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- 2026-04-03 10:41:00
- Policy
- BMS’s next-gen targeted drug repotrectinib approved in KOR
- by Lee, Hye-Kyung Jun 09, 2025 05:51am
- BMS Pharmaceuticals' ‘Augtyro Cap (repotrectinib),' which is regarded a next-generation targeted therapy for lung cancer, has been approved in Korea. On the 5th, the Ministry of Food and Drug Safety granted marketing authorization for 2 items - Augtyro Cap 40 mg and 160 mg. Specifically, repotrectinib is indicated as: ▲treatment for patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) ▲ treatment for pediatric patients 12 years and older and adult patients with locally advanced or metastatic solid tumors that are unsuitable for surgical resection due to high risk of severe complications and harbor an Neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Augtyro was first approved by the US FDA in November 2023 as a treatment for non-small cell lung cancer and was designated as an orphan drug in Korea last May. Since August last year, it has been prescribed to patients after receiving initial approval for its use in Korea for therapeutic purposes. The drug’s efficacy was confirmed through the multinational Phase I/II TRIDENT-1 trial. The trial results showed that the primary endpoint, the objective response rate (ORR), was 79% for repotrectinib in 71 TKI treatment-naïve patients. Progression-free survival (PFS) was nearly double that of previous targeted therapies. The ORR was defined as the proportion of patients treated within a specific time frame who either had a decrease in tumor size (partial response) or no further signs of cancer (complete response). The median duration of response was 34.1 months. In 56 ROS1 TKI–naïve and chemotherapy-naïve patients, the objective response rate was 38%, and the median duration of response was 14.8 months. The trial also examined the drug’s efficacy in treating patients with resistance to existing targeted therapies. In the 56 patients with resistance to existing therapies, repotrectinib showed an ORR of 38% and a PFS of 9 months, and 17 patients who had acquired a baseline G2032R resistance mutation showed an ORR of 59% and a PFS of 9.2 months. The results of the TRIDENT-1 trial were published in the New England Journal of Medicine (NEJM) (IF 176.082), with Byoung-Chul Cho, Director of the Lung Cancer Center at Yonsei Cancer Hospital in Korea, participating as a corresponding author. ROS1-positive NSCLC accounts for 2% of all lung cancers. The standard of care is to use targeted anti-cancer therapies that target the mutated gene. Commonly used drugs include ‘crizotinib’ and ‘entrectinib,’ and repotrectinib is gaining attention as a next-generation drug.
- Company
- GC’s US affiliate Curevo extends shingles vaccine trial
- by Cha, Jihyun Jun 09, 2025 05:50am
- GC Biopharma (CEO Eun-Chul Huh) announced on the 4th that its U.S. affiliate Curevo Vaccine has completed the enrollment of its first patient in the Phase 2 extension study of its shingles vaccine amezosvatein. This clinical trial was designed based on the results of the previously conducted Phase II trial. The extension trial will serve as a step toward determining the optimal dose prior to entering Phase III clinical trials, and the company explained that the study incorporates feedback from regulatory authorities and key stakeholders. The Phase 2 extension includes the key population of adults over age 50, targeting randomization of 640 participants to receive amezosvatein or Shingrix, the currently approved shingles vaccine. The company stated, “The inclusion of the key population of adults aged 70 and older holds significance in securing efficacy and safety data for the vaccine in the elderly population.” “I’m so proud of the Curevo team’s drive to get amezosvatein to people looking for a shingles vaccine alternative,” stated Dr. Guy De La Rosa, Chief Medical Officer for Curevo. “We are also proud to be working with a great collection of clinical trial sites, whose excitement for this trial and the overall potential of amezosvatein is gratifying.” “To enroll our first patients just over two months after announcing our $110 million Series B round demonstrates the Curevo team’s ability to execute quickly,” added George Simeon, Curevo’s CEO. Curevo plans to accelerate the entry of amezosvatein into Phase III clinical trials, as well as its commercialization and global approval strategies. Curevo is a vaccine-specialized subsidiary established in 2018 by GC Biopharma in Seattle, Washington, USA. As of the end of last year, GC Biopharma held a 78% stake in the company. Curevo secured a total investment of USD 60 million in its Series A funding round in 2022 and completed its Series B round in March this year with an investment of USD 110 million.
- Company
- 'Vonjo' for myelofibrosis expected to be marketed in KOR
- by Eo, Yun-Ho Jun 05, 2025 06:11am
- Product photo of Vonjo The oral myelofibrosis treatment 'Vonjo' is expected to be commercialized in Korea. According to industry sources, the Ministry of Food and Drug Safety is conducting an approval review of Vonjo (pacritinib). This drug obtained orphan drug designation (ODD) in September of last year. Vonjo is indicated for 'treatment of intermediate-risk or high-risk adult patients with myelofibrosis who have plate count below 50×10⁹/L.' Vonjo is regarded as a competitor of Novartis' 'Jakabi (ruxolitinib)' and it obtained accelerated approval from the U.S. Food and Drug Administration (FDA) in 2022. It is a novel oral kinase inhibitor that does not inhibit Janus kinase 1 (JAK1 )but instead inhibits JAK2 and IRAK1. The efficacy of Vonjo, developed by CTI BioPharma, was confirmed through the Phase 3 PERSIST-2 study. In the study, patients were provided with either twice-daily 200 mg Vonjo or once-daily or the existing best available therapy (BAT). The study participants included those who had previously used JAK2 inhibitors. The study showed that 29% of the patient group who had platelet counts below 50×10⁹/L at the beginning of the trial then took twice-daily 200 mg Vonjo had at least 35% reduction in spleen volume. The control group had a reduction rate of 3%. Meanwhile, myelofibrosis induces broad scarring in the bone marrow and suppresses hematopoiesis, ultimately causing platelet count reduction·anemia·weakness·tiredness·liver, and spleen edema. Previously, only 3% of patients who received conventional therapy targeting myelofibrosis experienced a treatment effect of spleen volume reduction. Myelofibrosis previously lacked second-line treatment options besides Jakabi in Korea. BMS' 'Inrebic (fedratinib)' was recently introduced. Insurance reimbursement has been applied since June of last year.
- Policy
- Lee 'will strengthen public nature of medical sector'
- by Lee, Jeong-Hwan Jun 05, 2025 06:10am
- With the election of President Lee Jae-Myung, the legal community predicts that the government will strengthen its public policy in the healthcare and pharmaceutical biotechnology sectors. The areas of AI-based digital healthcare industry, rare and intractable disease coverage, and regional essential medical infrastructure will see new opportunities. There are also predictions that the medical industry and related platform technology industries will be revitalized as the institutionalization of non-face-to-face medical care (telemedicine) and home visits will expand the provision of medical services beyond geographical limitations. There are also analyses that public support for the pharmaceutical industry will expand, increasing opportunities for pharmaceutical and biotechnology companies. On the 4th, Shin & Kim LLC announced this in a special report on the results and impact of the 21st presidential election. President Lee Jae-Myung announced in his campaign pledge that he would strengthen the public nature of the medical and pharmaceutical industries. According to Shin & Kim LLC analysis, the new government will strengthen the public return support system through national R&D investment to foster the pharmaceutical and bio industries. In particular, it is expected that the government will establish a public consignment production and distribution system for essential medicines and promote the construction, public acquisition, and conversion of public hospitals. With the expansion of public support for the medical and pharmaceutical sectors, opportunities will rise for relevant companies, and the industry recommended parties to closely monitor the new government's efforts to achieve the two goals of strengthening public nature and fostering industry growth. To resolve supply instability and establish a stable supply system for essential medicines, the report suggested that policy measures should be developed with a focus on providing incentives to pharmaceutical companies and promoting limited International Nonproprietary Names (INN) based prescriptions. With the promised establishment of a regional essential medical care fund, policies to strengthen regional essential medical care infrastructure centered on regional medical schools and national university hospitals are expected to be promoted, which is seen as an increase in opportunity for regional medical institutions. Shin & Kim LLC stated that in terms of strengthening health insurance reimbursement coverage for medicines, particular focus will be placed on treatments for rare and intractable diseases. It is anticipated that the door to health insurance coverage for high-priced innovative drugs targeting rare and intractable diseases will be expanded and that the threshold for new drugs to enter health insurance coverage will be significantly lowered through the expansion of the Risk Sharing Agreement (RSA) scheme. In line with the pledges to institutionalize telemedicine and expand home visits and primary care physician systems, it is analyzed that policies for medical services that transcend geographical limitations will activate the medical industry and related platform industries. The Lee Jae-myung administration's medical reform plan sets out to organize a public debate committee as central governance, where medical professionals, experts, patients, and citizen representatives participate. Shin & Kim LLC diagnosed that it is necessary to closely monitor the direction set for the medical delivery system that starts from outpatient clinics to tertiary hospitals, regional medical infrastructure, and medical personnel supply to predict and respond to changes in the industrial landscape. Shin & Kim LLC explained, “The strengthening of the public nature of the medical and pharmaceutical industries will increase corporate social responsibility and alter the structure of market competition,” emphasizing the need for proactive measures in response. It added, ”The importance of profit management for medical institutions and related companies will increase due to the strengthening of price management for non-reimbursed medical services to stabilize Korea’s national health insurance finances.”
- Company
- Global pharmas race to introduce bispecific antibodies
- by Son, Hyung Min Jun 05, 2025 06:10am
- Major global pharmaceutical companies are challenging the throne held by the immunotherapy Keytruda with their respective bispecific antibodies. Recently, BMS signed a partnership agreement with Germany's BioNTech to develop a new bispecific antibody, while Pfizer successfully introduced a bispecific antibody from China's 3SBio last month. MSD also secured bispecific antibodies from a Chinese pharmaceutical company in preparation for the post-Keytruda era. According to data released by KoreaBIO on the 4th, BMS recently secured the development rights for BioNTech's bispecific antibody candidate “BNT327.” Under the agreement, BMS will pay BioNTech a contract fee of USD 1.5 billion (approximately KRW 2 trillion) and an additional USD 2 billion in unconditional milestone payments by 2028. The total deal value, including milestones and the upfront payment, amounts to USD 11.1 billion (approximately KRW 15.3 trillion). MSDBNT327 is a new bispecific antibody that combines two complementary mechanisms of action proven in oncology into a single molecule. This new drug candidate targets both PD-1, the biomarker targeted by the existing Keytruda, and vascular endothelial growth factor (VEGF)-A. By inhibiting VEGF-A, BNT327 is expected to reverse the immune-suppressive effects of tumors in the tumor microenvironment and block the supply of blood and oxygen to tumor cells, thereby preventing tumor growth and proliferation. BNT327 is currently being developed as a first-line treatment for small cell lung cancer and non-small cell lung cancer. According to BioNTech, more than 1,000 clinical trial patients have been treated with the drug to date. BioNTech said in a statement, “Our major global partners are working to set new treatment standards in the anticancer drug market dominated by immunotherapies like Keytruda.” Pfizer also signed a partnership agreement with China's 3Sbio last month to secure SSGJ-707, a bispecific antibody candidate targeting PD-1 and VEGF-A. The upfront payment is USD 1.25 billion, with the total contract value reaching USD 4.8 billion (KRW 6.6 trillion) upon achievement of key milestones. Currently, SSGJ-707 is under clinical trials in China targeting various solid tumors, including non-small cell lung cancer, colorectal cancer, and gynecological cancers. MSD, the developer of Keytruda, has also secured a PD-1 and VEGF-A bispecific antibody candidate. Last November, MSD acquired the new drug candidate LM-299 from China's LaNova Medicine for up to USD 3.3 billion. The contract price was USD 588 million. LM-299 is currently under Phase I clinical trial in China. Will competition intensify for the global sales lead Keytruda? Major global pharmaceutical companies are targeting the market for Keytruda, the global No.1 top-selling drug. Last year, Keytruda's sales reached USD 29.482 billion (approximately KRW 43 trillion), an 18% increase from 2023. Last year, the total sales of major immunotherapy drugs amounted to USD 51.723 billion (approximately KRW 75 trillion), with Keytruda holding 57% of the market share. Keytruda first surpassed USD 10 billion in sales in 2019 and continued to grow, reaching USD 20.937 billion in 2022, successfully breaking the USD 20 billion mark for the first time. Immunotherapies like Keytruda target the PD-1/PD-L1 biomarker expressed in major solid tumors. As a result, their indications are being expanded to various types of solid tumors, leading to a surge in sales. In addition to their efficacy, immunotherapies have the advantage of having fewer side effects. Compared to first-generation cytotoxic anticancer drugs and second-generation targeted anticancer drugs, cancer immunotherapies are known to have fewer side effects. These drugs reinforce the body's own immune system to achieve anticancer effects, resulting in relatively mild side effects such as hair loss, nausea, vomiting, diarrhea, and bone marrow suppression. The industry attributes the growth in Keytruda’s sales to the expansion of indications for Keytruda and its demonstrated efficacy in combination with antibody-drug conjugates (ADCs). Recently, Keytruda has demonstrated efficacy as a combination therapy for first-line treatment of non-small cell lung cancer, leading to a steady increase in prescriptions. Positive clinical results are also emerging for various solid tumors, including breast cancer, stomach cancer, lung cancer, and melanoma. In the domestic market, Keytruda continues to hold the lead in overall pharmaceutical sales.
- Policy
- Lee Jae-Myung elected as president of South Korea
- by Lee, Jeong-Hwan Jun 05, 2025 06:10am
- Lee Jae-myung, the 21st President of South KoreaWith the election of Lee Jae-myung of the Democratic Party (Candidate No. 1) as the 21st President of South Korea, momentum is expected to build for key healthcare policies. These include the establishment of a National Medical Reform Public Opinion Committee to resolve conflicts between the medical community and the government, the promotion of limited International Nonproprietary Names-based prescriptions and generic substitutions to address drug supply instability, and the institutionalization of telemedicine with a standardized public e-prescription system. In particular, President Lee Jae-Myung has pledged to establish a system for telemedicine that complements in-hospital care, adheres to the principle of follow-up visits, and centers on neighborhood clinics, while halting indiscriminate pilot projects and establishing a management and supervision framework for intermediary platforms, is expected that the current unlimited telemedicine pilot project will be reasonably scaled back. From the pharmaceutical and biotech industry’s perspective, insiders are expecting a comprehensive overhaul of the drug pricing system, including granting higher drug prices to pharmaceutical companies that have invested heavily in R&D for innovative new drugs and strengthening mechanisms to remove generic drugs from the market if they fail to properly prove their efficacy. President Lee Jae-myung is expected to immediately begin implementing his campaign pledges on healthcare, pharmaceuticals and biotechnology, and health insurance without forming a transition committee. National Medical Reform Public Opinion Committee, Resolution of the medical-political conflict remains a challenge President Lee Jae-myung has decided to immediately begin work on establishing a National Medical Reform Public Opinion Committee that will involve the public, healthcare professionals, and experts from various fields. This is to resolve the ongoing issues triggered by the Yoon Suk-Yeol administration's policy to increase the number of medical school enrollment quotas by 2,000, which led to collective action by resident doctors and medical students in February last year and a medical staffing shortage. However, the Democratic Party has stated that it will not provide additional benefits to the resident doctors who participated in the collective action to resolve the conflict between the government and the medical community. Ultimately, it is likely that the committee will discuss solutions to the collective action by doctors and medical students. In addition, the policy to increase the number of medical school enrollment quotas is likely to be decided based on the results of the review by the Committee on Medical Manpower Planning, which was passed by the National Assembly with the agreement of both the ruling and opposition parties. This is because the Democratic Party of Korea's policy was to decide on the number of medical school enrollment quotas for the 2027 academic year and beyond through an objective and transparent deliberation process by the the Committee on Medical Manpower Planning, as the number of medical school enrollment quotas for the 2026 academic year has been set to return to 3,058. Furthermore, it is expected that Cho Kyoo-Hong, Minister of Health and Welfare, and Park Min-Soo, Second Vice Minister, who were at the forefront of the policy to increase the medical school enrollment quota, will be held accountable. As part of measures to strengthen regional and essential medical care, the government has promised to introduce a regional doctor system, establish public medical schools, and promote public medical academies. The government also plans to assign national university hospitals the role of base hospitals and expand public medical infrastructure by medical service area. Solutions to the drug shortage crisis, stronger government intervention, and INN-based prescriptions The solution to the supply instability of medicines pledged by the president involves strengthening government intervention in all stages of the process, from the supply of APIs for medicines that are frequently out of stock to the production of finished medicines and distribution to pharmacies. The government is expected to establish a list of frequently out-of-stock medicines and provide incentives for pharmaceutical companies to take an interest in producing APIs that are difficult to produce in Korea. The Democratic Party of Korea's policy is to increase profits for pharmaceutical companies that produce finished drugs using domestically produced raw materials show improved self-sufficiency rates and strengthen the public drug consignment manufacturing system for drugs in short supply. At the same time, the government will allow limited use of generic drug prescriptions for essential medicines with unstable supply. The government plans to resolve issues that caused significant inconvenience to the public during the COVID-19 pandemic, such as the shortage of acetaminophen for prescription drugs, by allowing limited INN-based prescriptions. President Lee also promised to promote substitute prescriptions as a solution to drug shortages. In response, there is a possibility that the current administration will go beyond allowing pharmacies to notify the Health Insurance Review and Assessment Service after dispensing substitute drugs, which is currently pending implementation, and introduce additional policies to increase the rate of substitute prescriptions. Legalization of telemedicine centered on local clinics and repeat patients gains momentum The possibility of legalizing telemedicine pilot projects within this year has also increased. President Lee promised to institutionalize telemedicine while ensuring safety and effectiveness. It is particularly noteworthy that the Democratic Party of Korea is preparing legislation to institutionalize telemedicine centered on “clinic-level” medical institutions and “repeat” patients. This is because the Democratic Party of Korea, which holds a majority of seats, has succeeded in changing the administration, greatly increasing the likelihood of the Democratic Party-led legislation of telemedicine. The Democratic Party of Korea is preparing a bill that would allow telemedicine to be used primarily by medical institutions at the clinic level, but also allow hospitals to provide telemedicine in special cases. In particular, the bill is expected to include provisions allowing telemedicine for initial consultations only for patients under 18 years of age and those over 65 years of age, while patients in other age groups would only be able to apply for telemedicine for follow-up consultations. In this case, the scope of eligible recipients for telemedicine would be significantly reduced compared to the current pilot program. Of course, since the amendment to the Medical Service Act to legalize telemedicine must undergo parliamentary review, the Democratic Party of Korea cannot make a unilateral decision on the matter. Unlike the 21st National Assembly, the 22nd National Assembly will see the ruling party change from the People Power Party to the Democratic Party of Korea, and it is expected that the Democratic Party's proposal will be reflected in the government's proposal to a considerable extent. The establishment of a public electronic prescription system will also be implemented along with the institutionalization of telemedicine. The Democratic Party of Korea plans to utilize public electronic prescriptions as a means to prevent the falsification and misuse of prescriptions and to prevent errors in the entry of prescription information during telemedicine. Pharmaceutical industry announces restructuring and advancement of drug pricing system President Lee announced a policy pledge to actively promote the pharmaceutical and bio industry as a new future growth engine for South Korea. As a measure to promote the pharmaceutical and bio industry, President Lee announced plans to revise the drug price system to focus on new drugs and strengthen the mechanism for removing generic drugs that have not been verified their effect from Korea’s health insurance reimbursement list. The most notable pledge is “drug price incentive linked to new drug R&D investment rates.” The vision is to create an environment where pharmaceutical and biotechnology companies can focus on developing new drugs by setting higher drug prices for medications produced by pharmaceutical companies that contribute significantly to innovative new drug R&D. This pledge was one of the policies proposed by multiple domestic pharmaceutical and biotech companies led by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The government also promised to establish a more predictable drug pricing system to serve as a catalyst for new drug development and a cash cow for domestic pharmaceutical companies. The vision is to integrate drug price reduction mechanisms to establish a drug pricing system that encourages investment in new drug R&D. The president has also outlined a plan for the government to take the lead in establishing an R&D investment system and forming large-scale funds (megafunds) to promote industry development. In addition, the candidate's campaign promises include advancing the certification system for Korea Innovative Pharmaceutical Companies to expand R&D tax credits for certified innovative pharmaceutical companies, establishing a governance system that combines AI and big data technologies for the development of new drugs targeting global markets, and expanding risk-sharing agreements (RSA). To secure health insurance funds for these initiatives, the candidate proposed removing non-verified generic drugs from the market. In other words, the intention is to create some health insurance funds by more actively reevaluating the reimbursement of generics that have been approved for a long time but are not effective, thereby narrowing the scope of health insurance coverage. On the morning of the 4th, when his election was certain, the president-elect took the stage in front of the National Assembly and said, “The responsibility of a president in a united country is to bring the people together. I will never forget that my duty is not to be a great ruler, but to greatly unite the people.” Meanwhile, President Lee began his term as president immediately after the National Election Commission officially confirmed his election as president at 7 a.m. on the same day. President Lee held a brief inauguration ceremony at the National Assembly at 11 a.m. that day, after which he immediately appointed the Chief of Staff and began forming his Cabinet, including the Prime Minister.
- Company
- "Effect of Camzyos confirmed in Korean patients with oHCM"
- by Son, Hyung Min Jun 05, 2025 06:09am
- Hyung-Kwan Kim, Professor of Seoul National University "After Camzyos was introduced to Korea, patients with obstructive hypertrophic cardiomyopathy (oHCM) and doctors have high treatment satisfaction. Notably, realworld data showed that Camzyos administration had a comparable effect to confirmatory clinical trial." During a recent meeting with Daily Pharm, Hyung-Kwan Kim, Professor of Seoul National University's Department of Internal Medicine, evaluated that the obstructive hypertrophic cardiomyopathy (oHCM) Camzyos showed a similar level of improving symptom compared to confirmatory clinical trial. oHCM is a condition where the left ventricular muscle abnormally thickens, obstructing the left ventricular outflow tract (LVOT) and preventing the heart from effectively pumping blood. More than 70% of all hypertrophic cardiomyopathy patients have the obstructive form. oHCM's key problem is 'excessive cardiac contractility.' Unlike typical heart failure patients, the hearts of oHCM patients contract excessively. This phenomenon occurs due to an abnormal over-binding of proteins called actin and myosin within the myocardial cells. This leads to excessive left ventricular contraction, blood flow obstruction, and patients experiencing shortness of breath during exercise, chest pain, and fainting. In severe cases, it can lead to heart failure, atrial fibrillation, and sudden death. Professor Kim pointed out, "Until now, treatment involved lowering the heart rate with beta-blockers or calcium channel blockers to alleviate symptoms. If necessary, alcohol septal ablation or surgical myectomy to remove muscle had to be considered. However, these were not treatments that controlled the fundamental mechanism of the disease." BMS's Camzyos is a treatment that works by reducing the excessive cross-bridge formation between actin and myosin within the heart muscle, which is the cause of oHCM. This allows the excessively contracted heart muscle to relax. Additionally, this treatment demonstrated a myocardial remodeling effect, improving not only the heart's function but also its structure. In December 2024, Camzyos received national health insurance reimbursement in Korea. This means that patients with oHCM in Korea now have access to a targeted treatment option other than surgery. Many patients are also being treated with Camzyos at Seoul National University Hospital. Professor Kim said, "In the case of a male patient in his 60s who hadn't responded to previous medications, his shortness of breath disappeared within three months of Camzyos administration, and his exercise capacity significantly improved." He added, "His quality of life reached a completely different level." 1-year Real-World Evidence (RWE) data released for Korean oHCM patients In the EXPLORER-HCM clinical trial, Camzyos significantly improved the primary endpoint, which considered both symptom severity and exercise capacity, compared to the placebo group. Furthermore, Camzyos's efficacy has been confirmed in Korean patients. In March of this year, the first Real-World Evidence (RWE) study results on the effectiveness and safety of Camzyos over one year in Korean oHCM patients were published. The study showed that in 46 symptomatic (NYHA class II-III) oHCM patients in Korea who received Camzyos, more than half (58.1%) experienced an improvement of at least one NYHA class. LVOT pressure gradients also decreased to 40.1 mmHg at rest and 68.1 mmHg during the Valsalva maneuver (a breathing technique of holding one's breath and applying pressure to the chest in a specific way). Significant improvements were also demonstrated in cardiac hypertrophy-related indicators such as left ventricular wall thickness and left atrial volume. This study holds significant meaning as it is the first to evaluate Camzyos's RWE not only in Korea but across Asia. Professor Kim stated, "Camzyos demonstrated an effect in the domestic clinical setting comparable to what was confirmed in its previous confirmatory clinical trials, and no concerning adverse reactions were observed. It is particularly impressive that despite Korean patients having higher clinical severity, with greater LVOT pressure gradients than participants in the global confirmatory trial, the domestic real-world data showed almost the same level of efficacy as the confirmatory clinical trial." Professor Kim added, "Concerns have been raised that Asian patients might have a higher risk of adverse reactions or require lower doses during Camzyos treatment due to lower activity of the CYP2C19 enzyme involved in drug metabolism compared to Western patients. This RWE study has alleviated such concerns." Another notable finding from this study is the confirmation that N-terminal pro-brain natriuretic peptide (NT-proBNP) levels alone can be used to monitor the treatment response to Camzyos. NT-proBNP is a biomarker used to assess the severity of heart failure and determine prognosis, increasing when myocardial cells in heart failure patients experience excessive load, such as ventricular stretching. According to Professor Kim, in the U.S. and Europe, patients must undergo echocardiography monthly for the first three months of Camzyos administration, and then every three months thereafter, posing a somewhat burdensome follow-up management process. However, Professor Kim explained that this RWE study confirmed that changes in NT-proBNP levels could be easily monitored through blood tests, without echocardiography, to assess LVOT pressure gradient reduction and Camzyos treatment response. Professor Kim evaluated, "We are currently preparing follow-up data for a larger number of patients, and a trend of approximately 1-2 mm reduction in left ventricular thickness and improvement in diastolic function is being observed after Camzyos treatment. Both medical professionals and patients who have experienced Camzyos treatment are showing high satisfaction." Camzyos efficacy proven..."More patient pool required" Despite the emergence of targeted treatment options like Camzyos, diagnosing oHCM remains challenging. According to Professor Kim, while approximately 70% of all HCM patients in the U.S. are diagnosed with oHCM, the proportion of oHCM patients in Korea is low, at around 20%. Professor Kim stated, "I believe that the low oHCM diagnosis rate is partly due to the lack of active utilization of exercise stress tests and echocardiography. For instance, many patients show no particular abnormalities or symptoms at rest, but significant issues are discovered during exercise stress tests or echocardiography." Furthermore, "I anticipate that a considerable number of patients currently diagnosed with non-obstructive HCM could be reclassified as oHCM if additional exercise stress tests or echocardiography are performed. Therefore, I believe there is an absolute need for national-level awareness campaigns and public relations regarding the necessity of exercise stress tests and echocardiography." oHCM patients who experience persistent symptoms such as shortness of breath or chest pain tend to increasingly avoid exercise. This leads to a higher risk of developing various complications as they age, including adult diseases like obesity, diabetes, and hypertension, as well as coronary artery disease. Professor Kim said, "If Camzyos is administered early to these patients, improving their symptoms and restoring their condition to a level where exercise is possible, it can help prevent weight gain and other complications. I believe this contributes not only to the individual patient's health but also, in the long term, to reducing indirect healthcare expenditures caused by HCM on the national health insurance finances." Professor Kim stressed, "Since the introduction of Camzyos, patients' symptom control has become stable, and the approach to HCM treatment in Korea is gradually changing. Based on actual clinical experience, all patients treated with Camzyos have shown symptom improvement, so I believe Camzyos can establish itself as an option to avoid surgery, which is often the last resort." Finally, Professor Kim said, "In conclusion, Camzyos is an option that can provide various direct and indirect benefits to patients, and its role is expected to expand further in the future. In my opinion, I strongly recommend active treatment for patients diagnosed with oHCM who are candidates for Camzyos."
- Company
- K-Bios eye US’s reintroduction of the Biosecure Act
- by Cha, Jihyun Jun 04, 2025 06:21am
- The U.S. is pushing ahead with its Biosecure Act that restricts transactions with Chinese biotech companies. According to the Korea Biotechnology Industry Organization (KoreaBIO) on the 2nd, U.S. Democrat Senator Gary Peters recently announced at a Brookings Institution event that he would soon reintroduce the Biosecure Act, which restricts transactions with certain Chinese biotech companies. The Biosecure Act was designed to protect the U.S. biotech industry and national security by restricting transactions with Chinese companies that could threaten U.S. security. The bill was introduced in January last year and passed the U.S. House of Representatives in just nine months, but failed to pass the Senate in December of the same year and was not included in the year-end budget resolution. If enacted, the Biosecure Act would require the U.S. to cease transactions with Chinese companies subject to regulation by 2032. Chinese biotech companies such as BGI, MGI, WuXi AppTec, and WuXi Biologics have been designated as “biotech companies of concern.” Senator Peters, a member of the Senate Homeland Security and Governmental Affairs Committee, said, “The new bill will also apply to foreign consultants and other companies may be added to the list of ‘biotech companies of concern.’ We are continuing to work on this bill and are in discussions with the administration.” Senator Peters also mentioned three additional legislative proposals addressing international competition in the biotech industry. First, Senator Peters emphasized that he is preparing a bill focused on gain-of-function research in collaboration with Republican Senator Rand Paul. Gain-of-function research involves artificially manipulating the genes or characteristics of organisms in the fields of biology and virology to give them new functions. Last month, President Trump issued an executive order suspending the use of federal funds for gain-of-function research conducted by China and other countries of concern or by government agencies without proper oversight. Senator Peters stated, “We are preparing a bill focused specifically on gain-of-function research ‘right now,’” adding, “The core of this bill is to establish an independent committee to decide whether dangerous research or gain-of-function research should be conducted.” He also mentioned that he is preparing legislation related to expanding investment in the biotech industry and protecting genetic information. Peters said, “We want to make broader investments in biotech,” and expressed support for a biotech bill similar to the CHIPS and Science Act, which aims to revitalize domestic technology industries. Additionally, Senator Peters mentioned that he is working with Senator Bill Cassidy, chairman of the Senate Committee on Health, Education, Labor, and Pensions (HELP), on a bill to establish protective measures allowing individuals to retrieve genetic information they have provided. This bill aims to address concerns raised by the recent bankruptcy of 23andMe, the world's largest genetic testing company, and the lack of control over the data it collected. It seeks to ensure that individuals have the right to retrieve or control their genetic information after providing it. The domestic pharmaceutical and biotech industry is closely monitoring the U.S.'s moves to counter China. Experts analyze that if the Biosecure Act is passed again, the global bio industry supply chain will be reorganized. Some believe that the Biosecure Act could present a positive opportunity for domestic bio companies that occupy a neutral position in the global bio supply chain. As the U.S. government strengthens its restrictions, domestic companies such as Samsung Biologics, Celltrion, and ST Pharm are expected to benefit from the situation, particularly those engaged in contract development and manufacturing (CDMO). In fact, ST Pharm was selected as the supplier of a blockbuster small molecule chemical synthesis drug that recorded annual sales of trillions of won last year. ST Pharm took over contracts previously supplied by China, thereby benefiting from the introduction of the Biosecure Act.
- Company
- More treatment options for PNH…entry of 'Piasky' imminent
- by Eo, Yun-Ho Jun 04, 2025 06:19am
- The entry 'Piasky,' a new PNH drug, into the Korean market is imminent. According to industry sources, Roche Korea's Piasky (crovalimab), a treatment for paroxysmal nocturnal hemoglobinuria (PNH), is undergoing final review for approval by the Ministry of Food and Drug Safety (MFDS). It is expected to be officially approved in the second half of this year. Piasky received the U.S. Food and Drug Administration (FDA) approval in June 2024. Then, it was commercialized in Europe in August of the same year. In February 2024, Piasky was designated as an orphan drug in South Korea. Discovered by Japan's Chugai Pharmaceutical and developed by Roche, crovalimab is a type of new anti-complement (C5) antibody. Low-dose subcutaneous administration every four weeks enables circulation of the drug in the blood, thereby repeatedly inhibiting the complement. Piasky's potential was confirmed based on the Phase 3 COMMODORE 2 study, which directly compared the drug to AstraZeneca's 'Soliris (eculizumab).' The study results showed that subcutaneously injected crovalimab provides disease control. The safety of the drug was non-inferior compared to Soliris, a standard therapy that is administered intravenously every two weeks. In the clinical study, adverse reactions occurred in 78% of the crovalimab group and 80% of the eculizumab group. The most common adverse reactions were infusion-related reactions. Based on the efficacy and the safety data secured from a separately conducted Phase 3 COMMODORE 1 study, patients with PNH who switched from complement C5 inhibitors that are approved and in use to crovalimab also showed a stable effectiveness profile. Meanwhile, competition in the market for PNH is expected to intensify. AstraZeneca has launched Ultomiris (ravulizumab) as a follow-up drug to Soliris. The European patent for Soliris expired in 2023, while the U.S. patents are set to expire in 207. Unlike Soliris, which is intravenously injected every two weeks, Ultomiris offers an expanded administration interval of once every eight weeks. Novartis obtained the U.S. approval of 'Fabhalta (iptacopan),' an orally administered treatment for PNH. Fabhalta is a Factor B inhibitor that acts proximally in the immune system's alternative complement pathway, providing comprehensive control of red blood cell (RBC) destruction. Fabhalta is currently undergoing drug price negotiations with the National Health Insurance Service (NHIS). Once an agreement is reached, this drug will be included in the national health insurance list. Additionally, 'Epysqli,' Samsung Biepis' biosimilar to Soliris, has been commercialized in South Korea. It was the first case of Soliris biosimilars to receive domestic approval, and Samsung Bioepis also obtained approval in Europe last year. Dr. Jang Jun Ho, professor at Samsung Medical Center Seoul, said, "When C5 inhibitors were introduced, experts viewed that it would bring a paradigm shift to the PNH treatment. However, C5 inhibitors are limited in controlling extravascular hemolysis (EVH). Thus, we have high hopes for new treatment options."
- Policy
- Premium pricing for 11 linagliptin products ends on the 9th
- by Lee, Tak-Sun Jun 04, 2025 06:19am
- As one year has passed since the entry of generic versions of the DPP-4 inhibitor diabetes treatment Trajenta (linagliptin), the price ceiling of 11 products that received pricing premiums will be adjusted on the 9th. Three products that entered the market in March following the expiration of the first generic exclusivity period will also have their prices reduced. According to industry sources on the 3rd, the price premiums set for the original linagliptin and 11 generic products will expire on the 9th, as 1 year has passed since the entry of its generics. The original Trajenta Tab (Boehringer Ingelheim Korea), which had been adjusted to 70% of the highest price due to the entry of generics, will be reduced from KRW 525 to KRW 402. Additionally, Hanmi Pharmaceutical's “Linaglo Duo Tab,” DongKoo Bio&Pharma’s “Linatop Tab 5mg,” and Daewon Pharmaceutical's “Tralitin Tab,” which received drug pricing premiums as products from innovative pharmaceutical companies, will also be adjusted from KRW 510 to KRW 402. Furthermore, the following products, which met all the 3 criteria and have received the first generic exclusivity premium, will have their price ceiling reduced from KRW 447 to KRW 402: Kukje Pharma’s ‘Tradi-M Tab 5mg,' Kyung Dong Pharma’s ‘Litagin Tab,’ Sinil Pharm’s ‘Tragliptin Tab,' Huons' ‘Linadipo Tab 5mg,' Jeil Pharmaceuticals 'Linatin Tab,,' Aprogen Biologics’ 'Linahana Tab,' and Genuone Science's ‘Tra-K Tab.' The first 15 Trajenta generics were listed for reimbursement on June 9 last year after successfully challenging the original drug’s patent and the expiry of the original drug’s remaining patents. At that time, 61 generic items were approved, but 15 items obtained the first generic exclusivity through successful patent challenges and initial approval applications, so the remaining items were listed for reimbursement at the time. And on March 8, after the 9-month first generic exclusivity period ended, 12 companies, including Hanmi Pharmaceutical, were able to enter the market. The list of products whose premium pricing has ended includes three products, including Hanmi Pharmaceutical's ‘Linaglo Tab,’ which was listed in March. Due to the patent issue, the market entry of the three drugs was delayed, so the premium pricing benefit for the drugs ended after only three months. Pharmaceutical companies whose premium pricing has ended are currently notifying their business partners of the price changes. This is a measure to minimize confusion during billing and return processing. Trajenta generics have been gradually increasing their market share upon their launch. According to UBIST, the outpatient prescription sales of generic versions of Trajenta (including Trajenta Duo) reached KRW 3.1 billion in the first quarter, accounting for 13% of the total linagliptin market. Starting this month, with the expiration of the pricing premiums, the original and generic versions will be priced identically, intensifying market competition. It remains to be seen whether the original product, now with improved price competitiveness, will mount a counterattack against the generics.
