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- 2026-04-13 17:39:02
- Policy
- Botulinum toxin by fraudulent means can be revoked
- by Lee, Jeong-Hwan Oct 01, 2021 06:08am
- Regulations on handling and management, such as reporting high-risk pathogens such as botulinum toxin and anthrax, will be strengthened, and permission for bioterrorism infectious disease pathogens licensed by fraudulent methods will be revoked. On the 28th, Baek Jong-heon (Busan Geumjeong-gu), a member of the National Assembly's Health and Welfare Committee, said that the "Partial Amendment to the Infectious Disease Prevention Act" has passed the plenary session of the National Assembly. The current law regulates those who want to install and operate high-risk pathogen handling facilities to obtain or report permission from the head of the KDCA by safety management level. If permission is obtained or reported by deception or fraudulent means, permission is revoked or the facility is ordered to be closed. In order for a person who has obtained permission to bring a high-risk pathogen into Korea to take over and move the high-risk pathogen, the movement plan must be reported in advance to the head of the KDCA. Rep. Baek Jong-heon pointed out that it is necessary to consider using facilities handling high-risk pathogens so that civilians or private businesses can diagnose and conduct academic research on infectious diseases. In particular, he pointed out the problem that there is no basis for processing high-risk pathogens when canceling permission for high-risk pathogens or ordering closure, and that there is no basis for canceling permission if they are not acquired for a long time after approval. In response, Rep. Baek proposed a bill that allows individuals and private businesses to use high-risk pathogen handling facilities for the purpose of diagnosing infectious diseases and academic research. In addition, it allows domestic entrants of high-risk pathogens to cancel if they have not taken over or reported, and also provides a basis for handling high-risk pathogens in case of cancellation or closure of handling facilities. He said, "With the passage of today's plenary session, safety management for high-risk pathogens will be further strengthened to protect the health of the people. In the future, we plan to come up with laws that can strongly punish high-risk pathogens such as botulinum toxin."
- Policy
- Domestic new drugs shouldn't be discriminated against
- by Lee, Jeong-Hwan Oct 01, 2021 06:08am
- Problems with the PVA system are expected to be discussed during this year's parliamentary audit of the National Assembly's Health and Welfare Committee. The domestic pharmaceutical community criticized that it is too harsh for the government to unilaterally decide on a drug price cut without acknowledging the innovation of new domestic drugs in the process of operating PVA. Accordingly, the National Assembly's welfare committee members agreed on this. On the 28th, the National Assembly's Health and Welfare Committee members plan to inquire about the current PVA system operation status, problems claimed by the pharmaceutical industry, and directions for improvement to government agencies such as the MOHW. Domestic pharmaceutical companies argue that a system should be introduced to exclude new domestic drugs developed by investing steady R&D costs from PVA targets or limit the number of drug cuts after negotiations. They say that PVA negotiations that do not consider structural and environmental differences between new drugs and domestic new drugs by overseas global big pharma are dampening domestic pharmaceutical companies' willingness to develop new drugs or invest in R&D. The National Assembly's welfare committee members also agree with the criticism of the pharmaceutical industry and try to raise the need to overhaul and advance the post-evaluation system for drug prices such as the PVA system. Due to the insufficient PVA system, domestic new drugs will be reversely discriminated against by global new drugs in the prescription market and inquire about the government's position. It is expected that inquiries will be made in a way that vaguely checks the problems of the system itself rather than preferential treatment of new domestic drugs over new global drugs. An official from belonging to the Welfare Committee said, "The PVA system is a post-drug price policy that realizes fiscal efficiency by improving the soundness of health insurance finances. However, some pharmaceutical companies with new domestic development drugs are complaining that the PVA system is unreasonable. "We plan to examine the operation status of the system itself and analyze whether there is a need for maintenance or improvement," he said. He added, "In this process, the government and the pharmaceutical industry will be able to improve their understanding of the PVA system," adding, "If the PVA system is insufficient as the pharmaceutical industry claims, we expect it to be improved through a parliamentary audit."
- Company
- Pfizer’s 2nd JAK inhibitor ‘Cibinqo’ to soon enter Korea
- by Eo, Yun-Ho Sep 30, 2021 05:57am
- Pfizer is planning to introduce a new JAK inhibitor after ‘Xeljanz’ to Korea. However, the new drug will target the ‘atopic dermatitis’ treatment market. According to industry sources, Pfizer Korea has recently submitted an application requesting marketing authorization for its Cibinqo (abrocitinib). The approval is expected to be made in the first half of next year. The drug, which is taken once daily, has been approved for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over that are candidates for systemic therapy. The drug has not received marketing authorization in the U.S yet. Cibinqo is a selective Janus kinase (JAK)1 inhibitor that modulates multiple cytokines involved in AD including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSL). Xeljanz inhibits JAK3 rather than JAK1 or JAK2. With only Lilly’s ‘Olumiant (baricitinib)’ currently approved for the atopic dermatitis indication, more JAK inhibitors are expected to soon enter the market. Lilly is working to extend Olumiant’s insurance benefit to its atopic dermatitis indication Meanwhile, Cibinqo’s efficacy in atopic dermatitis was identified through the Phase III JADE Mono-1 trial. Study results showed that at Week 12, 62.7% of patients who received 200mg of Cibinqo showed improvement in their EASI (Eczema Area and Severity Index 75 response rate) score of 75% or higher, a significant improvement compared to the 11.8% in the placebo group. Also, the proportions of patients who achieved EASI-90 were 38.6% and 5.3% for Cibinqo 200mg and placebo, respectively Also, the proportion of patients achieving an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin was 43.8% and 7.9% for Cibinqo 200mg and placebo, respectively, indicating that around half of the Cibinqo-treated group showed response within 12 weeks of treatment. Recently, the FDA had issued a Dear Healthcare Professional Letter regarding the safety of JAK inhibitors such as Pfizer’s ‘Xeljanz (tofacitinib),’ Lilly's ‘Olumiant (baricitinib),’ Abbvie’s ‘Rinvoq (Upadacitinib),’ etc. Whether the drugs may resolve the issue and settle as a viable treatment option for atopic dermatitis remains to be seen.
- Company
- It does not affect sales of Rivaroxaban 2.5mg
- by Kim, Jin-Gu Sep 30, 2021 05:57am
- Xarelto 2.5mg Hanmi dismissed the possibility of legal disputes over the patent registration of the original company ahead of the launch of Xarelto's generic. The company said that the scope of validity of patents registered late does not affect Hanmi's new drug to be released. In addition, Hanmi emphasizes that it did not take issue when it sent certification of contents to Bayer, the original company. According to the pharmaceutical industry on the 29th, Hanmi is planning to release Riroxban, Xarelto's generic, on the 4th of next month. 133 items from up to 66 companies, including Hanmi, will be released simultaneously after the expiration of Xarelto's patents. Expected items to be released are Rivaroxaban 10mg and Rivaroxaban 15mg. On top of that, Hanmi's Riroxban 2.5mg is the only one to release. This is because Hanmi succeeded in overcoming the composition patent registered exclusively in Rivaroxaban 2.5mg, and first of all, it received generic for exclusivity. In the case of Rivaroxaban 2.5 mg, there may be legal disputes with the original company. This is because Bayer registered a patent for use of Xarelto 2.5mg in September 2019, more than two years after obtaining generic for exclusivity. The patent expires in June next year. Regarding Bayer's registration, the pharmaceutical industry said it was aimed at hindering the early launch of generic. In addition, the pharmaceutical industry predicted that if Hanmi pushes ahead with the sale of Riroxban 2.5mg, it will lead to a legal dispute between the two companies in the future. Hanmi said, "There will be no impact on the launch of the Riroxban 2.5mg product." This is because the scope of validity of the registered patent is different from that of Hanmi's Riroxban 2.5mg. According to the Korean Intellectual Property Office, the patent registered by Bayer is about "Oxazolidinone for combination therapy." Specifically, it explains, "It relates to a composite agent of Oxazolidinone and other active ingredients, the preparation method and use of the composite agent as a drug, and in particular, its use as a drug for the prevention and treatment of thromboembolic disorders." In other words, if it is a "combination drug" with Xarelto 2.5mg added with other ingredients, Aspirin is likely to be added as another active ingredient if it is recognized as a patent for use. Bayer is said to have tried to register a combination therapy with other ingredients as a patent as a single drug. Bayer did not release domestic combination drug and only patents are listed. Hanmi said that Riroxban 2.5mg is not a combination type, so it is not a problem. An official from Hanmi said, "Actually, the use of Rivaroxaban 2.5mg is limited to combination drugs, so it does not affect the single drug Riroxban 2.5mg. There will be no problem with the launch of Riroxban 2.5mg."
- Policy
- Pts can participate in Phase III tx for terminal cancer
- by Lee, Tak-Sun Sep 30, 2021 05:57am
- The MFDS announced on the 29th that it has revised and distributed the "Guidelines for applying rapid screening of medicines" so that even early cancer patients can participate in clinical trials, considering the difficulty of recruiting large-scale phase 3 clinical trials for terminal cancer patients. However, even in the early stages of the disease, cancer, which can confirm clinical effects and safety at the end of the disease, is allowed, and domestic and foreign screening cases will be comprehensively reviewed and strictly applied after sufficient advice from experts. The MFDS permits patients who do not have a cure or who need a new treatment due to failure to comply with the effect or rapid progression on the condition of submitting data after completion of the test. The revision was made to give flexibility to phase 3 clinical trials of conditionally licensed anticancer drugs and expand treatment opportunities for patients by reflecting the screening criteria of overseas regulators such as the U.S. FDA and the EMA. The MFDS said it expects the revision to help carry out phase 3 clinical trials of conditionally licensed anticancer drugs and have a positive effect on rapid development of anticancer drugs and expansion of treatment opportunities for terminal cancer patients. The MFDS added that it will continue to communicate with the pharmaceutical industry and actively support drug development. Details can be found on the MFDS' website (www.mfds.go.kr) > statutes/data > statute information > civil service guidelines / civil petition guides.
- Policy
- 24 new drugs receive ₩177.9 billion benefit this year
- by Kim, Jung-Ju Sep 30, 2021 05:56am
- A total of 24 new drugs were newly listed or expanded reimbursement standards by this month, improving patient accessibility. Among new drugs that were already listed, reimbursement standards for 4 products were extended, improving coverage. Although only 10,000 patients in Korea will benefiting from the extension, the result could be interpreted as a result of Korean society’s effort to flexibly expand accessibility to drugs in recognition of the social importance of each drug. The government estimates around 104,849 patients will be benefiting from the new drugs. By fiscal scale, this will roughly translate to ₩177.9 billion’s worth of coverage reinforcement every year. First, 20 new drugs were newly listed on the reimbursement list or were already listed but their reimbursement standards (indication, administration criteria) were enhanced (based on the drug’s representative strength, etc.) from January to September this year. Newly listed drugs as of the 1st this month were Somavert (acromegaly), Atctrua and Enerzair Breezhaler capsules(asthma), and Yervoy inj (renal cell carcinoma). The expected number of patients using new drugs that were listed or expanded reimbursement is also diverse. For example, the number of patients expected to be applied reimbursement was 90, however, those for ), Atctrua and Enerzair Breezhaler capsules were 13,000 and 12,000, respectively. For Yervoy, the number is expected to be around 300. The two items that are newly expanded reimbursement are the cancer immunotherapy Opdivo inj. and the breast cancer treatment Kisquali tab. Reimbursement for Opdivo will be applied to 490 new patients, increasing finances invested by ₩14.5 billion, and for Kisquali, ₩5.1 billion will be invested to benefit 270 new patients. Such a large difference in the expected number of patients is interpreted as the result of the government’s policy to flexibly expand coverage for high-priced drugs that are used for a small number of rare diseases, and social maturity that can accommodate such policies. For the new listings and expanded reimbursement standards, the government and payer will spend around ₩177.9 billion annually to provide access to new drugs to around 104,849 patients.
- Company
- The cumulative sales of Biktarvy amounted to ￦60 billion
- by Sep 30, 2021 05:56am
- Gilead Science's Biktarvy dominated the AIDS tx market around the world, including Korea, two years after its launch. Biktarvy consists of Bictegravir Sodium, Emtricitabine, and Tenofovir Alafenamide Fumarate as Gilead's HIV treatment. Compared to conventional treatments, the effectiveness and safety are improved, the expression rate of resistance is low, the pill size is small, and it can be administered regardless of meal. After obtaining approval from the MFDS in January 2019, Biktarvy entered the market in earnest by applying benefit in July of the same year. According to IQVIA, a pharmaceutical market research firm, Biktarvy's sales increased to 4.6 billion won in the first quarter of its launch. In 2020, quarterly sales increased to 6.6 billion won, 7.9 billion won, and 9.8 billion won, respectively. It recorded 10.5 billion won in the first quarter of this year. Until the second quarter of this year, cumulative 24-month sales amounted to 59 billion won. In June 2019, just before the launch of Biktarvy, the HIV market had Genvoya and GSK's Triumeq. Genvoya and Triumeq accounted for 44.3% of cumulative market share over the year. Biktarvy recorded a cumulative market share of 19.4% over a year in June 2020, one year after its launch. In June this year, the market share was 38.3%, surpassing both Triumeq and Genvoya. As a result, Biktarvy topped the domestic HIV treatment market in the shortest time. This is because at the time of introduction in Korea, the time required from permission to notification was reduced to one-fifth, and permission and insurance benefit registration were completed in about 100 days. Gilead successfully made a replacement from Genvoya to Biktarvy. Biktarvy has already been a blockbuster in the global HIV treatment market. It posted about 8 trillion won in global sales last year, up 53.1% from about 5 trillion won a year earlier. Biktarvy ranked ninth in the world's most sold medicine last year. This is the first and only HIV treatment to be ranked in the top 10 in sales. Leading global HIV trends is analyzed as a factor in sales. Even in the COVID-19 pandemic, Biktarvy is recommended as a primary treatment. The BHIVA issued guidelines for ART to be applied to HIV-infected people in August last year, recommending Biktarvy as the only initial treatment drug among HIV treatments. It emphasized, "HIV infected people have a higher risk of COVID-19 death than the general population, so they should receive ART treatment, and it is important to use drugs that can effectively control the virus." Another HIV treatment trend is RapIT (Rapid Initation of Treatment). RapIT recommends major guidelines such as the WHO and IAS that treatment begins quickly within up to seven days of HIV diagnosis. Unlike other treatments, Biktarvy is considered a drug that meets the rapid treatment trend because it does not contain ABC and does not limit the virus level or CD4+ level of infected people. The DHHS recommends that acute and new HIV-infected people can start treatment through Biktarvy before confirming the results of genetic drug resistance tests. Biktarvy is the first and only HIV treatment to contain symptoms and emotional conditions that patients feel in their daily lives. In the PRO, patients evaluated that Biktarvy improved nausea, vomiting, sleep disorders, and fatigue compared to existing treatments, so patients' satisfaction was high. An official from Gilead Science Korea said, "Biktarvy has become the world's most prescribed HIV treatment, proving its strong and long-lasting virus suppression effect and long-term safety through the combination of upgraded integrated enzyme inhibitors and proven effective TAF drugs." He also said, "We will provide a good treatment experience for patients in need of drug switching and strengthen patient-centered marketing activities."
- Company
- SK C&C-GC Pharma, establish a big data platform for healthca
- by Chon, Seung-Hyun Sep 30, 2021 05:56am
- SK C&C announced on the 27th that it will carry out a project with GC Pharma Holdings to build a comprehensive healthcare big data analysis platform based on artificial functions (AI). During the project period, the two companies analyze and map various standard medical data based on the "cloud-type digital platform" and conduct AI convergence analysis activities based on domestic and foreign medical big data. "Cloud-type digital platform" is an all-in-one package platform that allows field practitioners to easily and quickly create necessary AI big data analysis models using AI, big data, cloud, and blockchain platforms and solutions without establishing a separate development environment. The company explains that cloud-type digital platforms allow users to freely develop various digital systems and services. The agreement was promoted with the aim of discovering new businesses related to digital healthcare through integration and analysis of data distributed to affiliates under GC. Starting with this agreement, the two companies will consider digital transformation for all affiliates under GC in the future. It plans to integrate distributed data from each company and collaborate closely in research and service solution development in the field of digital healthcare. Lee Jin-cheon, executive director of GC's Digital Transformation Office, said, "We will actively utilize domestic and foreign medical big data and DT technologies to strengthen our business capabilities in the digital sector and focus our capabilities on securing future competitiveness." Lee Ki-yeol, general manager of SK C&C's Digital Platform, said, "We will faithfully play a role as a digital transformation partner for GC Group, which plays a pivotal role not only in vaccine and new drug development but also in digital healthcare."
- Company
- Generic for Xarelto is about to be released.
- by Kim, Jin-Gu Sep 30, 2021 05:56am
- Bayer's new oral anticoagulant (NOAC) Xarelto (Rivaroxaban)' generic is imminent to be released. In particular, Hanmi, which received generic exclusivity, plans to release Xarelto 2.5mg exclusively, and Hanmi has a patent dispute with Bayer, drawing keen attention to the future response of the two companies. According to the pharmaceutical industry on the 24th, the Xarelto material patent will expire on the 3rd of next month. Generic for Xarelto will be released after the 4th of next month. In the case of the rest of the patents, Generic companies have succeeded through a Supreme Court ruling late last year. 133 generics for Xarelto are expected to be listed as starting next month. A total of 66 generic companies are expected to release generics for Xarelto 10mg and 15mg products, respectively. Hanmi's Riroxban 2.5mg was the only one to succeed in registering benefit. Hanmi is expected to release Riroxban 2.5 mg at the same time along with Riroxban 10mg and Riroxban 15mg. ◆ Bayer and Hanmi have registered their patents for use after obtaining generic for exclusivity In the case of Riroxban 2.5mg products, patent disputes still remain. This is because Bayer belatedly registered a patent for use in Riroxban 2.5mg after acquiring Hanmi's generic exclusivity. Hanmi and SK Chemicals challenged patent for Xarelto 2.5mg in March 2015. In November of that year, the two companies won the first trial. Then, as the two companies applied for permission for the first time, in July 2016, the two companies succeeded in obtaining generic for exclusivity. However, in September 2019, Bayer Xarelto 2.5 mg newly registered a patent for use. The patent expires in June next year, more than two years after acquiring generic for exclusivity. Since the new registration of the patent for use, the indication of Xarelto 2.5mg has also changed. Initially, Xarelto monotherapy was approved for the purpose of "reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation."However, after the registration of the patent for use, the combination therapy with Aspirin changed to "reduction of the incidence of atherosclerotic events such as myocardial infarction and stroke." ◆Will legal disputes continue? Riroxban's sales impact will be minimal The pharmaceutical industry predicts that it will lead to legal disputes between Bayer and Hanmi. Some predict that even if the two companies have legal disputes, sales of Riroxban 2.5mg will not be significantly disrupted. An official from the pharmaceutical industry said, "There was no problem with the approval of Riroxban 2.5mg after patent avoidance." However, if it is actually sold, there is a possibility that Bayer will raise the issue in the future, he said. ◆After the 4th of next month, it is predicted that generics for Xarelto such as Riloxvan will be released
- Policy
- Will a treatment for resistant hypertension be released?
- by Lee, Tak-Sun Sep 29, 2021 05:54am
- Attention is focused on whether a treatment for resistant hypertension that cannot be controlled with existing drugs, that is in the final stages of its clinical trial, will succeed in commercialization. The drug is firibastat, that is developed by Quantum Genomics. Dong Wha Pharmaceuticals owns exclusive commercialization rights to supply the drug in Korea. The Ministry of Food and Drug Safety approved the multinational Phase III trial for firibastat on the 24th. The clinical trial will verify the efficacy and long-term safety of once-daily oral administration of firibastat for a maximum of 48 weeks in difficult-to-treat resistant hypertension patients. A total of 750 patients will participate in the clinical trial, among which 75 are from Korea. The clinical trial will be conducted in 12 large hospitals in Korea including the Seoul National University Hospital. Resistant hypertension is high blood pressure that is not well controlled even with the use of three or more blood pressure medications. It accounts for 10% to 20% of all hypertension patients Such patients usually also have other accompanying diseases and take over 4 types of hypertension drugs or are considered for surgical options such as renal denervation. Firibastat is a promising new treatment option for resistant hypertension. It is a Brain Aminopeptidase A inhibitor (BAPA) that blocks the generation of angiotensin III in the brain’s RAS (Renin Angiotensin System) to bring a triple action of lowering blood pressure, diuretic effect, and heart rate control. In the clinical trial, the drug’s efficacy will be verified through the systolic blood pressure after 12 weeks of treatment. It seems that the company will immediately apply for marketing authorization if the drug’s efficacy is verified in the Phase III trial, In April, Dong Wha Pharmaceuticals has signed an exclusive license to supply firibastat in Korea with Quantum Genomics in France. Under the agreement, Dong Wha Pharmaceuticals owns an exclusive license to develop and sell the drug in Korea. Dong Wha Pharmaceuticals sees the commercialization of firibastat as an opportunity to rise to a new leader in the 1.4 trillion won hypertension market. The drug is currently under global Phase II trial in patients with heart failure.
