from Cyrus Therapeutics and Kanap Therapeutics. In the second quarter, the bank paid KRW 3 billion in technology fees to a biotech company, J Ints Bio. Celltrion reported cumulative R&D expenses of KRW 312.8 billion in the third quarter, up 34.0% YoY. Celltrion has received approval for 2 biosimilars in Europe so far this year. In May, the company received marketing authorization from the European Commission for its first biosimilar of Xolair, Omlyclo. Xolair is an antibody-based biological drug used to treat allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria. In August, the company received approval for SteQeyma, a biosimilar to the autoimmune disease treatment Stelara, received European marketing authorization. Stella Stelara is a Janssen-developed autoimmune disease treatment for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Celltrion has acquired 8 and 6 approvals in Europe and the U.S., respectively. Celltrion is developing follow-on biosimilars for Keytruda, Prolia, Actemra, Cosentyx, and Ocrevus. Dong-A S&T's R&D expenditure through the third quarter was KRW 103 billion, up 25.5% YoY. Its clinical expenses for new drug development increased significantly. DA-4505, an immuno-oncology drug, was approved for Phase I/IIa clinical trials in Korea in November last year. DA-4505 showed improved tumor suppression through preclinical studies compared to AhR antagonists being developed by global pharmaceutical companies. A Phase III clinical trial for DA-8010, a treatment for overactive bladder, was completed in Korea in May. However, DA-8010 did not show a statistically significant difference. In October, Dong-A ST’s Stelara biosimilar Imuldosa received final approval from the FDA, marking the company's entry into the U.S. market. The company passed the U.S. market gateway 11 years after starting the development of Imuldosa in 2013. SK Biopharmaceuticals, Boryung, Samsung Biologics, Daewoong Pharmaceuticals, Hanmi Pharmaceuticals, and HK Inno.N have expanded their R&D expenditures by more than 10% YoY through the third quarter of this year. The increase in R&D expenditures was larger among pharmaceutical companies with larger sales. Samsung Biologics, Celltrion, Yuhan Corp, GC Biopharma, Chong Kun Dang, Hanmi Pharmaceutical, Daewoong Pharmaceutical, Boryung Pharmaceutical, and HK Inno.N have invested KRW 1.49 trillion in R&D this year, up 16.8% from the previous year. Of the top 10 companies by revenue, nine, except for GC Biopharma, increased their investment from last year. It is analyzed that large pharmaceutical companies, which have accumulated experience in developing new drugs and are actively seeking to expand globally, have been actively investing in R&D to discover new items. SK Biopharmaceuticals had the highest R&D investment-to-sales ratio, at 30.7%. Dong-A ST and Daewoong Pharmaceutical followed with 19.9% and 18.3%, respectively, while Hanmi Pharmaceutical, Yuhan Corp, Celltrion, and JW Pharmaceutical also invested more than 10% of their sales in R&D.
